MINESSE Film-coated tablet Ref.[50575] Active ingredients: 17 alpha-Ethinylestradiol Gestodene

Posology

How to take MINESSE

In MINESSE 28-day packs, tablets 1-24 contain active ingredients (active tablets) and tablets 25-28 do not contain any active ingredients (inactive tablets).

MINESSE must be taken in the order as directed on the package and at the same time every day, preferably after the evening meal or at bedtime. One active tablet is to be taken daily for 24 consecutive days, then either followed by 4 days of inactive (placebo) tablets or a 4-day tabletfree interval.

Each subsequent pack is started on the day after the last inactive tablet. A withdrawal bleed usually starts on days 2-3, after the last active tablet and may not have finished before the next pack is started. The tablets are taken daily, and pack follows pack without interruption and without regard to bleeding.

How to start MINESSE

No preceding hormonal contraceptive use (in the past month)

On the first day of the woman’s natural menstrual cycle, i.e. the first day of menstrual bleeding, the patient will take the first tablet marked with the appropriate day of the week from those in the red area of the package. Starting on days 2-7 (e.g. Sunday start) is allowed, but for the first 7 days of tablet-taking during the first cycle a nonhormonal back-up method of contraception (such as condoms and spermicide) is recommended. Thereafter, one tablet is taken daily, following the arrows on the package, until all 28 tablets have been taken.

Changing from another combination oral contraceptive to MINESSE

The woman should start MINESSE preferably on the day after the last active tablet of her previous combination oral contraceptive, but at the latest, on the day following the usual inactive tablet interval of her previous combination oral contraceptive.

Changing from a progestin only method (progestin-only tablet, injection, implant)

The woman may switch any day from the progestin-only tablet and should begin MINESSE the next day. She should start MINESSE on the day of an implant removal or, if using an injection, the day the next injection would be due. In all of these situations, the woman should be advised to use a nonhormonal back-up method for the first 7 days of tablet-taking.

Following first-trimester abortion

The woman may start MINESSE immediately. Additional contraceptive measures are not needed.

Following delivery or second-trimester abortion

Since the immediate post-partum period is associated with an increased risk of thromboembolism, MINESSE should be started no earlier than day 28 after delivery in the nonlactating mother or after second-trimester abortion. The woman should be advised to use a nonhormonal back-up method for the first 7 days of tablet taking. However, if intercourse has already occurred, pregnancy should be excluded before the actual start of MINESSE use or the woman must wait for her first menstrual period (see section 4.4).

Management of missed tablets

Contraceptive protection may be reduced if active (yellow) tablets are missed and particularly if the missed tablets extend the inactive (white) tablet interval.

• If one active tablet is missed, but is less than 12 hours late, it should be taken as soon as it is remembered. Subsequent tablets should be taken at the usual time.
• If one active tablet is missed and is more than 12 hours late or if more than one active tablet is missed, contraceptive protection may be reduced. The last missed tablet should be taken as soon as it is remembered, even if this means taking two tablets in one day. Subsequent tablets should be taken at the usual time. In addition, a nonhormonal back-up method of contraception should be used for the next seven days.
• If the seven days where back-up is required run beyond the last active tablet in the current pack, the next pack must be started on the day following the intake of the last active tablet in the current pack; all inactive tablets should be discarded. This prevents an extended break in tablet-taking of active tablets that may increase the risk of escape ovulation. The user is unlikely to have a withdrawal bleed until the inactive-tablet interval of the second pack, but she may experience spotting or breakthrough bleeding on days when active tablets are taken.
• If the user does not have a withdrawal bleed at the end of the second pack, the possibility of pregnancy must be ruled out before resuming tablet-taking.

Advice in case of vomiting or diarrhoea

If vomiting or diarrhoea occurs within 4 hours after tablet-taking, absorption may not be complete (see section 4.4). In such an event, the advice concerning Management of missed tablets is applicable. The woman must take the extra active tablet(s) needed from a back-up pack.

How to delay a period

To delay a period the woman should continue with another pack of MINESSE without the inactivetablet interval. The extension can be carried on for as long as wished until the end of the second pack. During the extension the woman may experience breakthrough bleeding or spotting. Regular intake of MINESSE is then resumed after the usual 4-day inactive-tablet interval.

Special populations

Use in the elderly

MINESSE is not indicated for use in postmenopausal women.

Paediatric population

Safety and efficacy of MINESSE has been established in women of reproductive age. Use of MINESSE before menarche is not indicated.

Method of administration

For oral use.

Symptoms of MINESSE overdosage in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue, withdrawal bleeding, may occur in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.

36 months.

36 months.

Protect from moisture and light.

A carton containing a calendar pack consisting of a PVC and aluminium blister strip with 24 pale yellow hormonal tablets and 4 white non-hormonal tablets.

No special requirements.