MARVELON Tablet (2021)
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Περιεχόμενα
1. Name of the medicinal product
Marvelon.
2. Qualitative and quantitative composition
Desogestrel B.P. 150 micrograms. Ethinylestradiol Ph.Eur 30 micrograms. <u>Excipient with known effect:</u> lactose. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablets. Tablets are round, biconvex and 6 mm in diameter. They are coded on one side TR5 and on the reverse side Organon*.
4.1. Therapeutic indications
Oral contraception. The decision to prescribe Marvelon should take into consideration the individual womans current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of ...
4.2. Posology and method of administration
How to take Marvelon Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. One tablet is to be taken daily for 21 consecutive days. Each ...
4.3. Contraindications
Combined hormonal contraceptives (CHCs) 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 CHC use, the product should ...
4.4. Special warnings and precautions for use
4.4.1 Warnings If any of the conditions or risk factors mentioned below is present, the suitability of Marvelon should be discussed with the woman. In the event of aggravation, or first appearance of any ...
4.5. Interaction with other medicinal products and other forms of interaction
4.5.1 Interactions Interactions between oral contraceptives and other medicinal products may lead to breakthrough bleeding and/or contraceptive failure. The following interactions have been reported in ...
4.6. Pregnancy and lactation
Marvelon is not indicated for use during pregnancy. If pregnancy occurs during treatment with Marvelon, further intake should be stopped. However, most epidemiological studies have revealed neither an ...
4.7. Effects on ability to drive and use machines
No effects on ability to drive and use machines have been observed.
4.8. Undesirable effects
Description of selected adverse reactions As with all COCs, changes in vaginal bleeding patterns may occur, especially during the first months of use. These may include changes in bleeding frequency (absent, ...
4.9. Overdose
There have been no reports of serious deleterious effects from overdose. Symptoms that may occur in this case are: nausea, vomiting and slight vaginal bleeding. There are no antidotes and further treatment ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> progestogens and estrogens, fixed combinations <b>ATC code:</b> G03AA09 Marvelon is an oral contraceptive combination containing 150 micrograms desogestrel and 30 micrograms ...
5.2. Pharmacokinetic properties
Desogestrel Absorption Orally administered desogestrel is rapidly and completely absorbed and converted to etonogestrel. Peak serum concentrations are reached at about 1.5 hours. Bioavailability is 62-81%. ...
5.3. Preclinical safety data
Preclinical studies on ethinylestradiol and desogestrel revealed no special hazard for humans based on conventional studies of repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity ...
6.1. List of excipients
dl-alpha-tocopherol Potato starch Povidone Stearic acid Aerosil Lactose
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C. Store blisters in the original pouches.
6.5. Nature and contents of container
Push-through packs of 21 white tablets each. The pack is PVC/Al blister consisting of aluminium foil with a heat-seal coating and a PVC film. Each blister is packed in a printed aluminium pouch. The pouch ...
6.6. Special precautions for disposal and other handling
See Section 4.2.
7. Marketing authorization holder
Organon Pharma (UK) Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK
8. Marketing authorization number(s)
PL 00025/0596
9. Date of first authorization / renewal of the authorization
04 November 1981 / 16 March 2009
10. Date of revision of the text
26 February 2021
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