Cetirizine Tevagen 10 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Cetirizina Tevagen 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 as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you and must not be given to other people, even if they have the same symptoms, as 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.
Leaflet contents
- What Cetirizina Tevagen is and what it is used for
- What you need to know before taking Cetirizina Tevagen
- How to take Cetirizina Tevagen
- Possible side effects
- How to store Cetirizina Tevagen
- Contents of the pack and other information
1. What Cetirizina Tevagen is and what it is used for
Cetirizine dihydrochloride is the active substance in Cetirizina Tevagen. Cetirizina Tevagen is an antihistamine.
In adults and children aged 6 years and older, Cetirizina Tevagen is indicated for:
- Relief of nasal and ocular symptoms of seasonal or perennial allergic rhinitis.
- Relief of urticaria.
2. What you need to know before taking Cetirizina Tevagen
Do not take Cetirizina Tevagen
- If you have severe kidney disease (requiring dialysis)
- If you are allergic to cetirizine dihydrochloride or to any of the other components of this medicine (listed in section 6), to hydroxyzine, or to piperazine derivatives (active ingredients of other closely related medicines)
- If you have severe renal disease (severe renal impairment with creatinine clearance below 10 ml/min)
Warnings and precautions
Consult your doctor or pharmacist before taking Cetirizina Tevagen.
If you are a patient with renal impairment, consult your doctor for advice; if necessary, you will take a lower dose. Your doctor will determine the new dose.
If you have temporary urinary problems (such as spinal cord, prostate, or bladder issues), consult your doctor for advice.
If you are an epileptic patient or a patient at risk of seizures, consult your doctor for advice.
No clinically significant interactions have been observed between alcohol (blood levels of 0.5 g/l corresponding to one glass of wine) and cetirizine used at the recommended doses.
However, there are no available data on the safety of concomitant administration of higher doses of cetirizine and alcohol. Therefore, as with all antihistamines, it is recommended to avoid taking Cetirizina Tevagen with alcohol.
If you are scheduled to undergo allergy testing, consult your doctor about whether you should stop taking Cetirizina Tevagen several days before the test. This medicine may alter the results of allergy tests.
Children
Do not administer this medicine to children under 6 years of age, as the tablet formulation does not allow for the necessary dose adjustments.
Taking Cetirizina Tevagen with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Taking Cetirizina Tevagen with food
Food does not affect the absorption of cetirizine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Cetirizina Tevagen should not be taken by pregnant women. Accidental use of the medicine is unlikely to cause harmful effects on the fetus. However, this medicine should only be administered if necessary and after obtaining medical advice.
Cetirizine passes into breast milk. A risk of adverse reactions in breastfed infants cannot be excluded. Therefore, you should not take Cetirizina Tevagen during breastfeeding unless your doctor advises otherwise.
Driving and using machines
Clinical studies have shown no clinical evidence of reduced attention, alertness, or driving ability after taking cetirizine dihydrochloride at the recommended dose.
You should assess your individual response after taking Cetirizina Tevagen if you intend to drive, perform hazardous activities, or operate machinery. Do not exceed the recommended dose.
Cetirizina Tevagen contains Lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
Cetirizina Tevagen contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; i.e., essentially “sodium-free”.
3. How to take Cetirizine Tevagen
Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The tablets should be swallowed with a glass of liquid.
The tablets may be divided into equal doses.
Instructions for use
If your treatment with Cetirizine Tevagen requires you to split the tablets, you should do so as described below. Place the tablet on a hard, flat surface (for example, on a cutting board or a plate) with the break line facing upwards. Then press briefly and firmly at the same time with your index fingers (or thumbs) on the edges to the right and left of the break line, as shown in the graphic illustration below.
Adults and adolescents over 12 years of age
The recommended dose is 10 mg (1 tablet) once daily.
Other pharmaceutical forms may be more suitable for children; ask your doctor or pharmacist.
Use in children
Children between 6 and 12 years of age
The recommended dose is 5 mg (half a tablet) twice daily.
Other pharmaceutical forms may be more suitable for children; ask your doctor or pharmacist.
Patients with renal impairment
Patients with moderate renal impairment should take half a tablet (5 mg) once daily.
If you have severe kidney disease, consult your doctor or pharmacist so that your dose can be adjusted.
If your children have kidney disease, contact your doctor or pharmacist to adjust the dose according to their needs.
If you feel that the effect of Cetirizine Tevagen 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 Tevagen than you should
If you think you have taken an overdose of Cetirizine Tevagen, inform your doctor. Your doctor will decide which measures to take, if necessary.
After an overdose, the adverse effects described below may increase in intensity. Adverse effects such as confusion, diarrhea, dizziness, fatigue, headache, malaise (feeling unwell), weakness, pupil dilation, itching, restlessness, sedation, somnolence (drowsiness), stupor, rapid heartbeat, tremors, and urinary retention (difficulty emptying the bladder completely).
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Cetirizine Tevagen
Do not take a double dose to make up for missed doses.
If you stop taking Cetirizine Tevagen
If you stop taking Cetirizine Tevagen, in rare cases you may experience a return of pruritus (intense itching) and/or urticaria (hives).
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Cetirizine Tevagen may cause adverse effects, although not everyone experiences them.
The following effects are rare or very rare, but you should stop taking the medicine and inform your doctor immediately if you notice any of them:
- Allergic reactions, including severe reactions and angioedema (a serious allergic reaction causing swelling of the face or throat)
These reactions may begin when starting treatment or may occur later.
Frequent adverse effects (may affect up to 1 in 10 people)
- Drowsiness (sleepiness)
- Dizziness, headache
- Pharyngitis (sore throat), rhinitis (runny nose, nasal congestion) (in children)
- Dry mouth, nausea, diarrhea
- Fatigue
Uncommon adverse effects (may affect up to 1 in 100 people)
- Agitation
- Paresthesia (abnormal sensation in the skin)
- Abdominal pain
- Pruritus, rash
- Asthenia (severe fatigue), malaise (feeling unwell)
Rare adverse effects (may affect up to 1 in 1,000 people)
- Allergic reactions, some severe (very rare)
- Depression, hallucinations, aggression, confusion, insomnia
- Seizures
- Tachycardia (rapid heartbeat)
- Abnormal liver function
- Urticaria (hives)
- Edema (swelling)
- Weight gain
Very rare adverse effects (may affect up to 1 in 10,000 people)
- Thrombocytopenia (low platelet levels in blood)
- Tic (habitual spasm)
- Syncope (fainting), dyskinesia (involuntary movements), dystonia (prolonged abnormal muscle contractions), tremor, dysgeusia (taste disturbance)
- Blurred vision, visual accommodation disorders (difficulty focusing), oculogyric crisis (uncontrolled circular eye movements)
- Angioedema (serious allergic reaction causing swelling of the face or throat), fixed drug eruption (drug allergy)
- Abnormal urination (bedwetting, pain or difficulty urinating)
Adverse effects of unknown frequency (cannot be estimated from available data)
- Increased appetite
- Suicidal thoughts (recurring thoughts or preoccupation with suicide), nightmares
- Amnesia (memory loss), 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
- Limb pain, muscle pain
- Blistering rash containing pus
- Hepatitis (inflammation of the liver)
Reporting of adverse effects
If you experience any 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 via the Spanish Pharmacovigilance System for Human Medicinal Products website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Cetirizine Tevagen
Keep out of the sight and reach of children.
Do not use Cetirizine Tevagen after the expiry date which is stated on the outer packaging and blister, after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater drains or in household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Cetirizine Tevagen
Composition of Cetirizine Tevagen
- The active substance is cetirizine dihydrochloride.
Each film-coated tablet contains 10 mg of cetirizine dihydrochloride.
- The other components are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate, titanium dioxide (E-171), hypromellose (E-464), and macrogol.
Appearance of the medicinal product and content of the container
White to off-white, round, biconvex tablet with a break line on one side and a diameter of approximately 6.5 mm.
PVC/PVDC Aluminium blisters.
Cetirizine Tevagen is available in blister packs containing 7, 14, 15, 20, 28, 30, 50 and 100 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 1st floor
28108 Alcobendas, Madrid, Spain
Manufacturers:
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 - Blaubeuren (Germany)
This medicinal product is authorized in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under the following names:
Denmark: Cetiriva
France: CETIRIZINE TEVA SANTE 10 mg, film-coated tablet
Italy: Cetirizina Teva 10 mg
Spain: Cetirizina Tevagen 10 mg film-coated tablets EFG
Sweden: Cetirizine Teva, 10 mg, film-coated tablet
United Kingdom (Northern Ireland): Cetirizine 10 mg Film-Coated Tablets
Date of latest revision of this package leaflet: February 2025
“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/”