SIFROL Tablet (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

SIFROL 0.088 mg tablets. SIFROL 0.18 mg tablets. SIFROL 0.35 mg tablets. SIFROL 0.7 mg tablets.

2. Qualitative and quantitative composition

SIFROL 0.088 mg tablets: Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.088 mg pramipexole. SIFROL 0.18 mg tablets: Each tablet contains 0.25 mg pramipexole ...

3. Pharmaceutical form

Tablet. SIFROL 0.088 mg tablets: The tablets are white, flat, of round shape, and have a code embossed (one side with the code P6, and one side with the Boehringer Ingelheim company symbol). ...

4.1. Therapeutic indications

SIFROL is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinsons disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through ...

4.2. Posology and method of administration

Posology Parkinsons disease The daily dose is administered in equally divided doses 3 times a day. Initial treatment Doses should be increased gradually from a starting dose of 0.264 mg of base (0.375 ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

When prescribing SIFROL in a patient with Parkinsons disease with renal impairment a reduced dose is suggested in line with section 4.2. Hallucinations Hallucinations are known as a side effect of treatment ...

4.5. Interaction with other medicinal products and other forms of interaction

Plasma protein binding Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man. Therefore, interactions with other medicinal products affecting ...

4.6. Fertility, pregnancy and lactation

Pregnancy The effect on pregnancy and lactation has not been investigated in humans. Pramipexole was not teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses (see section ...

4.7. Effects on ability to drive and use machines

SIFROL can have a major influence on the ability to drive and use machines. Hallucinations or somnolence can occur. Patients being treated with SIFROL and presenting with somnolence and/or sudden sleep ...

4.8. Undesirable effects

Based on the analysis of pooled placebo-controlled trials, comprising a total of 1,923 patients on pramipexole and 1,354 patients on placebo, adverse drug reactions were frequently reported for both groups. ...

4.9. Overdose

There is no clinical experience with massive overdose. The expected adverse reactions would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: anti-Parkinson drugs, dopamine agonists ATC code: N04BC05 Mechanism of action Pramipexole is a dopamine agonist that binds with high selectivity and specificity ...

5.2. Pharmacokinetic properties

Absorption Pramipexole is rapidly and completely absorbed following oral administration. The absolute bioavailability is greater than 90% and the maximum plasma concentrations occur between 1 and 3 hours. ...

5.3. Preclinical safety data

Repeated dose toxicity studies showed that pramipexole exerted functional effects, mainly involving the CNS and female reproductive system, and probably resulting from an exaggerated pharmacodynamic effect ...

6.1. List of excipients

Mannitol Maize starch Anhydrous colloidal silica Povidone K25 Magnesium stearate

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Do not store above 30°C. Store in the original package in order to protect from light.

6.5. Nature and contents of container

OPA/aluminium/PVC-aluminium blisters. Each blister strip contains 10 tablets. Cartons containing 3 or 10 blister strips (30 or 100 tablets). Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany

8. Marketing authorization number(s)

SIFROL 0.088 mg tablets: EU/1/97/050/001-002 SIFROL 0.18 mg tablets: EU/1/97/050/003-004 SIFROL 0.35 mg tablets: EU/1/97/050/011-012 SIFROL 0.7 mg tablets: EU/1/97/050/005-006

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 14 October 1997 Date of latest renewal: 14 October 2007

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