Gastrostad

Package leaflet: Information for the patient

GASTROSTAD
40 mg, enteric-coated tablets
Pantoprazole
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Table of contents of the 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 the medicines belonging to the group of selective proton pump inhibitors,
which reduce the secretion of hydrochloric acid in the stomach.
GASTROSTAD is used:

• in combination with antibiotics for the treatment of duodenal and gastric ulcers. The treatment aims to completely eliminate (eradicate) the Helicobacter pylori bacteria, which cause the formation of stomach and duodenal ulcers;
• in the treatment of duodenal ulcer;
• in the treatment of gastric ulcer;
• in the treatment of moderate and severe forms of reflux esophagitis;
• in long-term treatment of conditions associated with increased gastric acid secretion (e.g. Zollinger-Ellison syndrome).

2. Important information before using Gastrostad

When not to use Gastrostad

• If the patient is allergic to pantoprazole, peanuts, or soy, or to any of the other ingredients of this medicine (listed in section 6).
• If the patient is allergic to medicinal products containing other proton pump inhibitors.

Warnings and precautions
Before starting treatment with Gastrostad, discuss this with your doctor, pharmacist, or
nurse, especially:

• If the patient has severe liver function impairment. Inform the doctor if there has ever been any liver problems. The doctor may recommend more frequent monitoring of liver enzyme activity, particularly during long-term treatment with Gastrostad. If liver enzyme activity increases, treatment should be discontinued.

• If the patient has vitamin B deficiency or risk factors indicating possible reduced vitamin B levels, and is receiving long-term treatment with pantoprazole. As with all drugs that reduce gastric acid secretion, pantoprazole may lead to reduced absorption of vitamin B.

• If the patient is taking an HIV protease inhibitor, such as atazanavir (used in the treatment of HIV infection), together with pantoprazole, they should seek detailed advice from their doctor. Taking a proton pump inhibitor such as pantoprazole, particularly for longer than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform the doctor if the patient has osteoporosis or is taking corticosteroids (which may increase the risk of osteoporosis).

• If the patient has been taking Gastrostad for longer than three months, magnesium levels in the blood may decrease. Low magnesium levels may manifest as fatigue, involuntary muscle spasms, confusion, seizures, dizziness, or increased heart rate. If any of these symptoms occur, the patient should inform the doctor immediately. Low magnesium levels may also lead to reduced potassium and calcium levels in the blood. The doctor may decide to perform regular tests to monitor blood magnesium levels.

• If the patient has ever experienced a skin reaction after using a medicine similar to Gastrostad that reduces gastric acid secretion.

• If the patient develops a skin rash, especially in areas exposed to sunlight, they should inform the doctor as soon as possible, as discontinuation of Gastrostad may be necessary. Also report any other adverse effects such as joint pain.

• If the patient is due to undergo a specific blood test (chromogranin A levels).

Immediately inform the doctor before or after taking this medicine if the
patient experiences any of the following symptoms, which may indicate another, more serious
disease:

• Unintentional weight loss,
• Vomiting, especially if recurrent,
• Vomiting blood or coffee-ground-like material,
• If the patient notices blood in the stool; stool may be black or tarry,
• Difficulty swallowing or pain when swallowing,
• Pallor and weakness (anemia),
• Chest pain,
• Abdominal pain,
• Severe and/or persistent diarrhea, as use of this medicine is associated with a slightly increased risk of infectious diarrhea.

The doctor may decide whether tests are necessary to rule out an underlying
tumorous disease, as treatment with pantoprazole may alleviate symptoms of cancer
and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
If Gastrostad is taken for a prolonged period (over 1 year), the patient will likely be under continuous medical supervision. During each doctor’s visit, report any new or unusual symptoms and the circumstances of their occurrence.

Children and adolescents
Gastrostad is not recommended for use 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 medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Gastrostad may affect the effectiveness of other medicines, so inform the doctor if the patient is taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used in certain types of cancer), because Gastrostad may inhibit the proper action of these and other drugs.
• Warfarin and phenprocoumon, which affect blood clotting or thinning. Additional testing may be required.
• Medicines used to treat HIV infection such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer); if the patient is taking methotrexate, the doctor may temporarily discontinue Gastrostad, as pantoprazole may increase methotrexate blood levels.
• Fluvoxamine (used to treat depression and other psychiatric disorders – the doctor may reduce the dose when fluvoxamine is taken).
• Rifampicin (used to treat infections).
• St. John's wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have
a baby, she should consult her doctor or pharmacist before using this medicine.
There are insufficient data on the use of pantoprazole in pregnant women.
Pantoprazole has been shown to pass into human breast milk.
The medicine should only be used if the doctor considers that the benefit outweighs the potential risk to the unborn child or infant.

Driving and operating machinery
Pantoprazole has no effect or has a negligible effect on the ability to drive
and operate machinery.
If adverse effects such as dizziness or visual disturbances occur, the patient should not drive or operate machinery.

Gastrostad contains maltitol
If the patient has previously been diagnosed with intolerance to certain sugars, they should
consult their doctor before taking this medicine.

Gastrostad contains soya lecithin
If the patient is allergic to peanuts or soy, they must not take this medicine.

Gastrostad contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Gastrostad

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Method of administration
Take the tablets 1 hour before a meal, without chewing or dividing them, swallowing them whole
with a small amount of water.
Recommended dose:
Adults and adolescents aged 12 years and older:

• For treatment of symptoms of reflux esophagitis The usual dose is one tablet per day. Your doctor may increase the dose to two tablets per day. Treatment of reflux esophagitis usually lasts from 4 to 8 weeks. Your doctor will decide how long you should take the medicine. Adults
• For treatment of Helicobacter pylori infection in patients with peptic ulcer disease of the duodenum and gastric ulcers, in combination with two antibiotics (eradication therapy) Concomitant use of the following medications is recommended:

or

or

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

For the treatment of gastric and duodenal ulcer disease
The usual dose is one tablet per day. After consultation with your doctor, the dose may be doubled.

Your doctor will advise you on how long to take the medicine. The treatment period for gastric ulcers usually lasts from 4 to 8 weeks. The treatment period for duodenal ulcers usually lasts from 2 to 4 weeks.

• In long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive hydrochloric acid secretion in the stomach *
  The 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 hydrochloric acid produced in the stomach. If more than two tablets have been prescribed, take them twice daily. If your doctor has prescribed more than four tablets per day, you will be given detailed instructions on how to take the medication.

Patients with kidney disease
If the patient has kidney problems, Gastrostad should not be used for eradication of Helicobacter pylori.
Patients with liver disease
If the patient has severe liver disease, they should not take more than one 20 mg tablet per day (for this purpose, tablets containing 20 mg pantoprazole are available).
If the patient has severe or moderate liver disease, Gastrostad should not be used for eradication of Helicobacter pylori.
Use in children and adolescents
This medicine is not recommended for children under 12 years of age.
Taking more than the recommended dose of Gastrostad
Contact your doctor or pharmacist immediately. Symptoms of overdose are not known.
Missing a dose of Gastrostad
Do not take a double dose to make up for a missed dose. Take the next scheduled dose at the usual time.
Stopping treatment with Gastrostad
Do not stop taking the tablets without first consulting your doctor or pharmacist.
If you have any further questions about the use of this medicine, please consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, discontinue use of the tablets immediately and
contact your doctor or go to the nearest hospital with emergency services:

• Severe allergic reactions (rare: may occur in no more than 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives (rash similar to nettle burn), difficulty breathing, angioedema (Quincke's edema/angioedema),

severe dizziness with rapid heartbeat and profuse sweating.

• Severe skin reactions (frequency unknown: frequency cannot be determined from available data): blistering of the skin and rapid deterioration in general condition, erosions (with slight bleeding) of the eyes, nose, oral cavity/mouth or genital organs (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme), and photosensitivity.
• Other severe reactions (frequency unknown): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice) or fever, rash, and kidney enlargement, sometimes with painful urination and pain in the lower back (severe kidney inflammation), which may lead to kidney failure.

Other adverse reactions that may occur:

• Common (may occur in no more than 1 in 10 patients): Benign gastric polyps.
• Uncommon (may occur in no more than 1 in 100 patients): Headache, dizziness, diarrhoea, nausea, vomiting, feeling of fullness in the abdomen and bloating (flatulence), constipation, dry mouth, abdominal pain and discomfort, skin rash, eruptions, acne, itching, weakness, fatigue or general malaise, sleep disturbances, fractures of the hip, wrist or spine.
• Rare (may occur in no more than 1 in 1,000 patients): Distortion or complete loss of taste, visual disturbances such as blurred vision, urticaria, joint pain, muscle pain, changes in body weight; elevated body temperature, high fever, swelling of limbs (peripheral oedema), allergic reactions, depression, gynaecomastia in males.
• Very rare (may occur in no more than 1 in 10,000 patients): Disorientation.
• Frequency unknown (cannot be estimated from available data): Hallucinations, confusional state (particularly in patients who have previously experienced such symptoms), decreased sodium concentration in blood, decreased magnesium levels in blood (see section 2), sensations of tingling, pricking, burning or numbness, skin rash possibly with joint pain (subacute cutaneous lupus erythematosus), inflammation of the large intestine causing persistent watery diarrhoea.

Adverse reactions identified by blood tests and occurring:

• Uncommon (may occur in no more than 1 in 100 patients): Increased liver enzyme activity.
• Rare (may occur in no more than 1 in 1,000 patients): Increased bilirubin levels, increased blood lipid levels, decreased circulating granulocyte count associated with high fever.
• Very rare (may occur in no more than 1 in 10,000 patients): Decreased platelet count, which may lead to increased bleeding and bruising, decreased white blood cell count, which may increase susceptibility to infections, and concurrent abnormal decrease in red blood cells, white blood cells and platelets.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Gastrostad

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton. The expiry date refers to the last day of the specified month.
Do not store above 25 °C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Gastrostad contains
The active substance is pantoprazole. Each enteric-coated tablet contains 40 mg of pantoprazole
(in the form of pantoprazole sodium sesquihydrate).
The other ingredients are:
Tablet core:
Maltitol, crospovidone type B, sodium carboxymethylcellulose, anhydrous sodium carbonate, calcium stearate.
Tablet coating:
Polyvinyl alcohol, talc, titanium dioxide (E 171), macrogol 3350, soy lecithin, yellow iron oxide (E 172), anhydrous sodium carbonate, copolymer (1:1) of methacrylic acid and ethyl acrylate, triethyl citrate.

What Gastrostad looks like and contents of the pack
Yellow, oval enteric-coated tablets.
Gastrostad is available in packs containing 14 or 28 enteric-coated tablets
or in bottles containing 100 enteric-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the European Economic Area member states 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 the latest revision: 16.11.2021