Belara

Belara is a combined birth control pill that contains the progestin chlormadinone acetate (CMA) and the estrogen ethinylestradiol. It is manufactured by Gedeon Richter.

What makes Belara special is its progestin, chlormadinone acetate. It has pronounced antiandrogenic properties – stronger than those of many other progestins.

When used correctly, Belara provides contraception with a Pearl Index of about 0.1 to 0.9.

Belara works through several mechanisms at the same time:

Suppression of ovulation: The combination of chlormadinone acetate and ethinylestradiol signals to the body that sufficient hormones are already present. The release of FSH and LH from the pituitary gland is suppressed, and ovulation does not take place.

Change in cervical mucus: The mucus in the cervix becomes thicker and harder for sperm to penetrate.

Effect on the uterine lining: The lining builds up less, which makes implantation more difficult.

Antiandrogenic effect: Chlormadinone acetate blocks the action of male hormones (androgens) at the receptors in the skin and hair follicles. This can improve acne, oily skin and excessive hair growth.

Belara is particularly suitable for women who:

• Want reliable hormonal contraception
• Are prone to skin blemishes or acne
• Suffer from oily skin or oily hair
• Have increased body hair
• Are looking for a well-tolerated pill

Particularly suitable for:

• Hormone-related acne
• The wish for a regular cycle

Before prescribing, the following should be clarified:

• Whether there are risk factors for thrombosis
• Which other medications are being taken
• Whether pregnancy has been ruled out

Active ingredient content:

• Chlormadinone acetate: 2 mg per tablet
• Ethinylestradiol: 0.030mg (30 micrograms) per tablet

Pack sizes:

• 1 x 21 film-coated tablets
• 3 x 21 film-coated tablets
• 6 x 21 film-coated tablets

Dosing schedule: One tablet daily for 21 days, followed by a 7-day break. The withdrawal bleed occurs during the break. The new pack is started on the 8th day.

Starting the pill: Start with the first tablet on the first day of your period. You are then protected immediately. If you start on days 2-5, also use a condom for contraception for 7 days.

Daily intake:

• Take one tablet every day at about the same time
• Swallow whole with water, without chewing
• The tablet can be taken regardless of meals

7-day break: After the last tablet of a pack, there is a 7-day break from taking the pill. The withdrawal bleed usually starts 2-3 days after the last tablet.

Missed tablet:

• Missed by less than 12 hours: Take it immediately, protection is maintained
• Missed by more than 12 hours: Take it and use a condom for an additional 7 days

Important: Never extend the 7-day break! A missed tablet at the beginning or end of the intake period is particularly critical.

Belara must not be used in cases of:

• Thrombosis or risk of thrombosis – current or previous venous/arterial thromboembolism
• Severe cardiovascular disease – heart attack, stroke, coronary heart disease
• Certain forms of migraine – migraine with aura
• Liver disease – acute or severe chronic liver disease
• Hormone-dependent tumors – known or suspected breast cancer
• Unexplained bleeding from the vagina
• Pregnancy

Caution is advised in cases of:

• Smoking (especially from age 35)
• Obesity (BMI over 30)
• High blood pressure
• Diabetes mellitus
• Elevated blood lipid levels
• Family tendency to thrombosis
• Prolonged immobility (e.g. after surgery)

Risk of thrombosis: Pills containing levonorgestrel, norgestimate or norethisterone have the lowest risk of venous thromboembolism. With pills containing chlormadinone acetate, such as Belara, the risk can be up to 1.25 times as high as with levonorgestrel. An estimated 6 to 9 in 10,000 women who use such a pill develop venous thromboembolism within one year, compared with about 6 in 10,000 with levonorgestrel-containing pills.

Common (1-10% of users):

• Headache
• Nausea
• Breast tenderness
• Mood swings
• Breakthrough bleeding (especially at the beginning)

Uncommon (0.1-1%):

• Migraine
• Decreased libido
• Weight gain
• Acne (at the start of use)
• Vaginal yeast infections

Rare, but to be taken seriously:

• Venous thromboembolism
• Arterial thromboembolic events
• Increased blood pressure

Warning signs – seek medical help immediately:

• Sudden swelling or pain in one leg
• Sudden shortness of breath, chest pain
• Severe headache, visual disturbances, signs of paralysis
• Severe upper abdominal pain

Reduced effectiveness possible with:

• Certain antiepileptics (e.g. phenytoin, carbamazepine, topiramate)
• Antibiotics for tuberculosis (rifampicin, rifabutin)
• HIV medications (certain protease inhibitors)
• St. John's wort (Hypericum perforatum)

No clinically relevant effect:

• Most common antibiotics (amoxicillin, azithromycin)
• Usual pain relievers
• Antihistamines

In case of interactions: While taking interacting medications and for 28 days afterwards, additionally use condoms for contraception or choose an alternative method of contraception.

Belara may affect the action of:

• Ciclosporin (immunosuppressant)
• Lamotrigine (antiepileptic)
• Certain blood pressure medications