PANTOPRAZOL VIATRIS 40 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

Pantoprazole Viatris 40 mg Gastro-Resistant Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

Pantoprazole is a selective “proton pump inhibitor” that reduces stomach acid secretion. It is used to treat diseases related to stomach acid secretion in the stomach and intestine.

Pantoprazole may be used:

Adults and adolescents from 12 years:

• Reflux esophagitis. Inflammation of your esophagus (the tube that connects 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 goal is to eliminate the bacteria and thus reduce the risk of these ulcers returning.
• Gastric and duodenal ulcers.

Zollinger-Ellison syndrome and other diseases that produce too much stomach acid.

2. What you need to know before you take Pantoprazole Viatris

Do not take Pantoprazole Viatris:

• If you are allergic to pantoprazole or 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:

Consult your doctor or pharmacist before starting to take Pantoprazole 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. In case of increased liver enzymes, treatment should be stopped.
• If you have a vitamin B12 deficiency or risk factors caused by this deficiency and receive pantoprazole long-term. Like all acid-reducing agents, pantoprazole may lead to a decrease in vitamin B12 absorption. Consult your doctor if you notice any of the following symptoms, as they may indicate a vitamin B12 deficiency:
• Extreme fatigue or lack of energy
• Numbness
• Pain in the tongue or red tongue, mouth ulcers
• Muscle weakness
• Visual disturbances
• Memory problems, confusion, depression
• If you are taking medicines with atazanavir (for HIV infection treatment) at the same time as pantoprazole, ask your doctor for advice.
• Taking a proton pump inhibitor like pantoprazole, especially for a period of more than one year, may slightly increase your risk of fracture in the hip, wrist, or spine. Inform your doctor if you have osteoporosis (reduced bone density) or if you 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, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also produce a decrease in blood potassium and calcium levels. 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.
• Severe skin reactions have been reported in relation to the use of pantoprazole, including Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis, drug hypersensitivity with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking pantoprazole and call your doctor immediately if you experience any of the symptoms related to severe skin reactions described in section 4.
• If you are scheduled to have a specific blood test (Chromogranin A).

Tell your doctor immediatelyif you notice any of the following symptoms:

• Unintentional weight loss.
• Recurring vomiting.
• Difficulty swallowing.
• Blood in vomit.
• Pale appearance and feeling of weakness (anemia).
• Blood in your stools.
• Severe and/or persistent diarrhea, as pantoprazole has been associated with a small increase in infectious diarrhea.

If you experience a skin rash, especially in areas exposed to the sun, inform your doctor as soon as possible, as you may need to stop treatment with pantoprazole. Also, mention other side effects such as joint pain.

Your doctor will decide if you need any additional tests to rule out a malignant disease because pantoprazole also relieves the symptoms of cancer and could delay its diagnosis. If, despite treatment, the symptoms persist, complementary tests will be performed.

If you take pantoprazole long-term (more than 1 year), your doctor will probably want to see you regularly. You should inform your doctor about any new and exceptional symptoms and any circumstances each time you see your doctor.

Other medicines and Pantoprazole Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines that may alter the effectiveness of other medicines:

• Medicines such as ketoconazole, itraconazole, and posaconazole (for fungal infection treatment) or erlotinib (for certain types of cancer treatment), as pantoprazole may cause these and other similar medicines to not work properly.
• Warfarin and phenprocoumon, which affect blood thickness. You may need more checks.
• Atazanavir (for HIV infection treatment) (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 diseases); if you are taking fluvoxamine, your doctor may reduce your dose.
• Rifampicin (used for infection treatment).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

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

Pregnancy, breastfeeding, and fertility

There are no adequate data on the use of pantoprazole in pregnant women. It has been observed to pass into breast milk. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. You should only take this medicine if your doctor considers that the benefits of treatment outweigh the risks to the baby.

Driving and using machines

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

Pantoprazole Viatris contains sodium

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

3. How to take Pantoprazole Viatris

Follow the instructions for administration of this medicine exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

When and how should you take Pantoprazole Viatris?

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

Unless your doctor tells you otherwise, the recommended dose is:

Adults and adolescents from 12 years:

Treatment of reflux esophagitis

The recommended dose is one tablet per day. Your doctor may increase your dose to 2 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 with a bacterium called Helicobacter pylori(H. pylori) in patients with gastric and duodenal ulcers in combination with two antibiotics (Eradication Therapy)

One tablet, twice a day, plus two tablets of amoxicillin, clarithromycin, and metronidazole (or tinidazole) antibiotics, each to be taken twice a day 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 to read the package leaflet of these antibiotics. The usual treatment period is one to two weeks.

Treatment of gastric and duodenal ulcers

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

Long-term treatment of Zollinger-Ellison syndrome and other diseases that produce too much stomach acid

The initial recommended dose is usually two tablets per day.

Take the two tablets 1 hour before a meal. Then, your doctor may adjust your dose, depending on the amount of stomach acid you produce. If you are prescribed more than two tablets per day, take the tablets twice a day.

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

Special patient groups:

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

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

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

If you take more Pantoprazole Viatris than you should

Consult your doctor or pharmacist. No symptoms are known in case of overdose.

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

If you forget to take Pantoprazole Viatris

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

If you stop taking Pantoprazole Viatris

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

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

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

• Severe skin diseases:you may notice one or more of the following symptoms - blisters on the skin and rapid deterioration of your general condition, erosion (including slight bleeding) of the eyes, nose, mouth/lips, or genitals, skin sensitivity/irritation, particularly in areas of the skin exposed to light/sun. You may also have 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.
• Light reddish spots, target-shaped or circular on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat ulcers, nose ulcers, genital ulcers, and eye ulcers. These severe rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• Generalized rash, elevated body temperature, and lymph node enlargement (DRESS or drug hypersensitivity syndrome).

Other severe diseases: yellowing of the skin or white coloring of the eyes (severe liver cell damage, jaundice) or fever, skin rash, and kidney swelling, sometimes with pain when urinating and mild back pain (severe kidney inflammation that can worsen to kidney failure).

Other side effects are:

Common(may affect up to 1 in 10 people)

• Benign polyps in the stomach.

Uncommon(may affect up to 1 in 100 people)

• Headache; dizziness; diarrhea; nausea, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, pruritus; itching; feeling of weakness, fatigue, or general malaise; sleep disorders; hip, wrist, or spine fractures.

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

• Alteration or complete loss of taste, vision changes such as blurred vision; urticaria; joint pain; muscle pain; weight changes; elevated body temperature; peripheral edema (swelling of the extremities); depression; breast enlargement in men.

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

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

Side 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 triglycerides in the blood.

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

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

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side 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 which is stated on the carton after CAD or EXP. The expiry date is the last day of the month shown.

For blister packs: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 should not be disposed of via wastewater or household waste. Return the containers and any unused medicine to a pharmacy for proper disposal. By doing so, you will help protect the environment.

6. Container Contents and Additional Information

Pantoprazol Viatris Composition

The active ingredient is pantoprazol sodium sesquihydrate, equivalent to 40 mg of pantoprazol.

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

Product Appearance and Container Contents

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

White HDPE bottle with a 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 packet containing silica gel and activated carbon to protect the tablets from moisture. The bag or packet should not be eaten and should not be removed from the bottle.

Aluminum blister, with or without a desiccant layer, packaged in cardboard boxes containing 7, 7x1, 14, 14x1, 28, 28x1, 30, 56, 70, 70x1, 96, 98 tablets.

PVC/PE/PVdC blister with an aluminum foil packaged in cardboard boxes containing 7, 7x1, 14, 14x1, 28, 28x1, 30, 56, 70, 70x1, 96, 98 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Area under the following names:

CountryMedication 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-resistant

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 last revision of this leaflet:August 2024

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