PANTOPRAZOL STADA 20 mg GASTRO-RESISTANT TABLETS

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

Do not takePantoprazol Stada

• If you are allergic to pantoprazole, peanuts, or soy, or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with Pantoprazol Stada. Especially:

• If you have severe liver problems. Inform your doctor if you have ever had liver problems in the past. Your doctor will monitor your liver enzymes more frequently, especially when you are on long-term treatment with pantoprazol. If your liver enzymes increase, treatment should be discontinued.
• If you need to take NSAID medicines continuously and take pantoprazol, as there is a higher risk of developing stomach and intestinal 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 vitamin B12 body stores or risk factors for this and receive long-term treatment with pantoprazol. Like all acid-reducing medicines, pantoprazol may reduce the absorption of vitamin B12.
• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV infection treatment) at the same time as pantoprazol.
• Taking a proton pump inhibitor like pantoprazol, especially for more than a year, may increase the risk of hip, wrist, or spine fractures. Inform 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 are taking pantoprazol for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, see your doctor immediately. Low magnesium levels can also lead to a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor your 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 interrupt 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 immediatelybefore 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 repeated
• blood in the vomit: it may appear as a dark coffee grounds-like substance in your vomit.
• if you notice blood in your stools, which may appear black or tarry
• difficulty swallowing, or pain when swallowing
• pale appearance and feeling of weakness (anaemia)
• chest pain
• stomach pain
• severe or persistent diarrhoea, as this medicine has been associated with a small increase in infectious diarrhoea.

Your doctor will decide if you need any additional tests to rule out a malignant disease, as pantoprazol may alleviate the symptoms of cancer and 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 may monitor you regularly. 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 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 monitoring.
• 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 stop your treatment with pantoprazol, as pantoprazol 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 and breastfeeding

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.

There is not enough data on the use of pantoprazol in pregnant women. It has been reported that pantoprazol is excreted in human 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 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 prescribed by your doctor or pharmacist. If you are unsure, 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

For treating symptoms associated with gastro-oesophageal 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, at most, within the following 4 weeks. Your doctor will tell you how long you should continue taking the medicine. If symptoms recur, you can control them by taking one tablet per day as needed.

For long-term treatment and prevention of relapses of reflux oesophagitis

The usual dose is one tablet per day. If the disease recurs, 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 back to one 20 mg tablet per day.

Adults

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

The usual dose is one tablet per day.

Patients with liver problems

If you have severe liver problems, you should not take more than one 20 mg tablet per day.

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

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

No symptoms of overdose are known.

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 consulting your doctor or pharmacist first.

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 (Quincke's oedema/angioedema), severe dizziness with very rapid heartbeats and profuse sweating.

• Severe skin disorders(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/reaction, particularly in areas of skin exposed to light/sun. You may also have joint pain or symptoms similar to flu, 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:frequency cannot be estimated from the available data): yellowing of the skin and the whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increased 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 people)

Benign polyps in the stomach.

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

Headache; dizziness; diarrhoea; 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; hip, wrist, and spine fractures.

• 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 limbs (peripheral oedema); allergic reactions; depression; breast enlargement 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), tingling, pinching, numbness, burning sensation, or tingling, skin rash, possibly with joint pain, inflammation of the large intestine that causes persistent watery diarrhoea.

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 blood fat levels; sharp drop in white blood cell count, associated with high fever.

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

Reduced platelet count, which may cause bleeding or more bruising than usual; reduced white blood cell count, which may 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 help provide 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 expiry date which is stated on the blister and carton after EXP. The expiry date is the last day of the month shown.

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. Return the containers and any unused medicine to the pharmacy. Ask your pharmacist how to dispose of containers and any unused medicine. This will help protect the environment.

6. Container contents and additional information

Composition ofPantoprazol Stada

The active ingredient is pantoprazol. Each gastro-resistant tablet contains 20 mg of pantoprazol (present in the form of 22,575 mg of pantoprazol sodium sesquihydrate)

The other components are:

Core

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

Coating

Poly(vinyl alcohol), talc (E 553b), 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 (E 1505).

Appearance of the product and container contents

Oval, yellow, gastro-resistant tablets.

It is available in:

Pantoprazol Stada 20 mg is available in blisters 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 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

Laboratory 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

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

Eurogenerics N.V.

Heizel Esplanade B 22

1020 Brussels

Belgium

or

Sanico NV

Veedijk 59

B-2300 Turnhout

Belgium

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

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

DE (RMS): Pantoprazol STADA 20 mg magensaftresistente Tabletten

AT: Pantoprazol Stada 20 mg - magensaftresistente Tabletten

BE: Pantoprazole EG 20 mg maagsapresistente tabletten

DK: Pantoprazol STADA

ES: Pantoprazol Stada 20 mg comprimidos gastrorresistentes EFG

FR: Pantoprazole EG 20 mg, comprimé gastro-résistant

IE: Pantium 20 mg gastro-resistant tablet

IT: Pantoprazolo EG 20 mg compressa gastroresistenti

LU: Pantoprazole EG 20 mg comprimé gastro-résistants

NL: Pantoprazole CF 20 mg

PL: Gastrostad 20 mg

PT: Pantoprazol Ciclum 20 mg comprimido gastroresistente

Date of last revision of this leaflet:April 2023

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