Leaflet: information for the user

Dasselta 5 mg film-coated tablets

desloratadine

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

What is Dasselta

Dasselta contains desloratadine, which is an antihistamine.

How Dasselta works

Dasselta is an antiallergic medication that does not cause drowsiness. It helps to control the allergic reaction and its symptoms.

When to use Dasselta

Dasselta relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or dust mite allergy) in adults and adolescents 12 years of age and older. These symptoms include sneezing, runny nose or nasal itching, palate itching, eye redness or tearing.

Dasselta is also used to relieve symptoms associated with urticaria (skin disease caused by an allergy). These symptoms include itching and skin hives.

The relief of these symptoms lasts a full day and helps you to continue your daily activities and normal sleep periods.

Do not take Dasselta

• if you are allergic to desloratadine or to any of the other ingredients of this medication (listed in section 6) or to loratadine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dasselta:

• if you have impaired renal function.
• if you have a personal or family history of seizures.

Children and adolescents

Do not administer this medication to children under 12 years of age.

Taking Dasselta with other medications

No known interactions of Dasselta with other medications.

Inform your doctor or pharmacist if you are taking, have taken recently, or may have to take any other medication.

Taking Dasselta with food, drinks, and alcohol

Dasselta can be taken regardless of meals.

Be careful when taking Dasselta with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Do not take Dasselta if you are pregnant or breastfeeding.

Fertility

No data available on male and female fertility.

Driving and operating machinery

At the recommended dose, it is not expected that this medication will affect your ability to drive or operate machinery. Although most people do not experience drowsiness, it is recommended not to perform activities that require a state of mental alertness, such as driving a car or operating machinery, until you have determined your own response to the medication.

Dasselta contains lactose and sodium

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults and adolescents 12 years of age and older

The recommended dose is one tablet once a day with water, with or without food.

This medication is for oral use.

Swallow the tablet whole.

Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you have and for how long you should take Dasselta.

If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days a week or for less than 4 weeks), your doctor will recommend a treatment plan that will depend on the evaluation of your disease history.

If your allergic rhinitis is persistent (presence of symptoms for 4 or more days a week and for more than 4 weeks), your doctor may recommend long-term treatment.

For urticaria, the duration of treatment may vary from patient to patient and therefore you should follow your doctor's instructions.

If you take more Dasselta than you should

Take Dasselta only as your doctor has instructed. An accidental overdose is not expected to cause severe side effects. However, if you take more Dasselta than you have been told, tell your doctor or pharmacist immediately.

If you forgot to take Dasselta

If you forgot to take your dose at the scheduled time, take it as soon as possible and then continue with your usual dosing schedule. Do not take a double dose to make up for the missed dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

During the marketing of desloratadine, very rarely reported cases of severe allergic reactions (difficulty breathing, hissing, itching, rashes, and swelling) have been reported. If you experience any of these severe side effects, stop taking this medicine and seek immediate medical attention.

In clinical trials in adults, side effects were approximately the same as with a placebo tablet. However, fatigue, dry mouth, and headache were reported more frequently than with a placebo tablet. In adolescents, headache was the most frequently reported adverse reaction.

In clinical trials with desloratadine, the following side effects were reported as:

Frequent: the following may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

Adults

During the marketing of desloratadine, the following side effects were reported as:

Very rare: the following may affect up to 1 in 10,000 people

• severe allergic reactions
• skin rash
• strong or irregular heartbeats
• rapid heartbeats
• stomach pain
• nausea (gag reflex)
• vomiting
• stomach upset
• diarrhea
• dizziness
• drowsiness
• difficulty sleeping
• muscle pain
• hallucinations
• seizures
• agitation with increased body movement
• inflammation of the liver
• alteration in liver function tests

Unknown frequency: the frequency cannot be estimated from available data

• unusual weakness
• yellowing of the skin and/or eyes
• increased sensitivity of the skin to the sun, even on cloudy days, and to ultraviolet light, for example, to ultraviolet light from a tanning bed
• changes in heart rhythm
• abnormal behavior
• aggression
• weight gain
• increased appetite
• depressed mood
• dry eyes

Children

Unknown frequency: the frequency cannot be estimated from available data

• slow heart rate
• change in heart rhythm
• abnormal behavior
• aggression

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after “EXP”. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

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

Medicines should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Dasselta

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

Appearance of the product and contents of the package

Film-coated tablets, light blue, round with beveled edges (diameter: 6.5 mm, thickness: 2.3-3.5 mm).

Dasselta is available in cartons of 7, 10, 20, 30, 50, 90 and 100 film-coated tablets in blisters and in a package of 250 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Responsible for manufacturing

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.