ASAVIXIN

PATIENT LEAFLET: information for the patient

ASAVIXIN 500 mg coated tablets

5-aminosalicylic acid (mesalazine)
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, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ASAVIXIN is and what it is used for

ASAVIXIN contains the active substance 5-aminosalicylic acid (mesalazine), which belongs to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
ASAVIXIN is indicated for both the treatment and prevention of inflammatory bowel diseases (ulcerative colitis and Crohn's disease).
In more severe cases, your doctor may advise you to combine ASAVIXIN with other anti-inflammatory medicines (corticosteroids).

2. What you should know before taking ASAVIXIN

Do not take ASAVIXIN

• if you are allergic to 5-aminosalicylic acid (mesalazine), to any of the other ingredients of this medicine (listed in section 6), or to medicines similar to this one (other salicylates);
• if you have severe kidney (established renal failure, severe nephropathies) or liver problems;
• if you have a stomach or intestinal lesion (pre-existing gastric or duodenal ulcers);
• if you have a tendency to bleeding (haemorrhagic diathesis);
• if the person taking this medicine is a child under 6 years of age (See section “Children”);
• if you are pregnant, especially during the last weeks of pregnancy, or if you are breastfeeding (See section “Pregnancy and breastfeeding”).

Contact your doctor before using mesalazine if you have ever developed a severe skin reaction, skin peeling, blisters and/or mouth ulcers after taking mesalazine.

Warnings and precautions

Talk to your doctor or pharmacist before taking ASAVIXIN.

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.

Serious skin 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.

Your doctor will carry out specific tests before starting treatment with this medicine in order to accurately identify the disease and therapeutic indications.

Take this medicine with great caution and inform your doctor in the following cases:

• if you have digestive problems (exceptionally slow gastric digestion, pyloric stenosis), as this may cause stomach irritation and reduced effectiveness of the medicine;
• if you have kidney or liver problems (reduced renal or hepatic function). In this case, during treatment with this medicine, your doctor should carefully monitor your kidney function, especially if you have previously had kidney disease. In case of severe reduction or serious kidney problems (established renal failure), this medicine must not be used (See section “Do not take ASAVIXIN”). Additionally, during active phases of the disease, your doctor will ensure adequate hydration.
• if you are taking medicines used to:
• lower blood sugar levels (oral hypoglycaemics);
• increase urine elimination (diuretics);
• thin the blood (coumarin anticoagulants);
• treat inflammation and allergies (corticosteroids).
• if you suffer from gastric problems;
• if you suffer from lung diseases (especially asthma);
• if you previously experienced adverse reactions during treatment with medicines containing sulfasalazine. Symptoms may reappear after discontinuation of treatment with this medicine or during inadequate maintenance therapy. Prolonged use of ASAVIXIN may cause hypersensitivity reactions; if this occurs, stop treatment immediately. If you notice bleeding, bruising, fever or sore throat, contact your doctor immediately. In cases of severe inflammation, your doctor may recommend taking other medicines used to treat inflammation (systemic corticosteroids).

Monitoring of kidney function before and during treatment with Asavixin

Before starting treatment, your doctor will check kidney function through appropriate tests, even if you and/or the child do not have kidney problems. If your doctor has prescribed long-term treatment with Asavixin, kidney function will be monitored periodically during treatment. If kidney function is severely reduced, your doctor will stop treatment (see “Possible side effects”).

Children

ASAVIXIN is not recommended for children under 6 years of age.

For children over 6 years of age, this medicine should only be used when absolutely necessary and under medical supervision.

Other medicines and ASAVIXIN

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Inform your doctor if you are taking:

• medicines containing lactulose or other preparations used to treat constipation;
• medicines containing sulfonylureas used to treat high blood sugar levels (diabetes);
• medicines that thin the blood (coumarin anticoagulants);
• medicines containing methotrexate, azathioprine, 6-mercaptopurine, or thioguanine used to treat certain tumours and autoimmune diseases;
• medicines containing probenecid or used to treat high blood uric acid levels (gout);
• medicines containing sulfinpyrazone used to treat heart diseases, especially after a heart attack, and also gout;
• medicines containing spironolactone or furosemide (diuretics) that increase urine elimination;
• medicines containing rifampicin used to treat infections.

The combination of ASAVIXIN with other medicines used to treat inflammation (corticosteroids) may increase their undesirable effects on the stomach. However, in cases of severe intestinal inflammation, your doctor may prescribe corticosteroid treatment (cortisone) as well.

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.

During pregnancy, take ASAVIXIN only when strictly necessary and under direct medical supervision. Do not take ASAVIXIN during the last weeks of pregnancy or while breastfeeding.

During the first part of pregnancy, take this medicine only if clearly needed, after your doctor has carefully assessed that potential benefits outweigh possible risks.

Breastfeeding

Take this medicine while breastfeeding only if clearly necessary, after your doctor has carefully assessed that potential benefits outweigh possible risks. If the newborn develops diarrhoea, breastfeeding should be discontinued.

Driving and using machines

ASAVIXIN does not affect the ability to drive vehicles or operate machinery.

ASAVIXIN contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take ASAVIXIN

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Swallow the tablets whole with a glass of water, away from meals.
Do not divide or chew the tablets.
The recommended dose is 1 tablet, 3 times daily. If necessary, in more severe cases, your doctor
may increase the dose up to 8 tablets per day.
The duration of treatment is 4-6 weeks.
To prevent recurrence of symptoms, long-term maintenance therapy will be required.
The frequency and dosage of maintenance therapy will be determined by your doctor.

Use in children over 6 years of age
At the start of treatment, the dose will be determined by the doctor, starting with 30–50 mg per kg of body
weight, taken in multiple doses throughout the day. The maximum dose is 75 mg per kg of body
weight, administered in multiple doses throughout the day. The total daily dose of ASAVIXIN must not exceed 4 g per
day (maximum adult dose).
The dose for maintenance therapy will be assessed on a case-by-case basis, starting with a dose of 15–
30 mg per kg of body weight, taken in multiple doses throughout the day. In such cases, the
total daily dose of ASAVIXIN must not exceed 2 g per day (recommended adult dose).
Generally, for children weighing up to 40 kg, the recommended dose corresponds to half the adult
dose. For children weighing more than 40 kg, the recommended dose is the adult dose.

If you take more ASAVIXIN than you should
Cases of overdose are not known.
In case of accidental ingestion/overdose of ASAVIXIN, inform your doctor immediately or go
to the nearest hospital, where appropriate supportive treatment will be administered (gastric
lavage/emesis, combined with supportive therapy).

If you forget to take ASAVIXIN
Do not take a double dose to make up for the missed tablet.

If you stop taking ASAVIXIN
After stopping treatment with ASAVIXIN or during inadequate maintenance therapy,
symptoms of the disease may recur. Always follow your doctor’s instructions carefully.

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.

Common (may affect up to 1 in 10 people)

• hypertension
• nausea
• abdominal pain (epigastric pain and other abdominal discomfort)
• diarrhoea
• abdominal distension
• headache (cephalalgia)
• skin rash
• fever
• feeling of weakness

Uncommon (may affect up to 1 in 100 people)

• drowsiness
• tremor
• tachycardia
• hypotension
• abdominal pain
• pruritus
• fatigue
• facial oedema

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

• dizziness
• flatulence, vomiting
• increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)

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

• blood cell disorders (leucopenia, neutropenia, thrombocytopenia, aplastic anaemia, agranulocytosis, pancytopenia)
• hypersensitivity reactions such as skin irritations and fever, lupus-like syndrome, pancolitis, which require discontinuation of treatment
• peripheral nervous system disorders (peripheral neuropathy)
• inflammation of the heart (pericarditis, myocarditis)
• allergic and fibrotic pulmonary reactions such as dyspnoea, cough, bronchospasm, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonia
• inflammation of the pancreas (pancreatitis, acute pancreatitis)
• worsening of colitis symptoms
• liver inflammation (hepatitis), liver failure, and presence of gallstones
• transient abnormalities in liver function tests
• kidney problems (interstitial nephritis, nephrotic syndrome, renal failure)
• hair loss (alopecia)
• muscle and joint pain
• oligospermia (reduced sperm concentration), reversible effect

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

• kidney stones and associated renal pain (see also section 2)
• angioedema

Stop taking mesalazine and contact your doctor immediately if you notice any of the following symptoms:

• red, non-elevated, target-like or circular skin lesions on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers, widespread skin rash, fever and swollen lymph nodes. These serious skin reactions may be preceded by fever and flu-like symptoms.

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 https://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 ASAVIXIN

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.
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 ASAVIXIN 500 mg tablets contain

• The active substance is 5-aminosalicylic acid (mesalazine). One tablet contains 500 mg of 5-aminosalicylic acid (mesalazine).
• The other components are: lactose, magnesium stearate, sodium carboxymethylcellulose, talc, povidone, methacrylic acid copolymer and methyl methacrylate, titanium dioxide, triethyl citrate, polysorbate 80, yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of ASAVIXIN and contents of the pack
Pack of 50 coated tablets.

Marketing Authorization Holder
Mylan Italia S.r.l.
Via Vittor Pisani, 20
20124 Milan, Italy

Manufacturer
SPECIAL PRODUCT’S LINE S.p.A.
Via Fratta Rotonda Vado Largo 1
03012 Anagni (FR)