BELARA FILM-COATED TABLET 0.03MG/2MG [SIN14870P]

Product Info

BELARA FILM-COATED TABLET 0.03MG/2MG

[SIN14870P]

5. INDICATION

Hormonal contraception.

6. RECOMMENDED DOSAGE

Dosage of the film-coated tablets

One film-coated tablet must be taken every day at the same time (preferably in the evening) on 21 consecutive days, followed by a seven-day break in which no film-coated tablets are taken; menstruation-like withdrawal bleeding should occur two to four days after the administration of the last film-coated tablet. After the seven-day medication-free interval, medication should be continued with the next pack of Belara, regardless of whether bleeding has ceased or not.

The film-coated tablets should be pressed out of the blister pack at the position marked with the corresponding weekday and swallowed whole, if necessary with a little liquid. The film-coated tablets are to be taken daily following the direction of the arrow.

7. MODE/ROUTE OF ADMINISTRATION

Starting the administration of the film-coated tablets

No previous administration of a hormonal contraceptive (during the last menstruation cycle)
The first film-coated tablet should be taken on day one of the women’s natural cycle, i.e. on the first day of the next menstruation. If the first film-coated tablet is taken on the first day of the menstruation, contraception starts on the first day of administration and also continues during the seven-day medication-free interval.

The first film-coated tablet can also be taken on the 2^nd–5^th day of menstruation, irrespective of whether bleeding has ceased or not. In this case additional mechanical contraceptive measures must be taken during the first seven days of administration.

If menstruation had started more than five days earlier, then the woman should be instructed to wait until her next menstruation before starting to take Belara.

Switching from another hormonal contraceptive to Belara

Switching from another combined hormonal contraceptive
The woman should start taking Belara on the day following the usual tablet-free or placebo tablet interval of her previous combined hormonal contraceptive.

Switching from a progestogen-only pill ("POP")
The first Belara film-coated tablet should be taken on the day after stopping the progestogen-only preparation. During the first seven days additional mechanical contraceptive measures must be used.

Switching from a contraceptive hormone injection or implant
Administration of Belara can be started on the day of the removal of the implant or on the day of the originally planned injection. During the first seven days additional mechanical contraceptive measures must be used.

After a miscarriage or an abortion in the first trimester
After a miscarriage or an abortion in the first trimester, administration of Belara can be started immediately. In this case no further contraceptive measures are necessary.

After childbirth or after a miscarriage or abortion in the second trimester
After childbirth, women who do not breast-feed can start administration 21–28 days after delivery, in which case no additional mechanical contraceptive measures are required.

If administration starts more than 28 days after childbirth, additional mechanical contraceptive measures are necessary during the first seven days.

If the woman has already had sexual intercourse, pregnancy must be ruled out or she must wait until her next menstruation before starting administration.

Lactation (see section 11 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.)
Belara should not be taken by breast-feeding women.

After discontinuation of Belara
After discontinuation of Belara the current cycle may be prolonged with about a week.

Irregular tablet administration
If the user has forgotten to take a film-coated tablet, but takes it within 12 hours, no further contraceptive measures are necessary. The user should continue taking the film-coated tablets as usual.

If the user is more than 12 hours late in taking the film-coated tablet, contraceptive protection may be reduced. The management of missed tablets can be guided by the following two basic rules:

1. tablet-taking must never be discontinued for longer than 7 days

2. 7 days of uninterrupted tablet-taking are required to attain adequate suppression of the hypothalamic-pituitary-ovarian-axis.

The last forgotten film-coated tablet should be taken immediately, even if this means taking two tablets at the same time. The other film-coated tablets should be taken as usual. In addition, other mechanical contraceptive measures, e.g. condoms, are also to be used for the next seven days. If tablets were missed in week 1 of the cycle and intercourse took place in the seven days prior to the missing of tablets (including the tablet-free interval), the possibility of a pregnancy should be considered. The more tablets are missed and the closer they are to the regular tablet-free interval, the higher the risk of a pregnancy.

If the current pack contains less than seven tablets, the next pack of Belara must be started as soon as the current pack is finished, i.e. there should be no interval between the packs. Normal withdrawal bleeding will probably not occur until the second pack has been used; however, breakthrough bleeding or spotting may often occur during tablet administration. If withdrawal bleeding does not occur after taking the second pack, then a pregnancy test should be carried out.

Instructions in case of vomiting or diarrhoea
If vomiting occurs within 4 hours after administration of the tablets or severe diarrhoea develops, absorption may be incomplete and reliable contraception is no longer ensured. In this case the instructions in section "Irregular tablet administration" (see above) should be followed. Belara administration should be continued.

How to postpone a withdrawal bleed
To delay a period the woman should continue with another blister pack of Belara without a tablet-free 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 Belara is then resumed after the usual 7-day tablet-free interval.
To shift her periods to another day of the week than the woman is used to with her current scheme, she can be advised to shorten her forthcoming tablet-free interval by as many days as she likes. The shorter the interval, the higher the risk that she does not have a withdrawal bleed and will experience breakthrough bleeding and spotting during the subsequent pack (just as when delaying a period).

8. CONTRAINDICATIONS

Combined oral contraceptives (COCs) must not be taken in the event of the diseases described below.
Belara should be discontinued immediately if one of these conditions occurs during administration:

• previous or existing arterial or venous thrombosis (e.g. deep-vein thrombosis, pulmonary embolism, myocardial infarction, stroke);

• prodromal or first signs of thrombosis, thrombophlebitis or embolic symptoms (e.g. transient ischaemic attack, angina pectoris);

• scheduled surgery (at least four weeks in advance) and for the period of immobilisation, e.g. after accidents (e.g. plaster cast after accidents);

• diabetes mellitus with vascular changes;

• loss of control of diabetes mellitus;

• uncontrolled hypertension or a significant increase in blood pressure (values constantly above 140/90 mm Hg);

• hereditary or acquired predisposition for venous or arterial thrombosis, such as APC-resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant);

• hepatitis, jaundice, liver function disorders until liver function values have returned to normal;

• generalised pruritus, cholestasis, in particular during a previous pregnancy or estrogen therapy;

• Dubin-Johnson syndrome, Rotor syndrome, bile-flow disorders;

• a history of, or existing liver tumours;

• severe epigastric pain, enlargement of the liver, or symptoms of intra-abdominal haemorrhage (see section 12 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.);

• first occurrence or recurrence of porphyria (all three forms, in particular acquired porphyria);

• presence, or a history, of malignant hormone-sensitive tumours, e.g. of the breast or uterus;

• severe disorders of lipid metabolism;

• pancreatitis or history of such a condition, if associated with severe hypertriglyceridemia;

• first-time symptoms of migrainous headache or more frequent occurrence of unusually severe headache;

• history of migraine with focal neurological symptoms ("migraine accompagnée");

• acute sensory disorders, e.g. visual or hearing disorders;

• motor disorders (particularly paresis);

• increase in epileptic seizures;

• severe depression;

• otosclerosis deteriorating during previous pregnancies;

• unexplained amenorrhoea;

• endometrial hyperplasia;

• unexplained genital bleeding;

• hypersensitivity to the active substances or to any of the excipients in section 3 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

One severe risk factor or multiple risk factors for venous or arterial thrombosis may constitute a contraindication (see section 9 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.).