Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr για έναν μήνα
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Μητρότητα και φάρμακα Ενημερωθείτε για την ασφάλεια χορήγησης ενός φαρμάκου κατά τη διάρκεια της εγκυμοσύνης ή του θηλασμού
Συνδρομές Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Ενδείξεις και αγωγές Βρείτε θεραπευτικές ενδείξεις και αγωγές για νόσους, συμπτώματα και ιατρικές πράξεις
Γνωρίζατε ότι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του Galinos.gr από το 2011 μέχρι σήμερα

ADARTREL Film-coated tablet (2021)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

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

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

Μπορείτε να υποστηρίξετε τον Γαληνό στην αποστολή του να παρέχει δωρεάν έγκυρη πληροφόρηση για κάθε φάρμακο απενεργοποιώντας το Ad Blocker για αυτόν τον ιστότοπο.