MELODENE Coated tablet (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
MELODENE 0,02 mg/0,075 mg coated tablets.
2. Qualitative and quantitative composition
21 hormone-containing white coated tablets Each coated tablet contains ethinylestradiol 0,02 mg and gestodene 0,075 mg. <u>Excipient:</u> lactose 35 mg and sucrose 20 mg. 7 hormone-free pink coated tablets ...
3. Pharmaceutical form
Coated tablets. The hormone-containing tablet is small, white round with convex faces. The hormone-free tablet is large, pink round with convex faces.
4.1. Therapeutic indications
MELODENE is indicated for the prevention of pregnancy (oral contraception).
4.2. Posology and method of administration
Posology How to take MELODENE MELODENE, when taken correctly, has a failure rate of approximately 1% per year. The failure rate may increase when tablets are missed or taken incorrectly. Tablets must be ...
4.3. Contraindications
MELODENE should not be used in the presence of any of the conditions listed below. Should any of the conditions appear for the first time during MELODENE use, MELODENE should be stopped immediately. Hypersensitivity ...
4.4. Special warnings and precautions for use
If any of the conditions/risk factors mentioned below are present, the benefits of MELODENE use should be weighed against the possible risks for each individual woman, and discussed with the woman before ...
4.5. Interaction with other medicinal products and other forms of interaction
Note: The prescribing information of concomitant medications should be consulted to identify potential interactions. Effects of other medicines on MELODENE Interactions can occur with medicines that induce ...
4.6. Pregnancy and lactation
Pregnancy MELODENE is contraindicated in pregnancy. If pregnancy occurs during treatment with MELODENE, further intake should be stopped. Lactation Lactation may be influenced by MELODENE as it may reduce ...
4.7. Effects on ability to drive and use machines
No observed effects.
4.8. Undesirable effects
a) Summary of safety profile The most commonly reported adverse reactions with MELODENE are nausea, abdominal pain, increased weight, headache, depressed mood, altered mood, breast pain, breast tenderness. ...
4.9. Overdose
There have been no reports of serious deleterious effects from overdose. Symptoms that may occur in case of taking an overdose of white hormone-containing tablets are: nausea; vomiting; and withdrawal ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group (ATC):</b> Progestogens and estrogens, fixed combinations <b>ATC Code:</b> G03AA MELODENE is a combined low-dose monophasic oral contraceptive with estrogenic (ethinylestradiol) ...
5.2. Pharmacokinetic properties
Gestodene Absorption Orally administered gestodene is rapidly and completely absorbed. Peak serum concentrations of 3,5 ng/ml are reached at about 1 hour after single dose ingestion. Bioavailability is ...
5.3. Preclinical safety data
None.
6.1. List of excipients
Calcium carbonate Ferric oxide pigment, red Ferric oxide, yellow Glycerol 85% (w/w) Lactose monohydrate Macrogol 6 000 Magnesium stearate Maize starch Montanglycol wax (wax E) Povidone 25 000 Povidone ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store at or below 30°C. Protect from light.
6.5. Nature and contents of container
MELODENE is packed in colourless transparent PVC/aluminium blisters containing 21 white hormone-containing tablets plus 7 pink hormone-free tablets per blister strip. The blister strip is packed into an ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Bayer (Pty) Ltd, Reg. No.: 1968/011192/07, 27 Wrench Road, ISANDO, 1609
8. Marketing authorization number(s)
31/18.8/0462
9. Date of first authorization / renewal of the authorization
6 April 1998
10. Date of revision of the text
20 May 2022
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