Pantoprazole Almus 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pantoprazole Almus 20 mg gastro-resistant tablets EFG

Read this 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, consult 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 adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Pantoprazole Almus 20 mg is and what it is used for
2. What you need to know before taking Pantoprazole Almus 20 mg
3. How to take Pantoprazole Almus 20 mg
4. Possible adverse effects
5. Storage of Pantoprazole Almus 20 mg
6. Contents of the pack and other information

1. What Pantoprazol Almus 20 mg is and what it is used for

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

Pantoprazol Almus 20 mg is used for:

Adults and adolescents aged 12 years and older:

• Treatment of symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, painful swallowing) caused by acid reflux from the stomach.

• Long-term treatment and prevention of relapses of reflux esophagitis (inflammation of the esophagus accompanied by acid regurgitation from the stomach).

Adults:

• Prevention of gastroduodenal ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in at-risk patients who require ongoing treatment with these medicines.

2. What you need to know before taking Pantoprazol Almus 20 mg

Do not take Pantoprazol Almus 20 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, lansoprazole, rabeprazole, esomeprazole).

Warnings and precautions

Talk to your doctor or pharmacist before taking Pantoprazol Almus 20 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 pantoprazole treatment. If liver enzymes increase, treatment should be discontinued.
• If you need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously while taking pantoprazole, as there is an increased risk of developing stomach and intestinal complications. Any increased risk will be assessed according to personal risk factors such as age (65 years or older), history of stomach or duodenal ulcer, or gastrointestinal bleeding.
• If you have reduced body stores of vitamin B12 or risk factors for this, and are receiving pantoprazole treatment for a long period. Like all medicines that reduce acid levels, pantoprazole may reduce the absorption of vitamin B12. 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
• Talk to 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 if you have been told you are at risk of osteoporosis (e.g., 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. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience 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 pantoprazole 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 it may be necessary to discontinue treatment with Pantoprazol Almus. 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
• Vomiting, particularly if repeated
• Blood in vomit: may appear as dark coffee-ground material in your vomit
• Blood in your stools, which may appear black or dark
• Difficulty swallowing or pain when swallowing
• Pale appearance and feeling weak (anaemia)
• Chest pain
• Stomach pain
• Severe or persistent diarrhoea, as pantoprazole has been associated with a small increased risk of infectious diarrhoea.
• 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 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 Almus 20 mg is not recommended in children, as it has not been studied in children under 12 years of age.

Use of Pantoprazol Almus 20 mg with other medicines

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

Pantoprazole may affect 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 for certain types of cancer), as pantoprazole may cause these and other medicines to be less effective.
• Warfarin and fenprocoumon, 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 Almus 20 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, think you might be pregnant, plan to become pregnant, or are breastfeeding, 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 infant.

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 20 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 20 mg

Follow exactly the instructions for use of this medicine as given by your doctor. 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 a meal.

Unless your doctor has instructed you otherwise, the usual dosage is:

Adults and adolescents aged 12 years and older:

To treat symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, pain when swallowing)

The usual dose is one tablet per day.

This dose generally provides relief within 2–4 weeks, and if not, within a maximum of 4 additional weeks. Your doctor will advise you on how long you should continue taking the medicine. Afterwards, any recurring symptoms can be managed as needed by taking one tablet per day.

For long-term treatment and prevention of relapse of reflux esophagitis

The usual dose is one tablet per day. If the disease recurs, your doctor may double your dose, in which case you may take pantoprazole 40 mg once daily. After healing, the dose may be reduced again to one 20 mg tablet per day.

Adults:

For prevention of duodenal and gastric ulcers in patients requiring long-term treatment with NSAIDs

The usual dose is one tablet per day.

Patients with liver problems:

• If you have severe liver problems, you must not take more than one 20 mg tablet per day.

Use in children and adolescents:

This tablet is not recommended for use in children under 12 years of age.

If you take more Pantoprazol Almus 20 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. Symptoms of overdose are not known.

If you forget to take Pantoprazol Almus 20 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 20 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 will experience them.

If you experience any of the following adverse effects, stop taking these tablets immediately and contact your doctor right away, 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, 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: blisters on the skin 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 serious rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). Widespread rash, high body temperature, and lymphadenopathy (DRESS or drug hypersensitivity).
• Other serious conditions (frequency not known): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, enlarged kidneys with occasional 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 stomach polyps.

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

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

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

Disturbance or complete loss of taste sensation; vision disorders 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 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 tingling sensation; 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)

Increased liver enzymes.

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

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 patients)

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 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)

Decreased 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 it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines. 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 20 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 is 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 containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazol Almus 20 mg

The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (present as 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 carboxymethyl starch (type A) (from potato) (Explotab), Anhydrous sodium carbonate, Calcium stearate, Purified water (removed during the process).

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

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

Appearance of the product and contents of the pack:

Pantoprazol Almus 20 mg is presented as gastro-resistant tablets.

The tablets are yellowish, round, convex, and oblong in shape.

Packaged in blisters containing 28 tablets.

Other presentations

Pantoprazol Almus 40 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 revision of this leaflet: February 2024

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/