Ethinylestradiol + Gestodene

Brand(s)

Manufacturer

• Pfizer Inc

Disease(s)

Minesse® tablet

What is this medicine?

Minesse® (ETHINYL ESTRADIOL and GESTODENE) is a low dose oral hormonal contraceptive. It Inhibits ovulation. Medicine is used to prevent pregnancy.

What should I tell my health care provider before I take this medicine?

Tell your doctor if any of the following conditions apply to you:
If the condition develops, or gets worse while you are using Minesse®, you should also tell your doctor;

• If a blood test has shown that you have a high level of sugar, a high level of cholesterol and fats or a high level of prolactin (hormone that stimulates milk production);
• If you are obese;
• If you have a benign breast tumour or if a close relative has ever had breast cancer;
• If you have a disease of the uterus (uterine dystrophy);
• If you suffer from epilepsy (see also ‘Taking or using other medicines’);
• If you suffer from migraine;
• If you have loss of hearing due to a disorder known as otosclerosis;
• If you suffer from asthma;
• If you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• If you have systemic lupus erythematosus (SLE – a disease affecting your natural defence system);
• If you have haemolytic uraemic syndrome (HUS - a disorder of blood clotting causing failure of the kidneys);
• If you have sickle cell anaemia (an inherited disease of the red blood cells);
• If you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family history for this condition. Hypertrig
• lyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• If you need an operation, or you are off your feet for a long time (see in section 2 ‘Blood clots’);
• If you have just given birth you are at an increased risk of blood clots. You should ask your doctor how soon after delivery you can start taking Minesse®;
• If you have an inflammation in the veins under the skin (superficial thrombophlebitis);
• If you have varicose veins;
• If you or a close relative (parents, grandparents, brothers, sisters...) has ever suffered from a disease with a tendency to develop blood clots (in the leg, lung or elsewhere, heart attack, stroke);
• If, during a pregnancy or when using another contraceptive pill, you had a skin condition which caused itching and red patches and blisters (herpes gestationis);
• If you have had patches of discolouration on your face (chloasma) during pregnancy or when using another contraceptive pill. In this case, avoid direct exposure to the sun while you are using Minesse®;
• If you have gallstones;
• If you suffer from heart, liver or kidney disease;
• If you suffer from depression;
• If you have high blood pressure;
• If you suffer from a disease known as chorea characterized by irregular, sudden, involuntary movements;

How should I use this medicine?

• Begin taking Minesse® with the tablet number 1 which is located next to the word “START”;
• Perforate the empty cell in the centre of the blister pack corresponding to the day of the week on which you have taken the first tablet. This will be the start day for every new blister pack. This will also be the day of the week you will take tablets number 8, 15 and 22 with a coloured border. This will help you to check that you are taking the tablets correctly;
• Each blister pack contains 28 tablets. Take one pill at the same time every day, on 28 consecutive days following the direction indicated by the arrows without fail as follows: take one pale yellow active tablet on each of the first 24 days and then one white placebo tablet on each day of the last 4 days;
• After taking the last tablet, continue taking Minesse® the following day starting another blister pack with no free interval between the blisters. You will always start a new blister pack on the same day of the week. As there are no breaks in taking the medication it is important that you already have the next blister pack ready before finishing one;
• Bleeding usually starts two to three days after you have taken the last pale yellow tablet of the blister pack and may not have finished before the next blister pack is started.

What if I miss a dose?

If you forget to take a tablet there is a risk you could become pregnant

If you realise you have missed a pale yellow tablet within 12 hours of the time you normally take your tablet, take the missed tablet immediately and continue as normal, taking the next tablet at the usual time until the end of the blister pack.
If you realise you have missed a pale yellow tablet more than 12 hours after you normally take it, there is a risk you could become pregnant. In this case:

• take the last missed tablet immediately, even if this means taking 2 tablets on the same day
• continue taking the contraceptive until the end of the blister pack
• in addition, use a barrier method of contraception (condoms, spermicides...) for the next 7 days
• if this 7-day period extends beyond the last pale yellow tablet, discard any remaining tablets and start the next blister pack

If you have forgotten pale yellow tablet(s) in a blister pack and you do not have the expected bleeding that should start while taking the white tablets, you may be pregnant.
If you have forgotten one or more white tablets, you are still protected provided that the time between the last pale yellow tablet of the current blister pack and the first pale yellow tablet of the next blister pack is not greater than 4 days.
Ask your doctor for advice.
Vomiting or severe diarrhoea within 4 hours of taking the pill is similar to if you forget a tablet. After vomiting or diarrhoea, you must take another tablet from a reserve blister pack as soon as possible. If possible take it within 12 hours of when you normally take your pill. If these episodes of vomiting or severe diarrhoea recur over several days, you should use a barrier method
of contraception (condoms, spermicides...) until the beginning of the next blister pack. Ask your doctor for advice.

What side effects may I notice from this medicine?

Like all medicines, Minesse® can cause side effects, although not everybody gets them. If you get any side effect, particularly if severe and persistent, or have any change to your health that you think may be due to Minesse®, please talk to your doctor.
An increased risk of blood clots in your veins (venous thromboembolism [VTE]) or blood clots in your arteries (arterial thromboembolism [ATE]) is present for all women taking combined hormonal contraceptives.
Common side effects (may affect between 1 and 10 users in 100):

• a vaginal infection including vaginal thrush
• altered mood swings including depression or altered sexual appetite
• nervousness or dizziness
• nausea, vomiting or abdominal pain
• acne
• breast problems such as pain, tenderness, swelling or secretion
• painful periods or change in blood flow during your period
• changes to vaginal discharge or change to the cervix (ectropion)
• water retention in tissue or oedema (severe fluid retention)
• weight loss or gain

Uncommon side effects (may affect between 1 and 10 users in 1,000):

• changed appetite
• abdominal cramps or wind
• skin rash, excessive growth of body hair, hair loss or discoloured patches on the face (chloasma)
• changes in laboratory test results: increase in cholesterol, triglyceride levels or increased blood pressure

Rare side effects (may affect between 1 and 10 users in 10,000):

• allergic reactions (very rare cases of hives, angioedema or severe breathing or blood circulation disorders)
• harmful blood clots in a vein or artery
• glucose intolerance
• contact lens into
• lerance
• jaundice
• a type of skin reaction called erythema nodosum

Where should I keep my medicine?

Keep out of the sight and reach of children.
Do not use Minesse® after the expiry date which is stated on the carton and the blister.
No particular storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.