Patient Leaflet Updated 23-Jun-2023 | Glenmark Pharmaceuticals Europe Ltd
Levocetirizine 5 mg film-coated tablets
Levocetirizine 5 mg Film-coated Tablets
Levocetirizine dihydrochloride
For adults and children aged 6 years and above
1. What Levocetirizine 5 mg film-coated tablets are and what they are used for
2. What you need to know before you take Levocetirizine 5 mg film-coated tablets
3. How to take Levocetirizine 5 mg film-coated tablets
4. Possible side effects
5. How to store Levocetirizine 5 mg film-coated tablets
6. Contents of the pack and other information
Levocetirizine dihydrochloride is the active ingredient of Levocetirizine 5 mg film-coated tablets.
Levocetirizine is an antiallergic medication. For the treatment of signs of illness (symptoms) associated with:
Talk to your doctor or pharmacist before taking Levocetirizine 5 mg film-coated 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 Levocetirizine 5mg film-coated tablets may cause seizure aggravation.
If you are scheduled for allergy testing, ask your doctor if you should stop taking Levocetirizine 5mg film-coated tablets for several days before testing. This medicine may affect your allergy test results.
The use of Levocetirizine is not recommended in children less than 6 years since the film-coated tablets do not allow for dose adaptation.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Caution is advised if Levocetirizine 5 mg Film-coated Tablets is taken at the same time as alcohol or other agents acting on the brain.
In sensitive patients, the concurrent administration of Levocetirizine 5mg film-coated tablets and alcohol or other agents acting on the brain may cause additional reductions in alertness and impairment of performance.
Levocetirizine 5mg Film-coated tablets can be taken with or without food.
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.
Some patients being treated with Levocetirizine 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.
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 recommended dose for adults and children aged 6 years and over is one tablet daily. Children under 6 years of age should not take this medicine.
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 a severe kidney disease requiring dialysis must not take Levocetirizine 5mg film-coated 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
No adaptation of the dose is necessary in elderly patients, provided their renal function is normal.
Levocetirizine 5mg Film-coated tablets is not recommended for children under 6 years of age.
For oral use only
Levocetirizine 5mg film-coated tablets should be swallowed whole with water and may be taken with or without food.
The duration of use depends on the type, duration and course of your complaints and is determined by your physician
If you take more Levocetirizine 5mg film-coated 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 Levocetirizine, please tell your doctor who will then decide what action should be taken.
If you forget to take Levocetirizine, 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.
Stopping treatment should have no negative effects. However, rarely pruritus (intense itching) may occur if you stop taking Levocetirizine 5mg film-coated 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)
Uncommon: (may affect up to 1 in 100 people)
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 (itchness), rash, urticaria (swelling, redness and itchiness of the skin), skin eruption, shortness of breath, weight increase, muscular pain, joint pain, aggressive or agitated behavior, hallucination, depression, insomnia, recurring thoughts of or preoccupation with suicide, nightmare, hepatitis, abnormal liver function, vomiting, increased appetite, nausea and diarrhea have also been reported. Pruritus (intense itching) upon discontinuation.
At the first signs of a hypersensitivity reaction, stop taking Levocetirizine 5mg film-coated tablets 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 of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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 carton and blister after Exp. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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.
Each film-coated tablet contains 5 mg levocetirizine dihydrochloride.
The 5mg film-coated tablets are white, oval, with a G breakline G on one side and the other side is plain. The tablet can be divided into equal doses.
The tablets are packed in either Aluminium/Aluminium blisters or PVC / PVdC – Aluminium blisters.
Pack Sizes
7, 10, 20, 21, 28, 30, 50, 90 and 100 tablets*
*Not all pack sizes may be marketed.
This leaflet was last revised in April/2023.
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