Desloratadine 0.5mg/Ml Oral Solution
Package leaflet: Information for the patient
Desloratadine 0.5 mg/ml oral solution
Desloratadine
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 this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
1. What this medicine is and what it is used for
This medicine contains desloratadine which is an antihistamine.
This is an anti-allergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.
This medicine 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.
This medicine 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.
2. What you need to know before you take this medicine Do not take this medicine
• if you are allergic to desloratadine, or to any of the other ingredients of this medicines (listed in section 6) or to loratadine.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking this medicine • if you have poor kidney function.
Use in children and adolescents
Do not give this medicine to children less than 1 year of age.
Taking other medicines
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 with food, drink and alcohol
This medicine may be taken with or without a meal.
Use caution when this medicine with alcohol.
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 this medicine 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.
This medicine contains sorbitol and sucralose
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 this medicine
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is
Adults and adolescents 12 years of age and over
The recommended dose is 10 ml (two 5 ml spoonfuls) of oral solution once a day. Children
Children 1 through 5 years of age:
The recommended dose is 2.5 ml ('A of a 5 ml spoonful) of oral solution once a day. Children 6 through 11 years of age:
The recommended dose is 5 ml (one 5 ml spoonful) of oral solution once a day.
In case an oral measuring syringe is provided with the bottle of oral solution, you can alternatively use it to take the appropriate amount of oral solution.
Route and method of administration
This medicine is for oral use.
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 this medicine.
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.
If you take more of this medicine than you should
Take this medicine only as it is prescribed for you. No serious problems are expected with accidental overdose. However, if you take more of this medicine than you were told to, tell your doctor, pharmacist or nurse immediately.
If you forget to take this medicine
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 stop taking this medicine
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
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 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:
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, 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 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 test,
Not known: frequency cannot be estimated from the available data
• Unusual weakness
• 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
• Yellowing of the skin and/or eyes
• 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
• Abnormal behaviour (including anger, aggression and agitation)
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 this medicine
• 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. Store in the original primary container.
• 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.
6. Contents of the pack and other information What this medicine contains
• The active substance is desloratadine 0.5 mg/ml
• The other ingredients of the oral solution are sorbitol, propylene glycol, sucralose, hypromellose, sodium citrate, citric acid anhydrous, flavour tutti frutti.
What this medicine looks like and contents of the pack
• This medicine is is supplied in 30, 50, 60, 100, 120, 150, 225 and 300 ml size type III amber glass bottles closed with a plastic child resistant (C/R) screw closure having a three layer polyethylene- faced liner. The capped bottles are subsequently packed into cardboard boxes. A measuring device (spoon or syringe) will be included in the secondary packaging.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Bristol Laboratories Ltd.,
Unit 3, Canalside, Northbridge Road,
Berkhamsted, HP4 1EG, United Kingdom.
Telephone: 0044 (0) 1442 200922 Fax: 0044 (0) 1442 873717
Email: info@bristol-labs.co.uk
This leaflet was last revised in January 2016
To request a copy of this leaflet in Braille, large print or audio format then please contact the licence holder at the address (or telephone, fax, email) above.
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