CETIRIZINE HYDROCHLORIDE 10MG TABLETS(ONE A DAY)

Active substance: CETIRIZINE DIHYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Aspar Hayfever and Allergy Relief
Cetirizine hydrochloride 10 mg Tablets (One a day)
Read all of this leaflet carefully because it contains important information for you
This medicine is available without prescription. However, you still need to use Cetirizine hydrochloride Tablets carefully to
get the best results from it.

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 after 3 days.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What Cetirizine hydrochloride Tablets is and what it is used for
2. Before you take Cetirizine hydrochloride Tablets
3. How to take Cetirizine hydrochloride Tablets
4. Possible side effects
5. How to store Cetirizine hydrochloride Tablets
6. Further information
1. WHAT CETIRIZINE HYDROCHLORIDE TABLETS IS AND WHAT IT IS USED FOR
Cetirizine hydrochloride is the active ingredient of Cetirizine hydrochloride Tablets.
Cetirizine hydrochloride Tablets are an anti allergy medication.
In adults and children aged 6 years and above, Cetirizine hydrochloride Tablets are used:
For the relief of symptoms of seasonal (hayfever) and year round allergies (e.g. sneezing, running or itchy nose, watery eyes).
For the relief of chronic nettle rash.
2. BEFORE YOU TAKE CETIRIZINE HYDROCHLORIDE TABLETS
Do not take Cetirizine hydrochloride Tablets:

If you are allergic (hypersensitive) to Cetirizine hydrochloride, to any of the other ingredients of Cetirizine hydrochloride
Tablets, to hydroxyzine or to piperazine derivatives (closely related active substances of other medicines).

If you have severe kidney problems.

If you have or there is a family history of problems with galactose intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption.
Cetirizine hydrochloride Tablets are not for use in children under 6 years of age.
Take special care with Cetirizine hydrochloride Tablets

If you have liver and kidney problems, please ask your doctor for advice; if necessary, your doctor may recommend a
lower dose.

When drinking alcohol while taking this medicine.

If you are an epileptic patient or a patient at risk of convulsions (fits), you should ask your doctor for advice.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines
obtained without a prescription.
Allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them.
The available information on this medicine suggests no interactions with other medicines should be expected.
Pregnancy and breast-feeding
Pregnancy: As with other drugs, use of Cetirizine hydrochloride 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 use of the
medicine during pregnancy should be discontinued.
Breast-feeding: Do not use this medicine while breast feeding because cetirizine passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
A few people have experienced dizziness, drowsiness or fatigue after taking cetirizine. If affected, do not attempt any
skilled task such as driving or operating machinery. Do not exceed the recommended dose.
Take special care if you drink alcohol while taking Cetirizine hydrochloride Tablets- the effect may be increased. Never drink
and then drive or operate tools and machines.
Important information about some of the ingredients of Cetirizine hydrochloride Tablets
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 HYDROCHLORIDE TABLETS

Always take Cetirizine hydrochloride Tablets exactly as your doctor has told you. You should check with your doctor or
your pharmacist if you are not sure.
Adults, elderly patients and children 12 years and over: 1 tablet daily
Children aged between 6 to 12 years: ½ tablet (5mg) twice daily
Patients with moderate kidney problems: ½ tablet (5mg) once daily
Method of administration
Cetirizine hydrochloride Tablets can be taken with food or without food. The tablets should be swallowed with water.
If you take more Cetirizine hydrochloride Tablets than you should
Contact your doctor or Accident and Emergency department at your nearest hospital. Take this leaflet and any tablets you
still have with you. Symptoms of overdose include confusion, diarrhoea, dizziness, tiredness, feeling generally unwell,
dilated pupils, itching, restlessness, sleepiness, loss of consciousness, tremor, headache, abnormal rapid heart rate or
problems passing urine.
If you forget to take Cetirizine hydrochloride Tablets
Do not take a double dose to make up for a forgotten dose.
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 hydrochloride Tablets can cause side effects, although not everybody gets them. Side effects
are usually mild and usually wear off as treatment continues. The following side effects have been reported.
If any of the following very rare but serious side effects happen, stop taking these tablets. Tell your
doctor immediately or contact the Accident and Emergency department at your nearest hospital.



An allergic reaction which may include fainting, swelling of face, lips, tongue or throat or difficulty breathing or swallowing.
A raised or blistering red itchy rash particularly likely on the back of the hand and lower arms.

Common (occurs in less than 1 in 10 patients given the medicine):
Somnolence (sleepiness or feeling drowsy), fatigue, headache, dizziness, dry mouth, nausea, diarrhoea, swelling and
irritation of the throat, swelling and irritation of the nose.
Uncommon (occurs in less than 1 in 100 patients given the medicine):
Abdominal pain, agitation, weakness, feeling generally unwell, pins and needles (tingling), rash which may be itchy.
Rare (occurs in less than 1 in 1000 patients given the medicine):
Racing heartbeat, oedema (swelling), allergic reactions, changes to liver function (detected through blood tests), weight
gain, fits, aggression, confusion, depression, sensing things that are not really there (hallucinations), difficulty sleeping, itching.
Very rare (occur in less than 1 in 10,000 patients given the medicine):
Reduction in blood platelets which increases the risk of bleeding or bruising, difficulty focusing your eyes, blurred vision,
allergic shock (serious allergic reaction which causes difficulty in breathing or dizziness), altered taste, restlessness,
problems with or pain on passing urine, urinary incontinence (weak bladder), tremor, tic,involuntary movements and
muscle contractions, involuntary circular movement of the eyeballs, fainting, red or purple lesions on the skin.
Not Known (can not be estimated from the available data):
Amnesia and memory impairment.
If you notice anything unusual or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5.

HOW TO STORE CETIRIZINE HYDROCHLORIDE TABLETS

Keep out of the reach and sight of children.
Do not use Cetirizine hydrochloride Tablets after the expiry date which is stated on the blister and the carton. The expiry
date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to protect the environment.
6.

FURTHER INFORMATION

What Cetirizine hydrochloride Tablets contains
The active substance is Cetirizine hydrochloride. Each tablet contains 10 mg of Cetirizine hydrochloride.
The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, colloidal anhydrous silica,
magnesium stearate, talc, hypromellose, titanium dioxide (E171), macrogol 4000 and sodium citrate.
What Cetirizine hydrochloride Tablets looks like and contents of the pack
Cetirizine hydrochloride Tablets are white circular film-coated tablets, marked ‘A’ on one side with a break line on the other
side and are available in blister pack containing 7 tablets.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is Cipla Chanelle Ltd.
Loughrea, Co. Galway, Ireland.
The manufacturer is Chanelle Medical, Loughrea, Co. Galway, Ireland.
The distributor is Aspar Pharmaceuticals.Ltd
This leaflet was revised 02/2011.

LB2630

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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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