1. What Levar is and what it is used for
Levocetirizine dihydrochloride is the
active ingredient of Levar.
Levar is an antiallergic medication.
For the treatment of signs of illness
(symptoms) associated with:
• allergic rhinitis (including persistent
allergic rhinitis);
• nettle rash (urticaria).

2. Before you take Levar

a. Do not take Levar

- if you are allergic to levocetirizine dihydrochloride, to cetirizine, to hydroxyzine or any of the other ingredients of this medicine.

- if you have a severe impairment of kidney function (severe renal failure with creatinine clearance below 10 ml/min).

b. Warning and Precautions

Talk to your doctor or pharmacist before taking Levar.

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

- If you suffer from epilepsy or are at risk of convulsions, please ask your doctor for advice as use of Levar may cause seizure aggravation.

- If you are scheduled for allergy testing, ask your doctor if you should stop taking Levar for several days before testing. This medicine may affect your allergy test results.

Children

The use of Levar is not recommended in children less than 6 years since the film-coated tablets do not allow for dose adaptation.

c. Taking other medicines,

herbal or dietary supplements

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

d. Taking with food, drink and

alcohol

Caution is advised if Levar is taken at the same time as alcohol or other

agents acting on the brain.
In sensitive patients, the concurrent administration of Levar and alcohol or other agents acting on the brain may cause additional reductions in alertness and impairment of

performance.

Levar can be taken with or without food.

e. Pregnancy, breast-feeding

and fertility

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.

f. Driving and using machines

Some patients being treated with Levar may experience somnolence / drowsiness, tiredness and exhaustion.

Use caution when driving or operating machinery untill you know how this medicine affects you. However, special tests have revealed no impairment of mental alertness, the ability to react or the ability to drive in healthy test persons after taking levocetirizine in the recommended dosage.

Levar contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Levar

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 recommended dose for adults and children aged 6 years and over is one tablet daily.

Special dosage instructions

for specific populations:

Renal and hepatic impairment Patients with impaired kidney function may be given a lower dose according to the severity of their kidney disease, and in children the dose will also be chosen on the basis of body weight; the dose will be determined by your doctor. Patients who have severe impairment of kidney function must not take Levar. 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, and in children the dose will also be chosen on the basis of body weight; the dose will be

determined by your doctor. Elderly patients aged 65 years and above No adaptation of the dose is necessary in elderly patients, provided their renal function is normal.

Use in children

Levar is not recommended for children under 6 years of age.

How and when should you

take Levar?

For oral use only.

Levar tablets should be swallowed whole with water and may be taken with or without food.

How long should you take Levar?

The duration of use depends on the type, duration and course of your complaints and is determined by your physician.

If you take more Levar than

you should

If you take more Levar than you should, somnolence can occur in adults. Children may initially show excitation and restlessness followed by somnolence.

If you think you have taken an overdose of Levar, please tell your doctor who will then decide what action should be taken.

If you forget to take Levar

If you forget to take Levar, or if you take a dose lower than that prescribed by your doctor, do not take a double dose to make up for a forgotten dose. Take your next dose at your normal time.

If you stop taking Levar

Stopping treatment should have no negative effects. However, rarely pruritus (intense itching) may occur if you stop taking Levar, even if those symptoms were not present before treatment initiation. The symptoms may resolve spontaneously. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.Possible side effects

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

Common: may affect up to 1 in 10 people Dry mouth, headache, tiredness and somnolence/drowsiness Uncommon: may affect up to 1 in 100 people Exhaustion and abdominal pain Not known: frequency cannot be estimated from the available data

Other side effects such as palpitations, increased heart rate, fits, pins and needles, dizziness, syncope, tremor, dysgeusia (distortion of the sense of taste), sensation of rotation or movement, visual disturbances, blurred vision, oculogyration (eyes having uncontrolled circular movements), painful or difficult urination, inability to completely empty the bladder, oedema, pruritus (itchiness), rash, urticaria (swelling, redness and itchiness of the skin), skin eruption, shortness of breath, weight increase, muscular pain, joint pain, aggressive or agitated behaviour, hallucination, depression, insomnia, recurring thoughts of or preoccupation with suicide, nightmare, hepatitis, abnormal liver function, vomiting, increased appetite, nausea and diarrhoea have also been reported. Pruritus (intense itching) upon discontinuation.
At the first signs of a hypersensitivity reaction, stop taking Levar and tell your doctor. Hypersensitivity reaction symptoms may include: swelling of the mouth, tongue, face and/or throat, breathing or swallowing difficulties (chest tightness or wheezing), hives, sudden fall in blood pressure leading to collapse or shock, which may be fatal.

To report any side effect(s):

Saudi Arabia:

National Pharmacovigilance and Drug Safety Center (NPC)

Fax: +966-11-205-7662

SFDA call center 19999

Toll free phone: 8002490000

Email: npc.drug@sfda.gov.sa

Website: www.sfda.gov.sa/npc

Other GCC States:

Please contact the relevant competent authority.

5. How to store Levar

-Keep this medicine out of the sight and reach of children.

Store below 30°C.

-Do not use Levar after the expiry date, which is stated on the label or carton after EXP.

-The expiry date refers to the last day of the month.

-This medicine does not require any special storage conditions.

-Do not throw away any medicine via wastewater or household waste.
Ask your pharmacist how to throw away any medicines you no longer use. These measures will help to protect the environment.