Patient leaflet - Levocetirizine Dihydrochloride 5 mg film-coated tablets
1. What Levocetirizine is and what it is used for
Levocetirizine Dihydrochloride 5mg film-coated Tablets (hereinafter referred to as Levocetirizine) is an antiallergic medication.
For treatment of signs of illness (symptoms) associated with: allergic rhinitis (including persistent allergic rhinitis)
nettle rash (urticaria)
2. What you need to know before you take Levocetirizine
Do not take Levocetirizine
if you are allergic (hypersensitive) 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 10ml/min)
Warnings and precautions
Talk to your doctor or pharmacist before taking Levocetirizine. 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 may cause seizure aggravation. If you are scheduled for allergy testing, ask your doctor if you should stop taking Levocetirizine for several days before testing. This medicine may affect your allergy test results.
Children
The use of Levocetirizine is not recommended in children less than 6 years since the film-coated tablets do not allow for dose adaptation. Other medicines and Levocetirizine
Tell your doctor or pharmacist ff you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription.
Levocetirizine with food, drink and alcohol
Caution is advised ff Levocetirizine is taken at the same lime as alcohol or other agents acting on the brain.
In sensitive patients, the concurrent administration of Levocelirizine and alcohol or other agents acting on the brain may cause additional reductions in alertness and impairment of performance.
Levocelirizine can be taken with or without food.
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.
Driving and using machines
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.
Levocetirizine contains lactose
These tablets contain lactose, ff you have been told by your doctor that you have an intolerance to some sugars you should contact your doctor before taking them.
3. How to take Levocetirizine
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Dosage
The usual dose for adults and children aged 6 years and over is one tablet daily.
Special dosage instructions for specific populations
Kidney and liver 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 Levocetirizine.
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.
Use in children
Levocetirizine is not recommended for children under 6 years of age. Elderly Patients
No adaption of the dose is necessary in elderly patients, provided their renal function is normal.
How and when should you take Levocetlrlzlne?
The tablets should be swallowed whole with water and may be taken with or without food.
If you take more Levocelirizine 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 Levocetirizine, please tell your doctor who will then decide what action should be taken. If you forget to take Levocetlrlzlne
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 compensate; just wait for the foreseen time for intake of the next dose, and take a normal dose as prescribed by your doctor.
If you stop taking Levocetirizine
Stopping the treatment with Levocetirizine earlier than foreseen should have no detrimental effects, in the sense that the symptoms of the disease should just progressively reappear with a severity not higher than the one experienced prior to treatment with Levocelirizine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Commonly (1% to 10%), mainly mild to moderate side effects such as dry mouth, headache, tiredness and somnolence/ drowsiness have been reported.
Uncommon (0.1% to 1%), side effects such as exhaustion and abdominal pain have been observed.
Package leaflet: Information for the user Levocetirizine Dihydrochloride 5mg film-coated Tablets
(continued overleaf)
Levocetirizine 5 mg Tabs Package leaflet
TBA
TW232250 (MAT) UK
[All]
NA
TBA
7 pts (Reg text)
-
26/09/2025 18/05/2026 22/05/2026
Black C
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 ccmpletely empty the bladder, oedema, prurttus (itchiness), rash, urticaria (swelling, redness and ttchiness of the skin), skin eruption, shortness of breath, weight increase, muscular pain, joint pain, aggressive or agttated behaviour, hallucination, depression, insomnia, recurring thoughts of or preoccupation with suicide, nightmare, hepatttis, 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 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 ccllapse or shock, which may be fatal. If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at
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.
5. How to store Levocetirizine
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.
This medicinal product does not require any special storage condttions. 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.
6. Contents of the pack and other information
What Levocelinizine contains
The active substance is levocetirizine dihydrochloride. Each film-coated tablet contains 5mg levocetirizine dihydrochloride.
The other ingredients are microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, hypromellose (E464), titanium dioxide (E171 ), macrogol 400 and polysorbate 80. What Levocellrlzlne looks like and contents of the pack
The film-coated tablets are whtte film coated, scored, round shaped, biconvex tablets debossed ‘161’ on one side and ‘H’ on the other side. They are supplied in blister packs of 1, 2, 4, 5, 7, 10, 14, 15, 20, 21, 28, 30, 40, 50, 56, 60, 70, 90, 112 and 120 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Tillomed Laboratories Limited
220 Butterfield, Great Marlings
Luton, LU2 8DL, United Kingdom
Manufacturer
Pharmadox Healthcare Ltd, KW20A Kordin Industrial Park, Paola, PLA 3000, Malta
or
Manx Healthcare Ltd, Taylor Group House, Wedgnock Lane, Warwick, CV34 5YA, UK
Other formats
To request a copy of this leaflet in braille, large print or audio please call 0800 970 6115.
This leaflet was revised in May 2026