It is used to treat symptoms

associated with allergic conditions, such as:

• hay fever
• year round allergies such as dust or pet allergies
• chronic allergic rhinitis (including persistent allergic rhinitis)
• nettle rash (urticaria)

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The tablet should be swallowed whole with water and may be taken with or without food.

The recommended dose for adults and children aged 6 years and over is one tablet daily. Levocetirizine tablets are not recommended for children under 6 years of age.

Special dosage instructions for specific populations:

If you suffer from mild to moderate kidney failure, your doctor may prescribe a lower dose according to the severity of your kidney disease. Patients who only have impaired liver function should take the usual prescribed dose.

Patients who have both impaired liver and kidney function may be given a lower dose depending on the severity of the kidney disease. No change of the dose is necessary in elderly, provided their kidney function is normal.

Use in children and adolescents

Levocetirizine tablets are not recommended in children less than 6 years since the tablets cannot be broken to provide the correct dose.

For children aged 2 to 6 years it is recommended to use a formulation of levocetirizine designed for children.

In children suffering from decreased kidney function the dose will be chosen on the basis of kidney function and body weight; the dose will be determined by your doctor.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Other medicines may be affected by levocetirizine. They, in turn, may affect how well levocetirizine works.

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

Tell your doctor immediately or contact the casualty department at your nearest hospital, if you get the following serious side effects:

Not known (frequency cannot be estimated from the available data)

• Allergic reaction like swelling of the mouth, face and/or throat or swallowing difficulties together with hives (angioedema), breathing difficulties or a sudden fall in blood pressure leading to collapse or shock, which may be fatal.
• Seizures
• Recurring thoughts of, or preoccupation with, suicide

Other possible side effects:

Common (may affect up to 1 in 10 people):

• Dry mouth
• Headache
• Tiredness
• Somnolence/downiness

Uncommon (may affect up to 1 in 100 people):

• Exhaustion
• Abdominal pain

Not known (frequency cannot be estimated from the available data):

• Aggression
• Agitation
• Visual disturbances
• Palpitations
• Nausea
• Diarrhoea
• Inflammation of the liver
• Pruritus (itchiness)
• Rash
• Hives
• Muscle pain
• Joint pain
• Weight increase
• Abnormal liver function tests
• Increased heart rate
• Pins and needles
• Dizziness
• Fainting
• Tremor
• Dysgeusia (distortion of the sense of taste)
• Blurred vision

Additional side effects (in children)

Common (may affect up to 1 in 10 people):

• Diarrhoea
• Constipation
• Difficulty in sleeping

Do not take Levocetirizine if you are:

• if you are allergic to levocetirizine or to other antihistamines (eg. Cetirizine hydroxyzine)
• if you suffer from severe kidney failure (severe renal failure with creatinine clearance below 10ml/min)

Warnings and precautions:

Talk to your doctor or pharmacist before taking Levocetirizine Tablets

If you are likely to be unable to be unable to empty your bladder (due to conditions such as a spinal cord injury or enlarged prostate), please ask your doctor for advice.

Levocetirizine dihydrochloride with alcohol

You should be cautious if you take levocetirizine at the same time as alcohol as it may cause a reduction in alertness and affect your performance.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy: Your doctor may advice you to take levocetirizine during pregnancy, if necessary.

Breast-feeding: Levocetirizine is not recommended for use while breast-feeding as it may pass into your breast milk. Do not take this medicine if you are breastfeeding, unless advised by your doctor.