Pantoprazole Stada 20 mg gastro-resistant tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Pantoprazol Stada 20 mg gastro-resistant tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.

Leaflet Contents

1. What Pantoprazol Stada is and what it is used for
2. What you need to know before taking Pantoprazol Stada
3. How to take Pantoprazol Stada
4. Possible side effects
5. How to store Pantoprazol Stada
6. Contents of the pack and other information

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

Pantoprazol Stada is a medicine that reduces the secretion of stomach acid (a selective proton pump inhibitor).

Pantoprazol 20 mg is used for:

• Treatment of mild reflux disease (esophageal disorder caused by acid rising from the stomach) and associated symptoms (e.g., heartburn, acid regurgitation, pain when swallowing)

• Long-term treatment and prevention of relapses in reflux esophagitis (inflammation of the esophagus).

• Prevention of gastric and duodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs), in at-risk patients who require ongoing treatment with these types of medicines.

2. What you need to know before taking Pantoprazole Stada

DO NOT take Pantoprazole 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

Talk to your doctor, pharmacist, or nurse before starting Pantoprazole 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 if you are on long-term pantoprazole treatment. If liver enzymes increase, treatment should be discontinued.
• If you need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously while taking pantoprazole, as there is an increased risk of developing stomach and intestinal complications. Any increase in risk will be assessed according to personal risk factors such as age (65 years or older), history of stomach or duodenal ulcer, or gastrointestinal bleeding.
• If you have reduced body stores of vitamin B12 or risk factors for this, and are receiving long-term pantoprazole treatment. Like all medicines that reduce acid levels, pantoprazole may reduce the absorption of vitamin B12.
• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for treatment of HIV infection) at the same time as pantoprazole.
• Taking a proton pump inhibitor such as pantoprazole, particularly for more than one year, may increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis (reduced bone density) or have been told you are at risk of osteoporosis (for example, if you are taking corticosteroids).
• If you are taking pantoprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. 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 pantoprazole used to reduce stomach acidity.
• If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop treatment with pantoprazole. 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)

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

• unintentional weight loss
• vomiting, particularly if repeated
• blood in vomit: this may appear as dark, coffee-ground-like material in your vomit
• notice blood in your stools, which may appear black or tarry (melena)
• difficulty swallowing, or pain when swallowing
• pale appearance and feeling weak (anemia)
• chest pain
• stomach pain
• severe or persistent diarrhoea, as this medicine has been associated with a small increased risk of infectious diarrhoea.

Your doctor will decide whether you need additional tests to rule out malignant disease, as pantoprazole may relieve cancer symptoms and could delay diagnosis. If your symptoms persist despite treatment, further investigations will be carried out.

If you take pantoprazole for a prolonged period (more than one year), your doctor will likely monitor you regularly. You should inform your doctor of any new or unexpected symptoms or events at each visit.

Children and adolescents

The use of pantoprazole is not recommended in children, as it has not been studied in children under 12 years of age.

Other medicines and Pantoprazole Stada

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

Pantoprazole may affect the effectiveness 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 for certain types of cancer), as pantoprazole may reduce the effectiveness of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting. You may require additional monitoring.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used for rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate, your doctor may temporarily discontinue your pantoprazole treatment, as pantoprazole may increase methotrexate blood levels.
• 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 become pregnant, consult your doctor or pharmacist before using this medicine.

There are insufficient data on the use of pantoprazole in pregnant women. It has been reported that pantoprazole is excreted in human breast milk.

This medicine should only be used if your doctor considers that the benefit to you outweighs the potential risk to the fetus or infant.

Driving and using machines

Pantoprazole has no or negligible influence on the ability to drive or operate machinery. However, you should not drive or operate machinery if you experience adverse effects such as dizziness or blurred vision.

Pantoprazole Stada contains maltitol

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

Pantoprazole Stada contains soya lecithin

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

Pantoprazole Stada contains sodium

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

3. How to take Pantoprazol Stada

Follow exactly the dosage instructions provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Method of administration

Take the tablets 1 hour before meals without chewing or breaking them, swallowing them whole with a little water.

The recommended dose is:

Adults and adolescents aged 12 years and older

To treat symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, painful swallowing).

The usual dose is one tablet per day. This dose generally provides relief within 2–4 weeks, and if not, within a maximum of 4 additional weeks. Your doctor will advise you on how long you should continue taking the medicine. Afterwards, any recurring symptoms can be managed as needed by taking one tablet per day.

For long-term treatment and prevention of relapse of reflux esophagitis

The usual dose is one tablet per day. If the disease recurs, your doctor may double your dose, in which case you may take pantoprazole 40 mg once daily. After healing, the dose may be reduced again to one 20 mg tablet per day.

Adults

For prevention of duodenal and gastric ulcers in patients requiring ongoing treatment with NSAIDs

The usual dose is one tablet per day.

Patients with liver problems

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

Use in children and adolescents

This medicine is not recommended for use in children under 12 years of age.

If you take more Pantoprazol Stada than you should

Inform your doctor or pharmacist, or call the toxicology information service at 91 562 04 20, indicating the name of the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

Symptoms of overdose are not known.

If you forget to take Pantoprazol Stada

Do not take a double dose to make up for missed 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 about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

If you experience any of the following adverse effects, stop taking these tablets immediately and contact your doctor right away, or contact the emergency department of your nearest hospital:

• Severe allergic reactions (rare frequency: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, rash (urticaria), difficulty breathing, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and excessive 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 in general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to light/sun. You may also experience 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's 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, enlarged kidneys with occasional pain when urinating and lower back pain (severe kidney inflammation), which could possibly lead to kidney failure.

Other adverse effects are:

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

Benign gastric polyps.

• 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, tiredness or general malaise; sleep disturbances; fracture of hip, wrist and spine.

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

Altered or complete loss of taste; vision disorders such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling in the extremities (peripheral oedema); allergic reactions; depression; enlargement of the breasts in men.

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

Disorientation.

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

Hallucination, confusion (especially in patients with a history of these symptoms), sensation of tingling, pricking, numbness, burning or stinging, skin rash, possibly with joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse 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 lipid levels; sudden drop in granular white blood cells in circulation, associated with high fever.

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

Reduction in the number of platelets, which could cause bleeding or more bruising than usual; reduction in the number of white blood cells, which could lead to more frequent infections; abnormal decrease in the balance between red blood cells, white blood cells, and platelets.

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

Decreased levels of sodium, magnesium, calcium or potassium in the blood (see section 2).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist or nurse, even if it is an adverse effect not listed in this leaflet. You can also report them directly via the national reporting system included in the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 on the carton after EXP. The expiry date refers to the last day of the month indicated.

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

Do not store above 25 °C.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazol Stada

The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (present as 22.575 mg of sodium pantoprazole 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, soybean 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 pack contents

Yellow, oval-shaped gastro-resistant tablets.

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

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

Lamp S. Prospero S.P.A

Via della Pace, 25/A

41030 San Prospero (MO)

Italy

or

Sofarimex

Industria Quimica e 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 European Economic Area member states 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 the most recent review of this leaflet: April 2023

Detailed and up-to-date 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/