PACKAGE LEAFLET: INFORMATION FOR THE USER
Dasselta 5 mg film-coated tablets
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. 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. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Dasselta is and what it is used for
2. Before you take Dasselta
3. How to take Dasselta
4. Possible side effects
5. How to store Dasselta
6. Further information
1. WHAT DASSELTA IS AND WHAT IT IS USED FOR
Dasselta is an antiallergy medicine that does not make you drowsy. It helps control your allergic
reaction and its symptoms.
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). 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
Dasselta is indicated for adults and adolescents (12 years of age and older).
2. BEFORE YOU TAKE DASSELTA
Do not take Dasselta
- if you are allergic (hypersensitive) to desloratadine, to any of the other ingredients of Dasselta
or to loratadine.
Take special care with Dasselta
- if you have poor kidney function.
If this applies to you, or if you are not sure, please check with your doctor before taking Dasselta.
Dasselta should not be used in children under 12 years old.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
There are no known interactions of Dasselta with other medicines.
Taking Dasselta with food and drink
Dasselta may be taken with or without a meal.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy and
If you are pregnant or nursing a baby, taking Dasselta is not recommended.
Driving and using machines
At the recommended dose, Dasselta is not expected to cause you to be drowsy or less alert. However,
very rarely some people experience drowsiness, which may affect their ability to drive or use
Important information about some of the ingredients of Dasselta
Dasselta contains lactose. If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE DASSELTA
Adults and adolescents (12 years of age and older): take one tablet once a day.
Swallow the tablet whole with water, with or without food.
Regarding the duration of treatment, your doctor will determine the type of allergic disease 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 problems are expected with accidental
overdose. However, if you take more Dasselta than you were told to, contact your doctor or
If you forget to take Dasselta
If you forget to take your dose on time, take it as soon as possible, 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, Dasselta can cause side effects, although not everybody gets them.
During the marketing of desloratadine, cases of severe allergic reactions (difficulty in breathing,
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1. NAME OF THE MEDICINAL PRODUCT
Dasselta 5 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg desloratadine.
- lactose: 16.15 mg/tablet
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Light blue, round, film-coated tablets with beveled edges.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Dasselta is indicated for the relief of symptoms associated with:
- allergic rhinitis (see section 5.1),
- urticaria (see section 5.1).
4.2 Posology and method of administration
Adults and adolescents (12 years of age and over): one tablet once a day, with or without a meal for
the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic
rhinitis) and urticaria (see section 5.1).
There is limited clinical trial efficacy experience with the use of desloratadine in adolescents 12
through 17 years of age (see sections 4.8 and 5.1).
Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than 4
weeks) should be managed in accordance with the evaluation of patient’s disease history and the
treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance.
In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4
weeks), continued treatment may be proposed to the patients during the allergen exposure periods.
Hypersensitivity to the active substance, to any of the excipients or to loratadine.
4.4 Special warnings and precautions for use
Efficacy and safety of Dasselta tablets in children under 12 years of age have not been established.
In the case of severe renal insufficiency, Dasselta should be used with caution (see section 5.2).
Dasselta contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp
lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
No clinically relevant interactions were observed in clinical trials with desloratadine tablets in which
erythromycin or ketoconazole were co-administered (see section 5.1).
In a clinical pharmacology trial desloratadine taken concomitantly with alcohol did not potentiate the
performance impairing effects of alcohol (see section 5.1).
4.6 Pregnancy and lactation
Desloratadine was not teratogenic in animal studies. The safe use of the medicinal product during
pregnancy has not been established. The use of desloratadine during pregnancy is therefore not
Desloratadine is excreted into breast milk, therefore the use of desloratadine is not recommended in
4.7 Effects on ability to drive and use machines
In clinical trials that assessed the driving ability, no impairment occurred in patients receiving
desloratadine. However, patients should be informed that very rarely some people experience
drowsiness, which may affect their ability to drive or use machines.
4.8 Undesirable effects
In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at
the recommended dose of 5 mg daily, undesirable effects with desloratadine were reported in 3 % of
patients in excess of those treated with placebo. The most frequent of adverse events reported in
excess of placebo were fatigue (1.2 %), dry mouth (0.8 %) and headache (0.6 %). In a clinical trial
with 578 adolescent patients, 12 through 17 years of age, the most common adverse event was
headache; this occurred in 5.9 % of patients treated with desloratadine and 6.9 % of patients receiving
Other undesirable effects reported very rarely during the post-marketing period are listed in the
Dizziness, somnolence, insomnia, psychomotor
Nervous system disorders
Abdominal pain, nausea, vomiting, dyspepsia,
Elevations of liver enzymes, increased
Musculoskeletal and connective tissue disorders
Hypersensitivity reactions (such as
anaphylaxis, angioedema, dyspnoea, pruritus,
rash, and urticaria)
In the event of overdose, consider standard measures to remove unabsorbed active substance.
Symptomatic and supportive treatment is recommended.
Based on a multiple dose clinical trial, in which up to 45 mg of desloratadine was administered (nine
times the clinical dose), no clinically relevant effects were observed.