PACKAGE LEAFLET INFORMATION FOR THE USER
CETIRIZINE DIHYDROCHLORIDE TABLETS 5MG
CETIRIZINE DIHYDROCHLORIDE TABLETS 10MG
Read all this leaflet carefully before you start taking this medicine, referred to as in this leaflet 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 to 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 a few days.
WHAT IS IN THIS LEAFLET:
- What CETIRIZINE DIHYDROCHLORIDE TABLETS 5mg/10mg Tablets are and what they are used for
- What you need to know before you take CETIRIZINE DIHYDROCHLORIDE TABLETS 5mg/10mg Tablets
- How to take CETIRIZINE DIHYDROCHLORIDE TABLETS 5mg/10mg Tablets
- Possible side effects
- How to store CETIRIZINE DIHYDROCHLORIDE TABLETS 5mg/10mg Tablet
- Contents of the pack and other information
1. WHAT CETIRIZINE DIHYDROCHLORIDE TABLETS 5mg/10mg TABLETS ARE AND WHAT THEY ARE USED FOR
The active ingredient (which makes this medicine work) is called cetirizine hydrochloride, which belongs to a family of medicines called antihistamines. CETIRIZINE DIHYDROCHLORIDE TABLETS 5mg/10mg Tablets are used to treat people who have hay fever (seasonal allergic rhinitis), year-round allergies such as dust or pet allergies (perennial allergic rhinitis) and urticaria (swelling, redness and itchiness of the skin). Antihistamines like CETIRIZINE DIHYDROCHLORIDE TABLETS 5mg/10mg Tablets relieve the unpleasant symptoms and discomfort associated with these conditions, such as sneezing, irritated, runny and blocked up nose, itchy, red and watering eyes and skin rashes.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETIRIZINE DIHYDROCHLORIDE TABLETS 10MG TABLETS
Do not take CETIRIZINE DIHYDROCHLORIDE TABLETS 5mg/10mg Tablets if you;
- are allergic to cetirizine hydrochloride or to any of the ingredients listed in section 6, to hydroxyzine or to any piperazine derivatives (closely related active substances of other medicines)
- suffer from severe kidney failure (creatinine clearance less than 10ml/min)
- have problems of urinary retention
- you are breast-feeding
If any of the above applies to you talk to your pharmacist.
Warnings and precautions:
- If you have liver or kidney problems please ask your pharmacist for advice.
- If you have predisposition factors of urinary retention (eg: spinal cord lesion, prostatic hyperplasia) as cetirizine increases the risk of urinary retention.,
- If you suffer from epilepsy or are at risk of convulsions, you should ask your pharmacist for advice.
Children and CETIRIZINE DIHYDROCHLORIDE TABLETS 5mg/10mg Tablets
The use of this medicine is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation.
Other medicines and CETIRIZINE DIHYDROCHLORIDE TABLETS 5mg/10mg Tablets
Please tell your doctor or a pharmacist if you are taking or have recently taken any other medicines, including any bought without a prescription.
CETIRIZINE DIHYDROCHLORIDE TABLETS 5mg/10mg Tablets with food and drink and alcohol
Food does not affect the absorption of this medicine.
Avoid alcohol while you are taking this medicine.
Pregnancy and breastfeeding
If you are pregnant or trying to become pregnant ask your pharmacist for advice before taking CETIRIZINE DIHYDROCHLORIDE TABLETS 5mg/10mg Tablets.
Do not take these tablets if you are breast-feeding.
If you are due to have an allergy test, ask your doctor if you should stop taking CETIRIZINE DIHYDROCHLORIDE TABLETS 5mg/10mg Tablets for several days before testing. This medicine may affect your allergy test results.
Driving and using machines
Some people have reported that they feel drowsy or dizzy while they are taking CETIRIZINE DIHYDROCHLORIDE TABLETS 5mg/10mg Tablets. If you are affected do not drive or use machines.
CETIRIZINE DIHYDROCHLORIDE TABLETS 5mg/10mg Tablets contain lactose
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 these tablets.
3. HOW TO TAKE CETIRIZINE DIHYDROCHLORIDE TABLETS 5mg/10mg TABLETS
Remember. Take the tablet with a glass of water. Do not take more than one tablet each day. If you do not feel better within a few days, consult your doctor.
Children aged 6 to 12 years: Half a tablet twice a day.
Adults and children aged 12 years and over: Take one tablet daily. If you have kidney problems (or liver and kidney problems together) please ask your doctor for advice: you may need to take a lower dose. The new dose will be determined by your doctor.
CETIRIZINE DIHYDROCHLORIDE TABLETS 5mg/10mg Tablets are not suitable for children under 6.
If you take more than you should
If you accidentally take too much medicine, contact your doctor or nearest casualty department at once.
If you forget to take a tablet
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Cetirizine Hydrochloride Tablets can cause side effects, although not everybody gets them.
The following side effects are very rare, but you must stop taking the tablets and speak to your doctor straight away if you notice these symptoms:
- A severe allergic reaction including rash, itchiness and fever, swollen throat, face, eyelids or lips. This reaction may start soon after you first take the medicine or it might start later.
- Bruising or bleeding more easily than normal.
- Convulsions or fits.
The following side effects have also been reported.
Common side effects (affects less than 1 in 10 people)
- Tiredness, feeling sleepy
- Dry mouth
- Diarrhoea (children only)
- Pain in the abdomen
- Sore throat
- Cold-like symptoms of the nose (children only)
Uncommon side effects (affects less than 1 in 100 people)
- Itching and rash
- Feeling weak or generally unwell
- Tingling in the hands and feet
- Feeling agitated.
Rare side effects (affects less than 1 in 1000 people)
- Fast heartbeat
- Oedema (generalised swelling due to water retention)
- Abnormal liver function test results (your doctor will know what to do)
- Increased weight
- Aggression, confusion, depression, hallucination (hearing or seeing things), sleepiness
- Urticaria (hives).
Very rare side effects (affects less than 1 in 10,000 people)
- Blurred vision, difficulty focussing
- Rotation of the eye
- Bad taste in the mouth
- Tremor, tics
- Involuntary movements and/or jerking of the limbs
- Muscle spasms in the neck and shoulders
- Swelling of the skin particularly around the face
- A recurring rash
- Bedwetting, pain and/or difficulty passing water.
Not known side effects
- Increased appetite
- Urinary retention
- Memory loss and/or impairment,
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.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE CETIRIZINE DIHYDROCHLORIDE TABLETS 5mg/10mg TABLETS
Keep this medicine out of the sight and reach of children. Do not take the tablets after the expiry date, which is stated on the blister and carton. The expiry date refers to the last day of that month. Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6.CONTENTS OF THE PACK AND OTHER INFORMATION
What CETIRIZINE DIHYDROCHLORIDE TABLETS 10MG Tablets contain
Each tablet contains 5mg of cetirizine hydrochloride (the active ingredient). They also contain lactose, microcrystalline cellulose, maize starch, colloidal anhydrous silica, magnesium stearate, talc, hypromellose, titanium dioxide (E171), macrogol 4000 and sodium citrate.
What CETIRIZINE DIHYDROCHLORIDE TABLETS 10MG Tablets look like
The tablets are white circular bi-convex, film-coated tablets marked C on one side and a broken line on the other.
Available in cartons containing 14 and 30 tablets.
- Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)