Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - desloratadine

Document Subject

Generated Narrative: MedicinalProductDefinition mpd51291e7d675a24203f1a2e152221f98

identifier: http://ema.europa.eu/identifier/EU/1/11/732/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Desloratadine Teva 5 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-d51291e7d675a24203f1a2e152221f98

identifier: http://ema.europa.eu/identifier/EU/1/11/732/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - desloratadine

Attesters

What is in this leaflet:

1. What Desloratadine Teva is and what it is used for
2. What you need to know before you take Desloratadine Teva
3. How to take Desloratadine Teva
4. Possible side effects
5. How to store Desloratadine Teva
6. Contents of the pack and other information

What Desloratadine Teva is Desloratadine Teva contains desloratadine which is an antihistamine.

How Desloratadine Teva works Desloratadine Teva is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.

When Desloratadine Teva should be used Desloratadine Teva 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 Teva 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 Teva

• 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 or pharmacist before taking Desloratadine Teva

• 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 Teva There are no known interactions of Desloratadine Teva with other medicines. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Desloratadine Teva with food, drink and alcohol Desloratadine Teva may be taken with or without a meal.
Use caution when taking Desloratadine Teva 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 Teva 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 Teva contains lactose Desloratadine Teva contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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 Teva. 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 Teva than you should Take Desloratadine Teva only as it is prescribed for you. No serious problems are expected with accidental overdose. However, if you take more Desloratadine Teva than you were told to, tell your doctor, pharmacist or nurse immediately.

If you forget to take Desloratadine Teva 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 Teva If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

During the marketing of Desloratadine Teva, 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 Teva, 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 depressed mood dry eyes

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 or pharmacist. 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.

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.

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.

What Desloratadine Teva contains

• The active substance is 5 mg desloratadine.
• The other ingredients are microcrystalline cellulose, pregelatinised maize starch, talc, silica colloidal anhydrous, lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 400, indigo carmine (E132).

What Desloratadine Teva looks like and contents of the pack Blue, round, biconvex film-coated tablet, plain on both sides. Desloratadine Teva 5 mg film-coated tablets are supplied in blister packs of 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 90, 100 and 105 film-coated tablets and in perforated blister packs of 50 x 1 film-coated tablet (unit dose). Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Teva B.V. Swensweg 5 2031 GA Haarlem The Netherlands

Manufacturer TEVA Pharmaceutical Works Private Limited Company Pallagi t 13, 4042 Debrecen, Hungary

or

Pharmachemie B.V. Swensweg 5, 2031 GA Haarlem, The Netherlands

or Merckle GmbH Ludwig-Merckle-Strasse 3 D-89143 Blaubeuren Germany

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

Belgi /Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG T l/Tel: +32 38207Lietuva UAB Teva Baltics Tel: +370 52660

Te : +359 24899Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien T l/Tel: +32 38207 esk republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007Magyarorsz g Teva Gy gyszergy r Zrt. Tel: +36 12886Danmark Teva Denmark A/S Tlf: +45 44985Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407Deutschland TEVA GmbH Tel: +49 73140Nederland Teva Nederland B.V. Tel: +31 8000228Eesti

UAB Teva Baltics Eesti filiaal Tel: +372 6610Norge Teva Norway AS Tlf: +47 66775
Specifar A.B.E.E. : +30 2118805 sterreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970Espa a Teva Pharma, S.L.U. Tel: +34 913873Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459France Teva Sant
T l: +33 155917Portugal Teva Pharma - Produtos Farmac uticos, Lda. Tel: +351 214767Hrvatska Pliva Hrvatska d.o.o. Tel: + 385 13720Rom nia Teva Pharmaceuticals S.R.L. Tel: +40 212306Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890 sland Alvogen ehf. S mi: +354 5222Slovensk republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267Italia Teva Italia S.r.l. Tel: +39 028917Suomi/Finland SanoSwiss UAB Puh/Tel: +370 70001
Specifar A.B.E.E.

: +30 2118805Sverige Teva Sweden AB Tel: +46 42121Latvija UAB Teva Baltics fili le Latvij
Tel: +371 67323United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407This leaflet was last revised in

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