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LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG FILM-COATED TABLETS

Active substance(s): LEVOCETIRIZINE DIHYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Levocetirizine dihydrochloride
5 mg film-coated tablets
levocetirizine

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 dihydrochloride 5 mg is and what it is
used for
2. Before you take Levocetirizine dihydrochloride 5 mg
3. How to take Levocetirizine dihydrochloride 5 mg
4. Possible side effects
5. How to store Levocetirizine dihydrochloride 5 mg
6. Further information

1. What Levocetirizine dihydrochloride
5 MG is and what it is used for
Levocetirizine is an anti allergic agent. It is used to treat symptoms
associated with allergic conditions, such as:
• hay fever
• year round allergies such as dust or pet allergies
• chronic nettle rash

2. Before you take Levocetirizine
dihydrochloride 5 MG
Do not take Levocetirizine dihydrochloride 5 mg if
• you are allergic (hypersensitive) to levocetirizine, any
other related substance, or any of the other ingredients of
Levocetirizine dihydrochloride 5 mg (see section 6, “What
Levocetirizine dihydrochloride 5 mg contains”)
• you suffer from severe kidney failure (less than 10 ml/min
creatinine clearance)
• you have been told by your doctor that you have an intolerance
to some sugars
Take special care with Levocetirizine dihydrochloride 5 mg
• if you suffer from epilepsy or are in any other way at risk of
suffering fits. You should ask your doctor for advice.
• If you suffer from kidney failure. You may require a lower dosage
and should discuss your situation with your doctor.
Levocetirizine is not recommended in children less than 6 years of
age since the currently available film-coated tablets do not allow for
dose adaptation.
Taking other medicines
Other medicines may be affected by levocetirizine. They, in turn, may
affect how well levocetirizine works.
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 dihydrochloride 5 mg with food and drink
Levocetirizine may be taken with or without food.

You should be cautious if you take levocetirizine at the same time as
alcohol. In sensitive patients the effect of alcohol may be increased
or different than expected.
Pregnancy and breast-feeding
No information is available on the safe use of levocetirizine during
pregnancy or breast-feeding. When you are pregnant or breastfeeding you should only use levocetirizine if there is a clear benefit
outweighing the possible risks. Your doctor will make this decision
for you.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
In some patients levocetirizine may cause drowsiness, tiredness and
exhaustion. If you experience any of these symptoms, then do not
drive or operate any machines.
Important information about some of the ingredients of
Levocetirizine dihydrochloride 5 mg
These tablets contain lactose; if you have been told by your doctor
that you have an intolerance to some sugars you must not take
Levocetirizine dihydrochloride 5 mg (see Section 2, Do not take).

3. How to take Levocetirizine
dihydrochloride 5 MG
Always take levocetirizine exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
You should swallow the tablet whole with water or another liquid.
The usual dose for adults and children aged 6 years and over is one
tablet daily.
Children under 6 years of age should not take levocetirizine.
If you suffer from mild to moderate kidney failure, your doctor
may prescribe a lower dose according to the severity of your kidney
disease.
The duration of treatment depends on the type, duration and course
of the complaints. Your doctor or pharmacist will advise you on this.
If you take more Levocetirizine dihydrochloride 5 mg than
you should
If you have taken more levocetirizine than you should, you may
experience the following symptoms: confusion, diarrhoea, dizziness,
fatigue, headache, feeling unwell, dilation of the pupils, itching,
restlessness, drowsiness, sleepiness, fast heart beat, shaking
and difficulty passing urine. Contact your doctor or pharmacist
immediately. They may empty your stomach or can take other
measures to alleviate the symptoms.

If you forget to take Levocetirizine dihydrochloride 5 mg
Do not take a double dose to make up for a forgotten dose. Skip the
missed dose and take the next tablet at the usual time.
If you stop taking Levocetirizine dihydrochloride 5 mg
If you stop the treatment with levocetirizine earlier than foreseen this
should not cause any side effects. The symptoms you took
levocetirizine for, may reappear however.
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.
Common side effects (occurring in more than 1 in 100
treated patients):
• Sleepiness
• Dizziness
• Headache
• Inflammation of the throat
• Swelling and irritation inside the nose (in children)
• Abdominal pain
• Dry mouth
• Feeling sick
• Tiredness
Uncommon side effects (occurring in more than 1 in 1000,
but in less than 1 in 100 treated patients):
• Sensation of tingling or numbness of the skin
• Diarrhoea
• Rash
• Itching
• Feeling of weakness
• Feeling unwell
• Agitation
Rare side effects (occurring in more than 1 in 10,000 but in
less than 1 in 1000 treated patients):
• Faster heart beat
• Fits
• Disorders of movement
• Hives
• Swelling of the skin
• Hypersensitivity (allergic reaction)
• Abnormal liver function
• Weight increase
• Aggression
• Confusion
• Depression
• Hallucinations
• Difficulty in sleeping
Very rare side effects (occurring in less than 1 in 10,000
treated patients):
• Reduction in blood platelets, which increases risk of bleeding or
bruising
• Changed or diminished taste sensation
• Fainting
• Blurry vision
• Painful urination
• Bedwetting

• Serious allergic reaction which causes swelling of the face or
throat
• Local skin reaction
• Serious allergic reaction which causes difficulty in breathing or
dizziness
• Shaking
• Muscle disorders
• Jerky movements
• Circular eye movements
• Tic

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
dihydrochloride 5 MG
Keep out of the reach and sight of children.
Do not use levocetirizine after the expiry date which is stated on the
packaging after ‘EXP’. The first two digits indicate the month and the
last four digits indicate the year.
The expiry date refers to the last day of that month.
Store in the original package to protect from moisture.
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 dihydrochloride 5 mg contains
• The active substance is levocetirizine. Each tablet contains 5 mg
of levocetirizine dihydrochloride equivalent to 4.2 mg
levocetirizine.
• The other ingredients are microcrystalline cellulose, lactose
monohydrate, magnesium stearate (core) and hypromellose
(E464), titanium dioxide (E171), and macrogol 400 (coating).
What Levocetirizine dihydrochloride 5 mg looks like and the
contents of the pack
The film-coated tablets are white to off-white, oval, biconvex tablets,
debossed with ‘L9CZ’ on one side and ‘5’ on the other side.
They are supplied in blister packs of 7, 10, 14, 15, 20, 21, 28, 30,
40, 50, 56, 60, 70, 90, 100, 112 or 120 tablets per box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder: Synthon BV,
Microweg 22, 6545 CM Nijmegen, The Netherlands.
Manufactured by: Synthon Hispania S.L.
Castelló 1, Polígono Las Salinas, 08830 Sant Boi de Llobregat,
Spain.
Distributed by: Consilient Health (UK) Limited.
No.1 Church Road, Richmond upon Thames, Surrey. TW9 2QE

This leaflet was last revised in February 2016

P0420

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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