Desloratadine 0.5mg/Ml Oral Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER
Desloratadine 0.5mg/ml Oral Solution
Read all of this leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
See section 4.
In this leaflet:
j What Desloratadine Oral Solution is and what it is used for
What you need to know before you take Desloratadine Oral Solution How to take Desloratadine Oral Solution Possible side effects
How to store Desloratadine Oral Solution
« Contents of the pack and other information
j What Desloratadine Oral Solution is and what it is used for
Desloratadine Oral Solution is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.
Desloratadine Oral Solution relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults, adolescents and children 1 year of age and older. These symptoms include sneezing, runny or itchy nose, itchy palate and itchy, red or watery eyes.
Other medicines and Desloratadine Oral Solution
There are no known interactions of Desloratadine Oral Solution with other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Taking Desloratadine Oral Solution with food, drink and alcohol
Desloratadine Oral Solution may be taken with or without a meal. Use caution when taking Desloratadine Oral Solution with alcohol.
Pregnancy, breast-feeding and fertility
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 any medicine. Taking Desloratadine Oral Solution is not recommended if you are pregnant or breast-feeding.
Fertility
The effect of Desloratadine Oral Solution on fertility is not known.
Driving and using machines
At the recommended dose, Desloratadine Oral Solution is 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. Do not engage in activities requiring mental alertness, such as driving a car or operating machinery until you have established your own response to the medicinal product.
Desloratadine Oral Solution contains sorbitol
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3| How to take Desloratadine Oral Solution
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Desloratadine Oral Solution is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives.
Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep.
What you need to know before you take Desloratadine Oral Solution
Do not take Desloratadine Oral Solution
• if you are allergic (hypersensitive) to desloratadine, loratadine, or to any of the other ingredients of Desloratadine Oral Solution (listed in section 6).
Warnings and precautions
Take special care with Desloratadine Oral
Solution
If you have poor kidney function or if you are not sure, please check with your doctor before taking Desloratadine Oral Solution.
The recommended dose of Desloratadine Oral Solution is:
Children 1 through to 5 years of age: 2.5ml (as marked on spoon) of oral solution once a day.
Children 6 through to 11 years of age: 5ml
(one 5ml spoonful) of oral solution once a day.
Adults and adolescents (12 years of age and older): 10ml (two 5ml spoonfuls) of oral solution once a day.
Swallow the dose of oral solution, then drink some water. You can take this medicine with or without food.
Your doctor will determine the duration of treatment which will depend on the severity of the allergic condition and may be variable from patient to patient. Therefore you should follow the instructions of your doctor.
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If you take more Desloratadine Oral Solution than you should
Take Desloratadine Oral Solution only as it is prescribed for you. No serious problems are expected with accidental overdose. However, if you take more Desloratadine Oral Solution than you were told to, tell your doctor or pharmacist immediately.
If you forget to take Desloratadine Oral Solution
If you forget to take your dose on time, take it as soon as possible, then go back to your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.
4| Possible side effects
Like all medicines, Desloratadine Oral Solution can cause side effects, although not everybody gets them.
During the marketing of Desloratadine Oral Solution, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely. If you notice any of these serious side effects, stop taking the medicine and seek urgent medical advice straight away.
In clinical studies in most children and adults, side effects with Desloratadine Oral Solution were about the same as with a dummy solution or tablet. However, common side effects in children less than 2 years of age were diarrhoea, fever and insomnia while in adults, fatigue, dry mouth and headache were reported more often than with a dummy tablet.
In clinical studies with Desloratadine Oral Solution, the following side effects were reported as:
Children
Common in children less than 2 years of age: the following may affect up to 1 in 10 children
• diarrhoea
• fever
• insomnia.
Adults
Common: the following may affect up to 1 in 10 people
• fatigue
• dry mouth
• headache.
During the marketing of Desloratadine Oral Solution, the following side effects were reported as:
Adults
Very rare: the following may affect up to 1 in 10,000 people
• severe allergic reactions
• rash
• pounding or irregular heartbeat
• fast heartbeat
• stomach ache
• feeling sick (nausea)
• vomiting
• upset stomach
• diarrhoea
• dizziness
• drowsiness
• inability to sleep
• muscle pain
• hallucinations
• seizures
• restlessness with increased body movement
• liver inflammation
• abnormal liver function tests.
Not known: frequency cannot be estimated from the available data
• unusual weakness
• yellowing of the skin and/or eyes
• increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to UV lights of a solarium
• change in the way the heart beats.
Children
Not known: frequency cannot be estimated from the available data
• slow heartbeat
• change in the way the heart beats.
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.
How to store Desloratadine Oral Solution
Keep out of the sight and reach of children.
Do not use Desloratadine Oral Solution after the expiry date which is stated on the bottle. The expiry date refers to the last day of that month.
Store in the original package. Do not freeze.
After first opening use within 2 months.
Do not use this medicine and tell your pharmacist if you notice any change in the appearance of the oral solution. 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| Contents of the pack and other information
What Desloratadine Oral Solution contains
The active substance is desloratadine.
1ml of oral solution contains 0.5mg desloratadine.
The other ingredients of the oral solution are:
Sorbitol, liquid (non-crystallizing), Propylene glycol, Citric acid monohydrate, Sodium citrate, Hypromellose 2910, Sucralose, Disodium edentate, Tutti frutti, Purified water.
What Desloratadine Oral Solution looks like
and contents of the
pack
Desloratadine Oral Solution is presented as a clear colourless solution, free from foreign matters.
Pack Sizes:
100ml and 150ml.
Desloratadine 0.5mg/ml Oral Solution is supplied in amber glass bottles containing 100ml or 150ml and closed with a plastic child resistant screw cap. Each bottle is supplied in a cardboard box with a measuring spoon marked for doses of 2.5ml and 5ml.
Marketing Authorisation Holder
Caduceus Pharma Ltd 6th floor
94 Wigmore Street London W1U 3RF UK
Manufacturer
Specifar S.A.
1,28 Octovriou str Ag. Varvara,
12351 Athens Greece
This leaflet was last revised in September 2015.
If you would like a leaflet with larger text, please contact 01271 385257.
vactavis
Actavis, Barnstaple, EX32 8NS, UK
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