Package leaflet: Information for the user

Pantoprazole Genoptim, 20 mg, enteric-coated tablets
Pantoprazolum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor, pharmacist or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet:

What Pantoprazole Genoptim is and what it is used for
Important information before taking Pantoprazole Genoptim
How to take Pantoprazole Genoptim
Possible side effects
How to store Pantoprazole Genoptim
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 used in adults and adolescents aged 12 years and older for:

Treatment of symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated with gastroesophageal reflux disease (GERD) caused by backflow of hydrochloric acid from the stomach.
Long-term treatment of reflux esophagitis (inflammation of the esophagus accompanied by reflux of gastric acid) and prevention of its recurrence.

Pantoprazole Genoptim is used in adults for:

Prevention of duodenal and/or gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in patients at risk who require continuous NSAID therapy.

2. Important information before taking Pantoprazole Genoptim
When not to use Pantoprazole Genoptim

If you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6).
If you have had an allergic reaction to medicines containing other proton pump inhibitors.

Warnings and precautions
Before starting treatment with Pantoprazole Genoptim, inform your doctor,
pharmacist or nurse.

If you have severe liver function disorders. 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 should be discontinued.
If you need to take NSAIDs continuously and also take Pantoprazole Genoptim, due to an increased risk of gastrointestinal complications. The increased risk will be assessed according to patient-specific risk factors such as age (65 years or older), history of gastric or duodenal ulcers, or gastrointestinal bleeding.
If you have vitamin B deficiency or risk factors indicating possible reduced vitamin B levels, and you are receiving long-term pantoprazole therapy. As with all medicines that reduce (inhibit) gastric acid secretion, pantoprazole may lead to reduced absorption of vitamin B.
If you are taking HIV protease inhibitors such as atazanavir (used in the treatment of HIV infection) concomitantly with pantoprazole, you should seek detailed advice from your doctor.
The use of a proton pump inhibitor such as pantoprazole, especially for more than 1 year, may slightly increase the risk of fractures of the hip, wrist or spine. Inform your doctor if you have osteoporosis (reduced bone density) or if your doctor has informed you that you are at risk of
developing osteoporosis (for example, if you are taking corticosteroids (which may increase the risk of osteoporosis).
If you take Pantoprazole Genoptim for longer than three months, you may experience decreased magnesium levels in the blood, which may lead to fatigue, tetany, disorientation, seizures, dizziness and ventricular arrhythmias. If you experience any of these symptoms, inform your doctor. Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood magnesium monitoring.
If you have ever had a skin reaction to a medicine similar to Pantoprazole Genoptim that reduces gastric acid secretion.
If you develop a skin rash, especially in sun-exposed areas, inform your doctor immediately, as discontinuation of Pantoprazole Genoptim may be necessary. Also report any other adverse reactions such as joint pain.
About a planned specific blood test (chromogranin A levels).

You must inform your doctor immediately before starting or during treatment
if any of the following symptoms occur, as they may indicate another,
more serious condition:

Unintentional weight loss
Vomiting, especially recurrent
Bloody vomiting, which may appear like dark coffee grounds
Blood in stool, black or tarry stool
Difficulty swallowing or pain during swallowing
Pallor and weakness (anaemia)
Chest pain
Abdominal pain
Severe and/or persistent diarrhoea, as use of this medicine is associated with a small increased risk of infectious diarrhoea.

Your doctor may decide to perform tests to exclude an underlying tumour, 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 body's absorption of vitamin B,
especially if long-term treatment is required. Contact your doctor if you notice
any of the following symptoms, which may indicate low vitamin B levels:

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

If you are taking Pantoprazole Genoptim for a prolonged period (over 1 year), you
are likely to be under continuous medical supervision. In such cases, report any new and unexpected symptoms and the circumstances of their
occurrence during each visit to your doctor.
Children and adolescents
Pantoprazole Genoptim is not recommended for use in children, as its effects have not been studied
in children under 12 years of age.
Pantoprazole Genoptim and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking,
have recently taken, or plan to take, including over-the-counter medicines.
Pantoprazole Genoptim may affect the efficacy of other medicines. Inform your doctor if you are 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); when methotrexate is used, your 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 you are taking fluvoxamine, your doctor may recommend a dose reduction.
Rifampicin (used to treat infections).
St. John's wort ( Hypericum perforatum ) (used in the treatment of mild depression).

Pregnancy, breastfeeding and fertility
Experience with use in pregnant women is limited. It has been shown that the active substance
passes into human milk.
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a
child, you should consult your doctor or pharmacist before using this medicine.
The medicine may be used only if your doctor considers that the benefit outweighs the potential
risk to the unborn child or infant.
Driving and operating machinery
Pantoprazole Genoptim has no effect or negligible effect on the ability to drive
motor vehicles and operate mechanical equipment.
Do not drive motor vehicles or operate mechanical equipment if you experience
adverse reactions such as dizziness or visual disturbances.
Pantoprazole Genoptim contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
3. How to take Pantoprazole Genoptim
Always take this medicine exactly as your doctor or pharmacist has told you. If in
doubt, consult your doctor or pharmacist again.
Method of administration
Take the medicine 1 hour before a meal, without chewing or dividing the tablet. Swallow whole with water.
Recommended dose:
Adults and adolescents aged 12 years and older:

For treatment of symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated with gastroesophageal reflux disease The usual dose is one tablet daily. This dose usually provides relief within 2-4 weeks of treatment - at the latest within the following 4 weeks. Your doctor will decide how long you should continue treatment. Recurrent symptoms can be managed by taking one tablet daily as needed.
For long-term treatment and prevention of recurrence of reflux esophagitis The usual dose is one tablet daily. If symptoms recur, your doctor may recommend doubling the dose. In this case, one tablet of Pantoprazole Genoptim 40 mg daily may be used. After symptoms resolve, the dose may be reduced again to one 20 mg tablet daily.

Adults:

For prevention of duodenal and/or gastric ulcers in patients who must continuously take NSAIDs The usual dose is one tablet daily. Patients with liver function disorders In cases of severe liver disease, do not take more than one 20 mg tablet daily.

Use in children and adolescents
Tablets are not recommended for use in children under 12 years of age.
Taking more Pantoprazole Genoptim than recommended
Inform your doctor or pharmacist. Symptoms of overdose are not known.
Missing a dose of Pantoprazole Genoptim
Do not take a double dose to make up for a missed dose. Take the next scheduled dose at the usual time.
Stopping Pantoprazole Genoptim
Do not stop taking the tablets without first consulting your doctor or pharmacist.
If you have any further questions about the use of this medicine, please consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, stop taking the tablets immediately and contact your doctor or go to the nearest hospital emergency department without delay:

Severe allergic reactions (rare: not more frequent than in 1 out of 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, urticaria (skin rash resembling nettle rash), difficulty breathing, allergic swelling of the face (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, erosion (with slight bleeding) of the eyes, nose, oral cavity/mouth or genital organs, or skin rash, particularly in areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, swelling of 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), 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), potentially leading to kidney failure.

Other adverse reactions occurring:

Common (not more frequent than in 1 out of 10 people): benign gastric polyps.
Uncommon (not more frequent than in 1 out of 100 people): headache; dizziness; diarrhoea; nausea, vomiting; feeling of fullness in the abdomen and bloating with flatulence (passing wind); constipation; dryness of the mouth; abdominal pain and discomfort; skin rash, erythema, skin eruptions; itching of the skin; weakness, fatigue or general malaise; sleep disorders, fractures of the hip, wrist or spine.
Rare (not more frequent than in 1 out of 1,000 people): disturbances 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 limbs (peripheral edema); allergic reactions; depression; breast enlargement in males.
Very rare (not more frequent than in 1 out of 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; tingling and pricking; burning or numbness.

Skin rash possibly associated with joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse reactions identified by blood tests occurring:

Uncommon (not more frequent than in 1 out of 100 people): increased liver enzyme activity.
Rare (not more frequent than in 1 out of 1,000 people): increased bilirubin levels; increased blood lipid levels; sudden decrease in circulating granulocytes – white blood cells, associated with high fever.
Very rare (not more frequent than in 1 out of 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 sodium levels in blood, decreased magnesium levels in blood (see section 2).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects 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 181 C, 02-222 Warsaw, phone: +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 marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Pantoprazole Genoptim
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton (indicated after the EXP symbol). The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines must not be disposed of via wastewater (e.g. toilet or sink) or household waste. Ask your pharmacist what to do with medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Pantoprazole Genoptim contains

The active substance is pantoprazole. Each enteric-coated tablet contains 20 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
Other ingredients are:
Tablet core: mannitol (E 421), crospovidone (Type A), anhydrous sodium carbonate, calcium stearate.
Coating: hypromellose 5 cP (E 464), povidone K25 (E 1201), propylene glycol (E 1520), titanium dioxide (E 171), iron oxide yellow (E 172), methacrylic acid and ethyl acrylate copolymer (1:1) [polysorbate 80, sodium lauryl sulfate], triethyl citrate (E 1505).

What Pantoprazole Genoptim 20 mg enteric-coated tablets look like and contents of the pack
Yellow, oval, biconvex enteric-coated tablets, smooth on both sides (approximately 8.45 mm x 4.20 mm).
Pantoprazole Genoptim 20 mg enteric-coated tablets are available in the following pack sizes: 28, 56, 90 or 100 enteric-coated tablets in blister packs.
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