Loratadine 5mg/5ml
Package leaflet: information for the user
Loratadine 5mg/5ml oral solution
Loratadine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist, or nurse has told you
Keep this leaflet. You may need to read it again.
Ask your pharamacist if you need more information or advice.
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
You must talk to a doctor if you do not feel better, if you feel worse.
What is in this leaflet:
1. What Loratadine oral solution is and what it is used for
2. What you need to know before you take Loratadine oral solution
3. How to take Loratadine oral solution
4. Possible side effects
5. How to store Loratadine oral solution
6. Contents of the pack and other information
1. What loratadine oral solution is and what it is used for
This medicine contains the active substance loratadine which belongs to a class of medicines called "antihistamines".
Loratadine oral solution is used in both adults and children over 2 years of age to relieve the symptoms of hayfever such as sneezing,runny nose and burning,itchy eyes. It may also used for skin allergies such as rash,itching or urticaria(hives)
You must talk to a doctor if you do not feel better or if you feel worse.
2. What you need to know before you take Loratadine 5 mg /5 ml oral solution
Do not take Loratadine oral solution
if you are allergic (hypersensitive) to loratidine or any of the other ingredients of this medicine (listed in section 6)
if you are pregnant,planning to become pregnant or are breast feeding.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Loratadine oral solution:
if you are scheduled to have any skin tests for allergies. Do not take Loratadine oral solution for two days before having these tests. This is because it may affect test results, if you have severe liver disease Children
Do not give Loratadine oral solution to children younger than 2 years old..
Other medicines and loratadine oral solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes taken without a prescription. This is particularly important if you are taking Cimetidine (for stomach problems)
Erythromycin (an antibiotic)
Ketoconazole or fluconazole (for fungal infections)
Loratadine oral solution with alcohol
Loratadine oral solution 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.
Do not take Loratadine oral solution if you are pregnant.
Do not take Loratadine oral solution if you are breast-feeding.
Loratadine is excreted in breast milk.
Driving and using machines
At the recommended dose, loratadine are not expected to cause you to be drowsy or less alert. However, very rarely some people experience drowsiness, which may affect their ability to drive or use machines. Please make sure you are not drowsy before performing these activities.
Loratadine oral solution contains maltitol and sucralose
This medicinal product contains maltitol and sucralose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take loratadine oral solution
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
Loratadine oral solution is for oral use only. Shake the bottle well before use.
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The usual dose is as shown in the table below:
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Adults and Children over 12 years of age |
10ml (lOmg) of the oral solution once daily |
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Children 2 to 12 years of age with: Body weight more than 30 kg Body weight 30 kg or less |
10ml (lOmg) of the oral solution once daily 5ml (5mg) of the oral solution once daily |
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If you have severe liver problems your doctor or pharmacist may advise you to take the recommended amount every other day. If this applies to you follow their instructions. | |
Children
Do not give to children under 2 years.
If you take more Loratadine oral solution than you should
If you may have taken more Loratadine oral solution than you should .talk to a doctor or pharmacist immediately . Overdose may cause sleepiness or a faster heart beat. Immediate medical attention should be sought in the event of an overdose.
If you forget to take Loratadine oral solution
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 a 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, this medicine can cause side effects, although not everybody gets them.
The most commonly reported side effects in adults and children over 12 years of age are: drowsiness headache increased appetite difficulty sleeping
The most commonly reported side effects in children aged 2 through 12 years are: headache nervousness tiredness
The following very rare side effects (may affect up to 1 in 10,000 people) have also been seen during the marketing of loratadine:
severe allergic reaction which causes difficulty in breathing or dizziness
liver problems (can be detected by laboratory tests)
faster heart beats
fainting
rash
Gastritis (abdominal pain, burning feeling in the stomach between meals or at night and nausea
(with or without vomiting)
hair loss
fatigue
dry mouth
serious allergic reaction which causes swelling of the face or throat nausea
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 oral solution
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after "Exp'. The expiry date relates to the last day of that month.
This medicinal product does not require any special storage conditions.
Loratadine oral solution is to be used within 3 months after opening.
Do not use Loratadine oral solution if you notice any defects or signs of deterioration.
If unsure, consult your doctor or pharmacist before taking it.
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. Contents of the pack and other information
What Loratadine oral solution contains
The active substance is loratadine.
The other ingredients are propylene glycol (E1520),sodium benzoate (E211), disodium edetate, maltitol (lycasin 80/55), glycerol (E422). citirc acid monohydrate, menthol, flavour peach (9/A07169) and sucralose.
What Loratadine oral solution looks like and contents of the pack
Loratadine oral solution is a clear, colourless liquid contained in either amber coloured glass bottles with a tamper proof child resistance cap or amber coloured transparent PET bottles with a tamper proof child resistance cap.
Pack size: 100ml y.
y.
Marketing Authorisation Holder
Cipla (ELI) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, LTnited Kingdom. ^ Manufacturer:
Cipla (EU) Limited, 4th Floor, 1 Kingdom Street, London, W2 6BY, United Kingdom. | _
This leaflet was last revised in Month of Variation approval.