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[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 or you feel worse.
What is in this leaflet:
1. What Loratadine Tablets are and what are they used for
2. What you need to know before you take Loratadine Tablets
3. How to take Loratadine Tablets
4. Possible side effects
5. Howto store Loratadine Tablets
6. Contents of the pack and other information
I. WHAT LORATADINE TABLETS ARE 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 dust 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 LORATADINE TABLETS
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you take Loratadine Tablets if you
• Have severe liver problems (you may need to take the medicine less often, see “How to take Loratadine 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 Loratadine Tablets.
Children
Do not give Loratadine 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 Loratadine 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 Loratadine Tablets if you are pregnant.
Do not take Loratadine Tablets if you are breastfeeding. Loratadine 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.
Loratadine 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 medicine.
Do not take Loratadine Tablets:
• If you are allergic to loratadine or any of the other ingredients in these tablets (listed in section 6).
3. HOW TO TAKE
LORATADINE TABLETS
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. For example, a 9 year old child weighs about 30kg (4st 71b). 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
If you take more Loratadine Tati ets than you should
If you take too many tablets by mistake contact your nearest nospital 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 feaflet. You can also report side effects directly via the Yellow Card Scheme at: www. m h ra.gov. u k/ye I lo wcard By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE
LORATADINE TABLETS
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 INFORMATION
What Loratadine Tablets contain:
Each tablet contains lOmg Loratadine.
The other ingredients are: Lactose monohydrate, microcrystalline cellulose, maize starch, magnesium stearate.
What Loratadine Tablets look like and contents of the pack
Each tablet is white round and flat with a scoreline.
Packs are 7, 10, 14, 20, 30, 50, 60 and 100 tablets in blister packs in cartons.
Marketing Authorisation Holder and manufacturer
Relonchem Limited Cheshire House, Gorsey Lane Widnes, Cheshire, WAS 0RR UK
PL 20395/0072
This leaflet was last revised in October 2014.