PROSPECTO : INFORMATION FOR THE USER

Pantoprazol Alter 20 mg gastro-resistant tablets EFG

Read this prospect carefully before starting to take the medicine,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Pantoprazol Alter and for what it is used

2.What you need to know before starting to take Pantoprazol Alter

3.How to take Pantoprazol Alter

4.Possible adverse effects

5.Storage of Pantoprazol Alter

6.Contents of the package and additional information

Pantoprazol Alter 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 Alter 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 recurrences 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 this type of medication.

Do not take Pantoprazol Alter

• If you are allergic (hypersensitive) to pantoprazole or to any of the othercomponents ofPantoprazol Alter (see 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, pharmacist or nurse before starting to take Pantoprazol Alter:

• 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 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 individual risk factors such as age (65 years or older), history of stomach or duodenal ulcers or stomach or intestinal bleeding.
• If you have reduced vitamin B12 stores or risk factors for it and receive pantoprazole treatment for a long period of time. Like all acid-reducing medicines, pantoprazole may reduce vitamin B12 absorption.
• Consult your doctor if you are taking any medicine that contains 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 (for example, if you are taking corticosteroids).

• If you take pantoprazole for more than three months,it is possible that you will experience a decrease in magnesium levels in the blood. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, disorientation, dizziness, or increased heart rate. If you have any of these symptoms, inform your doctor immediately. Low magnesium levels can cause a decrease in potassium and calcium levels in the blood. Your doctor will decide to perform periodic blood tests to monitor magnesium levels.
• If you have ever had a skin reaction after treatment with a similar medicine to Pantoprazol Alter 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 Alter. Remember to mention any other symptoms you may notice,such as joint pain.

• If you are scheduled to have a specific blood test (Cromogranin A).

Inform your doctor immediately if you notice any of the following symptoms:

-Unintended weight loss

-Repeated vomiting

-Difficulty swallowing

-Blood in the vomit; it may appear as a dark brown powder in your vomit

-Blood in your stools, which may appear black or melena

-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.

Your doctor will decide if you need any additional tests to rule out a malignant disease, as pantoprazole may alleviate cancer symptoms and potentially delay its 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 Alter is not recommended in children, as it has not been tested in children under 12 years.

Taking Pantoprazol Alter with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including medicines obtained without a prescription.

Pantoprazol Alter may affect the efficacy of other medicines, inform your doctor if you are taking:

• Medicines such asketoconazole, itraconazole and posaconazole (used for fungal infections) or erlotinib (used for certain types of cancer), as Pantoprazol Alter may make these and other medicines not work correctly.
• Warfarinandfenprocoumon, which affect blood clotting. You may need additional monitoring.

• Medicines used for HIV treatment, 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 Alter, 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 for treating infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy and breastfeeding

There is insufficient data on the use of pantoprazole in pregnant women.Pantoprazole is excreted in human breast milk.If you are pregnant or breastfeeding, or think you may be pregnant or intend 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 for you is greater than the potential risk to the fetus or baby.

Driving and operating machinery

Pantoprazol Alter has no influence or this is insignificant 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 Alter contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

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

When and how should you take Pantoprazol Alter?

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

Unless your doctor has indicated otherwise, theusual doseis:

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 taking1 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 recurs, your doctor may double the dose, in which case you can take Pantoprazol 40 mg,onceper day. After healing, you can reduce the dose again to1 tabletof 20 mg per day.

Adults:

For preventing duodenal and stomach ulcers in patients requiring long-term treatment with NSAIDs

The usual dose is 1 tablet per day.

Special patient groups:

- If you have severe liver problems,do not take more than1 tablet of 20 mg per day.

-Children under 12 years:This medication is not recommended for children under 12 years.

If you take more Pantoprazol Alter 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 symptoms of overdose are known.

If you forget to take Pantoprazol Alter

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

If you interrupt treatment with Pantoprazol Alter

Do not stop taking these tabletswithout consulting your doctor or pharmacist first.

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

Like all medications, Pantoprazol Alter 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 nearest hospital's emergency service:

• Severe allergic reactions (rare; may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, allergic swelling of the face (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats, and excessive sweating.

• Severe skin changes (frequency unknown; cannot be estimated with available data): you may notice one or more of the followingblistering on the skin and a rapid deterioration of overall conditions, erosion (including mild bleeding) of eyes, nose, mouth/lips, or genitalsor skin sensitivity/eruption, particularly in areas of exposed skin to light/sun. You may also have joint pain or symptoms similar to the flu, fever, swollen lymph nodes (e.g., in the armpit), and blood tests may show changes in certain white blood cells or liver enzymes. (Stevens-Johnson syndrome, Lyell syndrome, Multiform erythema, Subacute cutaneous lupus erythematosus, Pharmacological reaction with eosinophilia and systemic symptoms (DRESS), Photosensitivity).

• Other serious conditions (frequency unknown):yellowing of the skin and the white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased kidney size with occasional pain while 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 stomach polyps.

• Infrequent(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, exanthema, 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)

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

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

disorientation.

• Frequency unknown(cannot be estimated from available data)

hallucinations, confusion (especially in patients with a history of these symptoms),sensation of tingling, pinching, numbness, 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.

• Frequency unknown(cannot be estimated from available data) reduction in the level 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 pharmacist, even if it is possible side effects that do not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medication

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

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

Store in the original packaging.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Pantoprazol Alter

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

Theother components(excipients) are:

Core:mannitol (E-421), sodium carbonate, pregelatinized cornstarch, crospovidone, calcium stearate.

Coating:hypromellose, triacetin, titanium dioxide, copolymer of methacrylic acid and ethyl acrylate (1:1), dispersion at 30%, talc, triethyl citrate, red iron oxide (E-172), yellow iron oxide (E-172).

Appearance of the product and content of the packaging

Gastro-resistant tablet of yellow-orange color and round shape..

Packaging:

Each package contains 28 or 56 gastro-resistant tablets in a Poliamida/Al/PVC-Al blister.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Last review date of this leaflet: February 2023

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