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CETIRIZINE DIHYDROCHLORIDE 10 MG FILM-COATED TABLETS

Active substance(s): CETIRIZINE DIHYDROCHLORIDE

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eCTD Office [http://www.ectdoffice.com]

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

CETIRIZINE DIHYDROCHLORIDE 10mg
FILM-COATED TABLETS
Cetirizine dihydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
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This medicine is available without prescription. However, you still need to take it carefully to get the best results.

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

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Ask your pharmacist if you need more information or advice.

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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.

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You must talk to a doctor if you do not feel better or if you feel worse after a few days.

What is in this leaflet:

Warnings and precautions

1. What Cetirizine dihydrochloride Tablets are and what they are
used for

Talk to your doctor or pharmacist before taking Cetirizine
dihydrochloride Tablets if:

2. What you need to know before you take Cetirizine dihydrochloride
Tablets

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3. How to take Cetirizine dihydrochlorideTablets
4. Possible side effects
5. How to store Cetirizine dihydrochlorideTablets
6. Contents of the pack and other information

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you have problems with your kidneys;
you have predisposition factors of urinary retention (e.g.: spinal
cord lesion, prostatic hyperplasia) as cetirizine increases the
risk of urinary retention;
you suffer from epilepsy or are at risk of convulsions;
you want to use for children less than 6 years of age.

Cetirizine dihydrochlorideTablets with food, drink and alcohol

1. What Cetirizine dihydrochloride Tablets are and
what they are used for

Avoid alcoholic drink while you are taking this medicine.

The full name of this medicine is Cetirizine dihydrochloride 10mg
Film-coated tablets but within the leaflet it will be referred to as
Cetirizine dihydrochloride Tablets. Cetirizine dihydrochloride, the
active ingredient of the tablets is an antihistamine. It blocks the
effects of a substance called histamine which occurs naturally in the
body. Histamine is involved in allergic reactions.

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.

Cetirizine dihydrochloride Tablets are used to treat people who have
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).
Antihistamines like Cetirizine dihydrochloride Tablets relieve the
unpleasant symptoms and discomfort associated with these
conditions, such as sneezing, irritated, runny and blocked up nose,
itchy, red and watering eyes and skin rashes.

2. What you need to know before you take
Cetirizine dihydrochloride Tablets
Do not take Cetirizine dihydrochlorideTablets if:
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you are allergic to cetirizine dihydrochloride or any of the other
ingredients of this medicine (listed in section 6);
you are breast-feeding;
you have severe kidney failure (creatinine clearance less than 10
ml/min);
you have problems of urinary retention;
you have hereditary problems of galactose intolerance, the Lapp
lactase deficiency or glucose-galactose malabsorption.

If any of the above applies to you talk to your pharmacist.

Pregnancy and breast-feeding

AllergyTesting
If you are due to have an allergy test, ask your doctor if you should
stop taking Cetirizine dihydrochloride Tablets for several days before
testing.This medicine may affect your allergy test results.
Driving and using machines
Some people have reported that they feel drowsy or dizzy while they
are taking Cetirizine dihydrochloride Tablets. If you are affected DO
NOT drive or use machines.
Cetirizine dihydrochlorideTablets contain lactose
This medicine contains lactose. If you have been told by your doctor
that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.

3. How to take Cetirizine dihydrochlorideTablets
Remember.Take the tablet with a glass of water. DO NOT take more
than one tablet each day. If you do not feel better within a few days,
consult your doctor.
Children aged 6 to 12:
Take half a tablet twice a day.
Adults and children aged 12 years and over:
Take one tablet daily. If the tablets make you feel drowsy or dizzy,
taking half a tablet twice a day may be better than taking one tablet
once a day. Cetirizine dihydrochloride Tablets are not suitable for

children under 6.

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If you take more Cetirizine dihydrochloride Tablets than you
should

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If you accidentally take too many tablets go and see your doctor
straightaway.

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If you forget to take Cetirizine dihydrochlorideTablets

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If you forget to take a tablet, you should take one as soon as you
remember, but wait at least 24 hours before taking your next tablet.

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If you have any further questions on the use of this medicine, ask
your pharmacist.

Some cases of memory loss and/or impairment have also been
reported.

4. Possible side effects

In very rare cases people have thought about committing suicide
and if you feel this way then stop taking the tablets and see your
doctor.

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
The following side effect is very rare, but you must stop taking
the tablets and speak to your doctor straight away if you notice
these symptoms:
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A severe allergic reaction including rash, itchiness and fever,
swollen throat, face, eyelids or lips. This reaction may start soon
after you first take the medicine, or it might start later.

The following side effects have also been reported.
Common side effects (affects less than 1 in 10 people)
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Tiredness, feeling sleepy
Headache
Dry mouth
Nausea
Diarrhoea (children only)
Pain in the abdomen
Dizziness
Sore throat
Cold-like symptoms of the nose (children only).

Uncommon side effects (affects less than 1 in 100 people)
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Itching and rash
Diarrhoea
Feeling weak or generally unwell
Tingling in the hands and feet
Feeling agitated.

Rare side effects (affects less than 1 in 1000 people)
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Fast heart beat
Oedema (generalised swelling due to water retention)
Abnormal liver function test results (your doctor will know what to
do)
Convulsions
Increased weight
Aggression, confusion, depression, hallucination (hearing or
seeing things), sleeplessness
Urticaria (hives).

Very rare side effects (affects less than 1 in 10,000 people)
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Blurred vision, difficulty focussing
Rotation of the eyes
Unusual bleeding or bruising
Bad taste in the mouth
Tremor, tics
Involuntary movements and/or jerking of the limbs
Muscle spasms in the neck and shoulders

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Swelling of the skin particularly around the face
Fainting
A recurring rash
Bed wetting, pain and/or difficulty passing water

Not known side effects

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Increased appetite
Vertigo
Urinary retention

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 Cetirizine dihydrochlorideTablets
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.The expiry date refers to the last day of that month.
This medicine 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 Cetirizine dihydrochlorideTablets contains
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The active substance is cetirizine dihydrochloride.
The other ingredients are lactose monohydrate, microcrystalline
cellulose, colloidal anhydrous silica, magnesium stearate,
hydroxypropylmethylcellulose (E464), polydextrose, titanium
dioxide (E171), and macrogol/polyethylene glycol 4000.

What Cetirizine dihydrochloride Tablets look like and contents
of the pack
The tablets are white to off-white capsule-shaped film-coated
tablets, each with one plain face and with a break line on the other
face.
Your medicine is supplied in clear colourless PVC/PVdC-Aluminium
blisters packs of 7, 14, or 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Crescent Pharma Limited,
Units 3 & 4, Quidhampton Business Units,
Polhampton Lane, Overton,
Hants RG25 3ED
United Kingdom
This leaflet was last revised in 03/2016.

P0372T

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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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