Package Insert: Information for the Patient

Pantoprazol Viatris 40 mg gastro-resistant tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

2. What you need to know before starting to take Pantoprazol Viatris

3. How to take Pantoprazol Viatris

4. Possible adverse effects

5. Storage of Pantoprazol Viatris

6. Contents of the package and additional information

Pantoprazol is a "proton pump inhibitor" that selectively reduces the secretion of stomach acid. It is used to treat diseases related to stomach acid secretion and in the intestine.

Pantoprazol may be used:

Adults and adolescents 12 years and older:

• Esophagitis by reflux. Inflammation of your esophagus (the tube that connects your throat to your stomach), accompanied by the regurgitation of stomach acid.

Adults:

• Infection by a bacteria 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 thereby reduce the risk of these ulcers returning.
• Gastric and duodenal ulcers.

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

Do not take Pantoprazol Viatris:

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Pantoprazol Viatris:

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

If you experience a skin rash, especially in 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 if you need any additional tests to rule out malignant disease, as pantoprazole also alleviates cancer symptoms and may delay diagnosis. If symptoms persist despite treatment, further investigations will be performed.

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

Other medications and Pantoprazol Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication that may alter the effectiveness of other medications:

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

Pregnancy, breastfeeding, and fertility

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

Driving and operating machines

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

Pantoprazol Viatris contains sodium

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

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

When and how should you take Pantoprazol 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 12 years and older:

Treatment of esophagitis by reflux

The recommended dose is one tablet per day. Your doctor may increase your dose to 2 tablets per day. The usual treatment period for esophagitis by reflux is between 4 and 8 weeks. Your doctor will tell you how long you should take the medication.

Adults:

Treatment of an infection caused by a bacteria calledHelicobacter 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), 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 prospectus of these antibiotics. The usual treatment period is 1 to 2 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 medication. 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 acid in the stomach

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, the tablets should be taken twice a day.

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

Special patient groups:

If you take more Pantoprazol Viatris than you should

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

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 medication and the amount ingested), or go to the nearest hospital. Bring the packaging and the remaining tablets with you.

If you forgot to take Pantoprazol Viatris

Do not take a double dose to compensate for the missed doses. Take your next regular dose at the usual time.

If you interrupt the treatment with Pantoprazol Viatris

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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 heartbeats and excessive sweating.
• Reduction in the number of white blood cells and/or red blood cells and/or platelets, which may be seen in a blood test. You may notice more frequent infections, you may bruise or bleed more than normal.

Frequency not known(cannot be estimated from available data)

• Severe skin diseases:You may notice one or more of the following symptoms-blistering on the skin and rapid deterioration of your general condition, erosion (including light bleeding) of the eyes, nose, mouth/lips or genitals, skin sensitivity/irritation, particularly in areas of the skin exposed to light/ the sun. You may also have joint pain or flu-like symptoms, fever, swollen lymph nodes (e.g. in the armpit) and blood tests may show changes in certain white blood cells or liver enzymes..
• Lightly reddish spots, in the shape of a bull's eye or circular on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals and eye ulcers. These severe exanthems may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

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

Other severe diseases:yellow discoloration of the skin or white discoloration of the eyes (severe liver cell damage, jaundice) or fever, skin rash and kidney swelling, sometimes with urinary pain and mild back pain (severe kidney inflammation that may worsen to renal failure).

Other side effects are:

Frequent(may affect up to 1 in 10 people)

• Benign polyps in the stomach.

Occasional(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 discomfort; sleep disturbances; hip, wrist or spinal column fractures.

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

• Alteration or complete loss of taste, visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; elevated body temperature; swelling of the extremities (peripheral edema); 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); feeling ofpinching, numbness, tingling, burning sensation or numbness, inflammation of the large intestine causing persistent watery diarrhea..

Side effects identified through blood tests:

• Occasional(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 available data)

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

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

For blister pack:This medication does not require special storage conditions.

For PVC/PE/PVdC blister packs:Do not store at a temperature above 25°C.

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

Medications should not be disposed of through drains or trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pantoprazol Viatris

The active ingredient 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 a copolymer of methacrylic acid and ethyl acrylate (1:1), sodium lauryl sulfate, polisorbate 80, triethyl citrate, hypromellose, titanium dioxide, macrogol 400, and yellow iron oxide.

Appearance of the product and contents of the package

Pantoprazol Viatris are yellow banana-colored, oval-shaped, biconvex tablets, approximately 5.7 mm x 11.6 mm, that are white on both sides. They are available in plastic bottles and blisters.

HDPE white 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 sachet containing silica gel and activated carbon to protect the tablets from moisture. The bag or sachet cannot 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 layer packaged in cardboard boxes containing 7, 7x1, 14, 14x1, 28, 28x1, 30, 56, 70, 70x1, 96, 98 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturers

McDermott Laboratories Ltd. T/A Gerard Laboratories.

35/36 Baldoyle Industrial Estate

Grange Road, Dublin 13

Ireland

or

Mylan Hungary Kft

H-2900 Komárom

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 more information about this medication, please contact 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 with the following names:

Country Medication 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

Last reviewed date of this leaflet: August 2024

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es