MICROGYNON Sugar-coated tablets (2020)

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Περιεχόμενα

1. Name of the medicinal product

Microgynon 30.

2. Qualitative and quantitative composition

Each tablet contains: Actives: Levonorgestrel: 150 mcg Ethinylestradiol: 30 mcg Excipients: Lactose: 32.820 mg Sucrose: 19.371 mg For full list of excipients, see section 6.1.

3. Pharmaceutical form

Sugar-coated tablets. Each tablet is beige.

4.1. Therapeutic indications

Oral contraception and the recognised gynaecological indications for such oestrogen-progestogen combinations. The decision to prescribe Microgynon 30 should take into consideration the individual woman ...

4.2. Posology and method of administration

Tablets must be taken orally in the order directed on the blister package at about the same time every day, with some liquid if necessary. First treatment cycle: 1 tablet daily for 21 days, starting ...

4.3. Contraindications

Combined hormonal contraceptives (CHCs) should not be used in the following conditions. Should any of the conditions appear for the first time during CHC use, the product should be stopped immediately. ...

4.4. Special warnings and precautions for use

Warnings If any of the conditions or risk factors mentioned below is present, the suitability of Microgynon 30 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

Note: The prescribing information of concomitant medications should be consulted to identify potential interactions. Interactions Enzyme inducers Interactions can occur with drugs that induce microsomal ...

4.6. Pregnancy and lactation

Microgynon 30 is not indicated during pregnancy. If pregnancy occurs during treatment with Microgynon 30, further intake must be stopped. However, extensive epidemiological studies have revealed neither ...

4.7. Effects on ability to drive and use machines

Ethinylestradiol/levonorgestrel has no effects or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Summary of the safety profile The most commonly reported adverse reactions with Microgynon 30 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 effects from overdose. Overdosage may cause nausea, vomiting and, in females, withdrawal bleeding. Withdrawal bleeding may even occur in girls before their menarche, ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Sex hormones and modulators of the genital system, Progestogens and oestrogens, fixed combinations ATC Code: G03AA07 Microgynon 30 is an oestrogen-progestogen combination ...

5.2. Pharmacokinetic properties

Levonorgestrel Levonorgestrel is absorbed quickly and completely. Maximum active substance levels of approx 3 ng/ml were reached in serum just one hour after ingestion of Microgynon 30. The serum concentrations ...

5.3. Preclinical safety data

None stated.

6.1. List of excipients

Each tablet contains: Core: Lactose monohydrate Maize starch Povidone 25 Talc Magnesium stearate (E 572) Coating: Sucrose Povidone 90 Macrogol 6000 (polyethylene glycol 6000) Calcium carbonate ...

6.2. Incompatibilities

None known.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Not applicable.

6.5. Nature and contents of container

Deep drawn strips made of polyvinyl chloride film with counter-sealing foil made of aluminium with heat sealable coating. Presentation: Each carton contains either 1, 3 or 50 blister memo-packs. ...

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Bayer plc, 400 South Oak Way, Reading, RG2 6AD

8. Marketing authorization number(s)

PL 00010/0545

9. Date of first authorization / renewal of the authorization

Date of First Authorisation: 28 November 1973 Date of Renewal: 5 December 2008

10. Date of revision of the text

1 June 2020

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