CETIRIZINE EG 10 MG FILM-COATED TABLETS 7 DIVISIBLE TABLETS IN PVC-AL BLISTER

Name
CETIRIZINE EG 10 mg film-coated tablets

Equivalent medicine


What is it and what is it for?
Cetirizine dihydrochloride is the active ingredient of CETIRIZINA EG.
CETIRIZINE EG is an antiallergic drug.

In adults and children aged 6 years and above, CETIRIZINA EG 10 mg film-coated tablets are indicated:
- for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis;
- for the treatment of urticaria.


What you need to know before taking the medicine
Do not take CETIRIZINE EG
- if you have severe kidney disease (severe renal failure with creatinine clearance less than 10 ml/min);
- 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 (closely related active ingredients of other medicines).


Warnings and precautions
If you have kidney failure, ask your doctor for advice; if necessary, you should take a lower dose. Your doctor will determine the new dose.

Ask your doctor for advice if you have problems urinating (in conditions such as spinal cord injury or bladder or prostate problems).

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 (g/l) corresponding to one glass of wine) and cetirizine used at the recommended doses. However, no safety data are available when higher doses of cetirizine and alcohol are taken concomitantly.
Therefore, as with all antihistamines, it is recommended to avoid taking CETIRIZINA EG together with alcohol.

If you need to have an allergy test, ask your doctor if you should stop taking Cetirizine EG for a few days before the test. This medicine may affect the results of the allergy test.

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, this medicine can cause side effects, although not everybody gets them.

The following side effects are rare or very rare. However, you should stop taking the medicine and inform your doctor immediately if you notice any of the following:
- Allergic reactions, including serious reactions and angioedema (serious allergic reaction causing swelling of the face or throat).
These reactions may occur immediately after taking the medicine or later.
Common side effects (may affect up to 1 in 10 patients)
- Drowsiness
- Dizziness, headache
- Pharyngitis, rhinitis (in children)
- Diarrhea, nausea, dry mouth
- Fatigue

Uncommon side effects (may affect up to 1 in 100 patients)
- Agitation
- Paresthesia (abnormal skin sensation)
- Abdominal pain
- Pruritus (itchy skin), rash
- Asthenia (extreme fatigue), malaise

Rare side effects (may affect up to 1 in 1000 patients)
- Allergic reactions, some serious (very rare)
- Depression, hallucinations, aggression, confusion, insomnia
- Convulsions
- Tachycardia (rapid heartbeat)
- Abnormal liver function
- Hives
- Edema (swelling)
- Weight gain

Very rare side effects (may affect up to 1 in 10,000 patients)
- Thrombocytopenia (low level of platelets in the blood)
- Tic (habitual spasm)
- Syncope, dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions), tremor, dysgeusia (altered taste)
- Blurred vision, accommodation disorder (difficulty focusing), ocurotatory (eyes with uncontrolled circular movements)
- Angioedema (serious allergic reaction causing swelling of the face or throat), fixed drug eruption
- Abnormal urine output (involuntary emptying of the bladder during sleep at night, pain and/or difficulty urinating).

Side effects with unknown frequency (frequency cannot be estimated from the available data)
- Increased appetite
- Suicidal ideation (recurrent suicidal worries or thoughts), nightmare
- Amnesia, memory impairment
- Vertigo (sensation of rotation or movement)
- Urinary retention (inability to completely empty the bladder)
- Itching (intense itching) and/or hives following discontinuation of treatment
- Joint pain
- Skin rash with pus-containing blisters
- 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.