PANTOPRAZOL MABO-FARMA 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

PantoprazoleMABO-FARMA 20mggastro-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 MABO-FARMA and what is it used for
2. What you need to know before you take Pantoprazole MABO-FARMA
3. How to take Pantoprazole MABO-FARMA
4. Possible side effects
5. Storage of Pantoprazole MABO-FARMA
6. Contents of the pack and other information

1. What is Pantoprazole MABO-FARMA and what is it used for

Pantoprazole MABO-FARMA contains the active substance pantoprazole (as sodium sesquihydrate). Pantoprazole is a selective inhibitor of the "proton pump", a medicine that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach and intestine acid.

Pantoprazole is used in adults and adolescents from 12 years for:

• Treatment of symptoms associated with gastroesophageal reflux disease (such as heartburn, acid regurgitation, pain when swallowing) caused by acid reflux from the stomach.
• Long-term treatment and prevention of relapses of reflux esophagitis (inflammation of the esophagus accompanied by acid regurgitation from the stomach).

Pantoprazole is used in adults for:

Prevention of gastroduodenal ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen) in patients at risk who require continued treatment with this type of medication.

2. What you need to know before you take Pantoprazole MABO-FARMA

Do not take Pantoprazole MABO-FARMA

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medicine:

• If you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor will perform more frequent monitoring of liver enzymes, especially when you are on long-term treatment with pantoprazole. In case of an increase in liver enzymes, treatment should be discontinued.
• If you need to take medicines called NSAIDs continuously and take pantoprazole, as there is a greater risk of developing complications in the stomach and intestine. Any increase in risk will be assessed according to personal risk factors such as age (65 years or older), history of stomach or duodenal ulcers or stomach or intestinal bleeding.
• If you have decreased body reserves of vitamin B12 or risk factors for it and receive treatment with pantoprazole for a long period. Like all medicines that reduce the amount of acid, pantoprazole could reduce the absorption of vitamin B12.
• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV infection treatment) at the same time as pantoprazole.
• Taking a proton pump inhibitor like pantoprazole, especially for more than a year, may increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis (reduced bone density) or if you are taking corticosteroids (which can increase the risk of osteoporosis).
• If you take pantoprazole for more than three months, you may suffer from a decrease in magnesium levels in the blood. Symptoms of low magnesium levels can include fatigue, involuntary muscle contractions, disorientation, dizziness, or increased heart rate. If you have any of these symptoms, inform your doctor immediately. Additionally, low magnesium levels can produce a decrease in potassium and calcium levels in the blood. Your doctor will 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 to reduce stomach acidity.
• If you suffer from a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with pantoprazole. Remember to mention any other symptoms you may notice, such as joint pain.
• If you are scheduled to have a specific blood test (Chromogranin A).

Tell your doctor immediately,before or after taking this medicine, if you notice any of the following symptoms, which may be signs of more serious diseases:

• unintentional weight loss
• vomiting, particularly if it is repeated
• difficulty swallowing or pain when swallowing
• blood in the vomit: it may appear as a dark coffee grounds-like substance in your vomit
• pale appearance and feeling of weakness (anemia)
• chest pain
• stomach pain
• severe or persistent diarrhea, as pantoprazole has been associated with a small increase in infectious diarrhea.
• cases of severe skin reactions have been reported in relation to treatment with pantoprazole, including Stevens-Johnson syndrome, 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.

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

If you take pantoprazole for a prolonged period (more than a year), your doctor may perform regular follow-up. You should inform your doctor of any new or unexpected symptoms and/or events each time you visit your doctor.

Children and adolescents

The use of pantoprazole is not recommended in children as it has not been tested in children under 12 years of age.

Other medicines and Pantoprazole MABO-FARMA

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This is because pantoprazole can influence the effectiveness of other medicines. Inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as pantoprazole may make these and other medicines not work properly.
• Warfarin and phenprocoumon, which affect blood coagulation. You may need additional checks.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily stop treatment with pantoprazole, 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 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 have a specific urine test (for THC, tetrahydrocannabinol).

Pregnancy, breastfeeding, and fertility

There is not enough data on the use of pantoprazole in pregnant women. It has been reported that in humans, pantoprazole is excreted in breast milk.

If you are pregnant or breastfeeding, 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 only use this medicine if your doctor considers that the benefit for you is greater than the potential risk to the fetus or baby.

Driving and using machines

Pantoprazole has no or negligible influence on the ability to drive and use machines.

If you experience side effects such as dizziness or changes in vision (see section 4), do not drive or use machines.

Pantoprazole MABO-FARMA contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Pantoprazole MABO-FARMA

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Method of administration:

Swallow the tablets whole, without chewing or breaking them, with a little water, 1 hour before meals.

The recommended dose is:

Adults and adolescents from 12 years

To treat symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, pain when swallowing)

The recommended dose is 1 tablet per day.

This dose usually provides relief within 2-4 weeks, and if not, at most, within the following 4 weeks. Your doctor will tell you how long you should continue taking the medicine.

Afterwards, any recurring symptoms can be controlled by taking 1 tablet per day as needed.

For long-term treatment and prevention of relapses of reflux esophagitis

The recommended dose is 1 tablet per day. If the disease returns, your doctor may double the dose, in which case you can take pantoprazole 40 mg once a day. After healing, you can reduce the dose back to 1 tablet of 20 mg per day.

Adults

For the prevention of duodenal and stomach ulcers in patients who require continued treatment with NSAIDs

The usual dose is 1 tablet per day.

Patient with liver problems

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

Use in children and adolescents

The use of these tablets is not recommended in children under 12 years of age.

If you take more Pantoprazole MABO-FARMA than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Pantoprazole MABO-FARMA

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

If you stop taking Pantoprazole MABO-FARMA

Do not stop taking these tablets without consulting your doctor or pharmacist first.

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

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 inform your doctor immediately, or contact the emergency department of the nearest hospital:

• Severe allergic reactions (frequency rare):may affect up to 1 in 1,000 patients: swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, swelling of the face of allergic origin (Quincke's edema/angioedema), severe dizziness with very rapid heartbeats and excessive sweating.

• Severe skin disorders (frequency not known):cannot be estimated from the available data: blisters on the skin and rapid deterioration of general conditions, erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals, or sensitivity/ skin rash, particularly in areas of skin exposed to light/sun. You may also have joint pain or symptoms similar to those of the flu, fever, swollen glands (e.g., in the armpit), and blood tests may show changes in certain white blood cells or liver enzymes. (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug hypersensitivity with eosinophilia and systemic symptoms (DRESS), photosensitivity).

• Other serious conditions (frequency not known):yellowing of the skin and the whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increase in kidney size with occasional pain when urinating, and lower back pain (severe kidney inflammation), which may lead to kidney failure.

Other side effects are:

• Common (may affect up to 1 in 10 patients)

Benign polyps in the stomach.

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

Headache; dizziness; diarrhea; feeling of dizziness, vomiting; swelling and bloating (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; tingling; feeling of weakness, fatigue, or general malaise; sleep disturbances, hip, wrist, and spine fractures.

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

Alteration or complete loss of taste; vision disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; high fever, swelling in the limbs (peripheral edema); allergic reactions; depression; increased breast size in men.

• Very rare (may affect up to 1 in 10,000 patients)

Disorientation.

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

Hallucinations, confusion (especially in patients with a history of these symptoms), tingling, pinching, numbness, burning sensation, skin rash, possibly with joint pain, inflammation of the large intestine that causes persistent watery diarrhea.

Side effects identified through blood tests:

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

Increased liver enzymes.

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

Increased bilirubin; increased levels of fat in the blood; sharp drop in white blood cells, associated with high fever.

• Very rare (may affect up to 1 in 10,000 patients)

Reduction in the number of platelets that could lead to bleeding or more bruising than usual; reduction in the number of white blood cells that could lead to more frequent infections; abnormal reduction in the balance between the number of red and white blood cells, as well as platelets.

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

Decrease in 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazole MABO-FARMA

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 shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Composition of Pantoprazol MABO-FARMA

• The active ingredient is pantoprazol. Each gastro-resistant tablet contains 20 mg of pantoprazol (as sodium sesquihydrate).
• The other components are: mannitol, crospovidone, anhydrous sodium carbonate, hydroxypropylcellulose, calcium stearate, hypromellose, yellow iron oxide (E172), red iron oxide (E172), methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion, and triethyl citrate.

Appearance of the Product and Package Contents

Oval, biconvex tablets, orange in color, with an enteric coating, smooth on both sides, with approximate dimensions of 8.70 mm in length and 4.50 mm in width.

Pantoprazol MABO-FARMA tablets are available in blister packs.

Package sizes:

Blister packs: 14, 28, and 56 gastro-resistant tablets.

Marketing Authorization Holder

MABO-FARMA, S.A.

Vía de los Poblados Street, 3, Building 6

28033 Madrid, Spain.

Manufacturer

Misom Labs Ltd

Malta Life Sciences Park

LS2.01.06 Industrial Estate

San Gwann, SGN 3000, Malta

Date of the Last Revision of this Leaflet:08/2024

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