MEDOCRIPTINE Tablet (2014)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
Medocriptine 2.5 mg tablets.
2. Qualitative and quantitative composition
Medocriptine contain 2.5 mg bromocriptine as bromocriptine mesilate. Excipient with known effect: lactose monohydrate. Each tablet contains 100.0mg lactose monohydrate. For the full list of excipients, ...
3. Pharmaceutical form
Tablet. White, round, flat, scored tablet.
4.1. Therapeutic indications
Prevention or suppression of post-partum physiological lactation only where medically indicated (such as in case of intrapartum loss, neonatal death, HIV infection of the mother). Bromocriptine is not ...
4.2. Posology and method of administration
Posology Due to the variety of conditions, the recommended dosage regimes are variable. Irrespective of the final dosage, gradual introduction of bromocriptine to achieve the optimum response with minimal ...
4.3. Contraindications
Hypersensitivity to the active substance, to other ergot alkaloids or to any of the excipients listed in section 6.1. Bromocriptine is contraindicated in patients with uncontrolled hypertension, hypertensive ...
4.4. Special warnings and precautions for use
Impulse control disorders Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control ...
4.5. Interaction with other medicinal products and other forms of interaction
Alcohol may reduce tolerance to bromocriptine. Concomitant administration of erythromycin other macrolide antibiotics or octreotide may increase bromocriptine plasma levels. There is no conclusive evidence ...
4.6. Fertility, pregnancy and lactation
Pregnancy Bromocriptine should be withdrawn after the first missed menstrual period in pregnancy. Rapid expansion of pituitary tumours can sometimes occur in pregnancy, and this may also occur in patients ...
4.7. Effects on ability to drive and use machines
Bromocriptine may cause dizziness or drowsiness and/or sudden sleep episodes. Hypotensive reactions may be disturbing in some patients during the first few days of treatment. If affected patients should ...
4.8. 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 ...
4.9. Overdose
Symptoms Overdosage with Medocriptine 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, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Dopamine agonists <b>ATC code:</b> N04BC01 Bromocriptine is a dopaminergic receptor stimulant or dopamine agonist. The pharmacological action is shown in both normal individuals ...
5.2. Pharmacokinetic properties
About 30% of an oral dose is absorbed, and peak plasma levels are reached in about one hour. The elimination half life is about 50 hours. It is extensively protein bound, about 90% - 96%. It undergoes ...
5.3. Preclinical safety data
No further relevant information for the prescriber not presented elsewhere in the SmPC.
6.1. List of excipients
Medocriptine contain lactose monohydrate, microcrystalline cellulose, sodium starch glycollate, magnesium stearate, maleic acid and disodium edetate.
6.2. Incompatibilities
None known.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C, in the original package.
6.5. Nature and contents of container
Polyvinylchloride and aluminium combination blisters. Blisters and leaflet in an outer carton. Medocriptine 2.5 mg tablets are available in packs of 30, 100 or 500 tablets. Not all pack sizes may be marketed. ...
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
10640
9. Date of first authorization / renewal of the authorization
4/7/1986
10. Date of revision of the text
11/2014
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
