Alapanzol 40 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Alapanzol 40 mg gastro-resistant tablets EFG

Pantoprazole

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could 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.

Leaflet contents

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

1. What Alapanzol is and what it is used for

Alapanzol is a selective “proton pump inhibitor”, a medicine that reduces the amount of acid produced in your stomach. It is used for conditions related to stomach and intestinal acid.

Alapanzol is used for:

Adults and adolescents aged 12 years and older:

• Reflux esophagitis. This is inflammation of your esophagus (the tube connecting your throat to your stomach), accompanied by regurgitation of acid from the stomach.

Adults:

• Infection with a bacterium called Helicobacter pylori in patients with stomach and/or duodenal ulcer, in combination with two antibiotics (eradication treatment). The aim is to eliminate the bacteria and thereby reduce the likelihood of ulcers recurring.
• Stomach and duodenal ulcers, and
• Zollinger-Ellison syndrome and other conditions in which excessive acid is produced in the stomach.

2. What you need to know before taking Alapanzol

Do not take Alapanzol:

If you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in 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 before starting Alapanzol

• If you have had a skin reaction after treatment with a medicine similar to Alapanzol used to reduce stomach acid.

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop treatment with Alapanzol. Remember to mention any other symptoms you may notice, such as joint pain.

• If you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor will 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 have reduced body stores of vitamin B12 or risk factors for this and are receiving pantoprazole treatment for a long period of time. Like all medicines that reduce acid levels, pantoprazole may reduce the absorption of vitamin B12.
• Consult your doctor if you are taking a medicine containing atazanavir (for treatment of HIV infection) at the same time as pantoprazole.
• Before taking this medicine, inform your doctor if a specific blood test (chromogranin A) is planned.

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

• unintentional weight loss

• vomiting, particularly if repeated

• difficulty swallowing, or pain when swallowing

• blood in vomit: this may appear as dark, coffee-ground-like material in your vomit

• pale appearance and feeling weak (anemia)

• chest pain

• stomach pain

  • blood in your stools, which may appear black or tarry (melena)
  • severe or persistent diarrhea, as pantoprazole has been associated with a small increased risk of infectious diarrhea.

Your doctor will decide whether you need additional tests to rule out malignancy, as pantoprazole may relieve cancer symptoms 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 and/or events at each visit.

Children and adolescents

The use of Alapanzol is not recommended in children, as it has not been studied in children under 12 years of age.

Other medicines and Alapanzol

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

Alapanzol 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 Alapanzol may cause these and other medicines to be less effective.

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

• Atazanavir (used to treat HIV infection).

• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily discontinue pantoprazole treatment, 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 your dose.

• Rifampicin (used to treat infections).
• St. John’s wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy, breastfeeding, and fertility

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 or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. This medicine should only be used if your doctor considers that the benefit to you outweighs the potential risk to the fetus or baby.

Driving and using machines

Alapanzol has no effect or has a negligible effect on the ability to drive or use machines.

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

3. How to take Alapanzol

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

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

The recommended dose is:

Adults and adolescents from 12 years of age:

For the treatment of reflux esophagitis

The recommended dose is one tablet per day (40 mg of pantoprazole). Your doctor may instruct you to increase this to two tablets per day. The treatment duration for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will advise you on how long to take this medicine.

Adults:

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

One tablet (40 mg of pantoprazole) 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 make sure to read the package leaflets of the antibiotics.

The duration of treatment is normally one to two weeks.

For the treatment of stomach and duodenal ulcers

The recommended dose is one tablet (40 mg of pantoprazole) per day. Your doctor may double the dose. Your doctor will advise you on how long to take this medicine. The treatment duration for stomach 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 an increased gastric acid secretion

The recommended initial dose is two tablets per day.

Take both tablets 1 hour before a meal. Afterwards, 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 divided into two doses per day.

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

Patients with kidney problems

If you have severe kidney problems, you should not take pantoprazole for Helicobacter pylori eradication.

Patients with liver problems

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

Use in children and adolescents

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

If you take more Alapanzol than you should

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

If you forget to take Alapanzol

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

If you stop taking Alapanzol

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you consider that any of the adverse effects you are experiencing is severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist or contact the emergency service at your nearest hospital.

• Severe allergic reactions (uncommon frequency: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, rash (urticaria), difficulty breathing, allergic swelling of the face (Quincke's oedema/angioedema), severe dizziness with very rapid heartbeat and excessive sweating.

• Severe skin disorders (frequency not known: cannot be estimated from available data): blisters on the skin and rapid deterioration in general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson Syndrome, Lyell Syndrome, Erythema multiforme), and sensitivity to light.

• Other severe conditions (frequency not known: cannot be estimated from available data): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increased kidney size sometimes with pain on urination and lower back pain (severe kidney inflammation), which could possibly lead to kidney failure.

Other adverse effects are:

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

Benign gastric polyps.

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

Headache; dizziness; diarrhoea; feeling of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; pain and discomfort in the abdomen; skin rash, exanthema, eruption; tingling; feeling of weakness, tiredness or general malaise; sleep disturbances.

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

Disturbance or complete loss of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling in the extremities (peripheral oedema); allergic reactions; depression; enlargement of the breasts in men.

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

Disorientation.

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

Hallucination, confusion (especially in patients with a history of these symptoms), decreased levels of sodium in the blood. Sensation of tingling, pricking, numbness, burning or stinging. Inflammation of the large intestine causing persistent watery diarrhoea. Skin rash, possibly with joint pain.

If you are taking Alapanzol for more than three months, magnesium levels in the blood 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 perform periodic blood tests to monitor your magnesium levels.

If you are taking proton pump inhibitors such as Alapanzol, especially for more 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 if you are taking corticosteroids (which may increase the risk of osteoporosis).

Adverse 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 levels of blood lipids. Sudden drop in granular white blood cells in circulation, associated with high fever.

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

Reduction in the number of platelets, which could lead to bleeding or increased bruising; reduction in the number of white blood cells, which could lead to more frequent infections; abnormal imbalance between the number of red and white blood cells and platelets.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for 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 Alapanzol

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is 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 unused medicines at the SIGRE Point located at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alapanzol

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

The other components are:

Core: sodium carbonate, mannitol, sodium carboxymethylcellulose (sodium carmellose), sodium potato starch glycolate, magnesium stearate, anhydrous colloidal silica.

Coating: propylene glycol, yellow iron oxide (E-172), titanium dioxide (CI=77891, E-171), hypromellose, triethyl citrate, methacrylic acid and ethyl acrylate copolymer (1:1).

Appearance of the product and contents of the pack

Gastro-resistant, orange, oval, biconvex tablets.

Packs

Each pack contains 14, 28 or 500 gastro-resistant tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Especialidades Farmacéuticas Centrum, S.A.
C/ Sagitario 14
03006 Alicante, Spain
Telephone: +34 965 28 67 00
Fax: +34 965 28 64 34
Email: [email protected]

Manufacturer

Laboratorios Normon, S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos, Madrid, Spain

This leaflet was approved in June 2019.

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/