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LEVOCETIRIZINE DIHYDROCHLORIDE 5MG FILM-COATED TABLET

Active substance(s): LEVOCETIRIZINE DIHYDROCHLORIDE

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240 mm

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 sign of illness are the
same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
In this leaflet:
1. What Levocetirizine Dihydrochloride 5 mg film-coated tablets is
and what it is used for
2. What you need to know 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. Contents of the pack and other 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. What you need to know before you take Levocetirizine
Dihydrochloride 5 mg film-coated tablets
Do not take Levocetirizine Dihydrochloride 5 mg film-coated
tablets :
• if you are allergic to Levocetirizine Dihydrochloride to cetirizine, to
hydroxyzine or any of the other ingredients of this medicine (listed
in section 6).
• if you have a severe impairment of kidney function (severe
renal failure with creatinine clearance below 10 ml/min).
Warnings and precautions
Talk to your doctor or pharmacist before taking Levocetirizine
Dihydrochloride 5 mg film-coated tablets.
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.
If you are scheduled for allergy testing, ask your doctor if you should
stop taking Levocetirizine Dihydrochloride 5 mg film-coated tablets
for several days before testing. This medicine may affect your allergy
test results.
Children
The use of Levocetirizine Dihydrochloride 5 mg film-coated tablets is
not recommended in children less than 6 years since the film-coated

Front Side
170 x 240 mm

tablets do not allow for dose adaptation.
Other medicines and Levocetirizine Dihydrochloride 5 mg filmcoated tablets
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
Levocetirizine Dihydrochloride 5 mg film-coated tablets with
food, drink and alcohol.
Caution is advised if Levocetirizine Dihydrochloride is taken at the
same time as alcohol or other agents acting on the brain.
In sensitive patients, the concurrent administration of Levocetirizine
Dihydrochloride 5 mg film-coated tablets and alcohol or other agents
acting on the brain may cause additional reductions in alertness and
impairment of performance.
Levocetirizine Dihydrochloride can be taken with or without food.
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.
Driving and using machines
Some patients being treated with Levocetirizine Dihydrochloride may
experience somnolence / drowsiness, tiredness and exhaustion. Use
caution when driving or operating machinary 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
Dihydrochloride in the recommended dosage.
Levocetirizine Dihydrochloride 5 mg film-coated tablets
contains lactose
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 Dihydrochloride 5 mg filmcoated tablets
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose for adults and children aged 6 years and
over is one tablet daily.
Special dosage instructions for specific populations
Renal and hepatic impairment
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 Dihydrochloride 5 mg film-coated tablets.
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.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Serious side effects
At the first signs of an allergic reaction, stop taking Levocetirizine
Dihydrochloride 5 mg film-coated tablets and tell your doctor. Allergic
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.
Not known: frequency cannot be estimated from the available data
recurring thoughts of or preoccupation with suicide and hepatitis
(symptoms can include yellow skin or eyes (jaundice), nausea,
abdominal pain and tiredness).
Other side effects

Common: may affect up to 1 in 10 people Dry mouth, headache,
tiredness and somnolence/drowsiness.
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, joint pain,
aggressive or agitated behaviour, hallucination, depression,
insomnia, abnormal liver function, increased appetite, nausea,
vomiting and diarrhoea have also been reported.
Pruritus (intense itching) upon discontinuation.
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 Yellow Card
Scheme, Website: 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 Dihydrochloride 5 mg filmcoated tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.
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. Contents of the pack and other information
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
Macrogol 400.
What Levocetirizine Dihydrochloride 5 mg film-coated tablets
looks like and contents of the pack
Film-coated tablets are White colored oval shaped biconvex filmcoated tablet debossed with 'I' 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,
Tw4 5DQ, UK
This leaflet was last revised in 09/2017

Back Side
170 x 240 mm

Artwork Code

Levocetirizine Dihydrochloride

Elderly patients aged 65 years and above
No adaptation of the dose is necessary in elderly patients, provided
their renal function is normal.
Use in children
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?
For oral use only.
The tablets should be swallowed whole with water and may be taken
with or without food.
How long should you take Levocetirizine Dihydrochloride 5 mg
film-coated tablets?
The duration of use depends on the type,
duration and course of your complaints and is
determined by your physician.
If you take more Levocetirizine
Dihydrochloride 5 mg film-coated tablets
than you should
If you take more Levocetirizine Dihydrochloride
5 mg film-coated tablets than you should,
somnolence can occur in adults. Children may
initially show excitation and restlessness
followed by somnolence. If you think you have
taken an overdose of Levocetirizine Dihydrochloride 5 mg film-coated
tablets, please tell your doctor who will then decide what action
should be taken.
If you forget to take Levocetirizine Dihydrochloride 5 mg filmcoated 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 make up for a forgotten dose. Take your next dose at your
normal time.
If you stop taking Levocetirizine Dihydrochloride 5 mg filmcoated tablets
Stopping treatment should have no negative effects. However, rarely
pruritus (intense itching) may occur if you stop taking Levocetirizine
Dihydrochloride, even if those symptoms were not present before
treatment initiation. The symptoms may resolve spontaneously. In
some cases, the symptoms may be intense and may require
treatment to be restarted. The symptoms should resolve when the
treatment is restarted.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
Pharma Code

Levocetirizine Dihydrochloride 5mg film-coated Tablets

240 mm

Package leaflet: Information for the user

170 mm

Pharma Code

170 mm

BBUK Code

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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