Desloratadine 0.5mg/Ml Oral Solution
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■ 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.
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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
Package leaflet: Information for the patient
■ 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 bottle after EXP. The expiry date refers to the last day of that month.
■ This medicinal product does not require any special temperature storage conditions
■ Do not freeze. Store in the original package in order to protect from light.
■ Do not use 2 months after you first open it.
■ Do not use this medicine if you notice any change in the appearance of the oral solution.
■ 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.
Read all of this leaflet carefully before you start taking 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,
■ 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.
What is in this leaflet:
1. What Desloratadine oral solution is and what it is used for
2. What you need to know before you take Desloratadine oral solution
3. How to take Desloratadine oral solution
4. Possible side effects
5. How to store Desloratadine oral solution
6. Contents of the pack and other information
What desloratadine oral solution contains
■ The active substance is desloratadine 0.5mg/ml
■ The other ingredients of the oral solution are sorbitol solution (E420), propylene glycol (E1520), sucralose (E955), hypromellose (E464), sodium citrate (E331), citric acid monohydrate (E330), tartaric acid (E334), orange flavour, dilute hydrochloric acid - for pH adjustment, sodium hydroxide (E524) -for pH adjustment and purified water.
What desloratadine oral solution looks like and contents of the pack Desloratadine oral solution is a clear, colourless solution.
It comes in a brown glass bottle holding 150ml of solution with a white, polypropylene double ended spoon marked for doses of 2.5ml and 5ml.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.
Tel: + 44 (0) 113 244 1400.
This medicinal product is authorised in the Member States of the EEA under the following names:
UK and Ireland: Desloratadine 0.5mg/ml oral solution Germany Desloratadine 0.5mg/ml Losung zum Einnehmen
This leaflet was last revised in March 2015.
What desloratadine is
It contains desloratadine which is an antihistamine.
How desloratadine works
It is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.
When desloratadine should be used
Desloratadine 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.
Desloratadine 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.
Do not take desloratadine oral solution
■ if you are allergic to desloratadine, or to any of the other ingredients of this medicine (listed in section 6) or to loratadine.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking desloratadine:
■ if you have poor kidney function.
Use in children and adolescents
Do not give this medicine to children less than 1 year of age.
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Other medicines and desloratadine
There are no known interactions of desloratadine with other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Taking Desloratadine with food and drink
Desloratadine may be taken with or without a meal.
Pregnancy, breast-feeding and fertility
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.
Taking desloratadine is not recommended if you are pregnant or nursing a baby.
Fertility
There is no data available on male/female fertility.
Driving and using machines
At the recommended dose, this medicine is not expected to affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended not to 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
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.
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, pharmacist or nurse immediately.
If you forget to take desloratadine oral solution
If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule. 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, pharmacist or nurse.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How much to take
Children 1 through 5 years of age:
The recommended dose is 2.5ml (one 2.5ml spoonful) of oral solution once a day.
Children 6 through 11 years of age:
The recommended dose is 5ml (one 5ml spoonful) of oral solution once a day.
Adults and adolescents 12 years of age and over:
The recommended dose is 10ml (two 5ml spoonfuls) of oral solution once a day.
Taking this medicine
■ This medicine is for oral use.
■ Measure your dose using the spoon provided.
■ Swallow the dose of oral solution and then drink some water. You can take this medicine with or without food.
Duration of treatment
Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take desloratadine oral solution.
If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks), your physician will recommend you a treatment schedule that will depend on the evaluation of the history of your disease.
If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more than 4 weeks), your physician may recommend you a longer term treatment.
For urticaria, the duration of treatment may be variable from patient to patient and therefore you should follow the instructions of your physician.
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Like all medicines, this medicine can cause side effects, although not everybody gets them.
During the marketing of desloratadine 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 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 difficulty sleeping insomnia while in adults, fatigue, dry mouth and headache were reported more often than with a dummy tablet.
In clinical studies with desloratadine, the following side effects were reported as:
Common in children less than 2 years of age: the following may affect up to 1 in 10 children
■ diarrhoea
■ fever
■ difficulty sleeping
Common: the following may affect up to 1 in 10 people:
■ fatigue
■ dry mouth
■ headache
During the marketing of desloratadine, the following side effects were reported as:
Very rare, the following may affect up to 1 in 10,000 people:
■ severe allergic reactions
■ rash
■ pounding or irregular heartbeat
■ fast heart beat
■ stomach ache
■ feeling sick (nausea)
■ vomiting
■ upset stomach
■ diarrhoea
■ dizziness
■ drowsiness
■ inability to sleep
■ muscle pain
■ hallucinations
■ seizures (fits)
■ restlessness with increased body movement
■ liver inflammation
■ abnormal liver function tests
■ breathlessness Continued overleaf