Loratadine 5mg/5ml Syrup
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PATIENT INFORMATION LEAFLET
Loratadine 5mg/5ml Syrup Loratadine
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take your medicine 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.
- You must contact a doctor if your symptoms worsen or do not improve after a few days.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Loratadine is and what it is used for
2. Before you take Loratadine
3. How to take Loratadine
4. Possible side effects
5. How to store Loratadine
6. Further information
1.
WHAT LORATADINE IS AND WHAT IT IS USED FOR
Loratadine 5mg/5ml Syrup (‘Loratadine’) belongs to a group of medicines called antihistamines. It works by counteracting the effects of histamine which is produced naturally by your body’s defence system, but may be over-produced in allergic reactions.
Loratadine is used to relieve the symptoms of hayfever (allergic rhinitis) in adults and children over the age of 2 years, which include:
• sneezing
• irritated, runny or blocked nose
• itchy, red and watering eyes
It is also used to relieve the symptoms of skin allergies in adults and children (over the age of 2 years), which include:
• rash, itching and urticaria (hives).
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2.
BEFORE YOU TAKE LORATADINE
DO NOT TAKE Loratadine if you are:
• allergic to Loratadine, or any of the other ingredients of Loratadine 5mg/5ml Syrup (see Section 6 and end of Section 2).
• pregnant or planning to become pregnant.
• breast-feeding, as Loratadine can pass into breast milk.
Take special care with Loratadine if:
• you have severe liver problems
• you have an hereditary intolerance to some sugars.
Loratadine should not be taken for 48 hours before a skin test, since it may affect the results.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Especially, tell your doctor if you are taking any of the following:
• cimetidine (for stomach problems)
• erythromycin (an antibiotic)
• ketoconazole or fluconazole (for fungal infections)
• quinidine (for heart problems)
• fluoxetine (for depression).
Taking Loratadine with food and drink
You must avoid excessive alcohol consumption while you are taking this medicine, as with all antihistamine medicines. Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy.
Loratadine is not recommended in pregnant or breastfeeding women.
Driving and using machines
Loratadine does not usually cause drowsiness at the recommended dose. However, individuals react differently, so do not drive or operate machinery until you know how it affects you.
Important information about some of the ingredients of Loratadine
Loratadine also contains :
• sucrose: It contains 3.0g of sucrose per 5 ml dose which may be harmful to the teeth. Tell your doctor before taking this medicine if you have an intolerance to some sugars or diabetes mellitus.
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3. HOW TO TAKE LORATADINE
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Loratadine is to be taken only by mouth, and is not to be taken by children aged under 2 years.
The spoon provided holds 5ml of your medicine.
Shake the bottle well before use. The usual dose is:
|
Adults and children over 12 years: |
Two 5ml spoonfuls once daily |
|
Children aged 2 to 12 years: weighing more than 30 kg weighing less than 30 kg |
Two 5ml spoonfuls once daily One 5ml spoonful once daily |
|
Patients with severe liver problems Adults and children more than 30 kg Children weighing less than 30 kg |
Two 5ml spoonfuls on alternate days One 5ml spoonful on alternate days |
Do not exceed the stated dose
If you take more Loratadine than you should:
If you or your child may have taken too much of this medicine, talk to a doctor or pharmacist immediately. You or the child may feel drowsy, have a headache or rapid heartbeat.
If you forget to take Loratadine
If you forget to take a dose, take it as soon as you remember, unless it is nearly time for the next dose. Do not take a double dose to make up for the forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Loratadine can cause side effects, although not everybody gets them.
Swelling of the face, mouth, lips or throat can be signs of an allergic reaction. If this happens to you, STOP taking Loratadine and tell your doctor immediately, or go to your nearest hospital. Take the bottle with you if you can.
Tell your doctor as soon as possible if you notice any of the following:
nausea (feeling sick) dizziness
disturbances in heart rhythm drowsiness or tiredness (fatigue)
abdominal cramps or stomach pains
dry mouth
rash, hair loss
liver function problems
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE LORATADINE
Keep out of the reach and sight of children, and do not store above 25°C.
Do not use Loratadine after the expiry date which is stated on the label. The expiry date refers to the last day of that month. Use within 6 months after opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Loratadine contains
• The active ingredient is Loratadine: 5mg in each 5ml of syrup.
• The other ingredients are: sucrose, glycerol (E422), propylene glycol, sodium benzoate (E211), citric acid monohydrate, peach flavour and purified water (see end of Section 2 for further information).
What Loratadine looks like and contents of the pack
Loratadine is a colourless solution, with the taste of peach. It is available in pack sizes of 60ml, 100ml and 150ml amber glass bottles, and includes a 5ml spoon.
Marketing Authorisation Holder and Manufacturer
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
PL 04917/0067
This leaflet was last updated in 06/2008.
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