Desloratadine ratiopharm

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  • Desloratadine ratiopharm
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Staðsetning

  • Fáanlegt í:
  • Desloratadine ratiopharm
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Antihistamines for systemic use,
  • Lækningarsvæði:
  • Rhinitis, Allergic, Perennial, Urticaria, Rhinitis, Allergic, Seasonal
  • Ábendingar:
  • Relief of symptoms associated with:allergic rhinitis;urticaria.
  • Vörulýsing:
  • Revision: 7

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/002404
  • Leyfisdagur:
  • 12-01-2012
  • EMEA númer:
  • EMEA/H/C/002404
  • Síðasta uppfærsla:
  • 30-03-2019

Opinber matsskýrsla

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8416

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

An agency of the European Union

© European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged.

EMA/950479/2011

EMEA/H/C/002404

EPAR summary for the public

Desloratadine ratiopharm

desloratadine

This is a summary of the European public assessment report (EPAR) for Desloratadine ratiopharm. It

explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to

reach its opinion in favour of granting a marketing authorisation and its recommendations on the

conditions of use for Desloratadine ratiopharm.

What is Desloratadine ratiopharm?

Desloratadine ratiopharm is a medicine containing the active substance desloratadine. It is available as

tablets (5mg).

Desloratadine ratiopharm is a ‘generic medicine’. This means that Desloratadine ratiopharm is similar

to a ‘reference medicine’ already authorised in the European Union (EU) called Aerius. For more

information on generic medicines, see the question-and-answer document here

What is Desloratadine ratiopharm used for?

Desloratadine ratiopharm is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal

passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin

condition caused by an allergy, with symptoms including itching and hives).

The medicine can only be obtained with a prescription.

How is Desloratadine ratiopharm used?

The recommended dose for adults and adolescents (12 years of age and over) is 5 mg once a day.

How does Desloratadine ratiopharm work?

The active substance in Desloratadine ratiopharm, desloratadine, is an antihistamine. It works by

blocking the receptors to which histamine, a substance in the body that causes allergic symptoms,

Desloratadine ratiopharm

Page 2/2

normally attaches itself. When the receptors are blocked, histamine cannot have its effect, and this

leads to a decrease in the symptoms of allergy.

How has Desloratadine ratiopharm been studied?

Because Desloratadine ratiopharm is a generic medicine, studies in patients have been limited to tests

to determine that it is bioequivalent to the reference medicine, Aerius. Two medicines are

bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Desloratadine ratiopharm?

Because Desloratadine ratiopharm is a generic medicine and is bioequivalent to the reference

medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why has Desloratadine ratiopharm been approved?

The CHMP concluded that, in accordance with EU requirements, Desloratadine ratiopharm has been

shown to have comparable quality and to be bioequivalent to Aerius. Therefore, the CHMP’s view was

that, as for Aerius, the benefit outweighs the identified risk. The Committee recommended that

Desloratadine ratiopharm be given marketing authorisation.

Other information about Desloratadine ratiopharm

The European Commission granted a marketing authorisation valid throughout the European Union for

Desloratadine ratiopharm on 13 January 2012.

The full EPAR for Desloratadine ratiopharm can be found on the Agency’s website: ema.europa.eu/Find

medicine/Human medicines/European Public Assessment Reports. For more information about

treatment with Desloratadine ratiopharm, read the package leaflet (also part of the EPAR) or contact

your doctor or pharmacist.

The full EPAR for the reference medicine can also be found on the Agency’s website.

This summary was last updated in 12-2011.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Desloratadine ratiopharm 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. 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

What Desloratadine ratiopharm is and what it is used for

What you need to know before you take Desloratadine ratiopharm

How to take Desloratadine ratiopharm

Possible side effects

How to store Desloratadine ratiopharm

Contents of the pack and other information

1.

What Desloratadine ratiopharm is and what it is used for

What Desloratadine ratiopharm is

Desloratadine ratiopharm contains desloratadine which is an antihistamine.

How Desloratadine ratiopharm works

Desloratadine ratiopharm is an antiallergy medicine that does not make you drowsy. It helps control

your allergic reaction and its symptoms.

When Desloratadine ratiopharm should be used

Desloratadine ratiopharm 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 ratiopharm 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 ratiopharm

Do not take Desloratadine ratiopharm

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

Talk to your doctor, pharmacist or nurse before taking Desloratadine ratiopharm:

if you have poor kidney function.

if you have medical or familial history of seizures.

Use in children and adolescents

Do not give this medicine to children less than 12 years of age.

Other medicines and Desloratadine ratiopharm

There are no known interactions of Desloratadine ratiopharm with other medicines.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines.

Desloratadine ratiopharm with food, drink and alcohol

Desloratadine ratiopharm may be taken with or without a meal.

Use caution when taking Desloratadine ratiopharm 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 ratiopharm 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 ratiopharm contains lactose

Desloratadine ratiopharm tablets 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.

3.

How to take Desloratadine ratiopharm

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 ratiopharm.

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 ratiopharm than you should

Take Desloratadine ratiopharm only as it is prescribed for you. No serious problems are expected with

accidental overdose. However, if you take more Desloratadine ratiopharm than you were told to, tell

your doctor, pharmacist or nurse immediately.

If you forget to take Desloratadine ratiopharm

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 ratiopharm

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 ratiopharm, 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, 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 ratiopharm, 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

changes in the way the heart beats

abnormal behaviour

aggression

weight increased

increased appetite

Children

Not known: frequency cannot be estimated from the available data

slow heartbeat

change in the way the heart beats

abnormal behaviour

aggression

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side

effects not listed in this leaflet. You can also report side effects directly via the national reporting

system listed in Appendix V

By reporting side effects you can help provide more information on the

safety of this medicine.

5.

How to store Desloratadine ratiopharm

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 to protect the environment.

6.

Contents of the pack and other information

What Desloratadine ratiopharm contains

The active substance is desloratadine 5 mg.

The other ingredients are:

Tablet core:

poloxamer type 188, citric acid monohydrate, microcrystalline cellulose, maize

starch, croscarmellose sodium, lactose monohydrate (see section 2 “Desloratadine ratiopharm

contains lactose”), talc,

Film-coating: polyvinyl alcohol (part. hydrolysed), titanium dioxide (E171),

macrogol/PEG 3350, talc and indigo carmine aluminium lake (E132).

What Desloratadine ratiopharm looks like and contents of the pack

Round, biconvex, blue film-coated tablets.

Desloratadine ratiopharm 5 mg film-coated tablets are supplied in PVC/PVdC/aluminium blister

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

ratiopharm GmbH

Graf-Arco-Straße 3

89079 Ulm

Germany

info@ratiopharm.de

Manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13

4042 Debrecen

Hungary

Teva UK Limited

Brampton Road, Hampden Park, Eastbourne

East Sussex, BN22 9AG

United Kingdom

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Teva Czech Industries s.r.o.

Ostravaská

29, c.p. 305

74770 Opava-Komárov

Czech Republic

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80

31-546 Kraków

Poland

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

Teva Pharma Belgium N.V./S.A./AG

Tél/Tel: +32 3 820 73 73

Lietuva

UAB "Sicor Biotech"

Tel: +370 5 266 0203

България

Тева Фармасютикълс България ЕООД

Teл: +359 2 489 95 82

Luxembourg/Luxemburg

ratiopharm GmbH, Allemagne/Deutschland

Tél/Tel: +49 731 402 02

Česká republika

Teva Pharmaceuticals CR, s.r.o.

Tel: +420 251 007 111

Magyarország

Teva Gyógyszergyár Zrt.

Tel: +36 1 288 64 00

Danmark

Teva Denmark A/S

Tlf.: +45 44 98 55 11

Malta

Teva Pharmaceuticals Ireland, L-Irlanda

Tel: +353 51 321 740

Deutschland

ratiopharm GmbH

Tel: +49 731 402 02

Nederland

Teva Nederland B.V.

Tel.: +31 (0) 800 0228400

Eesti

UAB „Sicor Biotech“ Eesti filiaal

Tel: +372 661 0801

Norge

Teva Norway AS

Tlf: +47 66 77 55 90

Ελλάδα

Teva Ελλάς Α.Ε.

Τηλ: +30 210 72 79 099

Österreich

ratiopharm Arzneimittel Vertriebs-GmbH

Tel: +43 1 97 007

España

ratiopharm España, S.A.

Tel: +34 91 567 29 70

Polska

Teva Pharmaceuticals Polska Sp.z.o.o

Tel: +48 22 345 93 00

France

Teva Santé

Tél: +33 01 55 91 78 00

Portugal

ratiopharm, Comércio e Indústria de Produtos

farmacêuticos Lda

Tel: +351 21 476 75 50

Hrvatska

Pliva Hrvatska d.o.o.

Tel: +385 1 37 20 000

România

Teva Pharmaceuticals S.R.L

Tel: +4021 230 65 24

Ireland

Teva Pharmaceuticals Ireland

Tel: +353 51 321 740

Slovenija

Pliva Ljubljana d.o.o.

Tel: +386 1 58 90 390

Ísland

ratiopharm Oy, Finnland

Sími: +358 20 180 5900

Slovenská republika

TEVA Pharmaceuticals Slovakia s.r.o.

Tel: +421 2 5726 7911

Italia

Teva Italia s.r.l.

Tel: +39 02 8917981

Suomi/Finland

ratiopharm Oy

Puh/Tel: +358 20 180 5900

Κύπρος

Teva Ελλάς Α.Ε., Ελλάδα

Τηλ: +30 210 72 79 099

Sverige

Teva Sweden AB

Tel: +46 42 12 11 00

Latvija

UAB "Sicor Biotech" filiāle Latvijā

Tel: +371 673 23 666

United Kingdom

Teva UK Limited

Tel: +44 1977 628500

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu