Levocetirizine Dihydrochloride 5mg Film-Coated Tablets
PATIENT INFORMATION LEAFLET - INFORMATION FOR THE USER
Levocetirizine Dihydrochloride 5mg film-coated Tablets
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again I If you have any further questions, ask your doctor or pharmacist I This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
I If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What Levocetirizine is and what it is used for
2. Before you take Levocetirizine
3. How to take Levocetirizine
4. Possible side effects
5. How to store Levocetirizine
6. Further information
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. Before you take Levocetirizine
Do not take Levocetirizine
■ if you are allergic (hypersensitive) to levocetirizine dihydrochloride or to an antihistamine or any of the other ingredients of Levocetirizine (see What Levocetirizine contains')
■ if you have a severe impairment of kidney function (severe renal failure with creatinine clearance below 10ml/min)
Take special care with Levocetirizine
The use of Levocetirizine is not recommended in children less than 6
years since the film-coated tablets do not allow for dose adaptation.
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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Levocetirizine with food and drink
Caution is advised if Levocetirizine is taken at the same time as
alcohol.
In sensitive patients, the simultaneous use of cetirizine or levocetirizine and alcohol or other centrally acting agents may have effects on the central nervous system, although the racemate cetirizine has been shown not to increase the effect of alcohol.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.
Tell your doctor if you are pregnant, trying to get pregnant or breast-feeding.
Driving and using machines
Some patients being treated with Levocetirizine may experience somnolence / drowsiness, tiredness and exhaustion. If you are intending to drive, engage in potentially hazardous activities or use machines you are therefore advised first to wait and observe your response to the medication.
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. Important information about some of the ingredients of Levocetirizine
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.
3. How to take Levocetirizine
Always take Levocetirizine exactly as your doctor has told you. You should 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
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.
Levocetirizine is not recommended for children under 6 years of age.
No adaption of the dose is necessary in elderly patients, provided their renal function is normal.
How and when should you take Levocetirizine?
The tablets should be swallowed whole with water and may be taken with or without food.
(continued overleaf)
If you take more Levocetirizine 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 Levocetirizine 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
Levocetirizine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Levocetirizine 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.
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, aggressive or agitated behaviour, hallucination, depression, insomnia, recurring thoughts of or preoccupation with suicide, hepatitis, abnormal liver function, vomiting, increased appetite and nausea have also been reported.
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 collapse 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 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 at www.mhra.gov.uk/yellowcard. 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 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.
6. Further information
What Levocetirizine 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 Levocetirizine looks like and contents of the pack
The film-coated tablets are white 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
Manx Healthcare Ltd, Taylor Group House, Wedgnock Lane,
Warwick, CV34 5YA, UK Manufacturer
Pharmadox Healthcare Ltd, KW20A Kordin Industrial Park, Paola,
PLA 3000, Malta Other formats
To request a copy of this leaflet in braille, large print or audio please call 01926 482511.
This leaflet was last revised in January 2015
MANX
Healthcare
WIP URN: 280115-XXXX-PIL-01