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SPC: NEUPRO 2mg/24h Transdermal patch (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Neupro 2 mg/24 h transdermal patch.

Qualitative and quantitative composition

Each patch releases 2 mg of rotigotine per 24 hours. Each patch of 10 cm² contains 4.5 mg of rotigotine. For the full list of excipients, see section 6.1.

Pharmaceutical form

Transdermal patch. Thin, matrix-type, square-shaped with rounded edges, consisting of three layers. The outside of the backing layer is tan-coloured and imprinted with Neupro 2 mg/24 h.

Therapeutic indications

Restless Legs Syndrome Neupro is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS) in adults. Parkinsons disease Neupro is indicated for the treatment ...

Posology and method of administration

Posology The dose recommendations made are in nominal dose. Restless Legs Syndrome A single daily dose should be initiated at 1 mg/24 h. Depending on the individual patient response, the dose may be increased ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Magnetic resonance imaging or cardioversion (see section 4.4).

Special warnings and precautions for use

If a Parkinsons disease patient is insufficiently controlled while on treatment with rotigotine switching to another dopamine agonist might provide additional benefit (see section 5.1) Both indications ...

Interaction with other medicinal products and other forms of interaction

Because rotigotine is a dopamine agonist, it is assumed that dopamine antagonists, such as neuroleptics (e.g. phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness ...

Fertility, pregnancy and lactation

Women of childbearing potential, contraception in females Women of childbearing potential should use effective contraception to prevent pregnancy during treatment with rotigotine. Pregnancy There are no ...

Effects on ability to drive and use machines

Rotigotine may have major influence on the ability to drive and use machines. Patients being treated with rotigotine and presenting with somnolence and/or sudden sleep episodes must be informed not to ...

Undesirable effects

Restless Legs Syndrome Summary of the safety profile Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 748 Neupro- and 214 placebo-treated patients, 65.5% of the ...

Overdose

Symptoms The most likely adverse reactions would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hypotension, involuntary movements, hallucinations, confusion, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Anti-parkinson drugs, dopamine agonists ATC code: N04BC09 Rotigotine is a non-ergolinic dopamine agonist for the treatment of signs and symptoms of Parkinsons disease and Restless ...

Pharmacokinetic properties

Absorption Following application, rotigotine is continuously released from the transdermal patch and absorbed through the skin. Steady-state concentrations are reached after one to two days of patch application ...

Preclinical safety data

In repeated dose and long-term toxicity studies, the major effects were associated with the dopamine agonist related pharmacodynamic effects and the consequent decrease of prolactin secretion. After a ...

List of excipients

Backing layer: Polyester film, siliconized, aluminized, colour coated with a pigment (titanium dioxide (E171), pigment yellow 95, pigment red 166) layer and imprinted (pigment red 144, pigment yellow 95, ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 30 months.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

Peel off sachet in a plastic box: One side is composed of an ethylene copolymer (innermost layer), an aluminium foil, low density polyethylene film and paper; the other side is composed of polyethylene ...

Special precautions for disposal and other handling

After use the patch still contains active substance. After removal, the used patch should be folded in half, adhesive side inwards so that the matrix layer is not exposed, placed in the original sachet ...

Marketing authorization holder

UCB Pharma S.A., Allée de la Recherche 60, B-1070, Bruxelles, Belgium

Marketing authorization number(s)

EU/1/05/331/001 EU/1/05/331/002 EU/1/05/331/015 EU/1/05/331/018 EU/1/05/331/057

Date of first authorization / renewal of the authorization

Date of first authorisation: 15 February 2006 Date of latest renewal: 22 January 2016

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