CETIRIZINE SANDOZ 10 MG FILM-COATED TABLETS EFG
SpainIt is used to relieve the symptoms of allergic rhinitis (both seasonal and perennial) in the nose and eyes, and to relieve chronic urticaria.
Frequently asked questions
How should I take Cetirizine Sandoz?
Adults and adolescents over 12 years of age should take 1 tablet of 10 mg once daily. Children between 6 and 12 years of age should take half a tablet (5 mg) twice daily. The tablets should be swallowed with a glass of liquid.
When should I not take this medicine?
Do not take it if you have severe renal disease, or if you are allergic to cetirizine, hydroxyzine, piperazine derivatives, or any of its components. It should also not be administered to children under 6 years of age.
What side effects can Cetirizine Sandoz cause?
Common side effects include fatigue, drowsiness, dizziness, headache, dry mouth, nausea, or diarrhea. Less common or rare side effects may also occur, such as agitation, itching, swelling, tachycardia, or blurred vision. If you experience swelling of the face, mouth, or throat, or have difficulty breathing, you must seek immediate medical assistance.
Can I consume alcohol while undergoing treatment?
It is recommended to avoid alcohol consumption while taking this medicine. Although no serious interactions have been observed with normal doses of alcohol, there is no safety data for higher doses.
What should I do if I forget a dose?
If you forget to take a dose, do not take a double dose to make up for the one you missed.
Can I drive or use machinery after taking it?
You should closely observe how the medicine affects you before driving or performing dangerous activities; although studies do not show alterations in attention at recommended doses, it is important to monitor your personal response.
Can I take it if I am pregnant or breastfeeding?
If you are pregnant or breastfeeding, you must consult your doctor before use. The medicine should be avoided in pregnant women unless the doctor deems it necessary, and it should not be taken during lactation without prior consultation with a professional.
Instructions for use
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the patient
Cetirizine Sandoz 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. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.
Leaflet contents
- What Cetirizine Sandoz is and what it is used for
- What you need to know before taking Cetirizine Sandoz
- How to take Cetirizine Sandoz
- Possible side effects
- How to store Cetirizine Sandoz
- Contents of the pack and other information
1. What Cetirizina Sandoz is and what it is used for
Cetirizine dihydrochloride is the active substance in Cetirizina Sandoz.
Cetirizina Sandoz is an antiallergic medicine.
Cetirizina Sandoz is indicated in adults and children aged 6 years and older for:
- relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis,
- relief of chronic urticaria (chronic idiopathic urticaria).
2. What you need to know before taking Cetirizine Sandoz
Do not take Cetirizine Sandoz
-
if you have severe kidney disease (severe renal insufficiency with creatinine clearance below 10 ml/min),
-
if you are allergic to cetirizine dihydrochloride, hydroxyzine, piperazine derivatives (active substances closely related to other medicines), or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before taking Cetirizine Sandoz.
If you have difficulty urinating (such as spinal cord or prostate problems, or bladder issues), please consult your doctor.
If you have renal insufficiency, please consult your doctor; if necessary, you will take a lower dose. Your doctor will determine the new dose.
If you are an epileptic patient or a patient at risk of seizures, consult your doctor.
If you are scheduled to undergo an allergy test, consult your doctor whether you should stop taking cetirizine a few days before the test. This medicine may affect the results of your allergy tests.
No clinically significant interactions have been observed between alcohol (with a blood level of 0.5 per mille (g/l), corresponding to one glass of wine) and the use of cetirizine at normal doses. However, safety data are not available when higher doses of cetirizine and alcohol are taken together.
Therefore, as with all antihistamines, it is recommended to avoid taking cetirizine with alcohol.
Children
Do not give this medicine to children under 6 years of age, as this formulation does not allow for the necessary dose adjustment.
Taking Cetirizine Sandoz with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Taking Cetirizine Sandoz with food and drink
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.
Cetirizine 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 after consultation with the doctor.
Cetirizine passes into breast milk. A risk of adverse reactions in breastfed infants cannot be excluded. Therefore, you should not take cetirizine while breastfeeding unless advised by your doctor.
Driving and using machines
Clinical studies have not shown evidence that cetirizine causes disturbances in attention, reduced reaction ability, or impaired driving skills at the recommended dose.
You should carefully observe your response to the medicine after taking cetirizine if you intend to drive, perform potentially hazardous activities, or operate machinery. Do not exceed the recommended dose.
Cetirizine Sandoz contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Cetirizina Sandoz
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The tablets must be swallowed with a glass of liquid.
The tablet may be divided into equal doses.
Adults and adolescents over 12 years of age:
The recommended dose is 10 mg once daily as 1 tablet.
Other forms of this medicine may be more suitable for children: ask your doctor or pharmacist.
Use in children between 6 and 12 years of age:
The recommended dose is 5 mg twice daily as half a tablet twice daily.
Other forms of this medicine may be more suitable for children; ask your doctor or pharmacist.
Patients with renal impairment
Patients with moderate renal impairment are recommended to take 5 mg once daily.
If you suffer from severe renal disease, please contact your doctor or pharmacist, who can appropriately adjust the dose.
If your child suffers from renal disease, please contact your doctor or pharmacist, who can adjust the dose according to your child's needs.
If you notice that the effect of this medicine is too weak or too strong, 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.
If you take more Cetirizina Sandoz than you should
If you have taken more Cetirizina Sandoz than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount used.
After an overdose, the adverse reactions described below may occur with greater intensity. Adverse effects reported include confusion, diarrhea, dizziness, fatigue, headache, weakness, pupillary dilation, tingling, irritation, sedation, somnolence, stupor, abnormally increased heart rate, tremor, and urinary retention.
If you forget to take Cetirizina Sandoz
Do not take a double dose to make up for missed doses.
If you stop taking Cetirizina Sandoz
In rare cases, itching (intense pruritus) and/or urticaria may reappear if you stop taking cetirizine.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Stop taking Cetirizine Sandoz and seek immediate medical help if you experience any of the symptoms listed below:
- swelling of the mouth, face and/or throat,
- difficulty breathing (tightness in the chest or wheezing),
- sudden drop in blood pressure leading to fainting or shock.
These symptoms may be signs of allergic reactions, anaphylactic shock, and angioedema. These reactions may begin immediately after the first dose of this medicine or may start later.
The table below lists other adverse effects that have been reported, categorized by frequency.
Common (may affect up to 1 in 10 people):
- fatigue
- dry mouth, nausea, diarrhea
- dizziness, headache
- somnolence (drowsiness)
- pharyngitis (sore throat), rhinitis (swelling and irritation inside the nose)
Uncommon (may affect up to 1 in 100 people):
- agitation
- abdominal pain
- asthenia (extreme fatigue), malaise (feeling generally unwell)
- paresthesia (abnormal sensations in the skin)
- pruritus (itching), rash
Rare (may affect up to 1 in 1,000 people):
- tachycardia (rapid heartbeat)
- edema (swelling)
- altered liver function
- weight gain
- seizures
- aggression, confusion, depression, hallucination, insomnia
- urticaria (hives)
Very rare (may affect up to 1 in 10,000 people):
- thrombocytopenia (low platelet levels in the blood, manifested by bleeding or bruising more easily than normal)
- accommodation disorders (difficulty focusing), blurred vision, oculogyration (eyes making uncontrolled circular movements)
- syncope, tremor, dysgeusia (taste disturbance), dyskinesia (involuntary movements), dystonia (prolonged abnormal muscle contractions)
- tics (habitual spasms)
- abnormal urination (bedwetting, pain and/or difficulty urinating)
- drug-related rash
Frequency not known (frequency cannot be estimated from available data):
- amnesia, memory impairment
- increased appetite
- vertigo (sensation of spinning or movement)
- urinary retention (inability to completely empty the bladder)
- nightmares
- hepatitis (inflammation of the liver)
- joint pain
- blistering rash containing pus
- pruritus (intense itching) and/or urticaria after discontinuation of treatment
- suicidal thoughts (recurrent thoughts or obsession with suicide).
If you experience any of these symptoms, stop taking the medicine and consult your doctor.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 Sandoz
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and blister after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage temperature.
Store in the original packaging to protect from light.
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 unsure, please consult your pharmacist on how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the container and other information
Composition of Cetirizine Sandoz
Each tablet contains 10 mg of cetirizine dihydrochloride.
- The active substance is cetirizine dihydrochloride.
- The other components are:
Tablet core: microcrystalline cellulose, lactose monohydrate, magnesium stearate, colloidal anhydrous silica.
Coating: hypromellose, lactose monohydrate, titanium dioxide (E171) and macrogol 4000.
Appearance of the product and contents of the pack
Film-coated white, oblong tablets, scored on one side.
Presented in PVC/Al blisters, in pack sizes of: 7, 10, 14, 20, 21, 28, 30, 50, 60, 98 and 100 and 50 (50x1) film-coated tablets in unit dose packs.
Only certain pack sizes may be commercially available.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Sandoz Farmacéutica, S.A.
Parque Norte Business Park
Edificio Roble
C/ Serrano Galvache, 56
28033 Madrid
Spain
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1,
39179 Barleben,
Germany
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria: Cetirizin Sandoz 10 mg - Filmtabletten
Hungary: Cetirizin 1A Pharma 10 mg filmtabletta
Italy: Cetirizine Sandoz
Portugal: CETIRIZINA SANDOZ
Slovakia: Cetirizine Sandoz 10 mg
Slovenia: Cetirizin Lek 10 mg filmsko obložene tablete
United Kingdom: Cetirizine Hydrochloride 10mg tablets
Date of the most recent review of this leaflet: February 2019
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
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The original data is available in the language of the country of manufacture.
Data source: Online Medicines Information Centre (CIMA) — AEMPS
Data last verified: September 21, 2026