CETIRIZINE MY*7FC TAB 10MG

Cetirizina Mylan Generics 10 mg film-coated tablets
Cetirizine dihydrochloride
Equivalent medicinal product

What it is and what it is used for
Cetirizine dihydrochloride is the active ingredient in Cetirizina Mylan Generics.
Cetirizina Mylan Generics is an anti-allergic medicine.

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

What you need to know before taking the medicine
Do not take Cetirizina Mylan Generics
- if you have severe kidney disease;
- 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
Talk to your doctor or pharmacist before taking Cetirizina Mylan Generics:
- if you have kidney problems, you may need to take a lower dose. The new dose will be determined by your doctor;
- if you have problems urinating (such as spinal, prostate or bladder problems), consult your doctor;
- if you are an epileptic patient or a patient at risk of seizures.

Skin test
If you need to have an allergy skin test, tell your doctor that you are taking the tablets, as this medicine may affect the results of the skin test. You should stop treatment three days before the 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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Some side effects can be serious:
Very rare (may affect up to 1 in 10,000 people)
• sudden signs of allergy, such as rash, itching or hives on the skin, swelling of the face, lips, tongue or throat or other parts of the body, shortness of breath, wheezing or difficulty breathing

Not known (frequency cannot be estimated from the available data)
• Suicidal thoughts
• Inability to urinate
• Inability to completely empty the bladder

If any of these effects listed above occur, you must stop taking this medicine and tell your doctor immediately.
Other possible side effects

Common (may affect up to 1 in 10 people)
• Tiredness
• Dry mouth
• Feeling unwell
• Dizziness
• Headache
• Drowsiness
• Sore throat and difficulty swallowing

Uncommon (may affect up to 1 in 100 people)
• Weakness
• General feeling of being unwell
• Tingling or numbness of the hands or feet
• Agitation
• Itching
• Rash
• Diarrhoea
• Stomach ache

Rare (may affect up to 1 in 1,000 people)
• Accelerated heartbeat
• Abnormal liver function tests
• Weight gain
• Seizures
• Aggression
• Confusion
• Depression
• Seeing, hearing or perceiving things that do not exist
• Difficulty sleeping
• Hypersensitivity (usually occurs with skin reactions such as rashes, red and itchy skin)
• Hives
• Swelling, fluid retention (oedema)

Very rare (may affect up to 1 in 10,000 people)
• Bleeding or bruising more easily than normal
• Tics (habitual spasm)
• Blurred vision, eyes with uncontrolled circular movements
• Accommodation disorder (difficulty focusing)
• Fainting
• Tremor
• Taste disturbances or loss
• Uncontrolled body movements
• Involuntary muscle contractions
• Difficult, painful or involuntary urination

Not known (frequency cannot be estimated from the available data)
• Memory loss
• Memory impairment
• Increased appetite
• Vertigo (spinning sensation), nightmare
• Itching (intense itching) and/or hives following discontinuation of treatment
• Arthralgia (joint pain), myalgia (muscle pain)
• Acute generalised exanthematous pustulosis (skin rash with pus-containing vesicles)
• Hepatitis (inflammation of the liver)

Side effects in children and adolescents
In children and adolescents, the following side effects occur more commonly and may affect up to 1 in 10 people:
• Runny or blocked nose
• Diarrhoea

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.