Levocetirizine dihydrochloride is the active ingredient of Allercet Tablets.
Allercet Tablet is an antiallergic medication.
For the treatment of signs of illness (symptoms) associated with:
• allergic rhinitis (including persistent allergic rhinitis);
• nettle rash (urticaria).

• if you are allergic to levocetirizine dihydrochloride, to cetirizine, to
hydroxyzine or any of the other ingredients of this medicine (listed in
section 6)
• if you have a severe impairment of kidney function (severe renal failure with
creatinine clearance below 10 ml/min)
Warnings and Precautions
Talk to your doctor or pharmacist before taking Allercet Tablets.
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 Allercet Tablets may cause seizure aggravation.
If you are scheduled for allergy testing, ask your doctor if you should stop taking
Allercet Tablets for several days before testing. This medicine may affect your
allergy test results.
Children
The use of Allercet Tablets are not recommended in children less than 6 years
since the film-coated tablets do not allow for dose adaptation.
Other medicines and Allercet Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Allercet Tablets with food, drink and alcohol
Caution is advised if Allercet Tablets are taken at the same time as alcohol or
other agents acting on the brain.
In sensitive patients, the concurrent administration of Allercet Tablets and
alcohol or other agents acting on the brain may cause additional reductions in
alertness and impairment of performance.
Allercet Tablets can be taken with or without food.
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.

Driving and using machines
Some patients being treated with Levocetirizine dihydrochloride 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.
Allercet Tablets contain lactose
These tablets contain lactose, if you have been told by your doctor that you
have an intolerance to some sugars you should contact your doctor before
taking them.

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 Allercet
Tablets.
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
Allercet Tablets are not recommended for children under 6 years of age.
How and when should you take Allercet Tablets?
For oral use only.
Allercet Tablets should be swallowed whole with water and may be taken with
or without food.
How long should you take Allercet Tablets?
The duration of use depends on the type, duration and course of your
complaints and is determined by your physician.
If you take more Allercet Tablets than you should
If you take more Allercet Tablets 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 Allercet Tablets, please tell your doctor who will then decide what action should be taken.
If you forget to take Allercet Tablets
If you forget to take Allercet Tablets, 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 Allercet Tablets
Stopping treatment should have no negative effects. However, rarely pruritus
(intense itching) may occur if you stop taking Levocetirizine dihydrochloride
Tablets, 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.

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,
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, 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 Levocetirizine
dihydrochloride 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.
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
To report any side effect(s):
• Saudi Arabia:

- The National Pharmacovigilance and Drug Safety Centre (NPC)
o Fax: +966-11-205-7662
o Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
o Toll free phone: 8002490000
o E-mail: npc.drug@sfda.gov.sa
o Website: www.sfda.gov.sa/npc
• Other GCC States:
Please contact the relevant competent authority.

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the label
and carton after “EXP”. The expiry date refers to the last day of that month.
• This medicinal product does not require any special storage conditions.
• Store below 30°C.
• Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines.