Package leaflet: Information for the user

Zirid, 50 mg, coated tablets
Itopridi hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Contents of the leaflet

What Zirid is and what it is used for
Important information before taking Zirid
How to take Zirid
Possible side effects
How to store Zirid
Contents of the pack and other information

1. What Zirid is and what it is used for

Zirid contains the active substance itoprid, which enhances gastrointestinal motility
(spontaneous movements of the stomach and intestines necessary for the passage of food through
the gastrointestinal tract) and prevents nausea and vomiting.
The medicine is intended for the treatment of symptoms associated with delayed gastric emptying,
such as a feeling of fullness in the stomach or even painful pressure in the epigastrium, loss of appetite, heartburn,
nausea and vomiting related to digestive disturbances, due to causes other than peptic ulcer disease or
organic diseases causing altered gastrointestinal transit.
This medicine is intended for use in adults.

2. Information before taking Zirid

When not to take Zirid

if the patient is allergic to itopride or any of the other ingredients of this medicine (listed in section 6);
if the patient has a condition in which accelerated gastric emptying may be harmful, such as gastrointestinal bleeding, mechanical obstruction, or perforation.

The medicine is not intended for use in children or in pregnant or breastfeeding women.
Zirid and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Zirid and other concomitantly administered medicines may interact with each other.

Anticholinergic agents (used in the treatment of asthma, chronic lung diseases, diarrhoea, Parkinson's disease, and to relieve smooth muscle spasm, e.g. in the urinary bladder) reduce the effect of itopride.
Zirid affects gastrointestinal motility and therefore may influence the absorption of other medicines. Caution is advised, particularly with medicines having a narrow therapeutic index (small difference between the therapeutic and harmful dose), medicines with prolonged release, and enteric-coated tablets or capsules. The patient should consult a doctor or pharmacist if this applies to any medicines they are taking.
No other interactions have been demonstrated (i.e. the effect of itopride on other medicines and the effect of other medicines on itopride).

Zirid with food and drink
Take the medicine before meals.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Due to lack of data on safety during pregnancy and breastfeeding, the medicine should not be used during pregnancy, breastfeeding, or in women in whom pregnancy is suspected, unless the benefits of treatment clearly outweigh the potential risks.
If this applies to the patient, she should consult her doctor before taking the medicine.
Driving and using machines
Although no influence of the medicine on the ability to drive motor vehicles and operate machinery has been observed, dizziness, which may rarely occur, could impair the ability to concentrate. The patient should not drive or operate machinery if such symptoms occur.
Zirid contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, the medicine is considered "sodium-free".

3. How to take Zirid

This medicine should always be taken as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
The tablet has a score line on one side and can be divided into equal doses.
The tablet should be swallowed whole or divided, with water, before a meal.
The exact dosage and duration of treatment are determined by the physician.
Adults
The usual dose in adults is one tablet three times daily before meals.
This dose may be reduced depending on the course of the disease (e.g. to ½ tablet three times
daily).
Use in children
Due to lack of data on safety, the use of this medicine is not recommended in children.
Patients with hepatic or renal impairment and elderly patients
Patients with impaired liver or kidney function, as well as elderly patients, will be closely
monitored by the physician. If any adverse reactions occur, contact your doctor.
The physician may recommend reducing the dose or discontinuing treatment.
Taking more Zirid medicine than recommended
There is no experience regarding overdose in humans.
If too many tablets have been taken or if a child has accidentally swallowed the medicine,
seek immediate medical attention at the nearest hospital or contact your doctor.
In case of overdose, gastric lavage and symptomatic treatment are usually applied.
Missed dose of Zirid
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should stop taking the medicine and contact your doctor immediately or go to
hospital if any of the following occur:

swelling of the hands, feet, ankles, face, lips or throat, which may cause difficulty in swallowing or breathing. A rash or itching may also occur. This may indicate that the patient is experiencing an allergic reaction.

The following adverse reactions may occur during treatment with itopride (the active substance in Zirid):

Uncommon (may occur in not more than 1 in 100 patients):

diarrhoea, abdominal pain, constipation, increased salivation, headache, sleep disturbances, dizziness, back pain or chest pain, fatigue, restlessness, increased levels of substances called creatinine and blood urea nitrogen (BUN) in blood, decreased number of white blood cells (leukocytes) in blood, increased levels of the hormone prolactin in blood (this may lead to milk secretion and/or breast enlargement).

Rare (may occur in not more than 1 in 1,000 patients):

rash, redness of the skin and itching.

Frequency not known (frequency cannot be estimated from available data):

reduction in the number of platelets (may manifest as bruising or bleeding), tremor, nausea (feeling of needing to vomit), breast enlargement (gynaecomastia), yellowing of the skin (jaundice), increased activity of certain enzymes AspAT (SGOT), AlAT (SGPT), gamma-GTP, alkaline phosphatase and increased levels of bilirubin pigment in blood.

If milk production and secretion from the breast occurs outside the period of breastfeeding (galactorrhoea) or breast enlargement in males (gynaecomastia), treatment should be discontinued and medical advice sought.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C
02 - 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Zirid

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must 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 Zirid contains
The active substance is itopride hydrochloride. Each coated tablet contains 50 mg of
itopride hydrochloride.
The other ingredients are:
Core tablet composition:
monohydrate lactose, maize starch gelatinised, sodium croscarmellose, colloidal anhydrous silica,
magnesium stearate.
Coating composition:
hypromellose 2910/5, macrogol 6000, titanium dioxide, talc.
What Zirid looks like and contents of the pack
Zirid is a white or almost white, round, biconvex coated tablet with a break line on one side.
The tablet can be divided into equal doses.
The medicine is packed in blisters (transparent PVC/PVDC/aluminium foil). Each blister contains 10,
15 or 20 coated tablets.
The outer packaging is a cardboard box.
Each box contains a patient leaflet.
Pack sizes:
40 coated tablets
90 coated tablets
100 coated tablets
Marketing Authorisation Holder
Zentiva k.s., U Kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic
Manufacturer
Zentiva k.s., U Kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic
For further information about the medicine and its names in the European Economic Area countries,
please contact:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00