PANTOPRAZOL VIATRIS 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

Pantoprazole Viatris 20 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 acid secretion in the stomach and intestine.

Pantoprazole may be used:

Adults and adolescents from 12 years:

• Treatment of symptoms (e.g. heartburn, acid regurgitation, pain when swallowing) associated with gastro-oesophageal reflux disease, caused by acid reflux from the stomach.
• Long-term treatment and prevention of relapses of reflux oesophagitis (inflammation of the oesophagus accompanied by acid regurgitation from the stomach).

Adults:

• Prevention of gastroduodenal ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen), in patients at risk who require continued NSAID treatment.

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 problems with your liver 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 need to take NSAID medicines continuously and receive pantoprazole, as you have a higher risk of developing stomach and intestinal complications. Any increase in risk will be assessed according to your own personal risk factors, such as your age (65 years or older), history of gastric or duodenal ulcers or stomach or intestinal bleeding.
• If you have a vitamin B12 deficiency or risk factors caused by this deficiency and receive long-term pantoprazole. 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
• Tingling
• Pain in the tongue or red tongue, mouth ulcers
• Muscle weakness
• Vision problems
• Memory problems, confusion, depression

• If you are taking medicines containing 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 (e.g. if you are taking corticosteroids).
• If you are taking pantoprazole for more than three months, your magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, see your doctor immediately. Low magnesium levels can also lead to a decrease in potassium and calcium levels 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 that reduces stomach acid.
• Severe skin reactions have been reported in association with the use of pantoprazole, including Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and erythema multiforme. Stop taking pantoprazole and contact 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.
• Repeated vomiting.
• Difficulty swallowing.
• Blood in the vomit.
• Pale appearance and feeling of weakness (anaemia).
• Blood in your stools.
• Severe and/or persistent diarrhoea, as pantoprazole has been associated with a small increase in infectious diarrhoea.

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, as pantoprazole also relieves the symptoms of cancer and may delay its diagnosis. If, despite treatment, symptoms persist, additional tests will be performed.

If you take pantoprazole for a long time (more than 1 year), your doctor will probably want to see you regularly. You should inform your doctor about any new or 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 affect the efficacy 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 disorders), if you are taking fluvoxamine, your doctor may reduce the 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, breast-feeding 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 breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should take this medicine only if your doctor considers that the benefits of treatment are greater than the risks for 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, i.e. it 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 symptoms (e.g. heartburn, acid regurgitation, pain when swallowing) associated with gastro-oesophageal reflux disease

The recommended dose is one tablet per day. Healing is usually achieved in 2-4 weeks - at the latest, another 4 weeks. Your doctor will tell you how long you should continue to take the medicine. After that, any other recurrent symptoms can be controlled by taking 1 tablet per day, as needed.

Long-term treatment and prevention of relapses of reflux oesophagitis

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

Adults:

Prevention of gastroduodenal ulcers in patients at risk who require 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 one 20 mg tablet per day.

• 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, telephone 91 562 04 20 (indicating the medicine and the amount ingested), or go to the nearest hospital. Bring the package and the 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 casualty 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 oedema/angioedema), severe 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 red, target-like or circular patches on the trunk, often with blisters in the centre, 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, high body temperature and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

Other serious diseases: yellowing of the skin or white colouring of the eyes (serious 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; diarrhoea; 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; fracture of the hip, wrist or spine.

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

• Alteration or complete loss of taste, changes in vision 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 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 diarrhoea.

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 they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: 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 EXP. The expiry date is the last day of the month stated.

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

For PVC/PE/PVdC blister packs: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 medicines to a pharmacy for disposal. By doing this, you will help protect the environment.

6. Container Content and Additional Information

Pantoprazol Viatris Composition

The active ingredient is pantoprazol sodium sesquihydrate, equivalent to 20 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 Content

Pantoprazol Viatris are film-coated tablets with a yellow ocher color, oval, approximately 4.3 mm x 8.4 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, 14, 14x1, 28x1, 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 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

For further information on this medicinal product, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

CountryMedicinal Product Name

Germany Pantoprazol dura 20 mg magensaftresistente Tabletten

Belgium Pantoprazole Viatris 20 mg maagsapresistente tabletten

Denmark Pantoprazol Viatris enterotabletter 20 mg

Slovakia Pantomyl 20 mg

Slovenia PANSEMYL 20 mg gastrorezistentne tablete

Spain Pantoprazol Viatris 20 mg comprimidos gastrorresistentes EFG

Finland Pantoprazol Viatris 20 mg enterotabletti

France PANTOPRAZOLE VIATRIS 20 mg comprimé gastro-resistant

Ireland Pantoprazole Mylan 20 mg Gastro-resistant tablets

Luxembourg Pantoprazole Viatris 20 mg comprimé gastro-résistant

Malta Pantoprazole Mylan 20 mg Gastro-resistant tablets

Netherlands Pantoprazol Viatris 20 mg maagsapresistente tabletten

Poland Pamyl 20 mg tabletki dojelitowe

Portugal Pantoprazol Mylan 20 mg Comprimido gastrorresistente

Sweden Pantoprazol Viatris 20 mg enterotabletter

Date of the Last Revision of this Leaflet:August 2024

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