Desloratadine Gedeon Richter 5 Mg Film-Coated Tablets
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Desloratadine 5mg
film-coated tablets
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 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 antiallergy 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, to any of the other ingredients of Desloratadine or to loratadine.
Desloratadine is indicated for adults and adolescents (1 2 years of age and older).
Desloratadine contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product.
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
Please tell your doctor or pharmacist ifyou are taking or have recently taken any other medicines, including medicines obtained without a prescription.
There are no known interactions of Desloratadine with other medicines.
Taking Desloratadine with food and drink
Desloratadine may be taken with or without a meal. Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking anymedicine during pregnancy and breastfeeding. Ifyou 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.
3. HOW TO TAKE DESLORATADINE
Always take Desloratadine exactly as your doctor has told you. You should check with your doctor or pharmacist ifyou are not sure.
Adults and adolescents (1 2 years of age and older): take one tablet once a day.
Swallow the tablet whole with water, 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 Desloratadine.
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.
Use in children
Desloratadine is not indicated for children.
Desloratadine is indicated for adults and adolescents (1 2 years of age and older).
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 stop taking Desloratadine
Do not stop the treatment. Contact your doctor or pharmacist before stopping.
If you stop taking Desloratadine, your symptoms will come back.
Ifyou have any further questions on the use ofthis product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Desloratadine can cause side effects, although not everybodygets them.
In clinical trials, in adults, side effects were about the same as with a dummy tablet (i.e. a tablet without containing the active substance). However, fatigue, 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.
Ifany ofthe side effects gets serious, or ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOWTO STORE DESLORATADINE
Keep out of the reach and sight of children.
Do not use Desloratadine after the expiry date.
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not use Desloratadine ifyou notice any change in the appearance of the tablets.
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 5mg (as desloratadine hemisulphate).
- The other ingredients are:
Tabletcore: cellulose, microcrystalline, calcium hydrogen phosphate dihydrate, maize starch, pregelatinised, silica, colloidal anhydrous, magnesium stearate.
Film-coating: poly(vinyl alcohol) (E1 203), titanium dioxide (E 171), talc (E 553b), lecithin (soya) (E 322), quinoline yellow aluminium lake (E 104), xanthan gum (E 415), iron oxide yellow (E 172), indigo carmine aluminium lake (E 132).
What Desloratadine looks like and contents of the pack
Desloratadine 5mg film-coated tablets are yellow, round, biconvex film-coated tablets, of about 6mm diameter, one side engraved with 'R03'.
Desloratadine 5mg film-coated tablets are packaged in PVC/PE/PVDC//Al blisters. The blisters are packed into cardboard cartons.
Pack sizes are:
7 10, 20, 30, 50, 90, 100 film-coated tablets Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Gedeon Richter Plc.
Gyomroi ut 19-21 H-1 103 Budapest Hungary
Manufacturer:
Gedeon Richter Romania SA 99-105, Cuza Voda Street 540306 Targu-Mures Romania Distributor:
Aspire Pharma Ltd Bellamy House Winton Road Petersfield Hampshire GU32 3HA United Kingdom
This leaflet was last approved in 09/2013
Aspire
1010173 P3.1
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Artwork for: |
Aspire Pharma Limited |
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Product name: |
Desloratadine 5mg film-coated tablets |
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Size: | |
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PL/PA no: |
PL 17550/0044 |
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Type: |
Leaflet |
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Artwork dimensions: |
250mm x 170mm |
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Profile supplied: |
Yes |
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Date of first artwork: |
13 January 2012 |
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Reason for request: |
Artwork based on originator’s style: address change |
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Version no: |
3.1 |
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Date of revision: |
26 September 2013 |
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Colours: |
As swatches |
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Font(s): |
10pt Futura |
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A/w software: |
Quark XPress 7 |
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BAC ref: |
Q409 (formerly P390) |
