PANTOPRAZOL ALMUS 20 mg GASTRO-RESISTANT TABLETS

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

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

Pantoprazol Almus 20 mg is used for:

Adults and adolescents from 12 years:

• Treatment of symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, pain when 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 patients at risk who require continuous treatment with these types of drugs.

(NSAIDs, for example, ibuprofen) in patients at risk who require continuous treatment with these types of drugs.

2. What you need to know before you take 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 that contain other proton pump inhibitors (e.g. omeprazole, lansoprazole, rabeprazole, esomeprazole).

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 when you are on long-term treatment with pantoprazole. In case of an increase in liver enzymes, treatment should be discontinued.
• If you need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously and take pantoprazole, as there is a higher risk of developing complications in the stomach and intestine. Any increased risk will be assessed according to your personal risk factors such as age (65 years or older), history of stomach or duodenal ulcers or stomach or intestinal bleeding.
• If you have reduced body stores of vitamin B12 or risk factors for this 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 notice any of the following symptoms, as they may indicate a vitamin B12 deficiency:
• • Extreme fatigue or lack of energy
  • Numbness
  • Pain in the tongue or red tongue, mouth ulcers
  • Muscle weakness
  • Visual disturbances
  • Memory problems, confusion, depression
• Tell your doctor if you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection) at the same time as pantoprazole.
• Taking a proton pump inhibitor like pantoprazole, especially for more than a year, may increase the risk of hip, wrist, or spine fractures. 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 suffer from a decrease in blood magnesium levels. Symptoms of low magnesium levels can include fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Additionally, low magnesium levels can also cause a decrease in blood potassium and calcium levels. 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 to reduce stomach acid.
• If you get a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt 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).

Tell your doctor immediatelybefore or after taking this medicine, if you notice any of the following symptoms, which may be signs of more serious diseases:

• unintentional weight loss
• vomiting, particularly if it is repeated
• blood in the vomit: it may appear as a dark coffee grounds-like substance in your vomit
• if you notice blood in your stools, which may appear black or dark
• difficulty swallowing or pain when swallowing
• pale appearance and feeling of weakness (anemia)
• chest pain
• stomach pain
• severe or persistent diarrhea, as pantoprazole has been associated with a small increase in infectious diarrhea.
• cases of severe skin reactions have been reported in relation to treatment with Pantoprazol Almus, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug hypersensitivity with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking Pantoprazol Almus and call your doctor immediately if you experience any of the symptoms related to severe skin reactions described in section 4.

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

Children and adolescents

The use of Pantoprazol Almus 20 mg is not recommended in children as it has not been tested in children under 12 years of age.

Use of Pantoprazol Almus 20 mg with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pantoprazole may affect the efficacy 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 pantoprazole may make these and other medicines not work properly.
• Warfarin and phenprocoumon, which affect blood coagulation. You may need additional checks.
• 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 stop treatment with Pantoprazol Almus 20 mg, 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 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, think you may be pregnant, or are planning to have a baby, or if you are breastfeeding, consult your doctor or pharmacist before using this medicine.

You should only use this medicine if your doctor considers that the benefit for you is greater than the potential risk to the fetus or baby.

Driving and using machines

Pantoprazol Almus has no influence or negligible influence on the ability to drive and use machines.

You should not drive or use machines if you experience side 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 the instructions for administration of this medicine indicated by your doctor. If you are 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 indicated otherwise, the usual dose is:

Adults and adolescents from 12 years:

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

The usual dose is one tablet per day.

This dose usually provides relief within 2-4 weeks, and if not, at most, within the following 4 weeks. Your doctor will indicate how long you should continue taking the medicine. Later, any recurring symptoms can be controlled by taking one tablet per day as needed.

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

The usual dose is one tablet per day. If the disease recurs, your doctor may double the dose, in which case you can take pantoprazole 40 mg once a day. After healing, you can reduce the dose back to one 20 mg tablet per day.

Adults:

To prevent duodenal and stomach ulcers in patients who require continuous treatment with NSAIDs

The usual dose is one tablet per day.

Patients with liver problems:

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

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 20 mg than you should

Inform your doctor or pharmacist or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. No symptoms of overdose are known.

If you forget to take Pantoprazol Almus 20 mg

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

If you stop taking Pantoprazol Almus 20 mg

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

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 side effects, stop taking these tablets and inform your doctor immediately, or contact the emergency department of the nearest hospital:

• Severe allergic reactions (frequency rare:may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, rash (hives), difficulty breathing, swelling of the face of allergic origin (angioedema), severe dizziness with very rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency not known:frequency cannot be estimated from the available data):you may notice one or more of the following symptoms: blisters on the skin and rapid deterioration of general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals, or sensitivity/skin rash, particularly in areas of skin exposed to light/sun. You may also have 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 syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug hypersensitivity with eosinophilia and systemic symptoms (DRESS), photosensitivity) and circular or target-like red patches on the trunk, often with blisters in the center, peeling, mouth ulcers, throat, nose, genitals, and eyes. These severe rashes can 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):yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increase in kidney size with occasional pain when urinating, and lower back pain (severe kidney inflammation), which may lead to kidney failure.

Other side effects are:

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

Benign polyps in the stomach.

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

Headache; dizziness; diarrhea; feeling of dizziness, vomiting; swelling and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; numbness; feeling of weakness, fatigue, or general malaise; sleep disturbances; hip, wrist, and spine fractures.

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

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 patients)

Disorientation.

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

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

Side 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 white blood cells with high fever.

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

Reduced platelet count, which may cause bleeding or more bruising than usual; reduced white blood cell count, which may lead to more frequent infections; abnormal reduction in the balance between red and white blood cells and platelets.

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use. Website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazol Almus 20 mg

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Pantoprazol Almus 20 mg

The active ingredient is pantoprazol. Each gastro-resistant tablet contains 20 mg of pantoprazol (present in the form of pantoprazol sodium sesquihydrate)

The other components (excipients) are:

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

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

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

Appearance of the product and container content:

Pantoprazol Almus 20 mg is presented in the form of gastro-resistant tablets.

The tablets areround, yellowish in color, convex, and oblong in shape.

It is presented in blisters with 28 tablets.

Other presentations

Pantoprazol Almus 40 mg gastro-resistant tablets EFG

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Manufacturer:

Atlantic Pharma - Farmacêutica Productions, S.A.

Rua De Tapada Grande 2

Abrunheira, Sintra, 2710-228

Portugal

Date of the last revision of this prospectus:February 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/