CETIRIZINE SAND "10 MG FILM-COATED TABLETS" 7 TABLETS IN PVC/ALU BLISTER"

Name
Cetirizine Sandoz 10 mg film-coated tablets
Cetirizine dihydrochloride


What is it and what is it for?
Cetirizine dihydrochloride is the active ingredient of Cetirizine Sandoz.
Cetirizine Sandoz is an antiallergic medicine.

In adults and children aged 6 years and above, Cetirizine Sandoz is indicated:
- for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis;
- for the treatment of chronic urticaria (chronic idiopathic urticaria).


What you need to know before taking the medicine
Do not take Cetirizine Sandoz
- if you have severe kidney disease (severe renal failure with creatinine clearance less than 10 ml/min);
- if you are allergic to cetirizine dihydrochloride, hydroxyzine, piperazine derivatives (closely related active substances of other medicines) or any of the other ingredients of this medicine (listed in section 6).


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

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

If you have problems urinating (such as spinal cord injury, prostatic hyperplasia, 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.

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

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 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 Cetirizine Sandoz concomitantly with alcohol.

Children
Do not give this medicine to children under 6 years of age because the tablet formulation does not allow for the necessary dose adjustment.


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

Stop taking Cetirizine Sandoz and seek medical help immediately if you experience symptoms such as:
• swelling of the mouth, face and/or throat
• difficulty breathing (chest tightness or wheezing)
• sudden drop in blood pressure resulting in fainting or shock.

Symptoms may include signs of an allergic reaction, anaphylactic shock, and angioedema. These reactions may begin immediately after taking the medicine or even after ingestion.
The following section contains additional side effects listed by frequency:

Common (may affect up to 1 in 10 people):
• fatigue
• dry mouth, nausea, diarrhea
• dizziness, headache
• drowsiness (sleep)
• pharyngitis (sore throat), rhinitis (cold-like nose symptoms)

Uncommon (may affect up to 1 in 100 people):
• agitation
• abdominal pain
• asthenia (extreme tiredness), feeling of weakness or general malaise
• paresthesia (abnormal sensitivity of the skin)
• pruritus (itchy skin), rash

Rare (may affect up to 1 in 1,000 people):
• tachycardia (rapid heartbeat)
• edema (swelling)
• alteration of liver function
• weight gain
• convulsions
• aggression, confusion, depression, hallucinations, insomnia
• hives (skin rash)

Very rare (may affect up to 1 in 10,000 people):
• thrombocytopenia (low number of platelets in the blood which causes bleeding or bruising more easily than normal)
• accommodation disorder (difficulty focusing), blurred vision, oculogyration (uncontrolled circular movements of the eyes)
• syncope, tremor, dysgeusia (altered taste), dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions)
• tic (habitual spasm)
• abnormal urine output (involuntary emptying of the bladder during sleep at night, pain and/or difficulty urinating)
• fixed drug eruption

Frequency not known (frequency cannot be estimated from the available data):
• memory loss, memory impairment
• increased appetite
• vertigo (sensation of rotation or movement)
• urinary retention (inability to completely empty the bladder)
• nightmares
• hepatitis (inflammation of the liver)
• joint pain
• skin rash with pus-containing blisters
• pruritus (intense itching) and/or hives after stopping
• suicidal ideation (recurrent thoughts of worry or suicide)

If you feel this way, stop taking the tablets and consult your doctor.

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.