Pantoprazole Alter 40 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

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

Pantoprazol Alter is a selective "proton pump inhibitor", a medicine that reduces the amount of acid produced in your stomach. It is used to treat diseases related to stomach and intestinal acid.

Pantoprazol Alter 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 gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy). The aim is to eliminate the bacteria and thereby reduce the likelihood of ulcer recurrence.
• Gastric and duodenal ulcers, and
• Zollinger-Ellison syndrome and other conditions in which excessive stomach acid is produced.

2. What you need to know before taking Pantoprazol Alter

Do not take Pantoprazol Alter

• If you are allergic (hypersensitive) to pantoprazole or to any of the other components of Pantoprazol Alter (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, pharmacist, or nurse before starting to take Pantoprazol Alter:

• 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 any medicine containing atazanavir (used to treat HIV infection) at the same time as pantoprazole.
• Taking a proton pump inhibitor such as pantoprazole, particularly for over 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 have been told you are at risk of osteoporosis (for example, if you are taking corticosteroids).

• 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 contractions, confusion, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may lead to decreased levels of potassium and calcium in the blood. Your doctor will decide whether periodic blood tests are needed to monitor magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazol Alter used to reduce stomach acidity.

If you develop a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Pantoprazol Alter. 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).

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

• Unintentional weight loss

• Repeated vomiting

• Difficulty swallowing

• Blood in vomit; this may appear as dark coffee-ground-like material in your vomit

• Blood in your stools, which may appear black or tarry (melena)

• Difficulty swallowing, or pain when swallowing

• Pale appearance and feeling weak (anemia)

• Blood in your stools

  • Chest pain

• Stomach pain, severe or persistent diarrhea, as pantoprazole has been associated with a small increased risk of infectious diarrhea.

Your doctor will decide whether additional tests are needed to rule out malignancy, 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 will likely monitor you regularly. You should inform your doctor of any new or unexpected symptoms or events at each visit.

Children and adolescents

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

Taking Pantoprazol Alter with other medicines

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.

Pantoprazol Alter may affect 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 for certain types of cancer), as Pantoprazol Alter may cause these and other medicines to be less effective.

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

• 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 discontinue treatment with Pantoprazol Alter, 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).

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

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 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 outweighs the potential risk to the fetus or baby.

Driving and using machines

Pantoprazol Alter has no effect or 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.

Pantoprazol Alter contains sodium.

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

3. How to take Pantoprazol Alter

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

When and how should you take Pantoprazol Alter?

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 usual dose is:

Adults and adolescents aged 12 years and older:

For the treatment of reflux esophagitis

The usual dose is one tablet per day. Your doctor may instruct you to increase the dose to 2 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 infection with a bacterium called Helicobacter pylori in patients with stomach and/or duodenal ulcer, in combination with two antibiotics (eradication therapy)

One tablet twice daily, together with two antibiotic tablets—either amoxicillin, clarithromycin, and metronidazole (or tinidazole)—each to be taken twice daily along 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 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 usual duration of treatment for gastric ulcers is between 4 and 8 weeks. The usual duration of treatment for duodenal ulcers is normally between 2 and 4 weeks.

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

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 secretion. If you are prescribed more than two tablets per day, you should take the tablets divided into two 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 (in this case, 20 mg pantoprazole tablets are available).

• Children (under 12 years): the use of these tablets is not recommended in children under 12 years of age.

If you take more Pantoprazole Alter 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 Pantoprazol Alter

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

If you stop treatment with Pantoprazol Alter

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 Alter may have adverse effects, although not everyone experiences them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist or contact the nearest hospital emergency service.

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

• Severe skin disorders (frequency not known; frequency cannot be estimated from available data): you may notice one or more of the following skin blisters and a rapid deterioration in general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to light/sun. You may also experience joint pain or flu-like symptoms, 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 Reaction with Eosinophilia and Systemic Symptoms (DRESS), 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 sometimes with pain when urinating and lower back pain (severe kidney inflammation), which may possibly lead to kidney failure.

Other adverse 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; 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; fracture of hip, wrist and spine.

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

disturbance or complete loss of taste sensation; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increase in body temperature; swelling in the extremities (peripheral edema); allergic reactions; depression; enlargement of breasts in men.

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

disorientation.

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

hallucination, confusion (especially in patients with a history of these symptoms), sensation of tingling, pricking, numbness, burning or stinging, skin rash, possibly with joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse effects identified through blood tests:

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

increase in liver enzymes.

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

increase in bilirubin; increase in blood fat levels; sudden drop in granular white blood cells in circulation, associated with high fever.

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

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 decrease in the balance between the number of red blood cells, white blood cells, and platelets.

• Frequency not known (cannot be estimated from available data): decrease in levels of sodium, magnesium, calcium or potassium in the blood (see section 2).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazol Alter

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

Do not use Pantoprazol Alter after the expiry date which is 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.

Store in the original packaging.

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

6. Contents of the container and other information

Composition of Pantoprazole Alter

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

The other components (excipients) are:

Core: mannitol (E-421), sodium carbonate, pregelatinized maize starch, crospovidone, calcium stearate.

Coating: hypromellose, glyceryl triacetate, titanium dioxide, methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion, talc, triethyl citrate, iron oxide red (E-172), iron oxide yellow (E-172).

Appearance of the product and contents of the container

Gastro-resistant, round, dark pink tablet.

Packaging:

Each pack contains 28 or 56 gastro-resistant tablets in a Poliamide/Al/PVC-Al blister.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer:

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036 Madrid

Spain

or

Laboratorios Alter, S.A.

C/ Zeus, 6

Polígono Industrial R2

28880 Meco (Madrid)

Spain

Date of the most recent review of this leaflet: February 2024

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