Pramipexole (Tablets) Instructions for Use

Instructions
Dosage forms

ATC Code

N04BC05 (Pramipexole)

Active Substance

Pramipexole (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antiparkinsonian drug – stimulator of dopaminergic transmission in the CNS

Pharmacotherapeutic Group

Antiparkinsonian agents; dopaminergic agents; dopamine receptor agonists

Pharmacological Action

Antiparkinsonian agent, dopamine receptor agonist. It is believed that the mechanism of action is associated with the ability of pramipexole to stimulate dopamine receptors in the striatum. This is confirmed by its effect on the level of impulse activity in striatal neurons due to the activation of dopamine receptors in the striatum and substantia nigra.

It cannot be ruled out that Pramipexole inhibits prolactin secretion in humans.

Pharmacokinetics

After oral administration, Pramipexole is rapidly absorbed from the gastrointestinal tract, with C_max in plasma reached in approximately 2 hours. The absolute bioavailability of pramipexole exceeds 90%. Food does not affect the extent of pramipexole absorption, although the time to reach C_max in plasma increases by approximately 1 hour when the drug is taken with food.

Steady-state concentration (C_ss) is achieved within 2 days of starting pramipexole.

It is widely distributed in the body, with a V_d of about 500 L (coefficient of variation – 20%). Plasma protein binding is about 15%. Pramipexole accumulates in erythrocytes, as confirmed by the erythrocyte-to-plasma concentration ratio of 2.

T_1/2 is 8 hours in young healthy volunteers and about 12 hours in elderly volunteers.

Pramipexole is excreted primarily by the kidneys; 90% of the administered dose is found in the urine almost entirely unchanged. Non-renal routes of elimination may play some role in the elimination of pramipexole, although no metabolites were detected in plasma or urine. The renal clearance of pramipexole is approximately 400 mL/min (coefficient of variation – 25%), which is about 3 times higher than the glomerular filtration rate. Pramipexole is thus secreted by the renal tubules, possibly via the organic cation transport system.

The clearance of pramipexole is approximately 30% lower in women than in men, but this difference may be largely due to differences in body weight. There is no difference in T_1/2 values between men and women.

With age, the clearance of pramipexole decreases, with elderly individuals (aged 65 years and older) having a T_1/2 increased by approximately 40% (from 8.5 hours to 12 hours), and the total clearance of pramipexole reduced by 30% compared to young, healthy volunteers (under 40 years of age).

In patients with Parkinson’s disease, the clearance of pramipexole may be reduced by up to 30% compared to healthy elderly subjects. The reason for this difference appears to be reduced renal function in patients with Parkinson’s disease.

The pharmacokinetics of pramipexole in patients with hepatic impairment have not been studied. Since approximately 90% of the excreted dose is eliminated unchanged in the urine, it can be expected that impaired liver function does not significantly affect the elimination of pramipexole.

In severe renal impairment (CrCl about 20 mL/min), the clearance of pramipexole is reduced by approximately 75%; in moderate renal impairment (CrCl approximately 40 mL/min) – by 60%, compared to healthy subjects. In such patients, it is recommended to use the drug at a lower initial and maintenance dose. The clearance of pramipexole is extremely low in patients undergoing hemodialysis, as only insignificant amounts of pramipexole are removed by dialysis.

The pharmacokinetics of pramipexole in children have not been studied.

Indications

Treatment of Parkinson’s disease (as monotherapy and in combination with levodopa).

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
G20	Parkinson's disease
G21	Secondary parkinsonism

ICD-11 code	Indication
8A00.0Z	Parkinson's disease, unspecified
8A00.2Z	Secondary parkinsonism, unspecified
8A0Y	Other specified movement disorders
LD90.1	Early-onset parkinsonism-mental retardation

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets

For adults, when taken orally, the initial dose is 375 mcg/day in 3 divided doses. The dose should be increased every 5-7 days until the maximum therapeutic effect is achieved, which is observed at a dose of 1.5-4.5 mg/day.

In patients with renal impairment, the initial dose is 125 mcg/day, with a frequency of administration of 1-3 times/day depending on CrCl values.

Maximum doses single dose – 1.5 mg; daily dose for CrCl greater than 60 mL/min – 4.5 mg in 3 divided doses, for CrCl 35-59 mL/min – 3 mg in 2 divided doses, for CrCl 15-34 mL/min – 1.5 mg in 1 dose.

It is recommended to discontinue treatment over a period of 1 week.

Adverse Reactions

From the central and peripheral nervous system drowsiness, dyskinesias, hallucinations; in some cases – insomnia. With rapid dose reduction of pramipexole, as well as with abrupt withdrawal, the development of neuroleptic malignant syndrome (NMS) is possible.

From the digestive system nausea, constipation.

From the cardiovascular system in some cases at the beginning of treatment – arterial hypotension (especially when the dose is increased too quickly over too short a time).

Other in some cases – peripheral edema.

Contraindications

Hypersensitivity to pramipexole.

Use in Pregnancy and Lactation

Adequate and strictly controlled studies on the safety of pramipexole use during pregnancy have not been conducted. It is considered that use is possible in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

It is not known whether Pramipexole is excreted in breast milk. If use during lactation is necessary, breastfeeding should be discontinued.

Use in Renal Impairment

Use with caution in patients with renal impairment. In patients with CrCl less than 15 mL/min, experience with pramipexole is insufficient.

Pediatric Use

The safety and efficacy of pramipexole use in children have not been established.

Special Precautions

Use with caution in patients with renal impairment. In patients with CrCl less than 15 mL/min, experience with pramipexole is insufficient.

The safety and efficacy of pramipexole use in children have not been established.

Effect on ability to drive vehicles and operate machinery

During treatment, refrain from driving vehicles and engaging in other potentially hazardous activities.

Drug Interactions

With simultaneous use with drugs that are excreted by the renal cationic transport system, an increase in the plasma concentration of pramipexole is possible.

With simultaneous use with levodopa, the development of dyskinesia is possible; with cimetidine – a decrease in the clearance of pramipexole and an increase in its plasma concentration.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Pramipexole [Atoll LLC (Russia)]
Tablets 0.5 mg: 10, 20, 30, 40, 50, 60, 90, 100, 120, 150, or 300 pcs.
Tablets 0.25 mg: 10, 20, 30, 40, 50, 60, 90, 100, 120, 150, or 300 pcs.
Tablets 1.5 mg: 10, 20, 30, 40, 50, 60, 90, 100, 120, 150, or 300 pcs.
Tablets, 1 mg: 10, 20, 30, 40, 50, 60, 90, 100, 120, 150, or 300 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Forms

	Pramipexole	Tablets 0.5 mg: 10, 20, 30, 40, 50, 60, 90, 100, 120, 150, or 300 pcs.
		Tablets 0.25 mg: 10, 20, 30, 40, 50, 60, 90, 100, 120, 150, or 300 pcs.
		Tablets 1.5 mg: 10, 20, 30, 40, 50, 60, 90, 100, 120, 150, or 300 pcs.
		Tablets, 1 mg: 10, 20, 30, 40, 50, 60, 90, 100, 120, 150, or 300 pcs.

Dosage Form, Packaging, and Composition

Tablets from white to white with a yellowish tint, round, flat-cylindrical, with a cross-shaped score and a bevel.

	1 tab.
Pramipexole dihydrochloride monohydrate	0.5 mg

Excipients : mannitol – 57.9 mg, corn starch – 38 mg, magnesium stearate – 1.4 mg, povidone K25 – 1.1 mg, colloidal silicon dioxide – 1.1 mg.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
30 pcs. – contour cell packaging (1) – cardboard packs.
30 pcs. – contour cell packaging (2) – cardboard packs.
30 pcs. – contour cell packaging (3) – cardboard packs.
30 pcs. – contour cell packaging (4) – cardboard packs.
30 pcs. – contour cell packaging (5) – cardboard packs.
30 pcs. – contour cell packaging (10) – cardboard packs.

Tablets from white to white with a yellowish tint, round, flat-cylindrical, with a score and a bevel.

	1 tab.
Pramipexole dihydrochloride monohydrate	0.25 mg

Excipients : mannitol – 58.15 mg, corn starch – 38 mg, magnesium stearate – 1.4 mg, povidone K25 – 1.1 mg, colloidal silicon dioxide – 1.1 mg.

Tablets from white to white with a yellowish tint, round, flat-cylindrical, with a score and a bevel.

	1 tab.
Pramipexole dihydrochloride monohydrate	1.5 mg

Excipients : mannitol – 115.3 mg, corn starch – 76 mg, magnesium stearate – 2.8 mg, povidone K25 – 2.2 mg, colloidal silicon dioxide – 2.2 mg.

Tablets from white to white with a yellowish tint, round, flat-cylindrical, with a cross-shaped score and a bevel.

	1 tab.
Pramipexole dihydrochloride monohydrate	1 mg

Excipients : mannitol – 115.8 mg, corn starch – 76 mg, magnesium stearate – 2.8 mg, povidone K25 – 2.2 mg, colloidal silicon dioxide – 2.2 mg.

Pramipexole [Pharmazashchita SPC, FSUE FMBA of Russia (Russia)]
Tablets 0.25 mg: 10, 30, or 100 pcs.
Tablets 1 mg: 10, 30, or 100 pcs.

Marketing Authorization Holder

Pharmazashchita SPC, FSUE FMBA of Russia (Russia)

Dosage Forms

	Pramipexole	Tablets 0.25 mg: 10, 30, or 100 pcs.
		Tablets 1 mg: 10, 30, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a bevel; on one side a score and engraving “P1”.

	1 tab.
Pramipexole (as dihydrochloride monohydrate)	0.25 mg

Excipients : magnesium stearate – 1 mg, ludipress: lactose monohydrate – 184.83 mg, povidone K-30 – 6.96 mg, crospovidone – 6.96 mg.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.

Tablets white or almost white, round, flat-cylindrical, with a bevel; on one side a score and engraving “P2”.

	1 tab.
Pramipexole (as dihydrochloride monohydrate)	1 mg

Excipients : magnesium stearate – 1 mg, ludipress: lactose monohydrate – 184.14 mg, povidone K-30 – 6.93 mg, crospovidone – 6.93 mg.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.

Pramipexole [Evroservice Firm, CJSC (Russia)]
Tablets 0.25 mg: 21 or 30 pcs.

Marketing Authorization Holder

Evroservice Firm, CJSC (Russia)

Manufactured By

Synthon Hispania, S.L. (Spain)

Dosage Form

Pramipexole

Tablets 0.25 mg: 21 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, oblong, flat, with a narrow score and engraving “P9AL 0.18” on one side and a wide score on the other side.

	1 tab.
Pramipexole dihydrochloride monohydrate	0.25 mg,
Equivalent to pramipexole content	0.18 mg

Excipients : pregelatinized starch 39.9 mg, mannitol 61 mg, povidone 1.17 mg, colloidal silicon dioxide 1.17 mg, magnesium stearate 1.52 mg.

7 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.

Pramipexole [Evroservice Firm, CJSC (Russia)]
Tablets 0.25 mg: 21 or 30 pcs.

Marketing Authorization Holder

Evroservice Firm, CJSC (Russia)

Manufactured By

Synthon B.V. (Netherlands)

Labeled By

GE PHARMACEUTICALS, Ltd. (Bulgaria)

Dosage Form

Pramipexole

Tablets 0.25 mg: 21 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, oblong, flat, with a narrow score and engraving “P9AL 0.18” on one side and a wide score on the other side.

	1 tab.
Pramipexole dihydrochloride monohydrate	0.25 mg,
Equivalent to pramipexole content	0.18 mg

Excipients : pregelatinized starch 39.9 mg, mannitol 61 mg, povidone 1.17 mg, colloidal silicon dioxide 1.17 mg, magnesium stearate 1.52 mg.

7 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.

Pramipexole [Evroservice Firm, CJSC (Russia)]
Tablets 0.25 mg: 21 or 30 pcs.

Marketing Authorization Holder

Evroservice Firm, CJSC (Russia)

Manufactured By

Synthon B.V. (Netherlands)

Labeled By

ROTTENDORF PHARMA, GmbH (Germany)

Dosage Form

Pramipexole

Tablets 0.25 mg: 21 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, oblong, flat, with a narrow score and engraving “P9AL 0.18” on one side and a wide score on the other side.

	1 tab.
Pramipexole dihydrochloride monohydrate	0.25 mg,
Equivalent to pramipexole content	0.18 mg

Excipients: pregelatinized starch 39.9 mg, mannitol 61 mg, povidone 1.17 mg, colloidal silicon dioxide 1.17 mg, magnesium stearate 1.52 mg.

7 pcs. – blisters (3) – carton packs.
10 pcs. – blisters (3) – carton packs.

Pramipexole [Evroservice Firm, CJSC (Russia)]
Tablets 0.25 mg: 21 or 30 pcs.

Marketing Authorization Holder

Evroservice Firm, CJSC (Russia)

Manufactured By

Synthon B.V. (Netherlands)

Labeled By

SYNTHON HISPANIA, S.L. (Spain)

Dosage Form

Pramipexole

Tablets 0.25 mg: 21 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, oblong, flat, with a narrow score and engraving “P9AL 0.18” on one side and a wide score on the other side.

	1 tab.
Pramipexole dihydrochloride monohydrate	0.25 mg,
Equivalent to pramipexole content	0.18 mg

Excipients: pregelatinized starch 39.9 mg, mannitol 61 mg, povidone 1.17 mg, colloidal silicon dioxide 1.17 mg, magnesium stearate 1.52 mg.

7 pcs. – blisters (3) – carton packs.
10 pcs. – blisters (3) – carton packs.

Pramipexole [Evroservice Firm, CJSC (Russia)]
Tablets 0.5 mg: 21 or 30 pcs.

Marketing Authorization Holder

Evroservice Firm, CJSC (Russia)

Manufactured By

Synthon B.V. (Netherlands)

Labeled By

SYNTHON HISPANIA, S.L. (Spain)

Dosage Form

Pramipexole

Tablets 0.5 mg: 21 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, oblong, flat, with a narrow score and engraving “P9AL 0.35” on one side and a wide score on the other side.

	1 tab.
Pramipexole dihydrochloride monohydrate	0.5 mg,
Equivalent to pramipexole content	0.35 mg

Excipients: pregelatinized starch 79.8 mg, mannitol 121.99 mg, povidone 2.33 mg, colloidal silicon dioxide 2.33 mg, magnesium stearate 3.05 mg.

7 pcs. – blisters (3) – carton packs.
10 pcs. – blisters (3) – carton packs.

Pramipexole [Evroservice Firm, CJSC (Russia)]
Tablets 0.5 mg: 21 or 30 pcs.

Marketing Authorization Holder

Evroservice Firm, CJSC (Russia)

Manufactured By

Synthon Hispania, S.L. (Spain)

Dosage Form

Pramipexole

Tablets 0.5 mg: 21 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, oblong, flat, with a narrow score and engraving “P9AL 0.35” on one side and a wide score on the other side.

	1 tab.
Pramipexole dihydrochloride monohydrate	0.5 mg,
Equivalent to pramipexole content	0.35 mg

Excipients: pregelatinized starch 79.8 mg, mannitol 121.99 mg, povidone 2.33 mg, colloidal silicon dioxide 2.33 mg, magnesium stearate 3.05 mg.

7 pcs. – blisters (3) – carton packs.
10 pcs. – blisters (3) – carton packs.

Pramipexole [Evroservice Firm, CJSC (Russia)]
Tablets 0.5 mg: 21 or 30 pcs.

Marketing Authorization Holder

Evroservice Firm, CJSC (Russia)

Manufactured By

Synthon B.V. (Netherlands)

Labeled By

GE PHARMACEUTICALS, Ltd. (Bulgaria)

Dosage Form

Pramipexole

Tablets 0.5 mg: 21 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, oblong, flat, with a narrow score and engraving “P9AL 0.35” on one side and a wide score on the other side.

	1 tab.
Pramipexole dihydrochloride monohydrate	0.5 mg,
Equivalent to pramipexole content	0.35 mg

Excipients: pregelatinized starch 79.8 mg, mannitol 121.99 mg, povidone 2.33 mg, colloidal silicon dioxide 2.33 mg, magnesium stearate 3.05 mg.

7 pcs. – blisters (3) – carton packs.
10 pcs. – blisters (3) – carton packs.

Pramipexole [Evroservice Firm, CJSC (Russia)]
Tablets 0.5 mg: 21 or 30 pcs.

Marketing Authorization Holder

Evroservice Firm, CJSC (Russia)

Manufactured By

Synthon B.V. (Netherlands)

Labeled By

ROTTENDORF PHARMA, GmbH (Germany)

Dosage Form

Pramipexole

Tablets 0.5 mg: 21 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, oblong, flat, with a narrow score and engraving “P9AL 0.35” on one side and a wide score on the other side.

	1 tab.
Pramipexole dihydrochloride monohydrate	0.5 mg,
Equivalent to pramipexole content	0.35 mg

Excipients: pregelatinized starch 79.8 mg, mannitol 121.99 mg, povidone 2.33 mg, colloidal silicon dioxide 2.33 mg, magnesium stearate 3.05 mg.

7 pcs. – blisters (3) – carton packs.
10 pcs. – blisters (3) – carton packs.

Pramipexole [Evroservice Firm, CJSC (Russia)]
Tablets 1 mg: 21 or 30 pcs.

Marketing Authorization Holder

Evroservice Firm, CJSC (Russia)

Manufactured By

Synthon Hispania, S.L. (Spain)

Dosage Form

Pramipexole

Tablets 1 mg: 21 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, biconvex, with engraving “P9AL 0.7” on one side and a score on each side.

	1 tab.
Pramipexole dihydrochloride monohydrate	1 mg,
Equivalent to pramipexole content	0.7 mg

Excipients: pregelatinized starch 79.8 mg, mannitol 121.99 mg, povidone 2.33 mg, colloidal silicon dioxide 2.33 mg, magnesium stearate 3.05 mg.

7 pcs. – blisters (3) – carton packs.
10 pcs. – blisters (3) – carton packs.

Pramipexole [Evroservice Firm, CJSC (Russia)]
Tablets 1 mg: 21 or 30 pcs.

Marketing Authorization Holder

Evroservice Firm, CJSC (Russia)

Manufactured By

Synthon B.V. (Netherlands)

Labeled By

SYNTHON HISPANIA, S.L. (Spain)

Dosage Form

Pramipexole

Tablets 1 mg: 21 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, biconvex, with engraving “P9AL 0.7” on one side and a score on each side.

	1 tab.
Pramipexole dihydrochloride monohydrate	1 mg,
Equivalent to pramipexole content	0.7 mg

Excipients: pregelatinized starch 79.8 mg, mannitol 121.99 mg, povidone 2.33 mg, colloidal silicon dioxide 2.33 mg, magnesium stearate 3.05 mg.

7 pcs. – blisters (3) – carton packs.
10 pcs. – blisters (3) – carton packs.

Pramipexole [Evroservice Firm, CJSC (Russia)]
Tablets 1 mg: 21 or 30 pcs.

Marketing Authorization Holder

Evroservice Firm, CJSC (Russia)

Manufactured By

Synthon B.V. (Netherlands)

Labeled By

GE PHARMACEUTICALS, Ltd. (Bulgaria)

Dosage Form

Pramipexole

Tablets 1 mg: 21 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, biconvex, with engraving “P9AL 0.7” on one side and a score on each side.

	1 tab.
Pramipexole dihydrochloride monohydrate	1 mg,
Equivalent to pramipexole content	0.7 mg

Excipients: pregelatinized starch 79.8 mg, mannitol 121.99 mg, povidone 2.33 mg, colloidal silicon dioxide 2.33 mg, magnesium stearate 3.05 mg.

7 pcs. – blisters (3) – carton packs.
10 pcs. – blisters (3) – carton packs.

Pramipexole [Evroservice Firm, CJSC (Russia)]
Tablets 1 mg: 21 or 30 pcs.

Marketing Authorization Holder

Evroservice Firm, CJSC (Russia)

Manufactured By

Synthon B.V. (Netherlands)

Labeled By

ROTTENDORF PHARMA, GmbH (Germany)

Dosage Form

Pramipexole

Tablets 1 mg: 21 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, biconvex, with engraving “P9AL 0.7” on one side and a score on each side.

	1 tab.
Pramipexole dihydrochloride monohydrate	1 mg,
Equivalent to pramipexole content	0.7 mg

Excipients: pregelatinized starch 79.8 mg, mannitol 121.99 mg, povidone 2.33 mg, colloidal silicon dioxide 2.33 mg, magnesium stearate 3.05 mg.

7 pcs. – blisters (3) – carton packs.
10 pcs. – blisters (3) – carton packs.

Pramipexole [Evroservice Firm, CJSC (Russia)]
Tablets 1.25 mg: 21 or 30 pcs.

Marketing Authorization Holder

Evroservice Firm, CJSC (Russia)

Manufactured By

Synthon B.V. (Netherlands)

Labeled By

ROTTENDORF PHARMA, GmbH (Germany)

Dosage Form

Pramipexole

Tablets 1.25 mg: 21 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, biconvex, with engraving “P9AL 1.1” on one side and a score on each side.

	1 tab.
Pramipexole dihydrochloride monohydrate	1.25 mg
Equivalent to pramipexole content	1.1 mg

Excipients: pregelatinized starch 119.7 mg, mannitol 182.24 mg, povidone 3.5 mg, colloidal silicon dioxide 3.5 mg, magnesium stearate 4.57 mg.

7 pcs. – blisters (3) – carton packs.
10 pcs. – blisters (3) – carton packs.

Pramipexole [Evroservice Firm, CJSC (Russia)]
Tablets 1.25 mg: 21 or 30 pcs.

Marketing Authorization Holder

Evroservice Firm, CJSC (Russia)

Manufactured By

Synthon B.V. (Netherlands)

Labeled By

GE PHARMACEUTICALS, Ltd. (Bulgaria)

Dosage Form

Pramipexole

Tablets 1.25 mg: 21 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, biconvex, with engraving “P9AL 1.1” on one side and a score on each side.

	1 tab.
Pramipexole dihydrochloride monohydrate	1.25 mg
Equivalent to pramipexole content	1.1 mg

Excipients: pregelatinized starch 119.7 mg, mannitol 182.24 mg, povidone 3.5 mg, colloidal silicon dioxide 3.5 mg, magnesium stearate 4.57 mg.

7 pcs. – blisters (3) – carton packs.
10 pcs. – blisters (3) – carton packs.

Pramipexole [Evroservice Firm, CJSC (Russia)]
Tablets 1.25 mg: 21 or 30 pcs.

Marketing Authorization Holder

Evroservice Firm, CJSC (Russia)

Manufactured By

Synthon B.V. (Netherlands)

Labeled By

SYNTHON HISPANIA, S.L. (Spain)

Dosage Form

Pramipexole

Tablets 1.25 mg: 21 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, biconvex, with engraving “P9AL 1.1” on one side and a score on each side.

	1 tab.
Pramipexole dihydrochloride monohydrate	1.25 mg
Equivalent to pramipexole content	1.1 mg

Excipients: pregelatinized starch 119.7 mg, mannitol 182.24 mg, povidone 3.5 mg, colloidal silicon dioxide 3.5 mg, magnesium stearate 4.57 mg.

7 pcs. – blisters (3) – carton packs.
10 pcs. – blisters (3) – carton packs.

Pramipexole [Evroservice Firm, CJSC (Russia)]
Tablets 1.25 mg: 21 or 30 pcs.

Marketing Authorization Holder

Evroservice Firm, CJSC (Russia)

Manufactured By

Synthon Hispania, S.L. (Spain)

Dosage Form

Pramipexole

Tablets 1.25 mg: 21 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, biconvex, with engraving “P9AL 1.1” on one side and a score on each side.

	1 tab.
Pramipexole dihydrochloride monohydrate	1.25 mg
Equivalent to pramipexole content	1.1 mg

Excipients: pregelatinized starch 119.7 mg, mannitol 182.24 mg, povidone 3.5 mg, colloidal silicon dioxide 3.5 mg, magnesium stearate 4.57 mg.

7 pcs. – blisters (3) – carton packs.
10 pcs. – blisters (3) – carton packs.

Pramipexole Canon [Canonpharma Production, CJS (Russia)]
Tablets 0.25 mg: 10, 20, 30, 60, or 90 pcs.
Tablets 1 mg: 10, 20, 30, 60, or 90 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Forms

	Pramipexole Kanon	Tablets 0.25 mg: 10, 20, 30, 60, or 90 pcs.
		Tablets 1 mg: 10, 20, 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Tablets round, flat-cylindrical with a bevel and a score on one side, white or almost white in color; the score is intended for dividing the tablet into equal doses.

	1 tab.
Pramipexole dihydrochloride monohydrate	0.25 mg

Excipients: pregelatinized potato starch, colloidal silicon dioxide, mannitol, sodium stearyl fumarate.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
90 pcs. – jars (1) – cardboard packs.

Tablets round, flat-cylindrical with a bevel, white or almost white in color.

	1 tab.
Pramipexole dihydrochloride monohydrate	1 mg

Excipients: pregelatinized potato starch, colloidal silicon dioxide, mannitol, sodium stearyl fumarate.

Pramipexole-Alium [Aliym, JSC (Russia)]
Tablets 0.25 mg: 10 or 30 pcs.
Tablets 1 mg: 10 or 30 pcs.

Marketing Authorization Holder

Aliym, JSC (Russia)

Dosage Forms

	Pramipexole-Alium	Tablets 0.25 mg: 10 or 30 pcs.
		Tablets 1 mg: 10 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, oblong in shape with rounded ends, biconvex, with a score.

	1 tab.
Pramipexole dihydrochloride monohydrate	0.25 mg

Excipients: mannitol, corn starch, colloidal silicon dioxide (aerosil), povidone K-30, magnesium stearate.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.

Tablets white or almost white, round, flat-cylindrical, with a bevel and a score.

	1 tab.
Pramipexole dihydrochloride monohydrate	1 mg

Excipients: mannitol, corn starch, colloidal silicon dioxide (aerosil), povidone K-30, magnesium stearate.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.

Pramipexole-Teva [Teva Pharmaceutical Industries, Ltd. (Israel)]
Tablets 0.125 mg: 30, 50, 90, or 100 pcs.

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Teva Canada, Ltd. (Canada)

Dosage Form

Pramipexole-Teva

Tablets 0.125 mg: 30, 50, 90, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat, with a bevel; on one side – engraving “93”, on the other – “P1”.

	1 tab.
Pramipexole dihydrochloride monohydrate	0.125 mg

Excipients: mannitol – 35.185 mg, microcrystalline cellulose – 18 mg, sodium carboxymethyl starch – 3 mg, povidone K25 – 1.8 mg, colloidal silicon dioxide – 0.3 mg, magnesium stearate – 0.57 mg, sodium stearyl fumarate – 1.02 mg.

10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.
90 pcs. – bottles (1) – cardboard packs.

Pramipexole-Teva [Teva Pharmaceutical Industries, Ltd. (Israel)]
Tablets 0.25 mg: 30, 50, 90, or 100 pcs.

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Teva Canada, Ltd. (Canada)

Dosage Form

Pramipexole-Teva

Tablets 0.25 mg: 30, 50, 90, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat, with a bevel; on one side – engraving “93”, on the other – a score and engraving “P2” above and below the score.

	1 tab.
Pramipexole dihydrochloride monohydrate	0.25 mg

Excipients: mannitol – 70.37 mg, microcrystalline cellulose – 36 mg, sodium carboxymethyl starch – 6 mg, povidone K25 – 3.6 mg, colloidal silicon dioxide – 0.6 mg, magnesium stearate – 1.14 mg, sodium stearyl fumarate – 2.04 mg.

10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.
90 pcs. – bottles (1) – cardboard packs.

Pramipexole-Teva [Teva Pharmaceutical Industries, Ltd. (Israel)]
Tablets 0.5 mg: 30, 50, 90, or 100 pcs.

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Teva Canada, Ltd. (Canada)

Dosage Form

Pramipexole-Teva

Tablets 0.5 mg: 30, 50, 90, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, oval, biconvex; on one side – engraving “8023”, on the other – a score and engraving “9” and “3” to the left and right of the score.

	1 tab.
Pramipexole dihydrochloride monohydrate	0.5 mg

Excipients: mannitol – 140.74 mg, microcrystalline cellulose – 72 mg, sodium carboxymethyl starch – 12 mg, povidone K25 – 7.2 mg, colloidal silicon dioxide – 1.2 mg, magnesium stearate – 2.28 mg, sodium stearyl fumarate – 4.08 mg.

10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.
90 pcs. – bottles (1) – cardboard packs.

Pramipexole-Teva [Teva Pharmaceutical Industries, Ltd. (Israel)]
Tablets 1 mg: 30, 50, 90, or 100 pcs.

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Teva Canada, Ltd. (Canada)

Dosage Form

Pramipexole-Teva

Tablets 1 mg: 30, 50, 90, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat; on one side – engraving “93”, on the other – a score and engraving “8024” above and below the score.

	1 tab.
Pramipexole dihydrochloride monohydrate	1 mg

Excipients: mannitol – 140.24 mg, microcrystalline cellulose – 72 mg, sodium carboxymethyl starch – 12 mg, povidone K25 – 7.2 mg, colloidal silicon dioxide – 1.2 mg, magnesium stearate – 2.28 mg, sodium stearyl fumarate – 4.08 mg.

10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.
90 pcs. – bottles (1) – cardboard packs.

Medixlife (Author)

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