PANTOPRAZOL ALTER 20 mg GASTRO-RESISTANT TABLETS

2. What you need to know before you take Pantoprazole Alter

Do not take Pantoprazole Alter

• If you are allergic (hypersensitive) to pantoprazole or any of the other ingredients of Pantoprazole 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 Pantoprazole Alter:

• If you have serious 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 need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously and take pantoprazole, as there is a greater risk of developing stomach and intestine complications. 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 low body reserves of vitamin B12 or risk factors for it and receive long-term treatment with pantoprazole. Like all acid-reducing medicines, pantoprazole may reduce the absorption of vitamin B12.
• Tell your doctor if you are taking any medicine that contains 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.

Tell 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 the blood. Symptoms of low magnesium levels can include fatigue, involuntary muscle contractions, disorientation, dizziness or increased heart rate. If you have any of these symptoms, tell your doctor immediately. Low magnesium levels can cause a decrease in potassium and calcium levels in the blood. Your doctor will decide whether 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 Alter to reduce stomach acid.

If you get a skin rash, especially in areas exposed to the sun, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Pantoprazole Alter. 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 immediatelyif you notice any of the following symptoms:

• unintentional weight loss
• repeated vomiting
• difficulty swallowing
• blood in the vomit; it may appear as a dark coffee grounds-like substance in your vomit
• blood in your stools, which may appear black or tarry
• 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 because pantoprazole can alleviate the symptoms of cancer and may 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 perform regular follow-up. 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 Pantoprazole Alter is not recommended in children as it has not been tested in children under 12 years.

Taking Pantoprazole Alter with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Pantoprazole Alter may affect the effectiveness of other medicines. Tell 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 Alter may make these and other medicines not work properly.
• Warfarin and phenprocoumon, which affect blood coagulation. You may need additional tests.

• 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 Pantoprazole Alter because 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 and breastfeeding

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 or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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

Pantoprazole Alter has no 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.

Pantoprazole Alter contains sodium

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

3. How to take Pantoprazole Alter

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again.

When and how should you take Pantoprazole Alter?

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, difficulty swallowing)

The usual dose is one 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 take the medicine. After that, 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:

For the prevention of duodenal and stomach ulcers in patients who require continued treatment with NSAIDs

The usual dose is one tablet per day.

Special patient groups:

• If you have serious liver problems, you should not take more than one 20 mg tablet per day.
• Children under 12 years: The use of these tablets is not recommended in children under 12 years.

If you take more Pantoprazole Alter 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. No symptoms of overdose are known.

If you forget to take Pantoprazole Alter

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

If you stop taking Pantoprazole Alter

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, Pantoprazole Alter 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 (rare;may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, rash (urticaria), difficulty breathing, swelling of the face of allergic origin (angioedema), severe dizziness with very rapid heartbeat and profuse sweating.

• Severe skin reactions (frequency not known;frequency cannot be estimated from the available data):you may notice one or more of the following 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 have joint pain or flu-like symptoms, fever, swollen glands (e.g. in the armpit) and 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).

• 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:

• 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; feeling of dizziness, vomiting; swelling and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; tingling; 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; vision disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; 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)

hallucination, confusion (especially in patients with a history of these symptoms), tingling, pinching, numbness, burning sensation or tingling, 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)

increase in liver enzymes.

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

increase in bilirubin; increase in blood fat levels; sudden drop in white blood cells with high fever.

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

reduction in platelet count that could lead to bleeding or more bruising than usual; reduction in white blood cell count that could lead to more frequent infections; abnormal reduction in the balance between red and white blood cell and platelet counts.

• 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 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 to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazole Alter

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

Do not use Pantoprazole Alter after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Store in the original package.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazole Alter

The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).

The other ingredients (excipients) are:

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

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

Appearance of the product and contents of the pack

Gastro-resistant tablet, yellow-orange and round.

Packaging:

Each pack contains 28 or 56 gastro-resistant tablets in a blister pack of Polyamide/Al/PVC-Al.

Marketing authorization holder and manufacturer

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Date of last revision of this leaflet: February 2023

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