Cetirizine Zentiva 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Cetirizine Zentiva 10 mg film-coated tablets EFG

cetirizine dihydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

The active substance of Cetirizina Zentiva is cetirizine dihydrochloride.

Cetirizina Zentiva is an antiallergic medicine.

Cetirizina Zentiva is indicated in adults and children aged 6 years and older for the relief of:

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

2. What you need to know before taking Cetirizina Zentiva

Do not take Cetirizina Zentiva if:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Cetirizina Zentiva.

If you are a patient with kidney impairment, consult your doctor; if necessary, you will take a lower dose. Your doctor will determine the new dose.

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

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

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

If you have an allergy test scheduled, ask your doctor whether you should stop taking Cetirizina Zentiva 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 Cetirizina Zentiva

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

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

Taking Cetirizina Zentiva 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Cetirizina Zentiva should be avoided in pregnant women. Accidental use of the medicine in pregnant women is not expected to cause harmful effects on the fetus. However, the medicine should only be administered if necessary and under medical advice.

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

Driving and using machines

Clinical studies have not shown evidence that Cetirizina Zentiva causes disturbances in attention, reduced reaction capacity, or impaired driving ability after taking Cetirizina Zentiva at the recommended dose.

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

Cetirizina Zentiva contains Lactose monohydrate

Cetirizina Zentiva contains lactose monohydrate. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Cetirizina Zentiva

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.

The tablets must be swallowed with a glass of liquid. The tablet may be divided into equal doses.

The recommended doses are as follows.

Adults and adolescents over 12 years of age

The recommended dose is 10 mg once daily as 1 tablet.

Children between 6 and 12 years of age

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

Patients with renal impairment

Patients with moderate renal impairment are recommended to take 5 mg once daily.

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

If your child has severe renal 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 Cetirizina Zentiva 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 seek advice from your doctor or pharmacist.

If you take more Cetirizina Zentiva than you should

Inform your doctor if you think you have taken an overdose of Cetirizina Zentiva.

Your doctor will then decide what measures should be taken.

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

After an overdose, the adverse effects described below may occur with increased intensity. Adverse effects reported include confusion, diarrhoea, dizziness, fatigue, headache, weakness, pupillary dilation, itching, restlessness, sedation, somnolence, stupor, abnormally increased heart rate, tremor, and urinary retention.

If you forget to take Cetirizina Zentiva

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

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

If you stop treatment with Cetirizina Zentiva

In rare cases, pruritus (intense itching) and/or urticaria may reappear if you stop taking Cetirizina Zentiva.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following adverse effects are rare or very rare, but you should stop taking the medicine and consult your doctor immediately if you notice any of them.

• Allergic reactions, including anaphylactic shock (a severe allergic reaction that may be life-threatening) and angioedema (a severe allergic reaction causing swelling of the face or throat).

These reactions may begin shortly after the first dose, or may start later.

Frequent (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.
• Pruritus (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 (fast heartbeat).
• Abnormal liver function.
• Urticaria (blisters).
• Edema (swelling).
• Weight gain.

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

• Thrombocytopenia (low platelet levels).
• Tics (spasms).
• Syncope, dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions), tremor, dysgeusia (taste disturbance).
• Blurred vision, accommodation disorder (difficulty focusing), ocular rotation (eyes making uncontrolled circular movements).
• Fixed drug eruption.
• Abnormal urination (bedwetting, pain and/or difficulty passing urine).

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

• Increased appetite.
• Suicidal thoughts (recurring thoughts or preoccupation with suicide).
• Nightmares.
• Amnesia, memory impairment.
• Vertigo (sensation of spinning or movement).
• Urinary retention (inability to completely empty the urinary bladder).
• Pruritus (intense itching) and/or urticaria after discontinuation of treatment.
• Pustular rash (rash with pus-filled blisters).
• Joint pain.
• Hepatitis (inflammation of the liver).

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cetirizine Zentiva

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

What Cetirizine Zentiva contains

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

What Cetirizine Zentiva looks like and contents of the pack

Film-coated tablets, white to off-white, oblong, with a central break line on one side.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Zentiva Spain S.L.U.
Avenida de Europa, 19, Edificio 3, Planta 1
28224 Pozuelo de Alarcón, Madrid
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: August 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/