Desloratadine 5mg Film-Coated Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Desloratadine 5 mg tablets
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 signs of illness are the same as yours.
• If you get any side effects which worry you, talk to your doctor, pharmacist or nurse.
In this leaflet:
1. What Desloratadine is and what it is used for
2. What you need to know about 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 contains the active substance desloratadine which is an antihistamine. 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). 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.
Desloratadine is indicated for adults and adolescents (12 years of age and older).
2. What you need to know before you take desloratadine Do not take desloratadine if
- you are allergic (hypersensitive) to desloratadine or any of the other ingredients of the medicine (see section 6) or to loratadine.
• Are under 12 years
Warnings - talk to your doctor, pharmacist or nurse
- if you have poor kidney function.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
This medicine should not be taken if you are pregnant or breast-feeding. Always talk to your doctor or pharmacist before taking any medicine during pregnancy and breast-feeding.
Driving and using machines
This medicine is not expected to make you drowsy or less alert. However, very rarely some people do become drowsy. This may affect their ability to drive or use machines. You should not drive until you know whether or not the medicine affects you.
Important information about some of the ingredients of this medicine
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicinal product.
3. How to take desloratadine
Adults and adolescents (12 years of age and older): take one tablet once a day.
Swallow the tablet whole with water. Desloratadine may be taken 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 adults, side effects were about the same as with a dummy tablet. However, tiredness, dry mouth and headache were reported more often than with a dummy tablet. In adolescents, headache was the most commonly reported side effect.
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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
5. How to store desloratadine
This medicinal product should be stored below 25°C and in the original package. You should keep this medicine out of the sight and reach of children. Do not use the medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of the month.
Tell your pharmacist if you notice any changes in the colour of the tablets or if the package is damaged.
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 protect the environment.
6. Further information.
Desloratadine contains
- The active substance is desloratadine. Each tablet contains 5 mg desloratadine
- The other ingredients of the tablet are: starch pregelatinised, microcrystalline cellulose, lactose anhydrous, hypromellose, hydrogenated vegetable oil, silica colloidal anhydrous
- The tablets are coated and the coating contains the following: Hypro-mellose (E464), titanium dioxide (E171), macrogol, Indigo carmine (E132)
What desloratadine looks like and contents of the pack
Desloratadine tablets are light blue, circular biconvex film coated tablets, plain on both the sides and are approximately 6mm.
The product is available in blister packs containing 1, 2, 3, 5, 6, 7, 10, 12, 14, 15, 18, 20, 21,30, 50, 60, 90, 100 tablets although not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Lupin (Europe) Limited
Victoria Court
Bexton Road
Knutsford
Cheshire
WA160PF
United Kingdom
This leaflet was last revised 05/2012
CODE NO. GO/DRUGS/654
ID#: 229649