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SPC, UK: ROPIQUAL XL Prolonged-release tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

ROPIQUAL XL 2 mg prolonged-release tablets.

Qualitative and quantitative composition

Each prolonged-release tablet contains 2 mg of ropinirole (as hydrochloride). Excipients with known effect: 1.8 mg lactose monohydrate. For the full list of excipients, see section 6.1.

Pharmaceutical form

Prolonged-release tablet. 2 mg prolonged-release tablets: pink, round biconvex tablets 6.8 ± 0.1 mm.

Therapeutic indications

Treatment of Parkinsons disease under the following conditions: Initial treatment as monotherapy, in order to delay the introduction of levodopa In combination with levodopa, over the course of the disease, ...

Posology and method of administration

Oral use. Adults Individual dose titration against efficacy and tolerability is recommended. Ropinirole prolonged-release tablets should be taken once a day, at a similar time each day. The prolonged-release ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe renal impairment (creatinine clearance < 30 ml/min) without regular haemodialysis. Hepatic impairment. ...

Special warnings and precautions for use

Ropinirole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinsons disease. Sudden onset of sleep during daily activities, in some cases without ...

Interaction with other medicinal products and other forms of interaction

There is no pharmacokinetic interaction between ropinirole and levodopa or domperidone which would necessitate dosage adjustment of these medicinal products. Neuroleptics and other centrally active dopamine ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate data from the use of ropinirole in pregnant women. Ropinirole concentrations may gradually increase during pregnancy (see section 5.2). Studies in animals have shown reproductive ...

Effects on ability to drive and use machines

Patients being treated with ropinirole and presenting with hallucinations, somnolence and/or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness ...

Undesirable effects

Undesirable effects reported are listed below by system organ class and frequency. It is noted if these undesirable effects were reported in clinical trials as monotherapy or adjunct therapy to levodopa. ...

Overdose

The symptoms of ropinirole overdose are related to its dopaminergic activity. These symptoms may be alleviated by appropriate treatment with dopamine antagonists such as neuroleptics or metoclopramide. ...

Pharmacodynamic properties

Pharmacotherapeutic group: Dopamine agonists ATC code: N04BC04 Mechanism of action Ropinirole is a non-ergoline D2/D3 dopamine agonist which stimulates striatal dopamine receptors. Ropinirole alleviates ...

Pharmacokinetic properties

Absorption Bioavailability of ropinirole is approximately 50% (36–57%). Following oral administration, of ropinirole prolonged-release tablets plasma concentrations increase slowly, with a median time ...

Preclinical safety data

Reproductive Toxicity In fertility studies in female rats, effects were seen on implantation due to the prolactin-lowering effect of ropinirole. It should be noted that prolactin is not essential for implantation ...

List of excipients

Tablet core: Ammonio Methacrylate Copolymer, Type B Hypromellose Sodium lauryl sulfate Copovidone Magnesium stearate Tablet coat: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 2 years.

Special precautions for storage

Store below 25°C.

Nature and contents of container

ROPIQUAL XL is supplied in white opaque PVC/PCTFE-Aluminum foil blister packs of 28 & 30 tablets . Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

Marketing authorization number(s)

PL 16363\0236

Date of first authorization / renewal of the authorization

24/10/2012

Date of revision of the text

16/12/2019

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