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Haylief Hayfever and Allergy lOmg tablets

[Loratadine]

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse 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, pharmacist or nurse. 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 oryou feel worse.

What is in this Leaflet:

1.    What are Haylief Hayfever and Allergy lOmg tablets and what are they used for

2.    What you need to know before you take Haylief Hayfever and Allergy lOmgtablets

3.    How to take Haylief Hayfever andAllergy lOmgtablets

4.    Possible side effects

5.    How to store Haylief Hayfever andAllergy lOmgtablets

6.    Contents of the pack and other information

I. What are Haylief Hayfever and Allergy lOmg tablets and what are they used for

This medicine contains Loratadine which belongs to a group of medicines called antihistamines, which act to relieve the symptoms of allergies.

It can be used to relieve the symptoms of sneezing, runny and itchy nose and eye irritation and other allergies such as pet and duxt allergies.

It can also be used to treat raised symptoms of urticaria which is often known as hives and nettle rash.

2. What you need to know before you take Haylief Hayfever and Allergy lOmgtablets

Do not take Haylief Hayfever and Allergy lOmgtablets

• If you are allergic to Loratadine or any of the other ingredients in these tablets (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you take Haylief Hayfever & Allergy I Omg Tablets if you

•    Have severe liver problems (you may need to take the medine less often, see (”How to take Haylief Hayfever and Allergy I Omg tablets”)

•    Are having allergy tests, stop taking this medicine 48 hours before the test

If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Haylief Hayfever & Allergy I Omg Tablets.

Children

Do not give Haylief Hayfever & Allergy I Omg Tablets to children younger than 2 years or to children 2 to 12 years old who weigh less than 30kg. There are other formulations more suitable for children 2 to 12 years old who weigh less than 30kg.

Other medicines and Haylief Hayfever & Allergy I Omg Tablets

Talk to your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines taken without a prescription.

Pregnancy and Breastfeeding

Do not take Haylief Hayfever & Allergy I Omg Tablets if you are pregnant.

Do not take Haylief Hayfever & Allergy I Omg Tablets if you are breast-feeding. Haylief Hayfever & Allergy I Omg Tablets is excreted in breast milk.

Driving and using machines

These tablets can cause some people to feel drowsy. If you are affected do not drive or operate machinery.

Haylief Hayfever & Allergy I Omg Tablets contain lactose

If you have been told by your doctor that you have an intolerance to some sugars talk to your doctor before taking this medicines.

3. How to take Haylief Hayfever andAllergy lOmgtablets

The following section contains instructions on how many tablets to take and when.

How much to take:

Age

How much to take

How

often to take

Children of 2 to 12 years who weigh more than 30 kg (4 st 71b)

1 x tablet

Once daily

Adults and children over 12 years

1 x tablet

Once daily


Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

Giving this medicine to children

A syrup may be preferable for children. It is important to know how much your child weighs to make sure that you give the correct amount of medicine. Tor example, a 9 year old child weighs about 30kg (4st 7Id). If in doubt weigh your child and then follow the instructions in the table.

Do not give to children under 2 years or who weigh 30 kg (4st 71b) or less.

•    Swallow the tablet with a drink of water

•    Do not take more than the amount recommended above

•    If symptoms do not go away talk to your pharmacist or doctor

Ifyou take more Haylief Hayfever and Allergy lOmgtablets than you should

If you take too many tablets by mistake contact your nearest hospital casualty department or tell your doctor immediately. Take your tablet pack with you.

Symptoms of an overdose may include sleepiness, rapid heart beat and headache.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone gets them.

If you get any of these serious side effects, stop taking the tablets. See a doctor at once

• Difficulty in breathing, swelling of the face, neck, tongue or throat (these are severe allergic reactions)

The most commonly reported side effects in adults and children over 12 years of age:

•    Drowsiness

•    Headache

•    Increased appetite

•    Difficulty sleeping.

The most commonly reported side effects in children aged 2 to 12 years are:

•    Headache

•    Nervousness

•    Tiredness.

The following very rare side effects (may affect I in 10,000 people) have also been seen during the marketing of loratadine:

•    Dizziness

•    Fast or irregular heartbeat

•    Nausea (feeling sick)

•    Dry mouth

•    Upset stomach

•    Liver problems

•    Hair loss

•    Rash

•    Tiredness.

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:

vvww. m h ra.gov. u k/yel lowcard By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Haylief Hayfever andAllergy lOmgtablets

Check the expiry date printed on the label or side of the box. Do not use after the expiry date stated on the label.

There are no special storage recommendations for Loratadine. However, do not store your medicine in a very damp or very not place, such as the bathroom or kitchen.

In case of any visible signs of deterioration, you should discard the package.

Medicines should not be disposed of via waste water or household waste. Ask you pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.

Keep out of the sight and reach of children

6. CONTENTS OF THE PACK AND OTHER INFORMAT ION

What Haylief Hayfever and Allergy I Omg tablets contains

EachTHaylief Hayfever and Allergy I Omg tablet contains I Omg of Loratadine.

The other ingredients are: Lactose Monohydrate, Microcystalline cellulose, Maize starch, Magnesium stearate.

What Haylief Hayfever and Allergy I Omg tablets look like and contents of the pack:

Each tablet is white, round and flat with a score line. Packs are 60 in blister pack cartons.

Marketing Authorisation Holder and manufacturer

Relonchem Limited Cheshire House, Gorsey Lane Widnes, Cheshire, WA8 0RR U K PL 20395/0072 Tel: 0044 207419 5043 Email: info@relonchem.com

Distributor:

Leansave Limited

35 Greenhey Place, Skelmersdale

Lancashire, WN89SA, UK

This Leaflet was last revised in October 2014.