User Information Leaflet

Alapanzol 40 mg Gastric-Resistant Tablets EFG

Pantoprazole

Read this 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

Alapanzol is used for:

Adults and adolescents 12 years and older:

• Gastroesophageal reflux esophagitis. It is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by regurgitation of acid from your stomach.

Adults:

• Infection of a bacteria called Helicobacter pylori in patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment). The goal is to get rid of the bacteria and thus reduce the likelihood of ulcers reappearing.
• Stomach and duodenal ulcers, and
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

Do not take Alapanzol:

If you are allergic to pantoprazole or any of the other components of this medication (listed in section 6).

If you are allergic to medications 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 similar medication to Alapanzol for reducing stomach acid.

If you suffer from a skin rash, especially in exposed skin areas, 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 severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor will monitor your liver enzymes more frequently, especially when taking pantoprazole for a long time. In case of increased liver enzymes, treatment should be interrupted.
• If you have decreased vitamin B12 reserves or risk factors for it and receive pantoprazole treatment for a long period. Like all acid-reducing medications, pantoprazole may reduce vitamin B12 absorption.
• Consult your doctor if you are taking any medication containing atazanavir (for HIV treatment) at the same time as pantoprazole.
• Inform your doctor before taking this medication if you are scheduled for a specific blood test (Cromogranin A).

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

• Unintentional weight loss
• Vomiting, particularly if repeated
• Difficulty swallowing, or pain when swallowing
• Blood in vomit: may appear as a dark brown powder in your vomit
• Pale appearance and feeling of weakness (anemia)

- Dizziness

- Chest pain

• Blood in your stools, which may appear black or melena
• Severe or persistent diarrhea, as pantoprazole has been associated with a small increase in infectious diarrhea.

Your doctor will decide if you need additional testing to rule out a malignant disease, as pantoprazole may alleviate cancer symptoms and potentially delay diagnosis. If your symptoms persist despite treatment, further investigations will be performed.

If you take pantoprazole for a prolonged period (over one year), your doctor may regularly monitor you. You should inform your doctor of any new or unexpected symptoms and/or events each time you attend a consultation.

Children and adolescents

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

Other medications and Alapanzol

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

Alapanzol may affect the efficacy of other medications, so inform your doctor if you are taking:

• Medications such as ketoconazole, itraconazole, and posaconazole (used for fungal infections) or erlotinib (used for certain types of cancer), as Alapanzol may make these and other medications less effective.
• Warfarin and phenprocoumon, which affect blood clotting. You may need additional monitoring.
• Atazanavir (used for HIV treatment).

- Metotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking metotrexate, your doctor may temporarily interrupt pantoprazole treatment due to increased metotrexate 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 infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy, breastfeeding, and fertility

There is insufficient data on the use of pantoprazole in pregnant women. Pantoprazole has been reported to be excreted in human breast milk.

If you are pregnant, breastfeeding, believe you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.Only use this medication if your doctor considers the benefits for you to be greater than the potential risk to the fetus or baby.

Driving and operating machinery

Alapanzol has no influence or insignificant influence on the ability to drive or operate machinery.

Do not drive or operate machinery if you experience side effects such as dizziness or blurred vision.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

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

The recommended dose is:

Adults and adolescents 12 years and older:

For the treatment of esophagitis by reflux

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

Adults:

For the treatment of an infection with a bacteria calledHelicobacter 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 two antibiotic tablets, either amoxicillin, clarithromycin and metronidazole (or tinidazole), each should 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 antibiotic prospectuses.

The treatment duration is usually 1 to 2 weeks.

For the treatment of stomach and duodenal ulcers

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

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

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

Patients with kidney problems

If you have severe kidney problems, you should not take pantoprazole for the elimination ofHelicobacter pylori.

Patients with liver problems

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

Use in children and adolescents

These tablets are not recommended for use in children under 12 years.

If you take more Alapanzol than you should

Consult your doctor or pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used. No known symptoms of overdose.

If you forgot to take Alapanzol

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

If you interrupt treatment with Alapanzol

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist or contact the emergency department of the 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, allergic swelling of the face (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats and excessive sweating.

• Severe skin alterations (frequency unknown: cannot be estimated from available data):blistering of the skin and a rapid deterioration of general conditions, erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme) and light sensitivity.

• Other severe conditions (frequency unknown: cannot be estimated from available data):yellowing of the skin and the white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased size of the kidneys sometimes with painful urination and lower back pain (severe kidney inflammation), possibly leading to renal failure.

Other side effects are:

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

Benign polyps in the stomach.

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

Headache; dizziness; diarrhea; sensation of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; hives on the skin, exanthema, rash; tingling; sensation of weakness, fatigue or general malaise; sleep disturbances.

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

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

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

Disorientation.

- Frequency unknown(cannot be estimated from available data)

Illusion, confusion (especially in patients with a history of these symptoms), decrease in sodium levels in the blood.Sensation of tingling, pinching, numbness, burning or numbness.Colitis, which causes persistent watery diarrhea. Skin rash, possibly with joint pain.

If you are taking Alapanzol for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also produce 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 are taking proton pump inhibitors such as Alapanzol, especially for a period of more than one year, it may slightly increase the risk of hip, wrist, and spinal column fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Side effects identified through blood tests:

• Infrequent(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 fat in the blood.Acute drop in granulocytes in the circulation, associated with high fever.

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

Reduction in platelet count, which could cause bleeding or more frequent bruising; reduction in white blood cell count, 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 side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use. https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at your local SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Alapanzol

The active ingredient is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (in the form of sodium sesquihydrate)

The other components are:

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

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

Appearance of the product and contents of the packaging

Gastro-resistant, orange, oval, biconvex tablets.

Packaging

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

Not all package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Centrum Pharmaceutical Specialties, S.A.

C/ Sagitario 14

03006 Alicante, Spain

Phone: +34 965 28 67 00

Fax: +34 965 28 64 34

Email: [email protected]

Responsible manufacturer

Normon Laboratories, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid, Spain

This leaflet was approved in June 2019.

Further detailed information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/