Gastrostad

Package Leaflet: Information for the Patient

GASTROSTAD

20 mg, gastro-resistant tablets

Pantoprazole

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

• Keep this 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 get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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:

• for the treatment of mild gastro-oesophageal reflux disease (a condition in which the acid in the stomach flows back into the gullet) and its symptoms (such as heartburn, acid regurgitation, pain when swallowing);
• for the long-term treatment and prevention of relapse of gastro-oesophageal reflux disease (inflammation of the gullet);
• to prevent stomach and duodenal ulcers in patients who are taking non-steroidal anti-inflammatory drugs (NSAIDs) for a long time.

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 medicines containing 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 tell your doctor if you have ever had liver problems. Your doctor may need to monitor your liver function more closely during treatment with Gastrostad, especially if you are taking it for a long time. If your liver function is impaired, your doctor may decide to reduce the dose.
• If you have to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously and have been prescribed Gastrostad because you are at risk of developing stomach or duodenal ulcers. The risk should be assessed taking into account individual risk factors, such as age (65 years or older), a history of stomach or duodenal ulcers, or bleeding in the stomach or intestines.
• If you have a vitamin B12 deficiency or risk factors for a vitamin B12 deficiency, and you are taking long-term treatment with pantoprazole. Like all medicines that reduce stomach acid, pantoprazole may lead to a reduction in the absorption of vitamin B12.
• If you are taking an HIV protease inhibitor, such as atazanavir (used to treat HIV infection), you should ask your doctor for specific advice.
• Taking a proton pump inhibitor like pantoprazole, especially over a period of more than one year, may slightly increase the risk of hip, wrist, or spine fractures. You should 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 is possible that the level of magnesium in your blood may decrease. Low levels of magnesium can cause tiredness, muscle cramps, disorientation, seizures, dizziness, and an irregular heartbeat. If you experience any of these symptoms, you should contact your doctor as soon as possible. Low levels of magnesium can also lead to a decrease in the level of potassium and calcium in the blood. Your doctor may decide to perform regular blood tests to monitor the level of magnesium in your blood.
• 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, you should contact your doctor as soon as possible, as you may need to stop taking Gastrostad. You should 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 that could be a sign of a more serious condition:

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

Your doctor may decide to perform tests to rule out an underlying malignant disease, 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.
In the event that you are taking Gastrostad for a long period of time (more than 1 year), you will probably be under regular medical supervision. During each medical visit, you should report any new or special symptoms and the circumstances in which they occurred.
Children and adolescents
Gastrostad should not be used 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, or have recently taken, and about any medicines you plan to take.
Gastrostad may affect the action of other medicines, so you should tell 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 Gastrostad may reduce the effectiveness of these and other medicines.
• warfarin and phenprocoumon, which affect blood clotting or thinning. Further tests may be necessary.
• medicines used to treat HIV infections, such as atazanavir.
• methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer); if you are taking methotrexate, your doctor may temporarily stop the use of Gastrostad, as pantoprazole may increase the levels of methotrexate in the blood.
• fluvoxamine (used to treat depression and other mental health conditions - your 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 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 are no sufficient data on the use of pantoprazole in pregnant women.
Pantoprazole has been detected in breast milk.
The medicine should only be used if your doctor considers that the benefit to the mother outweighs the potential risk to the unborn child or baby.

Driving and using machines

Gastrostad 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 by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Gastrostad contains soya lecithin

If you are allergic to peanuts or soya, 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

Take this medicine exactly as your doctor 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 gastro-oesophageal reflux disease (such as heartburn, acid regurgitation, pain when swallowing)The usual dose is one tablet per day. This dose usually provides relief from symptoms within 2-4 weeks - at the latest after another 4 weeks. Your doctor will decide how long you should take the medicine. After this time, you can control any recurring symptoms by taking one tablet per day, as needed.
• For long-term treatment and prevention of relapse of gastro-oesophageal reflux diseaseThe usual dose is one tablet per day. In the event of a relapse, your doctor may double the dose; in this case, you can take Gastrostad 40 mg tablets, one tablet per day. After healing, the dose can be reduced and you can take one 20 mg tablet per day again.

Adults

• For the treatment of duodenal and stomach ulcers in patients who need to take NSAIDs continuouslyThe usual dose is one tablet per day.

Patients with liver disease

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

Use in children and adolescents

Gastrostad tablets should not be used in children under 12 years of age.

Taking a higher dose of Gastrostad than recommended

Contact your doctor or pharmacist immediately. The symptoms of overdose are not known.

Forgetting to take a dose of Gastrostad

Do not take a double dose to make up for a forgotten dose. Take the next planned 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, Gastrostad can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking the tablets and contact 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 oedema/anaphylactic shock), 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 photosensitivity.
• Other severe reactions (frequency not known):yellowing of the skin and the whites of the eyes (severe liver damage, jaundice) or fever, rash, and swelling 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 gastric polyps.
• Uncommon(may affect up to 1 in 100 people) Headache, dizziness, diarrhoea, nausea, vomiting, feeling of bloating in the abdomen and wind (flatulence), constipation, dry mouth, abdominal 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 the sense 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 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 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) and colitis (inflammation of the colon) that can cause persistent watery diarrhoea.

Side effects detected by 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, acute decrease in the number of circulating granulocytes associated with high fever.
• 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 make you more prone to infections, associated abnormal decrease in the number of red and white blood cells and platelets.

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Monitoring 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] .
Side effects can also be reported to the marketing authorisation holder.
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.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 20 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
The other ingredients are:
Core:
maltitol, crospovidone type B, sodium carmellose, anhydrous sodium carbonate, calcium stearate.
Coating:
polyvinyl alcohol, talc, titanium dioxide (E 171), macrogol 3350, soya 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 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 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 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

Date of last revision of the leaflet: 16.11.2021