
Ask a doctor about a prescription for CETIRIZINE RATIOPHARM 10 mg FILM-COATED TABLETS
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.
Contents of the package leaflet
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:
Do not take Cetirizine ratiopharm
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".
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.
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:
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):
Uncommon side effects(may affect up to 1 in 100 people):
Rare side effects(may affect up to 1 in 1,000 people):
Very rare side effects(may affect up to 1 in 10,000 people):
Side effects of unknown frequency(cannot be estimated from the available data):
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.
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.
Composition of Cetirizine ratiopharm
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/
The average price of CETIRIZINE RATIOPHARM 10 mg FILM-COATED TABLETS in November, 2025 is around 3.12 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
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