Prospecto: information for the user

Cetirizina Tevagen 10 mg film-coated tabletsEFG

Cetirizine dihydrochloride

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, 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 do not appear in this prospect. See section 4.

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

2.What you need to know before starting to take Cetirizina Tevagen

3.How to take Cetirizina Tevagen

4.Possible adverse effects

5.Storage of Cetirizina Tevagen

6.Contents of the package and additional information

Cetirizine dihydrochloride is the active ingredient of Cetirizina Tevagen. Cetirizina Tevagen is an antihistamine.

In adults and children 6 years of age and older, Cetirizina Tevagen is indicated for:

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

Do not take Cetirizina Tevagen

• If you have a severe kidney disease (severe renal insufficiency with a creatinine clearance below 10ml/min),
• If you are allergic to cetirizine dihydrochloride or to any of the other components of this medication (including in section 6),to hydroxyzine or to piperazine derivatives (active principles of other closely related drugs),
• Si tiene una enfermedad renal grave (insuficiencia renal grave con aclaramiento de creatinina por debajo de 10 ml/min).

Warnings and precautions

Consult your doctor or pharmacist before taking Cetirizina 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 transient 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 seizures, 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 the cetirizine used at the recommended doses.

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

If you are planning to undergo allergy tests, consult your doctor if you should stop taking Cetirizina Tevagen several days before the test. This medication may alter the results of allergy tests.

Children

Do not administer this medication to children under 6 years old because the tablet formulation does not allow for the necessary dose adjustments.

Taking Cetirizina Tevagen with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Taking Cetirizina Tevagen with food

Food does not affect the absorption of cetirizine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Cetirizina Tevagen should not be taken by pregnant women. An accidental use of the medication should not cause any harmful effects on the fetus. However, this medication should only be administered if necessary and after medical advice.

Cetirizine passes into breast milk. A risk of adverse reactions in infants cannot be ruled out. Therefore, do not take Cetirizina Tevagen during breastfeeding unless your doctor advises otherwise.

Driving and operating machinery

In clinical studies, there was no clinical evidence of decreased attention, alertness, and ability to drive after taking cetirizine dihydrochloride at the recommended dose.

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

Cetirizina Tevagen contains Lactose

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Cetirizina Tevagen contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.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 Cetirizina Tevagen involves dividing the tablets, you should update as indicated below. Place the tablet on a hard, flat surface (for example, on a table or plate) with the fracture line facing upwards. Then press with your index fingers (or thumbs) simultaneously briefly and firmly on the edges to the right and left of the fracture line as shown in the graphical representation below.

Adults and adolescents over 12 years old

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 old

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.

Patients with renal insufficiency

Patients with moderate renal insufficiency are recommended to take half a tablet (5 mg) once a day.

If you have severe kidney disease, consult your doctor or pharmacist to adjust your dose.

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 Cetirizina Tevagen is too weak or too strong, contact your doctor.

Treatment duration

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 Tevagen than you should

If you think you have taken an overdose of Cetirizina Tevagen, inform your doctor. Your doctor will decide what measures to take, if necessary.

After an overdose, the adverse effects described below may increase in intensity. Adverse effects such as feeling confused, diarrhea, dizziness, fatigue, headache, weakness, dilated pupils, itching, restlessness, sedation, drowsiness, stupor, rapid heartbeat, tremors, and urinary retention.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Cetirizina Tevagen

Do not take a double dose to compensate for the missed doses.

If you interrupt the Cetirizina Tevagen treatment

If you stop taking Cetirizina Tevagen, you may occasionally experience intense itching and/or urticaria again.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Cetirizina Tevagen can cause side effects, although not everyone will experience 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 (serious allergic reaction that causes swelling of the face or throat)

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

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

• Drowsiness (sleep)
• Dizziness, headache
• Pharyngitis, rhinitis (in children)
• Dry mouth, nausea, diarrhea
• Fatigue

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

• Restlessness
• Paresthesia (abnormal sensation in the skin)
• Abdominal pain
• Pruritus, rash
• Asthenia (intense fatigue), general 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 (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 blood)
• Tic (habitual spasm)
• Syncope, dyskinesia (involuntary movements), dystonia (prolonged abnormal muscle contractions), tremor, dysgeusia (alteration of taste)
• Blurred vision, visual accommodation disorders (difficulty focusing), oculogyric crisis (uncontrolled circular eye movements),
• Angioedema (serious allergic reaction that causes swelling of the face or throat), fixed drug eruption
• Abnormal urination (bedwetting, pain or difficulty urinating)

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

• Increased appetite
• Suicidal thoughts (recurring thoughts or concern about suicide), nightmares
• Amnesia, memory lapses
• Dizziness (sensation of rotation or movement)
• Urinary retention (inability to completely empty the bladder)
• Pruritus (intense itching) and/or urticaria after discontinuation
• Extremity pain
• Blistering rash with pus
• Hepatitis (inflammation of the liver)

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use websitewww.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not useCetirizina Tevagenafter the expiration date that appears on the packaging and blister, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines that you no longer need at the SIGRE pointof the pharmacy. In case of doubt, please ask your pharmacist how to dispose of the packaging and medicines that you no longer need. By doing so, you will help protect the environment.

Composition ofCetirizina Tevagen

• The active ingredient is cetirizine dihydrochloride.

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

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

Appearance of the product and contents of the package

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

PVC/PVDC Aluminum Blister

Cetirizina Tevagen is available in blister packs with 7, 14, 15, 20, 28, 30, 50 and 100 tablets.

Not all package sizes may be marketed.

Holder of the Marketing Authorization and Responsible for Manufacturing:

Holder of the marketing authorization:

Teva Pharma S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B 1st floor

28108 Alcobendas Madrid

Manufacturing Responsible:

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 - Blaubeuren (Germany)

This medicine is authorized in the member states of the European Economic Area with 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:Cetirizine 10 mg Film-Coated Tablets

Last review date of thisleaflet: March 2021

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/ ”