EM PHARMA DAILY HAYFEVER 10 MG TABLETS, CETIRIZINE DIHYDROCHLORIDE 10 MG FILM-COATED TABLETS, BELLS HEALTHCARE ALLERGY AND HAYFEVER RELIEF 10 MG TABLETS - patient leaflet, side effects, dosage

PACKAGE LEAFLET: INFORMATION FOR THE USER Bell's Healthcare Allergy and Hayfever Relief 10 mg Tablets

Cetirizine dihydrochloride

The name of this medicine is Bell's Healthcare Allergy and Hayfever Relief 10 mg Tablets, which will be referred to as Cetirizine Tablets throughout this leaflet.

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 Tablet is and what it is 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 tablet is and what it is used for

Cetirizine dihydrochloride is the active ingredient of Cetirizine tablet, which belongs to a group of medicines called antihistamines. Cetirizine is an antiallergic medication.

In adults and paediatric patients 6 years and above, Cetirizine is indicated

• – for the relief of hayfever (allergic rhinitis) and year round allergies such as dust or pet allergies (perennialallergic rhinitis)

• – for the relief of chronic nettle rash (chronic idiopathic urticaria).

You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

2. what you need to know before you take cetirizine tablets- if you are allergic to cetirizine or any of the other ingredients of this medicine (listed in section 6) or to hydroxyzine or to any piperazine derivatives

• – If you have a severe kidney disease – If you are breast-feeding Warnings and precautions

Talk to your doctor or pharmacist before taking Cetirizine Tablets.

• – If you want to use for children less than 6 years of age.

• – If you suffer from epilepsy or are at risk of convulsions (fits).

• – If you have an enlarged prostate. It may increase the risk of having difficulty passing water.

• – If you are having an allergy skin test you need to wait 3 days after taking Cetirizine Tablets.

Children

Cetirizine tablets are not recommended for use in children below 6 years of age.

Other medicines and Cetirizine Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines such as: – medication for anxiety or stress (CNS depressants) Cetirizine Tablets with drink

Avoid alcoholic drink while you are taking this medicine.

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.

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

Some people have reported that they feel drowsy

or dizzy while they are taking Cetirizine Tablets. If you are affected do not drive or use machines.

Cetirizine Tablets contains lactose monohydrate

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 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 recommended dose is

• - Adults and adolescents over 12 years of age: One tablet (lOmg) once daily. Your doctor may prescribe you starting dose 5 mg (a half tablet) if this leads to satisfactory control of the symptoms.

• - Children aged from 6 to 12 years: 5mg twice daily (a half tablet twice daily). – Children under 6 years: Not recommended.

• – If you have kidney problems you should talk to your doctor or pharmacist for advice before taking these tablets as a lower dose may be required.

If you take more Cetirizine Tablets than you should

If you accidentally take too many tablets go and see your doctor straightaway.

After an overdose, the side effects described in section 4 below may occur with increased intensity.

The following side effects have been reported: – confusion – diarrhoea – dizziness – tiredness – headache

• – a vague feeling of discomfort

• – dilating of pupils of the eyes

• – itching

• – restlessness

• – sedation

• – sleepiness

• – stunned state in which it is difficult to get a response

• – abnormal rapid heart rate – tremors

• – urinary retention

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 have any further questions on the use of this medicinet, 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 effect is very rare, but you must stop taking the tablets and speak to your doctor straight away if you notice these symptoms:

• – serious allergic reaction which causes difficulty in breathing or dizziness, swelling of the face or throat

• – reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)

• – suicidal ideation (recurring thoughts of or preoccupation with suicide)

The following side effects have also been reported.

– fatigue

• – dry mouth, nausea, diarrhoea (children only)

• – dizziness, headache

• – sleepiness

• – sore throat

• – sneezing, a blocked, congested or itchy nose (children only)

Uncommon: (may affect up to 1 in 100 people)

• – paraesthesia (feeling of pins and needles)

• – feelings of weakness and/or extreme tiredness (asthenia), feeling unwell (malaise)

• – diarrhoea

• – agitation

• – itching, rash

• – stomach ache

Rare: (may affect up to 1 in 1,000 people)

• – heart beating too fast

• – oedema (swelling of the feet or ankles)

• – allergic reactions, some severe (very rare)

• – changes in liver function tests, indicating the possibility of damage to the liver

• – weight increase

• – fits

• – aggression, confusion, depression, seeing or hearing things (hallucination), difficulty in sleeping (insomnia) – hives

Very rare: (may affect up to 1 in 10,000 people)

• – difficulty with focussing the eyes, blurred vision, eyes having uncontrolled circular movements

• – fainting, tremor, altered taste

• – difficult, painful or involuntary urination

• – tics, shaking (tremor)

• – loss of urinary control (enuresis)

• – dyskinesia (involuntary movements)

• – dystonia (abnormal prolonged muscular contractions)

• – swelling of the skin particularly around the face or throat

• – fixed drug eruption (appearance of red or blistered skin in the same place after taking this medicine)

Not known: (frequency can not be estimated from the available data)

• – forgetfulness, memory impairment

• – urinary retention (inability to completely empty the urinary bladder)

• – vertigo (sensation of rotation or movement)

• – increased appetite

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:

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.

This medicinal product does not require any special temperature storage conditions.

Keep the blister in the outer carton in order to protect from light.

Do not use this medicine after the expiry date which is stated on the carton after ‘EXP’. 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 medicine you no longer required. These measures will help protect the environment.

6. contents of the pack and other information- the active substance is cetirizine dihydrochloride. each film-coated tablet contains 10 mg cetirizine dihydrochloride.

• – 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 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.

The tablet can be divided into equal halves.

Cetirizine Tablets are presented in blister packs of 4, 5, 7, 14 or 30 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom.

Manufacturer

Cipla (EU) Limited, 20 Balderton Street, London W1K 6TL, United Kingdom

Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium

Distributor

Bell Sons Co Druggist Ltd, Gifford House, Slaidbum Crescent, Southport, PR9 9AL United Kingdom.

This leaflet was last revised in 09/2015.