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Boots Hayfever And Allergy Relief

Document: leaflet BOOTS_PL 00289-0595 change

Boots Pharmaceuticals

Patient Information Leaflet Hayfever & Allergy Relief Syrup (Cetirizine Hydrochloride)

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

•    Keep this leaflet, you may need to read it again

•    Ask your pharmacist if you need more information or advice

•    You must contact a doctor if your symptoms worsen or do not improve.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

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

This medicine contains Cetirizine Hydrochloride, which belongs to a group of medicines called antihistamines that act to relieve the symptoms of allergic reactions.

It can be used to treat the symptoms of hayfever (e.g. runny and itchy nose and eye irritation), and year round runny and itchy nose and eyes. These allergies may be caused by pollen, dust mites, animals or moulds. Sometimes the symptoms may be caused by pollution, poor air conditioning, central heating or hot weather.

It can also be used to treat raised red, itchy skin (symptoms of urticaria, which is often known as hives or nettle rash).

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETIRIZINE

This medicine can be taken by adults and children of 6 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

DO NOT take Cetirizine and talk to your doctor:

•    If you are under 6 years

•    If you are allergic to any of the ingredients in this medicine (see “What is in this medicine”)

•    If you are allergic to other antihistamines

•    If you have kidney failure

•    If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains sorbitol)

•    If you are pregnant or breastfeeding Warnings and precautions

Talk to your pharmacist or doctor before you start to take this medicine:

•    If you have kidney problems- your doctor may advise you to take a lower amount of this medicine

•    If you have epilepsy or are prone to fits

•    If you have urinary retention problems

Not recommended in children aged less than 2 years of age.

Other important information

If you are having any allergy tests, stop taking this medicine 72 hours before the test.

Pregnancy, breast-feeding and fertility

•    If you are pregnant or planning to become pregnant, ask your doctor for advice before taking any medicine.

•    DO NOT take Cetirizine if you are breast-feeding.

Driving and using machines: In clinical trials cetirizine has not been shown to affect attention, alertness and driving if taken at the recommended amount. However some people may me more sensitive to the side effects and should not drive or use machines if affected by drowsiness or dizziness. If this is the first time you are taking this medicine, check how you react first.

Cetirizine with food and drink: Do not drink alcohol (wine, beer, spirits) whilst taking this medicine.

Information about some of the ingredients: Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions (possibly delayed).

Other medicine and Cetirizine: This medicine is not expected to affect any other medicines that you may be taking. If you are unsure about interactions with any medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

3. HOW TO TAKE CETIRIZINE

Check the seal is not broken before first use. If it is, do not take the medicine. Use the measuring spoon provided. The spoon measures 5 ml.

Age

How much and how often to take

Children of 6 to 11 years

5 ml twice a day

Adults and children of 12 years and over

10 ml once a day


Swallow the medicine.

If you have kidney problems your doctor or pharmacist may advise you to take less than this amount. If this applies to you follow their instructions.

Do not give to children under 6 years.

Do not take more than the amount recommended above.

If symptoms do not go away talk to your doctor.

If you take too much: You may feel very sleepy or tired, dizzy confused, restless, shaky, or have a fast heart rate, a headache, dilated pupils, diarrhoea, difficulty passing urine or itchy skin. If this happens talk to a doctor straight away. Take your medicine and this leaflet with you.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Cetirizine can cause side effects, although not everybody gets them.

Stop taking the solution and tell your doctor immediately, if you experience the below:

• Difficulty breathing, swelling of the face, lips, tongue or throat (severe allergic reaction)

The following side effects have been reported at the approximate frequencies shown:

Common side effects (affecting 1 in 100 people to 1 in 10 people):

•    Tiredness, drowsiness, dizziness, headache, runny nose

•    Feeling sick, diarrhoea

•    Dry mouth, sore throat

Uncommon side effects (affecting 1 in 1000 people to 1 in 100 people):

•    Stomach pain

•    Extreme tiredness, generally feeling unwell

•    Pins and needles or numb limbs

•    Agitation

•    Skin rash, itchy skin

Rare side effects (affecting 1 in 10,000 people to 1 in 1000 people):

•    Fast heart rate

Swelling due to water retention


•    Fits, movement disorders

•    Aggression, confusion, depression, hallucinations (seeing or hearing things that are not real), difficulty sleeping

•    Raised, red itchy skin

•    Other allergic reactions

•    Weight gain

•    Changes in the way your liver works - this may show up in a blood test Very rare side effects (affecting less than 1 in 10,000 people):

•    Difficulty focussing, blurred vision, involuntary upward movement of the eye

•    Fainting, tremors, change or loss in taste, tics (involuntary body movements)

•    Unusual bruising and an increase in the number of infections that you get e.g. sore throats -this may be a sign of very rare changes in the blood

•    Difficulty passing urine, pain when passing urine, bed wetting Other side effects (where the frequency of affecting people is not known):

•    Memory loss, or impairment

•    Increased appetite

•    Vertigo

•    Urinary retention

In very rare cases people have thought about committing suicide and if you feel this way then stop taking the oral solution and see your doctor.

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or 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 CETIRIZINE

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton. After this date return any unused product to your nearest pharmacy for safe disposal.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What is in this medicine

Each 1 ml of oral solution contains Cetirizine Hydrochloride 1mg.

As well as the active ingredient the medicine also contains purified water, propylene glycol, sorbitol solution (E420), methyl parahydroxybenzoate (E216), sodium acetate, acetic acid, saccharin sodium, banana flavour.

The pack contains 70 ml of clear colourless syrup. The syrup smells of banana.

Who makes this medicine

Manufactured for The Boots Company PLC Nottingham NG2 3AA by TEVA Czech Industries s.r.o Opava Czech Republic.

Marketing Authorisation held by TEVA UK Ltd. Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG.

Leaflet prepared August 2011

If you would like any further information about this medicine please contact The Boots Company PLC Nottingham NG2 3AA

Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name: Boots Hayfever and Allergy Relief Syrup Reference number: 00289/0595

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised: July 2014 PL 00289/0595