ADARTREL Film-coated tablet (2021)
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Περιεχόμενα
1. Name of the medicinal product
ADARTREL 0.25, 0.5 or 2.0 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains 0.25 / 0.5 / 2.0 mg of ropinirole (as hydrochloride). <u>Excipient with known effect:</u> Each tablet contains 45.3 / 45.0 / 44.6 mg lactose (as monohydrate). For the full ...
3. Pharmaceutical form
Film-coated tablet. <u>0.25 mg:</u> White pentagonal-shaped, bevelled edge tablets, marked SB on one side and 4890 on the other. <u>0.5 mg:</u> Yellow pentagonal-shaped, bevelled edge tablets, marked ...
4.1. Therapeutic indications
ADARTREL is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (see section 5.1).
4.2. Posology and method of administration
Oral use. Adults Individual dose titration against efficacy and tolerability is recommended. Ropinirole should be taken just before bedtime, however the dose can be taken up to 3 hours before retiring. ...
4.3. 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. Severe hepatic impairment. ...
4.4. Special warnings and precautions for use
Ropinirole should not be used to treat neuroleptic akathisia, tasikinesia (neuroleptic-induced compulsive tendency to walk), or secondary Restless Legs Syndrome (e.g. caused by renal failure, iron deficiency ...
4.5. Interaction with other medicinal products and other forms of interaction
Ropinirole is principally metabolised by the cytochrome P450 isoenzyme CYP1A2. A pharmacokinetic study (with a ropinirole dose of 2 mg, three times a day) revealed that ciprofloxacin increased the C<sub> ...
4.6. 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 ...
4.7. 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 ...
4.8. Undesirable effects
Adverse drug reactions are listed below by system organ class and frequency. Frequencies from clinical trials are determined as excess incidence over placebo and are classed as very common (≥1/10); common ...
4.9. 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. ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Dopamine agonist <b>ATC code:</b> N04BC04 Mechanism of action Ropinirole is a non-ergoline D2/D3 dopamine agonist which stimulates striatal dopamine receptors. Clinical ...
5.2. Pharmacokinetic properties
Absorption The bioavailability of ropinirole is about 50% (36% to 57%), with C<sub>max</sub> reached on average 1.5 hours after the dose. A high fat meal decreases the rate of absorption of ropinirole, ...
5.3. Preclinical safety data
Toxicology The toxicology profile is principally determined by the pharmacological activity of ropinirole: behavioural changes, hypoprolactinaemia, decrease in blood pressure and heart rate, ptosis and ...
6.1. List of excipients
<u>Tablet cores:</u> Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Magnesium stearate <u>Film coating:</u> 0.25mg (white): Hypromellose, Macrogol 400, Titanium dioxide (E171), Polysorbate ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from light.
6.5. Nature and contents of container
<u>0.25 mg:</u> PVC/PE/PVdC-Aluminium /paper child-resistant blister in cartons of 2 or 12 tablets. <u>0.5 mg:</u> PVC/PE/PVdC-Aluminium/paper child-resistant blister in cartons of 28 or 84 tablets. <u> ...
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
GlaxoSmithKline UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS
8. Marketing authorization number(s)
Adartrel 0.25 mg film coated tablets: PL 19494/0033 Adartrel 0.5 mg film coated tablets: PL 19494/0034 Adartrel 2.0 mg film coated tablets: PL 19494/0036
9. Date of first authorization / renewal of the authorization
10 May 2006 / 27 July 2009
10. Date of revision of the text
22 October 2021
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