Loratadine 5mg/5ml Syrup
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PATIENT INFORMATION LEAFLET
Read this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
IN THIS LEAFLET:
1. What this medicine is for
2. Before you take the medicine
3. How to take the medicine
4. Possible side effects
5. Storing the medicine
6. Further information
WHAT THIS MEDICINE IS FOR
Loratadine 5mg/5ml Syrup contains loratadine, which belongs to a group of drugs called antihistamines. These medicines help to relieve the symptoms of some allergies.
This medicine is used to relieve:
• symptoms of hayfever and other allergies such as sneezing, runny nose and burning, itchy eyes.
• symptoms of skin allergies such as rash, itching or urticaria (hives).
BEFORE YOU TAKE THE MEDICINE
This medicine can be taken by adults and children aged 2 years and over. Some people should not take this medicine or should talk to their pharmacist or doctor first.
Do not take if you:
• Are allergic (hypersensitive) to loratadine or any of the other ingredients in the medicine, listed in section 6.
Talk to your pharmacist or doctor before taking if you:
• Have liver problems. You may need to take a lower dose.
Pregnancy and breastfeeding
• Do not take if you are pregnant or breastfeeding.
Other important information
• Tests have shown that this medicine does not cause drowsiness in the vast majority of people using it. Therefore it will not normally affect your ability to drive or operate machinery. However there may be very rare exceptions and if you experience dizziness, nausea or drowsiness, do not drive or operate machinery.
• This product contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Each 5ml contains 3.1 g of sucrose. This should be taken into account if you suffer from diabetes mellitus.
• If you are going to have skin tests to identify allergies, stop taking this medicine 48 hours before the tests.
Taking other medicines
• Loratadine 5mg/5ml Syrup is not expected to interact with other medicines you may be taking. However if you are unsure talk to your pharmacist or doctor.
Further information overleaf.
El HOW TO TAKE THE MEDICINE
DOSAGE: For oral use.
|
AGE |
DOSE |
|
Adults and children 2 years of age and over with a body weight of more than 30 kg |
Two 5ml spoonfuls (1 Omg) once daily |
|
Children 2 to 12 years of age with a body weight of less than 30 kg |
One 5ml spoonful (5mg) once daily |
|
DO NOT GIVE to children under the age of 2 years. As a guide, an average 9 year old child weighs approximately 30 kg (equivalent to 4 and a half stone). Check the child’s weight if you are not sure before you give them this medicine. | |
|
If you have severe liver problems: Adults and children 2 years of age and over with a body weight of more than 30 kg Children 2 to 12 years of age with a body weight of less than 30 kg (Check with your pharmacist or doctor) |
Two 5ml spoonfuls (10mg) every other day One 5ml spoonful (5mg) every other day |
|
DO NOT EXCEED THE RECOMMENDED DOSE | |
If symptoms worsen or do not improve, talk to your doctor or pharmacist.
If you take too much of this medicine: Talk to a doctor straight away, or contact your nearest hospital casualty department. Take the carton and this leaflet with you.
If you forget to take a dose of Loratadine 5mg/5ml Syrup: Take the recommended dose as soon as you remember; wait at least 24 hours before taking another dose. Do not take a double dose to make up for the missed doses.
[] POSSIBLE SIDE EFFECTS
Like all medicines, Loratadine 5mg/5ml Syrup can sometimes have side effects, although not everybody gets them.
Serious side effects
Stop taking this medicine and tell your doctor or go to a casualty department immediately if:
• you get any swelling of the face, lips, tongue or throat
• you have any difficulty in swallowing or breathing
• you get a skin rash after taking this medicine.
The above symptoms may mean you are having a very rare, serious allergic reaction to this medicine.
Other possible side effects
If any of the following side effects get serious or concerns you, or you notice any side effects not listed in this leaflet, stop taking this medicine and tell your doctor or pharmacist.
• Headache, nervousness and tiredness in children aged 2-12 years.
• Drowsiness, headache, increased appetite and difficulty sleeping in adults and children over 12.
• Very rare side effects are severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling), dizziness, rapid heartbeat, palpitations, feeling sick (nausea), dry mouth, upset stomach, changes in liver lunction, rash, hair loss and tiredness.
El STORING THE MEDICINE
Do not use after the expiry date shown on the pack. Once opened use within 28 days.
This product does not require any special storage conditions.
Keep out of the reach and sight of children.
El FURTHER INFORMATION
What is in this medicine:
The active ingredient is: Loratadine 5mg per 5ml. The other ingredients are: Sucrose, sodium benzoate (E211), citric acid, peach flavour (benzyl alcohol, propylene glycol), glycerol and purified water.
What this medicine looks like and contents of the pack:
Loratadine 5mg/5ml Syrup is a clear colourless to pale yellow liquid solution with a peach odour.
This medicine is available in a bottle containing 100ml (or other relevant marketed pack sizes).
Marketing Authorisation Holder:
Galpharm Healthcare Ltd, Upper Cliffe Road, Dodworth Business Park, Dodworth, South Yorkshire S75 3SP Manufacturer: TEVA UK Ltd, Eastbourne, BN22 9AG.
Date of Approval: 05/2010