Ropynerol | Sindranol tablets is covered.pl.ob. prolong. 8 mg 28 pcs.

Release form

Sustained-release film-coated tablets, 8 mg.

Pharmacological action

antiparkinsonian agent - dopamine agonist

Indications

Parkinson's disease:

is an early stage monotherapy in patients requiring dopaminergic therapy to delay the administration of levodopa drugs.

- as a combination therapy in patients receiving levodopa drugs, in order to increase the effectiveness of levodopa, including control of fluctuations in the therapeutic effect of levodopa (on-off phenomenon) and the effect of the end of the dose against the background of chronic therapy of levodopa, as well as to reduce the daily dose of levodopa.

Contraindications

- Hypersensitivity to ropinirole or any of the components of the

preparation - severe renal failure (creatinine clearance (CC) <30 ml / min) in patients not receiving treatment with programmatic (chronic) hemodialysis - srdlp dysfunction liver

- under 18 years old

- breastfeeding

- lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome.

Caution:

With caution, ropinirole is prescribed to patients with severe diseases of the cardiovascular system and with severe cardiovascular failure.

Ropinirole can be prescribed to patients with a history of psychotic disorders only if the expected benefits of its use outweigh the potential risk.

Use during pregnancy and lactation

Insufficient data on the use of ropinirole in pregnant women. Animal studies have identified reproductive toxicity. The potential risk of use in pregnant women is unknown, therefore, the use of the drug during pregnancy is possible if the potential benefit to the mother outweighs the risk to the fetus.

Should not be used during breastfeeding, as it can inhibit lactation.

Special instructions

Given the risk of developing arterial hypotension in patients with severe cardiovascular insufficiency (in particular, with coronary heart disease), it is recommended to control blood pressure, especially at the beginning of treatment. The simultaneous use of antihypertensive and antiarrhythmic drugs has not been studied. Caution should be exercised with simultaneous use with these drugs, since the risk of developing arterial hypotension, bradycardia, or other arrhythmias is unknown.

Patients with a psychotic disorder or a history of them should be prescribed dopamine receptor agonists only if the expected benefits outweigh the potential risk.

Caution patients about the possible development of drowsiness or episodes of sudden falling asleep, sometimes without prior drowsiness. In the event of such reactions, consideration should be given to discontinuing ropinirole therapy.

Impairment of impulse control (disorder of habits and drives)

It is necessary to regularly monitor the possibility of impairment of impulse control. Patients and their guardians should be informed that with the use of dopamine receptor agonists, including ropinirole, the development of impulsive drive syndrome, including compulsive behavior, is possible, including pathological attraction to gambling, increased libido, hypersexuality, irresistible attraction to shopping, overeating. Attraction disorders are usually reversible after a dose reduction or drug withdrawal.

In some cases, when using ropinirole, other risk factors may be a history of compulsive behavior or the combined use of several dopaminergic drugs. In this case, consider reducing the dose or discontinuing therapy.

Paradoxical aggravation of restless legs syndrome was observed with ropinirole therapy (earlier onset, increased intensity of manifestations, or progression of symptoms with seizure of previously unaffected limbs), or rebound syndrome (relapse of symptoms) in the early morning hours (relapse of symptoms in the early morning hours ) When these symptoms appear, it is necessary to revise the treatment with ropinirole, to clarify the dosage up to the possible withdrawal of the drug.

Sindranol® is available in the form of film-coated sustained release tablets with the release of the active substance within 24 hours. In the case of the rapid passage of the drug through the digestive tract, there is a risk of incomplete release of the drug and its residue in the stool.

Special information on excipients

The drug contains lactose, therefore it is contraindicated in patients with lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome.

Impact on the ability to drive transp. Wed and fur .:

Patients should be warned of possible adverse reactions during ropinirole therapy. Patients should be informed that there are very rare cases of the development of episodes of sudden falling asleep without any precursors and cases of dizziness (up to vertigo).

If a patient develops sleepiness during the day and / or there are episodes of sudden falling asleep during the day that require active intervention, the patient should be warned that he should not drive and should avoid other activities that require a high rate of psychomotor reactions.

Composition

For 1 tablet:

Active ingredient: ropinirole hydrochloride 9.121 mg, which corresponds to ropinirole 8 mg.

Excipients: methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate copolymer 21.12 mg hypromellose 359, 819 mg sodium lauryl sulfate 27 mg copovidone 178.56 mg magnesium stearate 4.38 mg.

Shell: Opadry II pink 32K14834 (4.5 mg) / Opadra tan OY-27207 (9 mg) / Opadri red 03B25227 (18 mg).

Opadray II pink 32K14834: lactose monohydrate 40% (1.8 mg) hypromellose-2910 (hypromellose-15cP) 28% (1.26 mg) titanium dioxide 23.46% (1.0557 mg) triacetin 8% (0, 36 mg) dye iron oxide red 0.54% (0.0243 mg).

Opadry Fawn OY-27207: Hypromellose-2910 (Hypromellose-6cP) 62.5% (5.625 mg) Titanium Dioxide 21.25% (1.9125 mg) Dye Sun Sunset Yellow, Aluminum Varnish (FD & Yellow # 6) ( E110) 9% (0.81 mg) macrogol-400 6.25% (0.5625 mg) indigo carmine, aluminum varnish (FD&C blue # 2) (E132) 1% (0.09 mg).

Opadry red 03B25227: hypromellose-2910 (hypromellose-bsR) 62.5% (11, 25 mg) titanium dioxide 24.19% (4.3542 mg) macrogol-400 6.25% (1.125 mg) iron dye red oxide 6.14% (1.105 mg) iron dye black oxide 0.89% (0.1602 mg) iron dye oxide yellow 0.03% (0.0054 mg).

Dosage and Administration

Take orally. SindranolΠshould be taken once a day at the same time, regardless of the meal. Patients, in order to achieve the required dose of ropinirole, are advised to take the minimum number of sustained-release tablets using the maximum possible dosage of the drug tablets. In some patients, simultaneous use with fatty foods can increase AUC and / or Cmax by 2 times.

SindranolΠTablets should be swallowed whole. It should not be chewed or divided into parts, since the shell of the tablet provides a sustained release of ropinirole.

Recommended individual dose selection of the drug, taking into account the effectiveness and tolerability. If the patient experiences drowsiness at any stage of dose selection, it is recommended to reduce the dose of the drug. With the development of other adverse reactions, it is necessary to reduce the dose of the drug, followed by a gradual increase in dose.

The need for dose selection should be considered when skipping a dose (one or more).

Monotherapy

Initial dose selection

The recommended starting dose of SindranolΠis 2 mg once daily for the first week. In the second week, the dose should be increased to 4 mg once a day. The therapeutic effect can be achieved by using the drug SindranolΠin a dose of 4 mg once a day.

Treatment regimen

It is necessary to carry out therapy with ropinirole in the minimum effective dose. Further, if necessary, the dose is increased by 2 mg at intervals of at least 1 week to 8 mg per day.

If the therapeutic effect of SindranolΠat a dose of 8 mg / day is not sufficiently pronounced or unstable, you can continue to increase the daily dose of the drug by 2-4 mg every 2 weeks or at longer intervals (until the desired therapeutic effect is achieved). The maximum daily dose is 24 mg in one dose.

Combination therapy

With the simultaneous use of the drug SindranolΠin the doses used for monotherapy with levodopa, a gradual reduction in the dose of levodopa is possible (up to 30%), depending on the clinical effect. In patients with a progressive form of Parkinson's disease who are simultaneously receiving levodopa, dyskinesia may develop during the period of selecting a dose of ropinirole prolonged release. If dyskinesia occurs, the dose of levodopa should be reduced.

In the event of switching from treatment with another dopamine receptor agonist to the SindranolΠpreparation, it is necessary to follow the recommendations regarding the cancellation of a previously taken drug.

Cancellation of

therapy As with other dopamine receptor agonists, SindranolΠshould be discontinued gradually, reducing the daily dose for at least 1 week.

Interruption of

therapy If a dose is missed (one or more) and therapy is resumed, dose selection must be repeated.

Special patient groups

Elderly patients

The clearance of ropinirole after oral administration is reduced by about 15% in elderly patients compared to younger patients. Dose adjustment in this category of patients is not required.

In patients 75 years of age and older, a slower dose selection is appropriate.

Impaired renal function

In patients with mild or moderate impaired renal function (CC 30-50 ml / min), ropinirole clearance does not change. Therefore, dose adjustment of ropinirole is not required. The recommended starting dose of ropinirole in patients with end-stage renal failure undergoing hemodialysis is 2 mg once a day. In the future, the dose is increased taking into account the tolerance and effectiveness of the drug. The maximum daily dose of ropinirole in patients undergoing program (chronic) hemodialysis is 18 mg. Acceptance of additional doses after hemodialysis is not required.

In patients with severe renal failure (CC

Side effects

The adverse reactions listed below are listed according to organ system damage and frequency of occurrence. The frequency of occurrence is determined as follows: very often:? 1/10 often: from? 1/100 to

Within each group, the frequency of adverse reactions is presented in decreasing order of importance.

Drug Interactions

No pharmacokinetic interaction was observed between ropinirole and levodopa or domperidone, which would require dose adjustment for these drugs.

Antipsychotics and other centrally acting dopamine receptor antagonists, such as sulpiride or metoclopramide, may decrease the effectiveness of ropinirole, so the simultaneous use of these drugs should be avoided.

In patients receiving high doses of estrogen, an increase in the concentration of ropinirole in the blood plasma was noted. In women who have already received hormone replacement therapy (HRT) before starting treatment with ropinirole, dose adjustment of ropinirole is not required. However, if HRT is prescribed or canceled during treatment with ropinirole, dose adjustment of the Sindranol® preparation may be required.

Ropinirol is mainly metabolized by the CYP1A2 isoenzyme. With the simultaneous use of ropinirole (at a dose of 2 mg three times a day) with ciprofloxacin, the indicators of max and AUC of ropinirole increased by 60% and 84%, respectively. which can lead to the development of adverse events. In this regard, in patients receiving ropinirole, its dose should be adjusted when prescribing or discontinuing drugs that inhibit the CYP1A2 isoenzyme, such as ciprofloxacin, enoxacin or fluvoxamine.

In patients with Parkinson's disease who were taking digoxin at the same time, there was no interaction of digoxin with ropinirole, which would require dose adjustment. The pharmacokinetic interaction between ropinirole (at a dose of 2 mg three times a day) and theophylline, which is a substrate of the CYP1A2 isoenzyme, was not observed in patients with Parkinson's disease.

There is no information on the possibility of interaction of ropinirole and alcohol. As with other centrally acting drugs, patients should be warned about the need to refrain from drinking alcohol during treatment with ropinirole.

Nicotine increases the activity of the CYP1A2 isoenzyme. If the patient stops or begins to smoke during treatment with ripinirol, dose adjustment may be required.

Overdose

Symptoms: mainly associated with dopaminergic activity (nausea, vomiting, dizziness, drowsiness).

Treatment: Prescribing dopamine receptor antagonists such as typical antipsychotics and metoclopramide.

Terms and conditions

prescription

Dosage form

tablets prolong.