Cetirizine Hydrochloride 10mg Film-Coated Tablets
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Package leaflet: Information for the user
CETIRIZINE HYDROCHLORIDE 10mg FILM-COATED TABLETS (Cetirizine hydrochloride)
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 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must contact a doctor if your symptoms worsen or do not improve after few days.
What is in this leaflet:
1. What Cetirizine tablets are and what they are used for
2. What you need to know before you take Cetirizine tablets
3. How to take Cetirizine tablets
4. Possible side effects
5. How to store Cetirizine tablets
6. Contents of the pack and other information
1. What Cetirizine tablets are and _what they are used for_
The name of your medicine is Cetirizine Hydrochloride 10mg film-coated tablets, referred as Cetirizine tablets in this leaflet. The active ingredient, Cetirizine hydrochloride belongs to a group of medicines called
antihistamines. It blocks the effects of a substance called histamine which occurs naturally in the body. Histamine is involved in allergic reactions.
Cetirizine 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). Cetirizine tablets also 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 tablets Do not take if you:
• have severe kidney disease (severe renal failure with creatinine clearance below 10 ml/min)
• are allergic to cetirizine hydrochloride or any of the other ingredients (listed in section 6) or to hydroxyzine or to piperazine derivatives (closely related active substances of other medicines)
Warnings and precautions
Talk to your doctor or pharmacist before taking Cetirizine
tablets if:
• you are a patient with renal insufficiency, please ask your doctor for advice; if necessary, you will take a lower dose. The new dose will be determined by your doctor.
• you have problems passing urine (like spinal cord problems or prostate or bladder problems), please ask your doctor for advice.
• you are an epileptic patient or a patient at risk of convulsions, you should ask your doctor for advice.
No clinically significant interactions have been observed between alcohol (at the blood level of 0.5 per mille (g/l)
corresponding to one glass of wine) and cetirizine used at the recommended 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 with alcohol.
If you are scheduled for allergy testing, ask your doctor if you should stop taking Cetirizine for several days before testing. This medicine may affect your allergy test results. Children
Do not give this medicine to children below the age of 6 years because the tablet formulation does not allow the necessary dose adjustments.
Other medicines and Cetirizine tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Cetirizine tablets with food and drink Food does not affect absorption of Cetirizine. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Cetirizine 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 medicine should only be administered if necessary and after medical advice.
Cetirizine passes into breast milk. Therefore, you should not take Cetirizine during breast-feeding unless you have contacted a doctor.
Driving and using machines Clinical studies have produced no evidence of impaired attention, alertness and driving capabilities after taking Cetirizine at the recommended dose.
You should closely observe your response to the drug after you have taken Cetirizine if you are intending to drive, engage in potentially hazardous activities or operate machinery. You should not exceed the recommended dose.
Cetirizine tablets 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 tablets |
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The tablets need to be swallowed with a glass of liquid. The tablet can be divided into equal doses. Do not take more than one tablet each day.
The recommended doses are as follows:
Adults and children aged 12 years and over:
The recommended dose is 10 mg once daily as one tablet daily. If the tablets make you feel drowsy or dizzy, taking half a tablet twice a day may be better than taking one tablet once a day.
Other form(s) of this medicine may be more suitable for children; ask your doctor or pharmacist.
Children aged 6 to 12:
The recommended dose is 5 mg twice daily as half a tablet.
Other form (s) of this medicine may be more suitable for children; ask your doctor or pharmacist.
Not recommended for children under 6 years.
Patients with moderate to severe renal impairment
Patients with moderate renal impairment are recommended to take 5 mg once daily. S
If you suffer from severe kidney disease, please contact your doctor or pharmacist who may adjust the dose accordingly. If your child suffers from kidney disease, please contact your doctor or pharmacist who may adjust the dose according to your child's needs.
If you feel that the effect of Cetirizine 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. Please ask your doctor or pharmacist for advice.
If you take more Cetirizine tablets than you should
If you think you have taken an overdose of Cetirizine please inform your doctor. Your doctor will then decide what measures, if any, should be taken.
After an overdose, the side effects described below may occur with increased intensity. Adverse effects such as confusion, diarrhoea, dizziness, tiredness, headache, ailing, dilating of pupil, itching, restlessness, sedation, somnolence, stupor, abnormal rapid heart rate, tremors and urinary retention have been reported.
If you forget to take Cetirizine tablet Do not take a double dose to make up for a 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 medicine, ask your doctor or pharmacist.
| 4. Possible side effects |
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects are rare or very rare, but you must stop taking the tablets and speak to your doctor straight away if you notice them:
Allergic reactions, including severe reactions and angioedema (serious allergic reaction which causes swelling of the face or throat).
These reactions may start soon after you first take the medicine, or it might start later.
Common side effects (may affect up to 1 in 10 people)
• Somnolence (sleepiness)
• Headache
• Dizziness
• Dry mouth
• Fatigue
• Nausea
• Pharyngitis, rhinitis (in children)
• Diarrhoea
Uncommon side effects (may affect up to 1 in 100 people)
• Agitation
• Paraesthesia (abnormal feelings of the skin)
• Abdominal pain
• Pruritus (itchy skin), rash
• Asthenia (extreme fatigue), malaise
Rare side effects (may affect up to 1 in 1,000 people)
• Allergic reactions, some severe (very rare)
• Depression, hallucination, aggression, confusion, insomnia
• Convulsions
• Tachycardia (heart beating too fast)
• Liver function abnormal
• Urticaria (hives)
• Oedema (swelling)
• Weight increased
Very rare side effects (may affect up to 1 in 10,000 people)
• Thrombocytopenia (low levels of blood platelets)
• Tics (habit spasm)
• Syncope, dyskinesia (involuntary movements), dystonia (abnormal prolonged muscular contractions), tremor, dysgeusia (altered taste)
• Blurred vision, accommodation disorder (difficulty focusing), oculogyration (eyes having uncontrolled circular movements)
• Angioedema (serious allergic reaction which causes swelling of the face or throat), fixed drug eruption
• Abnormal elimination of urine (bed wetting, pain and/or difficulty passing water)
Not known side effects (frequency cannot be estimated from the available data)
• Increased appetite
• Suicidal ideation (recurring thoughts of or preoccupation with suicide)
• Amnesia, memory impairment
• Vertigo (sensation of rotation or movement)
• Urinary retention (inability to completely empty the urinary bladder)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 this medicine out of the sight and reach of children.
• Do not store above 25oC. Store in the original package.
• Do not use the tablets after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
• Do not throw away any 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 tablets contain
• Each tablet contains 10mg of the active ingredient cetirizine hydrochloride.
• The other ingredients are lactose monohydrate, maize starch, pregelatinised starch, purified talc, magnesium stearate, hypromellose, titanium dioxide (E171) and macrogol.
What Cetirizine tablets look like and the contents of the pack
• Cetirizine tablets are white to off white capsule shaped film coated tablets with a scoreline and 'B' and 'L' embossed on either side of the scoreline and '10' embossed on the other side.
• Cetirizine tablets are available in packs of 10, 14, 28, 30, 56, 60, 84, 100, 250, 500 or 1000 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and address:
Bristol Laboratories Ltd.,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom Telephone: 0044 (0)1442 200922 Fax: 0044 (0)1442 873717
Email: info@bristol-labs.co.uk
Cetirizine Hydrochloride 10mg film-coated tablets; PL 17907/0047
This leaflet was last revised in September 2016
To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.
V05 16-09-2016 D2
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