Cetirizine Dihydrochloride 10mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Cetirizine Dihydrochloride 10 mg Film-coated Tablets
Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to take this medicine 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.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The name of your medicine is Cetirizine Dihydrochloride 10mg Film-coated Tablets. In the rest of this leaflet it is called Cetirizine Tablets.
In this leaflet:
1. What Cetirizine Tablets are and what they are used for
2. Before you take Cetirizine Tablets
3. How to use 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 your medicine is Cetirizine Tablets; the active ingredient is cetirizine. These tablets belong to the group of medicines called antihistamines and are used to relieve the symptoms of some allergies.
In adults and children aged 6 years and above, Cetirizine Tablets are indicated
• for the relief of nasal and eye symptoms of seasonal and 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 allergic (hypersensitive) to cetirizine dihydrochloride, any of the other ingredients in Cetirizine Tablets (see section 6, Further information), hydroxyzine or piperazine derivatives (medicines that are closely related to cetirizine)
• you have severe kidney problems (severe renal failure with creatinine clearance below 10 ml/min).
You should not take Cetirizine Tablets if:
• if you have hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Take special care with Cetirizine Tablets:
• if you are a patient with kidney problems, please ask your doctor for advice; if necessary, you will take a lower dose. The dose will be determined by your doctor • if you are an epileptic patient or a patient at risk of convulsions
• if you are elderly
• if you are due to have an allergy test. Ask your doctor if you should stop taking Cetirizine Tablets for several days before testing, as this medicine may affect your allergy test results.
• if you have difficulty passing urine, you should ask your doctor for advice.
Cetirizine Tablets are not recommended for children under 6 years of age as the dose cannot be modified.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines.
• Medication for anxiety or stress (CNS depressants)
• Any other medicines, including medicines obtained without a prescription.
Taking Cetirizine Tablets with food and drink
This medicine can be taken with or without food at any time of the day.
No significant interactions have been observed with alcohol and cetirizine tablets. However, as it is the case with all antihistamines, it is recommended to avoid taking alcohol.
Pregnancy and breast-feeding
Do not take Cetirizine Tablets if you are pregnant or breast feeding, unless your doctor has specifically recommended it. 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 Tablets 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 ingredients of Cetirizine Tablets
This product contains lactose. You should speak to your doctor before taking this medicine if you have been told by your doctor that you have an intolerance to some sugars.
3. How to use Cetirizine Tablets
Always take Cetirizine Tablets exactly as described on the label, it will tell you how many tablets to take and how often to take them. You should check with your doctor or pharmacist if you are not sure.
The tablets need to be swallowed with a glass of liquid.
Adults and adolescents over 12 years of age:
• usual dose is one tablet once daily.
Children aged 6-12 years:
• usual dose is 5mg twice daily as a half tablet twice daily.
Patients with kidney problems
If you have kidney problems speak to your doctor or pharmacist, as you may require a lower dose.
If you feel that the effect of Cetirizine Dihydrochloride 10 mg Tablets is too strong or too weak, talk to your doctor or pharmacist.
If you take more Cetirizine Tablets than you should
If you (anyone else or a child), takes more Cetirizine Tablets than you
104238/3
|
Product |
Reference |
|
name |
number |
|
Cetirizine | |
|
Dihydrochloride |
PL 29831/0035 |
|
10 mg Film-coated | |
|
Tablets |
should contact a doctor or go to your nearest hospital casualty department immediately. Take this leaflet and the container with you, even if empty. Some of the symptoms of taking too much of this medicine include diarrhoea, confusion, dizziness, tiredness, shaking, headache, difficulty passing urine, fast heartbeat or dilated pupils.
If you forget to take Cetirizine Tablets
Take your missed tablet as soon as you remember. Do not take a double dose to make up for a forgotten dose, and always leave at least 12 hours between doses.
4. Possible side effects
Like all medicines, Cetirizine Tablets can have side effects, although not everybody gets them. The following side effects have sometimes been noticed by people taking this medicine.
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:
• 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.
• In very rare cases people have thoughts about committing suicide and if you feel this way then stop taking the tablets and see your doctor.
The following side effects have also been reported.
Common side effects (affects less than 1 in 10 people)
• Tiredness, feeling sleepy
• Headache
• Dry mouth
• Nausea
• Diarrhoea (children only)
• Pain in the abdomen
• Dizziness
• Sore throat
• Cold-like symptoms of the nose (children only).
Uncommon side effects (affects less than 1 in 100 people)
• Itching and rash
• Diarrhoea
• Feeling weak or generally unwell
• Tingling in the hands and feet
• Feeling agitated.
Rare side effects (affects less than 1 in 1000 people)
• fast heart beat
• oedema (generalised swelling due to water retention)
• abnormal liver function test results (your doctor will know what to do)
• convulsions
• increased weight
• aggression, confusion, depression, hallucination (hearing or seeing things), sleeplessness
• urticaria (hives).
Very rare side effects (affects less than 1 in 10,000 people)
• blurred vision, difficulty focussing
• rotation of the eyes
• unusual bleeding or bruising
• 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
• fainting
• a recurring rash
• bed wetting, pain and/or difficulty passing water.
Not known (cannot be estimated from the available data)
• memory loss and/or impairment
• anaemia
• palpitations (feeling your heartbeat)
• vomiting
• constipation
• bronchospasm (difficulty breathing)
• photosensitivity (allergic reaction caused by the sun)
• anorexia
• lack of coordination
• difficulty emptying the bladder
• alopecia (hair loss)
• increased appetite
• vertigo
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: http://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 Cetirizine Tablets out of the sight and reach of children.
This medicinal product does not require any special storage conditions. Do not use after the expiry date which is stated on the blister strip and carton.
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; each film-coated tablet contains 10 mg of cetirizine dihydrochloride. The other ingredients are microcrystalline cellulose, lactose monohydrate, crospovidone, anhydrous colloidal silica, magnesium stearate, hypromellose (E464), titanium dioxide (E171) and polyethylene glycol (macrogol 400).
What Cetirizine Tablets look like and contents of the pack
Cetirizine Tablets are white, or almost white, oval-shaped tablets with a score line on one side. Cetirizine Dihydrochloride 10 mg Tablets are available from your pharmacist in packs of 7, 10, 14, 20, 30, 50 or 90 Tablets. Not all pack sizes may be marketed.
Other formats:
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Marketing Authorisation Holder:
Wockhardt UK Limited,
Ash Road North, Wrexham,
LL13 9UF. United Kingdom
Manufacturer:
CP Pharmaceuticals Limited,
Ash Road North, Wrexham,
LL13 9UF. United Kingdom
Leaflet revised: 06/2015