FEMODENE ED Coated tablets (2022)
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Περιεχόμενα
1. Name of the medicinal product
FEMODENE ED 0,03 mg/0,075 mg coated tablets.
2. Qualitative and quantitative composition
The 28-day pack (Every-Day pack) contains: 21 hormone-containing small white tablets: Each coated tablet contains ethinylestradiol 0,03 mg and gestodene 0,075 mg. Contains sugar (lactose 36 mg and sucrose ...
3. Pharmaceutical form
Coated tablets. The hormone-containing tablets are small, white, round with convex faces. The hormone-free tablets are larger, white, round with convex faces.
4.1. Therapeutic indications
Oral contraception.
4.2. Posology and method of administration
Posology How to take FEMODENE ED The first course of FEMODENE ED is started on the first day of the menstrual period (day 1 of the cycle) from the silver section of the pack by selecting the appropriate ...
4.3. Contraindications
Combined oral contraceptives 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 combined oral contraceptive use, the ...
4.4. Special warnings and precautions for use
If any of the conditions/risk factors mentioned below are present, the benefits of combined oral contraceptive use should be weighed against the possible risks for each individual woman and discussed with ...
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 FEMODENE ED Interactions can occur with medicines that ...
4.6. Pregnancy and lactation
Pregnancy FEMODENE ED is contraindicated during pregnancy (see section 4.3). If pregnancy occurs during treatment with FEMODENE ED, further intake must be stopped. Extensive epidemiological studies have ...
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. No effects on ability to drive and use machines have been observed in users of FEMODENE ED.
4.8. Undesirable effects
a) Summary of the safety profile The most commonly reported adverse reactions with FEMODENE ED are nausea, abdominal pain, increased weight, headache, depressed mood, altered mood, breast pain, breast ...
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 hormone-containing smaller white 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 Gestodene and ethinylestradiol have estrogenic and progestogenic peripheral effects. The contraceptive ...
5.2. Pharmacokinetic properties
Gestodene Absorption Orally administered gestodene is rapidly and completely absorbed. Peak serum concentrations of 4 ng/ml are reached at about 1 hour after single ingestion. Bioavailability is about ...
5.3. Preclinical safety data
None.
6.1. List of excipients
Calcium carbonate Lactose monohydrate Macrogol 6000 Magnesium stearate Mairue starch Montanglycol wax Povidone 25 000 Povidone 700 000 Sodium calcium edetate Sucrose Talc
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Store at or below 30°C. Protect from light.
6.5. Nature and contents of container
FEMODENE ED is packed in colourless transparent PVC/aluminium blisters containing 21 small, white hormonal tablets plus 7 large white non-hormonal tablets per blister strip. The blister strip is sealed ...
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)
W/21.8.2/98
9. Date of first authorization / renewal of the authorization
15 September 1989
10. Date of revision of the text
20 May 2022
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