PROGIT 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Progit 50mg film-coated tablets EFG

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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What is Progit 50 mg and what is it used for

Progit 50 mg belongs to a group of medicines called prokinetic agents. Prokinetic agents are medicines that normalize or improve and accelerate intestinal movement (motility).

This medicine is indicated for the treatment of symptoms derived from slow gastric emptying, such as a feeling of gastric fullness or pain in the upper abdominal area, lack of appetite, heartburn, nausea, and vomiting, which are not caused by an ulcerative disease or an organic disease that affects the speed of passage of digested food through the gastrointestinal tract.

This medicine is intended for adults.

2. What you need to know before you take Progit 50 mg

Do not take Progit 50mg

• if you are allergic to itopride or any of the other ingredients of this medicine (listed in section 6).
• if accelerated gastric emptying may be harmful to you, e.g., if you have a gastrointestinal hemorrhage, obstruction, or perforation.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

Itopride hydrochloride enhances the action of acetylcholine and caution should be exercised when administering this medicine.

In case of adverse effects in elderly patients, the doctor will take appropriate measures, such as reducing the dose or interrupting treatment.

Other medicines and Progit 50mg

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

No interactions have been observed with the co-administration of warfarin, diazepam, diclofenac, ticlopidine, nifedipine, and nicardipine.

Since this medicine has gastrokinetic effects, it may influence the absorption of drugs administered simultaneously by mouth.

Anticholinergics (used to treat asthma, chronic obstructive pulmonary disease, diarrhea, support anesthesia, Parkinson's disease, and to reduce muscle spasms – e.g., the urinary bladder or the gastrointestinal tract) may decrease the effect of itopride.

Anti-ulcer drugs (used to prevent and treat ulcers in the digestive tract), such as cimetidine, ranitidine, teprenone, and cetrexate, do not affect the effect of this medicine on gastrointestinal motility.

Itopride may influence the absorption of other medicines due to its effect on the digestive tract, particularly medicines with a narrow therapeutic index, sustained-release medicines, and those released in the intestine.

Progit 50mg with food and drinks

This medicine should be taken before meals.

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.

In pregnant or breastfeeding women, or in those who cannot rule out pregnancy, this medicine should only be used if the therapeutic benefits clearly outweigh the potential risks.

Due to the potential risk of side effects in breastfed infants, the doctor will decide whether to suspend breastfeeding or interrupt treatment.

Driving and using machines

Although no influence of this medicine on the ability to drive and use machines has been observed, it cannot be ruled out that it may alter the state of alertness. In very rare cases, dizziness may occur. In these cases, do not drive or use machines until these symptoms disappear.

Progit 50mg contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Progit 50mg contains sodium

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

3. How to take Progit 50 mg

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, ask your doctor or pharmacist.

The recommended daily dose for adults is 1 tablet three times a day before a meal.

Your doctor may reduce this dose depending on your age and the symptoms of the disease.

The duration of treatment will be determined by your doctor. This medicine should not be used for more than 8 weeks.

Use in children and adolescents

This medicine should not be administered to children and adolescents under 16 years of age.

If you take more Progit 50mg than you should

If you take more itopride than you should, or in case of accidental ingestion by a child, consult a doctor.

If you forget to take Progit 50mg

If you forget to take this medicine, continue with your usual dose schedule. Do not take a double dose to make up for forgotten doses.

If you stop taking Progit 50mg

If you stop taking this medicine before time, your symptoms may worsen. Consult your doctor before stopping 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 inform your doctor:

• If you experience swelling of the hands, feet, face, lips, or throat that may cause difficulty swallowing or breathing. You may also experience rash or itching. This could be a sign of an allergic reaction.

During treatment with this medicine, the following side effects may occur:

Uncommon(may affect up to 1 in 100 people)

• Diarrhea.
• Constipation.
• Abdominal pain.
• Excessive saliva production.
• Headache.
• Dizziness.
• Increased levels of the hormone prolactin.
• Changes in blood test values (low white blood cell count, low platelet count).

Rare(may affect up to 1 in 1,000 people)

• Rash formation, redness, and itching of the skin.

Frequency not known(cannot be estimated from the available data)

• Increased blood test values (AST, ALT, γ-GT, alkaline phosphatase, and bilirubin).
• Decrease in platelet count (may manifest as bruising and increased bleeding).
• Tremor.
• Nausea.
• Jaundice.
• Enlargement of the breasts in men.

If galactorrhea (production and secretion of breast milk not associated with breastfeeding) or gynecomastia (enlargement of the breasts in men) occurs, treatment should be interrupted or discontinued.

Reporting of side effects

If you experience 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 Spanish Medicines Surveillance System for Human Use:

www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Progit 50 mg

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton and blister after 'EXP'. The expiry date refers to the last day of the month stated.

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 further information

Composition of Progit 50mg

• The active substance is itopride hydrochloride. Each film-coated tablet contains 50 mg of itopride hydrochloride.
• The other ingredients are lactose monohydrate, pregelatinized corn starch, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, and film coating Opadry II white 85F18422 (partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, and talc).

Appearance of the product and pack contents

Progit 50 mg are film-coated tablets, white or almost white, round, biconvex, scored, 7 mm in diameter.

The score line is only to facilitate breaking the tablet if you have difficulty swallowing it whole.

This medicine is available in blister packs of 15, 20, 30, 40, 60, 90, 100, or 120 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Kappler Pharma Consult GmbH,

Fonyoder Strasse 18,

89340 Leipheim, Bavaria

Germany

Manufacturer

Pro.Med.Cs Praha A.S.,

Telcská 377/1,

140 00 Michle, Prague,

Czech Republic

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic Itopride Kappler

Estonia Itoprom

Latvia Progit 50 mg apvalkotas tabletes

Spain Progit 50 mg film-coated tablets EFG

Portugal Itomed

Italy Progit

Denmark Progit

Bulgaria Progit 50 mg ????????? ????????

Finland Progit 50 mg kalvopäällysteiset tabletit

Date of last revision of this leaflet:December 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.