Leaflet: information for the user

Pantoprazol Almus 40 mg gastro-resistant tablets EFG

Read this 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. Do not pass it on to others even if they have similar symptoms to you, as it may harm them.

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

Contentsoftheleaflet:

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

Pantoprazol is a selective proton pump inhibitor, a medication that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach and intestinal acid.

Pantoprazol Almus 40 mg is used for:

Adults and adolescents 12 years and older:

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

Adults:

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

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

Do not take Pantoprazol Almus 40 mg

• If you are allergic to the active ingredient or to any of the other components of this medication (including those listed in section 6).

• If you are allergic to medications 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 monitor your liver enzymes more frequently, especially when you are on long-term treatment with pantoprazole. If liver enzyme levels increase, treatment should be discontinued.
• If you have reduced vitamin B12 reserves or risk factors for it and receive long-term treatment with pantoprazole. Like all medications that reduce acid production, pantoprazole may reduce vitamin B12 absorption. Consult your doctor if you notice any of the following symptoms, as they may indicate vitamin B12 deficiency:
• • Extreme fatigue or lack of energy
  • Tickling
  • Pain or redness in the tongue or mouth, mouth ulcers
  • Muscle weakness
  • Visual disturbances
  • Mental impairment, confusion, depression

• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV 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 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 developing 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 your blood. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Additionally, low magnesium levels can also cause decreased potassium and calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor magnesium levels.
• If you have ever had a skin reaction after treatment with a similar medication to Pantoprazol Almus for reducing stomach acid.
• If you experience a skin rash, especially in sun-exposed areas, 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 notice, such as joint pain.
• If you are scheduled to have a specific blood test (Cromogranin A).

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

• Unintentional weight loss

• Repeated vomiting
• Blood in the vomit: it may appear as a dark brown powder in your vomit
• 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
• Abdominal pain
• Severe or persistent diarrhea, as Pantoprazol Almus has been associated with a small increase in infectious diarrhea.
• Severe skin reactions have been reported in relation to Pantoprazol Almus treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug-induced hypersensitivity syndrome 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 severe skin reactions described in section 4.

Your doctor will decide if you need additional testing to rule out cancer, as pantoprazole may alleviate cancer symptoms and potentially delay diagnosis. If your symptoms persist despite treatment, further investigations will be performed.

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

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 old.

Use of Pantoprazol Almus 40 mg with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including medications purchased without a prescription.

Pantoprazol Almus may affect the efficacy of other medications, so inform your doctor if you are taking:

• Medications 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 medications less effective.
• Warfarin and phenprocoumon, which affect blood clotting. You may need additional monitoring.
• Medications 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 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 insufficient data on the use of pantoprazole in pregnant women. Pantoprazole has been 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 medication.

You should only use this medication if your doctor considers the benefits for you to be greater than the potential risk to the fetus or baby.

Driving and operating machinery

Pantoprazol Almus has no influence or insignificant influence on the ability to drive or operate machinery.

You should not drive or operate machinery if you experience side effects such as dizziness or blurred vision.

Pantoprazol Almus 40 mg tablets contain sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

When and how should you take Pantoprazol Almus?

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

Unless your doctor has indicated otherwise, the normal dose is:

Adults and adolescents 12 years and older

For the treatment of esophagitis by reflux:

The usual dose is 1 tablet a day. Your doctor may indicate an increase to 2 tablets a day. The treatment time for esophagitis by reflux usually lasts between 4 and 8 weeks. Your doctor will tell you for how long you should take this medication.

Adults

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

1 tablet twice a day plus the two antibiotic tablets, either amoxicillin, clarithromycin, and metronidazole (or tinidazole), each should be 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 antibiotic prospectuses.

The treatment duration is usually 1 to 2 weeks.

For the treatment of stomach and duodenal ulcers:

The usual dose is 1 tablet a day. The dose may be doubled by your doctor.

Your doctor will tell you for how long you should take this medication. 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 production:

The initial recommended dose is 2 tablets a day. Take the two tablets 1 hour before a meal. Your doctor may then adjust your dose, depending on the amount of stomach acid you produce. If you are prescribed more than 2 tablets a day, you should take the tablets twice a day. If you are prescribed more than 4 tablets a day, you will be told exactly when to stop treatment.

Patients with kidney problems

If you have kidney problems, you should not take pantoprazol for the elimination of Helicobacter pylori.

Patients with liver problems

If you have severe liver problems, you should not take more than 1 tablet of 20 mg of pantoprazol a day (for this case, tablets of 20 mg of pantoprazol are available).

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

This medication is not recommended for use in children under 12 years old.

If you take more Pantoprazol Almus 40 mg than you should

Inform your doctor or pharmacist or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.No known symptoms of overdose.

If you forgot to take Pantoprazol Almus 40 mg

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

If you interrupt the treatment with Pantoprazol Almus 40 mg

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience any of the following side effects, stop taking these tablets and inform your doctor immediately, or contact the hospital's emergency service nearest to you:

Other side 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; sensation of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; hives on the skin, exanthem, rash; tingling; feeling of weakness, fatigue, or general discomfort; sleep disturbances; hip, wrist, and spinal column fractures.

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

Alteration or complete absence of the sense of taste; visual disturbances such as blurred vision; urticaria; joint pain;muscle pain; weight changes; elevated body temperature; high fever; swelling in the extremities (peripheral edema); allergic reactions; depression; gynecomastia in men.

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

Disorientation.

• Unknown frequency(cannot be estimated from the available data)

Illusion; confusion (especially in patients with a history of these symptoms); sensation of tingling; pinpricks, numbness; sensation of burning or numbness; skin rash, possibly with joint pain; inflammatory bowel disease causing persistent watery diarrhea.

Side 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 levels of fats in the blood;brusque 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 frequent bruising; 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.

• Unknown frequency(cannot be estimated from the available data)

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use. Website:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication 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 at a temperature above 30°C.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications that you no longer need at the SIGRE collection pointof the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

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 cornstarch (Starch 1500), Sodium carboxymethylstarch (type A) (from 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:Copolymer of methacrylic acid and ethyl acrylate, Polysorbate 80, Sodium lauryl sulfate, Triethyl citrate,Purified water (removed during the process).

Appearance of the product and content of the container:

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

The tablets areyellowish, convex, and oblong in shape.

It is presented in blisters with 14 or 28 tablets.

Other presentations

Pantoprazol Almus 20 mg gastro-resistant tablets EFG

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Responsible for manufacturing:

Atlantic Pharma - Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2, Abrunheira

2710-089 Sintra

Portugal

Date of the last review of this leaflet:February 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/