Cetirizine Hydrochloride 10 Mg Film-Coated Tablets
Package leaflet: Information for the user
Cetirizine Hydrochloride 10 mg Film-coated Tablets
cetirizine hydrochloride
The name of this medicine is Cetirizine Hydrochloride 10 mg Film-Coated 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.
What is in this leaflet
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
1. What Cetirizine Tablet is and what it is used for
Cetirizine hydrochloride 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 (perennial allergic 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:
• 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 severe kidney problems.
• 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.
Children
Cetirizine Tablets are not recommended for use in children below 6 years.
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)
Cetirizine Tablets with drinkAvoid alcoholic drink while you are taking this medicine.
Pregnancy and breast-feeding
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.
Driving and using machines
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.
Cetirizine Tablets contains lactose monohydrate
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 Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
This medicine is recommended in:
• 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
If you forget to take Cetirizine Tablets
Do not take double dose to make up for a 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.
If you stop taking Cetirizine Tablets
Do not stop the treatment unless your doctor tells you so. Contact your doctor or pharmacist before stopping.
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)
The following side effects have also been reported:
Common side effects (may affect up to 1 in 10 people):
• fatigue
• dry mouth, nausea,
• diarrhoea (children only)
• dizziness, headache
• sleepiness
• sore throat
• sneezing, a blocked, congested or itchy nose (children only)
Uncommon side effects (may affect up to 1 in 100 people):
• agitation
• paraesthesia (feeling of pins and needles)
• stomach ache
• rash, itching
• feelings of weakness and/or extreme tiredness (asthenia), feeling unwell (malaise)
• diarrhoea
Rare side effects (may affect up to 1 in 1,000 people):
• allergic reactions, some severe (very rare)
• aggression, confusion, depression, seeing or hearing things (hallucination), difficulty in sleeping (insomnia) abnormal liver function test results (your doctor will know what to do)
• fast heart beat (tachycardia)
• oedema (swelling of the feet or ankles)
• hives (urticaria)
• weight increase
• fits
Very rare side effects (may affect up to 1 in 10,000 people):
• difficulty with focussing the eyes, blurred vision, eyes having uncontrolled circular movements
• fainting, tremor, altered taste
• tics, shaking (tremor)
• loss of urinary control (enuresis)
• dyskinesia (involuntary movements)
• dystonia (abnormal prolonged muscular contractions)
• difficult, painful or involuntary urination
• 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)
Not known: (frequency can not be estimated from the available data)
• forgetfulness, memory impairment
• urinary retention (inability to completely empty the urinary bladder)
• vertigo (sensation of rotation or movement)
• increased appetite
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 Tablets
Keep this medicine out of the reach and sight of children.
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.
This medicinal product 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 medicine you no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information What Cetirizine Tablets contain:
The active ingredient is cetirizine hydrochloride. Each tablet contains 10 mg of cetirizine
hydrochloride.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, maize starch, talc, magnesium stearate. The film-coat contains titanium dioxide (E171), hypromellose (E464), lactose monohydrate, macrogol, sodium citrate (E331).
What Cetirizine Tablets look like and the contents of the pack:
Cetirizine Tablets are white coloured, circular, biconvex film coated tablets. They are marked with ‘A’ on one side and a break-line on the other.
Cetirizine Tablets are available in packs containing 7, 10, 14, 28, 30, 60 and 100 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.