Gestodene, ethinylestradiol.
The active tablet is yellow, round and biconvex film-coated tablet, plain on both sides. The inactive tablet is white, round and biconvex film-coated tablet, plain on both sides.
Each yellow active tablet contains Gestodene 60 mcg and Ethinylestradiol 15 mcg.
Each white placebo (inactive) tablet does not contain active ingredients.
The yellow tablet contains lactose monohydrate 57.61 mg and lecithin (soya) 0.042 mg.
The white tablet contains lactose monohydrate 70.897 mg.
Excipients/Inactive Ingredients: Active tablets: Tablet core: Lactose monohydrate, Microcrystalline cellulose, Polacrilin potassium, Magnesium stearate.
Coating: Polyvinyl alcohol, Titanium dioxide, Lecithin (soya), Talc, Iron Oxide Yellow, Xanthan gum.
Inactive tablets (Placebo): Lactose monohydrate, Povidone K25, Sodium starch glycolate, Colloidal anhydrous silica, Aluminium oxide, Magnesium stearate.
Pharmacology: Pharmacodynamics: Minidoz is used to prevent pregnancy. The contraceptive effect is based on the interaction of various factors. The most important of these factors are the inhibition of ovulation and changes in the endometrium. Oral contraceptives have been shown to be effective in reducing inflammatory and non-inflammatory lesions in women with acne who require contraception, probably by a multifactorial action on circulating androgens.
Pharmacokinetics: Gestodene is well absorbed with a high bioavailability when given orally. It is extensively bound to plasma proteins; 75 to 87% to sex hormone binding globulin, and 13 to 24% to albumin. Gestodene is metabolised in the liver, less than 1% of a dose being excreted in the urine unchanged. After multiple doses with ethinylestradiol, gestodene has an elimination half-life of about 20 hours.
Ethinylestradiol is rapidly and well absorbed from the gastrointestinal tract, systemic bioavailability is about 40%. Ethinylestradiol is highly protein bound, but unlike naturally occurring oestrogens, which are mainly bound to sex-hormone binding globulin, it is principally bound to albumin. It is metabolised in the liver, initially by aromatic hydroxylation catalysed by the cytochrome P450 isoenzyme CYP3A4, to form 2-hydroxyethinylestradiol and various conjugated metabolites. These are excreted in urine and faeces. Metabolites undergo enterohepatic recycling.
Toxicology: Pre-clinical Safety Data: Ethinylestradiol and gestodene are not genotoxic. Carcinogenicity studies with ethinylestradiol alone or in combination with various progestogens do not indicate any particular carcinogenic hazard to women when used as indicated for contraception. However it should be noted that sex hormones can advance the growth of certain hormone-dependent tissues and tumours.
Reproductive toxicity studies on fertility, development of the fetus or reproductive ability with ethinylestradiol alone or in combination with progestogens revealed no undesirable effects for humans when used as recommended.
Minidoz is used to prevent pregnancy. Oral contraceptives have been shown to be effective in reducing inflammatory and non-inflammatory lesions in women with acne who require contraception, probably by a multifactorial action on circulating androgens.
Minidoz is a low-dose combined oral contraceptive. Minidoz should be taken at regular intervals. Irregular intake may lead to breakthrough-bleeding and/or spotting and reduced contraceptive efficacy.
Minidoz should always be taken according to the doctor's instructions. The patient should check with the doctor or pharmacist if she is unsure.
Start of treatment (when no hormonal contraceptive has been used in the past month). Wait for the next period to occur. Take the first yellow tablet on the first day of bleeding. Start with a pill marked with number 1. It is important to follow the exact order administration of tablets, taking in first place the yellow tablets (active) and, once these are finished, the white tablets (inactive). The patient should try to take the pill in the same time everyday, for example, after breakfast.
During taking white tablets or inactive tablets, the patient will have a period. The periods will be regular, probably lighter than before and almost always painless. The feeling that often make the last days before a period unpleasant (called premenstrual syndrome) usually disappear.
Taking the next pack of Minidoz: In order to continue with the treatment, next day after ingesting the last white tablet, a new container must be used taking the first yellow tablet. With this scheme, 1 tablet must be administered every day (without stopping); during the time the contraception is wanted to be maintained.
When changing from another combined pill: The patient can start taking Minidoz the day after the last tablet from the present pill pack (this means no tablet-free break). If the present pill pack also contains inactive tablets, the patient can start Minidoz on the day after taking the last active tablets (if the patient is not sure which this is, ask the doctor or pharmacist). The patient can also start later, but never later than the day following the tablet-free break of the present pill (or the day after the last inactive tablet of the present pill). If the patient follows these instructions, it is not necessary to use an additional contraceptive method.
When changing from a progestogen-only pill (minipill): The patient can stop taking the minipill any day and start taking Minidoz the next day, at the same time. But make sure to also use an additional contraceptive method (a barrier method) for the first 7 days of tablet-taking when having intercourse.
Starting Minidoz after having a baby: If the patient just had a baby, the doctor may advise her to start taking Minidoz after 21 days delivery. The patient does not have to wait for a period. She will need to use another method of contraception until she starts Minidoz and for the first 7 days of pill taking. Follow the instructions as before. The patient must not breastfeed if she takes Minidoz.
What to do if the patient misses a period: In the case of absence of menstruation during 2 to 3 days after finishing the active tablets of the previous contraceptive, a physician must be consulted in order to avoid possibility of pregnancy, before starting treatment with Minidoz.
In the meantime, do not have sex unless using condoms or a cap plus spermicide.
What to do if the patient has bleeding between periods: A small number of women may have a little breakthrough bleeding or spotting while taking this medicine, especially during the first few months. Normally, this bleeding is nothing to worry about, and will stop in a day or two. Keep taking the pills as usual; the problem should disappear after the first few packs.
If the bleeding keeps on returning, is annoying or long-lasting, talk to the doctor. Also, if the patient starts to have breakthrough bleeding for the first time after being on this medicine for a long time, the patient should see the doctor.
Unexpected bleeding may also be a sign of irregular pill-taking, so try to take the pill at the same time every day.
What to do if the patient forgets to take a pill and are relying on Minidoz for contraceptive: 1. If more than 12 hours elapse from the time that the patient normally takes the tablet, the contraceptive protection in this cycle may be reduced. The patient must nevertheless continue to take the other tablets in the pack at the usual time, forgetting about the one she have missed. At the same time, however, a non-hormonal method of contraception (with the exception of the rhythm and temperature methods) must be employed additionally until bleeding occurs. The tablet or tablets which the patient missed should not be taken at all. After the pack has been used up, the usual 7 day tablet free interval follows during which a bleeding normally occurs. If bleeding fail to occur, the doctor must be consulted before tablet-taking is resumed.
2. If one pill is 12 hours late or less, don't worry. Contraceptive protection should not be affected if the patient takes the late pill at once, and keep taking the next pills at the usual time.
There have been no reports of serious adverse effects from overdose. Symptoms that may be caused by overdose are nausea, vomiting and, in young girls, slight vaginal bleeding. There are no antidotes and the treatment is symptomatic.
Pregnancy, breast feeding, the patient or any member of the patient's close family has or has ever had blood clots in the legs, lungs, eyes or anywhere.
The patient or any member of the patient's close family has had a heart attack or stroke, or have any medical condition which makes the patient more at risk of developing blood clots.
Abnormal red blood cells (sickle-cell anaemia), disorders of blood fat (lipid) metabolisms, cancer of the breast or of the lining of the womb (mammary or endometrial carcinoma) or have ever had either of these conditions, abnormal bleeding from vagina of unknown cause, certain types of jaundice (Dubin-Johnson or Rotor syndromes), severe diabetes with changes to the blood vessels, live tumours or have ever had these, any other long or short term liver disease, allergy to any of the ingredients of Minidoz.
Do not take this medicine if the patient has had any of these conditions when she was pregnant: itching of the whole body (pruritus of pregnancy), the rash known as herpes gestations, worsening of inherited deafness (otosclerosis), light browning of the skin (jaundice).
Do not use in the presence of thrombosis and hepatic disease.
Should not be used in women who have a higher risk of thrombosis, such as a history of thrombophlebitis, obesity, diabetes and hypertension.
Should not use in presence or history of liver tumors, known or suspected sex hormones related cancer such as breast cancer or genital organs cancer.
Use carefully in women who smoke cigarette, especially women older than 35 years of age should consult the physician before using this medication.
Use other than contraceptive, consult the physician.
Consult the physician if any abnormal symptoms occur while using this medication.
The following conditions need watching carefully while the patient is taking Minidoz: Severe depressive states (past or present), varicose vein, diabetes (diabetes mellitus) or a tendency towards diabetes, high blood pressure (hypertension), fits (epilepsy), the inherited from of deafness known as otosclerosis, the disease of the nervous system called multiple sclerosis, the inherited disease called porphyria, calcium deficiency with cramps (tetany), the movement disorder called Sydenham's chorea, breast problems (past of present), diseases of the heart and blood vessels (cardiovascular diseases), kidney diseases, disturbed liver function, the patient is overweight (obese), an intolerance to contact lenses, systemic lupus erythematosus-SLE (inflammation of connective tissue), asthma, uterine fibroids (benign tumour of the womb), gallstones, migraine, brown patched on the face and body (chloasma), any disease that is prone to worsen during pregnancy or if: Inflamed veins (phlebitis), anyone in the family has had breast cancer, any illness caused by blood clots, or a heart attack or stroke at a young age.
Reason for stopping Minidoz immediately: If the patient experiences any of the following conditions take no further tablets of Minidoz and consult the doctor immediately. In the meantime use another method of contraception such as a condom: Migraine for the first time, (or if existing migraine occurs more often than before), unusually bad headaches or if the patient had headaches more often than before, (sudden changes to the eyesight, hearing, speech, sense of smell, taste or touch), dizziness or fainting, unusual pains in the leg or unusual swelling of the arms or legs, sharp pains in the chest or sudden shortness of breath, crushing pains or feeling of heaviness in the chest, coughing for no apparent reason or if one side of the body suddenly becomes very weak or numb. These may be symptoms of blood clot formation or symptoms of an inflammation of veins combined with the formation of blood clots (thrombophlebitis), the skin becomes light brown (jaundice), the patient develops hepatitis (inflammation of the liver) or if the whole body starts itching, an increase in the number of fits (epileptic seizures), a large increase in the blood pressure, severe depression, severe upper abdominal pains or unusual swelling of the abdomen, definite worsening of conditions which had got worse during a previous pregnancy or whilst previously using the pill or other hormonal contraception, pregnancy, pending operation (six weeks beforehand), any surgery to the legs, varicose veins, immobilization (for instance, following accidents).
Effects on ability to drive and use machines: No effects on the ability to drive and to use machines have been observed.
Pregnancy must be rule out before taking Minidoz.
Pregnancy is an absolute contraindication for treatment with Minidoz and must be excluded before such treatment is begun.
The use of Minidoz is contraindicated during lactation. Very small amount of gestodene and ethinylestradiol are transferred to the breast milk.
Serious adverse event: Thrombosis (the formation of a clot in blood vessels) or liver disease.
Stop Minidoz, if serious adverse event occurs and contact the doctor, immediately.
If the patient notices any side effects not mentioned in this monograph, inform the doctor or pharmacist.
Non-serious adverse event: Bleeding and spotting between periods can sometimes occur for the first few months but this usually stops once the body has adjusted to Minidoz. If it continues becomes heavy or starts again, contact the doctor.
Headaches, feeling sick, being sick and stomach upsets, sore breasts, depressive moods, loss of interest in sex, changes in weight, chloasma (yellow brown patches on the skin). This may happen even if the patient has been using Minidoz for a number of months. Chloasma may be reduced by avoiding too much sunlight.
Poor tolerance to contact lenses.
If the patient notices any side effects not mentioned in this monograph, inform the doctor or pharmacist.
Enzyme-inducing drug can cause failure of Minidoz. This effect is well established for a number of antiepileptics (e.g. phenytoin, barbiturates, phenobarbital, primidone, carbamazepine, oxcarbazepine, felbamate, topiramate), griseofulvin, antibacterials (e.g. rifampicin, rifabutin, penicillins), antidepressants (St. John's wort), and also been suggested for some antivirals (e.g. neflinavir, ritonavir) and for modafinil.
Inform the doctor or pharmacist if the patient is taking, or has recently taken, any other medicines, even those not prescribed.
Incompatibilities: Not applicable.
Store below 30° C.
Shelf-life: 2 years.
G03AA10 - gestodene and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
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