Levocetirizine Dihydrochloride 5mg Film-Coated Tablet
PACKAGE LEAFLET: INFORMATION FOR THE USER
BROWN & BURK
Levocetirizine Dihydrochloride 5mg film-coated Tablets Levocetirizine Dihydrochloride
Read all of this leaflet carefully before you start taking this
medicine.
• Keep this leaflet. You may needtoread itagain.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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.
In this leaflet:
1. What Levocetirizine Dihydrochloride 5 mg film-coated tablets is and what it is used for
2. Before you take Levocetirizine Dihydrochloride 5 mg film-coated tablets
3. How to take Levocetirizine Dihydrochloride 5 mg film-coated tablets
4. Possible side effects
5. How to store Levocetirizine Dihydrochloride 5 mg film-coated tablets
6. Further information
1.WHAT LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG FILM-COATED TABLETS IS AND WHAT IT IS USED FOR
Levocetirizine Dihydrochloride is the active ingredient of Levocetirizine Dihydrochloride 5 mg film-coated tablets. Levocetirizine Dihydrochloride 5 mg film-coated tablets 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 DIHYDROCHLORIDE 5 MG FILM-COATED TABLETS
Do not take Levocetirizine Dihydrochloride 5 mg film-coated tablets if:
• you are allergic (hypersensitive) to Levocetirizine Dihydrochloride or to an antihistamine or any of the other ingredients of Levocetirizine dihydrochloride 5 mg (see section 6 'What Levocetirizine dihydrochloride 5 mg contains').
• you have a severe impairment of kidney function (severe renal failure with creatinine clearance below 10 ml/min).
Take special care with Levocetirizine Dihydrochloride 5 mg film-coated tablets
The use of Levocetirizine Dihydrochloride is not recommended in children less than 6 years since the currently available film-coated tablets do not allow dose adaptation.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained withouta prescription.
Taking Levocetirizine Dihydrochloride 5 mg film-coated tablets with food and drink
Caution is advised if Levocetirizine Dihydrochloride 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 breastfeeding.
Driving and using machines
Some patients being treated with Levocetirizine Dihydrochloride 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 Dihydrochloride in the recommended dosage.
Important information about some of the ingredients of Levocetirizine Dihydrochloride 5 mg film-coated tablets
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. HOWTOTAKE LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG FILM-COATED TABLETS
Always take Levocetirizine Dihydrochloride exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose for adults and children aged 6 years and over is one tablet daily.
Special dosage instructions forspecific populations
Patients with impaired kidney function may be given a lower dose according to the severity of their kidney disease.
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Patients who only have impaired liverfunction 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 Dihydrochloride is not recommended for children under 6 years of age.
How and when should you take Levocetirizine Dihydrochloride 5 mg film-coated tablets?
The tablets should be swallowed whole with water and may be taken with or without food.
If you take more Levocetirizine Dihydrochloride 5 mg film-coated tablets than ~ cd ~ you should
™ "O ™
” O “
■ co ■ A substantial overdose may cause somnolence in
■ i ■ adults. Children may initially show excitation and 5 5 restlessness followed by somnolence.
— — If you think you have taken an overdose of Levocetirizine Dihydrochloride, please tell your doctor who will then decide what action should be
taken.
If you forget to take Levocetirizine Dihydrochloride 5 mg film-coated tablets
If you forget to take Levocetirizine Dihydrochloride, 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 Dihydrochloride 5 mg film-coated tablets
Stopping the treatment with Levocetirizine Dihydrochloride 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 Dihydrochloride.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Dihydrochloride and see your doctor immediately. Hypersensitivity reaction symptoms may include: swelling of the mouth, tongue, face and/or throat, breathing or swallowing difficulties together with hives (angioedema), 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.
5. HOWTO STORE LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG FILM-COATED TABLETS
Keep out of the reach and sight of children.
Do not use Levocetirizine Dihydrochloride after the expiry date which is stated on the carton after 'EXP'. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
6. FURTHER INFORMATION
4. POSSIBLE SIDE EFFECTS
Like all medicines, Levocetirizine Dihydrochloride 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, convulsions, visual disturbances, 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, hepatitis, abnormal liverfunction, nausea and vomiting have also been reported. At the first signs of a hypersensitivity reaction, stop taking Levocetirizine
What Levocetirizine Dihydrochloride 5 mg film-coated tablets contains
• The active substance is Levocetirizine Dihydrochloride. Each film-coated Tablet contains 5 mg of Levocetirizine Dihydrochloride equivalent to 4.2mg of levocetirizine.
• The other ingredients are Lactose monohydrate, Cellulose microcrystalline (E460), Colloidal anhydrous silica (E551), Magnesium stearate (E572) and Opadry white (Y-1-7000) consisting of Hypromellose (E464), Titanium dioxide (E 171) and Macrogol400.
What Levocetirizine Dihydrochloride 5 mg film-coated tablets looks like and contents of the pack
Film-coated tablets are White colored oval shaped biconvex film-coated tablet debossed with T and '12' on one side and score line on the other side.
They are supplied in Aluminium - Aluminium blister pack with pack size of 1,2,4,5,7,10,14,15,20,21,28,30,40,50,60,70,90,100, 120's per pack
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Brown & Burk UK Limited 5 Marryat Close, Hounslow West, Middlesex,
TW45DQ.UK
This leaflet was last approved in 07/2012
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