DESLORATADINE ARROW 0.5 MG/ML ORAL SOLUTION

Active substance: DESLORATADINE

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Desloratadine Oral Solution - PL 33786/0047 – Post-DCP National stage

PACKAGE LEAFLET: INFORMATION FOR THE USER
Desloratadine 0.5 mg/ml oral solution
Desloratadine
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 or pharmacist.
• • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
• • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
In this leaflet:
1. What Desloratadine oral solution is and what it is used for
2. 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. Further information
1. WHAT DESLORATADINE ORAL SOLUTION IS AND WHAT IT IS USED FOR
Desloratadine oral solution is an antiallergic medicine that does not make you drowsy. It helps control
your allergic reaction and its symptoms.
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). These symptoms include sneezing,
runny or itchy nose, itchy palate, and itchy, red or watery eyes.
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.

2. BEFORE YOU TAKE DESLORATADINE ORAL SOLUTION
Do not take Desloratadine oral solution:
• if you are allergic (hypersensitive) to desloratadine, to any of the other ingredients of Desloratadine
oral solution or to loratadine.
Desloratadine oral solution is indicated for children 1 through 11 years of age, adolescents (12 years of
age and older), and adults, including the elderly.
Take special care with Desloratadine oral solution:
• if you have poor kidney function.
If this applies to you, or if you are not sure, please check with your doctor before taking desloratadine.

Desloratadine Oral Solution - PL 33786/0047 – Post-DCP National stage

Taking other medicines:
There are no known interactions of desloratadine with other medicines.
Taking Desloratadine oral solution with food and drink:
Desloratadine oral solution may be taken with or without a meal.
Pregnancy and breast-feeding:
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy and breastfeeding.
If you are pregnant or nursing a baby, taking desloratadine is not recommended.
Driving and using machines:
At the recommended dose, desloratadine 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.
Important information about some of the ingredients of Desloratadine oral solution:
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


Children 1-5 years of age: take 2.5 ml (½ of a 5 ml spoonful) of oral solution once a day.



Children 6-11 years of age: take 5 ml (one 5 ml spoonful) of oral solution once a day.



Adults and adolescents (12 years of age and older): take 10 ml (two 5 ml spoonfuls) 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.
Swallow the dose of oral solution, then drink some water. You can take this medicine with or without
food.
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 your 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 doctor.
If you take more Desloratadine oral solution than you should:

Desloratadine Oral Solution - PL 33786/0047 – Post-DCP National stage

Take desloratadine only as it is prescribed for you. No serious problems are expected with accidental
overdose. However, if you take more desloratadine than you were told to, contact your doctor or
pharmacist.
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.
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, desloratadine can cause side effects, although not everybody gets them. In most
children and adults, side effects 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.
During the marketing of desloratadine, cases of severe allergic reactions (difficulty in breathing,
wheezing, itching, hives and swelling) and rash have been reported very rarely. Cases of palpitations,
rapid heartbeat, stomach pain, nausea (feeling sick), vomiting, upset stomach, diarrhoea, dizziness,
drowsiness, inability to sleep, muscle pain, hallucinations, seizures, restlessness with increased body
movement, liver inflammation and abnormal liver function tests have also been reported very rarely.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.

5. HOW TO STORE DESLORATADINE ORAL SOLUTION
Keep out of the reach and sight of children.
Do not use your medicine after the expiry date which is stated on the carton and on the blister 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.
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. FURTHER INFORMATION
What Desloratadine oral solution contains:
• The active substance is desloratadine 0.5mg/ml.

Desloratadine Oral Solution - PL 33786/0047 – Post-DCP National stage



The other ingredients are: sodium citrate, sorbitol, sucralose, citric acid anhydrous, propylene glycol,
hypromellose, tutti-frutti flavour and purified water.

What Desloratadine oral solution looks like and contents of the pack:
Desloratadine oral solution is available in bottles with a plastic childproof cap having a three-layer
polyethylene liner. Packages of 30ml, 50ml, 60ml, 100ml, 120ml and 150ml are supplied with a
measuring spoon or a measuring syringe. Packages of 225ml and 300ml are supplied with a measuring
spoon.
30, 50, 60, 100, 120, 150, 225 and 300 ml oral solution
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Arrow ApS, Sankt Peders Stræde 2, 1, 4000 Roskilde, Denmark
Manufacturer:
Genepharm S.A., 18 Km Marathon Avenue, 15351 Pallini, Greece
This leaflet was last approved in: 03/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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