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SPC, UK: Cerazette 75 microgram film-coated tablet (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Merck Sharp & Dohme Limited
Διεύθυνση :
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
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Δωρεάν εγγραφή

Name of the medicinal product

Cerazette 75 microgram film-coated tablet.

Qualitative and quantitative composition

Each tablet contains 75 microgram desogestrel. Excipient: lactose <65mg. For a full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. The tablet is white, round, biconvex and 5 mm in diameter. On one side it is coded KV above 2 and on the reverse side Organon*.

Therapeutic indications

Contraception.

Posology and method of administration

How to take Cerazette Tablets must be taken every day at about the same time so that the interval between two tablets always is 24 hours. The first tablet should be taken on the first day of menstrual ...

Contraindications

Active venous thromboembolic disorder. Presence or history of severe hepatic disease as long as liver function values have not returned to normal. Known or suspected sex-steroid sensitive malignancies. ...

Special warnings and precautions for use

If any of the conditions/risk factors mentioned below is present, the benefits of progestogen use should be weighed against the possible risks for each individual woman and discussed with the woman before ...

Interaction with other medicinal products and other forms of interaction

Interactions Interactions between hormonal contraceptives and other medicinal products may lead to breakthrough bleeding and/or contraceptive failure. The following interactions have been reported in the ...

Pregnancy and lactation

Cerazette is not indicated during pregnancy. If pregnancy occurs during treatment with Cerazette, further intake should be stopped. Animal studies have shown that very high doses of progestogenic substances ...

Effects on ability to drive and use machines

Cerazette has no or negligible influence on the ability to drive and use machines.

Undesirable effects

The most commonly reported undesirable effect in the clinical trials is bleeding irregularity. Some kind of bleeding irregularity has been reported in up to 50% of women using Cerazette. Since Cerazette ...

Overdose

There have been no reports of serious deleterious effects from overdose. Symptoms that may occur in this case are nausea, vomiting and, in young girls, slight vaginal bleeding. There are no antidotes and ...

Pharmacodynamic properties

Pharmacotherapeutic group: hormonal contraceptives for systemic use ATC code: G03AC09 Cerazette is a progestogen-only pill, which contains the progestogen desogestrel. Like other progestogen-only pills, ...

Pharmacokinetic properties

ABSORPTION After oral dosing of Cerazette desogestrel (DSG) is rapidly absorbed and converted into etonogestrel (ENG). Under steady-state conditions, peak serum levels are reached 1.8 hours after tablet-intake ...

Preclinical safety data

Toxicological studies did not reveal any effects other than those, which can be explained from the hormonal properties of desogestrel.

List of excipients

TABLET CORE: Silica, colloidal anhydrous All-rac-α-tocopherol Lactose monohydrate Maize starch Povidone Stearic acid FILM COATING: Hypromellose Macrogol 400 Talc Titanium dioxide (E 171)

Incompatibilities

Not applicable.

Shelf life

3 Years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

PVC/Aluminium blister. Each blister contains 28 tablets. Each carton contains 1, 3, 6 or 13 blisters packed separately in an aluminium laminated sachet. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Organon Laboratories Ltd Cambridge Science Park Milton Road Cambridge CB4 0FL UK

Marketing authorization number(s)

PL0065/0159

Date of first authorization / renewal of the authorization

09 November 1998 / 12 December 2007

Date of revision of the text

10 Oct 2012