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SPC, UK: Parlodel 5mg Capsules (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Meda Pharmaceuticals
Διεύθυνση :
Sky Way House, Parsonage Road, Takeley, Bishop's Stortford, CM22 6PU
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Name of the medicinal product

PARLODEL 5mg Capsules.

Qualitative and quantitative composition

Active substance: Ergotaman-3', 6', 18-trione, 2-bromo-12'-hydroxy-2'-(1-methylethyl-5'-(2-methylpropyl)-, (5alpha)-mono-methanesulphonate. Each capsule contains 5.735mg of bromocriptine mesilate (equivalent ...

Pharmaceutical form

Light blue and white opaque hard gelatine capsules imprinted with 5 MG on the capsule body.

Therapeutic indications

Inhibition of lactation for medical reasons The inhibition or suppression of puerperal lactation where medically indicated such as after intrapartum loss or neonatal death. PARLODEL is not recommended ...

Posology and method of administration

PARLODEL should always be taken with food. A number of disparate conditions are amenable to treatment with PARLODEL and for this reason the recommended dosage regimens are variable. In most indications, ...

Contraindications

Hypersensitivity to bromocriptine or to any of the excipients of PARLODEL (see Section 2 Qualitative and Quantitative composition and Section 6.1 List of excipients) or to other ergot alkaloids. Uncontrolled ...

Special warnings and precautions for use

PARLODEL is contraindicated for use in the suppression of lactation or other non-life threatening indications in patients with severe coronary artery disease, or symptoms and/or a history of serious mental ...

Interaction with other medicinal products and other forms of interaction

Tolerance to PARLODEL may be reduced by alcohol. Caution is required in patients who are on concomitant therapy with, or have recently been treated with drugs that can alter blood pressure. Although there ...

Pregnancy and lactation

Pregnancy If pregnancy occurs it is generally advisable to withdraw PARLODEL after the first missed menstrual period. Rapid expansion of pituitary tumours sometimes occurs during pregnancy and this may ...

Effects on ability to drive and use machines

Hypotensive reactions may be disturbing in some patients during the first few days of treatment and particular care should be exercised when driving vehicles or operating machinery. Patients being treated ...

Undesirable effects

The occurrence of side-effects can be minimised by gradual introduction of the dose or a dose reduction followed by a more gradual titration. If necessary, initial nausea and/or vomiting may be reduced ...

Overdose

Signs and Symptoms Overdosage with PARLODEL is likely to result in vomiting and other symptoms which could be due to over stimulation of dopaminergic receptors and might include nausea, dizziness, hypotension, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Dopamine agonist (ATC code: N04BC01), Prolactin inhibitor (ATC code: G02CB01) PARLODEL, active ingredient bromocriptine, is an inhibitor of prolactin secretion and a stimulator ...

Pharmacokinetic properties

Following oral administration, PARLODEL (bromocriptine) is rapidly and well absorbed. Peak plasma levels are reached within 1-3 hours. An oral dose of 5mg of bromocriptine results in a C<sub>max</sub> ...

Preclinical safety data

Pre-clinical data for PARLODEL (bromocriptine) reveal no special hazard for humans based on conventional studies of single and repeat dose toxicity, genotoxicity, mutagenicity, carcinogenic potential or ...

List of excipients

Capsule Content: Silica, colloidal anhydrous Magnesium stearate Maleic acid Maize starch Lactose monohydrate Capsule Shell: Indigo carmine (E132) Titanium dioxide (E171) Gelatin Printing Ink: Shellac (E904) ...

Incompatibilities

None.

Shelf life

Opaque white PV/PVDC blister strip: 24 months. Amber glass bottle: 36 months.

Special precautions for storage

Amber glass bottle: Store below 30°C. Store in the original package in order to protect from light. Opaque white PV/PVDC blister strip: Store below 25°C. Store in the original package in order to protect ...

Nature and contents of container

Opaque white PV/PVDC blister strip containing 30 PARLODEL 5mg capsules. Amber glass bottle with a tamper resistant closure containing 100 PARLODEL 5mg capsules. Not all pack sizes will be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Meda Pharmaceuticals Ltd 249 West George Street Glasgow G2 4RB Trading as: Meda Pharmaceuticals Skyway House Parsonage Road Takeley Bishops Stortford CM22 6PU

Marketing authorization number(s)

PL 15142/0052

Date of first authorization / renewal of the authorization

9 October 1981 / 27 October 1997

Date of revision of the text

16 July 2012