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DESLORATADINE 0.5 MG/ML ORAL SOLUTION

Active substance(s): DESLORATADINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Desloratadine 0.5 mg/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 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 is and what it is used for
2.
Before you take Desloratadine
3.
How to take Desloratadine
4.
Possible side effects
5.
How to store Desloratadine
6.
Further information

1.

WHAT DESLORATADINE IS AND WHAT IT IS USED FOR

Desloratadine is an anti-allergy 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 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

Do not take Desloratadine
• if you are allergic (hypersensitive) to desloratadine, loratadine, or to any of the other ingredients of
Desloratadine.
Desloratadine 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
• 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.
Taking other medicines
There are no known interactions of Desloratadine with other medicines.
Taking Desloratadine with food and drink
1

Desloratadine can be taken with or without 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 make you 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
Desloratadine contains sorbitol. If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.

3.

HOW TO TAKE DESLORATADINE

Children 1 through 5 years of age: take 2.5 ml (½ of a 5 ml spoonful) of oral solution once a day.
Children 6 through 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.
Use the oral dosing spoon provided with the bottle of oral solution to take your dose.
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 doctor will determine the type of allergic rhinitis you are suffering
from and will determine for how long you should take Desloratadine.
If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than
4 weeks), your doctor 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 doctor 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 than you should
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
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.
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

Keep out of the reach and sight of children.
Do not use Desloratadine after the expiry date which is stated on the bottle and outer carton after “EXP”. The
expiry date refers to the last day of the month.
Do not refrigerate or freeze. Store in the original bottle in order to protect from light.
Use Desloratadine within 2 months after first opening of the bottle.
Tell your pharmacist if you notice any change in the appearance of the 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 contains
The active substance is desloratadine 0.5mg/ml.
The other ingredients are sorbitol, liquid (non-crystallising) (E420), propylene glycol (E1520),
sucralose (E955), hypromellose (E464), sodium citrate (E331), N&A Bubblegum type FL #25685
flavour, citric acid anhydrous (E330) and purified water
What Desloratadine looks like and contents of the pack
Desloratadine is available in bottles of 50, 60, 100, 120, 150 ml, with a white child resistant PP closure and
yellow tamper evidence ring. For all packages, a measuring spoon is provided, marked for doses of 2.5 ml
and 5 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
TEVA Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, HUNGARY
OR*

TEVA Pharmaceutical Works Private Limited Company, H-2100 Gödöllő, Táncsics Mihály út 82,
HUNGARY
OR*
Teva UK Limited, Eastbourne, BN22 9AG, UK
OR*
Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, THE NETHERLANDS
OR*
TEVA Santé, Rue Bellocier, 89100 Sens, FRANCE
OR*
Teva Czech Industries s.r.o., Ostravska 29, c.p. 305, 74770 Opava-Komarov, CZECH REPUBLIC
OR*
Teva Operations Sp. z.o.o, ul. Mogilska 80. 31-546, Krakow, POLAND
OR*
TEVA PHARMA S.L.U., C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza, SPAIN
OR*
Teva Operations Sp. z.o.o, Ul. Sienkiewicza 25, 99-300 Kutno, POLAND
OR*
Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren, GERMANY
OR*
Merckle GmbH, Graf-Arco-Str. 3, 89079 Ulm, GERMANY
OR*
Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem, THE NETHERLANDS
OR*
CT Arzneimittel GmbH, Graf-Arco-Stra8e 3, 89079 UIm, GERMANY

This leaflet was last revised in 03/2013.
PL 00289/1699
*Only the actual site of batch release will appear on the printed version of the leaflet

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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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