Patient leaflet - Progit 50 mg film-coated tablets
1. What Progit® 50 mg is and what it is used for
Progit® 50 mg belongs to a group of drugs called prokinetic agents. Prokinetic agents are drugs which normalise or enhance and accelerate bowel movement (motility). Their administration results in accelerated gastric emptying, accelerated rate of passage of digested food through the small intestine and increased tonus of the lower oesophageal sphincter. In addition, Progit® 50 mg suppresses vomiting.
Progit® 50 mg is indicated for the treatment of symptoms resulting from the slow gastric emptying, such as feeling of gastric fullness up to upper abdominal pain, lack of appetite, heartburn, nausea and vomiting in gastrointestinal disorders, which are not caused by ulcer disease or organic disease affecting the rate of passage of digested food through the gastrointestinal tract.
Progit® 50 mg is intended for adults.
2. What you need to know before you take Progit® 50 mg
Do not take Progit® 50 mg
- if you are allergic to itopride or any of the other ingredients of this medicine (listed in section 6),
- if accelerated gastric emptying can be harmful for you, e. g. if you suffer from gastrointestinal bleeding, obstruction or perforation.
Progit® 50 mg is not intended for children, pregnant and breast-feeding women.
Warnings and precautions
In case side effects occur in elderly patients, doctor takes appropriate measures such as reduction of dosage or discontinuation of the medicine.
Other medicines and Progit® 50 mg
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The effect of Progit® 50 mg and of the other concomitantly used medicines may interact.
- Anticholinergic agents (used for treatment of asthma, chronic obstructive pulmonary disease, diarrhoea, Parkinson’s disease and for decrease of spasms of smooth muscles – e. g. urine bladder) may decrease effect of itopride.
- Itopride can influence absorption of other medicines due to its effect on digestive tract, in particular medicines with narrow therapeutic range, sustained released medicines and medicines released in intestine.
Progit® 50 mg with food and drink
Progit® 50 mg should be taken before meals.
Pregnancy, breast-feeding and fertility
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.
There are no or limited amount of data from the use of itopride in pregnant women. Therefore, it can be used in pregnant women or women in that pregnancy cannot be excluded only if therapeutic benefits outweigh possible risks considerably.
It is unknown whether itopride and its metabolites are excreted in human milk. Because of lack of experience with use of itopride during breast-feeding it is not recommended for breast-feeding women.
No effect of Progit® on fertility has been found.
Driving and using machines
Although no influence of Progit® 50 mg on the ability to drive and use machines has been observed, impaired alertness cannot be excluded. Very rarely, dizziness can occur. In these cases, you should not drive or use machines until these symptoms disappear.
Progit® 50 mg contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Progit® 50 mg
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The usual daily dose for adults is 1 tablet three times a day before the meal.
This dose can be reduced according to the course of the disease. The exact dosage of Progit® 50 mg and duration of the treatment will be determined by your doctor.
If you take more Progit® 50 mg than you should
If you take more tablets of Progit® 50 mg than you should, or in case of accidental ingestion by children, consult a doctor.
If you forget to take Progit® 50 mg
If you forget to take Progit® 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 Progit® 50 mg
If you stop taking Progit® 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 Progit® 50 mg and inform your doctor
- If you experience swelling of your hands, legs, swelling of face, lips or throat that can cause you swallowing or breathing difficulties. Rash or pruritus can also appear. This can indicate that you have an allergic reaction.
Following side effects can occur during the treatment with Progit® 50 mg:
Uncommon (may affect up to 1 in 100 people)
- Diarrhoea.
- Constipation.
- Abdominal pain.
- Hypersalivation.
- Headache.
- Irritability.
- Sleep disorders.
- Dizziness.
- Chest pain or back pain.
- Fatigue.
- Increased levels of hormone prolactin.
- Change in laboratory blood values (reduced white cell count, increased urine and creatinine).
Rare (may affect up to 1 in 1,000 people)
- Rash formation, redness and itching of the skin.
Not known (frequency cannot be estimated from the available data)
- Increased laboratory blood values (AST, ALT, gamma-GTP, alkaline phosphatase, bilirubin).
- Decreased amount of platelets (it can manifest with contusions and increased bleeding).
- Tremor.
Nausea.
- Jaundice.
- Enlarged breasts in men.
If galactorrhea (production and secretion of breast milk not associated with breast-feeding) or gynecomastia (enlarged breasts in men) occurs, the treatment must be discontinued or terminated.
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 Yellow Card Scheme at: Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store 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 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 Progit® 50 mg contains
- The active substance is itopride hydrochloride. Each film-coated tablet contains 50 mg of itopride hydrochloride.
- The other ingredients are lactose monohydrate, pregelatinised maize starch, croscarmellose sodium, silica colloidal anhydrous, magnesium stearate, coating composition Opadry II 85F18422 (partially hydrolyzed polyvinylalcohol, titanium dioxide (E171), macrogol 4000, talc).
What Progit® 50 mg looks like and contents of the pack
Progit® 50 mg are white to almost white round biconvex scored tablets, 7 mm in diameter. The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
Progit® 50 mg is supplied in blister packs of 15, 20, 30, 40, 60, 90, 100 or 120 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
PRO.MED.CS Praha a. s., Telčská 377/1, Michle, 140 00 Praha 4, Czech Republic