Pantoprazole Viatris 40 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Pantoprazole Viatris 40 mg gastro-resistant tablets EFG

Read the entire leaflet carefully before you start 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Pantoprazol Viatris is and what it is used for

Pantoprazole is a selective "proton pump inhibitor" that reduces gastric acid secretion. It is used to treat conditions related to acid secretion in the stomach and intestine.

Pantoprazole may be used:

Adults and adolescents aged 12 years and older:

• Reflux esophagitis. Inflammation of the esophagus (the tube connecting your throat to your stomach), accompanied by regurgitation of stomach acid.

Adults:

• Infection with a bacterium called Helicobacter pylori (H. pylori) in patients with gastric and duodenal ulcers, in combination with two antibiotics (eradication therapy). The aim is to eliminate the bacteria and thereby reduce the risk of recurrence of these ulcers.
• Gastric and duodenal ulcers.

Zollinger-Ellison syndrome and other conditions causing excessive stomach acid production.

2. What you need to know before taking Pantoprazol Viatris

Do not take Pantoprazol Viatris:

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

Warnings and precautions:

Talk to your doctor or pharmacist before taking Pantoprazol Viatris:

• If you have severe liver disease. Please inform your doctor if you have ever had liver problems in the past. Your doctor will monitor your liver enzymes more frequently, especially if you are taking pantoprazole as long-term treatment. If liver enzymes increase, treatment should be stopped.
• If you have vitamin B12 deficiency or risk factors for such deficiency and are receiving long-term pantoprazole treatment. As with all agents that reduce acid, pantoprazole may lead to decreased absorption of vitamin B12. Consult your doctor if you notice any of the following symptoms, as they may indicate vitamin B12 deficiency:
• Extreme tiredness or lack of energy
• Tingling
• Tongue pain or red tongue, mouth ulcers
• Muscle weakness
• Vision disorders
• Memory problems, confusion, depression
• If you are taking medications containing atazanavir (for treatment of HIV infection) at the same time as pantoprazole, consult your doctor for advice.
• Taking a proton pump inhibitor such as pantoprazole, particularly for more than one year, may slightly increase your risk of fracture of the hip, wrist, or spine. Inform your doctor if you have osteoporosis (reduced bone density) or have been told you are at risk of osteoporosis (for example, if you are taking corticosteroids).
• If you are taking pantoprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to pantoprazole that reduces stomach acidity.
• Serious skin adverse reactions have been reported with the use of pantoprazole, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking pantoprazole and contact your doctor immediately if you experience any symptoms related to serious skin reactions described in section 4.
• If you are scheduled to have a specific blood test (Chromogranin A).

Contact your doctor immediately if you notice any of the following symptoms:

• Unintentional weight loss.
• Repeated vomiting.
• Difficulty swallowing.
• Blood in vomit.
• Pale appearance and feeling weak (anaemia).
• Blood in your stools.
• Severe and/or persistent diarrhoea, as pantoprazole has been associated with a small increased risk of infectious diarrhoea.

If you develop a skin rash, especially in sun-exposed areas, inform your doctor as soon as possible, as you may need to discontinue treatment with pantoprazole. Remember to also mention other adverse effects such as joint pain.

Your doctor will decide whether additional tests are needed to rule out malignancy, as pantoprazole also relieves symptoms of cancer and could delay its diagnosis. If symptoms persist despite treatment, further investigations will be carried out.

If you take pantoprazole long-term (more than 1 year), your doctor will likely want to see you regularly. You should inform your doctor of any new or unusual symptoms and any changes in your condition at each visit.

Other medicines and Pantoprazol Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines that could affect the efficacy of other medicines:

• Medicines such as ketoconazole, itraconazole, and posaconazole (for treatment of fungal infections) or erlotinib (for treatment of certain types of cancer), as pantoprazole may cause these and similar medicines to be less effective.
• Warfarin and phenprocoumon, which affect blood clotting. You may need more frequent monitoring.
• Atazanavir (for treatment of HIV infection) (see section “Warnings and precautions”).
• Methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancer), as pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric disorders); your doctor may reduce your dose if you are taking fluvoxamine.
• Rifampicin (used to treat infections).
• St. John’s wort (Hypericum perforatum) (used to treat mild depression).

Talk to your doctor before taking pantoprazole if you need to undergo a specific urine test (for THC, tetrahydrocannabinol).

Pregnancy, breastfeeding, and fertility

There are insufficient data on the use of pantoprazole in pregnant women. It has been observed that pantoprazole passes into breast milk. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. You should take this medicine only if your doctor considers that the benefits of treatment outweigh the risks to the baby.

Driving and using machines

If you experience adverse effects such as dizziness or blurred vision, you should not drive or operate machinery.

Pantoprazol Viatris contains sodium

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

3. How to take Pantoprazol Viatris

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

When and how should you take Pantoprazol Viatris?

Take the tablets 1 hour before a meal, without chewing or crushing them, swallowing them whole with a little water.

Unless otherwise directed by your doctor, the recommended dose is:

Adults and adolescents aged 12 years and older:

Treatment of reflux esophagitis

The recommended dose is one tablet per day. Your doctor may increase your dose to two tablets per day. The usual treatment period for reflux esophagitis is between 4 and 8 weeks. Your doctor will tell you how long you should take the medicine.

Adults:

Treatment of infection by a bacterium called Helicobacter pylori (H. pylori) in patients with gastric and duodenal ulcers, in combination with two antibiotics (Eradication therapy)

One tablet twice daily, plus two antibiotics (amoxicillin, clarithromycin, and metronidazole (or tinidazole)), each to be taken twice daily together with your pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second pantoprazole tablet 1 hour before dinner. Follow your doctor's instructions and make sure you read the package leaflet of these antibiotics. The usual treatment duration is one to two weeks.

Treatment of gastric and duodenal ulcers

The recommended dose is one tablet per day. After consulting with your doctor, the dose may be doubled. Your doctor will tell you how long you should take your medicine. The usual treatment duration for gastric ulcers is between 4 and 8 weeks. The usual treatment duration for duodenal ulcers is between 2 and 4 weeks.

Long-term treatment of Zollinger-Ellison syndrome and other conditions causing excessive stomach acid production

The usual recommended initial dose is two tablets per day.

Take both tablets 1 hour before a meal. Your doctor may then adjust your dose depending on the amount of stomach acid you produce. If more than two tablets per day are prescribed, the tablets should be taken twice daily.

If your doctor prescribes a daily dose of more than four tablets per day, they will tell you exactly when to stop taking the medicine.

Special patient groups:

• If you have kidney problems, or moderate to severe liver problems, you should not take pantoprazole for Helicobacter pylori eradication.

• If you have severe liver problems, you should not take more than one 20 mg tablet per day (tablets containing 20 mg of pantoprazole are available for this purpose).

• Children under 12 years: It is not recommended that children under 12 years of age take these tablets.

If you take more Pantoprazol Viatris than you should

Consult your doctor or pharmacist. Symptoms of overdose are not known.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, call the Toxicology Information Service at telephone number 91 562 04 20 (indicating the medicine and the amount ingested), or go to the nearest hospital. Take the packaging and any remaining tablets with you.

If you forget to take Pantoprazol Viatris

Do not take a double dose to make up for forgotten doses. Take your next dose at the usual time.

If you stop taking Pantoprazol Viatris

Do not stop taking the tablets without talking to your doctor or pharmacist.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience any of the following adverse effects, stop taking these tablets immediately and contact a doctor straight away or go to the nearest hospital emergency department:

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

• Severe allergic reactions: swelling of the tongue and/or throat, difficulty swallowing, hives (rash), difficulty breathing, allergic facial swelling (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and excessive sweating.
• Reduction in the number of white and red blood cells and/or platelets, which may be seen in a blood test. You may notice more frequent infections, or may bruise or bleed more than usual.

Frequency not known (cannot be estimated from available data)

• Serious skin diseases: you may notice one or more of the following symptoms – skin blisters and rapid deterioration in your general condition, erosion (including slight bleeding) of the eyes, nose, mouth/lips or genitals, skin sensitivity/irritation, particularly in areas of skin exposed to light/sun. You may also experience joint pain or flu-like symptoms, fever, swollen glands (e.g. in the armpit), and blood tests may show changes in certain white blood cells or liver enzymes.
• Slightly reddish, target-shaped or circular rashes on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other serious illnesses: yellowing of the skin or whitening of the eyes (severe liver cell damage, jaundice), or fever, skin rash and kidney swelling, sometimes with pain on urination and mild back pain (severe kidney inflammation which may worsen to kidney failure).

Other adverse effects are:

Common (may affect up to 1 in 10 people)

• Benign gastric polyps.

Uncommon (may affect up to 1 in 100 people)

• Headache; dizziness; diarrhoea; nausea, vomiting; bloating and flatulence; constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, pruritus; itching; feeling of weakness, exhaustion or general malaise; sleep disorders; hip, wrist or spinal fracture.

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

• Disturbance or complete loss of taste sensation; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; swelling of the limbs (peripheral oedema); depression; breast enlargement in men.

Frequency not known (cannot be estimated from available data)

• Hallucinations, confusion (especially in patients with a history of these symptoms); tingling sensation, numbness, pins and needles, burning or tingling sensation, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse effects identified through blood tests:

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

Increased liver enzymes.

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

Increased bilirubin; increased blood triglycerides.

• Frequency not known (cannot be estimated from available data)

Decreased levels of sodium, magnesium, calcium or potassium in the blood (see section 2).

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazole Viatris

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 CAD or EXP. The expiry date is the last day of the month indicated.

For blisters: This medicine does not require any special storage conditions.

For PVC/PE/PVdC blisters: Do not store above 25°C.

For HDPE bottles: Once opened, use within 100 days. Keep the container tightly closed to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and any unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazol Viatris

The active substance is pantoprazole sodium sesquihydrate, equivalent to 40 mg of pantoprazole.

The other components are sodium carbonate, mannitol, crospovidone, povidone and calcium stearate. The coating contains methacrylic acid copolymer and ethyl acrylate (1:1), sodium lauryl sulfate, polysorbate 80, triethyl citrate, hypromellose, titanium dioxide, macrogol 400 and yellow iron oxide.

Appearance of the product and contents of the pack

Pantoprazol Viatris are yellowish-banana coloured, oval, film-coated tablets, approximately 5.7 mm x 11.6 mm, biconvex, with blank faces on both sides. They are available in plastic bottles and blisters.

White HDPE bottle with screw cap containing 14, 28, 30, 50, 56, 60, 90, 98, 100 or 250 tablets. The bottle also contains a small plastic bag with silica gel or a sachet containing silica gel and activated carbon, to protect the tablets from moisture. The bag or sachet is not edible and must not be removed from the bottle.

Aluminium blister, with or without a desiccant layer, packed in cardboard cartons containing 7, 7x1, 14, 14x1, 28, 28x1, 30, 56, 70, 70x1, 96, 98 tablets.

PVC/PE/PVdC blister with aluminium foil, packed in cardboard cartons containing 7, 7x1, 14, 14x1, 28, 28x1, 30, 56, 70, 70x1, 96, 98 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturers

Mcdermott Laboratories Ltd. T/A Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road, Dublin 13
Ireland

or

Mylan Hungary Kft
H-2900 Komarom
Mylan utca 1
Hungary

or

Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Höhe
Benzstrasse 1, 61352 Bad Homburg v. d. Höhe
Germany

or

Logiters, Logística Portugal, S.A.
Estrada dos Arneiros, 4
Azambuja, 2050-306
Portugal

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorised in the European Economic Area member states under the following names:

Country Medicinal product name

Germany Pantoprazol dura 40 mg magensaftresistente Tabletten
Belgium Pantoprazole Viatris 40 mg maagsapresistente tabletten
Denmark Pantoprazol Viatris enterotabletter 40 mg
Slovakia Pantomyl 40 mg
Spain Pantoprazol Viatris 40 mg comprimidos gastrorresistentes EFG
Finland Pantoprazol Viatris 40 mg enterotabletti
France Pantoprazole Viatris 40 mg comprimé gastro-résistant
Greece Pantoprazole/Mylan Generics 40 mg tablets
Ireland Pantoprazole Mylan 40 mg Gastro-resistant tablets
Luxembourg Pantoprazole Viatris 40 mg comprimé gastro-résistant
Malta Pantoprazole Mylan 40 mg Gastro-resistant tablets
Netherlands Pantoprazol Viatris 40 mg maagsapresistente tabletten
Poland Pamyl 40 mg tabletki dojelitowe
Portugal Pantoprazol Mylan 40 mg Comprimido gastrorresistente
Czech Republic Pantomyl 40 mg enterosolventní tablety
Sweden Pantoprazol Viatris 40 mg enterotabletter

Date of the latest revision of this leaflet: August 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) https://www.aemps.gob.es/