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BELLS HEALTHCARE ALLERGY AND HAYFEVER RELIEF 10 MG TABLETS

Active substance(s): CETIRIZINE DIHYDROCHLORIDE

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If you forget to take Cetirizine Tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER
Bell's Healthcare Allergy and Hayfever Relief 10 mg Tablets
Cetirizine dihydrochloride

Do not take a double dose to make up for the forgotten dose.
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.
If you have any further questions on the use of this medicinet, ask your doctor or pharmacist.

The name of this medicine is Bell's Healthcare Allergy and Hayfever Relief 10 mg Tablets, which will be
referred to as Cetirizine Tablets throughout this leaflet.
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 has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- 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.
- You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

4. Possible side effects
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:
- serious allergic reaction which causes difficulty in breathing or dizziness, swelling of the face or throat
- reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)
- suicidal ideation (recurring thoughts of or preoccupation with suicide)

What is in this leaflet:

The following side effects have also been reported.
Common: (may affect up to 1 in 10 people)

1. What Cetirizine Tablet is and what it is used for
2. What you need to know before you take Cetirizine Tablets
3. How to take Cetirizine Tablets
4. Possible side effects
5. How to store Cetirizine Tablets
6. Contents of the pack and other information

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1. What Cetirizine Tablet is and what it is used for

Uncommon: (may affect up to 1 in 100 people)

Cetirizine dihydrochloride is the active ingredient of Cetirizine tablet, which belongs to a group of medicines
called antihistamines. Cetirizine is an antiallergic medication.
In adults and paediatric patients 6 years and above, Cetirizine is indicated
- for the relief of hayfever (allergic rhinitis) and year round allergies such as dust or pet allergies
(perennialallergic rhinitis)
- for the relief of chronic nettle rash (chronic idiopathic urticaria).
You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

2. What you need to know before you take Cetirizine Tablets
Do not take Cetirizine Tablets
- If you are allergic to cetirizine or any of the other ingredients of this medicine (listed in
section 6) or to hydroxyzine or to any piperazine derivatives
- If you have a severe kidney disease
- If you are breast-feeding

Warnings and precautions
Talk to your doctor or pharmacist before taking Cetirizine Tablets.
- If you want to use for children less than 6 years of age.
- If you suffer from epilepsy or are at risk of convulsions (fits).
- If you have an enlarged prostate. It may increase the risk of having difficulty passing water.
- If you are having an allergy skin test you need to wait 3 days after taking Cetirizine Tablets.

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fatigue
dry mouth, nausea, diarrhoea (children only)
dizziness, headache
sleepiness
sore throat
sneezing, a blocked, congested or itchy nose (children only)

- paraesthesia (feeling of pins and needles)
- feelings of weakness and/or extreme tiredness (asthenia), feeling unwell (malaise)
- diarrhoea
- agitation
- itching, rash
- stomach ache

Rare: (may affect up to 1 in 1,000 people)
-

heart beating too fast
oedema (swelling of the feet or ankles)
allergic reactions, some severe (very rare)
changes in liver function tests, indicating the possibility of damage to the liver
weight increase
fits
aggression, confusion, depression, seeing or hearing things (hallucination), difficulty in sleeping (insomnia)
hives

Very rare: (may affect up to 1 in 10,000 people)

Cetirizine Tablets with drink

-

Avoid alcoholic drink while you are taking this medicine.

Not known: (frequency can not be estimated from the available data)

Pregnancy and breast-feeding

-

Children
Cetirizine tablets are not recommended for use in children below 6 years of age.

Other medicines and Cetirizine Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines such as:
- medication for anxiety or stress (CNS depressants)

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 Tablets should be avoided in pregnant women. Accidental use of the drug by a pregnant woman
should not produce any harmful effects on the foetus. Nevertheless, the medicine should only be administered
if necessary and after medical advice.
Do not take Cetirizine Tablets during breast-feeding because cetirizine passes into breast milk.

difficulty with focussing the eyes, blurred vision, eyes having uncontrolled circular movements
fainting, tremor, altered taste
difficult, painful or involuntary urination
tics, shaking (tremor)
loss of urinary control (enuresis)
dyskinesia (involuntary movements)
dystonia (abnormal prolonged muscular contractions)
swelling of the skin particularly around the face or throat
fixed drug eruption (appearance of red or blistered skin in the same place after taking this medicine)
forgetfulness, memory impairment
urinary retention (inability to completely empty the urinary bladder)
vertigo (sensation of rotation or movement)
increased appetite

Reporting of side effects

Some people have reported that they feel drowsy
or dizzy while they are taking Cetirizine Tablets. If you are affected do not drive or use machines.

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.

Cetirizine Tablets contains lactose monohydrate

5. How to store Cetirizine Tablets

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.

Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special temperature storage conditions.
Keep the blister in the outer carton in order to protect from light.
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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicine you no longer required. These measures will help protect the environment.

Driving and using machines

3. How to take Cetirizine Tablets
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose is
- Adults and adolescents over 12 years of age: One tablet (10mg) once daily. Your doctor may prescribe you
starting dose 5 mg (a half tablet) if this leads to satisfactory control of the symptoms.
- Children aged from 6 to 12 years: 5mg twice daily (a half tablet twice daily).
- Children under 6 years: Not recommended.
- If you have kidney problems you should talk to your doctor or pharmacist for advice before
taking these tablets as a lower dose may be required.
If you take more Cetirizine Tablets than you should
If you accidentally take too many tablets go and see your doctor straightaway.
After an overdose, the side effects described in section 4 below may occur with increased intensity.
The following side effects have been reported:
- confusion
- diarrhoea
- dizziness
- tiredness
- headache
- a vague feeling of discomfort
- dilating of pupils of the eyes
- itching
- restlessness
- sedation
- sleepiness
- stunned state in which it is difficult to get a response
- abnormal rapid heart rate
- tremors
- urinary retention

6. Contents of the pack and other information
What Cetirizine Tablets contain
- The active substance is cetirizine dihydrochloride. Each film-coated tablet contains 10 mg cetirizine
dihydrochloride.
- The other ingredients are microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica,
maize starch, purified talc, magnesium stearate. The film-coat contains hypromellose 15cP, lactose
monohydrate, titanium dioxide (E171), macrogol 4000 and sodium citrate.

What Cetirizine Tablets look like and contents of the pack
Cetirizine Tablets are white coloured, circular, biconvex film-coated tablets, marked with ‘A’ on one side and a
breakline score on the other.
The diameter of each tablet is 8 mm.
The tablet can be divided into equal halves.
Cetirizine Tablets are presented in blister packs of 4, 5, 7, 14 or 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom.
Manufacturer
Cipla (EU) Limited, 20 Balderton Street, London W1K 6TL, United Kingdom
Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium
Distributor
Bell Sons Co Druggist Ltd, Gifford House, Slaidburn Crescent, Southport, PR9 9AL United Kingdom.
This leaflet was last revised in 09/2015.

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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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