Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - dasselta

Document Subject

Generated Narrative: MedicinalProductDefinition mpb8e0f0c67dccb3d602a95a4f091082dc

identifier: http://ema.europa.eu/identifier/7 film-coated tablets: EU/1/11/739/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Dasselta 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-b8e0f0c67dccb3d602a95a4f091082dc

identifier: http://ema.europa.eu/identifier/7 film-coated tablets: EU/1/11/739/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - dasselta

Attesters

What is in this leaflet

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

What Dasselta is Dasselta contains desloratadine which is an antihistamine.

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

When Dasselta should be used Dasselta 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 years of age and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.

Dasselta 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 Dasselta

• if you are allergic to desloratadine, to 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 Dasselta:

• if you have poor kidney function.
• if you have medical or familial history of seizures.

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

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

Dasselta with food, drink and alcohol Dasselta may be taken with or without a meal. Use caution when taking Dasselta 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. If you are pregnant or nursing a baby, taking Dasselta is not recommended.

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.

Dasselta contains lactose and sodium If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium- free .

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

If you forget to take Dasselta 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 tablet.

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, 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-containing products, 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 body movement,
• liver inflammation,
• abnormal liver function tests.

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 packaging after EXP. The expiry date refers to the last day of that month.

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

Shelf life after first opening of the tablet container: 3 months.

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 Dasselta contains

• The active substance is desloratadine. Each film-coated tablet contains 5 mg desloratadine.
• The other ingredients in the tablet core are: microcrystalline cellulose (E460), hypromellose (E464), hydrochloric acid (E507) (for pH adjustment), sodium hydroxide (E524) (for pH adjustment), maize starch, lactose monohydrate (see section 2 under Dasselta contains lactose and sodium .) and talc (E553b).
• The other ingredients in the film-coating are: hypromellose (E464), macrogol, lactose monohydrate (see section 2 under Dasselta contains lactose and sodium .), titanium dioxide (E171) and indigo carmine (E132).

What Dasselta looks like and contents of the pack Light blue, round, film-coated tablets with beveled edges (diameter: 6.5 mm, thickness: 2.3 3.5 mm).

Dasselta is available in carton boxes of 7, 10, 20, 30, 50, 90 and 100 film-coated tablets in blisters and in tablet container of 250 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder KRKA, d.d., Novo mesto, marje ka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer KRKA, d.d., Novo mesto, marje ka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Stra e 5, 27472 Cuxhaven, Germany

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

Belgi /Belgique/Belgien KRKA Belgium, SA. T l/Tel: + 32 (0) 487 50 73 Lietuva UAB KRKA Lietuva Tel: + 370 5 236 27

Te .: + 359 (02) 962 34 Luxembourg/Luxemburg KRKA Belgium, SA. T l/Tel: + 32 (0) 487 50 73 62 (BE)

esk republika KRKA R, s.r.o. Tel: + 420 (0) 221 115 Magyarorsz g KRKA Magyarorsz g Kereskedelmi Kft. Tel.: + 36 (1) 355 8Danmark KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE)

Malta E. J. Busuttil Ltd. Tel: + 356 21 445 Deutschland TAD Pharma GmbH Tel: + 49 (0) 4721 606-0

Nederland KRKA Belgium, SA. Tel: + 32 (0) 487 50 73 62 (BE)

Eesti KRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0) 6 671 Norge KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE)

KRKA
: + 30 2100101 sterreich KRKA Pharma GmbH, Wien Tel: + 43 (0)1 66 24 Espa a KRKA Farmac utica, S.L. Tel: + 34 911 61 03 Polska KRKA-POLSKA Sp. z o.o. Tel.: + 48 (0)22 573 7France KRKA France Eurl T l: + 33 (0)1 57 40 82 Portugal KRKA Farmac utica, Sociedade Unipessoal Lda. Tel: + 351 (0)21 46 43 Hrvatska KRKA - FARMA d.o.o. Tel: + 385 1 6312 Rom nia KRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 Ireland KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3Slovenija KRKA, d.d., Novo mesto Tel: + 386 (0) 1 47 51 sland LYFIS ehf. S mi: + 354 534 3Slovensk republika KRKA Slovensko, s.r.o. Tel: + 421 (0) 2 571 04 Italia KRKA Farmaceutici Milano S.r.l. Tel: + 39 02 3300 8Suomi/Finland KRKA Finland Oy Puh/Tel: + 358 20 754 5
KI.PA. (PHARMACAL) LIMITED : + 357 24 651 Sverige KRKA Sverige AB Tel: + 46 (0)8 643 67 66 (SE) Latvija KRKA Latvija SIA Tel: + 371 6 733 86 United Kingdom (Northern Ireland) KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3This leaflet was last revised in

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