CETIRIZINE EG*7FC TABS 10MG

CETIRIZINA EG 10 mg film-coated tablets

Equivalent medicine

What it is and what it is used for
Cetirizine dihydrochloride is the active ingredient of CETIRIZINA EG.
CETIRIZINA EG is an anti-allergic drug.

In adults and children from 6 years of age, CETIRIZINA EG 10 mg film-coated tablets is 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 CETIRIZINA EG
- if you have severe kidney disease (severe renal insufficiency 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 (active ingredients of other closely related medicines).

Warnings and precautions
If you are a patient with renal insufficiency, ask your doctor for advice; if necessary, you should take a lower dose. The new dose will be defined by your doctor.

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

If you are an epileptic patient or a patient at risk of seizures, you should ask your doctor for advice.

No clinically significant interactions between alcohol (at blood levels of 0.5 per mille (g/l) corresponding to a glass of wine) and cetirizine used at recommended doses have been observed. However, there are no data available on safety when higher doses of cetirizine and alcohol are taken simultaneously.
Therefore, as with all antihistamines, it is recommended to avoid simultaneous intake of CETIRIZINA EG with alcohol.

If you need to have an allergy test, ask your doctor if you should stop taking CETIRIZINA EG for a few days before the test. This medicine may alter 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 the necessary dose adjustments.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.

The following side effects are rare or very rare. However, you must stop taking the medicine and immediately inform your doctor if you notice the appearance of:
- Allergic reactions, including severe reactions and angioedema (severe allergic reaction causing swelling of the face or throat).
These reactions can 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 sensitivity)
- Abdominal pain
- Pruritus (itchy skin), rash
- Asthenia (extreme fatigue), malaise

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

Very rare side effects (may affect up to 1 in 10000 patients)
- Thrombocytopenia (low platelet count in the blood)
- Tic (habitual spasm)
- Syncope, dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions), tremor, dysgeusia (alteration of taste)
- Blurred vision, accommodation disorder (difficulty focusing), oculorotation (uncontrolled circular eye movements)
- Angioedema (severe allergic reaction causing swelling of the face or throat), fixed drug eruption
- Abnormal urine elimination (involuntary emptying of the bladder during nocturnal sleep, pain and/or difficulty urinating).

Side effects with unknown frequency (frequency cannot be defined based on available data)
- Increased appetite
- Suicidal ideation (recurrent suicidal worries or thoughts), nightmare
- Amnesia, memory impairment
- Dizziness (sensation of rotation or movement)
- Urinary retention (inability to completely empty the bladder)
- Pruritus (intense itching) and/or urticaria following treatment discontinuation
- Joint pain
- Skin rash with pus-filled vesicles
- Hepatitis (inflammation of the liver)

Reporting of side effects
If you get any side effects, including those 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.