CETIRIZINE TEVAGEN 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Cetirizine Tevagen 10 mg film-coated tabletsEFG

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 pack

1. What is Cetirizine Tevagen and what is it used for
2. What you need to know before you take Cetirizine Tevagen
3. How to take Cetirizine Tevagen
4. Possible side effects
5. Storage of Cetirizine Tevagen
6. Pack contents and further information

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

Cetirizine dihydrochloride is the active substance of Cetirizine Tevagen. Cetirizine Tevagen is an antihistamine.

In adults and children from 6 years of age, Cetirizine Tevagen is indicated:

• Relief of nasal and ocular symptoms of seasonal or perennial allergic rhinitis.
• Relief of urticaria.

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

Do not take Cetirizine Tevagen

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

Warnings and precautions

Consult your doctor or pharmacist before taking Cetirizine Tevagen.

If you are a patient with renal insufficiency, 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 or prostate or bladder problems), consult your doctor for advice.

If you are an epileptic patient or a patient at risk of convulsions, consult your doctor for advice.

No clinically significant interactions have been observed between alcohol (blood levels of 0.5 g/l corresponding to a glass of wine) and cetirizine used at the recommended doses.

However, there are no data available on safety when higher doses of cetirizine and alcohol are administered together. Therefore, as with all antihistamines, it is recommended to avoid taking Cetirizine Tevagen with alcohol.

If you are going to undergo allergy tests, consult your doctor if you should stop taking Cetirizine Tevagen 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 Tevagen with other medicines

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

Taking Cetirizine 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Cetirizine Tevagen should not be taken during pregnancy. Accidental use of the medicine should 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. A risk of adverse reactions in breastfed infants cannot be excluded. Therefore, you should not take Cetirizine Tevagen 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 dose.

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

Cetirizine Tevagen contains Lactose

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

Cetirizine Tevagen 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 Tevagen

Follow exactly the administration instructions of this medicine indicated 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 tablets can be divided into equal doses.

Instructions for use

If your treatment with Cetirizine Tevagen involves dividing the tablets, you should update as indicated below. Place the tablet on a hard, flat surface (e.g., on a board or plate) with the break line facing up. Then press briefly and firmly with your index fingers (or thumbs) on the edges to the right and left of the break line as shown in the graphic representation below.

Adults and adolescents over 12 years

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

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

Use in children

Children between 6 and 12 years

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

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

Patient with renal insufficiency

It is recommended that patients with moderate renal insufficiency take half a tablet (5 mg) once a day.

If you have severe kidney disease, consult your doctor or pharmacist so that they can adjust the dose.

If your children have kidney disease, contact your doctor or pharmacist to adjust the dose to your children's 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 what measures to take, if any are necessary.

After an overdose, the adverse effects described below may increase in intensity. Adverse effects such as feeling confused, 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 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 forgotten doses.

If you stop taking Cetirizine Tevagen

If you stop taking Cetirizine Tevagen, you may rarely have itching (intense itching) and/or urticaria (hives) again.

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

4. Possible side effects

Like all medicines, Cetirizine Tevagen can cause side effects, although not everybody gets them.

The following medicines 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 (severe allergic reaction that causes swelling of the face or throat)

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

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

• Somnolence (sleepiness)
• Dizziness, headache
• Pharyngitis (sore throat), rhinitis (runny, stuffy nose) (in children)
• Dry mouth, nausea, diarrhea
• Fatigue

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

• Agitation
• Paresthesia (abnormal sensation in the skin)
• Abdominal pain
• Itching, rash
• Asthenia (severe fatigue), malaise (feeling unwell)

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 (very 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)
• Tic (habitual spasm)
• Syncope (fainting), dyskinesia (involuntary movements), dystonia (prolonged abnormal muscle contractions), tremor, dysgeusia (altered taste)
• Blurred vision, disorders of visual accommodation (difficulty focusing), oculogyric crisis (uncontrolled circular movements of the eyes),
• Angioedema (severe allergic reaction that causes swelling of the face or throat), fixed drug eruption (allergy to the medicine)
• Abnormal urine elimination (bedwetting, pain or difficulty urinating)

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

• Increased appetite
• Suicidal thoughts (recurring thoughts or concern about suicide), nightmares
• Amnesia (memory loss), memory lapses
• Vertigo (feeling of rotation or movement)
• Urinary retention (inability to empty the bladder completely)
• Itching (intense itching) and/or urticaria after discontinuation
• Pain in the limbs, muscle pain
• Blistering rash
• Hepatitis (inflammation of the liver)

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 via the Spanish Medicines Surveillance System for Human Use website www.notificaram.es. By reporting side 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 carton and blister, after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Place the empty cartons and any remaining medicines in the SIGRE collection point at your pharmacy. If you have any further questions on how to dispose of the cartons and any remaining medicines, ask your pharmacist. This will help protect the environment.

6. Cetirizine Tevagen

Composition ofCetirizine Tevagen

• The active substance is cetirizine dihydrochloride.

Each film-coated tablet contains 10 mg of cetirizine dihydrochloride.

• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, titanium dioxide (E-171), hypromellose (E-464), and macrogol.

Appearance and pack contents

White to off-white, round, biconvex tablet with a break line on one side and a diameter of approximately 6.5 mm

PVC/PVDC Aluminum blisters

Cetirizine Tevagen is available in blisters of 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 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 and in the United Kingdom (Northern Ireland) under the following names:

Denmark: Cetiriva

France: CETIRIZINE TEVA SANTE 10 mg, film-coated tablet, divisible

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 last revision of thisleaflet: February 2025

“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/”