Loratadine 5mg/5ml Syrup
Loratadine 5 mg/5ml Syrup
Loratadine
Package leaflet: Information for the user
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• 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 5mg/5ml 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
T] What Loratadine syrup is and what it is used for
The active ingredient in Loratadine Syrup is loratadine. Loratadine belongs to the group of medicines called antihistamines. It helps soothe the symptoms of some allergies.
Loratadine Syrup relieves symptoms of allergic rhinitis such as sneezing, runny nose. These symptoms might be related to hay fever or could occur all through the year.
Loratadine Syrup is also useful for the treatment of chronic idiopathic urticaria (raised, red, itchy rash or 'hives').
You may have previously taken this medicine from another company and it may have looked slightly different. Either brand will have the same effect.
2j What you need to know before you take Loratadine syrup
Do not take Loratadine Syrup
• If you are allergic to loratadine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Loratadine syrup:
• if you have serious liver problems
If you are due to have skin test (e.g. for allergies) do not take Loratadine Syrup for at least 48 hours before this test. Loratadine may affect your response to such a skin test.
Children
Children under the age of 2 years should not be given Loratadine syrup.
Other medicines and Loratadine syrup
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular these include erythromycin (an antibiotic), cimetidine (for increased acid secretion and stomach ulcers), ketoconazole or fluconazole (antifungals), quinidine (for heart problems), and fluoxetine (an antidepressant).
Loratadine syrup with food, drink and alcohol
The syrup may be taken with or without food, without regard to mealtime.
Loratadine syrup has not been shown to add to the effects of an alcoholic drink.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The use of Loratadine Syrup is not recommended if you are pregnant or trying to get pregnant, or are breast-feeding. Loratadine is excreted into breast milk.
Driving and using machines
It is usually safe to drive while being on Loratadine Syrup. However, not all of us react in the same way to the same medicine. Very rarely some people experience drowsiness, which may affect their ability to drive or use machines. When first taking the syrup, you should take care until you are sure about the way it affects you.
Loratadine Syrup contains sucrose
A daily dose of 10 ml Loratadine 5mg/5ml Syrup contains 6 g of sucrose. This should be taken into account in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3j How to take Loratadine syrup
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults and children over 12 years of age:
10 ml (10 mg) of the syrup once daily.
Children 2 to 12 years of age with:
Body weight more than 30 kg: 10 ml (10 mg) of the syrup once daily.
Body weight 30 kg or less: 5 ml (5 mg) of the syrup once daily.
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Efficacy and safety of loratadine in children under 2 years of age has not been established.
If you have liver problems you should take a lower dose. An initial dose of 10 ml (10 mg) every other day is recommended for adults and children weighing more than 30 kg, and for children weighing 30 kg or less, 5 ml (5 mg) every other day is recommended.
No dosage adjustments are required in the elderly or in patients with renal insufficiency (kidney problems).
You may take the syrup with or without food, without regard to mealtime.
If you take more Loratadine syrup than you should
If you (or someone else) accidentally take too much Loratadine Syrup contact your doctor immediately. Somnolence (drowsiness), rapid heart beat, and headache may occur.
If you forget to take Loratadine syrup
Take your medicine at the same time each day. If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects after taking this medicine, do not take more Loratadine syrup. Tell your doctor immediately, or go to the casualty department at your nearest hospital:
• sudden wheezing and chest pain or chest tightness
• swelling of your eyelids, face, lips, mouth or tongue
• skin rash - red spots or lumps under your skin (hives) anywhere on your body
• collapse
Other side effects:
• Common (may affect up to 1 in 10 people): somnolence (drowsiness),
• Uncommon (may affect up to 1 in 100 people): headache, increased appetite, insomnia (unable to sleep),
• Very rare (may affect up to 1 in 10.000 people): tiredness, rapid heart beat, palpitations (pounding heart beats), dizziness, convulsion, skin rash feeling sick, dry mouth, gastritis (vomiting, upset stomach), abnormal
liver function tests (found on blood tests), and alopecia (hair loss).
Additional side effects in children
(aged 2 through 12 years):
Common side effects (may affect up to 1 in 10 people): headache, nervousness, tiredness.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme,
Website: 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
The syrup may be used for 6 months after the bottle being opened.
Both opened and unopened: Do not store above 25°C. Do not freeze.
Store in the original container.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Further information
What Loratadine Syrup contains
• The active substance is: loratadine
(5 m of the syrup contains 5 mg of the active substance loratadine)
• The other ingredients are sodium benzoate, sucrose, propylene glycol, glycerol, anhydrous citric acid, aroma vanillin (AB 710), aroma strawberry (AB 180) and purified water.
What Loratadine Syrup looks like and contents of the pack
Slightly yellow coloured, transparent, sweet homogenous syrup having a characteristic (fruit aroma) odour and taste.
Loratadine 5mg/5ml Syrup comes in amber glass bottles containing 120 ml syrup.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
EGIS Pharmaceuticals U.K. Limited 127 Shirland Road, London W9 2EP
The Manufacturer responsible for batch release and distributor is: Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom.
This leaflet was last revised in May, 2015
PL No. 18190/0006 P
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