PANTOPRAZOL STADA 40 mg GASTRO-RESISTANT TABLETS

2. What you need to know before you take Pantoprazol Stada

Do not takepantoprazol

• If you are allergic to pantoprazol, peanuts, or soy, 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.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take pantoprazol. Especially:

• 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 pantoprazol. In case of an increase in liver enzymes, treatment should be discontinued.
• If you have reduced body stores of vitamin B12 or risk factors for it and receive long-term treatment with pantoprazol. Like all medicines that reduce the amount of acid, pantoprazol may reduce the absorption of vitamin B12.
• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection) at the same time as pantoprazol. Taking a proton pump inhibitor like pantoprazol, 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 that you are at risk of osteoporosis (for example, if you are taking corticosteroids).
• If you are taking pantoprazol for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you have any of these symptoms, go to the doctor immediately. Low magnesium levels can also produce a decrease in blood potassium and calcium levels. 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 to reduce stomach acid.
• If you get 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. Remember to mention any other symptoms you may notice, such as joint pain.
• It is planned that you will have a specific blood test (Chromogranin A).

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

• unintentional weight loss
• vomiting, especially if it is repeated
• blood in the vomit: it may appear as a dark coffee grounds-like substance in your vomit
• difficulty swallowing, or pain when swallowing
• pale appearance and feeling of weakness (anemia)
• chest pain
• stomach pain
• severe or persistent diarrhea, as this medicine 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 pantoprazol may alleviate the symptoms of cancer and could delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

If you take pantoprazol for a prolonged period (more than a year), your doctor will probably monitor you regularly. You should inform your doctor of any new symptoms and/or events each time you visit your doctor.

Children and adolescents

The use of pantoprazol is not recommended in children as it has not been tested in children under 12 years of age.

Other medicines and Pantoprazol Stada

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pantoprazol may affect the efficacy of other medicines, 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 may make these and other medicines not work properly.
• Warfarin and phenprocoumon, which affect blood coagulation. You may need additional checks.
• 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 because pantoprazol may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric diseases) - 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

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.

There are no sufficient data on the use of Pantoprazol in pregnant women.

It has been reported that in humans, pantoprazol is excreted in breast milk.

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

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

Pantoprazol Stada contains maltitol

This medicine contains maltitol (E-965). If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Pantoprazol Stada contains soy lecithin

If you are allergic to peanuts or soy, do not use this medicine.

Pantoprazol Stada contains sodium

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

3. How to take Pantoprazol Stada

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

Method of administration Take the tablets 1 hour before meals without chewing or breaking them and swallow them whole with a little water.

The recommended dose is:

Adults and adolescents from 12 years

• Treatment of reflux esophagitis

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

Adults

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

The following combinations are recommended:

or

or

Take the first tablet of pantoprazol 1 hour before breakfast and the second tablet of pantoprazol 1 hour before dinner. Follow your doctor's instructions and make sure to read the package leaflet of these antibiotics. The duration of treatment is usually one to two 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 indicate how long you should take this medicine. The duration of treatment for stomach ulcers is usually between 4 and 8 weeks. The duration of treatment 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 acid secretion from the stomach

The recommended initial dose is usually two tablets per day. Take the two tablets 1 hour before a meal. Later, 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 your doctor prescribes more than four tablets per day, you will be told exactly when to finish the treatment.

Patients with kidney problems

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

Patients with liver problems

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

If you have moderate or severe liver problems, you should not take pantoprazol for the eradication 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 Stada than you should

Consult your doctor, pharmacist, or call the toxicology information service, telephone 91 562 04 20, indicating the medicine and the amount used. It is recommended to take the package and package leaflet of the medicine to the healthcare professional.

There are no known symptoms of overdose.

If you forget to take Pantoprazol Stada

Do not take a double dose to make up for forgotten doses.

Take your next dose as usual.

If you stop taking Pantoprazol Stada

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, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine 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/Quincke's edema), intense 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 symptoms similar to those of the flu, fever, swollen glands (for example, 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: frequency cannot be estimated from the available data): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increase in kidney size, sometimes with pain when urinating, and pain in the lower back (severe kidney inflammation), which may possibly cause kidney failure.

Other side effects are:

• Common(may affect up to 1 in 10 people)

Benign polyps in the stomach.

• Uncommon(may affect up to 1 in 100 people)

Headache; dizziness; diarrhea; feeling of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; tingling; feeling of weakness, fatigue, or general malaise; sleep disturbances; fracture of the hip, wrist, and spine.

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

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

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

Disorientation

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

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

Increased liver enzymes

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

Increased bilirubin; increased levels of fat in the blood; sharp drop in white blood cells in the circulation, associated with high fever.

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

Reduction in the number of platelets that could cause bleeding or more bruising 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 side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a side effect not listed in this leaflet. You can also report them directly through the national reporting system included in the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Pantoprazol Stada

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

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

For tablets packaged in plastic bottles: Use Pantoprazol Stada within three months of first opening the bottle.

Do not store above 25 °C.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Pantoprazol Stada:

The active ingredient is pantoprazol. Each gastro-resistant tablet contains 40 mg of pantoprazol (present as 45.150 mg of pantoprazol sodium sesquihydrate)

The other ingredients are:

Core

Maltitol (E 965), crospovidone type B, sodium carmellose, sodium carbonate (E 500), calcium stearate.

Coating

Poly(vinyl alcohol), talc (E553b), titanium dioxide (E 171), macrogol 3350, soy lecithin, yellow iron oxide (E 172), sodium carbonate (E 500), methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate (E1505).

Appearance of the Product and Package Contents

Oval, yellow, gastro-resistant tablets.

Available in:

Pantoprazol Stada 40 mg is available in blister packs of 2 (starter pack), 7, 10, 14, 15, 20, 28, 30, 30x1, 50, 56, 60, 90, 98, 100, 120, 126, 140, 140 (10x14) (5x28), 154, 196, 280 (20x14) (10x28), 500, 700 (5x140) tablets, and in plastic bottles of 2 (starter pack), 7, 10, 14, 15, 20, 28, 30, 30x1, 50, 56, 60, 90, 98, 100, 120, 126, 140, 140 (10x14) (5x28), 154, 196, 280 (20x14) (10x28), 500, 700 (5x140) tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastr. 2-18,

D-61118 Bad Vilbel,

Germany

or

Centrafarm Services B.V.

Van de Reijstraat 31-E

4814 NE Breda

Netherlands

or

Eurogenerics N.V.

Heizel Esplanade B 22, 1020 Brussels

Belgium

or

Sanico NV

Veedijk 59

B-2300 Turnhout

Belgium

or

Lamp S. Prospero S.P.A

Via della Pace, 25/A

41030 San Prospero (MO)

Italy

or

Sofarimex

Industria Quimicae Farmaceutica, SA

Av. das Industrias

Alto de Colaride, Agualva

2735-213 Cacem

Portugal

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Austria

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

This medicine is authorized in the Member States of the European Economic Area under the following names:

DE (RMS): Pantoprazol STADA 40 mg magensaftresistente Tabletten

AT: Pantoprazol Stada 40 mg - magensaftresistente Tabletten

BE: Pantoprazole EG 40 mg maagsapresistente tabletten

DK: Pantoprazol STADA

ES: Pantoprazol Stada 40 mg comprimidos gastrorresistentes EFG

IT: Pantoprazolo EG 40 mg compressa gastroresistenti

LU: Pantoprazole EG 40 mg comprimé gastro-résistants

NL: Pantoprazole CF 40 mg

PL: Gastrostad 40 mg

PT: Pantoprazol Ciclum 40 mg comprimido gastroresistente

Date of the last revision of this leaflet:April 2023

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