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LEVOCETIRIZINE 5 MG FILM-COATED TABLETS

Active substance(s): LEVOCETIRIZINE DIHYDROCHLORIDE

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TEVA UK Ref:

LEVOCETIRIZINE 5 mg
Film-coated Tablets
Levocetirizine Dihydrochloride
Package leaflet: Information for the user

REG0073712

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for
you.
• 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 only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. See section 4.

Pregnancy and breast-feeding
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.
Breast feeding: When taking Levocetirizine 5 mg
Film-coated Tablets, levocetirizine may be present in
breast-milk.
Driving and using machines
Levocetirizine 5 mg Film-coated Tablets are not expected to
affect your ability to drive a car or operate machinery. Use
caution when driving or operating machinery untill 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.

Pharma code 1701

Version 2.4

Levocetirizine 5 mg Film-coated Tablets contains lactose
Levocetirizine 5 mg Film-coated Tablets contains lactose. If
What is in this leaflet:
you
have been told by your doctor that you have
1. What Levocetirizine 5 mg Film-coated Tablet is and what
intolerance to some sugars, contact your doctor before
it is used for
taking
this medicinal product.
2. What you need to know before you take Levocetirizine
5 mg Film-coated Tablets
How to take Levocetirizine 5 mg Film-coated
3
3. How to take Levocetirizine 5 mg Film-coated Tablets
Tablets
4. Possible side effects
5. How to store Levocetirizine 5 mg Film-coated Tablets
Always take this medicine exactly as your doctor or
6. Contents of the pack and other information
pharmacist has told you, even when you have no
symptoms. Check with your doctor or pharmacist if you are
1 What Levocetirizine 5 mg Film-coated Tablet is and not sure.

what it is used for

Levocetirizine 5 mg Film-coated Tablets belong to a group
of medicines called antihistamines. They relieve the
unpleasant symptoms and discomfort associated with the
below conditions, such as sneezing, irritated runny or
blocked up nose, itchy, red and watering eyes and skin
rashes.

Approved

Your doctor has prescribed Levocetirizine 5 mg Film-coated
Tablets to treat hay fever (seasonal allergic rhinitis), year
round allergies such as dust or pet allergies (perennial
allergic rhinitis) and urticaria (swelling, redness and
itchiness of the skin).

2

What you need to know before you take
Levocetirizine 5 mg Film-coated Tablets

Do not take Levocetirizine 5 mg Film-coated Tablets:
• if you are allergic to Levocetirizine dihydrochlorideor
any of the other ingredients of this medicine (listed in
section 6).
• if you have severe kidney problems (severe renal failure
with creatinine clearance below 10 ml/min).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Levocetirizine 5 mg Film-coated Tablets.
Tell your doctor or pharmacist if you have trouble or a
condition that may increase your risk of trouble urinating
(e.g. enlarged prostate, spinal cord lesion)

Page 2 of 3

Children and adolescents
• Levocetirizine 5 mg Film-coated Tablets are not
recommended for use in children under 6 years of age.
Other medicines and LEVOCETIRIZINE 5 mg Film-coated
Tablets
Levocetirizine 5 mg Film-coated Tablets may be used
together with other medicines you may be taking.

The recommended dose is:
The recommended dose for adults is one 5 mg tablet daily.
Use in children and adolescents
The recommended dose for children aged between 6 and
12 years upwards is one 5 mg tablet daily.
Levocetirizine 5 mg Film-coated Tablets is not
recommended for children under 6 years of age.
Older people
The elderly, at present there are no data to suggest that the
dose needs to be reduced in elderly subjects provided that
their kidney function is normal.
Kidney problems
In patients with kidney problems it may be necessary to
reduce the dose of levocetirizine to one tablet every two or
three days. Your doctor will decide how often you should
take levocetirizine depending on how well your kidneys are
working.
Liver problems
In patients with liver problems it is not necessary to adjust
the dose of levocetirizine you are taking.
Kidney and liver problems
In patients with kidney and liver problems it may be
necessary to reduce the dose of levocetirizine to one tablet
every two or three days. Your doctor will decide how often
you should take levocetirizine depending on how well your
kidneys are working.
Your doctor will tell you how long to take levocetirizine
The tablets should be swallowed whole with liquid and can
be taken with or without food.

If you take more Levocetirizine 5 mg Film-coated Tablets
than you should
It is important not to take too many tablets. Contact your
Tell your doctor or pharmacist if you are taking, have
nearest hospital Accident and Emergency department or a
recently taken or might take any other medicines,
doctor for advice if you have swallowed too many tablets
including those medicines obtained without a prescription. or if you think a child has swallowed any. Symptoms of
overdose may include drowsiness in adults and initially
Taking Levocetirizine 5 mg Film-coated Tablets with food,
agitation and restlessness, followed by drowsiness in
drink and alcohol
children
Levocetirizine 5 mg Film-coated Tablets may be taken with Take this leaflet and any of the remaining tablets with you
or without food.
to show the doctor.
Caution should be taken if Levocetirizine 5 mg Film-coated
Tablets are taken at the same time as alcohol or other
centrally acting agents, although the racemate ceterizine
has been shown not to increase the effect of alcohol.

Version:

231-30-86507-V LEA LEVOCETIRIZINE 5mg TAB TUK

If you forget to take Levocetirizine 5 mg Film-coated Tablets
If you forget to take a tablet, just carry on with the next one
as usual. Do not take a double dose to make up for a
forgotten dose.

2

03 July 2015

If you stop taking Levocetirizine 5 mg Film-coated Tablets
There are no harmful effects if you stop taking
Levocetirizine 5 mg Film-coated Tablets.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
The following side effects have been reported at the
approximate frequencies shown:

What Levocetirizine 5 mg Film-coated Tablets looks like
and contents of the pack
Levocetirizine 5 mg Film-coated Tablets are white to off
white, film-coated oval shaped tablet; one side of the tablet
is debossed with "LC5". The other side of the tablet is plain.
Levocetirizine 5 mg Film-coated Tablets are available in
packs of 7, 10, 14, 15, 20, 21, 28, 30, 40, 50, 60, 90 and 100
film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG

Common: may affect up to 1 in 10 people
Dry mouth, headache, tiredness and somnolence/
drowsiness

This leaflet was last revised: April 2015
PL 00289/1033

Uncommon: may affect up to 1 in 100 people
Exhaustion and abdominal pain
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,
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 5 mg Film-coated Tablets and tell your
doctor. 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 you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.
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 5 mg Film-coated
Tablets

Keep this medicine out of the sight and reach of children.
There are no special storage conditions
Do not use this medicine after the expiry date which is
stated on the blister foil and carton. The expiry date refers
to the last day of that month
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 to
protect the environment.

6

Contents of the pack and other 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, titanium dioxide
and macrogol 400.
86507-V

323 x 200

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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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