Progit

Package leaflet: Information for the user

Progit 50 mg film-coated tablets

itopride hydrochloride
equivalent medicine
Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Progit 50 mg belongs to a group of medicines called prokinetic agents. Prokinetic agents are drugs that normalize, promote, and accelerate intestinal movements (motility).
Progit 50 mg is indicated for the treatment of symptoms caused by delayed gastric emptying, such as upper abdominal fullness up to upper abdominal pain, loss of appetite, heartburn, nausea, and vomiting, which are not due to ulcer disease or organic disease affecting the rate of passage of digested food through the gastrointestinal tract.
Progit 50 mg is indicated in adults.

2. What you should know before taking Progit 50 mg

Do not take Progit 50 mg

• if you are allergic to itopride or to any of the other ingredients of this medicine (listed in section 6),
• if accelerated gastric emptying could be harmful for you, for example if you suffer from gastrointestinal bleeding, obstruction, or perforation.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine.
Hydrochloride itopride enhances the action of acetylcholine, and caution should be exercised when administering Progit.
If adverse effects occur in elderly patients, the doctor will take appropriate measures such as reducing the dose or discontinuing treatment with the medicine.

Other medicines and Progit 50 mg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions have been observed with concomitant administration of warfarin, diazepam, diclofenac, ticlopidine, nifedipine, or nicardipine.
Since Progit has gastrokinetic effects, it may affect the absorption of drugs administered concomitantly by oral route.
Anticholinergic drugs (used for the treatment of asthma, chronic obstructive pulmonary disease, diarrhea, as support during anesthesia, for Parkinson's disease, and to reduce spasms of smooth muscle, for example in the bladder and gastrointestinal tract) may reduce 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 alter the effect of Progit on gastrointestinal motility.
Itopride may affect the absorption of other medicines due to its effect on the gastrointestinal tract, particularly medicines with a narrow therapeutic index, prolonged-release medicines, and medicines released in the intestine.

Progit 50 mg with food and drinks
Progit 50 mg should be taken before meals.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
In women who are pregnant or in whom pregnancy cannot be ruled out, Progit should be used only on a doctor’s recommendation, and only if the therapeutic benefits clearly outweigh the potential risks.
Due to the potential risk of adverse effects in infants, your doctor will need to decide whether to discontinue breastfeeding or discontinue treatment.

Driving and using machines
Although no effects of Progit 50 mg on the ability to drive or operate machinery have been observed, a reduction in alertness cannot be excluded. Dizziness may very rarely occur. In such cases, do not drive or operate machinery until these symptoms have resolved.

Progit 50 mg contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

Progit 50 mg contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially "sodium-free".

3. How to take Progit 50 mg

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended daily dose for adults is 1 tablet three times a day, taken before meals.
Your doctor may reduce this dose depending on age and symptoms of the disease.
The duration of treatment will be determined by your doctor. Progit must not be used for longer than 8 weeks.

Use in children and adolescents
Progit must not be given to children and adolescents under 16 years of age.

If you take more Progit 50 mg than you should
If you take more Progit 50 mg tablets than you should, or if a child accidentally ingests the medicine, contact your doctor immediately.

If you forget to take Progit 50 mg
If you forget to take a dose of Progit 50 mg, continue taking your usual doses as normal. Do not take a double dose to make up for the forgotten dose.

If you stop taking Progit 50 mg
If you stop treatment with Progit 50 mg prematurely, your symptoms may worsen. Consult your doctor before stopping treatment.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment with Progit 50 mg and inform your doctor

• If you experience swelling of the hands, legs, face, lips, or throat, which may cause difficulty in swallowing or breathing. Skin rash or itching may also occur. This could indicate that you are having an allergic reaction.

During treatment with Progit 50 mg, the following side effects may occur:
Uncommon (may affect up to 1 in 100 people)

• Diarrhea.
• Constipation.
• Abdominal pain.
• Excessive salivation.
• Headache.
• Dizziness.
• Increased levels of the hormone prolactin.
• Altered blood test results (low white blood cell count, low platelet count).

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

• Skin rash, redness, and itching.

Not known (frequency cannot be estimated from the available data)

• Increased blood test values (AST, ALT, gamma-GT, alkaline phosphatase, bilirubin).
• Decreased platelets (this effect may present as bruising and increased bleeding).
• Tremor.
• Nausea.
• Jaundice.
• Breast enlargement in males.

If galactorrhea (production and secretion of breast milk not related to breastfeeding) or gynaecomastia (breast enlargement in males) occurs, treatment must be discontinued or permanently suspended.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
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 requires no special storage conditions.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents 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 monohydrate lactose, pregelatinized corn starch, sodium croscarmellose, anhydrous colloidal silicon dioxide, magnesium stearate, and the tablet coating Opadry II White 85F18422 (partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc).

Description of the appearance of Progit 50 mg and package contents
The film-coated tablets of Progit 50 mg are white or almost white, round, biconvex, with a score line, and 7 mm in diameter.
The score line is intended to facilitate breaking the tablet if you have difficulty swallowing it whole.
Progit 50 mg is supplied in packages containing blisters 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
PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Prague 4, Czech Republic

Marketing Authorization Holder in Italy
Fenix Pharma s.c.p.a., Via A. Zanetta, 118, 00143 Rome, Italy

This medicinal product is authorized in the European Economic Area countries under the following names:
Czech Republic Refla
Estonia Itoprom
Latvia Progit 50 mg apvalkotās tabletes
Spain Progit 50 mg comprimidos recubiertos con película EFG
Portugal Itomed
Italy Progit
Denmark Progit
Bulgaria Progit 50 mg филмирани таблетки
Finland Progit 50 mg kalvopäällysteiset tabletit