Patient leaflet - Dasselta 5 mg film-coated tablets
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 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 12 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.
2. What you need to know before you take Dasselta
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’.
3. How to take Dasselta
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.
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 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 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 Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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 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.
6. Contents of the pack and other information
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, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom (Great Britain)
Krka UK Ltd.
Tel: +44 (0)207 400 3352