Land: Malaysia
Språk: engelska
Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Chlormadinone acetate; Ethinylestradiol
PAHANG PHARMACY SDN. BHD.
Chlormadinone acetate; Ethinylestradiol
21tablet Tablets; 63tablet Tablets
Gedeon Richter Plc
BELARA ® 0.03 mg/2 mg film coated tablets (ethinylestradiol/chlormadionacetate; 0.03 mg/2 mg 1 _CONSUMER MEDICATION INFORMATION LEAFLET _ _(RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Belara is used for 2. How Belara works 3. Before you use Belara 4. How to use Belara 5. While you are using it 6. Side effects 7. Storage and Disposal of Belara 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT BELARA IS USED FOR Oral contraception. HOW BELARA WORKS Belara works by inhibition of ovulation and changes in the cervical secretion to prevent pregnancy. BEFORE YOU USE BELARA - _When you must not use it _ _ _ - if you are allergic to ethinylestradiol or chlormadinone acetate, or any of the other ingredients of this medicine; - if you suffer from blood clots in the veins or arteries or these have occurred in the past; - if you notice the first stages or signs of a blood clot, inflammation of the veins or embolism, such as transient brain circulatory disturbance, fleeting stabbing pain, chest pain or feeling of tightness in the chest; - if you are forced to rest for a long period of time (e.g. on strict bed-rest or due to a plaster cast) or if you plan to have an operation; - if you have diabetes and your blood sugar fluctuates uncontrollably; - if you have high blood pressure which is difficult to control or if your blood pressure rises considerably; - if you have (or have ever had) a condition that causes severe chest pain and may be a first sign of a heart attack or temporary disturbance of the blood flow of the brain, ; - if you have any of the following diseases that may increase your risk of a clot in the arteries: - severe diabetes with blood vessel damage - very high blood pressure - a very high level of fat in the blood - a condition known as hyperhomocysteinaemia - if you have a disturbance of blood clotting; - if you suffer from inflammation of the liver or from jaundice and your liver values have not yet returned to normal; - if you have itching all over your body or yo Läs hela dokumentet
Brand or Product Name Belara 0.03 mg/2 mg film -coated tablets Name and Strength of Active Substance(s) One film -coated tablet contains 0.030 mg ethinylestradiol and 2 mg chlormadinone acetate (corresponding to 1.71 mg chlormadinone). Excipient with known effect: lactose monohydrate 69.5 mg Product Description Film -coated tablet. Round, pale pink, biconvex film -coated tablet . Inactive ingredients: Tablet core: lactose monohydrate, maize starch, povidone K 30, magnesium stearate Film -coating: hypromellose, lactose monohydrate, macrogol 6000, propylene glycol, talc, titanium dioxide (E 171), red iron oxide ( E 172) . Pharmacodynamics/ Pharmacokinetics Pharmacodynamics Pharmacotherapeutic group: Sex hormones and modulators of the genital system; Progestogens and estrogens, fixed combinations, ATC code: G03AA15. Mechanism of action The continuous intake of Belara for 21 days inhibits pituitary FSH and LH secretion, and thus ovulation. The endometrium proliferates and undergoes secretory transformation. The consistency of the cervical mucus is changed. This prevents sperm migration through the cervical canal and alters sperm motility. The lowest daily dose of chlormadinone acetate for complete inhibition of ovulation is 1.7 mg. The full endometrial transformation dose is 25 mg per cycle. Chlormadinone acetate is an antiandrogenic progestogen. Its effect is b ased on its ability to displace androgens from their receptors. Clinical efficacy In clinical studies in which the administration of Belara was tested for up to 2 years in 1655 women and more than 22 000 menstruation cycles, there were 12 pregnancies. I n 7 women administration errors, concomitant diseases causing nausea or vomiting, or concomitant administration of medicines known to reduce the contraceptive effect of hormonal contraceptives were present in the period of conception. Type of use Number o f pregnancies Pearl index 95% confidence interval Typical use 12 0.698 [0.389; 1.183] Perfect use 5 0.291 [0.115; 0.650] Pharmacokinetics Chlormadinone aceta Läs hela dokumentet