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CETIRIZINE 10 MG FILM-COATED TABLETS

Active substance(s): CETIRIZINE DIHYDROCHLORIDE / CETIRIZINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Cetirizine 10mg Allergy Relief Tablets
(Cetirizine hydrochloride)

Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
This medicine is available without prescription.
However, you still need to use Cetirizine 10mg
Allergy Relief Tablets carefully to get the best results
from it.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor
or pharmacist.
- You must contact a doctor if your symptoms
worsen or do not improve after 3 days.
- 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 Cetirizine 10mg Allergy Relief Tablets
will be called Cetirizine 10mg tablets.
What is in this leaflet:
1. What Cetirizine 10 mg Tablets are and what they
are used for
2. What you need to know before you take Cetirizine
10 mg Tablets
3. How to take Cetirizine 10 mg Tablets
4. Possible side effects
5. How to store Cetirizine 10 mg Tablets
6. Contents of the pack and other information
1. WHAT CETIRIZINE 10 MG TABLETS ARE AND
WHAT THEY ARE USED FOR
Cetirizine hydrochloride is the active ingredient of
Cetirizine 10 mg Tablets. Cetirizine 10 mg Tablets is
an antiallergic medication.
In adults and children aged 6 years and above,
Cetirizine 10 mg Tablets are indicated
- For the relief of symptoms of hay fever (seasonal
allergic rhinitis) and allergies such as dust or pet
allergies (perennial allergic rhinitis), such as
sneezing, itchy, runny and blocked nose, red and
watery eyes.
- For the relief of swelling, redness and itchiness of
the skin (symptoms of chronic idiopathic urticaria,
which is also known as chronic nettle rash).
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE CETIRIZINE 10 MG TABLETS
Do not take Cetirizine 10 mg Tablets
- If you have a severe kidney disease (severe renal
failure with creatinine clearance below 10 ml/min).
- If you are known to be allergic (hypersensitive) to
the active substance of Cetirizine 10 mg Tablets or
any of the other ingredients of these tablets (these
are listed below, in section 6 “Further information”).
- If you are known to be allergic (hypersensitive) to
hydroxyzine (a closely related active substance of
other medicines).
- If you are known to be allergic (hypersensitive) to
drugs from the piperazine family, for example
buclizine, cyclizine, meclozine, levocetirizine.
- If you are breast-feeding
- If you have problems of urinary retention
- If you have an intolerance to some sugars (this
medicine contains lactose)
Warnings and precautions
Check with your doctor before taking Cetirizine 10
mg Tablets:
- If you have problems with your kidneys
- If you have predisposition factors of urinary
retention (eg: spinalcord 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
Take special care with Cetirizine 10 mg Tablets
If you have kidney problems, please ask your doctor
for advice; if necessary, you may have to take a lower
dose. The new dose will be determined by your
doctor.
If you are an epileptic patient or a patient at risk of

convulsions, you should ask your
doctor for advice.
Other medicines and Cetirizine 10 mg Tablets
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
Due to the profile of cetirizine, no interactions with
other drugs are expected.
Taking Cetirizine 10 mg Tablets with food and
drink
Food does not noticeably affect the absorption of
cetirizine.
No interactions having a noticeable impact have
been observed between alcohol (at the blood level of
0.5 per millilitre corresponding to one glass of wine)
and cetirizine used at the normal doses. However, as
it is the case with all antihistamines, it is
recommended to avoid consumption of alcohol while
taking this medicine.
Pregnancy and breast-feeding
Ask your doctor for advice before taking any
medicine.
As with other drugs, use of Cetirizine10 mg Tablets
should be avoided by pregnant women. Accidental
use of the drug by a pregnant woman should not
produce any harmful effects on the foetus.
Nevertheless, the administration of the medicine
should be discontinued.
You should not take Cetirizine 10 mg Tablets during
breastfeeding because cetirizine passes into breast
milk.
Allergy skin test
If you are going to have an allergy skin test stop
taking Cetirizine 10 mg Tablets for three days before
the test. This medicine may affect your allergy test
results.
Driving and using machines
Clinical studies have produced no evidence of
impaired attention, alertness and driving capabilities
after taking Cetirizine 10 mg Tablets at the
recommended dose.
If you intend to drive, operate machinery, or perform
other tasks that need your full attention, you should
not exceed the recommended dose and you should
closely observe your response to the drug. If you are
a sensitive patient, you may find that the
simultaneous use of alcohol or other nervous
depressant agents may additionally affect your
attention and ability to react.
Cetirizine 10 mg Tablets contains lactose
Cetirizine 10 mg Tablets contain lactose; if you have
been told by your doctor that you have an
intolerance to some sugars, please contact your
doctor before taking this medicinal product.
3. HOW TO TAKE CETIRIZINE 10 MG TABLETS
Always take Cetirizine 10 mg Tablets exactly as
your doctor has told you. Check with your doctor if
you are not sure.
Tablets need to be swallowed with a glass of liquid.
The recommended dose is:
Use in adults and adolescents above 12 years old:
10 mg once daily as one tablet.
Use in children between 6 and 12 years old:
5 mg twice daily as a half tablet.
Patients with kidney problems:
Patients with moderate renal impairment are
recommended to take 5 mg once daily as a half
tablet.
If you feel that the effect of Cetirizine 10 mg Tablets
is too weak or too strong, please consult your doctor.
If you take more Cetirizine 10 mg Tablets than
you should
If you think you have taken an overdose of Cetirizine

10 mg Tablets, please inform your doctor. Your
doctor will then decide what measures, if any, should
be taken.
After an overdose, the side effects described below
may occur with increased intensity.
Adverse effects such as confusion, diarrhoea,
dizziness, tiredness, headache, ailing, dilating
(widening) of the pupil, itching, restlessness,
sedation, somnolence, stupor, abnormal rapid heart
rate, tremors and urinary retention have been
reported.
If you forget to take Cetirizine 10 mg Tablets
If you forget to take a tablet, take it as soon as you
remember, but wait at least 24 hours before taking
the next tablet. Do not take a double dose to make
up for a forgotten dose.
If you stop taking Cetirizine 10 mg Tablets
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Cetirizine 10 mg Tablets 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:
- 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)
- Fatigue, somnolence (sleepiness)
- Dizziness, headache,
- Dry mouth, nausea (feeling sick), diarrhoea
(children only)
- Pain in the abdomen
- Pharyngitis (sore throat), rhinitis (swelling and
irritation inside the nose (children only)
Uncommon side effects (affects less than 1 in
100 people)
- Pruritus (itching), rash
- Diarrhoea
- Agitation
- Asthenia (feeling of weakness), malaise (feeling of
being generally unwell)
- Paraesthesia (abnormal feelings of the skin),
tingling in the hands and feet
Rare side effects (affects less than 1 in 1,000
people
- Tachycardia (heart beating fast)
- Oedema (generalised swelling due to water
retention)
- Allergic reactions
- Liver function abnormal (your doctor will know what
to do)
- Convulsions
- Weight increased
- Aggression, confusion, depression, hallucination
(hearing or seeing things), insomnia (difficulty
sleeping)
- Urticaria (swelling,redness and itchiness of the skin)
Very rare side effects (affects less than 1 in
10,000 people)
- Severe allergic reactions
- Thrombocytopenia (low level of blood platelets)
- Accommodation disorder (impaired ability of the
eye to focus), blurred vision, oculogyration (eyes
moving in an uncontrolled circular manner)
- Unusual bleeding or bruising
- Syncope (fainting), tremor, dysgeusia (altered
taste)
- Tics (sudden abnormal repetitive muscle
movement)
- Bed wetting, pain and/or difficulty passing water
- Swelling of the skin particularly around the face,
fixed drug eruption
- Muscle spasms in the neck and shoulders
- Fainting
- A recurring rash
Not known side effects
- Loss of memory, memory impairment

Hayfever and Allergy Relief 10mg Tablets
14’s

- Increased appetite
- Vertigo
- Urinary retention
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.
If you develop one of the side effects described
above, please inform your doctor. At the first
signs of an allergic (hypersensitivity) reaction,
stop taking Cetirizine 10 mg Tablets and contact
your doctor immediately. Symptoms of an
allergic (hypersensitivity) reaction include
difficulty breathing, swelling of the face, neck,
tongue or throat. Your doctor will then assess the
severity and decide on any further measures that
may be necessary.
If you think you have any side-effects not
mentioned in this leaflet, please inform 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 10 MG TABLETS
Keep out of reach and sight of children.
Do not use Cetirizine 10 mg Tablets after the expiry
date which is stated on the box and blister.
This medicine does not require any special storage
conditions.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Cetirizine 10 mg Tablets contain
- The active substance of Cetirizine 10 mg Tablets is
cetirizine hydrochloride. One film-coated tablet
contains 10 mg cetirizine hydrochloride.
- The other ingredients are: pregelatinized starch,
lactose, maize starch, povidone, magnesium
stearate, macrogol 6000, basic polymethacrylate,
titanium dioxide (E171), talc.
What Cetirizine 10 mg Tablets look like and
contents of the pack
White, capsule shaped film-coated tablets with a
score on one side.
There are 7, 10 or 30 tablets in a pack.
Not all pack sizes may be marketed.

Marketing Authorisation Holder / Manufacturer:
Dexcel ®-Pharma Ltd.,7 Sopwith Way, Drayton
Fields, Daventry, Northamptonshire, NN11 8PB,UK.
This leaflet was last revised in February 2014

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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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