CETIRIZINE ZENT 10 MG FILM-COATED TABLETS 7 TABLETS IN PVC/PVDC/AL BLISTER

Name
Cetirizine Zentiva 10 mg film-coated tablets
Equivalent medicine


What is it and what is it used for?
Cetirizine dihydrochloride is the active ingredient of Cetirizine Zentiva.
Cetirizine Zentiva is an antiallergic medicine.
In adults and children aged 6 years and over, Cetirizine Zentiva is indicated for the relief of
- nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
- hives.


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


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

If you have kidney failure, consult your doctor; if necessary, you will need to take a lower dose. The new dose will be determined by your doctor.
If you have problems passing urine (in conditions such as spinal cord injury 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 seek medical advice.
No clinically significant interactions have been observed between alcohol (at blood levels of 0.5 per thousand corresponding to a glass of wine) and cetirizine used at the recommended doses.
However, there are no safety data available when high doses of cetirizine and alcohol are taken together. Therefore, as with all antihistamines, it is recommended to avoid taking Cetirizine Zentiva and alcohol together.

If you have scheduled allergy tests, ask your doctor if you should stop taking Cetirizine 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, Cetirizine Zentiva can cause side effects, although not everybody gets them.

The following side effects are rare or very rare, but you should stop taking the medicine and talk to your doctor immediately if you notice any of them.

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

These reactions may occur soon after you first take the medicine or may start later.

Common (may affect up to 1 in 10 people)
• Drowsiness (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 serious (very rare).
• Depression, hallucination, aggression, confusion, insomnia.
• Convulsions.
• Tachycardia (rapid heartbeat).
• Abnormal liver function.
• Hives.
• Edema (swelling).
• Weight gain.

Very rare (may affect up to 1 in 10,000 people)
• Thrombocytopenia (low levels of platelets in the blood).
• Tic (habitual spasm).
• Syncope, dyskinesia (involuntary movements), dystonia (prolonged abnormal muscle contractions), tremor, dysgeusia (altered taste).
• Blurred vision, accommodation disorder (difficulty focusing), oculogyric crisis (eyes with uncontrolled circular movements).
• Fixed drug eruption.
• Abnormal urine output (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 worries or thoughts).
• Nightmare.
• Amnesia, memory impairment.
• Vertigo (sensation of spinning or movement).
• Urinary retention (inability to completely empty the bladder).
• Itching (intense itching) and/or hives following discontinuation of treatment.
• Skin rash with pus-containing blisters.
• Joint pain.
• Hepatitis (inflammation of the liver).

Reporting of side effects
If you experience 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.