Levocetirizine dihydrochloride is the active ingredient of Allertec.

Allertec is an antiallergic mediation.

For the treatment of signs of illness (symptoms) associated with:

-             allergic rhinitis (including persistent allergic rhinitis);

-             nettle rash (urticaria).

Do not take Allertec

-             if you are allergic (hypersensitive) to levocetirizine dihydrochloride, to cetririzone, to hydroxyzine or to any of the other ingredients of Allertec (see ‘What Allertec contains’),

-             if you have a severe kidney disease requiring dialysis

Warnings and precautions

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

Allertec may cause seizure aggravation.

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

Children

The use of Allertec is not recommended for children under 6 years since the film‑coated tablets do not allow dose adaptation.

Other medicines and Allertec

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

Allertec with food, drink and alcohol

Caution is advised if Allertec is taken at the same time as alcohol or other agents acting on the brain.

In sensitive patients, the concurrent use of Allertec and alcohol or other agents acting on the brain may have cause additional reductions in alertness and impairment of performance.

Allertec can be taken with or without food.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

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 Allertec may experience somnolence/drowsiness, tiredness and exhaustion. Use caution when driving or operating machinery until 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.

Allertec 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.

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 usual dose for adults and adolescents 12 years of age and above is one tablet daily.

Renal and hepatic impairment

Patients with impaired kidney function may be given a lower dose, according to the severity of their 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 a severe kidney disease requiring dialysis must not take Allertec.

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

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

How and when should you take Allertec?

For oral use only.

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

How long should you take Allertec?

The duration of use depends on the type, duration and course of your complaints and is determined by your physician. You should talk to your doctor if you do not feel better or if you feel worse despite taking Allertec film-coated tablets.

If you take more Allertec than you should

A substantial overdose may cause somnolence in adults.

Children may initially show excitation and restlessness followed by somnolence.

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

If you forget to take use Allertec

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

If you stop taking Allertec

Stopping treatment should have no negative effects. However, rarely pruritus (intense itching) may occur if you stop taking Allertec, 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 mecicine, ask your doctor or pharmacist.

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

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

Dry mouth, headache, tiredness and somnolence/drowsiness

Uncommon side effects (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 Allertec and see your doctor immediately. 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 packaging after EXP. The expiry date refers to the last day of that month.

Store below 30°C. Store in the original package.

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