Cetirizine Dihydrochloride 10 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER Cetirizine Dihydrochloride 10 mg Film-coated Tablets
(Cetirizine dihydrochloride)
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- 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.
1. What Cetirizine Tablets are and what they are used for
2. Before you take Cetirizine Tablets
3. How to take Cetirizine Tablets
4. Possible side effects
5. How to store Cetirizine Tablets
6. 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 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).
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 a severe kidney disease (severe kidney failure with creatinine clearance below 10 ml/min).
• 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
- If you are a patient with renal insufficiency, that is. when the kidneys fail to function properly, please ask your doctor for advice. If necessary, you will take a lower dose. The new dose will be determined by your doctor.
- If you are an epileptic patient or a patient at risk of experiencing fits, you should ask your doctor for advice.
No noticeable interactions have been observed between alcohol (at a level of 0.5 per millilitre in the blood, which is equivalent to one glass of wine) and cetirizine used at the normal doses. As with all antihistamines, it is recommended to avoid excessive alcohol consumption when taking Cetirizine.
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 in pregnant women. Accidental use of the drug by a pregnant woman should not produce any harmful effects on the foetus. Nevertheless, the administration of the medicine 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?
These guidelines apply unless your doctor has given you different instructions on how to use Cetirizine tablets. Please follow these instructions; otherwise Cetirizine tablets may not be fully effective.
Tablets need to be swallowed with a glass of liquid.
Dosage
- Adults and adolescents above 12 years old: 10 mg once daily as 1 tablet.
- Children between 6 and 12 years old: 10 mg once daily (1 tablet).
- Patients with moderate to severe kidney failure: Patients with moderate kidney failure are recommended to take 5 mg once daily (half a tablet).
If you feel that the effect of Cetirizine tablets is too weak or too strong, please consult your doctor.
The duration of treatment depends on the type, duration and course of your complaints and is determined by your doctor.
If you take more Cetirizine Tablets than you should
If you think you have taken an overdose of Cetirizine tablets please inform your doctor. Your doctor will then decide what measures, if any. should be taken.
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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
- general aches and uneasiness
- dilating of pupils of the eyes
- itching
- restlessness
- sedation
- sleepiness
- reduced responsiveness
- 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 doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines. Cetirizine tablets can cause side effects, although not everybody gets them.
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
- abnormal feelings of the skin
- 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
- aggression, confusion, depression, hallucination, insomnia
- hives
very rare: (affects less than 1 user in 10,000)
- low levels of blood platelets
- accommodation disorder, blurred vision, eyes having uncontrolled circular movements
- fainting, tremor, altered taste
- tic
- severe allergic reactions
- abnormal elimination of urine
- oedema, fixed drug eruption
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.
5. HOW TO STORE CETIRIZINE TABLETS
Keep out of the reach and sight 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 7, 14, 21, 28, 30 or 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
APTIL Pharma Limited,
9th floor, CP House, 97-107 Uxbridge Road, Ealing, London W5 5TL.
APC Pharmaceuticals & Chemicals (Europe) Ltd.,
9th floor, CP House, 97-107 Uxbridge Road, Ealing, London W5 5TL.
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