PANTOPRAZOLE GENOPTIM

Patient Information Leaflet

Pantoprazole Genoptim 40 mg, enteric-coated tablets
Pantoprazolum
Please read the entire leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents:

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

1. What Pantoprazole Genoptim is and what it is used for

Pantoprazole Genoptim contains the active substance pantoprazole.
Pantoprazole Genoptim is a selective "proton pump inhibitor", a medicine that reduces gastric acid secretion. It is used in the treatment of stomach and intestinal disorders related to hydrochloric acid secretion.
Pantoprazole Genoptim is indicated in adults and adolescents aged 12 years and older for the treatment of:

• Gastroesophageal reflux disease (GERD). This condition involves inflammation of the esophagus due to backflow of hydrochloric acid from the stomach.

Pantoprazole Genoptim is indicated in adults for:

• Helicobacter pylori infection in patients with gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy), to eliminate the bacteria and prevent ulcer recurrence.
• Gastric and/or duodenal ulcer disease.
• Zollinger-Ellison syndrome and other pathological conditions associated with excessive gastric acid secretion.

2. Important information before using Pantoprazole Genoptim

When not to take Pantoprazole Genoptim:

• If the patient is allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6).
• If the patient has had an allergic reaction to medicines containing other proton pump inhibitors.

Warnings and precautions
Before starting treatment with Pantoprazole Genoptim, please inform your doctor,
pharmacist or nurse.
If the patient has severe liver function impairment. Please inform
your doctor if you have ever had liver problems in the past. Your doctor
may recommend more frequent monitoring of liver enzyme activity, especially if long-term treatment with Pantoprazole Genoptim is required. If liver enzyme activity increases, treatment with the medicine should be discontinued.

• If the patient has vitamin B deficiency or risk factors indicating possible reduced vitamin B levels, and the patient is being treated long-term with pantoprazole. As with all medicines that reduce (inhibit) gastric hydrochloric acid secretion, pantoprazole may lead to reduced absorption of vitamin B.
• If the patient is taking HIV protease inhibitors such as atazanavir (used in the treatment of HIV infection) concomitantly with pantoprazole, the patient should consult their doctor for specific advice.
• Use of a proton pump inhibitor such as pantoprazole, especially for periods longer than 1 year, may slightly increase the risk of fractures of the hip, wrist or spine. Please inform your doctor if the patient has osteoporosis (reduced bone density) or if the doctor has informed the patient that they are at risk of developing osteoporosis (e.g. if the patient is taking corticosteroids, which increase the risk of osteoporosis). If the patient takes Pantoprazole Genoptim for longer than three months, magnesium levels in the blood may decrease, which may subsequently cause fatigue, tetany, disorientation, seizures, dizziness and ventricular arrhythmias. If any of these symptoms occur, the patient should inform their doctor. Low magnesium levels in the blood may also lead to reduced potassium and calcium levels in the blood. The doctor may decide that periodic blood magnesium monitoring is necessary. If the patient has ever had a skin reaction due to use of a medicine similar to Pantoprazole Genoptim that reduces gastric hydrochloric acid secretion.
• If the patient has ever developed a skin rash, especially in areas exposed to sunlight, they should inform their doctor immediately, as discontinuation of Pantoprazole Genoptim may be necessary. Also inform your doctor about any other adverse reactions occurring, such as joint pain.
• About planned specific blood tests (chromogranin A levels).

Contact your doctor immediately before starting or during treatment with the medicine,
if any of the following symptoms occur, as they may indicate another, more serious
disease:

• Unintentional weight loss (not related to diet or exercise program)
• Vomiting, particularly recurrent
• Bloody vomiting, which may look like dark coffee grounds
• Presence of blood in stool (stool may be black or tarry)
• Difficulty swallowing or pain when swallowing
• Pallor and weakness (anaemia)
• Chest pain
• Abdominal pain
• Severe and (or) persistent diarrhoea, as use of this medicine is associated with a slight increase in the risk of infectious diarrhoea.

Your doctor may decide to perform tests to rule out an underlying tumour disease, as treatment with pantoprazole may alleviate symptoms of tumour disease and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
Pantoprazole Genoptim may affect the way vitamin B is absorbed by the body,
especially if it needs to be taken for a long time. Contact your doctor if you notice
any of the following symptoms, which may indicate low vitamin B levels:

• Extreme tiredness or lack of energy
• Tingling
• Painful or red tongue, mouth ulcers
• Muscle weakness
• Vision disturbances
• Memory problems, confusion, depression.

If Pantoprazole Genoptim is taken for a prolonged period (over 1 year), the patient
will likely be under continuous medical supervision. In such cases, any new or unexpected symptoms and circumstances of their occurrence should be reported during every visit to the doctor.
Children and adolescents
Pantoprazole Genoptim is not recommended for use in children, as its efficacy has not been studied in children under 12 years of age.
Pantoprazole Genoptim and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Since Pantoprazole Genoptim may affect the effectiveness of other medicines,
please inform your doctor if the patient is taking:

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used in certain types of cancer), because Pantoprazole Genoptim may inhibit the proper action of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting and prevent thrombosis. Further testing may be required.
• Medicines used in the treatment of HIV infection, such as atazanavir.
• Methotrexate (used in the treatment of rheumatoid arthritis, psoriasis and cancer diseases); when methotrexate is used, the doctor may temporarily discontinue Pantoprazole Genoptim, as pantoprazole may increase methotrexate blood levels.
• Fluvoxamine (used in the treatment of depression and other psychiatric disorders – if the patient is taking fluvoxamine, the doctor may recommend dose reduction).
• Rifampicin (used to treat infections).
• St John’s wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy, breastfeeding and fertility
Experience with use in pregnant women is limited. It has been established that the active substance
of the medicine passes into human milk.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
The medicine may be used only if the doctor considers that the benefit of treatment outweighs the potential risk to the unborn child or infant.
Driving and operating machinery
Pantoprazole Genoptim has no effect or has a negligible effect on the ability to drive
motor vehicles and operate mechanical equipment.
If the patient experiences adverse reactions such as dizziness or visual disturbances, driving motor vehicles or operating machinery should be avoided.
Pantoprazole Genoptim contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 1 tablet, meaning the medicine is considered "sodium-free".

3. How to take Pantoprazole Genoptim
This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt,
please consult your doctor or pharmacist.
Recommended dose:
Adults and adolescents aged 12 years and above:
For treatment of reflux oesophagitis
The recommended dose is one tablet daily. Your doctor may recommend increasing the dose to 2 tablets daily. The treatment period for reflux oesophagitis usually lasts 4 to 8 weeks. Your doctor will decide how long the medicine should be taken.

Adults:
For treatment of infection with a bacterium called Helicobacter pylori, in patients with duodenal
and (or) gastric ulcers, in combination with two antibiotics (eradication therapy)
One tablet twice daily plus two antibiotic tablets: amoxicillin, clarithromycin or metronidazole (or tinidazole), each taken twice daily together with the pantoprazole tablet.
The first pantoprazole tablet should be taken 1 hour before breakfast, and the second pantoprazole tablet 1 hour before dinner. Follow the instructions provided by your doctor and read the patient leaflets included in the antibiotic packaging. The recommended treatment duration is one or two weeks.

For treatment of gastric and (or) duodenal ulcers
The recommended dose is one tablet daily. After consultation with the doctor, the dose may be doubled. The doctor will decide how long the medicine should be taken. The treatment period for gastric ulcers usually lasts 4 to 8 weeks. The treatment period for duodenal ulcers usually lasts 2 to 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with
excessive gastric hydrochloric acid secretion
The usual initial recommended dose is two tablets daily.
Both tablets should be taken 1 hour before a meal. Later, the dosage may be adjusted appropriately by the doctor, depending on the amount of gastric hydrochloric acid secreted. If a higher number of tablets than two per day is prescribed, they should be taken twice daily.
If your doctor prescribes a daily dose higher than four tablets per day, you will be clearly informed when to discontinue treatment.

Patients with renal impairment
In case of kidney problems, do not take Pantoprazole Genoptim
for eradication of Helicobacter pylori.

Patients with hepatic impairment
In case of moderate or severe liver function impairment, do not take Pantoprazole Genoptim
for eradication of Helicobacter pylori.

Use in children and adolescents
The tablets are not recommended for use in children under 12 years of age.

Method of administration
Take the medicine 1 hour before a meal, without chewing or dividing the tablet. Swallow whole with water.

Overdose of Pantoprazole Genoptim
Contact your doctor or pharmacist. Symptoms of overdose are unknown.

Missed dose of Pantoprazole Genoptim
Do not take a double dose to make up for a missed tablet. Take the next dose at the usual time.

Stopping Pantoprazole Genoptim
Do not stop taking the medicine without first consulting your doctor or pharmacist.
If you have any further questions about using this medicine, please consult
your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, the medicine Pantoprazole Genoptim may cause adverse reactions, although
they do not occur in everyone.
If any of the following adverse reactions occur, discontinue taking the tablets and immediately
inform your doctor or contact the nearest hospital with an emergency department:

• Severe allergic reactions (rare; occurring in no more than 1 in 1,000 people): swelling of the tongue and (or) throat, difficulty swallowing, hives (rash resembling nettle burns), difficulty breathing, angioedema (Quincke's edema/angioedema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency unknown; frequency cannot be estimated from available data): the patient may notice one or more of the following symptoms: formation of skin blisters and sudden worsening of general condition, erosions (with slight bleeding) of the eyes, nose, mouth/oral cavity or genital organs, or rash, especially in areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arms) may also occur, and blood tests may show changes in certain white blood cells or liver enzymes (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug rash with eosinophilia and systemic symptoms (DRESS syndrome), and photosensitivity).
• Other severe reactions (frequency unknown; frequency cannot be estimated from available data): yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever, rash, and kidney problems manifested by their enlargement, sometimes with pain during urination and pain in the lower back (severe kidney inflammation), possibly leading to kidney failure.

Other adverse reactions occurring:

• Common (no more than 1 in 10 people): benign gastric polyps
• Uncommon (no more than 1 in 100 people): headache; dizziness; diarrhoea; nausea; vomiting; feeling of fullness in the abdomen and bloating with flatulence; constipation; dryness in the mouth; pain and discomfort in the abdomen; skin rash, erythema, skin eruptions; itching of the skin; weakness, exhaustion or general malaise; sleep disturbances; fractures of the hip, wrist or spine.
• Rare (no more than 1 in 1,000 people):

disturbance or complete loss of taste sensation; visual disturbances, such as blurred
vision; urticaria; joint pain; muscle pain; changes in body weight; elevated body
temperature; high fever; swelling of the limbs (peripheral edema); allergic reactions;
depression; gynaecomastia in men.

• Very rare (no more than 1 in 10,000 people): disorientation.
• Frequency unknown (frequency cannot be estimated from available data): hallucinations, confusion (particularly in patients who have previously experienced such symptoms), sensations of tingling, pricking, numbness, burning or numbness, rash possibly associated with joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse reactions identified by blood tests occurring:

• Uncommon (no more than 1 in 100 people): increased liver enzyme activity.
• Rare (no more than 1 in 1,000 people): increased bilirubin concentration, increased blood lipid levels, sudden decrease in circulating granulocytes - white blood cells, associated with high fever.
• Very rare (no more than 1 in 10,000 people): decreased platelet count, which may cause more frequent bleeding and bruising; decreased white blood cell count, which may predispose to more frequent infections; concurrent, abnormal decrease in red blood cells, white blood cells and platelets.
• Frequency unknown (frequency cannot be estimated from available data): decreased concentration of sodium, magnesium, calcium or potassium in the blood (see section 2).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your
doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Pantoprazole Genoptim

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
primary packaging. The expiry date refers to the last day of the specified month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater (e.g. toilet or sink) or household waste.
Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Pantoprazole Genoptim contains

• The active substance is pantoprazole. One tablet contains 40 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
• Other ingredients are:
  Tablet core: Mannitol (E 421), crospovidone type A (E 1202), anhydrous sodium carbonate, calcium stearate.
  Coating: Hypromellose 5 cP (E 464), povidone K-25 (E 1201), propylene glycol (E 1520), titanium dioxide (E 171), yellow iron oxide (E 172), methacrylic acid copolymer (1:1), 30% dispersion, triethyl citrate (E 1505).

What Pantoprazole Genoptim 40 mg enteric-coated tablets look like and contents of the pack
Yellow, oval, biconvex, enteric-coated tablets, smooth on both sides.
Pantoprazole Genoptim 40 mg enteric-coated tablets are available in the following pack sizes:
28, 56, 90 or 100 enteric-coated tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
tel. 22 32 16 240

Manufacturer / Importer
IDIFARMA DESARROLLO FARMACÉUTICO, S.L.
Polígono Mocholí
C/Noain, n 1 Noain, 31110 Navarra
Spain

Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz
Poland

Macleods Pharma UK Limited
Wynyard Park House
Wynyard Avenue
Wynyard, Billingham
TS22 5TB, United Kingdom

Netpharmalab Consulting Services
Carretera de Fuencarral 22,
Alcobendas, Madrid, 28108,
Spain