Patient leaflet - CETIRIZINE DIHYDROCHLORIDE 10 MG FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
Cetirizine Dihydrochloride 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.
This medicine is available without prescription. However, you still need to use Cetirizine Tablets carefully to get the best results from it.
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– Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist
have told you.
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– Keep this leaflet. You may need to read it again.
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– Ask your pharmacist if you need more information or advice.
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– If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet (see section 4) please tell your doctor or pharmacist.
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– You must contact a doctor if your symptoms worsen or do not improve after 3 days.
What is in this leaflet
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1. What Cetirizine Tablets are and what they are used for
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2. What you need to know before you take Cetirizine Tablets
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3. How to take Cetirizine Tablets
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4. Possible side effects
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5. How to store Cetirizine Tablets
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6. Contents of the pack and other information
1. WHAT CETIRIZINE TABLETS ARE AND WHAT THEY ARE USED FOR
The name of this medicine is Cetirizine Dihydrochloride 10 mg Film-coated Tablets (referred to as Cetirizine Tablets or Cetirizine throughout this leaflet).
Cetirizine dihydrochloride is the active ingredient of Cetirizine Tablets. Cetirizine is an anti-allergic medication (antihistamine).
In adults and children aged 6 year and above, Cetirizine is indicated
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– for the relief of hayfever (allergic rhinitis) and year round allergies such as dust or pet allergies (perennial allergic rhinitis)
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– for the relief of swelling, redness and itchiness of the skin (Urticaria).
2. what you need to know before you take cetirizine tablets
Do not take Cetirizine Tablets
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– if you are known to be allergic (hypersensitive) to the active substance of Cetirizine, to any of its excipients (listed in section 6), to hydroxyzine or to piperazine derivatives (closely related active substances of other medicines).
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– if you have a severe kidney disease (severe kidney failure with creatinine clearance below 10 ml/min).
Warning and precautions
– If you are a patient with renal insufficiency, that is, when the kidneys fail to function properly, please ask your doctor for advice. If necessary, you will take a lower dose. The new dose will be determined by your doctor.
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– If you have problems passing urine (like spinal cord problems or prostate or bladder problems), please ask your doctor for advice.
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– If you are an epileptic patient or a patient at risk of experiencing fits, you should ask your doctor for advice.
No noticeable interactions have been observed between alcohol (at a level of 0.5 per millilitre in the blood, which is equivalent to one glass of wine) and cetirizine used at the recommended doses. As with all antihistamines, it is recommended to avoid alcohol consumption when taking Cetirizine.
If you are scheduled for allergy testing, ask your doctor if you should stop taking Cetirizine Tablets 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
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Cetirizine with food and drink
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 for advice before taking this medicine.
As with other drugs, use of Cetirizine Tablets 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.
Do not take Cetirizine Tablets during breast-feeding because cetirizine passes into breast milk.
Driving and using machines
Antihistamines can cause drowsiness in some patients.
Although this has not been reported with cetirizine at the recommended dose, please be cautious whilst driving or operating machinery.
Cetirizine Tablets contains lactose
Cetirizine tablets contain 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.
Other ingredients
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. how to take cetirizine tablets
How and when should you take Cetirizine?
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.
Please follow these instructions; otherwise Cetirizine tablets may not be fully effective.
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.
Dosage
- Children between 6 and 12 years old : 5 mg twice daily (a half tablet twice daily).
Other form(s) of this medicine may be more suitable for children; ask your doctor or pharmacist.
Patients with 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.
If you feel that the effect of Cetirizine tablets 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 Tablets, 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. The following side effects have been reported: – confusion – diarrhoea – dizziness – tiredness – headache
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– general aches and uneasiness
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– dilating of pupils of the eyes
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– itching
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– restlessness
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– sedation
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– sleepiness
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– reduced responsiveness
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– abnormal rapid heart rate
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– tremors
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– urinary retention
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– stupor
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– ailing (feeling unwell),
If you forget to take Cetirizine Tablets
Do not take a double dose to make up for the 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 stop taking Cetirizine Tablets
Rarely, pruritus (intense itching) and/or urticaria may return if you stop taking Cetirizine Tablets.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, Cetirizine tablets can cause side effects, although not everybody gets them.
The following side effects are rare or very rare, but you must stop taking the medicine and speak to your doctor straight away if you notice them:
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– 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 patients)
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– fatigue
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– dry mouth, nausea, diarrhoea
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– dizziness, headache
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– sleepiness
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– sore throat, sneezing, a blocked, congested or itchy nose (Pharyngitis, rhinitis).
Uncommon side effects: (may affect up to 1 in 100 patients)
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– abdominal pain
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– extreme fatigue, malaise
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– abnormal feelings of the skin (Paraesthesia)
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– agitation
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– itching, rash
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– pruritus (itchy skin), rash
Rare side effects: (may affect up to 1 in 1,000 patients)
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– heart beating too fast
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– swelling
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– allergic reactions, some severe (very rare)
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– abnormal liver function
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– weight increase
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– fits, movement disorders (Convulsions)
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– aggression, confusion, depression, hallucination, insomnia
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– hives
Very rare side effects: (may affect up to 1 in 10,000 patients)
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– low levels of blood platelets
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– accommodation disorder, blurred vision, eyes having uncontrolled circular movements
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– Involuntary movements, abnormal prolonged muscular contractions, fainting, tremor, altered taste
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– tic (habit spasm)
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– severe allergic reactions
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– abnormal elimination of urine (bed wetting, pain and/or difficulty passing water)
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– angioedema (which causes swelling of the face or throat), fixed drug eruption
Not known frequency of side effects (frequency cannot be estimated from the available data)
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– Increased appetite
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– Suicidal ideation (recurring thoughts of or preoccupation with suicide), nightmare
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– Amnesia, memory impairment
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– Vertigo (sensation of rotation or movement)
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– Urinary retention (inability to completely empty the urinary bladder)
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– Pruritus (intense itching) and/or urticaria upon discontinuation
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– Joint pain
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– Rash with blisters containing pus
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– Hepatitis (inflammation of the liver)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 r search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
Store in the original package.
Do not use Cetirizine after the expiry date which is stated on the carton after ‘EXP’. The expiry date refers to the last day of that month.
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. contents of the pack and other information
What Cetirizine Tablets contain
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– The active substance is cetirizine dihydrochloride. One film-coated tablet contains 10 mg cetirizine dihydrochloride.
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– The other ingredients are microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, maize starch, purified talc, magnesium stearate. The film-coat contains hypromellose 15cP, lactose monohydrate, titanium dioxide (E171), macrogol 4000 and sodium citrate.
What Cetirizine Tablets look like and contents of the pack
Cetirizine 10 mg film-coated tablets are white coloured, circular, biconvex film-coated tablets, marked with ‘A’ on one side and a breakline score on the other.
The diameter of each tablet is 8 mm.
Cetirizine tablets are presented in blister packs of 4, 5, 7, or 14 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Torrent Pharma (UK) Ltd.
3rd Floor, Nexus Building,
4 Gatwick Road,
Crawley,
West Sussex,
RH10 9BG
United Kingdom
This leaflet was last amended 01/2022