CETIRIZINE HYDROCHLORIDE 10 MG FILM-COATED TABLETS

Active substance: CETIRIZINE HYDROCHLORIDE

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Patient Information Leaflet
CETIRIZINE HYDROCHLORIDE 10 mg FILM-COATED TABLETS
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.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
You must contact a doctor if your symptoms worsen or do not improve.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist. This includes any side effects not listed in the leaflet. See section 4.
The name of this medicine is Cetirizine Hydrochloride 10 mg Film-coated Tablets but will be referred to as
Cetirizine in the rest of the leaflet.
What is in this leaflet
1.
2.
3.
4.
5.
6.

What Cetirizine is and what it is used for
What you need to know before you take Cetirizine
How to take Cetirizine
Possible side effects
How to store Cetirizine
Contents of the pack and other information

1. WHAT CETIRIZINE IS AND WHAT IT IS USED FOR
!
!

Cetirizine is an antihistamine. Antihistimines help to relieve the symptoms of some allergies.
In adults and children 12 years and above, Cetirizine is used
! to relieve the nasal symptoms of hay fever, seasonal rhinitis (runny and itchy nose)
! To relieve the symptoms of other allergies e.g. pet or house dust mite allergies.
! for skin allergies such as rash, itching and urticaria (hives).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETIRIZINE
Do not take Cetirizine if you:
!
!
!

Are allergic to cetirizine or similar products e.g. hydroxyzine, cyclizine, meclozine or to any of the other
ingredients of this medicine (listed in section 6).
Are undergoing dialysis for kidney problems
Have a hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

Warnings and precautions
Talk to your doctor or pharmacist before taking Cetirizine.
! Have liver problems
! Kidney problems, as the dose may need to be adjusted.
! Are epileptic or at risk of convulsions
! have urinary retention problem
Allergy tests: If you are going to have an allergy skin test, stop taking this medicine 3 days before the test.

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If you take Cetirizine for a long time, there is an increased risk of tooth decay due to mouth dryness. It is
important to brush your teeth regularly whilst taking Cetirizine.

Children and adolescents
! Not recommended in children aged less than 12 years of age.
Other medicines and Cetirizine
Talk to your doctor if you are taking any of the following
! Sedatives e.g. nitrazepam, as their effects may be increased by Cetirizine.
Due to the profile of cetirizine, no interactions with other drugs are expected.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.

Cetirizine with food, drink and alcohol
! Do not take large amounts of alcohol whilst taking Cetirizine, as this medicine may increase the effects
of alcohol.

Pregnancy, breast-feeding and fertility
If you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before
taking this medicine.
! Do not take Cetirizine, if you are breast-feeding.
Driving and using machines:
! When taken at the recommended dose, Cetirizine is not expected to affect your ability to drive or operate
machinery. However, there are exceptions and you should take care when using this medicine for the
first time.
! If this product makes you feel drowsy, DO NOT drive or operate machinery. This effect will be worse if
you are also taking sedatives or drinking alcohol.

Cetirizine contains lactose
Patients who are intolerant to lactose should note that Cetirizine contains a small amount of lactose. If your
doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this
medicinal product.

3. HOW TO TAKE CETIRIZINE
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
Check with your doctor or pharmacist if you are not sure.
Cetirizine should be swallowed whole with a drink of water.
The recommended dosage is given below:
!

Adults and children 12 years and over:
One tablet (10 mg) once daily.

!

Children under 12 years of age:
Cetirizine is not recommended for children under this age.

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Patients with moderate kidney problems should only take 5 mg (half a 10 mg tablet) once daily..
Patients with severe kidney problems should only take 5 mg (half a 10 mg tablet) once every two days.

If you take more Cetirizine than you should
If you (or someone else) swallow a lot of the tablets all together or if you think a child has accidentally
swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.
The effects of an overdose may cause confusion, diarrhoea, dizziness, tiredness, headache, a general feeling
of being unwell, restlessness, feeling sleepy, a state of semi-unconsciousness, faster heartbeat, shaking or
problems urinating.
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they
know which tablets were consumed.

If you forget to take Cetirizine
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one.
Do not take a double dose to make up for a forgotten tablet or dose. Take the remaining doses at the correct
time.
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 have side effects, although not everybody gets them.
Stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest
hospital if the following happens:
! a severe allergic reaction (swelling of the face, lips, mouth or throat leading to severe difficulty in
breathing or swallowing; skin rash or hives).
This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.
The below side effect has been reported with Cetirizine. Tell your doctor if you notice the following:
! abnormal liver function tests (diagnosed by blood and/or urine tests).
The following side effects have been reported at the approximate frequencies shown:
Common (affecting fewer than one person in 10 but more than one person in 100)
! tiredness or sleepiness
! dizziness or headache
! nausea or diarrhoea
! dry mouth or difficulty in swallowing accompanied by earache and swollen glands, sore throat
! runny and itchy nose.
Uncommon (affecting less than one person in 100 but more than one person in 1,000):
! agitation
! abdominal pain
! lethargy or feeling weak and/or unwell

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!
!

pins and needles
skin itchiness or rashes.

Rare (affecting less than one person in 1,000 but more than one person in 10,000):
! rapid heartbeat
! water retention
! liver problems
! weight gain
! fits or unusual movements of your arms and/or legs
! aggression or depression
! confusion
! hallucinations
! difficulty in sleeping
! red and/or blotchy skin rash.
Very rare (affecting less than one person in 10,000):
! bleeding and bruising easily (could indicate problems with your blood)
! sight problems including difficulty focusing and blurred vision
! unusual movements of the eyeball
! fainting
! decreased sense of taste
! bed wetting
! pain in passing water
! inflammatory skin eruption
! unusual movements or contractions in the face
! abnormal muscle rigidity or movements
! shaking.
Side effects with frequency not known
! Amnesia -Partial or total loss of memory, memory impairment
! Increased appetite
! Vertigo
! Urinary retention
In very rare cases people have thoughts about committing suicide and if you feel this way then
stop taking these tablets and see your doctor.

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, pharmacist or nurse. 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
Keep this medicine out of sight and reach of children.
There are no special storage conditions. Do not transfer to another container.

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Do not take Cetirizine after the expiry date which is stated on the outer packaging. The expiry date refers to
the last day of that month.
Do not take this medicine if you notice any defects or signs of deterioration in the tablets such as broken
tablets.
.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer take. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Cetirizine contain
! The active ingredient is cetirizine dihydrochloride 10 mg.
! The other ingredients are microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica,
magnesium stearate (E572), hypromellose (E464), macrogol, titanium dioxide (E171) and polydextrose.

What Cetirizine look like and contents of the pack
! Cetirizine Tablets are white to off white, capsule-shaped tablets, debossed with C10 on one side and a
deep breakline on the other.
! The product is available in pack sizes of 7 and 14 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder and company responsible for manufacture: TEVA UK Limited, Eastbourne,
BN22 9AG.
This leaflet was last revised: August 2014
PL 00289/0388 - GSL category

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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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