PANTOPRAZOL ALMUS 40 mg GASTRO-RESISTANT TABLETS

1. What is Pantoprazol Almus 40 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 40 mg is used for:

Adults and adolescents from 12 years:

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

Adults:

• Infection with a bacterium called Helicobacter pyloriin patients with stomach and/or duodenal ulcer in combination with two antibiotics (eradication treatment). The goal is to get rid of the bacterium and thus reduce the likelihood of ulcer recurrence.
• Stomach and duodenal ulcers.

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

2. What you need to know before you take 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 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 40 mg.

• If you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor will perform more frequent monitoring of liver enzymes, especially when you are on long-term treatment with pantoprazole. In case of an increase in liver enzymes, treatment should be discontinued.
• If you have decreased body reserves of vitamin B12 or risk factors for it and receive long-term treatment with pantoprazole. Like all medicines that reduce acid, 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
  • Vision problems
  • Memory problems, confusion, depression

• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV infection treatment) 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 magnesium levels in your blood. Low magnesium levels can cause fatigue, 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 lead to decreased potassium and calcium levels in your 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 to reduce stomach acid.
• If you suffer from 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 discontinue treatment with Pantoprazol Almus. Remember to mention any other symptoms you may notice, such as joint pain.
• If you are scheduled to undergo a specific blood test (Chromogranin A).

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

• unintentional weight loss

• repeated vomiting
• 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 Pantoprazol Almus has been associated with a small increase in infectious diarrhea.
• serious skin reactions have been reported in relation to treatment with Pantoprazol Almus, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash 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 serious skin reactions described in section 4.

Your doctor will decide if you need any additional tests to rule out a malignant disease because pantoprazole can alleviate cancer symptoms and may delay its diagnosis. If, despite treatment, your symptoms persist, further tests will be performed.

If you take Pantoprazol Almus for a prolonged period (more than a year), your doctor may regularly monitor you. You should inform your doctor of any new or unexpected symptoms or events each time you visit your doctor.

Children and adolescents

The use of Pantoprazol Almus 40 mg is not recommended in children as it has not been tested in children under 12 years of age.

Use of Pantoprazol Almus 40 mg with other medicines

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

Pantoprazol Almus may affect the efficacy 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 to treat certain types of cancer), as Pantoprazol Almus may make these and other medicines not work properly.
• Warfarin and phenprocoumon, which affect blood coagulation. 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 40 mg, as pantoprazole may increase methotrexate levels in your 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).

Pregnancy, breastfeeding, and fertility

There is not enough 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 is greater than the potential risk to the fetus or baby.

Driving and using machines

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

Do not drive or use machines if you experience side 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; it is essentially "sodium-free".

3. How to take Pantoprazol Almus 40 mg

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, 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 told you otherwise, the usual dose is:

Adults and adolescents from 12 years:

For the treatment of reflux esophagitis:

The usual dose is one tablet per day. Your doctor may increase the dose to 2 tablets per day. The treatment duration for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will tell you how long to take this medicine.

Adults

For the treatment of an infection with a bacterium called Helicobacter pylori in patients with stomach and/or duodenal ulcer in combination with two antibiotics (eradication treatment)

One tablet twice a day plus the two antibiotic tablets, either amoxicillin, clarithromycin, and metronidazole (or tinidazole), each 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 leaflets of the antibiotics.

The treatment duration is usually 1 to 2 weeks.

For the treatment of stomach and duodenal ulcers:

The usual dose is one tablet per day. The dose may be doubled by your doctor.

Your doctor will tell you how long to take this medicine. The treatment duration for stomach ulcers is usually between 4 and 8 weeks. The treatment duration for duodenal ulcers is usually between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions in which there is an increase in stomach acid secretion:

The recommended initial dose is two tablets per day. Take the two tablets 1 hour before a meal. Afterwards, your doctor may adjust the dose, depending on the amount of acid secretion you produce. If you are prescribed more than two tablets per day, you should take the tablets divided into two doses per 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 kidney problems, you should not take pantoprazole for the elimination 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 case).

If you have moderate or severe liver problems, you should not take Pantoprazol Almus for the elimination 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, telephone 91 562 04 20, indicating the medicine and the amount taken. 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 forgotten 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 on 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 all people suffer from them.

If you experience any of the following adverse effects, stop taking these tablets and inform your doctor immediately, or contact the emergency service of the 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, hives (urticaria), difficulty breathing, swelling of the face of allergic origin (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats and profuse sweating.
• Severe skin disorders (frequency not known: their frequency cannot be estimated with the available data):you may notice one or more of the following symptoms: blisters on the skin and rapid deterioration of general conditions, 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 experience joint pain or symptoms similar to those of the flu, 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 Reaction with Eosinophilia and Systemic Symptoms (DRESS), Photosensitivity) and circular or target-shaped spots of slightly reddish color on the trunk, often with blisters in the center, peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe exanthems may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). Generalized exanthema, elevated body temperature, and adenopathy (DRESS or drug hypersensitivity).
• Other severe conditions (frequency not known: their frequency cannot be estimated with the available data):yellowish discoloration of the skin and the whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increased kidney size sometimes with pain when urinating and pain in the lower back (severe kidney inflammation), which may lead to kidney failure.

Other adverse effects are:

• Frequent(may affect between 1 and 10 patients in 100)

Benign polyps in the stomach.

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

Headache; dizziness; diarrhea; feeling of dizziness, vomiting; swelling and flatulence (gas); constipation; dry mouth; pain and discomfort in the abdomen; 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 patients)

Alteration or complete loss of taste; vision 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; increased breast size in men.

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

Disorientation.

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

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

Adverse effects identified through blood tests:

• Infrequent(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 that could cause bleeding or more hematomas than usual; reduction in the number of white blood cells that could lead to more frequent infections; abnormal reduction in the balance between the number of red and white blood cells, as well as platelets.

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

Decrease in sodium, magnesium, calcium, or potassium levels 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 adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines. Website: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Pantoprazol Almus 40 mg

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

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

Do not store above 30 °C.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Pantoprazol Almus 40 mg:

The active ingredient is pantoprazol. Each gastro-resistant tablet contains 40 mg of pantoprazol 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 starch (from corn) (Starch 1500), Sodium carboxymethylcellulose (type A) (from potato) (Explotab), Anhydrous sodium carbonate, Calcium stearate, Purified water (removed during processing).

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

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

Appearance of the product and package contents:

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

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

They are presented in blisters with 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

Phone: 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 last revision of this prospectus:February 2024

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