Bells Healthcare Allergy And Hayfever Relief 10 Mg Tablets
Out of date information, search anotherPACKAGE LEAFLET: INFORMATION FOR THE USER Cetirizine Dihydrochloride 10 mg Film-coated Tablets
(Cetirizine dihydrochloride)
; 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 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:
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3.
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What Cetirizine Tablets are and what they are used for
Before you take Cetirizine Tablets
How to take Cetirizine Tablets
Possible side effects
How to store Cetirizine Tablets
Further information
1. WHAT CETIRIZINE TABLETS ARE AND WHAT THEY ARE USED FOR
The name of this medicine is Cetirizine Dihydrochloride 10 mg Film-coated Tablets (referred to as Cetirizine Tablets or Cetirizine throughout this leaflet).
Cetirizine dihydrochloride is the active ingredient of Cetirizine Tablets. Cetirizine is an antiallergic medication. In adults and children aged 6 year 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 swelling, redness and itchiness of the skin
2. BEFORE YOU TAKE CETIRIZINE TABLETS
Do not take Cetirizine Tablets
• if you are known to be allergic (hypersensitive) to the active substance of Cetirizine, to any of its excipients (other constituents), to hydroxyzine or to piperazine derivatives (closely related active substances of other medicines).
• if you have severe kidney problems.
• if you have hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
• if you are breast-feeding
Take special care with Cetirizine Tablets
- Cetirizine Tablets are not recommended for use in children below 6 years
- Do not take more medicine that the labelling and leaflet tell you to Drinking alcohol whilst taking these tablets is not recommended.
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.
Due to the profile of cetirizine, no interactions with other drugs are expected.
Taking Cetirizine with food and drink
Food does not noticeably affect the absorption of cetirizine.
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.
As with other drugs, use of Cetirizine tablets should be avoided during pregnancy and the administration of Cetirizine should be discontinued.
Do not take Cetirizine Tablets during breast-feeding because cetirizine passes into breast milk.
Driving and using machines
Antihistamines can cause drowsiness in some patients.
Although this has not been reported with cetirizine at the recommended dose, please be cautious whilst driving or operating machinery.
Important information about some of the ingredients of Cetirizine
Cetirizine 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 TABLETS
How and when should you take Cetirizine?
Please follow the instructions below unless your pharmacist has advised differently:
The tablets need to be swallowed with a glass of liquid.
Dosage
- Adults and adolescents above 12 years old: One tablet (10 mg) once daily.
- Children between 6 and 12 years old: One tablet (10 mg) once daily.
- Patients with moderate to severe kidney failure: Patients with moderate kidney failure are recommended to take half a tablet (5 mg) once daily.
If you feel that the effect of Cetirizine tablets is too weak or too strong, please consult your pharmacist.
If you take more Cetirizine Tablets than you should
If you think you have taken an overdose of Cetirizine Tablets, please inform your pharmacist.
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
PACKAGING DEVELOPMENT
Product Name : Cetrizine Dihydrochloride Tablets 10mg GSL Item Code : KT15 A Item : PIL Date : 26-02-14
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- 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 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 product, ask your pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Cetirizine tablets can cause side effects, although not everybody gets them.
Stop taking Cetirizine and seek immediate medical attention if you experience:
- Sudden signs of severe allergic reaction such as rash, swelling of mouth, eyelids or face or difficulty in breathing
- Bruising or bleeding more easily than normal
- Convulsions or fits
- Fainting (loss of consciousness)
- Confusion
- Hallucination
- Rapid heart beat
Some side effects will be determined by blood tests such as abnormal liver function tests or low levels of blood platelets
common: (affects 1 to 10 users in 100)
- fatigue
- dry mouth, nausea, diarrhoea
- dizziness, headache
- sleepiness
- sore throat, sneezing, a blocked, congested or itchy nose.
uncommon: (affects 1 to 10 users in 1,000)
- abdominal pain
- extreme fatigue
- tingling in hands and feet
- agitation
- itching, rash
rare: (affects 1 to 10 users in 10,000)
- heart beating too fast
- swelling
- allergic reactions
- abnormal liver function
- weight increase
- fits, movement disorders such as shaking, muscle spasm or tics
- aggression, confusion, depression, hallucination, insomnia
- hives
very rare: (affects less than 1 user in 10,000)
- low levels of blood platelets
- difficulty with focussing the eyes, blurred vision, eyes having uncontrolled circular movements
- fainting, tremor, altered taste
- tic
- severe allergic reactions
- difficult, painful or involuntary urination
- Fixed drug eruption (red or purple raised area on the skin that occurs in the same place when cetirizine tablets are taken).
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 TABLETS
Keep out of the sight and reach of children.
Store in the original package.
Do not use Cetirizine after the expiry date which is stated on the carton after ‘EXP’. The expiry date refers to the last day of that month.
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 protect the environment.
6. FURTHER INFORMATION
What Cetirizine Tablets contain
- The active substance is cetirizine dihydrochloride. One 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 10 mg film-coated 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.
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, 4th Floor, 1 Kingdom Street, London, W2 6BY, United Kingdom
This leaflet was last revised in February 2014. _
KT15 A