Alerin

ALERIN is a white or pale yellow, oval-shaped, film-coated tablet, engraved on one side with letter "K" and on the other side with letter "V".
The active substance is Levocetirizine Hydrochloride.
Each film-coated tablet contains 5 mg Levocetirizine Hydrochloride.
Excipients/Inactive Ingredients: The other ingredients are Microcrystalline Cellulose, Lactose Monohydrate, Colloidal Silicon Dioxide, Carboxymethylcellulose Calcium, Magnesium Stearate, Hypromellose, Polyethylene Glycol 400 & Titanium Oxide.

Levocetirizine hydrochloride is the active ingredient of ALERIN.
ALERIN is an antiallergic medication for adults and children aged 6 years and above.
For the treatment of signs of illness (symptoms) associated with: allergic rhinitis (including persistent allergic rhinitis); nettle rash (urticaria).

Always take this medicine exactly as prescribed. Patients must be advised to check with the doctor or pharmacist if they are not sure.
For oral use. 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 the doctor.
Patients who have a severe kidney disease requiring dialysis must not take ALERIN.
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 the 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: ALERIN is not recommended for children under 6 years of age.
How and when to take ALERIN: For oral use only.
ALERIN tablets should be swallowed whole with water and may be taken with or without food.
How long to take ALERIN: The duration of use depends on the type, duration and course of the complaints and is determined by the physician.
Forgotten intake of ALERIN: If the patient forgets to take ALERIN, or a dose lower than that prescribed by the doctor is taken, a double dose should not be taken to make up for a forgotten dose. The next dose should be taken at the normal time.
Stopping intake of ALERIN: Stopping treatment should have no negative effects. However, rarely pruritus (intense itching) may occur if the patient stops taking ALERIN, 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.
Patients must be advised if they have any further questions on the use of this medicine.

If the patient takes more ALERIN than they should, somnolence can occur in adults. Children may initially show excitation and restlessness followed by somnolence.
If the patient thinks they have taken an overdose of ALERIN, they must be advised to inform the doctor who will then decide what action should be taken.

ALERIN should not be taken: if the patient is allergic to levocetirizine hydrochloride, to cetirizine, to hydroxyzine or any of the other ingredients of this medicine (listed in Description); if the patient has a severe kidney disease requiring dialysis.

Patients must be advised to inform the doctor or pharmacist before taking ALERIN.
If the patient is likely to be unable to empty the bladder (with conditions such as spinal cord injury or enlarged prostate), the patient must be advised by the doctor.
If the patient suffers from epilepsy or is at risk of convulsions, the patient must be advised by the doctor as use of ALERIN may cause seizure aggravation.
If the patient is scheduled for allergy testing, advise the patient to ask the doctor if they should stop taking ALERIN for several days before testing. This medicine may affect the allergy test results.
ALERIN contains lactose: If the patient has been told by the doctor that they have an intolerance to some sugars, advise the patient to contact the doctor before taking this medicinal product.
Driving and using machines: Some patients being treated with ALERIN may experience somnolence/drowsiness, tiredness and exhaustion. Use caution when driving or operating machinery until the patient knows how this medicine affects them. 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.
Use in Children: The use of ALERIN is not recommended in children less than 6 years since the film-coated tablets do not allow for dose adaptation.

If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, she must be advised by the doctor or pharmacist before taking this medicine.

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, the patient must be advised to stop taking ALERIN and inform the 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.
Reporting of side effects: If the patient gets any side effects, advise the patient to talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph. Reporting side effects can help provide more information on the safety of this medicine.

Patients must be advised to inform the doctor or pharmacist if they are taking, have recently taken or might take any other medicines.
ALERIN with food, drink and alcohol: Caution is advised if ALERIN is taken at the same time as alcohol or other agents acting on the brain.
In sensitive patients, the concurrent administration of ALERIN and alcohol or other agents acting on the brain may cause additional reductions in alertness and impairment of performance.
ALERIN can be taken with or without food.

Store below 30°C.

Antihistamines & Antiallergics

R06AE09 - levocetirizine ; Belongs to the class of piperazine derivatives used as systemic antihistamines.

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