Cetirizine Hydrochloride 10mg Film-Coated Tablets
PATIENT INFORMATION LEAFLET
The name of this medicine is Cetirizine Hydrochloride 10 mg Film-Coated Tablets, which will be referred to as Cetirizine Tablets throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, askyour doctor or your pharmacist.
• Do not pass this medicine on to others; it may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What Cetirizine Tablets are and what they are used for
2. Before you take Cetirizine Tablets
3. How to take Cetirizine Tablets
4. Possible side effects
5. Howto store Cetirizine Tablets
6. Further Information
1. WHAT CETIRIZINE TABLETS ARE AND WHAT THEY ARE USED FOR
The active ingredient in your tablets is cetirizine hydrochloride, which belongs to a group of medicines called antihistamines. These are used to relieve the symptoms of seasonal allergic rhinitis (e.g. hay fever), perennial allergic rhinitis (e.g. year round allergies often due to house dust mites or animal allergies) and urticaria (itchy, red, swollen skin). These symptoms include itchy skin rashes; sneezing; itchy, runny or blocked nose; red, itchy and watering eyes.
2. BEFORE YOU TAKE CETIRIZINE TABLETS
Do nottake Cetirizine Tablets if you:
• are allergic (hypersensitive) to
cetirizine hydochloride, hydroxyzine, piperazine derivatives or any of the other ingredients in Cetirizine Tablets (these are listed in section 6, Further Information)
• have a severe kidney disease (severe renal failure with creatine clearance below 10/ml/min)
• have hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Take special care with 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 byyourdoctor.
If you are an epileptic patient or a patient at risk of convulsions, you should ask your doctor for advice
No interactions susceptible to have a noticeable impact have been observed between alcohol (at the blood level of 0.5 per ml corresponding to one glass of wine) and cetirizine used at the normal doses. However, as is the case with all antihistamines, it is recommended to avoid concurrent consumption of alcohol.
Cetirizine Tablets can affect the results of allergy skin tests. If you require an allergy test you should stop taking Cetirizine Tablets three days before you have the tests.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any of the following medicines, as they may decrease or increase the effect of Cetirizine Tablets and vice versa.
• medication for anxiety or stress (CNS depressants)
It may still be alright for you to take Cetirizine Tablets and your doctor will be able to decide what is suitable for you. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking your medicine with food and drink
Cetirizine Tablets can be taken with or without food.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, think you might be pregnant, or are planning to become pregnant. As with other drugs, the 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 administration of the medicine should be discontinued.
You should not take Cetirizine Tablets during breast-feeding because cetirizine passes into breast milk.
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 yourattention and ability to react.
Important information about some of the ingredients of Cetirizine Tablets
This product 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 Cetirizine Tablets exactly as your doctor or pharmacist has told you to do so. You should check with your doctor or pharmacist if you are not sure.
Dosage
The usual dosage is:
Adults, elderly and children over 12 years:
Take one tablet (10 mg) once daily.
Children aged 6-12 years: Take half a tablet (5 mg) twice daily (morning and evening).
Children weighing less than 30 kg: Haifa tablet (5 mg) should be taken once daily. Patients with moderate to severe renal impairment: Patients with moderate or severe renal impairment are recommended to take 5 mg once daily.
Ifdrowsiness occurs, yourtabletcan be taken in the evening
Method of administration: Fororal use.
If you take more Cetirizine Tablets than you should
If you have accidentally taken more than the recommended dose, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you.
The most common signs and symptoms of overdose may include feeling unwell, confused, restless, shaky, dizzy, tired or very sleepy. You may also notice a rapid heart beat, having dilated pupils or blurred vision, and experience headache, itching, diarrhoea, or difficulty urinating.
If you forget to take Cetirizine Tablets
If you have forgotten to take your tablet, take it as soon as you remember and then wait 24 hours before taking your next dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
• Severe blistering skin rash
• Difficult and/or painful urination
• Loss of urinary control
• Movement disorders
At a very low frequency that cannot be estimated:
Increased appetite, memory loss, feeling of dizziness. In very rare cases people have had suicidal thoughts when taking this medication. If you experience these stop taking the medicine 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. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.aov.uk/vellowcard By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE CETIRIZINE TABLETS
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the medicine and seek immediate medical help if you experience:
• Sudden signs of an allergic reaction such as developing a rash, swelling of the mouth orfaceordifficulty breathing.
• Bruising or bleeding more easily than normal
• Convulsions or fits
• Loss of consciousness.
Stop taking the medicine and tell your
doctor if you experience:
Confusion, hallucinations, rapid heartbeat, abnormal liverfunction tests.
The following side effects have also been reported:
Uncommon side effects (> 1/1,000 to 1/100)
• Agitation
• Diarrhoea
• Paraesthesia (feeling of pins and needles)
• Rash, itching
• Feelings of weakness and/or extreme tiredness, feeling unwell.
Rare side effects (>1/10,000 to 1/1,000)
• Allergic reactions, some severe (very rare)
• Feelings of aggression, depression
• Difficulty in sleeping
• Abnormal eye movements
• Oedema (swelling of the feet or ankles)
• Hives (urticaria)
• Unusual weight gain
Very rare side effects (1/10,000)
• Tics, shaking
• Distorted sense of taste
• Fainting
• Blurred vision, eyes having uncontrolled circular movements (oculogyration)
Keep out of the sight and reach of children.
Do not take this medicine after the expiry date (Exp.) stated. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions.
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 to protect the environment.
6. FURTHER INFORMATION
What Cetirizine Tablets contain:
The active ingredient is cetirizine hydrochloride. Each tablet contains 10 mg of cetirizine hydrochloride.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, maize starch, talc, magnesium stearate, titanium dioxide (E171), hypromellose, macrogol, sodium citrate.
What Cetirizine Tablets look like and the contents of the pack:
Cetirizine Tablets are white coloured, circular, biconvex film coated tablets. They are marked with “A” on one side, and a break-line on the other.
Your medicine is available in packs containing 7,10,14,28,30,60 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder I Manufacturer:
Relonchem Limited, Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 0RP, UK.
This leaflet was last revised in December 2014.