Desloratadine Archie Samuel 5 mg filmomhulde tabletten

Desloratadine Archie Samuel is an anti-allergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.

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). 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.

Do not take Desloratadine Archie Samuel

• if you are allergic (hypersensitive) to desloratadine, to any of the other ingredients of Desloratadine Archie Samuel or to loratadine.

Desloratadine Archie Samuel is indicated for adults and adolescents (12 years of age and older).

Take special care with Desloratadine Archie Samuel

• 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 Archie Samuel.

Taking other medicines

Desloratadine 5 mg film-coated tablets;

NL/H/2327; 20.08.12

PIL clean

Page 2/4

There are no known interactions of Desloratadine Archie Samuel with other medicines.

Taking Desloratadine Archie Samuel with food and drink

Desloratadine Archie Samuel may be taken with or without food.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine during pregnancy and breast-feeding. If you are pregnant or breast-feeding, taking Desloratadine Archie Samuel is not recommended.

Driving and using machines

At the recommended dose, Desloratadine Archie Samuel 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. If affected do not drive or operate machinery.

Important information about some of the ingredients of Desloratadine Archie Samuel

Desloratadine Archie Samuel contains 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.

Adults and adolescents (12 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 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.

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, contact your doctor or pharmacist.

If you forget to take Desloratadine Archie Samuel

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.

Like all medicines, Desloratadine Archie Samuel can cause side effects, although not everybody gets them.

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.

Desloratadine 5 mg film-coated tablets;

NL/H/2327; 20.08.12

PIL clean

Page 3/4

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 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.

Keep this medicine out of the reach and sight of children.

Do not use Desloratadine Archie Samuel after the expiry date which is stated on the carton and blister or the bottle respectively. The expiry date refers to the last day of the month.

PVC/PVdC/aluminium blisters:

Store in the original package in order to protect from moisture.

HDPE bottles with PP caps:

After first opening the HDPE bottle, Desloratadine Archie Samuel has a shelf life of 6 months. This medicinal product does not require any special storage conditions.

Tell your pharmacist if you 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.

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, 100 and 250 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Archie Samuel s.r.o.

Slunná 16, 617 00 Brno

Czech Republic

Desloratadine 5 mg film-coated tablets;

NL/H/2327; 20.08.12

PIL clean

Page 4/4

Manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 3

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 Kraków Poland

Teva Pharma S.L.U.

C/C, n.4 Pologono Industrial Malpica

50016 Zaragoza

Spain

Teva Santé

Rue Bellocier

89100 Sens

France

Teva UK Ltd.

Brampton Road, Hampden Park, Eastbourne

East Sussex, BN22 9AG

United Kingdom

This medicinal product is authorised in the Member States of the EEA under the following names: <{Country}>: <{Name of the medicinal product}>

<{Country}>: <{Name of the medicinal product}> <{Country}>: <{Name of the medicinal product}> <{Country}>: <{Name of the medicinal product}>

This leaflet was last approved in 09-08-2012