Container with 28 film-coated tablets (24 active tablets + 4 tablets with placebo)
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 combined oral contraceptive. Each light brown tablet contains a small amount of two different female hormones. These are gestodene (a progesterone) and ethinylestradiol (an estrogen). Each green film coated tablet contains placebo. Minidoz is a low-dose oral contraceptive.

Dosage and administration
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 a doctor's instructions. You should check with your doctor or pharmacist if you are unsure.

• Start of treatment. (when no hormonal contraceptive has been used in the past month)

Wait for your next period to occur. Take your first light brown 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 light brown tablets (active) and, once these are finished, the green tablets (inactive). You should try to take the pill in the same time every day, for example, after breakfast.
During you have taken green tablets or inactive tablets, you will have a period. Your periods will be regular, probably lighter than before and almost always painless. The feelings that often make the last days before a period unpleasant (called premenstrual syndrome) usually disappear.

• Taking your next pack of Minidoz

In order to continue with the treatment, next day after ingesting the last green tablet, a new container must be used taking the first light brown 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.
You can start taking Minidoz the day after you take the last tablet from your present Pill pack (this means no tablet-free break). If your present Pill pack also contains inactive tablets you can start Minidoz on the day after taking the last active tablets (if you are not sure which this is, ask your doctor or pharmacist). You can also start later, but never later than the day following the tablet-free break of your present Pill (or the day after the last inactive tablet of your present Pill). If you follow these instructions, it is not necessary to use an additional contraceptive method.

When changing from a progestogen-only pill (minipill).

You can stop taking the minipill any day and start taking Minidoz the next day, at the same time. But make sure you 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 you have just a baby, your doctor may advise you to start taking Minidoz after 21 days delivery. You do not have to wait for a period. You will need to use another method of contraception until you start Minidoz and for the first 7 days of pill taking. Follow the instructions as before .You must not breastfeed if you take Minidoz.

What to do if you miss a period?

In the case of absence of menstruation during 2 to 3 days after finishing the active tablets of the previous contraceptive, physician must be consulted in order to avoid possibility of pregnancy, before starting treatment with Minidoz.
In the meantime, do not have sex unless you use condoms or a cap plus spermicide.

What to do if you have 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 your doctor. Also, if you start to have breakthrough bleeding for the first time after being on this medicine for a long time, you should see your doctor.
Unexpected bleeding may also be a sign of irregular pill-taking, so try to take your pill at the same time everyday.

What to do if you forget to take a pill and are relying on Minidoz for contraceptive

1. If more than 12 hrs elapse from the time that you normally take the tablet,the contraceptive protection in this cycle may be reduced. You must nevertheless continue to take the other tablets in the pack at the usual time, forgetting about the one you 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 you 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 you take the late pill at once, and keep taking your next pills at the usual time.

Contraindication

Pregnancy, breast feeding, you or any member of your close family has or has ever had blood clots in the legs, lungs, eyes or anywhere
You or any member of your close family has had a heart attack or stroke, or have any medical condition which makes you more at risk of developing blood clots
Abnormal red blood cells (sickle-cell anaemia), disorders of blood fat (lipid) metabolisms, cancer of the beast 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 you have had any of these conditions when you were pregnant: itching of your whole body (pruritus of pregnancy), the rash known as herpes gestations, worsening of inherited deafness (otosclerosis), and light browning of the skin (jaundice).

The following conditions need watching carefully while you are 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, you are overweight (obese), an intolerance to contact lenses, systemic lupus erytematosus-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 your family has had breast cancer, any illness caused by blood clots, or a heart attack or stroke at a young age.

Taking Minidoz with other medicines
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.
Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, even those not prescribed.

Reason for stopping Minidoz immediately

If you experience any of the following conditions take no further tablets of Minidoz and consult your 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 you have headaches more often than before, (sudden changes to your eyesight, hearing, speech, sense of smell, taste or touch), dizziness or fainting , unusual pains in your leg or unusual swelling of your arms or legs, sharp pains in your chest or sudden shortness of breath, crushing pains or feeling of heaviness in your chest, coughing for no apparent reason or if one side of your 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), your skin become light brown (jaundice), you develop hepatitis (inflammation of the liver) or if your whole body starts itching, an increase in the number of fits(epileptic seizures) ,a large increase in your blood pressure , severe depression, severe upper abdominal pains or unusual swelling of your 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).

Side effects

- Thrombosis (the formation of a clot in blood vessels) or liver disease
- Bleeding and spotting between your periods can sometimes occur for the first few months but this usually stops once your body has adjusted to Minidoz. If it continues and becomes heavy or starts again, contact your doctor.
Headaches, feeling sick, being sick and stomach upsets, sore breasts, depressive moods, loss of interest in sex, changes in weight.

• Chloasma (light brown brown patches on the skin). This may happen even if you have been using Minidoz for a number of months. Chloasma may be reduced by avoiding too much sunlight.
• Poor tolerance to contact lenses.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Storage condition: Store below 300C and keep them out of reach of children.
Manufacturer by Laboratorios Recalcine S.A. Santiago, Chile
Imported by Sinensix Pharma(Thailand) Ltd. Bangkok, Thailand