Marvelon/Marvelon 28

Marvelon/Marvelon 28

desogestrel + ethinylestradiol

Manufacturer:

Organon

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Desogestrel 0.15 mg, ethinylestradiol 0.03 mg, 7 placebo tab (Marvelon 28 only)
Indications/Uses
OC. Prevents pregnancy. Reduce incidence of endometrium & ovarian cancer; development of functional ovarian cysts & improves PCOS; develop Fe-deficiency anemia due to menstrual blood loss. Decrease severity of dysmenorrhea & premenstrual syndrome (PMS)/premenstrual dysphoric disorder (PMDD). Improves acne vulgaris, hirsutism & other androgen-mediated disorders.
Dosage/Direction for Use
1 tab daily starting on 1st day of menstruation, follow direction of arrows until all 21 tab + 7 tab-free days (Marvelon) or 21 active tab + 7 placebo tab (Marvelon 28) have been taken. May be started on days 2-5 of cycle but w/ additional contraceptive method (barrier method) for the 1st 7 days of administration in the 1st cycle. Changing from another combined hormonal contraceptive (combined OC pill, vag ring or transdermal patch) Start on the day after the last active tab of combined OC, or on the day of removal of vag ring or patch. Changing from progestogen-only method (minipill, injectable, implant) or progestogen-releasing IUD May start the next day at the same time, or when the next inj is due, or on the day the implant or IUD is removed, but use barrier method for the 1st 7 days of tab-taking if having intercourse.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Presence or history of thrombosis of leg or other organs & lung embolus; heart attack or stroke; condition that may be 1st sign of heart attack (eg, angina pectoris or chest pain) or stroke (eg, transient ischaemic attack or small reversible stroke); migraine w/ aura; pancreatitis associated w/ high levels of fatty substances in blood; breast or genital cancer influenced by sex hormones. Blood clotting disturbance (eg, protein C deficiency); major surgery w/ prolonged immobilisation; DM w/ blood vessel damage; serious or several risk factors for thrombosis; jaundice; unexplained vag bleeding; hepatitis C. Combination drug regimen w/ ombitasvir/paritaprevir/ritonavir w/ or w/o dasabuvir. Presence or history of severe liver disease or liver tumour. Pregnancy.
Special Precautions
Discontinue taking pill if possible signs of thrombosis (eg, unusual cough, severe chest pain which may reach left arm, breathlessness, any unusual, severe, or prolonged headache or migraine attack, partial or complete vision loss or double vision, slurring or speech disability, sudden hearing changes, sense of smell or taste, dizziness or fainting, weakness or numbness in any part of the body, severe pain in abdomen, severe pain or swelling in either of the legs) occur. Not for protection against HIV infection (AIDS) or any other STD. Not to be used in patients w/ history of blood clot in blood vessel & liver disease; women w/ history of angiitis, obesity, diabetes & HTN. Not recommended in patients w/ or w/ history of liver tumours & patients w/ or suspected to have sex hormone related cancer eg, breast or reproductive organ. Smoking (especially women >35 yr); diabetes; overwt; high BP; heart valve or certain heart rhythm disorder; vein inflammation (superficial phlebitis); varicose veins; migraine; epilepsy; liver or gallbladder disease; Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease); SLE; haemolytic uraemic syndrome; sickle cell disease; operation w/ prolonged immobilisation; hereditary & acquired angioedema. Occurrence or worsening of hearing loss, porphyria, herpes gestationis, Sydenham's chorea. History or presence of chloasma (avoid excessive sun or UV light exposure); high blood cholesterol or triglycerides. Family history of thrombosis, heart attack or stroke; high blood cholesterol or triglycerides; breast cancer. Benign & malignant liver tumours; diarrhea; unusual heavy vag bleeding. Increased risk of blood clots in patients who recently gave birth. High risk of thrombosis especially during 1st yr of starting therapy & restarting after ≥4 wk. Increased occurrence of breast & cervical cancer in long term use. Glucose intolerance. May affect blood or urinary test results. Not to have sexual intercourse or take extra non-hormonal contraceptive precautions eg, use condom or another barrier method. Not to use rhythm or temp methods. Women of childbearing potential. Not to be used during pregnancy. Not recommended during breast-feeding. Childn.
Adverse Reactions
Depressed mood, mood changes; headache; nausea, abdominal pain; breast pain & tenderness; increased body wt. Erythema nodosum & multiforme.
Drug Interactions
Concomitant use w/ medicines for epilepsy eg, primidone, phenytoin, phenobarb, carbamazepine, oxcarbazepine, topiramate, felbamate; TB eg, rifampicin; HIV infection eg, ritonavir, nelfinavir, nevirapine, efavirenz; HCV infection eg, boceprevir, telaprevir; other infectious diseases eg, griseofulvin; bosentan; St. John's wort. Increased effect w/ ciclosporin. Decreased effect w/ lamotrigine. Increased ALT w/ combination drug regimen ombitasvir/paritaprevir/ritonavir w/ or w/o dasabuvir; glecaprevir/pibrentasvir.
MIMS Class
Oral Contraceptives
ATC Classification
G03AA09 - desogestrel and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
Presentation/Packing
Form
Marvelon 28 tab
Packing/Price
28's
Form
Marvelon tab
Packing/Price
21's
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