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Bells Healthcare Allergy Relief 10mg Film-Coated Tablets

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Document: leaflet BELL SONS & CO_PL 20395-0129 change

'PATIENTINF0RMATION LEAFCET

BELL'S HEALTHCARE ALLERGY RELIEF 10 MG FILM-COATED TABLETS ;(cetirizine hydrochloride)


The name of this medicine is Bell's Healthcare Allergy Relief 10mg Film-Coated Tablets, which will be referred to as Allergy Relief 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, ask your 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 Allergy Relief Tablets are and what they are used for

2.    Before you take Allergy Relief Tablets

3.    How to take Allergy Relief Tablets

4.    Possible side effects

5.    How to store Allergy Relief Tablets

6.    Further Information

1.    WHAT ALLERGY RELIEF 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 ALLERGY RELIEF TABLETS

Do not take Allergy Relief Tablets if you:

•    are allergic (hypersensitive) to cetirizine hydochloride, hydroxyzine, piperazine derivatives or any of the other ingredients in Allergy Relief 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 Allergy Relief 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. 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.

Allergy Relief Tablets can affect the results of allergy skin tests. If you require an allergy test you should


stop taking Allergy Relief 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 Allergy Relief Tablets and vice versa.

• medication for anxiety or stress (CNS depressants)

It may still be alright for you to take Allergy Relief 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 Allergy Relief 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 Allergy Relief 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 Allergy Relief 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 Allergy Relief 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 the ingredients of Allergy Relief 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 ALLERGY RELIEF TABLETS

Always take Allergy Relief 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: Half a tablet (5 mg) should be taken once daily.

Patients with moderate to severe renal impairment: Patients with moderate or severe


150.00 x 300.00 mm


renallmpairment are recommended to take 5 mg once daily.

If drowsiness occurs, your tablet can be taken in the evening

Method of administration: For oral use.

If you take more Allergy Relief 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 heartbeat, having dilated pupils or blurred vision, and experience headache, itching, diarrhoea, or difficulty urinating.

If you forget to take Allergy Relief 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.

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 or face or difficulty 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 liver function 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)


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•    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.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE ALLERGY RELIEF TABLETS

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 Allergy Relief Tablets contain:

The active ingredient is cetirizine hydrochloride.

Each film-coated 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 Allergy Relief Tablets look like and the contents of the pack:

Allergy Relief 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 / Manufacturer:

Relonchem Limited, Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 0RR UK.

This leaflet was revised in February 2015.


150.00 x 300.00 mm