Leaflet: information for the user

Pantoprazol Almus 20 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 give it to others even if they have the same symptoms as you, as it may harm them.

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

Contentsoftheleaflet:

1. What Pantoprazol Almus 20 mg is and what it is used for
2. What you need to know before you start taking Pantoprazol Almus 20 mg
3. How to take Pantoprazol Almus 20 mg
4. Possible side effects
5. Storage of Pantoprazol Almus 20 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 20 mg is used for:

Adults and adolescents 12 years and older:

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

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

Adults:

• Prevention of gastroduodenal ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patients at risk who require continued treatment with these types of medications.

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

Do not take Pantoprazol Almus 20 mg

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• If you are allergic to medications containing 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. If liver enzyme levels increase, treatment should be discontinued.
• If you need to take nonsteroidal anti-inflammatory drugs (NSAIDs) continuously and take pantoprazole, as there is a higher risk of developing complications in the stomach and intestines. Any increased risk will be evaluated based on individual risk factors such as age (65 years or older), history of stomach or duodenal ulcers, or gastrointestinal bleeding.
• If you have decreased vitamin B12 reserves or risk factors for it and receive long-term treatment with pantoprazole. Like all acid-reducing medications, pantoprazole may reduce vitamin B12 absorption. Inform your doctor if you observe 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 ulcers
  • Muscle weakness
  • Vision problems
  • Mental confusion, depression
• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV treatment) at the same time as pantoprazole.
• Long-term use of 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 decreased magnesium levels in your 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. Additionally, low magnesium levels may 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 pantoprazole 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 undergo a specific blood test (Cromogranin A).

Inform your doctor immediatelybefore 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
• Vomiting, particularly if repeated
• Blood in vomit: may appear as a dark brown powder in your vomit
• Blood in 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 pantoprazole has been associated with a small increase in infectious diarrhea.
• Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme, have been reported in relation to Pantoprazol Almus treatment. 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 malignant disease, as pantoprazole may alleviate cancer symptoms and potentially delay diagnosis. If your symptoms persist despite treatment, further investigations will be performed.

If you take pantoprazole 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 and/or events each time you attend your consultation.

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 old.

Use of Pantoprazol Almus 20 mg with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

Pregnancy, breastfeeding, and fertility

There is insufficient data on the use of pantoprazole in pregnant women. Pantoprazole has been reported to be excreted in breast milk.

Inform your doctor or pharmacist if you are pregnant, think you may be pregnant, or are breastfeeding, and plan to use this medication.

Only use this medication if your doctor considers the benefits for you to outweigh the potential risks for the fetus or baby.

Driving and operating machinery

Pantoprazole Almus has no influence or negligible influence on the ability to drive or operate machinery.

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

Pantoprazol Almus 20 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. 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 a meal.

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

Adults and adolescents 12 years and older:

For treating symptoms associated with gastroesophageal reflux disease (stomach burning, acid regurgitation, difficulty swallowing)

The usual dose is 1 tablet per day.

This dose usually provides relief within 2-4 weeks, and if not, within a maximum of 4 weeks. Your doctor will tell you how long you should continue taking the medication. Subsequently, any recurring symptoms can be controlled as needed by taking 1 tablet per day.

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

The usual dose is 1 tablet per day. If the disease returns, your doctor may double the dose, in which case you can take pantoprazol 40 mg once a day. After healing, you can reduce the dose again to 1 tablet of 20 mg per day.

Adults:

For preventing duodenal and stomach ulcers in patients requiring continued treatment with NSAIDs

The usual dose is 1 tablet per day.

Patients with liver problems:

- If you have severe liver problems, do not take more than 1 tablet of 20 mg per day.

Use in children and adolescents:

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

If you take more Pantoprazol Almus 20 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 taken. No symptoms of overdose are known.

If you forgot to take Pantoprazol Almus 20 mg

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

If you interrupt treatment with Pantoprazol Almus 20 mg

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

If you have any other questions 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:

• Common(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; sensation of dizziness, vomiting; swelling 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 loss 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 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:

• 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 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 available data)

Decreased sodium, magnesium, calcium, or potassium levels 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 side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for 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 trash.Deposit the packaging and medications 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 you no longer need. By doing so, you will help protect the environment.

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 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 packaging:

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

The tablets areyellowish, convex, and oblong in shape.

It is presented in blisters with 28 tablets.

Other presentations

Pantoprazol Almus 40 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/