Gastrostad

Package Leaflet: Information for the Patient

GASTROSTAD

40 mg, gastro-resistant tablets

Pantoprazole

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What Gastrostad is and what it is used for
• 2. Important information before taking Gastrostad
• 3. How to take Gastrostad
• 4. Possible side effects
• 5. How to store Gastrostad
• 6. Contents of the pack and other information

1. What Gastrostad is and what it is used for

Gastrostad is one of a group of medicines called proton pump inhibitors, which reduce the amount of acid produced in the stomach. Gastrostad is used:

• in combination with antibiotics for the treatment of duodenal and stomach ulcers caused by the bacteria Helicobacter pylori. The aim is to completely eradicate the bacteria, which causes stomach and duodenal ulcers;
• for the treatment of duodenal ulcers;
• for the treatment of stomach ulcers;
• for the treatment of moderate to severe reflux esophagitis;
• for the long-term treatment of diseases characterized by excessive acid production in the stomach (e.g., Zollinger-Ellison syndrome).

2. Important information before taking Gastrostad

When not to take Gastrostad

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

Warnings and precautions

Before taking Gastrostad, tell your doctor, pharmacist, or nurse, especially:

• If you have severe liver problems. You should inform your doctor if you have ever had liver problems. Your doctor may need to monitor your liver function more closely, especially during long-term treatment with Gastrostad. If your liver function is impaired, your doctor may need to adjust the dose.
• If you have a deficiency of vitamin B12 or risk factors for a reduced vitamin B12 level, and you are taking pantoprazole for a long time. Like all medicines that reduce stomach acid, pantoprazole may lead to a reduced absorption of vitamin B12.
• If you are taking HIV protease inhibitors such as atazanavir, tell your doctor. Taking a proton pump inhibitor like pantoprazole, especially for more than one year, may slightly increase the risk of hip, wrist, or spine fractures. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
• If you are taking Gastrostad for more than three months, it may lead to a decrease in magnesium levels in the blood. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, tell your doctor immediately. Low magnesium levels can also lead to a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor magnesium levels.
• If you have ever had a skin reaction after taking a medicine that reduces stomach acid.
• If you get a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as possible. You may need to stop taking Gastrostad. Also, tell your doctor about any other side effects, such as joint pain.
• If you are going to 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 could be a sign of a more serious condition:

• unintentional weight loss,
• vomiting, especially if it is repeated,
• blood in your vomit, which may look like coffee grounds,
• if you notice blood in your stool, which may be black or tarry,
• difficulty swallowing or pain when swallowing,
• pale skin and weakness (anemia),
• chest pain,
• stomach pain,
• severe and/or persistent diarrhea, as the use of this medicine is associated with a small increased risk of infectious diarrhea.

Your doctor may decide to perform tests to rule out a malignant condition, as treatment with pantoprazole may alleviate the symptoms of the disease and delay its diagnosis. If the symptoms persist despite treatment, further tests should be considered. If you are taking Gastrostad for a long time (more than 1 year), you will probably be under regular medical supervision. During each medical visit, report any new or unusual symptoms and their circumstances. Children and adolescents The use of Gastrostad is not recommended in children, as its efficacy has not been demonstrated in children under 12 years of age.

Gastrostad and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as Gastrostad may reduce the effectiveness of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting or thinning. Further tests may be necessary.
• HIV protease inhibitors such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer); if you are taking methotrexate, your doctor may temporarily stop Gastrostad, as pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other mental health conditions); your doctor may reduce the dose if you are taking fluvoxamine.
• 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 limited experience with the use of pantoprazole during pregnancy. Pantoprazole has been detected in breast milk. The medicine should only be used if your doctor considers it necessary and the potential benefits outweigh the potential risks to the unborn child or baby.

Driving and using machines

Pantoprazole has no or negligible influence on the ability to drive and use machines. If you experience side effects such as dizziness or blurred vision, do not drive or operate machinery.

Gastrostad contains maltitol

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Gastrostad contains soy lecithin

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

Gastrostad contains sodium

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

3. How to take Gastrostad

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Method of administration Take the tablets 1 hour before a meal, without chewing or breaking them, and swallow them whole with a small amount of water. Recommended dose:

Adults and adolescents 12 years and older:

• For the treatment of symptoms of reflux esophagitisThe usual dose is one tablet per day. Your doctor may increase the dose to 2 tablets per day. Treatment of reflux esophagitis usually lasts from 4 to 8 weeks. Your doctor will decide how long you need to take the medicine.

Adults

• For the treatment of Helicobacter pylori infection in patients with duodenal and stomach ulcers (eradication) in combination with two antibioticsThe following combinations are recommended:

or
or
Take the first pantoprazole tablet 1 hour before breakfast and the second 1 hour before the evening meal. Follow your doctor's instructions and read the package leaflets for the antibiotics. Treatment usually lasts from 1 to 2 weeks.

• For the treatment of stomach and duodenal ulcersThe usual dose is one tablet per day. After consulting your doctor, the dose may be doubled.

Your doctor will tell you how long to take the medicine. The treatment of stomach ulcers usually lasts from 4 to 8 weeks. The treatment of duodenal ulcers usually lasts from 2 to 4 weeks.

• For the long-term treatment of Zollinger-Ellison syndrome and other conditions characterized by excessive acid production in the stomachThe recommended initial dose is usually two tablets per day. Take two tablets 1 hour before a meal. Your doctor may adjust the dose depending on the amount of acid produced in the stomach. If your doctor prescribes more than two tablets, you will be informed about how to take them. If your doctor prescribes more than four tablets per day, you will be informed about how to take them.

Patients with kidney problems

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

Patients with liver problems

If you have severe liver disease, you should not take more than one 20 mg tablet per day (20 mg pantoprazole tablets are available for this purpose). If you have severe or moderate liver disease, you should not take Gastrostad for the eradication of Helicobacter pylori.

Use in children and adolescents

The use of Gastrostad tablets is not recommended in children under 12 years of age.

Taking more Gastrostad than prescribed

Immediately tell your doctor or pharmacist. Symptoms of overdose are not known.

Missing a dose of Gastrostad

Do not take a double dose to make up for a forgotten dose. Take the next scheduled dose at the usual time.

Stopping treatment with Gastrostad

Do not stop taking the tablets without first talking to your doctor or pharmacist. If you have any further questions on the use of this product, 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 the tablets and tell your doctor or go to the nearest hospital immediately:

• Severe allergic reactions (rare:may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives (nettle rash), difficulty breathing, allergic swelling of the face (Quincke's edema/angioedema),

severe dizziness with rapid heartbeat and excessive sweating.

• Severe skin reactions (frequency not known:cannot be estimated from the available data): blistering of the skin and rapid deterioration of the general condition, erosion (with slight bleeding) of the eyes, nose, mouth/throat, or genitals (Stevens-Johnson syndrome, Lyell syndrome, polymorphic erythema) and sensitivity to light.
• Other severe reactions (frequency not known):yellowing of the skin and whites of the eyes (severe liver damage, jaundice) or fever, rash, and enlargement of the kidneys, sometimes with painful urination and back pain (severe kidney inflammation), which can lead to kidney failure.

Other side effects:

• Common(may affect up to 1 in 10 people) Mild stomach polyps.
• Uncommon(may affect up to 1 in 100 people) Headache, dizziness, diarrhea, nausea, vomiting, feeling of fullness in the stomach and bloating (gas), constipation, dry mouth, stomach pain and discomfort, skin rash, itching, weakness, fatigue, or general feeling of being unwell, sleep disorders, fractures of the hip, wrist, or spine.
• Rare(may affect up to 1 in 1,000 people). Distortion or complete loss of taste, visual disturbances such as blurred vision, hives, joint pain, muscle pain, changes in body weight; elevated body temperature, high fever, swelling of the limbs (peripheral edema), 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 who have had these symptoms before), decreased sodium levels in the blood, decreased magnesium levels in the blood (see section 2), feeling of tingling, prickling, burning, or numbness, rash with possible joint pain (subacute cutaneous lupus erythematosus), colitis (inflammation of the colon) causing persistent watery diarrhea.

Side effects identified through blood tests:

• Uncommon(may affect up to 1 in 100 people) Increased liver enzyme activity.
• Rare(may affect up to 1 in 1,000 people). Increased bilirubin levels, increased fat levels in the blood, decreased white blood cell count, which can lead to more frequent infections.
• Very rare(may affect up to 1 in 10,000 people). Decreased platelet count, which can lead to more frequent bleeding and bruising, decreased white blood cell count, which can lead to more frequent infections, associated abnormal decrease in red and white blood cell and platelet count.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the national reporting system via the contact details listed below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gastrostad

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month. Store in a cool, dry place, below 25°C. Medicines should not be disposed of via wastewater or household waste. 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

What Gastrostad contains

The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as pantoprazole sodium sesquihydrate). The other ingredients are:

Core of the tablet:

Maltitol, crospovidone type B, sodium carmellose, anhydrous sodium carbonate, calcium stearate.

Coating of the tablet:

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

What Gastrostad looks like and contents of the pack

Yellow, oval, gastro-resistant tablets. Gastrostad is available in packs of 14 or 28 gastro-resistant tablets or in bottles of 100 gastro-resistant tablets. Not all pack sizes may be marketed.

Marketing authorization holder

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Manufacturer

STADA Arzneimittel AG, Stadastrasse 2-18, D-61118 Bad Vilbel, Germany
Centrafarm Services B.V., Van de Reijstraat 31, 4814 NE Breda, Netherlands
Eurogenerics N.V., Heizel Esplanade B 22, 1020 Brussels, Belgium
Sanico NV, Veedijk 59, B-2300 Turnhout, Belgium
Lamp S. Prospero S.P.A., Via della Pace, 25/A, 41030 San Prospero (MO), Italy
Sofarimex, Industria Quimica e Farmaceutica, SA, Av. Das Industrias, Alto do Colaride, Agualva, 2735-213 Cacém, Portugal
STADA Arzneimittel GmbH, Muthgasse 36, 1190 Vienna, Austria

This medicinal product 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 40 mg enterotablet
ES:
Pantoprazol STADA 40 mg comprimidos gastrorresistentes EFG
IT:
Pantoprazolo EG 40 mg compressa gastroresistente
LU:
Pantoprazole EG 40 mg comprimés gastro-résistants
NL:
Pantoprazole CF 40 mg
PL:
Gastrostad
PT:
Pantoprazol Ciclum 40 mg comprimido gastroresistente

Date of last revision: 16.11.2021