Cetirizine 10 Mg Film-Coated Tablets
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teva UK Ref: 231-30-51069-A.LEA CETIRIZINE 10mg FC TAB TUK <ULM |
Version: 5 12 December 2014 | ||
Cetirizine 10 mg Film-coated Tablets
cetirizine dihydrochloride
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 talk to a doctor if you do not feel better or if you feel worse after 3 days.
What is in this leaflet:
1. What Cetirizine is and what it is used for
2. What you need to know before you take Cetirizine
3. How to take Cetirizine
4. Possible side effects
5. How to store Cetirizine
6. Contents of the pack and other information
1 What Cetirizine is and what it is used for
Cetirizine dihydrochloride is the active ingredient of Cetirizine 10 mg Film-coated Tablets. Cetirizine is an antiallergic medication.
In adults and children aged 6 years and above, Cetirizine is indicated
• for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis
• for the relief of urticaria.
You must talk to a doctor if you do not feel better or if you feel worse after 3 days.
What you need to know before you take Cetirizine
Do not take CETIRIZINE
• if you are allergic (hypersensitive) to the active substance of Cetirizine or any of the other ingredients of Cetirizine (listed in section 6), to hydroxyzine or to piperazine derivatives (closely related active substances of other medicines)
• if you have a severe kidney disease (severe renal failure with creatinine clearance below 10 ml/min).
Warnings and precautions
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.
If you have problems passing urine (like spinal cord problems or prostate or bladder problems), please ask your doctor for advice.
If you are an epileptic patient or a patient at risk of convulsions, you should ask your doctor for advice.
If you are going to have an allergy skin test please tell your doctor that you currently take Cetirizine. Usually you will need to stop taking any medicines for a period of 3 days before the allergy skin test.
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.
Other medicines and Cetirizine
Tell your doctor or pharmacist if you are taking/using or have recently taken/used or might take/use any other medicines.
Due to the profile of cetirizine, no interactions with other drugs are expected.
Taking Cetirizine with food
Food does not noticeably affect the absorption of cetirizine.
Pregnancy and breast-feeding
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.
As with other drugs, use of 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 administration of the medicine should be discontinued.
You should not take Cetirizine during breast-feeding because cetirizine passes into breast milk.
Driving and using machines
Clinical studies have produced no evidence of impaired attention, alertness and driving capabilities after taking Cetirizine 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.
Cetirizine contains 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
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How and when should you take Cetirizine?
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.
These guidelines apply unless your doctor has given you different instructions on how to use Cetirizine.
Please follow these instructions; otherwise Cetirizine may not be fully effective.
Tablets need to be swallowed with a glass of liquid.
Adults and adolescents above 12 years old
10 mg once daily as 1 tablet.
Children between 6 and 12 years old
5 mg twice daily as a half tablet twice daily.
Patients with moderate renal impairment
Patients with moderate renal impairment are recommended to take 5 mg once daily.
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.
The tablet can be divided into equal doses.
|
TEVA UK Ref: 231-30-51069-A.LEA CETIRIZINE 10mg FC TAB TUK <ULM |
Version: 5 12 December 2014 | ||
Directions for use
If your treatment with Cetirizine stipulates that you have to split tablets, you should ideally do so as follows.
Place the tablet on a hard, flat surface (such as a table top or plate) with the score line facing upwards. Then press with both of your index fingers (or thumbs) at the same time briefly and firmly on the outer edges to the left and right of the score line as shown in the graphical representation below.
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 and is determined by your doctor.
If you take more CETIRIZINE 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 ncreased intensity. Adverse effects such as confusion, diarrhoea, dizziness, tiredness, headache, ailing, dilating of pupils, itching, restlessness, sedation, somnolence, stupor, abnormal rapid heart rate, tremors and urinary retention have been reported.
If you forget to take CETIRIZINE
Do not take a double dose to make up for a forgotten dose.
If you stop taking Cetirizine
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
^ Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects listed in this section have been reported in post marketing experience.
angioedema (serious allergic reaction which causes swelling of the face or throat)
allergic reactions (causing symptoms such as wheezing, difficulty breathing, rash, hives).
At the first signs of a hypersensitive reaction, stop taking Cetirizine. Your doctor will then assess the severity and decide on any further measures that may be necessary.
Tell your doctor immediately if you get any of these symptoms: thrombocytopenia (low levels of blood platelets causing symptoms such as bleeding, bruises, blotches or red spots on the skin) dyskinesia (involuntary movements) dystonia (abnormal prolonged muscular contractions convulsions
suicidal ideation (recurring thoughts of, or preoccupation with suicide).
Other side effects:
common (may affect up to 1 in 10 people): fatigue
dry mouth, nausea, diarrhoea
• dizziness, headache somnolence (sleepiness) pharyngitis, rhinitis (in children).
uncommon (may affect up to 1 in 100 people):
• abdominal pain asthenia (extreme fatigue), malaise
• paresthesia (abnormal feelings of the skin)
• agitation
• pruritus (itchy skin), rash.
rare (may affect up to 1 in 1,000 people):
• tachycardia (heart beating too fast)
• oedema (swelling)
• liver function abnormal
• weight increased
• aggression, confusion, depression, hallucination, insomnia
• urticaria (hives).
very rare (may affect up to 1 in 10,000 people):
• accommodation disorder (difficulty focusing), blurred vision, oculogyration (eyes having uncontrolled circular movements)
• syncope, tremor, dysgeusia (altered taste)
• tic (habit spasm)
• abnormal elimination of urine (bed wetting, pain and/or difficulty passing water)
• fixed drug eruption.
not known (frequency cannot be estimated from the available data):
• amnesia, memory impairment
• increased appetite
• 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, 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:
By reporting side effects you can help provide more information on the safety of this medicine.
How to store Cetirizine
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box and blister after EXP The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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.
©Contents of the pack and other information
What CETIRIZINE contains
The active substance is cetirizine dihydrochloride.
One film-coated tablet contains 10 mg cetirizine dihydrochloride.
The other ingredients are lactose monohydrate, microcrystalline cellulose, colloidal silica, magnesium stearate, titanium dioxide (E171), hypromellose (E464) and macrogol.
What CETIRIZINE looks like and contents of the pack The film-coated tablet is white to almost white, round, biconvex with a break-line on one side and is approximately 6.5 mm in diameter.
The tablet can be divided into equal doses.
PVC//PVDC/alu blisters.
Blister with 7, 14, 15, 20, 28, 30, 50 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Teva UK Limited, Eastbourne,
BN22 9AG, UK
Manufacturer
Merckle GmbH, Ludwig-Merckle-Strasse 3, D-89143 Blaubeuren, GERMANY
This leaflet was last revised in 12/2014
PL 00289/1523
51069-A 148x420