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Levocetirizine 5mg Film-Coated Tablets

SAME SIZE ARTWORK

SIZE: 170 mm x 320 mm

320 mm


PACKAGE LEAFLET: INFORMATION FOR THE USER

Levocetirizine 5 mg film-coated tablets

Levocetirizine dihydrochloride


Read all of this leaflet carefully before you start

taking this medicine.

-    Keep this leaflet. You may need to read it again.

-    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 5 mg film-coated tablets are and what they are used for

2.    Before you take Levocetirizine 5mg 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.    Further information


1. WHAT LEVOCETIRIZINE 5 MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR


Levocetirizine is a type of medicine called a non-sedating antihistamine. It is used to treat signs of an allergic reaction such as:

• an itchy rash (similar to nettle rash) which lasts a long time (chronic idiopathic urticaria).


Taking Levocetirizine 5 mg film-coated tablets with food and drink

Levocetirizine should be swallowed with a drink of water. It may be taken with or without food.

You should be careful if Levocetirizine is taken at the same time as alcohol as the effects of alcohol may be increased.

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 drowsiness, tiredness and exhaustion. If you are intending to drive, do some potentially hazardous activity or use machines you should not do so until you have found out how you respond to the medication. However, tests have shown no effects on mental alertness, the ability to react or the ability to drive in healthy people after taking levocetirizine in the recommended dosage. Important information about some of the ingredients of Levocetirizine 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.HOW TO TAKE LEVOCETIRIZINE 5 MG FILM-COATED TABLETS


2. BEFORE YOU TAKE LEVOCETIRIZINE 5 MG FILM-COATED TABLETS


Do not take Levocetirizine 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 (see 'What Levocetirizine 5 mg film-coated tablets contains')

•    if your kidneys do not work well (severe renal failure with creatinine clearance below

10 ml/min)

•    if your doctor has told you that you have intolerance to some sugars. If this is the case, contact your doctor before taking this medicine.

Take special care with Levocetirizine 5 mg film-coated tablets

The use ofLevocetirizine is not recommended in infants and toddlers less than 2 years. The use of Levocetirizine is not recommended in children aged less than 6 years since the currently available film-coated tablets do not allow appropriate 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 without a prescription.


Always take Levocetirizine 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 (5mg). Children under 6 years of age should not take this medicine. Patients whose kidneys do not work very well may be given a lower dose according to the severity of their kidney disease.

If your liver does not work very well you can still take the usual prescribed dose.

If both your liver and your kidneys do not work very well, you may be given a lower dose depending on how well your kidneys work. Levocetirizine is not recommended for infants and toddlers under the age of 2 and should not be used in children under 6 years of age.

For adults and children aged 6 years and over, the tablets should be swallowed with water.

If you take more Levocetirizine 5 mg film-coated tablets than you should A large overdose may cause drowsiness in adults. Children may initially get excited and restless and then become drowsy.

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


85 mm


Date: 11-04-2014 Version: 01 (UK)


320 mm


If you forget to take Levocetirizine 5 mg film-coated tablets

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 it; just wait for the time to take the next dose, and take a normal dose as prescribed by your doctor.

If you stop taking Levocetirizine 5 mg film-coated tablets

Stopping the treatment with Levocetirizine earlier than you thought should not have any harmful effects, however, your illness may come back.

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.

If you suffer from any of the following, stop taking levocetirizine and tell your doctor immediately or go to your nearest hospital emergency department:

•    Serious allergic reaction symptoms include swelling of the mouth, face and/or throat, breathing or swallowing difficulties, together with hives, a sudden fall in blood pressure leading to collapse or shock, which may be fatal.

At the first signs of an allergic reaction, stop taking levocetirizine and see your doctor straight away.

Common side effects (occur in less than 10 users in 100)

•    dry mouth

•    headache

•    tiredness

•    drowsiness

Uncommon side effects (occur in less than 10 users in 1000)

•    exhaustion

•    abdominal pain

Very rare side effects (occur in less than 1 user in

10,000):

•    palpitations

•    convulsions

•    visual disturbances (such as blurred vision)

•    oedema ( water retention causing swelling)

•    pruritus (itchiness)

•    rash and urticaria or eruption (swelling, or outbreak, redness and itchiness of the skin)

•    shortness ofbreath

•    weight gain

•    muscular pain

•    aggressive or agitated behaviour

•    hepatitis or liver problems (the skin or whites of the eyes may become yellow)

•    nausea

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. HOW TO STORE LEVOCETIRIZINE 5 MG FILM-COATED TABLETS


Keep out of the reach and sight of children.

Do not use Levocetirizine 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.


85 mm


This medicinal product does not require any special storage conditions Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.


6. FURTHER INFORMATION


What Levocetirizine 5 mg film-coated tablets contains

•    The active substance is levocetirizine dihydrochloride

Each film-coated tablet contains 5 mg levocetirizine dihydrochloride.

•    The other ingredients are microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, hypromellose (E464), titanium dioxide (E171), and macrogol 400.

What Levocetirizine 5 mg film-coated tablets looks like and contents of the pack

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 halves The tablets are packed in either Aluminium/ Aluminium blisters or PVC / PVdC -Aluminium blisters

Pack Sizes

10, 20, 21, 28, 30, 50, 90 and 100*

*Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Glenmark Pharmaceuticals Europe Limited, Laxmi House, 2 B Draycott Avenue,

Kenton, Middlesex HA3 0BU,

United Kingdom

Manufacturer

Glenmark Pharmaceuticals s.r.o,

Fibichova 143, 566 17 Vysoke Myto,

Czech Republic

Tillomed Laboratories Ltd.

3 Howard Road,Eaton Socon, St.Neots, Cambridgeshire, PE19 8ET United Kingdom

Glenmark Pharmaceuticals Europe Limited. Building 2, Croxley Green Business Park, Croxley Green, Hertfordshire, WD18 8YA United Kingdom

This leaflet was last approved in 04/2014.


Date: 11-04-2014 Version: 01 (UK)