CETIRIZINE ZENT*7FC TAB 10MG

Cetirizina Zentiva 10 mg film-coated tablets
Equivalent medicine

What it is and what it is used for
Cetirizine dihydrochloride is the active ingredient of Cetirizina Zentiva.
Cetirizina Zentiva is an anti-allergic medicine.
In adults and children from 6 years of age, Cetirizina Zentiva is indicated to relieve
- nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
- urticaria.

What you need to know before taking the medicine
Do not take Cetirizina Zentiva if
- you have severe end-stage kidney disease (severe renal failure requiring dialysis);
- you are allergic to cetirizine dihydrochloride or any of the other ingredients of this medicine (listed in section 6) or to hydroxyzine or piperazine derivatives (active ingredients of other closely related medicines).

Warnings and precautions
Talk to your doctor or pharmacist before taking Cetirizina Zentiva.

If you are a patient with kidney failure, ask your doctor for advice; if necessary, you will need to take a lower dose. The new dose will be determined by your doctor.
If you have problems urinating (in conditions such as spinal cord injuries or prostate or bladder problems) ask your doctor for advice.
If you are an epileptic patient or a patient at risk of seizures, you should ask your doctor for advice.
No clinically significant interactions have been observed between alcohol (at blood levels of 0.5 per mille, corresponding to one glass of wine) and cetirizine used at recommended doses.
However, there are no data available on safety when high doses of cetirizine and alcohol are taken together. Therefore, as with all antihistamines, it is recommended to avoid the concomitant intake of Cetirizina Zentiva and alcohol.

If you have allergy tests scheduled, ask your doctor if you should stop taking Cetirizina Zentiva several days before the tests. This medicine may affect the test results.

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.

Possible side effects
Like all medicines, Cetirizina Zentiva 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 talk to your doctor immediately if you notice them.

• Allergic reactions, including anaphylactic shock (life-threatening severe allergic reaction) and angioedema (severe allergic reaction causing swelling of the face or throat).

These reactions may occur immediately after the first dose of the medicine or may start later.

Common (may affect up to 1 in 10 people)
• Somnolence (need to sleep).
• Dizziness, headache.
• Pharyngitis, rhinitis (in children).
• Diarrhea, nausea, dry mouth.
• Fatigue.

Uncommon (may affect up to 1 in 100 people)
• Agitation.
• Paresthesia (abnormal sensation on the skin).
• Abdominal pain.
• Pruritus (itchy skin), rash.
• Asthenia (extreme fatigue), malaise.

Rare (may affect up to 1 in 1,000 people)
• Allergic reactions, some severe (very rare).
• Depression, hallucination, aggression, confusion, insomnia.
• Convulsions.
• Tachycardia (accelerated heartbeat).
• Abnormal liver function.
• Urticaria.
• Edema (swelling).
• Weight gain.

Very rare (may affect up to 1 in 10,000 people)
• Thrombocytopenia (low blood platelet levels).
• Tic (habitual spasm).
• Syncope, dyskinesia (involuntary movements), dystonia (prolonged abnormal muscle contractions), tremor, dysgeusia (taste alteration).
• Blurred vision, accommodation disorder (difficulty focusing), oculogyric crisis (eyes with uncontrolled circular movements).
• Fixed drug eruption.
• Abnormal urine elimination (involuntary emptying of the bladder during sleep, pain and/or difficulty urinating).

Not known (frequency cannot be estimated from the available data)
• Increased appetite.
• Suicidal ideation (recurrent suicidal concerns or thoughts).
• Nightmare.
• Amnesia, memory impairment.
• Vertigo (sensation of spinning or movement).
• Urinary retention (inability to completely empty the bladder).
• Pruritus (intense itching) and/or urticaria following discontinuation of treatment.
• Rash with pus-filled vesicles.
• Joint pain.
• Hepatitis (inflammation of the liver).

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.