Cetirizine Hydrochloride 10mg Film-Coated Tablets
Aspar Cetirizine 30's PIL V23 (Sp) PL0099_Victor 17/04/2015 13:20 Page 1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Cetirizine hydrochloride 10 mg film-coated Tablets
Cetirizine Dihydrochloride
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, pharmacist or nurse 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 you do not feel better or if you feel worse after 3 days.
• If you get any of the side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Cetirizine hydrochloride is and what it is used for
2. What you need to know before you take Cetirizine hydrochloride
3. How to take Cetirizine hydrochloride
4. Possible side effects
5. How to store Cetirizine hydrochloride
6. Contents of the pack and other information
1. WHAT CETIRIZINE HYDROCHLORIDE IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active ingredient of Cetirizine hydrochloride 10 mg Tablets.
Cetirizine hydrochloride 10 mg Tablets is an antiallergic medication.
In adults and children aged 6 year and above, Cetirizine hydrochloride 10 mg Tablets is indicated
- For the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis (hayfever and year-round allergies affecting the nose and eyes).
- For the relief of chronic nettle rash (chronic idiopathic urticaria)
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETIRIZINE HYDROCHLORIDE
Do not take Cetirizine hydrochloride:
• If you are allergic (hypersensitive) to Cetirizine hydrochloride, to any of the other ingredients of Cetirizine hydrochloride 10 mg Tablets, to hydroxyzine or to piperazine derivatives (closely related active substances of other medicines).
• If you have severe kidney problems (severe renal failure with creatinine clearance below 10 ml/min).
You should not take Cetirizine hydrochloride:
• If you have hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
Cetirizine hydrochloride 10 mg tablets are not for use in children under 6 years of age.
Take special care with Cetirizine hydrochloride
• If you have kidney problems, please ask your doctor for advice; if necessary, you will take a lower dose. The new dose will be determined by your doctor.
• No interactions suspected to have a noticeable impact have been observed between alcohol (at the blood level of 0.5 per mille corresponding to one glass of wine) and cetirizine used at the normal doses. However, there are no data available on the safety when higher doses of cetirizine and alcohol are taken together. Therefore, as it is the case with all antihistamines, it is recommended to avoid taking Cetirizine hydrochloride with alcohol.
• If you are an epileptic patient or a patient at risk of convulsions (fits), you should ask your doctor for advice.
• If you have predisposition factors of urinary retention (eg: spinalcord lesion, prostatic hyperplasia) as cetirizine increases the risk of urinary retention.
Allergy Testing
If you are due to have an allergy test, ask your doctor if you should stop taking Cetirizine dihydrochloride for several days before testing. This medicine may affect your allergy test results.
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. The available information on this medicine suggests no interactions with other medicines should be expected.
Taking Cetirizine hydrochloride with food and drink
Food does not affect noticeably the absorption of cetirizine.
Avoid alcoholic drink while you are taking this medicine.
Pregnancy and breast-feeding
Pregnancy: Pregnant women should consult their doctor before taking this medicine. As with other drugs, use of Cetirizine hydrochloride 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
Clinical studies have produced no evidence of impaired attention, alertness and driving capabilities after taking Cetirizine hydrochloride at the recommended dose. If you are intending to drive, engage in potentially hazardous activities or operate machinery, you should not exceed the recommended dose. You should closely observe your response to the drug. If you are a sensitive patient, you may find that the simultaneous use of alcohol or other nervous depressant agents may additionally affect your attention and ability to react.
Important information about some of the ingredients of Cetirizine hydrochloride 10 mg 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
Always take Cetirizine hydrochloride 10 mg Tablets exactly as your doctor has told you. You should check with your doctor or your pharmacist if you are not sure.
Adults, elderly and adolescents above 12 years old: 1 tablet (10 mg) daily Children aged between 6 to 12 years: A tablet (5 mg) twice daily Patients with moderate kidney problem: A tablet (5 mg) once daily
Method of administration
Cetirizine hydrochloride 10 mg Tablets can be taken with food or without food. The tablets should be swallowed with a glass of liquid.
If you feel that the effect of Cetirizine hydrochloride is too weak or too strong, please consult your doctor.
Duration of treatment:
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 hydrochloride 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, dilating of pupil, itching, restlessness, sedation, sleepiness, unconsciousness, tremor, headache, abnormal rapid heart rate or problems passing urine.
If you forget to take Cetirizine hydrochloride
If you forget to take a dose, take it as soon as you remember it, then continue taking your medicine as before but always leave at least 12 hours between doses. 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 10 mg 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.
These reactions may start soon after you first take the medicine, or it might start later
Common (occurs in more than 1 in 100 but fewer than 1 in 10 patients given the medicine):
Tiredness, feeling sleepy, drowsiness, fatigue, headache, dizziness, dry mouth, abdominal pain, nausea, diarrhoea (children only), swelling and irritation of the throat, cold-like symptoms of the nose (children only)
Uncommon (occurs in more than 1 in 1000 but fewer than 1 in 100 patients given the medicine):
Agitation, weakness, feeling generally unwell, paresthesia (abnormal feeling of the skin), rash which may be itchy, diarrhoea
Rare (occurs in more than 1 in 10,000 but fewer 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 fewer 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, fainting, problems with or pain on passing urine, urinary incontinence (weak bladder), tremor, tic, involuntary movements and muscle contractions, involuntary circular movement of the eyeballs, a recurring rash, swelling of the skin particularly around the face or throat.
Not Known (can not be estimated from the available data):
Memory loss, forgetfulness, urinary retention, increased appetite, vertigo.
In very rare cases people have thought about committing suicide and if you feel this way then stop taking the tablets and see your doctor.
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, Website: 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 HYDROCHLORIDE
Keep out of the reach and sight of children.
Do not use Cetirizine hydrochloride 10 mg 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. CONTENTS OF THE PACK AND OTHER INFORMATION
What Cetirizine hydrochloride contains
The active substance is Cetirizine dihydrochloride. Each tablet contains 10 mg of Cetirizine dihydrochloride
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 looks like and contents of the pack
Cetirizine hydrochloride 10 mg Tablets are white circular film-coated tablets, marked 'A' on one side and a break line on the other side.
They come in blister packs of 7, 10, 14, 20, 21, 28, 30 and 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is Chanelle Medical.
The manufacturer is Chanelle Medical, Loughrea, Co. Galway, Ireland.
The distributor is Aspar Pharmaceuticals Ltd.
This medicinal product is authorised in the Member States of the EEA under the following names
|
NAME OF MEMBER STATE |
NAME OF MEDICINAL PRODUCT |
|
UK |
Cetirizine hydrochloride 10 mg film coated Tablets |
|
Ireland |
Tiritek Allergy 10 mg film coated Tablets |
|
Italy |
Cetirizina Germed 10 mg compresse rivestite con film |
|
Malta |
ALTACURA ALLERGY |
|
Poland |
Acatarick Allergy |
LD2629
This leaflet was last approved in 04/2015