Medicinal Products

ADARTREL 0.25 mg

Generic Drug Therapeutic Class: Neurology-Psychiatry
Active ingredients: Ropinirole
laboratory: Glaxosmithkline

Coated tablet
Box of 12
All forms

Indication

Symptomatic treatment of moderate to severe Idiopathic Restless Legs Syndrome (see section 5.1).

Dosage ADARTREL 0.25 mg Film-coated tablet Box of 12

Oral way.
ADULTS:
- The dosage should be adapted individually, depending on the efficacy and tolerance.
- Ropinirole should be administered at bedtime but not more than 3 hours before bedtime. Ropinirole can be taken during the meal to improve gastrointestinal tolerance.
- Establishment of treatment (week 1):
The recommended starting dose is 0.25 mg once daily (as indicated below) for two days. If this dose is well tolerated, it will be increased to 0.5 mg once a day until the end of the first week .
- Continuation of treatment (from week 2):
. After the initiation phase of the treatment, the daily dose will be increased until an optimal therapeutic response is obtained. In clinical trials, the average dose used in patients with moderate-to-severe Restless Legs Syndrome was 2 mg once daily.
. The dose can be increased to 1 mg once a day by the second week. The dose may then be increased by 0.5 mg per week for the next two weeks until a dose of 2 mg once daily is reached. In some patients, for optimal improvement, the dose may be increased gradually to a maximum of 4 mg once daily. In clinical trials, the dose was increased from 0.5 mg per week to 3 mg once daily and then to 1 mg until the maximum recommended dose of 4 mg once daily. day, as shown in Table 1 .
. Doses greater than 4 mg once daily have not been studied in patients with Rest Without Leg Syndrome.
Table 1: Dosage schedule .
Week: 2/3/4 // 5 * / 6 * / 7 *.
Daily dose (mg / day once): 1 / 1, 5 / 2 // 2, 5 / 3/4.
* To achieve optimal improvement in some patients.
The patient's response to ropinirole should be evaluated after 3 months of treatment (see section on pharmacodynamic properties). At the end of this period, the prescribed dose and the need to continue treatment should be reassessed. If the treatment is interrupted for more than a few days, the resumption of treatment should be done according to the same dosing regimen described above.
CHILDREN AND ADOLESCENTS:
ADARTREL is not recommended for children and adolescents under 18 years of age due to the lack of tolerability and efficacy data.
AGES:
The clearance of ropinirole is decreased in patients over 65 years of age. Dose increases will be more gradual and tailored to the clinical response.
RENAL INSUFFICIENT:
In patients with mild to moderate renal impairment (creatinine clearance 30-50 ml / min), dosage adjustment is not required.

Against indications

CONTRAINDICATED:
- Hypersensitivity to the active substance or to any of the excipients.
- Severe renal insufficiency (creatinine clearance <30 ml / min).
- Severe hepatic insufficiency.
- Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this medicine.
NOT RECOMMENDED :
- Children and adolescents: ADARTREL is not recommended for children and adolescents under the age of 18 due to lack of tolerance and efficacy data.
- Pregnancy: There are no data on the use of ropinirole in pregnant women. Studies in animals have shown reproductive toxicity. As the potential risk in humans is unknown, ropinirole is not recommended during pregnancy unless the benefit to the patient outweighs the potential risk to the fetus.
- Breast-feeding: Ropinirole should not be used in nursing mothers as it may inhibit lactation.
- Neuroleptics and other centrally acting dopaminergic antagonists, such as sulpiride or metoclopramide, may decrease the efficacy of ropinirole. Therefore, the combination of ropinirole with these drugs should be avoided.

Adartrel Adverse Effects

- The undesirable effects below are classified by organ system and by frequency. Frequencies from clinical trials are determined to have a higher incidence than placebo and are classified as very common (> 1/10), frequent (> 1/100, 1/1000, <1/100).
- Within each frequency group, adverse effects are presented in order of decreasing severity.
USE OF ROPINIROLE IN THE SYNDROME OF THE LEGS WITHOUT REST:
- In clinical trials in patients with Restless Legs Syndrome, the most commonly observed adverse events were nausea (approximately 30% of patients). In general, the side effects were mild to moderate and occurred at the start of treatment or when the dose was increased. Few patients have gone out of testing because of adverse effects.
Table 2 below shows the adverse effects reported at a frequency of 1% or more compared to that of placebo in clinical trials over 12 weeks in patients treated with ropinirole, or those reported infrequently but known to be associated with ropinirole.
Table 2: Adverse Reactions Reported in 12-Week Clinical Trials in Patients Before Restless Legs Syndrome (ropinirole: n = 309, placebo: n = 307) .
- Psychiatric disorders:
. Frequent : Nervousness.
. Uncommon : Confusion.
- Nervous system disorders:
Frequent : Syncope, drowsiness, dizziness.
- Vascular disorders:
Uncommon : Orthostatic hypotension, hypotension.
- Gastrointestinal disorders:
. Very common : Vomiting, nausea.
. Common : Abdominal pain.
- General disorders:
Frequent : Fatigue.
- Hallucinations have been infrequently reported in long-term open-label clinical studies.
- A paradoxical aggravation of the symptoms of Restless Legs Syndrome: earlier onset (increase) and reappearance of symptoms early in the morning (early morning rebound) may be observed during treatment with ropinirole.
MANAGEMENT OF UNDESIRABLE EFFECTS:
Dose reduction should be considered if significant adverse events occur. After improvement of the undesirable effect, the dosage may be increased gradually. Anti-nausea drugs that are not centrally acting dopaminergic antagonists, such as domperidone, may be used if necessary.
OTHER CLINICAL EXPERIENCE WITH ROPINIROLE:
Ropinirole is also indicated for the treatment of Parkinson's disease. Adverse reactions reported with greater incidence than placebo in patients with Parkinson's disease treated with ropinirole, monotherapy or combination therapy, at doses up to 24 mg daily, are presented below.
Table 3: Adverse reactions reported in clinical trials in Parkinson's disease at doses up to 24 mg daily .
- Psychiatric disorders:
. Frequent : Hallucinations, confusion.
. Uncommon : Increased libido.
- Nervous system disorders:
Very common : Syncope, dyskinesia, drowsiness.
- Gastrointestinal disorders:
. Very common : Nausea.
. Frequent : Vomiting, abdominal pain, heartburn.
- General disorders:
Frequent : Edema of the lower limbs.
POST-MARKETING DATA:
- Psychotic reactions (other than hallucinations) including delusions, delusions, paranoia have been observed.
- Impulse control disorders (including pathological gambling and hypersexuality), and an increase in libido, have been reported (see Warnings and Precautions section).
- Ropinirole used in Parkinson's disease is associated with somnolence and has been infrequently (> 1/1000, <1/100) associated with excessive daytime sleepiness and sudden onset of sleep onset. However, these effects are very rare (<1/10000) in Restless Legs Syndrome.
- Following administration of ropinirole, orthostatic hypotension or hypotension, rarely severe, have been reported infrequently (> 1/1000, <1/100).
- Very rare cases (<1 / 10, 000) of hepatic reactions, mainly elevated liver enzymes, have been reported.

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