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CETIRIZINE RATIOPHARM 10 mg FILM-COATED TABLETS

This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use CETIRIZINE RATIOPHARM 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

Package Leaflet: Information for the User

Cetirizine ratiopharm 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

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

Cetirizine dihydrochloride is the active substance of Cetirizine ratiopharm.

Cetirizine ratiopharm is an antiallergic medicine.

Cetirizine ratiopharm is indicated in adults and children aged 6 years and above:

  • For the relief of symptoms of seasonal and perennial allergic rhinitis and urticaria.
Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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

Do not take Cetirizine ratiopharm

  • if you have severe renal impairment (severe renal failure with creatinine clearance below 10 ml/min).
  • if you know that you are allergic to cetirizine dihydrochloride or any of the other ingredients of this medicine (described in section 6), or to hydroxyzine or piperazine derivatives (closely related active substances of other medicines),

Warnings and precautions

Consult your doctor or pharmacist before taking Cetirizine ratiopharm.

If you have renal insufficiency, consult your doctor; if necessary, you may take a lower dose. Your doctor will determine the new dose.

If you have problems eliminating urine (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, you should consult your doctor.

No clinically significant interactions have been observed between alcohol (blood alcohol levels of 0.5 per thousand (g/l) corresponding to a glass of wine) and cetirizine used at the recommended doses. However, there are no data available on safety when administered at higher doses with alcohol. Therefore, as with all antihistamines, it is recommended to avoid taking Cetirizine ratiopharm with alcohol.

If you are going to undergo allergy testing, consult your doctor if you should stop taking Cetirizine ratiopharm several days before the test. This medicine may alter the results of allergy tests.

Children

Do not give this medicine to children under 6 years of age because the tablet formulation does not allow for the necessary dose adjustments.

Taking Cetirizine ratiopharm with other medicines

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

Taking Cetirizine ratiopharm with food and drinks

Food does not affect the absorption of Cetirizine ratiopharm.

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.

Cetirizine ratiopharm should be avoided in pregnant women. Accidental use of the medicine by a pregnant woman will not produce any harmful effect on the fetus. However, this medicine should only be administered if necessary and after medical advice has been obtained.

Cetirizine passes into breast milk. The risk of side effects in breastfed infants cannot be excluded. Therefore, you should not take Cetirizine ratiopharm during breastfeeding unless your doctor advises you to do so.

Driving and using machines

In clinical studies, no clinical evidence of decreased attention, alertness, and ability to drive has been observed after taking cetirizine dihydrochloride at the recommended doses.

You should see your individual response after taking Cetirizine ratiopharm if you are going to drive, perform hazardous activities, or work with machines. Do not exceed the recommended dose.

Cetirizine ratiopharm contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Cetirizine ratiopharm contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially "sodium-free".

3. How to take Cetirizine ratiopharm

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The tablets should be swallowed with a glass of liquid.

The tablet can be divided into equal doses.

Adults and adolescents over 12 years:

The recommended dose is 10 mg (1 tablet) once daily.

Other pharmaceutical forms may be suitable for children; ask your doctor or pharmacist.

Children between 6 and 12 years:

The recommended dose is 5 mg (half a tablet) twice daily.

Other pharmaceutical forms may be suitable for children; ask your doctor or pharmacist.

Patients with renal insufficiency

It is recommended that patients with moderate renal insufficiency take 5 mg once daily.

If you suffer from severe kidney disease, contact your doctor or pharmacist so that they can adjust the dose accordingly.

If your child suffers from severe kidney disease, contact your doctor or pharmacist so that they can adjust the dose accordingly to your child's needs.

If you feel that the effect of Cetirizine ratiopharm is too weak or too strong, contact 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.

If you take more Cetirizine ratiopharm than you should

If you think you have taken an overdose of Cetirizine ratiopharm, consult your doctor. Your doctor will decide what measures, if any, should be taken.

After an overdose, the following adverse effects may occur with greater intensity. The following adverse effects have been described: confusion, diarrhea, dizziness, fatigue, headache, feeling unwell, pupil dilation, pruritus, agitation, sedation, somnolence, stupor, abnormally rapid heartbeats, tremors, and urinary retention.

In case of overdose or accidental ingestion, consult the Toxicology Information Service telephone: 91 562 04 20.

If you forget to take Cetirizine ratiopharm

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

If you stop taking Cetirizine ratiopharm

Rarely, pruritus (intense itching) and/or urticaria may reappear if you stop taking Cetirizine ratiopharm.

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

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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 inform your doctor immediately if you notice any of them:

  • Allergic reactions including severe reactions and angioedema (serious allergic reaction that causes swelling of the face or throat)

These reactions can start when you start taking the medicine or may start later.

Common side effects(may affect up to 1 in 10 people):

  • Somnolence (drowsiness)
  • Dizziness, headache
  • Pharyngitis, rhinitis (in children)
  • Diarrhea, nausea, dry mouth
  • Fatigue

Uncommon side effects(may affect up to 1 in 100 people):

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

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

  • Allergic reactions, some severe (very rare)
  • Depression, hallucinations, aggression, confusion, insomnia
  • Seizures
  • Tachycardia (abnormally rapid heartbeats)
  • Abnormal liver function
  • Urticaria (hives)
  • Edema (swelling)
  • Weight gain

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

  • Thrombocytopenia (low platelet count in the blood)
  • Tics (involuntary habits)
  • Syncope, dyskinesia (involuntary movements), dystonia (prolonged abnormal muscle contractions), tremors, dysgeusia (altered taste)
  • Blurred vision, accommodation disorders (difficulty focusing), oculogyric crisis (uncontrolled circular eye movements)
  • Angioedema (serious reactions that cause swelling of the face or throat, drug-related rash
  • Abnormal urine elimination (bedwetting, pain and/or difficulty urinating)

Side effects of unknown frequency(cannot be estimated from the available data):

  • Increased appetite
  • Suicidal thoughts (recurring thoughts or concerns about suicide), nightmares
  • Amnesia, memory failure
  • Vertigo (sensation of rotation or movement)
  • Urinary retention (inability to complete emptying of the urinary bladder)
  • Pruritus (intense itching) and/or urticaria after discontinuation
  • Limbs pain
  • Blistering rash
  • Hepatitis (liver inflammation)

Reporting of side effects

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

5. Storage of Cetirizine ratiopharm

Keep this medicine out of the sight and reach of children.

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

This medicine does not require any special storage conditions.

Medicines should 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

Composition of Cetirizine ratiopharm

  • The active substance is cetirizine dihydrochloride. Each film-coated tablet contains 10 mg of cetirizine dihydrochloride.
  • The other ingredients are:

Core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate,

Coating: titanium dioxide (E-171), hypromellose (E464), macrogol 400.

Appearance of the product and contents of the pack

White to off-white film-coated tablet with a score line on one side.

Cetirizine ratiopharm is available in blister packs containing 2, 7, 10, 14, 20, 20x1, 30, 50, 90, 100, or 100x1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1ª Planta

28108 Alcobendas, Madrid

Manufacturers:

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 - Blaubeuren (Germany)

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

Belgium Cetirizine Teva 10 mg film-coated tablets

Norway Cetirizin ratiopharm 10 mg tablets

Portugal Allertek

Spain Cetirizina ratiopharm 10 mg film-coated tablets EFG

Date of last revision of this leaflet: February 2021

Detailed and updated 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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Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

  • seasonal and perennial allergies
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Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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Frequently Asked Questions

Is a prescription required for CETIRIZINE RATIOPHARM 10 mg FILM-COATED TABLETS?

CETIRIZINE RATIOPHARM 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 RATIOPHARM 10 mg FILM-COATED TABLETS?

The active ingredient in CETIRIZINE RATIOPHARM 10 mg FILM-COATED TABLETS is cetirizine. This information helps identify medicines with the same composition but different brand names.

How much does CETIRIZINE RATIOPHARM 10 mg FILM-COATED TABLETS cost in pharmacies?

The average pharmacy price for CETIRIZINE RATIOPHARM 10 mg FILM-COATED TABLETS is around 3.12 EUR. Prices may vary depending on the manufacturer and dosage form.

Who manufactures CETIRIZINE RATIOPHARM 10 mg FILM-COATED TABLETS?

CETIRIZINE RATIOPHARM 10 mg FILM-COATED TABLETS is manufactured by Teva Pharma S.L.U.. Pharmacy brands and packaging may differ depending on the distributor.

Which doctors can assess the use of CETIRIZINE RATIOPHARM 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 RATIOPHARM 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.

How to buy CETIRIZINE RATIOPHARM 10 mg FILM-COATED TABLETS in Spain?

Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.

You can buy CETIRIZINE RATIOPHARM 10 mg FILM-COATED TABLETS in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.

To obtain a prescription, you can use Oladoctor:

What are the alternatives to CETIRIZINE RATIOPHARM 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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