MESALAZINE DOC GENERICI

Package leaflet: Information for the patient

MESALAZINA DOC 400 mg gastro-resistant tablets, 800 mg gastro-resistant tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What MESALAZINA DOC is and what it is used for
2. What you need to know before taking MESALAZINA DOC
3. How to take MESALAZINA DOC
4. Possible side effects
5. How to store MESALAZINA DOC
6. Contents of the pack and other information

1. What MESALAZINA DOC is and what it is used for

MESALAZINA DOC contains the active substance mesalazine, which is used to treat inflammatory bowel diseases.
MESALAZINA DOC is used for the treatment of ulcerative colitis and Crohn's disease (chronic inflammatory bowel diseases).
This medicine is indicated both for the treatment of active disease and for the prevention of relapses.

2. What you need to know before taking MESALAZINA DOC

Do not take MESALAZINA DOC

• if you are allergic to mesalazine, to chemically closely related substances, salicylates, or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney problems (severe impairment of renal function, severe nephropathies);
• if you have severe liver problems (severe impairment of hepatic function);
• if you have active ulcers in the stomach or the first part of the intestine (peptic ulcer);
• if you have a tendency to bleed from blood vessels (hemorrhagic diathesis);
• if you are in the last weeks of pregnancy or if you are breastfeeding (see "Pregnancy and breastfeeding");
• in children under 6 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking MESALAZINA DOC.
Prolonged use of the medicine may lead to allergic reactions.
Before starting treatment, appropriate clinical investigations must be carried out to confirm diagnosis and therapeutic indications.
Inform your doctor before using mesalazine:

• if you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking mesalazine.

Be especially cautious and consult your doctor:

• if you have unusually slow gastric digestion or narrowing of the opening between the stomach and intestine (pyloric stenosis), as the medicine may cause gastric irritation and may lose its effectiveness;
• if you have liver problems;
• if you have or have had kidney problems. Your doctor may decide to perform kidney function tests;
• if you are being treated with one or more of the following medicines: oral hypoglycemic agents (medicines that lower blood sugar levels), diuretics (medicines that increase urine production), anticoagulants (coumarins, e.g. warfarin), or corticosteroids (medicines used for inflammatory conditions) (see "Other medicines and MESALAZINA DOC");
• if you have lung problems (especially asthma);
• if you have previously experienced adverse effects from products containing sulfasalazine (see section 4).

Serious skin adverse reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with mesalazine treatment. Discontinue mesalazine and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
The use of mesalazine may lead to the formation of kidney stones. Symptoms may include flank pain and blood in the urine. It is recommended to drink sufficient fluids during treatment with mesalazine.
During treatment with mesalazine, you may develop certain problems (e.g. appearance of bruises, unexplained bleeding, anemia), fever, and sore throat. In such cases, your doctor will perform blood tests and, if necessary, instruct you to stop treatment.
Before starting treatment, your doctor may wish to perform blood tests, liver enzyme tests (ALT, AST, serum creatinine), and/or urine analysis. Your doctor will decide how often these tests should be repeated.
Disease relapse may occur both after discontinuation of treatment and during inadequate maintenance therapy.
Prolonged use of this medicine may lead to sensitization phenomena. If allergic reactions occur, treatment must be stopped immediately.
Children and adolescents
Do not use MESALAZINA DOC gastro-resistant tablets in children under 6 years of age (see "Do not take MESALAZINA DOC").
Other medicines and MESALAZINA DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Be especially cautious and inform your doctor if you are taking:

• lactulose or other medicines that lower colonic pH, as they may slow down mesalazine absorption;
• medicines that lower blood sugar levels, such as oral hypoglycemics (sulfonylureas);
• methotrexate, a medicine used to treat certain cancers and autoimmune diseases;
• 6-mercaptopurine and thioguanine, medicines used to treat blood cancers (leukemias);
• azathioprine, a medicine used to treat immune system disorders;
• probenecid or sulfinpyrazone, medicines used to lower blood uric acid levels;
• spironolactone or furosemide, medicines used to increase urine production (diuretics);
• rifampicin, an antibiotic;
• corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs), medicines used for inflammation;
• coumarins (e.g. warfarin), medicines used for blood coagulation disorders (anticoagulants).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take MESALAZINA DOC during pregnancy unless strictly necessary. The use of MESALAZINA DOC is contraindicated in the last weeks of pregnancy (see "Do not take MESALAZINA DOC").
Mesalazine is excreted in breast milk. Therefore, take MESALAZINA DOC only if clearly needed and under direct medical supervision. If the infant develops diarrhea, discontinue breastfeeding (see "Do not take MESALAZINA DOC").
Driving and using machines
MESALAZINA DOC does not impair the ability to drive or operate machinery.
MESALAZINA DOC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per gastro-resistant tablet and is therefore essentially 'sodium-free'.

3. How to take MESALAZINE DOC

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Your doctor will determine the recommended dose suitable for you.
Adults:
The recommended dose is 1-2 tablets of 400 mg or 1 tablet of 800 mg, three times a day.
For severe forms, the doctor may increase the dose up to 10 tablets of 400 mg or 5 tablets of
800 mg per day.
At the beginning of treatment, it is advisable to reach the full dose after a few days of treatment,
gradually increasing the dosage.
Use in children and adolescents
Do not use MESALAZINE DOC gastro-resistant tablets in children under 6 years of age (see the
section “Do not take MESALAZINE DOC”).
Doses should be proportionally reduced at the doctor's discretion.
Swallow the tablets whole (without dividing or chewing them), preferably with a glass of water,
away from meals.
The duration of treatment for active disease is 6-12 weeks and may vary, at the doctor's discretion,
according to the course of the disease.
If you take more MESALAZINE DOC than you should
In case of accidental overdose of MESALAZINE DOC, contact your doctor immediately or go to the nearest hospital.
If you forget to take MESALAZINE DOC
Do not take a double dose to make up for the missed dose; resume your normal dosing schedule as directed by your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop treatment with mesalazine and contact your doctor immediately if you experience any of the following symptoms:

• flat, reddish patches on the trunk, target-shaped or circular, often with central blisters, skin peeling, mouth ulcers, and ulcers in the throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms;
• allergic reactions, with symptoms such as cramps and abdominal pain, bloody diarrhoea, fever, severe headache, and skin rash.

The possible side effects are listed below by frequency:
Common (may affect up to 1 in 10 people):

• nausea;
• diarrhoea;
• abdominal distension;
• skin lesions (rashes);
• headache (cephalalgia);
• high blood pressure (hypertension);
• weakness (asthenia);
• fever (pyrexia).

Uncommon (may affect up to 1 in 100 people):

• abdominal pain;
• passage of gas from the bowel (flatulence);
• vomiting;
• itching;
• drowsiness;
• tremors;
• increased heart rate (tachycardia);
• low blood pressure (hypotension);
• fatigue;
• facial swelling.

Rare (may affect up to 1 in 1,000 people):

• increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity);
• dizziness;
• nerve disease causing abnormalities in sensation and movement, including of internal organs (peripheral neuropathy).

Very rare (may affect up to 1 in 10,000 people):

• decrease in blood cell count (leucopenia, neutropenia, thrombocytopenia, pancytopenia, agranulocytosis);
• decrease in haemoglobin levels due to failure of bone marrow to produce certain blood cells (aplastic anaemia);
• loss of hair and body hair (alopecia);
• kidney disease (impaired kidney function including acute and chronic interstitial nephritis and renal failure);
• muscle and joint pain (myalgia and arthralgia);
• allergic reactions (allergic rash, drug fever, lupus erythematosus syndrome, pancolitis);
• decreased number of sperm produced (oligospermia). This side effect is reversible;
• inflammation of the membrane surrounding the heart (pericarditis);
• inflammation of the heart muscle (myocarditis);
• allergic and inflammatory lung reactions (including difficulty breathing, cough, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonia);
• inflammation of the pancreas (pancreatitis, including acute pancreatitis);
• inflammation of the liver (hepatitis, cholestatic hepatitis);
• temporary abnormalities in liver function tests;
• gallstones (cholelithiasis);

Not known (frequency cannot be estimated from the available data):

• swelling of the face, lips and throat due to an allergic reaction (angioedema);
• kidney stones and associated kidney pain (see also section 2).

With oral formulations, gastrointestinal disturbances (nausea, diarrhoea, and abdominal pain) and headache have been rarely reported in some patients who previously did not tolerate sulfasalazine.
There have also been isolated reports of: leucopenia, neutropenia, thrombocytopenia, aplastic anaemia, pancreatitis, hepatitis, interstitial nephritis, nephrotic syndrome and renal failure, pericarditis, myocarditis, eosinophilic pneumonia and interstitial pneumonia.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MESALAZINE DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use the medicine if the packaging shows visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MESALAZINA DOC contains
MESALAZINA DOC 400 mg gastro-resistant tablets

• The active substance is mesalazine. Each tablet contains 400 mg of mesalazine.
• The other components are: maltodextrin, povidone, sodium lauryl sulfate, sodium starch glycolate, talc, magnesium stearate. Coating: methacrylic acid - methyl methacrylate and methyl methacrylate copolymer (eudragit FS30D), sodium hydroxide, triethyl citrate, yellow iron oxide, red iron oxide, titanium dioxide, talc, polyethylene glycol 6000.

MESALAZINA DOC 800 mg gastro-resistant tablets

• The active substance is mesalazine. Each tablet contains 800 mg of mesalazine.
• The other components are: maltodextrin, povidone, sodium lauryl sulfate, sodium starch glycolate, talc, magnesium stearate. Coating: methacrylic acid - methyl methacrylate and methyl methacrylate copolymer (eudragit FS30D), sodium hydroxide, triethyl citrate, yellow iron oxide, red iron oxide, titanium dioxide, talc, polyethylene glycol 6000.

Description of the appearance of MESALAZINA DOC and pack sizes
Gastro-resistant tablets, pack of 50 tablets of 400 mg in blister packs.
Gastro-resistant tablets, pack of 24 or 60 tablets of 800 mg in blister packs.
Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati, 40 – 20121 Milan, Italy
Manufacturer
Fine Foods & Pharmaceuticals N.T.M. S.p.A. - Via Grignano 43 - 24041 Brembate (BG), Italy
Package leaflet: information for the patient

MESALAZINA DOC 2 g/50 ml rectal suspension, 4 g/100 ml rectal suspension

Generic medicine
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What MESALAZINA DOC is and what it is used for
2. What you need to know before using MESALAZINA DOC
3. How to use MESALAZINA DOC
4. Possible side effects
5. How to store MESALAZINA DOC
6. Package contents and other information

1. What MESALAZINA DOC is and what it is used for

MESALAZINA DOC contains the active substance mesalazine, which is used to treat inflammatory bowel diseases.
MESALAZINA DOC is used for the treatment of ulcerative colitis localized in the rectal area.
This medicine is indicated both for the treatment of active disease and for the prevention of relapses.

2. What you should know before using MESALAZINA DOC

Do not use MESALAZINA DOC

• if you are allergic to mesalazine, to closely related substances from a chemical point of view, to salicylates, or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney problems (severe impairment of renal function, severe nephropathies);
• if you have severe liver problems (severe impairment of hepatic function);
• if you have active ulcers in the stomach or the first part of the intestine (peptic ulcer);
• if you have a tendency to bleeding from blood vessels (hemorrhagic diathesis);
• if you are in the last weeks of pregnancy or if you are breastfeeding (see "Pregnancy and breastfeeding");
• in children under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using MESALAZINA DOC.
Prolonged use of this medicine may cause allergic reactions.
Before starting treatment, appropriate clinical investigations must be carried out to confirm the diagnosis and establish therapeutic indications.
Mesalazine may cause a red-brown discoloration of urine after contact with sodium hypochlorite contained in bleach present in toilet water. This is due to a harmless chemical reaction occurring between mesalazine and bleach.
Inform your doctor before using mesalazine:

• if you have ever developed a severe skin rash or skin peeling, blisters and/or mouth ulcers after taking mesalazine.

Exercise particular caution and consult your doctor:
if you have liver problems;
if you have or have had kidney problems. Your doctor may decide to perform tests to monitor your kidney function;
if you are being treated with one or more of the following medicines:

• medicines that lower blood sugar levels (oral hypoglycemics),
• medicines that increase urine production (diuretics),
• medicines for blood clotting disorders (coumarins, e.g. warfarin),
• medicines used to treat inflammation (corticosteroids) (see "Other medicines and MESALAZINA DOC");
  if you have lung problems (especially asthma);
  if you have previously experienced adverse effects with sulfasalazine-containing preparations (see section 4).
  Serious skin adverse reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment. Stop taking mesalazine immediately and contact your doctor if you notice any of the symptoms related to these serious skin reactions described in section 4.
  Use of mesalazine may lead to the formation of kidney stones. Symptoms may include pain in the sides of the abdomen and blood in the urine. It is recommended to drink sufficient fluids during treatment with mesalazine.
  After treatment with mesalazine, you may develop certain problems (e.g. appearance of bruises, unexplained bleeding, anemia), fever, and sore throat. In such cases, your doctor will perform blood tests and, if necessary, instruct you to discontinue treatment.
  Before starting treatment, your doctor may wish to perform blood tests, liver enzyme tests (ALT, AST, serum creatinine), and/or urine analysis. Your doctor will determine how often these tests should be repeated.
  Disease relapse may occur both after discontinuation of treatment and during inadequate maintenance therapy.
  Prolonged use of this medicine may lead to sensitization phenomena. If allergic reactions occur, treatment must be stopped immediately.

Children and adolescents
Do not use MESALAZINA DOC in children under 2 years of age (see "Do not use MESALAZINA DOC").

Other medicines and MESALAZINA DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Exercise particular caution and inform your doctor if you are taking:

• lactulose or other medicines that lower colonic pH, as they may slow down the absorption of mesalazine;
• medicines that lower blood sugar levels, such as hypoglycemics (sulfonylureas);
• methotrexate, a medicine used to treat certain cancers and autoimmune diseases;
• 6-mercaptopurine and thioguanine, medicines used to treat blood cancers (leukemias);
• azathioprine, a medicine used to treat immune system disorders;
• probenecid or sulfinpyrazone, medicines used to lower blood uric acid levels;
• spironolactone or furosemide, medicines used to increase urine production (diuretics);
• rifampicin, an antibiotic;
• corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs), medicines used for inflammation;
• coumarins (e.g. warfarin), medicines for blood clotting disorders (anticoagulants).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not take MESALAZINA DOC during pregnancy unless strictly necessary. Use of MESALAZINA DOC is contraindicated in the last weeks of pregnancy (see "Do not use MESALAZINA DOC").
Mesalazine is excreted in breast milk. Therefore, take MESALAZINA DOC only if clearly needed and under direct medical supervision. If your child develops diarrhea, stop breastfeeding (see "Do not use MESALAZINA DOC").

Driving and using machines
MESALAZINA DOC does not affect the ability to drive or operate machinery.

MESALAZINA DOC contains sodium metabisulfite
This substance may rarely cause severe hypersensitivity reactions and bronchospasm.

MESALAZINA DOC 2 g/50 ml rectal suspension contains sodium benzoate
This medicine contains 50 mg of sodium benzoate per dose equivalent to 1 mg/ml. Sodium benzoate may cause local irritation.

MESALAZINA DOC 4 g/100 ml rectal suspension contains sodium benzoate
This medicine contains 100 mg of sodium benzoate per dose equivalent to 1 mg/ml. Sodium benzoate may cause local irritation.

3. How to use MESALAZINA DOC

Adults
Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the recommended doses are 1 single-dose container of 4 g once daily (preferably in the evening before going to bed), or 1 single-dose container of 2 g once or twice daily (in the morning and/or in the evening before going to bed).
The treatment duration for active disease is typically 6-8 weeks, and may vary at the doctor's discretion depending on your condition and disease progression.
For long-term treatment to prevent relapses, the daily dosage and treatment duration will be determined by your doctor according to your individual condition and disease course.

Administration instructions for rectal suspension:
Shake well before use to obtain a homogeneous suspension. To administer the single-dose container, follow these instructions:

• Gently press the cap of the cannula and push until fully inserted;
• Remove the cap from the rectal cannula;
• Lie on your left side, keeping your left leg straight and bending your right leg;
• Gently insert the cannula into the anal opening and press the container with gradual, steady pressure until completely emptied;
• Turn several times from side to side to facilitate distribution of the medicine, and remain lying down for at least 30 minutes;
• To achieve optimal effectiveness, retain the medication as long as possible, preferably overnight. For this reason, it is recommended that at least one daily administration be performed at bedtime.

Use in children over two years of age
MESALAZINA DOC is contraindicated in children under 2 years of age (see section "Do not take MESALAZINA DOC"). In children over two years of age, doses should be proportionally reduced at the doctor's discretion.

If you use more MESALAZINA DOC than you should
Cases of overdose have not been reported.
In case of accidental administration of an excessive dose of MESALAZINA DOC, immediately contact your doctor or go to the nearest hospital.

If you forget to use MESALAZINA DOC
Do not use a double dose to make up for the missed dose. Resume your regular dosing schedule as directed by your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment with mesalazine and contact your doctor immediately if you experience any of the following symptoms:

• flat, reddish patches on the trunk, target-shaped or circular, often with central blisters, skin peeling, mouth ulcers, ulcers in the throat, nose, genitals and eyes, widespread rash, fever and swollen lymph nodes. These serious skin rashes may be preceded by fever and flu-like symptoms;
• allergic reactions, with symptoms such as cramps and abdominal pain, diarrhoea with blood, fever, severe headache and skin rash.

The possible side effects listed below are categorized according to frequency:
Common (may affect up to 1 in 10 people):

• nausea;
• diarrhoea;
• abdominal distension;
• skin lesions (rashes);
• headache (cephalalgia);
• high blood pressure (hypertension);
• weakness (asthenia);
• fever (pyrexia).

Uncommon (may affect up to 1 in 100 people):

• abdominal pain;
• passing wind (flatulence);
• vomiting;
• itching (pruritus);
• drowsiness;
• tremors;
• increased heart rate (tachycardia);
• low blood pressure (hypotension);
• fatigue;
• facial swelling.

Rare (may affect up to 1 in 1,000 people):

• increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity);
• dizziness;
• nerve disease causing abnormalities in sensation and movement, including of internal organs (peripheral neuropathy).

Very rare (may affect up to 1 in 10,000 people):

• decrease in blood cell counts (leucopenia, neutropenia, thrombocytopenia, pancytopenia, agranulocytosis);
• decrease in haemoglobin levels due to failure of bone marrow to produce certain blood cells (aplastic anaemia);
• loss of hair and body hair (alopecia);
• kidney disease (impaired kidney function including acute and chronic interstitial nephritis and renal failure);
• muscle and joint pain (myalgia and arthralgia);
• allergic reactions (allergic rash, drug fever, lupus erythematosus-like syndrome, pancolitis);
• reduced number of sperm produced (oligospermia). This side effect is reversible;
• inflammation of the membrane surrounding the heart (pericarditis);
• inflammation of the heart muscle (myocarditis);
• allergic and inflammatory reactions in the lungs (including difficulty breathing, cough, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonia);
• inflammation of the pancreas (pancreatitis, including acute pancreatitis);
• inflammation of the liver (hepatitis, cholestatic hepatitis);
• temporary abnormalities in liver function tests;
• gallstones (cholelithiasis);

Not known (frequency cannot be estimated from the available data):

• swelling of the face, lips and throat due to an allergic reaction (angioedema);
• kidney stones and associated kidney pain (see also section 2).

With rectal formulations (rectal suspension and suppositories), nausea, diarrhoea, abdominal pain, headache and skin rashes have been reported only sporadically.
There are also sporadic reports of: leucopenia, neutropenia, thrombocytopenia, aplastic anaemia, pancreatitis, hepatitis, interstitial nephritis, nephrotic syndrome and renal failure, pericarditis, myocarditis, eosinophilic pneumonia and interstitial pneumonia.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MESALAZINA DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Do not use the medicine if the packaging shows visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MESALAZINA DOC contains
MESALAZINA DOC 2 g/50 ml rectal suspension

• The active substance is mesalazine. Each single-dose container of 50 ml contains 2 g of mesalazine (5-aminosalicylic acid).
• The other components are: purified water, disodium edetate, tragacanth gum, xanthan gum, sodium metabisulphite, sodium benzoate, sodium acetate.

MESALAZINA DOC 4 g/100 ml rectal suspension

• The active substance is mesalazine. Each single-dose container of 100 ml contains 4 g of mesalazine (5-aminosalicylic acid).
• The other components are: purified water, disodium edetate, tragacanth gum, xanthan gum, sodium metabisulphite, sodium benzoate, sodium acetate.

Description of the appearance of MESALAZINA DOC and contents of the pack
The 2 g/50 ml rectal suspension is available in a soft polyethylene bottle of 50 ml, including a cannula, in packs of 7 ready-to-use single-dose units for rectal administration.
The 4 g/100 ml rectal suspension is available in a soft polyethylene bottle of 100 ml, including a cannula, in packs of 7 ready-to-use single-dose units for rectal administration.
Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati, 40 – 20121 Milan
Manufacturer
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo 1 - 03012 Anagni (Frosinone) – Italy.
Patient Information Leaflet

MESALAZINA DOC 500 mg suppositories

Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
• If any adverse reaction occurs, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What MESALAZINA DOC is and what it is used for
2. What you need to know before using MESALAZINA DOC
3. How to use MESALAZINA DOC
4. Possible adverse reactions
5. How to store MESALAZINA DOC
6. Contents of the pack and other information

1. What MESALAZINA DOC is and what it is used for

MESALAZINA DOC contains the active substance mesalazine, used to treat inflammatory bowel diseases.
MESALAZINA DOC is used for the treatment of ulcerative colitis localized in the rectal area.
This medicine is indicated both for the treatment of active disease and for the prevention of relapses.

2. What you need to know before using MESALAZINA DOC

Do not use MESALAZINA DOC

• if you are allergic to mesalazine, to substances chemically closely related, to salicylates, or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney problems (severe impairment of renal function, severe nephropathies);
• if you have severe liver problems (severe impairment of hepatic function);
• if you have active stomach or duodenal ulcers (active peptic ulcer);
• if you have a tendency to bleed from blood vessels (hemorrhagic diathesis);
• if you are in the last weeks of pregnancy or during breastfeeding (see "Pregnancy and breastfeeding");
• in children under 2 years of age (see "Children and adolescents").

Warnings and precautions
Talk to your doctor or pharmacist before using MESALAZINA DOC.
Prolonged use of the medicine may cause allergic reactions.
Before starting treatment, appropriate clinical investigations must be carried out to confirm diagnosis and therapeutic indications.
Inform your doctor before using mesalazine:

• if you have ever developed a severe skin rash, skin peeling, blisters and/or mouth ulcers after taking mesalazine.

Pay special attention and consult your doctor:

• if you have liver problems;
• if you have or have had kidney problems. Your doctor may decide to perform kidney function tests;
• if you are being treated with one or more of the following medicines: oral hypoglycemics (medicines that lower blood sugar levels), diuretics (medicines that increase urine production), anticoagulants (coumarins, e.g. warfarin), or corticosteroids (medicines used to treat inflammation) (see "Other medicines and MESALAZINA DOC");
• if you have lung problems (especially asthma);
• if you have previously experienced adverse effects with sulfasalazine-containing preparations (see section 4).

Serious skin adverse reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported during treatment with mesalazine. Discontinue use of mesalazine and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Use of mesalazine may lead to the formation of kidney stones. Symptoms may include pain in the sides of the abdomen and blood in the urine. It is recommended to drink sufficient fluids during treatment with mesalazine.
During treatment with mesalazine, you may develop certain problems (e.g. appearance of bruises, unexplained bleeding, anemia), fever, and sore throat. In such cases, your doctor will perform blood tests and, if necessary, instruct you to stop treatment.
Before starting treatment, your doctor may wish to perform blood tests, liver enzyme tests (ALT, AST, serum creatinine) and/or urine analysis. Your doctor will decide how often these tests should be repeated.
Disease relapse may occur both after discontinuation of treatment and during inadequate maintenance therapy.
Any occurrence of allergic reactions requires immediate discontinuation of treatment.

Children and adolescents
Do not use MESALAZINA DOC in children under 2 years of age (see "Do not use MESALAZINA DOC").

Other medicines and MESALAZINA DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay special attention and inform your doctor if you are taking:

• lactulose or other medicines that lower colonic pH, as they may delay absorption of mesalazine;
• medicines that lower blood sugar levels, such as oral hypoglycemics (sulfonylureas);
• methotrexate, a medicine used to treat certain cancers and autoimmune diseases;
• 6-mercaptopurine and thioguanine, medicines used to treat blood cancers (leukemias);
• azathioprine, a medicine used to treat immune system disorders;
• probenecid or sulfinpyrazone, medicines used to reduce blood uric acid levels;
• spironolactone or furosemide, medicines used to increase urine production (diuretics);
• rifampicin, an antibiotic;
• corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs), medicines used for inflammation;
• coumarins (e.g. warfarin), medicines used for blood clotting disorders (anticoagulants).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use MESALAZINA DOC during pregnancy unless strictly necessary. Use of MESALAZINA DOC is contraindicated in the last weeks of pregnancy (see "Do not use MESALAZINA DOC").
Mesalazine is excreted in breast milk. Therefore, take MESALAZINA DOC only if clearly needed and under strict medical supervision. If the infant develops diarrhea, breastfeeding should be discontinued (see "Do not use MESALAZINA DOC").

Driving and using machines
MESALAZINA DOC does not affect the ability to drive vehicles or operate machinery.

3. How to use MESALAZINA DOC

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults
Unless otherwise prescribed by the physician, the recommended dose during the active phase of the disease is 3 suppositories per day, divided into two or three administrations.
For the prevention of relapses, the recommended dose is 1–2 suppositories per day.

Use in children and adolescents
MESALAZINA DOC is contraindicated in children under 2 years of age (see “Do not take MESALAZINA DOC”). In children over two years of age, doses should be proportionally reduced, at the physician's discretion.

To achieve a better therapeutic effect, retain the suppository for at least 30 minutes, or preferably for longer periods (e.g., overnight).

During hot weather, it may be necessary to immerse the suppository container in cold water to re-solidify suppositories that may have softened.

The duration of treatment during active disease is usually 4–6 weeks and may vary, at the physician’s discretion, depending on your condition and disease progression.

For long-term treatment to prevent relapses, the daily dosage and duration of treatment will be determined by your doctor according to your condition and disease progression.

If you use more MESALAZINA DOC than you should
Cases of overdose have not been reported.
In case of accidental ingestion/over-administration of an excessive dose of MESALAZINA DOC, contact your doctor immediately or go to the nearest hospital.

If you forget to use MESALAZINA DOC
Do not use a double dose to make up for the missed dose; resume your normal dosing schedule as directed by your doctor.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop treatment with mesalazine and contact your doctor immediately if you notice any of the following symptoms:

• flat, reddish patches on the trunk, target-shaped or circular, often with central blisters, skin peeling, mouth ulcers, and ulcers in the throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms;
• allergic reactions, with symptoms such as cramps and abdominal pain, bloody diarrhoea, fever, severe headache, and skin rash.

The possible side effects are listed below by frequency:
Common (may affect up to 1 in 10 people):

• nausea;
• diarrhoea;
• bloated abdomen;
• skin lesions (rashes);
• headache (cephalalgia);
• high blood pressure (hypertension);
• weakness (asthenia);
• fever (pyrexia).

Uncommon (may affect up to 1 in 100 people):

• abdominal pain;
• passage of intestinal gas (flatulence);
• vomiting;
• itching (pruritus);
• drowsiness;
• tremors;
• increased heart rate (tachycardia);
• low blood pressure (hypotension);
• fatigue;
• facial swelling.

Rare (may affect up to 1 in 1,000 people):

• increased skin sensitivity to sunlight and ultraviolet light (photosensitivity);
• dizziness;
• nerve disease causing sensory and motor abnormalities, including in internal organs (peripheral neuropathy).

Very rare (may affect up to 1 in 10,000 people):

• decrease in blood cells (leucopenia, neutropenia, thrombocytopenia, pancytopenia, agranulocytosis);
• decrease in haemoglobin levels due to failure of bone marrow to produce certain blood cells (aplastic anaemia);
• loss of hair and body hair (alopecia);
• kidney disease (impaired kidney function, including acute and chronic interstitial nephritis and renal failure);
• muscle and joint pain (myalgia and arthralgia);
• allergic reactions (allergic rash, drug fever, lupus-like syndrome, pancolitis);
• reduced number of sperm produced (oligospermia). This side effect is reversible;
• inflammation of the membrane surrounding the heart (pericarditis);
• inflammation of the heart muscle (myocarditis);
• allergic and inflammatory reactions in the lungs (including difficulty breathing, cough, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonia);
• inflammation of the pancreas (pancreatitis, including acute);
• inflammation of the liver (hepatitis, cholestatic hepatitis);
• temporary abnormalities in liver function tests;
• gallstones (cholelithiasis).

Not known (frequency cannot be estimated from the available data):

• swelling of the face, lips, and throat due to an allergic reaction (angioedema);
• kidney stones and associated kidney pain (see also section 2).

With rectal formulations (rectal suspension and suppositories), nausea, diarrhoea, abdominal pain, headache, and skin rashes have been reported only sporadically.
There have also been sporadic reports of: leucopenia, neutropenia, thrombocytopenia, aplastic anaemia, pancreatitis, hepatitis, interstitial nephritis, nephrotic syndrome, renal failure, pericarditis, myocarditis, eosinophilic pneumonia, and interstitial pneumonia.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you help provide more information on the safety of this medicine.

5. How to store MESALAZINA DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
This medicine requires no special storage precautions.
Do not use the medicine if the packaging shows visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MESALAZINA DOC contains

• The active substance is mesalazine (5-aminosalicylic acid). Each suppository contains 500 mg of mesalazine.
• The other components are: semisynthetic glycerides.

Description of the appearance of MESALAZINA DOC and contents of the pack
The suppositories are available in packs of 20 suppositories.
Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati, 40 – 20121 Milan
Manufacturer
Special Product’s Line S.p.A – Via Campobello, 15 – 00040 Pomezia (Rome)

Package leaflet: Information for the patient

MESALAZINA DOC 1200 mg gastro-resistant tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What MESALAZINA DOC is and what it is used for
2. What you need to know before taking MESALAZINA DOC
3. How to take MESALAZINA DOC
4. Possible side effects
5. How to store MESALAZINA DOC
6. Contents of the pack and other information

1. What MESALAZINA DOC is and what it is used for

MESALAZINA DOC contains the active substance mesalazine, used to treat inflammatory bowel diseases.
MESALAZINA DOC 1200 mg gastro-resistant tablets are used for the treatment of ulcerative colitis, a chronic inflammatory bowel disease.

2. What you need to know before taking MESALAZINA DOC

Do not take MESALAZINA DOC

• if you are allergic to mesalazine, to closely related substances from a chemical standpoint, to salicylates, or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney problems (severe impairment of renal function, severe nephropathies);
• if you have severe liver problems (severe impairment of hepatic function);
• if you have active ulcers in the stomach or the first part of the intestine (active peptic ulcer);
• if you have a tendency to bleeding from blood vessels (hemorrhagic diathesis);
• if you are in the last weeks of pregnancy or if you are breastfeeding (see "Pregnancy and breastfeeding");
• in children and adolescents under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking MESALAZINA DOC.
Prolonged use of the medicine may cause allergic reactions.
Before starting treatment, you must undergo appropriate clinical investigations to confirm the diagnosis and establish therapeutic indications.
Mesalazine may cause a red-brown discoloration of urine after contact with sodium hypochlorite contained in bleach present in toilet water. This is due to a harmless chemical reaction occurring between mesalazine and bleach.
If you experience severe or recurrent headache, visual disturbances, or ringing or buzzing in the ears, contact your doctor immediately.
Inform your doctor before using mesalazine:

• if you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking mesalazine.

Be especially careful and consult your doctor:

• if you have unusually slow gastric digestion or narrowing of the opening between the stomach and intestine (pyloric stenosis), as the medicine could cause gastric irritation and may lose its effectiveness;
• if you have liver problems;
• if you have or have had kidney problems. Your doctor may decide to perform kidney function tests;
• if you are being treated with one or more of the following medicines: oral hypoglycemic agents (medicines that lower blood sugar levels), diuretics (medicines that increase urine production), anticoagulants (medicines for blood clotting disorders, such as coumarins, e.g., warfarin), or corticosteroids (medicines used to treat inflammation) (see "Other medicines and MESALAZINA DOC");
• if you have lung problems (especially asthma);
• if you have previously experienced adverse effects with preparations containing sulfasalazine (see section 4).

Serious skin adverse reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment. Stop using mesalazine and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
The use of mesalazine may lead to the formation of kidney stones. Symptoms may include pain in the sides of the abdomen and blood in the urine. It is recommended to drink an adequate amount of fluids during treatment with mesalazine.
After treatment with mesalazine, you may develop certain problems (e.g., appearance of bruises, unexplained bleeding, anemia), fever, and sore throat. In such cases, your doctor will perform blood tests and, if necessary, instruct you to discontinue treatment.
Before starting treatment, your doctor may wish to perform blood tests, liver enzyme tests (ALT, AST, serum creatinine), and/or urine analysis. Your doctor will decide how often these tests should be repeated.
Relapse of the disease may occur both after discontinuation of treatment and during inadequate maintenance therapy.
Prolonged use of the medicine may lead to sensitization phenomena. The occurrence of allergic reactions requires immediate discontinuation of treatment.
Children and adolescents
MESALAZINA DOC 1200 mg gastro-resistant tablets must not be administered to children and adolescents under 18 years of age, as they may have difficulty swallowing the tablets.
Other medicines and MESALAZINA DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Be especially careful and inform your doctor if you are taking:

• lactulose or other medicines that lower the pH of the colon, as they may slow down the absorption of mesalazine;
• medicines that lower blood sugar levels, such as oral hypoglycemics (sulfonylureas);
• methotrexate, a medicine used to treat certain cancers and autoimmune diseases;
• 6-mercaptopurine and thioguanine, medicines used to treat blood cancers (leukemias);
• azathioprine, a medicine used to treat immune system disorders;
• probenecid or sulfinpyrazone, medicines used to lower blood uric acid levels;
• spironolactone or furosemide, medicines used to increase urine production (diuretics);
• rifampicin, an antibiotic;
• corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs), medicines used for inflammation;
• coumarins (e.g., warfarin), medicines used for blood clotting disorders (anticoagulants).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take MESALAZINA DOC during pregnancy unless strictly necessary. The use of MESALAZINA DOC is contraindicated in the last weeks of pregnancy (see "Do not take MESALAZINA DOC").
Mesalazine is present in breast milk. Therefore, take MESALAZINA DOC only if clearly necessary and under direct medical supervision. If the infant develops diarrhea, discontinue breastfeeding (see "Do not take MESALAZINA DOC").
Driving and using machines
MESALAZINA DOC does not affect the ability to drive vehicles or operate machinery.
MESALAZINA DOC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per gastro-resistant tablet, i.e., it is essentially 'sodium-free'.

3. How to take MESALAZINA DOC

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will tell you the recommended dose suitable for you.

Treatment of ulcerative colitis
Maintenance phase of remission
The recommended daily dose for adults is 2.4 g of mesalazine (6 tablets of 400 mg,
or 3 tablets of 800 mg, or 2 tablets of 1200 mg), to be taken in two or three divided doses per day.

Induction phase of remission in ulcerative colitis
In mild acute forms of the disease, the recommended starting daily dose of
MESALAZINA DOC is 2.4 g of mesalazine (6 tablets of 400 mg, or 3 tablets of 800 mg,
or 2 tablets of 1200 mg), to be taken in two or three divided doses per day.
In moderate acute forms of the disease, your doctor may increase the recommended daily dose of
MESALAZINA DOC up to 4.8 g of mesalazine, to be taken in two or three divided doses per day.

If you take more MESALAZINA DOC than you should
If you accidentally take an excessive dose of MESALAZINA DOC, contact your doctor immediately or go to the nearest hospital.

If you forget to take MESALAZINA DOC
Do not take a double dose to make up for the missed dose. Resume your regular dosing schedule as directed by your doctor.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Stop treatment with mesalazine and contact your doctor immediately if you notice any of the following symptoms:

• flat, reddish patches on the trunk, target-shaped or circular, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers, widespread rash, fever and swollen lymph nodes. These severe skin rashes may be preceded by fever and flu-like symptoms;
• allergic reactions, with symptoms such as cramps and abdominal pain, diarrhoea with blood, fever, severe headache and skin rash.

Contact your doctor immediately if you experience severe or recurring headache, vision disturbances, or ringing or buzzing in the ears. These could be symptoms of increased pressure inside the skull (idiopathic intracranial hypertension) [Frequency not known (frequency cannot be estimated from the available data)].

The possible side effects are listed below by frequency:

Common (may affect up to 1 in 10 people):

• nausea;
• diarrhoea;
• bloated abdomen;
• skin lesions (rashes);
• headache (cephalalgia);
• high blood pressure (hypertension);
• weakness (asthenia);
• fever (pyrexia).

Uncommon (may affect up to 1 in 100 people):

• abdominal pain;
• passing wind (flatulence);
• vomiting;
• itching (pruritus);
• drowsiness;
• tremors;
• increased heart rate (tachycardia);
• low blood pressure (hypotension);
• fatigue;
• facial swelling.

Rare (may affect up to 1 in 1,000 people):

• increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity);
• dizziness;
• nerve disease causing abnormalities in sensation and movement, including of internal organs (peripheral neuropathy).

Very rare (may affect up to 1 in 10,000 people):

• decrease in blood cells (leucopenia, neutropenia, thrombocytopenia, pancytopenia, agranulocytosis);
• decrease in haemoglobin levels due to failure of bone marrow to produce certain blood cells (aplastic anaemia);
• loss of body and scalp hair (alopecia);
• kidney disease (impaired kidney function, including acute and chronic interstitial nephritis and renal failure);
• muscle and joint pain (myalgia and arthralgia);
• allergic reactions (allergic rash, drug fever, lupus-like syndrome, pancolitis);
• reduced number of sperm produced (oligospermia). This side effect is reversible;
• inflammation of the membrane surrounding the heart (pericarditis);
• inflammation of the heart muscle (myocarditis);
• allergic and inflammatory lung reactions (including difficulty breathing, cough, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonia);
• inflammation of the pancreas (pancreatitis, including acute pancreatitis);
• liver inflammation (hepatitis, cholestatic hepatitis);
• temporary abnormalities in liver function tests;
• gallstones (cholelithiasis).

Not known (frequency cannot be estimated from the available data):

• swelling of the face, lips and throat due to an allergic reaction (angioedema);
• kidney stones and associated kidney pain (see also section 2);
• in case of severe or recurring headache, vision disturbances, ringing or buzzing in the ears. These could be symptoms of increased pressure inside the skull (idiopathic intracranial hypertension).

With oral formulations, gastrointestinal disturbances (nausea, diarrhoea, and abdominal pain) and headache have been reported rarely in some patients who previously did not tolerate sulfasalazine.
There have also been occasional reports of: leucopenia, neutropenia, thrombocytopenia, aplastic anaemia, pancreatitis, hepatitis, interstitial nephritis, nephrotic syndrome, renal failure, pericarditis, myocarditis, eosinophilic pneumonia, and interstitial pneumonia.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MESALAZINE DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
This medicine requires no special storage precautions.
Do not use the medicine if the packaging shows visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MESALAZINA DOC contains
The active substance is mesalazine. One gastro-resistant tablet contains 1200 mg of mesalazine.
The other components are: maltodextrin, povidone, sodium lauryl sulfate, sodium starch glycolate, talc, magnesium stearate.
Coating: methacrylic acid copolymer - methyl methacrylate and methyl methacrylate (Eudragit FS30D), sodium hydroxide, triethyl citrate, yellow iron oxide, red iron oxide, titanium dioxide, talc, polyethylene glycol 6000.
Description of the appearance of MESALAZINA DOC and package contents
Oblong gastro-resistant tablet, brown-red in colour, with "12" engraved on one side. Pack containing 60 or 120 tablets in blisters.
Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati, 40 – 20121 Milano
Manufacturer
Fine Foods & Pharmaceuticals N.T.M. S.p.A. - Via Grignano 43 - 24041 Brembate (BG)