Zirid

Package Leaflet: Information for the User

Zirid, 50 mg, Coated Tablets

Itopride Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• The package leaflet should be kept in case it needs to be read again.
• In case of any further doubts, the patient should consult a doctor or pharmacist.
• This medication has been prescribed to a specific person. It should not be given to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Zirid and What is it Used For
• 2. Important Information Before Taking Zirid
• 3. How to Take Zirid
• 4. Possible Side Effects
• 5. How to Store Zirid
• 6. Package Contents and Other Information

1. What is Zirid and What is it Used For

Zirid contains the active substance itopride, which increases the motility of the gastrointestinal tract (spontaneous movements of the stomach and intestines necessary for the passage of food through the gastrointestinal tract) and prevents the occurrence of nausea and vomiting. The medication is intended for the treatment of symptoms resulting from delayed gastric emptying, such as a feeling of fullness in the stomach or even painful pressure in the upper abdomen, loss of appetite, heartburn, nausea, and vomiting associated with digestive disorders, for reasons other than peptic ulcer disease or organ diseases that cause changes in the passage through the gastrointestinal tract. The medication is intended for use in adults.

2. Important Information Before Taking Zirid

When Not to Take Zirid

The medication is not intended for use in children, pregnant or breastfeeding women.

Zirid and Other Medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take. Zirid and other medications taken at the same time may interact with each other.

• Substances with anticholinergic activity (used to treat asthma, chronic pulmonary diseases, diarrhea, Parkinson's disease, and to relieve smooth muscle spasms, e.g., in the urinary bladder) reduce the effect of itopride.
• Zirid affects the motility of the gastrointestinal tract, so it may affect the absorption of other medications. Particular caution is advised when taking medications with a narrow therapeutic index (small difference between the therapeutic dose and the harmful dose), medications with prolonged release, and enteric-coated tablets or capsules. The patient should consult their doctor or pharmacist if they are taking any of these medications.

In the case of other interactions (i.e., the effect of itopride on other medications and the effect of other medications on itopride), no other interactions have been found.

Zirid with Food and Drink

The medication should be taken before a meal.

Pregnancy, Breastfeeding, and Fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or is planning to have a child, they should consult their doctor or pharmacist before taking this medication. Due to the lack of data on the safety of use, the medication should not be used during pregnancy, breastfeeding, or in women who are suspected to be pregnant, unless the benefits of treatment significantly outweigh the potential risks. If the above applies to the patient, they should consult their doctor before taking the medication.

Driving and Operating Machines

Although no effect of the medication on the ability to drive vehicles or operate machines has been found, it cannot be ruled out that the patient's ability to concentrate may be impaired due to rare dizziness. The patient should not drive if they experience such symptoms.

Zirid Contains Lactose Monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medication. This medication contains less than 1 mmol of sodium (23 mg) per tablet, which means it is considered "sodium-free".

3. How to Take Zirid

This medication should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist. The tablet has a dividing line on one side and can be divided into equal doses. The tablet should be swallowed whole or divided, with a glass of water, before a meal. The exact dosage and duration of treatment are determined by the doctor. Adults: The usual dose for adults is one tablet 3 times a day before meals. This dose may be reduced depending on the course of the disease (e.g., to ½ tablet 3 times a day).

Use in Children

Due to the lack of data on the safety of use, it is not recommended to use the medication in children.

Patients with Liver or Kidney Impairment and Elderly Patients

Patients with liver or kidney impairment, as well as elderly patients, will be closely monitored by their doctor. If any side effects occur, the patient should contact their doctor. The doctor may recommend reducing the dose or stopping treatment.

Taking a Higher Dose of Zirid than Recommended

There is no experience with overdose of the medication in humans. In case of taking too many tablets or accidental ingestion of the medication by a child, the patient should immediately go to the nearest hospital or consult their doctor. In case of overdose, gastric lavage and symptomatic treatment are usually used.

Missing a Dose of Zirid

The patient should not take a double dose to make up for a missed dose. In case of any further doubts about taking this medication, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Zirid can cause side effects, although not everybody gets them.

The Patient Should Stop Taking the Medication and Immediately Consult their Doctor or Go to the Hospital if they Experience:

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

During treatment with itopride (the active substance of Zirid), the following side effects may occur: Uncommon (may affect up to 1 in 100 people):

• diarrhea, abdominal pain, constipation, increased salivation, headache, sleep disorders, dizziness, back pain or chest pain, fatigue, restlessness, increased levels of creatinine and urea in the blood, decreased white blood cell count, increased prolactin levels in the blood (which may lead to milk secretion and/or breast enlargement).

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

• rash, skin redness, and itching.

Frequency Not Known (frequency cannot be estimated from the available data):

• decreased platelet count (which may manifest as bruising or bleeding), tremors, nausea (feeling of needing to vomit), breast enlargement (gynecomastia), yellowing of the skin (jaundice), increased activity of certain enzymes (ASAT, ALAT, gamma-GT, alkaline phosphatase) and bilirubin levels in the blood.

In case of milk production by the breast outside of breastfeeding (galactorrhea) or breast enlargement in men (gynecomastia), treatment should be stopped and the doctor consulted.

Reporting Side Effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance 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. Side effects can also be reported to the marketing authorization holder. Reporting side effects will help to gather more information on the safety of the medication.

5. How to Store Zirid

The medication should be stored out of sight and reach of children. The medication should not be used after the expiration date stated on the blister pack and carton after "EXP". The expiration date refers to the last day of the month. There are no special precautions for storage. Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What Zirid Contains

The active substance of the medication is itopride hydrochloride. Each coated tablet contains 50 mg of itopride hydrochloride. The other ingredients are: Core tablet:lactose monohydrate, corn starch, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate. Coating:hypromellose 2910/5, macrogol 6000, titanium dioxide, talc.

What Zirid Looks Like and What the Package Contains

Zirid is a white or almost white, round, biconvex, coated tablet with a dividing line on one side. The tablet can be divided into equal doses. The medication is packaged in blisters (transparent PVC/PVDC/Aluminum foil). Each blister contains 10, 15, or 20 coated tablets. The outer packaging is a carton box. Each carton box contains a patient information leaflet. Package sizes: 40 coated tablets, 90 coated tablets, 100 coated tablets.

Marketing Authorization 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 More Detailed Information on the Medication and its Names in the Member States of the European Economic Area, Please Contact:

Zentiva Polska Sp. z o.o., ul. Bonifraterska 17, 00-203 Warsaw, tel.: +48 22 375 92 00, Date of Last Revision of the Leaflet:February 2025