IRIREOS ANT*OS GTT 10FL10MG1ML

IRIREOS ANTISTAMINICO 10 mg/ml oral drops, solution
Cetirizine dihydrochloride
Equivalent medicine

What it is and what it is used for
Cetirizine Dihydrochloride is the active ingredient in IRIREOS ANTISTAMINICO.
IRIREOS ANTISTAMINICO is an anti-allergic medicine.
In adults and adolescents from 12 years of age, IRIREOS ANTISTAMINICO 10 mg/ml oral drops, solution is indicated for:
• the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis;
• the treatment of urticaria.

What you need to know before taking the medicine
Do not take IRIREOS ANTISTAMINICO:
• if you have severe kidney disease requiring dialysis;
• 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
Talk to your doctor or pharmacist before taking IRIREOS ANTISTAMINICO.

If you are a patient with kidney failure, ask your doctor for advice; if necessary, you should take a lower dose. The new dose will be determined by your doctor.

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 ask your doctor for advice.

No clinically significant interactions have been observed between alcohol (at blood levels of 0.5 per mille (g/l) corresponding to a glass of wine) and cetirizine used at recommended doses. 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 the simultaneous intake of IRIREOS ANTISTAMINICO with alcohol.

If you need to have an allergy test, ask your doctor if you should stop taking IRIREOS ANTISTAMINICO for a few days before the test. This medicine can alter the results of the allergy test.

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 must stop taking the medicine and inform your doctor immediately 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 (need to sleep)
• Dizziness, headache
• Pharyngitis (sore throat), rhinitis (blocked nose, runny nose) (in children)
• Diarrhoea, 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 (feeling unwell)

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

Very rare side effects (may affect up to 1 in 10000 patients)
• Thrombocytopenia (low blood platelet count)
• Tics (habitual spasm)
• Syncope, dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions), tremor, dysgeusia (altered taste)
• Blurred vision, accommodation disorder (difficulty focusing)
• Oculogyric crisis (eyes with uncontrolled circular movements)
• Angioedema (severe allergic reaction causing swelling of the face or throat), fixed drug eruption (drug allergy)
• Abnormal urine elimination (involuntary emptying of the bladder during nocturnal sleep, 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 loss), memory impairment
• Vertigo (sensation of spinning or movement)
• Urinary retention (inability to completely empty the bladder)
• pruritus (intense itching) and/or urticaria following treatment discontinuation
• Arthralgia (joint pain), myalgia (muscle pain)
• Acute generalised exanthematous pustulosis (skin rash with pus-filled vesicles)
• Hepatitis (inflammation of the liver).