Pantoprazole Almus 40 mg gastro-resistant tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Pantoprazole Almus 40 mg gastro-resistant tablets EFG

Read the entire package 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 may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What Pantoprazole Almus 40 mg is and what it is used for
2. What you need to know before taking Pantoprazole Almus 40 mg
3. How to take Pantoprazole Almus 40 mg
4. Possible side effects
5. How to store Pantoprazole Almus 40 mg
6. Contents of the pack and other information

1. What is Pantoprazol Almus 40 mg and what is it used for?

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

Pantoprazol Almus 40 mg 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 therapy). The aim is to eliminate the bacterium and thereby reduce the likelihood of ulcer recurrence.
• Stomach and duodenal ulcers.

Zollinger-Ellison syndrome and other conditions in which excessive acid is produced in the stomach.

2. What you need to know before taking Pantoprazol Almus 40 mg

Do not take Pantoprazol Almus 40 mg

• If you are allergic to the active substance 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, lansoprazol, rabeprazole, esomeprazole).

Warnings and precautions:

Talk to your doctor or pharmacist before taking Pantoprazol Almus 40 mg.

• 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 notice any of the following symptoms, as they may indicate vitamin B12 deficiency:

  • Extreme tiredness or lack of energy
  • Tingling
  • Tongue pain or red tongue, mouth ulcers
  • Muscle weakness
  • Vision disturbances
  • Memory problems, confusion, depression

• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for treatment of HIV infection) at the same time as pantoprazole.

• Taking a proton pump inhibitor such as pantoprazole, especially for more than one 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 magnesium levels in the blood. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you have any of these symptoms, inform your doctor immediately. In addition, 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 magnesium levels.

• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazol Almus used to reduce stomach acidity.

• If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as treatment with Pantoprazol Almus may need to be stopped. 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).

Inform your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which may be signs of more serious conditions:

• Unintentional weight loss

• Repeated vomiting

• Blood in vomit: this may appear as dark coffee-ground-like specks in your vomit

• Blood in your stools, which may appear black or dark in color

• Difficulty swallowing or pain when swallowing

• Pale appearance and feeling weak (anemia)

• Chest pain

• Stomach pain

• Severe or persistent diarrhea, as Pantoprazol Almus has been associated with a small increased risk of infectious diarrhea.

• Serious skin reactions have been reported with Pantoprazol Almus treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking Pantoprazol Almus and contact your doctor immediately if you experience any symptoms related to serious skin reactions described in section 4.

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 Pantoprazol Almus 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 Almus 40 mg is not recommended in children, as it has not been studied in children under 12 years of age.

Taking Pantoprazol Almus 40 mg 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 Almus 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 Pantoprazol Almus may cause these and other medicines to be less effective.
• Warfarin and phenprocoumon, which affect blood clotting. You may require 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 Almus 40 mg, as pantoprazole may increase methotrexate levels in the blood.
  • Fluvoxamine (used to treat depression and other psychiatric conditions). 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 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 Almus 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 Almus 40 mg tablets contain sodium

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

3. How to take Pantoprazol Almus 40 mg

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

When and how should you take Pantoprazol Almus?

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

Unless your doctor has prescribed 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 two tablets per day. The treatment duration for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will inform you 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 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 treatment duration 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 of the treatment duration. The usual treatment duration for gastric ulcers is between 4 and 8 weeks. For duodenal ulcers, the treatment duration is normally between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions with 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 your level of gastric acid secretion. If more than two tablets per day are prescribed, you should take the tablets divided into two daily doses. If more than four tablets per day are prescribed, you will be given specific instructions on when to stop treatment.

Patients with kidney problems

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

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 Pantoprazol Almus for the eradication of Helicobacter pylori.

Use in children and adolescents

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

If you take more Pantoprazol Almus 40 mg than you should

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

If you forget to take Pantoprazol Almus 40 mg

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

If you stop taking Pantoprazol Almus 40 mg

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 experiences them.

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

• 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, allergic swelling of the face (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 symptoms: skin blisters and 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). Blood tests may show changes in certain white blood cells or liver enzymes (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity), and circular or target-shaped slightly reddish spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). Generalized rash, high body temperature, and lymphadenopathy (DRESS or drug hypersensitivity).
• Other serious conditions (frequency not known: frequency cannot be estimated from available data): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, enlarged kidneys 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 between 1 and 10 out of 100 people)

Benign gastric polyps.

• 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; fractures of the hip, wrist, and spine.

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

Altered or complete loss of taste; vision disorders such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling in the limbs (peripheral edema); 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)

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

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 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 people)

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

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

Decreased levels of sodium, magnesium, calcium, or potassium in blood (see section 2).

Reporting of adverse effects

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

5. Storage of Pantoprazole Almus 40 mg

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 refers to the last day of the month indicated.

Do not store above 30 °C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazol Almus 40 mg:

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

The other components (excipients) are:

Core: Mannitol (Pearlitol 160C) (E-421), Microcrystalline cellulose (Avicel PH101), Microcrystalline cellulose (Avicel PH102), Pregelatinized starch (from maize) (Starch 1500), Sodium carboxymethylstarch (type A) (from potato) (Explotab), Anhydrous sodium carbonate, Calcium stearate, Purified water (removed during processing).

Isolating coating: Hypromellose, Propylene glycol (E1520), Titanium dioxide (E171), Iron oxide yellow (E172).

Enteric coating: Methacrylic acid and ethyl acrylate copolymer, Polysorbate 80, Sodium lauryl sulfate, Triethyl citrate, Purified water (removed during processing).

Appearance of the product and contents of the pack:

Pantoprazol Almus is presented as gastro-resistant tablets.

The tablets are yellowish, round, convex, and oblong-shaped.

Available in blisters containing 14 or 28 tablets.

Other presentations

Pantoprazol Almus 20 mg gastro-resistant tablets EFG

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer:

Atlantic Pharma - Produções Farmacêuticas, S.A.

Rua De Tapada Grande 2

Abrunheira, Sintra, 2710-228

Portugal

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

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/