Skip to Content

UK Edition. Click here for US version.

DESLORATADINE 0.5 MG/ML ORAL SOLUTION

Active substance(s): DESLORATADINE / DESLORATADINE / DESLORATADINE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the user
Desloratadine Teva Oral Solution 0.5 mg/ml
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 or pharmacist.
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 or pharmacist. This includes any possible side effects
not listed in this leaflet. See section

What is in this leaflet:
1.
What Desloratadine Teva is and what it is used for
2.
What you need to know before you take Desloratadine Teva
3.
How to take Desloratadine Teva
4.
Possible side effects
5.
How to store Desloratadine Teva
6.
Contents of the pack and other information
1.
What Desloratadine Teva is and what it is used for
Desloratadine Teva is an anti-allergy medicine that does not make you drowsy. It helps control your allergic
reaction and its symptoms.
Desloratadine Teva 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 Teva 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 Desloratadine Teva
Do not take Desloratadine Teva
 if you are allergic to desloratadine, loratadine, or to any of the other ingredients of this medicine (listed
in section 6)..
Desloratadine Teva is indicated for children 1 through 11 years of age, adolescents (12 years of age and
older), and adults, including the elderly.
Warnings and precautions
Talk to your doctor or pharmacist before taking Desloratadine Teva:
 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 Teva.
Other medicines and Desloratadine Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

There are no known interactions of Desloratadine Teva with other medicines.
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 this medicine.
.
If you are pregnant or nursing a baby, taking Desloratadine Teva is not recommended.
Driving and using machines
At the recommended dose, Desloratadine Teva 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.
Desloratadine Teva 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 Teva

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:
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 Teva.
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 Teva than you should
Take Desloratadine Teva only as it is prescribed for you. No serious problems are expected with accidental
overdose. However, if you take more Desloratadine Teva than you were told to, contact your doctor or
pharmacist.
If you forget to take Desloratadine Teva
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, this medicine 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 (may affect up to 1 in 10 people) 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 (may affect up to 1 in 10,000 people).
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 (may affect up to 1 in 10,000 people)..
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 Desloratadine Teva

Keep out of the sight and reach of children.
Do not use Desloratadine Teva 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 Teva within 2 months after first opening of the bottle.
Do not use this medicine if you notice any change in the appearance of the solution.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use medicines no longer required. These measures will help protect the
environment.
6.

Contents of the pack and other information

What Desloratadine Teva 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 Teva looks like and contents of the pack
Desloratadine Teva 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 and Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG, UK
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 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*
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
This leaflet was last revised in 03/2016.
PL 00289/1699
*Only the actual site of batch release will appear on the printed version of the leaflet

Expand Transcript

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.

Hide