Desloratadine Archie Samuel 5 Mg Film-Coated Tablets
Desloratadine 5 mg film-coated tablets;
NL/H/2327;
PIL
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Package leaflet: Information for the user
Desloratadine Archie Samuel 5 mg 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. Y ou 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 4.
What is in this leaflet:
1. What Desloratadine Archie Samuel is and what it is used for
2. What you need to know before you take Desloratadine Archie Samuel
3. How to take Desloratadine Archie Samuel
4. Possible side effects
5. How to store Desloratadine Archie Samuel
6. Contents of the pack and other information
1. What Desloratadine Archie Samuel is and what it is used for What Desloratadine Archie Samuel is
Desloratadine Archie Samuel contains desloratadine which is an antihistamine.
How Desloratadine Archie Samuel works
Desloratadine Archie Samuel is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.
When Desloratadine Archie Samuel should be used
Desloratadine Archie Samuel 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 Archie Samuel 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 Archie Samuel Do not take Desloratadine Archie Samuel
• if you are allergic to desloratadine or any of the other ingredients of this medicine (listed in section 6) or to loratadine.
Warnings and precautions
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Talk to your doctor, pharmacist or nurse before taking Desloratadine Archie Samuel:
• 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 Archie Samuel
There are no known interactions of Desloratadine Archie Samuel with other medicines. Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
Desloratadine Archie Samuel with food, drink and alcohol
Desloratadine Archie Samuel may be taken with or without a meal.
Use caution when taking Desloratadine Archie Samuel 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 Archie Samuel 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 Archie Samuel contains lactose.
Desloratadine Archie Samuel contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Desloratadine Archie Samuel
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 doctor will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Desloratadine Archie Samuel.
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.
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If you take more Desloratadine Archie Samuel than you should
Take Desloratadine Archie Samuel only as it is prescribed for you. No serious problems are expected with accidental overdose. However, if you take more Desloratadine Archie Samuel than you were told to, tell your doctor or pharmacist immediately.
If you forget to take Desloratadine Archie Samuel
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 Archie Samuel
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 Archie Samuel, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) 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. 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 Archie Samuel, the following side effects were reported as:
Common: the following may affect up to 1 in 10 people
• fatigue
• dry mouth
• headache
Adults
|
During the marketing of Desloratadine Archie Samuel, the following side effects were reported as: Very rare: the following may affect up to 1 in 10,000 people | ||
|
• severe allergic reactions |
• rash |
• pounding or irregular heartbeat |
|
• fast heartbeat |
• stomach ache |
• feeling sick (nausea) |
|
• vomiting |
• upset stomach |
• diarrhoea |
|
• dizziness |
• drowsiness |
• inability to sleep |
|
• muscle pain |
• hallucinations |
• seizures |
|
• restlessness with increased |
• liver inflammation |
• abnormal liver function tests |
body movement
Not known: frequency cannot be estimated from the available data
• unusual weakness • yellowing of the skin and/or eyes
• increased 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
• change in the way the heart beats
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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 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 Archie Samuel Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
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 Archie Samuel contains
- The active substance is desloratadine. Each film-coated tablet contains 5 mg desloratadine.
- The other ingredients are:
- Tablet core:
poloxamer type 188, citric acid monohydrate, microcrystalline cellulose, maize starch, croscarmellose sodium, lactose monohydrate, talc.
- Tablet coat:
polyvinyl alcohol (part. hydrolyzed), titanium dioxide (E 171), macrogol/peg 3350 and indigo carmine aluminium lake (E 132), talc.
What Desloratadine Archie Samuel looks like and contents of the pack
Desloratadine Archie Samuel are round, biconvex, blue film-coated tablets.
The product is supplied in packs of 7, 10, 14, 15, 20, 30, 40, 50, 60, 90 and 100 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder Archie Samuel s.r.o.
Slunna 16, 617 00 Brno Czech Republic
Manufacturer
Merckle GmbH Ludwig-Merckle-Str. 3
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89143 Blaubeuren Germany
Pharmachemie B.V.
Swensweg 5 2031 GA Haarlem The Netherlands
Teva Operations Poland Sp Z.o.o. ul.Mogilska 80 31-546 Krakow Poland
Teva Pharma S.L.U.
C/C, n.4 Pologono Industrial Malpica
50016 Zaragoza
Spain
Teva Sante Rue Bellocier 89100 Sens France
Teva UK Ltd.
Brampton Road, Hampden Park, Eastbourne East Sussex, BN22 9AG United Kingdom