Desloratadine Gedeon Richter 5 Mg Film-Coated Tablets
Package leaflet: information for the user
Desloratadine 5mg
film-coated tablets
desloratadine
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, pharmacist or nurse.
- 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Desloratadine is and what it is used for
2. What you need to know before you take Desloratadine
3. How to take Desloratadine
4. Possible side effects
5. How to store Desloratadine
6. Contents of the pack and other information
1. WHAT DESLORATADINE IS AND WHAT IT IS USED FOR
What Desloratadine is
Desloratadine contains desloratadine which is an antihistamine.
How Desloratadine works
Desloratadine is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.
When Desloratadine should be used
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) in adults and adolescents 12 years of age and older. 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. What you need to know before you take Desloratadine
Do not take Desloratadine
- i f you are allergic to desloratadine or any of the other ingredients of this medicine (listed in section 6), to peanut or to loratadine.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Desloratadine
- if you have poor kidney function.
Use in children and adolescents
Do not give this medicine to children less than 12 years of age
Other medicines and Desloratadine
There are no known interactions of Desloratadine with other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Desloratadine with food, drink and alcohol
Desloratadine may be taken with or without a meal.
Use caution when taking Desloratadine with alcohol. Pregnancy, breast-feeding and fertility
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.
Taking Desloratadine is not recommended if you are pregnant or nursing a baby.
Fertility
There is no data available on male/female fertility.
Driving and using machines
At the recommended dose, this medicine is not expected to affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended not to engage in activities requiring mental alertness, such as driving a car or operating machinery until you have established your own response to the medicinal product.
Desloratadine contains soya oil
Desloratadine contains soya lecithin. If you are allergic to peanut or soya, do not use this medicinal product.
3. How to take Desloratadine
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults and adolescents 12 years of age and over
The recommended dose is one tablet once a day with water, with or without food.
This medicine is for oral use. Swallow the tablet whole. 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.
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 or nurse immediately.
If you forget to take Desloratadine
If you forget to take your dose on time, take it as soon as possible, and 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
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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.
If you notice any of these serious side effects, stop taking the medicine and seek urgent medical advice straight away.
In clinical studies, 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.
In clinical studies with Desloratadine, the following side effects were reported as:
Common: the following may affect up to 1 in 10 people
- fatigue
- dry mouth
- headache
During the marketing of Desloratadine, the following side effects were reported as:
Adults
During the marketing of Desloratadine, the following side effects were reported as:
Very rare: the following may affect up to 1 in 10,000 people:
- severe allergic reactions
- fast heartbeat
- vomiting
- dizziness
- muscle pain
- restlessness with increased body movement
- rash
- stomach ache
- upset stomach
- drowsiness
- hallucinations
- liver inflammation
- pounding or irregular heartbeat
- feeling sick (nausea)
- diarrhoea
- inability to sleep
- seizures
- abnormal liver function tests
Not known: frequency cannot be estimated from the available data
- i ncreased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to UV lights of a solarium
- unusual weakness
- yellowing of the skin and/or eyes
- change in the way the heart beats Children
Not known: frequency cannot be estimated from the available data
- slow heartbeat
- change in the way the heart beats
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (website: 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
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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 this medicine if you notice any change in the appearance of the tablets.
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. Contents of the pack and other information
What Desloratadine contains
- The active substance is desloratadine 5mg (as desloratadine hemisulphate).
- The other ingredients are:
Tablet core: cellulose, microcrystalline, calcium hydrogen phosphate dihydrate, maize starch, pregelatinised silica, colloidal anhydrous, magnesium stearate.
Film-coating: poly(vinyl alcohol) (E1203), titanium dioxide (E171), talc (E553b), lecithin (soya) (E322), quinoline yellow aluminium lake (E104), xanthan gum (E415), iron oxide yellow (E172), indigo carmine aluminium lake (E132).
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-1103 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 GU323HA United Kingdom
This leaflet was last revised in ,0/20'5
1010173 P4.4 Pharma
|
Artwork for: |
Aspire Pharma Limited |
|
Product name: |
Desloratadine 5mg film-coated tablets |
|
Size: |
? |
|
PL/PA no: |
PL 17550/0044 |
|
Type: |
Leaflet |
|
Artwork dimensions: |
250mm x 170mm |
|
Profile supplied: |
Yes |
|
Date of first artwork: |
13 January 2012 |
|
Reason for request: |
Text revisions |
|
Version no: |
4.4 |
|
Date of revision: |
23 October 2015 |
|
Colours: |
As swatch(es) |
|
Font(s): |
9pt Futura |
|
Artwork software: |
InDesign CS6 |
|
BAC ref: |
S872 |
