Loratadine 5 Mg/ 5 Ml Syrup
Patient Information Leaflet LORATADINE 5 MG/ 5 ML SYRUP
Read this leaflet carefully before you start taking this medicine because it contains important information for you. This medicine is available without prescription for you to treat a mild illness without a doctor’s help. Nevertheless, you still need to use Loratadine Syrup 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 talk to a doctor if you do not feel better or if you feel worse.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET _:
1. What Loratadine Syrup is and what it is used for
2. What you need to know before you take Loratadine syrup
3. How to take Loratadine syrup
4. Possible side effects
5. How to Store Loratadine syrup
6. Contents of the pack and other information
1. What Loratadine Syrup is and what it is used for
The name of your medicine is Loratadine 5 mg/ 5 ml Syrup
■ Loratadine belongs to a group of drugs called antihistamines which help to relieve the symptoms of some allergies.
■ Your medicine is used to relieve symptoms such as sneezing, running nose and burning, itchy eyes due to hayfever and other allergies. This medicine can also be taken to relieve symptoms due to skin allergies such as rash, itching or urticaria (hives). It can also be given to children aged 2 to 12 years to relieve the symptoms of hay fever or skin allergies.
2. What you need to know before you take Loratadine syrup
Do not take if you:
• Are sensitive to any of the ingredients in the medicine, listed in section 6.
Warnings and precautions :
Talk to your doctor or pharmacist before taking Loratadine if you:
• have severe liver problems (see section 3).
Other precautions you should take
• Antihistamines may prevent a response to allergens in skin allergy testing; therefore you should stop taking this medicine at least 2 days before any such testing.
Pregnancy and Breast-feeding
• Do not take this product if you are pregnant or breast-feeding.
Loratadine Syrup contains sucrose and glycerol
• Each 5 ml measure of the medicine contains 3.125 g of sucrose (sugar). Sucrose is unsuitable for people with fructose, glucose or sucrose intolerance. This should be taken into account in patients with diabetes mellitus.
• Glycerol can be harmful in high doses as it can cause headache, stomach upset and diarrhoea
Driving and using machines:
• Loratadine may make you feel drowsy. Do not drive or operate any tools or machines if affected.
3. How to take Loratadine syrup
If your doctor has prescribed this medicine, always follow your doctor’s instructions. Otherwise, follow the instructions below. If you do not understand these instructions, or you are in any doubt, ask your doctor or pharmacist.
Use the spoon provided to make sure you have the correct dose.
Adults and Children over 12 years of age
Two 5 ml spoonfuls (10 mg) once daily.
Children aged 2 to 12 years
Bodyweight more than 30kg: Two 5 ml spoonfuls (10 mg) once daily.
Bodyweight 30kg or less: One 5 ml spoonful (5 mg) once daily.
Children under 2 years of age
Not recommended.
Patients with severe liver impairment Adults and children over 2 years of age
Bodyweight more than 30kg: Two 5 ml spoonfuls (10 mg) every other day.
Bodyweight 30kg or less: One 5 ml spoonful (5 mg) every other day.
If you take more than you should
If you (or someone else) swallow a lot of the liquid all together or if you think a child has accidentally swallowed any of the liquid, contact your nearest hospital casualty department or your doctor immediately. Overdose may cause sleepiness, fast heart rate and headache.
If you forget to take your medicine
If you forget to take a dose, take one as soon as you remember, unless it is nearly time to take the next one. Never take two doses together. Take the remaining doses at the correct time.
4. Possible side effects
Like all medicines, this medicine can have side effects, although not everybody gets them.
If you experience the following, stop taking the product and tell you doctor immediately or go to the casualty department at your nearest hospital:
• a severe allergic reaction (swelling of the face, lips, mouth or throat which may cause difficulty swallowing or breathing).
This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.
The following common side effects have been reported at the approximate frequencies shown:
Children aged 2 to 12 years:
Common (may affect up to 1 in 10 people): headache, nervousness and tiredness.
Adults and children over 12 years:
Common (may affect up to 1 in 10 people): drowsiness (somnolence).
Uncommon (may affect up to 1 in 100 people): headache, increased appetite and difficulty sleeping.
Very rare (may affect up to 1 in 10,000 people): dizziness, convulsions
palpitation (feeling your heartbeat) and fast heart rate
nausea (feeling sick), dry mouth, gastritis (nausea and vomiting)
liver problems
rash and hair loss
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. How to store Loratadine syrup
Keep this medicine out of the sight and reach of children. This medicinal product does not require any special storage instructions. Do not transfer the liquid to another container. Do not use after the use before date on the outer carton. Do not throw away any medicines via wastewater or household waste. Once opened, use within 28 days. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information What Loratadine Syrup contains:
• The active ingredient is Loratadine.
• Other ingredients are sucrose, sodium benzoate (E211), citric acid, peach flavour, benzyl alcohol, glycerol, propylene glycol and purified water
Each 5ml spoonful contains 5 mg of loratadine.
What Loratadine Syrup looks like and contents of the pack:
■ The product is available in bottles containing 50, 60, 70, 100,150 and 200 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible for manufacture:
Teva UK Limited, Eastbourne BN22 9AG UK.