Gastrostad

Package leaflet: Information for the patient

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

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your 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 belongs to a group of medicines known as selective proton pump inhibitors, which reduce the secretion of hydrochloric acid in the stomach.
GASTROSTAD is used:

• for the treatment of mild gastroesophageal reflux disease (a condition of the oesophagus caused by the backflow of acidic stomach contents) and associated symptoms (such as heartburn, regurgitation of stomach contents, pain during swallowing);
• for long-term treatment and prevention of relapses of reflux oesophagitis (inflammation of the oesophagus);
• for the prevention of gastric and duodenal ulcers in patients taking pain-relieving medicines long-term (non-selective non-steroidal anti-inflammatory drugs, so-called NSAIDs).

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 disorders. Inform the doctor if there has ever been any liver dysfunction. The doctor may recommend more frequent monitoring of liver enzyme activity, particularly during long-term treatment with Gastrostad. If liver enzyme activity increases, administration of the medicine should be discontinued.
• If the patient is taking non-steroidal anti-inflammatory drugs (NSAIDs) chronically and has been prescribed Gastrostad due to an increased risk of gastrointestinal complications. This increased risk should be assessed considering individual patient risk factors, such as advanced age (65 years or older), history of gastric or duodenal ulcer disease, or gastrointestinal bleeding.
• If the patient has vitamin B deficiency or risk factors indicating possible reduced vitamin B levels, and is receiving long-term pantoprazole therapy. Like all medicines that reduce gastric acid secretion, pantoprazole may reduce vitamin B absorption.
• If the patient is taking an HIV protease inhibitor, such as atazanavir (used in the treatment of HIV infection), concurrently with pantoprazole, they should seek detailed advice from their doctor.
• Taking a proton pump inhibitor such as pantoprazole, particularly for more 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 takes Gastrostad for longer than three months, magnesium levels in the blood may decrease. Low magnesium levels may manifest as fatigue, involuntary muscle spasms, disorientation, seizures, dizziness, 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 blood tests to monitor magnesium levels.
• If the patient has ever had 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. The patient should also report any other adverse reactions, such as joint pain.
• If the patient is scheduled for a specific blood test (chromogranin A levels).

The patient should inform the doctor immediately before or after taking this medicine, if they notice any of the following symptoms, which may indicate another, more serious condition:

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

The doctor may decide to perform tests to rule out an underlying tumour disease, as pantoprazole treatment may alleviate symptoms of tumour-related disease 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, any new or unusual symptoms and their circumstances should be reported.

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 with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
Gastrostad may affect the effectiveness of other medicines, so inform the doctor if the patient is taking:

• Medicines such as ketoconazole, itraconazole, or posaconazole (used to treat fungal infections) or erlotinib (used in certain types of cancer), because Gastrostad may impair the proper action of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting or thinning. Additional tests may be required.
• Medicines used to treat HIV infections 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 – if fluvoxamine is taken, the 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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
There is 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 the benefit outweighs the potential risk to the unborn child or infant.

Driving and operating machinery
Gastrostad has no effect or negligible effect on the ability to drive and operate machinery.
However, if adverse reactions 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 soya, 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 used exactly as directed by your doctor. In case of 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 gastroesophageal reflux disease (e.g. heartburn, acid regurgitation, pain during swallowing)
  The usual dose is one tablet per day. This dose usually provides symptom relief within 2–4 weeks—at the latest after an additional 4 weeks. Your doctor will decide how long you should continue treatment. After this period, any recurring symptoms can be controlled by taking one tablet per day, as needed.

• Long-term treatment and prevention of relapse in gastroesophageal reflux disease
  The usual dose is one tablet per day. If symptoms recur, your doctor may double the dose; in such a case, the patient may take Gastrostad 40 mg tablets, one tablet per day. After healing, the dose may be reduced again to one 20 mg tablet per day.

Adults

• For treatment of gastric and duodenal ulcers in patients requiring continuous use of NSAIDs
  The usual dose is one tablet per day.

Patients with liver disease
If the patient has severe liver disease, they should not take more than one 20 mg tablet per day.

Use in children and adolescents
Gastrostad tablets are not recommended for children under 12 years of age.

Taking more Gastrostad than recommended
Inform 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 Gastrostad treatment
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, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
If any of the following adverse reactions occur, stop taking the tablets immediately and contact your
doctor or go to the nearest hospital with emergency services without delay:

• 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 excessive sweating.
• Severe skin reactions (frequency unknown: frequency cannot be estimated from available data): blistering of the skin and rapid deterioration in general condition, erosions (with slight bleeding) of the eyes, nose, mouth/oral cavity, 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 lower back pain (severe kidney inflammation), which may lead to kidney failure.

Other adverse reactions occurring:

• 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, abdominal fullness and flatulence (wind), 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 sensation, visual disturbances such as blurred vision, urticaria, joint pain, muscle pain, changes in body weight, elevated body temperature, high fever, limb swelling (peripheral edema), allergic reactions, depression, gynaecomastia (breast enlargement 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 blood concentration, decreased magnesium blood levels (see section 2), sensations of tingling, pricking, burning, or numbness, skin rash possibly associated with joint pain (subacute cutaneous lupus erythematosus), colitis causing persistent watery diarrhoea.

Adverse reactions identified through blood tests 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 concentration, increased blood lipid levels, acute decrease in circulating granulocytes 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 predispose to more frequent infections, and concurrent abnormal reduction in red blood cells, white blood cells, and platelets.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
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 cardboard box.
The expiry date refers to the last day of the stated 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. This will 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 20 mg of pantoprazole (as sodium pantoprazole 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, iron oxide yellow (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, 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 countries 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 20 mg enterotablet
ES: Pantoprazol STADA 20 mg comprimidos gastrorresistentes EFG
IT: Pantoprazolo EG 20 mg compressa gastroresistente
LU: Pantoprazole EG 20 mg comprimés gastro-résistants
NL: Pantoprazole CF 20 mg
PL: Gastrostad
PT: Pantoprazol Ciclum 20 mg comprimido gastroresistente
IE: Pantium 20 mg Gastro-Resistant Tablets
FR: Pantoprazole EG 20 mg, comprimé gastro-résistant