Loratadine 5mg/5ml Syrup
Loratadine 5mg/5ml Syrup PL 16028/0099
Loratadine 5mg/5ml Syrup 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
1. WHAT THIS MEDICINE IS FOR
Loratadine 5mg/5ml Syrup contains loratadine, which belongs to a group of drugs called antihistamines. These medicines help 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).
2. 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 contain 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.
3. 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 (10mg) 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 |
Two 5ml spoonfuls (10mg) every other day. One 5ml spoonful (5mg) every other day. |
|
DO NOT EXCEED THE STATED 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 dose.
4. 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, throat or other parts of the body
• you have any difficulty in swallowing or breathing or wheezing
• you get a skin rash, itching or hives on the skin after taking this medicine.
The above symptoms may mean you are having a very rare, serious allergic reaction to this medicine.
• you experience convulsions (fits).
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 dizziness, rapid heartbeat, palpitations, feeling sick (nausea), dry mouth, upset stomach, changes in liver function, rash, hair loss and 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: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. STORING THE MEDICINE
Do not use after the expiry date shown in the pack.
Once opened use within 28 days.
This product does not to require any special storage conditions. Keep out of the sight and reach of children.
6. FURTHER INFORMATION What is in this medicine:
The active ingredient is: Loratadine 5 mg 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 the contents of the pack:
Loratadine 5mg/5ml Syrup is a clear colourless to a 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, Wrafton, Braunton, Devon, EX33 2DL, United Kingdom.
Manufacturer:
TEVA UK Ltd, Eastbourne. BN22 9AG.
Date of Approval: February 2016.
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