Pantoprazole Mabo 40 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pantoprazole MABO 40 mg gastro-resistant tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Pantoprazole is a selective "proton pump inhibitor", a medicine that reduces the amount of acid produced in your stomach. It is used to treat acid-related disorders of the stomach and intestine.

Pantoprazole is used for:

Adults and adolescents aged 12 years and older:

• Treatment of symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, painful swallowing) caused by reflux of acid from the stomach.

• Long-term treatment and prevention of relapses of reflux esophagitis (inflammation of the esophagus accompanied by acid regurgitation from the stomach).

Adults:

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

2. What you need to know before starting to take Pantoprazole MABO

Do not take Pantoprazole

• If you are allergic (hypersensitive) to pantoprazole, to soya lecithin, or to any of the other ingredients of pantoprazole (see section 6)
• If you are allergic to medicines containing other proton pump inhibitors (e.g., omeprazole, lansoprazole, rabeprazole, esomeprazole)

Warnings and precautions

Talk to your doctor or pharmacist before taking pantoprazole if you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor may monitor your liver enzymes more frequently, especially if you are on long-term treatment with pantoprazole. If liver enzymes increase, treatment should be discontinued.

• If you need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously while taking pantoprazole, as there is an increased risk of developing stomach and intestinal complications. Any increase in risk will be assessed according to personal risk factors such as age (65 years or older), history of stomach or duodenal ulcer, or gastrointestinal bleeding.

• If you have reduced body stores of vitamin B12 or risk factors for this, and are receiving long-term pantoprazole treatment. Like all medicines that reduce acid levels, pantoprazole may reduce the absorption of vitamin B12.

• Talk to your doctor if you are taking a medicine containing atazanavir (for the treatment of HIV infection) at the same time as pantoprazole.

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

• Unintentional weight loss
• Repeated vomiting
• Difficulty swallowing
• Blood in vomit
• Pale appearance and feeling weak (anaemia)
• Blood in your stools
• Severe or persistent diarrhoea, as pantoprazole has been associated with a small increased risk of infectious diarrhoea.

Your doctor will decide whether you need additional tests to rule out a malignant disease, as pantoprazole may relieve symptoms of cancer and could delay diagnosis. If your symptoms persist despite treatment, further investigations will be carried out.

If you take pantoprazole for a prolonged period (more than one year), your doctor may monitor you regularly. You should inform your doctor of any new or unexpected symptoms or events at each visit.

Talk to your doctor before starting Pantoprazole MABO

• If you have ever had a skin reaction after treatment with a medicine similar to pantoprazole used to reduce stomach acid.
• If you develop a skin rash, especially on areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop treatment with pantoprazole. Remember to mention any other symptoms you may experience, such as joint pain.
• If you take pantoprazole for more than three months, you may experience a decrease in blood magnesium levels. Symptoms of low magnesium levels may include fatigue, involuntary muscle spasms, confusion, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. In addition, low magnesium levels may lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Before taking this medicine, inform your doctor if:

• A specific blood test (Chromogranin A) is planned

Other medicines and pantoprazole

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Pantoprazole may affect the effectiveness of other medicines; therefore, inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as pantoprazole may cause these and other medicines to be less effective.

• Warfarin and phenprocoumon, which affect blood clotting. You may require additional monitoring.

• Atazanavir (used for the treatment of HIV infection).

Pregnancy and breastfeeding

There are insufficient data on the use of pantoprazole in pregnant women. It has been reported that pantoprazole is excreted in human breast milk. If you are pregnant, think you may be pregnant, or are breastfeeding,

you should only use this medicine if your doctor considers that the benefit to you outweighs the potential risk to the fetus or infant.

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

You should not drive or operate machinery if you experience adverse effects such as dizziness or blurred vision.

Pantoprazole MABO contains soya lecithin

This medicine contains soya lecithin. It must not be used if you are allergic to peanuts or soya.

Pantoprazole MABO contains maltitol (E-965)

This medicine contains maltitol. If your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor before taking this medicine.

Pantoprazole MABO contains sodium

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

3. How to take Pantoprazol MABO

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist.

When and how should you take Pantoprazol?

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

Unless your doctor has instructed you otherwise, the recommended dose is:

Adults and adolescents aged 12 years and older:

For the treatment of reflux esophagitis:

The usual dose is one tablet daily. Your doctor may instruct you to increase the dose to 2 tablets daily. The treatment duration for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will advise you on how long you should take this medicine.

Adults:

For the treatment of infection with a bacterium called Helicobacter pylori in patients with gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy)

One tablet twice daily, plus two antibiotic tablets—either amoxicillin, clarithromycin, and metronidazole (or tinidazole)—each to be taken twice daily together with your pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second 1 hour before dinner. Follow your doctor's instructions and be sure to read the package leaflets of the antibiotics.

The duration of treatment is normally one to two weeks.

For the treatment of gastric and duodenal ulcers:

The usual dose is one tablet per day. Your doctor may double the dose.

Your doctor will inform you how long you should take this medicine. The treatment duration for gastric ulcers is usually between 4 and 8 weeks. The treatment duration for duodenal ulcers is normally between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions in which there is increased gastric acid secretion:

The recommended initial dose is two tablets per day.

Take both tablets 1 hour before a meal. Subsequently, your doctor may adjust your dose depending on the amount of gastric acid secreted. If more than two tablets per day are prescribed, you should take the tablets in two divided doses daily.

If you are prescribed more than four tablets per day, you will be informed exactly when to stop treatment.

Special patient groups:

• If you have kidney problems or moderate to severe liver problems, you should not take pantoprazole for the eradication of Helicobacter pylori.

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

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 than you should:

Inform your doctor or pharmacist or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested. There are no known symptoms of overdose.

If you forget to take Pantoprazole:

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

If you stop taking Pantoprazole:

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

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

4. Possible adverse effects

Like all medicines, Pantoprazole may cause adverse effects, although not everyone experiences them.

The frequency of the possible adverse effects described below is classified as follows:

very common (affects more than 1 in 10 people)
common (affects between 1 and 10 in 100 people)
uncommon (affects between 1 and 10 in 1,000 people)
rare (affects between 1 and 10 in 10,000 people)
very rare (affects fewer than 1 in 10,000 people)
frequency not known (cannot be estimated from available data)

If you experience any of the following adverse effects, stop taking these tablets immediately and contact your doctor or the nearest hospital emergency department straight away:

• Severe allergic reactions (rare frequency): swelling of the tongue and/or throat, difficulty swallowing, rash (urticaria), breathing difficulties, facial swelling due to allergy (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and excessive sweating.

• Severe skin disorders (frequency not known): skin blisters and rapid deterioration in general condition, erosion (including slight bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme), and photosensitivity.

• Other serious conditions (frequency not known): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, kidney enlargement with occasional pain during urination and lower back pain (severe kidney inflammation).

Other adverse effects include:

• Common (affects between 1 and 10 in every 100 patients): benign gastric polyps.

• Uncommon (affects between 1 and 10 in every 1,000 patients):
  headache, dizziness, diarrhoea, feeling of dizziness, vomiting, bloating and flatulence (gas), constipation, dry mouth, abdominal pain and discomfort, skin rash, exanthema, eruption, tingling, feeling of weakness, fatigue or general malaise, sleep disturbances.

• Rare (affects between 1 and 10 in every 10,000 patients):
  vision disturbances such as blurred vision, urticaria, joint pain, muscle pain, weight changes, increased body temperature, swelling in the extremities (peripheral oedema), allergic reactions, depression, enlargement of the breasts in men.

• Very rare (affects fewer than 1 in 10,000 patients):
  disorientation.

• Frequency not known (cannot be estimated from available data):
  hallucinations, confusion (especially in patients with a history of such symptoms), decreased levels of sodium in the blood, sensation of tingling, pins and needles, paresthesia (tingling), burning or numbness, skin rash, possibly with joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

If you are taking this medicine for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to carry out periodic blood tests to monitor your magnesium levels.

If you are taking proton pump inhibitors such as this medicine, especially for longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

Adverse effects identified through blood tests:

• Uncommon (affects between 1 and 10 in every 1,000 patients):
  increased liver enzymes.

• Rare (affects between 1 and 10 in every 10,000 patients):
  increased bilirubin, increased blood lipid levels.

• Very rare (affects fewer than 1 in 10,000 patients):
  reduction in platelet count which could lead to bleeding or more bruising than usual, reduction in white blood cell count which could lead to more frequent infections.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazol MABO

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

Do not use pantoprazole after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and any unused medicines at the SIGRE Point located at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazole MABO

The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate).

The other components are:

Core: maltitol, crospovidone, sodium carmellose, anhydrous sodium carbonate, calcium stearate.

Coating: polyvinyl alcohol, talc, titanium dioxide, macrogol 4000, soya lecithin, yellow iron oxide, anhydrous sodium carbonate, copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion 30%, triethyl citrate.

Appearance of the product and contents of the pack

Yellow to brownish-yellow, oval-shaped gastro-resistant tablet.

Packaging: blister packs (Al/Al)

Packs containing 14, 28, 56 or 500 gastro-resistant tablets.

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturer

Sofarimex. Industria Química e Farmaceutica Lda. Av. das Industrias. Alto do Colaride, Agalva 2735-213 Cacem, Portugal.

Or

MEDREICH PLC,

Warwick House, Plane Tree Crescent, Feltham, TW13 7HF, United Kingdom

Or

MEIJI PHARMA SPAIN, S.A.

Avda. de Madrid, 94,

28802, Alcala de Henares, Madrid

Spain

Date of the most recent revision of this leaflet: July 2022

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