Product: Itoprid Saneca 50 mg tbl Document: 1.3.1 SPC Labelling and Package Leaflet

Package leaflet: Information for the patient

Itoprid Xantis 50 mg tablets

itopride hydrochloride

Read all of this leaflet carefully before you start taking this medicine because 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 or pharmacist.  This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.  If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Itoprid Xantis 50 mg is and what it is used for 2. What you need to know before you take Itoprid Xantis 50 mg 3. How to take Itoprid Xantis 50 mg 4. Possible side effects 5. How to store Itoprid Xantis 50 mg 6. Contents of the pack and other information

1. What Itoprid Xantis 50 mg is and what it is used for

Itoprid Xantis 50 mg contains active substance itopride, which improves motility (automatic bowel and stomach movements, which are necessary to pass food through digestive tract) and prevent from nausea and vomiting.

Itoprid Xantis 50 mg is used to treat symptoms caused by delayed gastric emptying, such as gastric fullness, to painful pressure in the upper abdomen (epigastrium), loss of appetite, heartburn, nausea and vomiting (not caused by ulcer or organ disease), affecting the movement of food through digestive tract.

Itoprid Xantis 50 mg is used only in adults.

2. What you need to know before you take Itoprid Xantis 50 mg

Do not take Itoprid Xantis 50 mg:  if you are allergic to itopride or any of the other ingredients of this medicine (listed in section 6),  if you are in condition, in which fasten gastric emptying can be dangerous, e.g., bleeding from digestive tract, as a reason of mechanical obstruction or perforation.

Warnings and precautions Talk to your doctor or pharmacist before taking Itoprid Xantis 50 mg. Medicine is not suitable for children, pregnant and breast-feeding women.

Other medicines and Itoprid Xantis 50 mg Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. Effect of Itoprid Xantis 50 mg and other medicines can influence each other.

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- Anticholinergic agents (medicines used to treat asthma, long-term lung disease, diarrhoea, Parkinson's disease and medicines used to release small intestine spasms – e.g. in bladder) decrease the effect of itopride. - Itoprid Xantis 50 mg can affect the absorption of other medicines because of its effect on the motility of digestive tract, mainly medicines with narrow therapeutic index, with prolonged release and gastro-resistant medicines (coated with layer that protects active substance before gastric acid). Ask your doctor if any of this relates to you.

No other interactions (effect of itopride on other medicines and other medicines to itopride) have been reported.

Itoprid Xantis 50 mg with food and drink Itoprid Xantis 50 mg should be taken before meals.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Due to lack of safety data, this medicine should not be used during pregnancy, breast-feeding or in women with suspected pregnancy, unless the therapeutic benefits significantly outweigh the risks. If any of these conditions refer to you, ask your doctor before you use this medicine.

Driving and using machines No influence on ability to drive vehicles or use machines was observed. Impaired ability to concentrate due to rare occurrence of dizziness cannot be excluded. If this happens to you, do not drive vehicle or use machines until these symptoms disappear.

Itoprid Xantis 50 mg contains lactose monohydrate. If you have been told by your doctor that you do not tolerate some sugars, contact your doctor before using this medicine.

3. How to take Itoprid Xantis 50 mg

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor of pharmacist if you are not sure.

Tablet has score line on one side and can be divided into equal doses. Use the tablet whole or divided into halves before meal and drink with water. The recommended dose and length of treatment determines the doctor.

Use in adults The recommended dose is one tablet three times a day before meal. This dose can be reduced according to course of disease (e.g. half tablet tree times/day).

Use in children Due to the lack of safety data, this medicine should not be used in children.

Use in patients with impaired liver or renal function and elderly If you have impaired liver or renal function or are elderly, your doctor will monitor you closely. If any side effect occurs, contact your doctor. Your doctor can recommend you to lower your dose or to discontinue the treatment.

If you take more Itoprid Xantis 50 mg than you should No experience with overdose in human is known.

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If you or anybody else take too much tablets or child accidentally takes Itoprid Xantis 50 mg, immediately contact the emergency or your doctor. In case of overdose, gastric lavage or symptomatic treatment is common precaution.

If you forget to take Itoprid Xantis 50 mg If you forget to take Itopride Xantis 50 mg, continue at your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

If you stop taking Itoprid Xantis 50 mg If you stop taking Itoprid Xantis 50 mg early your symptoms may worsen. Consult your doctor before stopping the treatment. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking this medicine and visit a doctor or go to emergency if, you get swelling of the hands, feet, ankles, face, lips or throat, which can cause troubles with swallowing or breathing. You can see also rash or itching. This can be an allergic reaction.

While taking Itoprid Xantis 50 mg you can have following side effects: Uncommon (may affect less than 1 in 100 people) - diarrhoea, - stomach ache, - constipation, - increased salivation - headache, - impaired sleeping, - dizziness, - back pain or pain on chest, - fatigue, - irritability - increased level of substances called creatinine and blood urea nitrogen (BUN) - decreased level of leukocytes (white blood cells) – leukopenia - increased level of hormone prolactin in blood (can lead to excretion of milk or enlargement of mammary gland)

Rare (may affect less than 1 in 1000 people) - rash, - redness of skin, - itching

Unknown (frequency cannot be estimated from the available data) - decreased blood platelet (as bruise or bleeding) - trembling, nausea (feeling to vomit) - enlargement of mammary gland (gynecomastia), - yellow skin (jaundice) - increased level of certain enzymes in blood – AST, ALT, GGT, alkaline phosphatase and colouring matter bilirubin - anaphylactoid reaction (severe allergic reaction)

In case of production or excretion of milk from mammary gland besides breast-feeding (galactorrhea) or enlargement of mammary gland in men (gynecomastia) stop the treatment and contact your doctor.

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Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Itoprid Xantis 50 mg

Keep this medicine out of sight and reach of children. Store below 30 °C, store in the original package in order to protect from moisture. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Itoprid Xantis 50 mg contains The active substance is itopride hydrochloride. Each tablet contains 50 mg of itopride hydrochloride. The other ingredients are lactose mohohydrate, pregelatinized starch, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.

What Itoprid Xantis 50 mg looks like and contents of the pack Itoprid Xantis 50 mg are white or almost white, round, lenticular, uncoated tablet half-scored on one side, diameter 7 mm. Tablet can be divided into equal doses.

Pack size: 10, 20, 30, 40, 50, 60, 90 and 100 tablets Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Saneca Pharmaceuticals a.s. Nitrianska 100 920 27 Hlohovec Slovak Republic

This medicine was approved in Member states of European Economic area (EEA) in following names: Czech Republic Itoprid Xantis 50 mg Slovak Republic Itoprid Xantis 50 mg

This leaflet was last revised in

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