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CETIRIZINE ZENTIVA 10 mg FILM-COATED TABLETS

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About the medicine

How to use CETIRIZINE ZENTIVA 10 mg FILM-COATED TABLETS

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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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.
Doctor consultation

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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.

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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:

Country

Name

Germany

Cetirizine Zentiva 10 mg film-coated tablets

Portugal

Cetirizine Zentiva 10 mg tablets

Spain

Cetirizine Zentiva 10 mg film-coated tablets EFG

Italy

Cetirizine - Zentiva

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/

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Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
  • Chest pain, shortness of breath, arrhythmias (tachycardia, bradycardia, palpitations).
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  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • Individual treatment plans including oral medications and insulin therapy.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
  • Metabolic syndrome – obesity, lipid disorders, insulin resistance.
Gastroenterology – Digestive health:
  • Abdominal pain, nausea, heartburn, gastroesophageal reflux (GERD).
  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
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Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

Areas of expertise:

  • Endocrinology: diabetes type 1 and type 2, prediabetes, thyroid disorders, metabolic syndrome, hormonal imbalance.
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  • Preventive medicine: regular check-ups, health screenings, long-term management of chronic conditions.

Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

Patients commonly seek her help for:

  • High blood pressure, headaches, dizziness, swelling, palpitations.
  • Diagnosis and management of hypertension, arrhythmias, and tachycardia.
  • Metabolic syndrome, excess weight, high cholesterol.
  • Chronic fatigue, insomnia, poor concentration, anxiety.
  • Respiratory symptoms: colds, flu, sore throat, cough, fever.
  • Digestive issues: heartburn, bloating, constipation, IBS symptoms.
  • Chronic conditions: diabetes, thyroid disorders.
  • Interpretation of lab tests and medical reports, therapy adjustment.
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  • Cardiovascular disease prevention and metabolic risk reduction.
  • Long-term follow-up and dynamic health monitoring.

Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

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Alexander Nazarchuk

Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

You can consult Dr. Nazarchuk for:

  • Test interpretation and guidance on diagnostic plans.
  • Allergic rhinitis, hay fever, bronchial asthma (including severe cases).
  • Food and drug allergies, skin rashes, angioedema.
  • Atopic dermatitis, urticaria, contact allergies.
  • Allergen-specific immunotherapy (AIT) – initiation and ongoing management.
  • Abdominal pain, bloating, changes in bowel habits, nausea, heartburn.
  • High blood pressure and adjustment of baseline antihypertensive therapy.
  • Hyperlipidaemia and elevated cholesterol.
  • Cough, nasal congestion, fever, sore throat.
  • Anaemia, including iron deficiency and related conditions.
  • Other issues related to allergology and internal medicine.

During consultations, Dr. Nazarchuk takes a thorough, structured approach — analysing symptoms, identifying potential causes, and helping patients make informed decisions. Whether treatment, further investigation, or monitoring is needed, he explains each step clearly so you understand your health and how best to manage it.

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Marta Reguero Capilla

Allergology 8 years exp.

Dr Marta Reguero Capilla is an allergist and immunologist who works with both adults and children. She specialises in the diagnosis, treatment, and ongoing management of allergic and immune-related conditions through online consultations.

In her practice, Dr Reguero Capilla helps patients understand the causes of their symptoms, review test results, and choose appropriate treatment or monitoring strategies. Her consultations are suitable both for first-time assessments and for follow-up care over time.

Patients commonly consult Dr Marta Reguero Capilla for:

  • allergic rhinitis, seasonal allergies, and perennial allergy symptoms;
  • allergic conditions in adults and children;
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  • urticaria (acute and chronic) and angioedema;
  • food allergies and reactions to foods, additives, or medications;
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Dr Reguero Capilla works in a structured and attentive manner, explaining medical decisions clearly and helping patients make informed choices about their own health or their child’s care.

When clinically appropriate, she may provide recommendations for further tests or referrals that patients can use within Spanish medical networks, including Sanitas and DKV, in accordance with the terms and conditions of those services.

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Frequently Asked Questions

Is a prescription required for CETIRIZINE ZENTIVA 10 mg FILM-COATED TABLETS?
CETIRIZINE ZENTIVA 10 mg FILM-COATED TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in CETIRIZINE ZENTIVA 10 mg FILM-COATED TABLETS?
The active ingredient in CETIRIZINE ZENTIVA 10 mg FILM-COATED TABLETS is cetirizine. This information helps identify medicines with the same composition but different brand names.
How much does CETIRIZINE ZENTIVA 10 mg FILM-COATED TABLETS cost in pharmacies?
The average pharmacy price for CETIRIZINE ZENTIVA 10 mg FILM-COATED TABLETS is around 3.12 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures CETIRIZINE ZENTIVA 10 mg FILM-COATED TABLETS?
CETIRIZINE ZENTIVA 10 mg FILM-COATED TABLETS is manufactured by Zentiva K.S.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of CETIRIZINE ZENTIVA 10 mg FILM-COATED TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether CETIRIZINE ZENTIVA 10 mg FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to CETIRIZINE ZENTIVA 10 mg FILM-COATED TABLETS?
Other medicines with the same active substance (cetirizine) include ALERCINA 10 mg TABLETS, ALERLISIN 1 mg/ml ORAL SOLUTION, ALERLISIN 10 mg FILM-COATED TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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