Follow exactly the administration instructions of this medication as 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 symptoms (e.g. stomach burning, acid regurgitation, difficulty swallowing) associated with gastroesophageal reflux disease

The recommended dose is one tablet per day. General healing usually occurs within 2-4 weeks - at most, another 4 weeks. Your doctor will tell you how long you should continue taking the medication. After that, any other recurring symptoms can be controlled by taking1 tablet per day, as needed.

Long-term treatment and prevention of esophagitis relapse due to reflux

The recommended dose is one tablet per day. If the disease reappears, your doctor may double the dose, in these cases you can take pantoprazol 40 mg tablets, one per day. Once healing is achieved, you can reduce the dose again to 1 tablet of 20 mg per day.

Adults:

Prevention of gastric and duodenal ulcers in high-risk patients requiring continued NSAID treatment

The recommended dose is one tablet per day.

Special patient groups:

• If you have severe liver problems, do not take more than 1 tablet of 20 mg per day.

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

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 Toxicological Information Service, phone 91 562 04 20 (indicating the medication and the amount ingested), or go to the nearest hospital. Bring the packaging and 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 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 nearest hospital's emergency service:

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, allergic facial 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.

Unknown frequency(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 form 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 exanthem, 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 painful urination 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, exanthem, 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.

Unknown frequency(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.

• Unknown frequency(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 pack: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. This will help protect the environment.

Pantoprazol Viatris Composition

The active ingredient is pantoprazole sodium sesquihydrate, equivalent to 20 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.

Product Appearance and Packaging Contents

Pantoprazol Viatris are yellow ochre-coated, oval-shaped, biconvex tablets, approximately 4.3 mm x 8.4 mm in size, with white faces. 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 consumed and should not be removed from the bottle.

Aluminum blister, with or without a desiccant layer, packaged in cardboard boxes containing 7, 14, 14x1.28, 28 x 1, 30, 56, 70, 70x1, 96, or 98 tablets.

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

Only some packaging 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 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 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 European Economic Area with the following names:

CountryMedication Name

GermanyPantoprazol dura 20 mg magensaftresistente Tabletten

BelgiumPantoprazole Viatris 20 mg maagsapresistente tabletten

DenmarkPantoprazol Viatris enterotabletter 20 mg

SlovakiaPantomyl 20 mg

SloveniaPANSEMYL 20 mg gastrorezistentne tablete

SpainPantoprazol Viatris 20 mg comprimidos gastrorresistentes EFG

FinlandPantoprazol Viatris 20 mg enterotabletti

FrancePANTOPRAZOLE VIATRIS 20 mg comprimé gastro-resistant

IrelandPantoprazole Mylan 20 mg Gastro-resistant tablets

LuxembourgPantoprazole Viatris 20 mg comprimé gastro-résistant

MaltaPantoprazoleMylan20 mg Gastro-resistant tablets

NetherlandsPantoprazol Viatris 20 mg maagsapresistente tabletten

PolandPamyl 20 mg tabletki dojelitowe

PortugalPantoprazol Mylan 20 mg Comprimido gastrorresistente

SwedenPantoprazol Viatris 20 mg enterotabletter

Last reviewed date of this leaflet:August 2024

For detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/