ALAPANZOL 40 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Alapanzol 40 mg Gastro-Resistant Tablets EFG

Pantoprazole

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 and other information

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

1. What is Alapanzol and what is it used for

Alapanzol is a selective inhibitor of the "proton pump", a medicine that reduces the amount of acid produced in your stomach. It is used for diseases related to stomach and intestine acid.

Alapanzol is used for

Adults and adolescents from 12 years:

• Reflux esophagitis. It is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by acid reflux 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 goal is to get rid of the bacteria and thus reduce the likelihood of ulcer recurrence.
• Stomach and duodenal ulcers, and
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

2. What you need to know before you take Alapanzol

Do not take Alapanzol:

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 that contain other proton pump inhibitors (e.g., omeprazole, lansoprazole, rabeprazole, esomeprazole).

Warnings and precautions

Consult your doctor before starting to take Alapanzol

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

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

• If you have serious 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 have low body reserves of vitamin B12 or risk factors for it and receive long-term treatment with pantoprazole. Like all acid-reducing medicines, pantoprazole may reduce the absorption of vitamin B12.
• Consult your doctor if you are taking any medicine that contains atazanavir (for HIV infection treatment) at the same time as pantoprazole.
• Before taking this medicine, inform your doctor if a specific blood test (Chromogranin A) is scheduled.

Inform your doctor immediatelyif you notice any of the following symptoms:

• 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
  • blood in your stools, which may appear black or tarry
  • severe or persistent diarrhea, as pantoprazole has been associated with a small increase in infectious diarrhea.

Your doctor will decide if you need any additional tests to rule out a malignant disease because pantoprazole can alleviate cancer symptoms 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 monitoring. You should inform your doctor of any symptoms and/or new or unexpected events each time you visit your doctor.

Children and adolescents

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

Other medicines and Alapanzol

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

Alapanzol may influence the effectiveness of other medicines, so 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 Alapanzol may cause these and other medicines to not work properly.
• Warfarin and phenprocoumon, which affect blood coagulation. 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 interrupt treatment with pantoprazole because pantoprazole can increase methotrexate levels in the blood.

Fluvoxamine (used to treat depression and other psychiatric diseases). 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).

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 plan to become pregnant, consult your doctor or pharmacist before using this medicine. You should only use this medicine if your doctor considers that the benefit to you is greater than the potential risk to the fetus or baby.

Driving and using machines

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

You should not drive or use machines if you suffer from side effects such as dizziness or blurred vision.

3. How to take Alapanzol

Follow the instructions for administration of this medicine exactly as indicated by your doctor. In case of 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:

For the treatment of reflux esophagitis

The recommended dose is one tablet a day (40 mg of pantoprazole). Your doctor may indicate an increase to 2 tablets a day. The treatment time for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will indicate how long you should take this medicine.

Adults:

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

One tablet (40 mg of pantoprazole) twice a day plus the two antibiotic tablets, either amoxicillin, clarithromycin, and metronidazole (or tinidazole), each to be taken twice a day 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 usually 1 to 2 weeks.

For the treatment of stomach and duodenal ulcers

The recommended dose is one tablet (40 mg of pantoprazole) a day. The dose may be doubled by your doctor. Your doctor will indicate how long you should take this medicine. The treatment duration for stomach ulcers is usually between 4 and 8 weeks. The treatment duration for duodenal ulcers is usually between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions in which there is an increase in stomach acid secretion

The initial recommended dose is two tablets a day.

Take the two tablets 1 hour before a meal. Later, your doctor may adjust the dose, depending on the amount of acid secretion you produce. If you are prescribed more than two tablets a day, you should take the tablets divided into two doses a day.

If you are prescribed more than four tablets a day, you will be told exactly when you should finish the treatment.

Patient with kidney problems

If you have serious kidney problems, you should not take pantoprazole for the eradication of Helicobacter pylori.

Patient with liver problems

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

Use in children and adolescents

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

If you take more Alapanzol than you should

Consult your doctor or pharmacist, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount used. 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 on the use of this product, 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 serious side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist or contact the emergency department of your nearest hospital.

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

• Severe skin reactions (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 (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme), and sensitivity to light.

• Other serious conditions (frequency not known: cannot be estimated from the available data): yellowing of the skin and the whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increase in kidney size sometimes with pain when urinating and pain in the lower back (severe kidney inflammation), which may possibly cause 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; diarrhea; 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 (may affect up to 1 in 1,000 people)

Alteration or complete loss of taste; visual 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; breast enlargement in men.

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

Disorientation.

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

Hallucinations, confusion (especially in patients with a history of these symptoms), decrease in sodium levels in the blood. Feeling of tingling, pinching, numbness, burning sensation, or tingling. Inflammation of the large intestine that causes persistent watery diarrhea. Skin rash, possibly with joint pain.

If you are taking Alapanzol for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also produce a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

If you are taking proton pump inhibitors like Alapanzol, especially for a period of more than one year, you may have a slightly increased risk of hip, wrist, and spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

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 blood fat levels. Sudden drop in white blood cells, 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 more bruising than usual; reduction in the number of white blood cells, which could lead to more frequent infections; abnormal reduction in the balance between the number of red and white blood cells, as well as platelets.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. 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. Storing Alapanzol

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

Do not use this medicine after the expiration date that appears on the packaging after EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. 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 (in the form of sodium sesquihydrate)

The other ingredients are:

Core: sodium carbonate, mannitol, sodium carboxymethylcellulose (sodium carmellose), sodium 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 - ethyl acrylate copolymer (1:1).

Appearance of the product and packaging contents

Gastro-resistant tablets, orange, oval, biconvex.

Packaging

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

Phone: +34 965 28 67 00

Fax: +34 965 28 64 34

Email: asacpharma@asac.net

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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/