What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL04416/0693 .

Boots Hayfever Relief Instant-Melts 10 mg Orodispersible Tablets

Information for the user

Boots Hayfever Relief Instant-Melts

10 mg Orodispersible Tablets

(Loratadine)

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

What this medicine is 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 hayfever (e.g. sneezing, runny and itchy nose and eye irritation) and other allergies such as pet and dust allergies. It can also be used to treat raised, red itchy skin (symptoms of urticaria, which is often known as hives or nettle rash).

Before you take this medicine

This medicine can be taken by adults and children of 12 years and over. This medicine can also be taken by children of 2 to 11 years of age who weigh more than 30 kg (see “How to take this medicine”). However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take:

  • If you are allergic to any of the ingredients in this medicine (see “What is in this medicine”)
  • If you have phenylketonuria (this medicine contains aspartame, a source of phenylalanine, which may be harmful to you)
  • If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains lactose and sorbitol)
  • If you are pregnant or breastfeeding

Talk to your pharmacist or doctor:

  • If you have severe liver problems (you may need to take the medicine less often, see “How to take this medicine”)

Other important information

If you are having any allergy tests, stop taking this medicine 48 hours before the test.

Driving and using machines: This medicine may make you feel dizzy and very rarely make you feel drowsy. Do not drive or use machinery until you are sure you are not affected.

If you take other medicines

This medicine is not expected to affect any other medicines that you may be taking.

However, some medicines may affect the way that the active ingredient in this medicine is broken down in the body.

If you are unsure about interactions with any other medicines, talk to your pharmacist.

This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

How to take this medicine

The tablets, which are “melt in the mouth” orange flavoured tablets, are designed to be placed on the tongue and allowed to completely disintegrate before swallowing. The tablets will normally disintegrate in the mouth in contact with saliva, therefore water or other liquids are not normally needed.

The tablets break easily. Always handle the tablets carefully with dry hands only.

Check the foil is not broken before use. If it is, do not take that tablet.

Tear one blister from the strip along the perforations in the foil. Don’t push the tablet through the backing foil. Instead, peel open the backing foil in the direction of the arrow. With dry hands take out the tablet and place immediately on the tongue and allow to completely disintegrate before swallowing.

Giving this medicine to children:

It is important to know how much your child weighs to make sure you give them the correct amount of medicine. As a guide a child of 9 years of age will weigh about 30 kg (four and a half stone). If in doubt weigh your child, then follow the instructions in the table.

Do not give to children who weigh less than 30 kg.

Do not give to children under 2 years.

Adults and children of 12 years and over: take one tablet once a day.

Children of 2 to 11 years who weigh more than 30 kg: take one tablet once a day.

Children of 2 to 11 years who weigh less than 30 kg: Do not give this medicine. For children over 2 years of age and who weigh less than 30 kg a syrup form if this medicine may be more suitable.

If you have severe liver problems your doctor or pharmacist may advise you to take the recommended amount every other day. If this applies to you, follow their instructions.

Do not take more than the amount recommended above.

If symptoms worsen, do not improve or do not go away talk to your pharmacist or doctor.

If you take too many tablets: Talk to your doctor or pharmacist. Taking more tablets than recommended may cause drowsiness, rapid heart beat and headache.

Possible side effects

Most people will not have problems, but some may get some.

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 (severe allergic reactions)

These other effects are less serious. If they bother you talk to a pharmacist:

  • Other allergic reactions such as skin rash
  • Feeling drowsy, dizzy or exhausted, headaches, difficulty sleeping
  • Feeling sick, dry mouth, stomach pain, increased appetite
  • Fast or irregular heart rate, palpitations
  • Hair loss
  • Changes in the way your liver works – this may show up in a blood test
  • For children of 2 to 11 years of age headaches, feeling exhausted or nervous were more common

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.

How to store this medicine

The tablets should be stored in the original packaging, in order to protect from moisture.

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

What is in this medicine

Each orodispersible tablet contains Loratadine 10 mg, which is the active ingredient.

As well as the active ingredient, the tablets also contain aspartame (E951), citric acid anhydrous, silica colloidal anhydrous, maize starch dried, lactose anhydrous, magnesium stearate, croscarmellose sodium, mannitol (E421), sorbitol (E420), crospovidone, silica colloidal hydrated, polysorbate 80, povidone, microcrystalline cellulose, sweet orange flavour.

The pack contains 14 white, round flat tablets.

Who makes this medicine

Manufactured for

The Boots Company PLC
Nottingham
NG2 3AA

by

Lek Pharmaceuticals d.d.
Verovśkova 57 SLO-1526
Ljubljana
Slovenia

Marketing Authorisation held by

Sandoz Ltd
Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR

Leaflet prepared May 2015

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 Relief Instant-Melts 10 mg Orodispersible Tablets

Reference number: 04416/0693

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