5 mg film-coated tablets 
desloratadine

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Dasselta is and what it is used for 
2. What you need to know before using Dasselta 
3. How to use Dasselta 
4. Possible side effects 
5. How to store Dasselta 
6. Contents of the packaging and other information 

1. What Dasselta is and what it is used for

What Dasselta is

Dasselta contains desloratadine, which is an antihistamine .

How Dasselta works

Dasselta is an anti-allergic medicine that does not make you drowsy. It helps keep your allergic reactions and their symptoms under control.

When to use Dasselta

Dasselta relieves the symptoms of allergic rhinitis ( inflammation of the nasal mucosa caused by allergies, such as hay fever or allergy to dust mites) in adults and adolescents 12 years and older. These symptoms include sneezing, runny or itchy nose, palate itching, and itchy, red, or watery eyes.

Dasselta is also used to relieve symptoms associated with urticaria (a skin condition caused by allergies ). These symptoms include itching and hives.

Relieving these symptoms lasts all day and helps you maintain normal daily activities and normal sleep.

2. What you need to know before using Dasselta

Do not use Dasselta

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

Warnings and cautions

Talk to your doctor or pharmacist before taking Dasselta:

  • if you have impaired kidney function.
  • if you or someone in your family has had seizures.

Children and young people

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

Other medicines and Dasselta

There are no known interactions between Dasselta and 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 can be taken with or without food.

Be careful if you take Dasselta with alcohol.

Pregnancy, breastfeeding, 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 Dasselta is not recommended if you are pregnant or breast-feeding.

Fertility

There are no fertility data for men and women.

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 feel drowsy, it is recommended that you do not perform activities that require sharp attention, such as driving a vehicle or using machinery until you know how you react to the medicine.

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 medicine.

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to use Dasselta

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Adults and adolescents 12 years and older:

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

This medicine should be swallowed.

The tablet is swallowed whole.

Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you are suffering from and decide how long to take Dasselta.

If your allergic rhinitis is recurrent (presence of symptoms for less than 4 days a week or less than 4 weeks), your doctor will recommend a treatment schedule based on the assessment of your medical history.

If your allergy is persistent (presence of symptoms for 4 days or more per week and more than 4 weeks) then your doctor may recommend a longer-term treatment.

In urticaria, the duration of treatment may vary from patient to patient and you should therefore follow your doctor’s prescription.

If you use more Dasselta then you should 

Take Dasselta as prescribed for you. No serious side effects are to be expected from an accidental overdose. However, if you take more Dasselta than you have been prescribed, contact a doctor, pharmacist, or nurse immediately.

If you forget to use Dasselta

If you forget to take your dose at the right 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 have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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 breathing, wheezing, itching, hives, and swelling) have been reported in very rare cases. If you have any of these serious side effects is, stop taking the drug and seek immediate emergency medical attention.

In clinical trials in adults, the side effects were about the same as with an inactive tablet. However, fatigue, dry mouth, and headache were reported more often than with an inactive tablet. In adolescents, headache was the most commonly reported side effect.

In clinical trials with desloratadine, the following side effects have been reported:

Common (may affect up to 1 in 10 people) :

  • fatigue
  • dry mouth
  • headache

Adults

During the marketing of desloratadine, the following side effects have been reported:

Very rare (may affect up to 1 in 10,000 people):

  • severe allergic reactions
  • rash
  • throbbing or irregular heartbeat
  • fast heartbeat
  • stomach ache
  • nausea
  • vomiting
  • upset stomach
  • diarrhea
  • dizziness
  • drowsiness
  • difficulty sleeping
  • muscle pain
  • hallucinations
  • cramps
  • restlessness with increased body movement
  • hepatitis
  • abnormal liver function tests

Has been reported (occurs in an unknown number of users):

  • unusual weakness
  • yellowing of the skin and/or eyes
  • increased sensitivity of the skin to sunlight, even in sunlight and to UV light, for example for UV light in solarium
  • changes in how the heartbeats
  • abnormal behavior
  • aggression
  • weight gain
  • increased appetite

Children

Has been reported (occurs in an unknown number of users):

  • slow heartbeat
  • change in how the heartbeats
  • abnormal behavior
  • aggression

5. How to store Dasselta

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 after EXP. The expiration date is the last day of the specified month.

Store in the original package. Moisture sensitive.

Shelf life after first opening the jar: 3 months.

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.

6. Contents of the packaging and other information

Content declaration

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

What the medicine looks like and the contents of the pack

Light blue, round, film-coated tablet 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 cans of 250 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

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

Contact the representative of the marketing authorization holder to find out more about this medicine:

Muhammad Nadeem

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