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EURODASTIN SR 2MG PROLONGED RELEASE CAPSULES

Active substance(s): EMEDASTINE DIFUMARATE / EMEDASTINE DIFUMARATE / EMEDASTINE DIFUMARATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Eurodastin SR 2mg Prolonged Release Capsules

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release capsule contains 2mg emedastine difumarate. This medicinal product contains 96mg of sucrose. For full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Prolonged-release capsule, hard. Size 4, white opaque, hard gelatine capsules, marked 2mg, filled with round white granules.

4
4.1

CLINICAL PARTICULARS
Therapeutic indications
The symptomatic treatment of seasonal allergic rhinitis (including ocular symptoms), perennial allergic rhinitis and chronic idiopathic urticaria.

4.2

Posology and method of administration
For oral administration. Adults The recommended daily dose is 4mg (two Eurodastin 2mg Prolonged Release capsules) in divided doses (in the morning and at bedtime) with or without food. The duration of treatment should be in accordance with medical advice. Elderly patients

There is insufficient evidence to support the use of emedastine difumarate in the elderly. Children over the age of 12 years As for adult dose. Children aged 12 and below There is insufficient evidence to support the use of emedastine difumarate in children aged 12 years and below. Hepatic disease There is insufficient pharmacokinetic evidence to support the use of emedastine difumarate in patients with hepatic impairment.

Renal disease There is insufficient evidence to support the use of emedastine difumarate in patients with severe renal impairment.

4.3

Contraindications
Hypersensitivity to emedastine difumarate or to any of the other ingredients of this medicinal product.

4.4

Special warnings and precautions for use
Although emedastine difumarate was not shown to result in prolongation of the QT interval in clinical trials, patients with relevant cardiac abnormalities (pre-existing QT prolongation) should be monitored carefully during initiation of therapy. The clearance of emedastine was shown to be reduced in patients with renal impairment. There is insufficient pharmacokinetic data to recommend a dose adjustment in patients with mild to moderate renal impairment. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

4.5

Interaction with other medicinal products and other forms of interaction
The changes in emedastine plasma concentrations observed in a multiple dose pharmacokinetic interaction study with ketoconazole were considered not clinically relevant. No other interaction studies were performed with emedastine difumarate. As with all antihistamines, excessive alcohol consumption should be avoided. Concurrent use of emedastine difumarate with other CNS depressants should also be avoided as reduction in alertness and impairment of performance may occur.

4.6

Fertility, pregnancy and lactation
Reproductive studies in various animal species, at doses higher than those achieved with the recommended human clinical dose, showed no evidence of teratogenicity or other effects on foetal development or reproductive function. However, there is no experience with Eurodastin Prolonged Release capsules in pregnant women and it is recommended that they should not be used during pregnancy, unless the expected benefit to the patient outweighs any possible risk to the foetus. There are no data on the levels in breast milk after administration of emedastine to nursing mothers. However, as animal studies have shown its presence in maternal milk, and as with other antihistamines, it is not advisable to take Eurodastin capsules whilst breast feeding.

4.7

Effects on ability to drive and use machines
Since in some patients emedastine difumarate may cause sleepiness, patients should be cautioned against engaging in hazardous activities.

4.8

Undesirable effects
In controlled clinical studies, the most common adverse events which have been reported (with an incidence of >5% and <10% on the whole population treated with emedastine difumarate) are: Body as a whole: migraine, fatigue, sleepiness and drowsiness. Drowsiness appears usually during the first few days of treatment and then reduces quickly as treatment continues. Other common (>1% and <5%) adverse events include: Gastrointestinal system: dry mouth, nausea and thirst. Central and peripheral nervous system: dizziness. Uncommon side effects (<1%) are: Body as a whole: allergy, vertigo, mental dullness Gastrointestinal system: diarrhoea Musculo-skeletal system: athralgia Skin/appendages: erythema, herpes labialis Ear, nose and throat: dry nose, epistaxis Less frequent side effects reported are: Body as a whole: flu-like symptoms, malaise, apathy, confusion, feeling cold Gastrointestinal system: abdominal pain, stomach ache, dyspepsia Respiratory system: difficulty in expectorating, dyspnoea

4.9

Overdose
Sleepiness is the symptom that most frequently occurs in case of overdosage. In such cases, general supportive measures should be applied, including gastric lavage for treatment of overdose.

5
5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Emedastine difumarate is a pharmaceutical compound with a benzimidazole skeleton. It is a therapeutic agent for allergic diseases. Emedastine difumarate is an antihistamine antagonist with selective peripheral H1receptor antagonist activity. Emedastine difumarate has an antihistaminic action together with actions of suppressing substance P induced histamine release and inhibiting eosinophil chemotaxis.

5.2

Pharmacokinetic properties
Absorption When emedastine difumarate was administered orally, the maximum plasma concentration was reached after 3.1 hours, with a half life of 6 to 8 hours. In a study of repeated oral administration of 4mg/day for 14 days, the plasma concentration of the drug reached a steady state after the fifth dose, the range being 0.96-1.87 ng/ml. Metabolism The main metabolite pathway of the drug is hydroxylation of the benzimidazole ring and subsequent conjugation following the hydroxylation. Excretion The total of the unchanged form of emedastine and its metabolites excreted into the urine up to 24 hours after administration was 44.1% of the administered quantity. The unchanged form amounted to 3.6% of the total amount excreted.

5.3

Preclinical safety data
Pre-clinical studies conducted with emedastine difumarate demonstrated no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and reproductive studies.

6
6.1

PHARMACEUTICAL PARTICULARS
List of excipients
Sucrose maize starch ethylcellulose magnesium stearate hydroxypropylcellulose Capsule Shell : Gelatin Titanium Dioxide (E171) Printing Ink: Shellac Purified Water Dehydrated alcohol Isopropyl alcohol Butyl alcohol Propylene Glycol Ammonia solution Potassium Hydroxide Iron oxide (E172)

6.2

Incompatibilities
Not applicable

6.3

Shelf life
36 months

6.4

Special precautions for storage
Do not store above 25C

6.5

Nature and contents of container
Packs of 30 capsules in PVC/aluminium blister strips with an outer cardboard carton.

6.6

Special precautions for disposal
No special requirements.

7

MARKETING AUTHORISATION HOLDER
Geymonat S.P.A, Via S. Anna 2, Anagni (FR) Italy

8

MARKETING AUTHORISATION NUMBER(S)
PL 19608/0001

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10/08/2010

10

DATE OF REVISION OF THE TEXT
01/07/2011

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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