ROPIQUAL XL Prolonged-release tablet (2023)
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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). <u>Excipients with known effect:</u> 1.8 mg lactose monohydrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Prolonged-release tablet. <u>2 mg prolonged-release tablets:</u> 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
Somnolence and episodes of sudden sleep onset Ropinirole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinsons disease. Sudden onset of sleep ...
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
<b>Pharmacotherapeutic group:</b> Dopamine agonists <b>ATC code:</b> N04BC04 Mechanism of action Ropinirole is a non-ergoline D<sub>2</sub>/D<sub>3</sub> dopamine agonist which stimulates striatal dopamine ...
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
<u>Tablet core:</u> Ammonio Methacrylate Copolymer, Type B Hypromellose Sodium lauryl sulfate Copovidone Magnesium stearate <u>Tablet coat:</u> Lactose monohydrate Hypromellose (E464) Titanium dioxide ...
Incompatibilities
Not applicable.
Shelf life
3 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, 42 and 84 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
30/07/2021
Date of revision of the text
01/06/2023
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