CETIRIZINE ZENTIVA 10 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Zentiva Cetirizine 10 mg film-coated tablets EFG

cetirizine dihydrochloride

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

Contents of the pack

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

1. What is Zentiva Cetirizine and what is it used for

The active substance of Zentiva Cetirizine is cetirizine dihydrochloride.

Zentiva Cetirizine is an antiallergic medicine.

Zentiva Cetirizine is indicated in adults and children over 6 years for the relief of:

• nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
• urticaria.

2. What you need to know before you take Zentiva Cetirizine

Do not take Zentiva Cetirizine if:

• you have severe kidney disease (renal failure requiring dialysis),
• you are allergic to cetirizine dihydrochloride, or any of the other ingredients of this medicine (listed in section 6), or to hydroxyzine or piperazine derivatives (closely related active substances).

Warnings and precautions

Consult your doctor or pharmacist before taking Zentiva Cetirizine.

If you have kidney problems, consult your doctor; if necessary, a lower dose will be taken. Your doctor will determine the new dose.

If you have problems urinating (such as spinal cord problems or prostate or bladder problems), consult your doctor.

If you are an epileptic patient or a patient at risk of convulsions, consult your doctor.

No clinically significant interactions have been observed between alcohol (with a blood level of 0.5 per thousand (g/l), corresponding to a glass of wine) and the use of cetirizine at the recommended dose. However, there are no data available on safety when taking high doses of cetirizine and alcohol together. Therefore, as with all antihistamines, it is recommended to avoid consuming Zentiva Cetirizine together with alcohol during treatment.

If you have been scheduled for an allergy test, ask your doctor if you should stop taking Zentiva Cetirizine a few days before the test. This medicine may affect the results of allergy tests.

Children

Do not give this medicine to children under 6 years of age, as this formulation does not allow for the necessary dose adjustment.

Other medicines and Zentiva Cetirizine

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

If you are a sensitive patient, you may find that the simultaneous use of alcohol or other central nervous system depressants may also affect your attention and ability to react.

Taking Zentiva Cetirizine with food, drinks, and alcohol

Food does not affect the absorption of cetirizine.

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.

Zentiva Cetirizine should be avoided in pregnant women. Accidental use of the medicine in pregnant women should not produce any harmful effect on the fetus. However, the medicine should only be taken if necessary and under medical advice.

Cetirizine is excreted in breast milk. The risk of side effects in breastfed babies cannot be excluded. Therefore, you should not take Zentiva Cetirizine during breastfeeding, unless you have contacted your doctor.

Driving and using machines

Clinical studies have not shown evidence that Zentiva Cetirizine produces alterations in attention, reduced ability to react, and ability to drive after taking Zentiva Cetirizine at the recommended dose.

You should carefully observe your response to the medicine after taking Zentiva Cetirizine. You should not exceed the recommended dose if you intend to drive, perform potentially hazardous activities, or use machinery.

Zentiva Cetirizine contains Lactose monohydrate

Zentiva Cetirizine contains lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Zentiva Cetirizine

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The tablets should be swallowed with a glass of liquid. The tablet can be divided into equal doses.

The recommended doses are those indicated below.

Adults and adolescents over 12 years

The recommended dose is 10 mg once a day as 1 tablet.

Children between 6 and 12 years

The recommended dose is 5 mg twice a day, as half a tablet twice a day.

Patients with renal impairment

It is recommended that patients with moderate renal impairment take 5 mg once a day.

If you have severe kidney disease, contact your doctor or pharmacist as they may adjust the dose accordingly.

If your child has severe kidney disease, contact your doctor or pharmacist as they may adjust the dose according to your child's needs.

If you notice that the effect of Zentiva Cetirizine is too weak or too strong, please consult your doctor.

Duration of treatment

The duration of treatment depends on the type, duration, and course of your symptoms and will be determined by your doctor. Please ask your doctor or pharmacist for advice.

If you take more Zentiva Cetirizine than you should

Tell your doctor if you think you have taken an overdose of Zentiva Cetirizine.

Your doctor will then decide what measures should be taken.

You can also call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

After an overdose, the following side effects may occur with greater intensity. Adverse effects such as confusion, diarrhea, dizziness, fatigue, headache, weakness, pupil dilation, itching, restlessness, sedation, somnolence, stupor, abnormally fast heart rate, tremor, and urinary retention have been reported.

If you forget to take Zentiva Cetirizine

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If you stop taking Zentiva Cetirizine

In rare cases, itching and/or urticaria may reappear if you stop taking Zentiva Cetirizine.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects are rare or very rare, but you must stop taking the medicine and consult your doctor immediately if you notice them.

• Allergic reactions, including anaphylactic shock (a severe, potentially life-threatening allergic reaction) and angioedema (a severe allergic reaction that causes swelling in the face or throat).

These reactions may start soon after the first intake or may start later.

Common (may affect up to 1 in 10 people)

• Somnolence (lack of sleep).
• Dizziness, headache.
• Pharyngitis, rhinitis (in children).
• Diarrhea, nausea, dry mouth.
• Fatigue.

Uncommon (may affect up to 1 in 100 people)

• Agitation.
• Paresthesia (abnormal sensations in the skin).
• Abdominal pain.
• Itching (skin itching), rash.
• Asthenia (extreme fatigue), malaise.
• Diarrhea.

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

• Allergic reactions, some severe (very rare).
• Depression, hallucination, aggression, confusion, insomnia.
• Seizures.
• Tachycardia (the heart beats very fast).
• Abnormal liver function.
• Urticaria (hives).
• Edema (swelling).
• Weight gain.

Very rare (may affect up to 1 in 10,000 people)

• Thrombocytopenia (low platelet count).
• Tics (spasms).
• Syncope, dyskinesia (involuntary movements), dystonia (abnormal, prolonged muscle contractions), tremor, dysgeusia (altered taste).
• Blurred vision, accommodation disorder (difficulty focusing), ocular gyration (the eyes have uncontrolled circular movements).
• Fixed drug eruption.
• Abnormal urine elimination (bedwetting, pain and/or difficulty urinating).

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

• Increased appetite.
• Suicidal thoughts (recurring thoughts or concerns about suicide).
• Nightmares.
• Amnesia, memory lapses.
• Vertigo (sensation of rotation or movement).
• Urinary retention (inability to completely empty the urinary bladder).
• Itching (intense itching) and/or urticaria after stopping treatment.
• Pustular rash.
• Joint pain.
• Hepatitis (inflammation of the liver).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zentiva Cetirizine

Keep out of the sight and reach of children.

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicinal products in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicinal products. This will help protect the environment.

6. Contents of the pack and other information

What Zentiva Cetirizine contains

• The active substance of Zentiva Cetirizine is cetirizine dihydrochloride. One film-coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other ingredients are lactose monohydrate, corn starch, povidone 30, magnesium stearate, titanium dioxide (E 171), hypromellose 2910/5 (E 464), macrogol 6000, talc, simethicone emulsion SE 4.

What Zentiva Cetirizine looks like and contents of the pack

White to off-white, oblong, film-coated tablets with a score line on one face.

Pack sizes: 7, 10, 15, 20, 30, 50, or 100 tablets.

Not all pack sizes are marketed.

Marketing authorisation holder and manufacturer:

Marketing authorisation holder

Zentiva, k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

Manufacturer

Zentiva, k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

or

Winthrop Arzneimittel GmbH

Brünigstrasse 50

65926 Frankfurt am Main

Germany

You can obtain further information on this medicine from the local representative of the marketing authorisation holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

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

Date of last revision of this leaflet:August 2023

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/