Minulet

Generic Name: gestodene, ethinyloestradiol
Product Name: Minulet

Indication: What Minulet is used for

Minulet is an oral contraceptive. Minulet tablets contain two hormones (gestodene and ethinyloestradiol), which prevent you from becoming pregnant if taken correctly. They are similar to the hormones that your body normally produces.

Your doctor may have prescribed Minulet for another reason. Ask your doctor if you have any questions about why Minulet has been prescribed for you.

Minulet is not habit-forming.

This medicine is available only with a doctor’s prescription.

Action: How Minulet works

Minuletprevents pregnancy in several ways:

• It inhibits the egg release by stopping it maturing;
• It changes the cervical mucus consistency making it difficult for the sperm to reach the egg;
• It changes the lining of the uterus making it less suitable for implantation.

Each white tablet contains 75 micrograms of gestodene and 30 micrograms of ethinyloestradiol as the active ingredients.

Red tablets do not contain active ingredients.

The white tablets contain the inactive ingredients lactose, maize starch, povidone, sodium calcium edetate, magnesium stearate, sucrose, calcium carbonate, talc, macrogol 6000, and glycol montanate.

The red tablets contain lactose, maize starch, povidone, magnesium stearate, sucrose, calcium carbonate, talc, macrogol 6000, glycol montanate, brilliant scarlet 4R CI 16255, and erythrosine CI 45430.

Minulet does not contain gluten, tartrazine or any other azo dyes.

Dose advice: How to use Minulet

Before you take Minulet

When you must not take Minulet

Do not take Minulet if you have an allergy to:

• Any medicine containing ethinyloestradiol or gestodene;
• Any of the ingredients listed here;
• Any other similar medicines (such as other oral contraceptives).

Some of the symptoms of an allergic reaction may include:

• Shortness of breath;
• Wheezing or difficulty breathing;
• Swelling of the face, lips, tongue or other parts of the body;
• Rash, itching or hives on the skin.

Do not take Minuletif you have or have had any of the following medical conditions:

• Venous thromboembolism (VTE) and are on medicines called anticoagulants which are used to “thin the blood”;
• Blood clots or a history of blood clots in the:
  • Legs (thrombophlebitis or deep vein thrombosis (DVT));
  • Lungs (pulmonary embolism);
  • Eyes;
• Hereditary or an acquired disposition for venous thromboembolism;
• Multiple risk factors for VTE including obesity, age above 35 years, smoking, high cholesterol;
• Major surgery and have been confined to bed for long periods of time;
• Arterial thromboembolism (ATE) or a past history of these that include:
  • Stroke;
  • Angina;
  • Transient ischaemic attack or “mini-stroke”;
• Hereditary or an acquired disposition for ATE;
• History of migraine, accompanied by blurred vision, difficulty in speaking, muscle weakness, or increased sensitivity to light, sound, or noise;
• Multiple risk factors for ATE or a serious risk factor for ATE that include:
  • Uncontrolled high blood pressure;
  • Diabetes with blood vessel damage;
  • Severe lipid disease;
  • Sickle cell anaemia;
• Disease in any blood vessel(s);
• Inflammation of the pancreas, which is associated with very high blood levels of triglycerides (fatty substances);
• Breast cancer or cancer of the lining of the womb, cervix or vagina, or you think you have these conditions;
• Unexplained vaginal bleeding;
• Liver tumour or liver disease;
• Yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during previous use of an oral contraceptive.
• Severe skin itchiness during pregnancy;
• A history of herpes in pregnancy;
• A history of a hearing problem known as otosclerosis, which is worse during pregnancy.

If you are not certain whether these may apply to you, or you are worried by anything in this list, tell your doctor.

Do not take this medicine if you are pregnant or you think you are pregnant. Pregnancy must be excluded before you start taking Monofeme.

Minulet is not for use in children or in postmenopausal women.

Do not take this medicine if you are taking anti-viral hepatitis C virus (HCV) medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin. If you are not sure about your anti-HCV medication, tell your doctor.

Do not take this medicine if the expiry date (EXP) printed on the pack has passed. Minulet may have no effect at all, or worse, an entirely unexpected effect if you take it after the expiry date.

Do not take this medicine if the packaging is torn or shows signs of tampering. If this is the case, take the tablets back to your pharmacist.

Before you start to take Minulet

You must have a thorough medical check-up, including a Pap smear, breast check, blood pressure check and urine test.

You must tell your doctor if you or anyone in your immediate family has, or has had blood clots in the legs or lungs. Blood clots are a rare occurrence when taking an oral contraceptive. The risk of a blood clot is highest during the first year of taking an oral contraceptive for the first time or if you are re-starting the “pill” after a break of 4 weeks or more. The risk of having a blood clot is higher in oral contraceptive users than in non-users but is not as high as during pregnancy.

Tell your doctor about any of the following conditions as these are risk factors for developing blood clots:

• Cancer;
• Systemic lupus erythematosus (SLE);
• Haemolytic uraemic syndrome (HUS) – a disorder of blood coagulation causing failure of the kidneys);
• Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• Sickle cell disease;
• Smoking particularly if you are heavy smoker (15 or more cigarettes per day) and are aged over 35 years;
• Have had any recent surgery or trauma;
• Recently had a baby;
• Lost a baby in the second trimester;
• Are pregnant;
• Had major surgery and have been confined to bed for long periods of time;
• Also, tell your doctor if you are planning a long haul plane flight (greater than 4 hours).

You must tell your doctor if you or anyone in your immediate family has, or has had a stroke or heart attack.

Taking oral contraceptives is linked with an increased risk of having a heart attack, angina, stroke or a “mini-stroke”.

Tell your doctor if you have any of the following conditions:

• Heart disease including heart valve disorders or certain heart rhythm disorders;
• High blood pressure, a history of high blood pressure or high blood pressure during pregnancy;
• High cholesterol;
• Diabetes;
• Migraine or other headaches;
• Hyperhomocysteinemia.

Tell your doctor if over 35 years of age or are overweight.

If you are not certain whether any of the above may apply to you, check with your doctor.

Tell your doctor if you have any other health problems, especially:

• Breast lumps, abnormal breast X-ray or mammogram;
• Epilepsy;
• Depression;
• Gallbladder disease;
• Fluid retention or kidney disease;
• Asthma;
• Fibroids;
• Yellowing of the whites of the eyes or skin (jaundice) during pregnancy or during previous oral contraceptive use;
• Hereditary angioedema.

If you have any of these conditions you should have regular check-ups with your doctor to make sure that taking Minulet is not making the conditions worse.

Tell your doctor if you plan to become pregnant or you think you are pregnant. Like most medicines, Minulet is not recommended during pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed. Like most medicines, Minulet is not recommended while you are breastfeeding. Small amounts of oral contraceptives have been found in breast milk. It is not known what effect this may have on the baby. A decrease in milk supply may also occur.

If you have not told your doctor about any of the above, tell them before you start taking Minulet.

Minulet contains lactose. If you know that you are intolerant to some sugars, or your doctor has told you so, speak to your doctor before taking it.

Tell your doctor if you are allergic to any foods, dyes, preservatives or any other medicines.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may stop Minulet from working properly. These include medicines such as:

• Rifampicin and rifabutin for the treatment of tuberculosis;
• Antibiotics such as ampicillin, other penicillins, and tetracyclines;
• Anti-fungal agents such as griseofulvin;
• Barbiturates (certain types of medicines prescribed for epilepsy, such as phenobarbitone);
• Medicines for epilepsy (such as phenytoin, primidone, carbamazepine, and topiramate);
• Ritonavir for the treatment of HIV infection;
• Modafinil used to treat excessive daytime sleepiness;
• St. John’s Wort, an ingredient in many medicines you can buy without a prescription from a pharmacy, health food shop or supermarket;
• Corticosteroids such as dexamethasone.

While you are taking any of these medicines and for the next 7 days after stopping them, you must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods). If you come to the end of the white tablets during these 7 days, start the next pack straight away. Skip the 7 red tablets.

If you take rifampicin and some other medicines, you may need to use additional non-hormonal contraception for four weeks after finishing the course of treatment. Ask your doctor or pharmacist about how long you need to use additional non-hormonal contraception.

Some medicines may increase the levels of Minulet in your blood, which may lead to unwanted side effects. These medicines include:

• Atorvastatin used to treat high cholesterol;
• Indinavir for the treatment of HIV infection;
• Anti-fungal agents such as itraconazole and fluconazole;
• Paracetamol and ascorbic acid (Vitamin C).

Minulet may also affect how well some other medicines work. These medicines include:

• Anti-viral hepatitis C virus (HCV) medicines such as ombitasvir, paritaprevir, ritonavir and dasabuvir;
• Cyclosporin used to prevent organ rejection;
• Theophyllines used for asthma and other breathing difficulties;
• Corticosteroids;
• Lamotrigine used for seizures.

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking Minulet.

If you are scheduled for any laboratory tests, tell your doctor you are taking Minulet. Some blood tests may be affected by taking Minulet.

How to take Minulet

Follow the directions on the blister pack.

If your doctor has prescribed Minulet for some other purpose than contraception, follow their directions closely, even if they are not the same as on the pack.

When to take Minulet

You must take Minulet every day, even if you do not have sex very often. Minulet will work best if you do not miss any tablets and take it at the same time each day. Taking your tablet at the same time each day will also help you remember when to take the tablets.

It does not matter if you take Minulet before or after food.

If you are concerned about this, please speak with your doctor or pharmacist.

How to take Minulet

Swallow Minulet with a glass of water.

Starting a hormonal contraceptive for the first time

To start taking Monofeme follow these steps:

• On the first day of your menstrual bleed, take a white tablet that matches the day of the week from the green shaded section of the blister pack;
• Then take one white tablet each day, following the arrows so that you are taking the correct tablet for the day of the week until all 21 white tablets have gone;
• Then take one red tablet each day for the next 7 days;
• You will have a ‘withdrawal’ bleed, similar to having a period, during the week of red tablets.

Minulet is effective from the first day of use if begun as instructed. Your first cycle is likely to be shorter than usual, approximately 23 to 24 days long. Thereafter, your cycles should be about 28 days long.

If you do not bleed and there is any chance that you have not followed all the instructions, contact your doctor to check if you are pregnant.

Going on to further blister packs

• On the day after your last red tablet, begin the next pack with a white tablet from the purple shaded section of the blister pack that matches the day of the week. Do this even if you are still bleeding;
• Each new pack is started with a white tablet on the same day as the first pack so that you have 21 days on white tablets, then 7 days on red tablets. There is no break between packs;
• If you start the new pack later than the day after your last red tablet, you may have started a normal fertile cycle.

If you start late, you must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) until a white tablet has been taken daily for 7 days without a break.

Switching from a different combined oral contraceptive

Follow these steps if your current oral contraceptive contains an oestrogen and a progestogen:

• Stop taking your current oral contraceptive after you have taken the last tablet in the pack;
• If your current oral contraceptive is a 28-day pack, start Minulet the next day by taking take the first white tablet from the purple shaded section that matches the day of the week. If your current oral contraceptive is a 21-day pack, wait 7 days from when the last tablet was taken. On the 8th day, start Minulet by taking take the first white tablet from the purple shaded section that matches the day of the week.
  • You must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) until a white tablet has been taken daily for 7 days without a break;
• Then take one white tablet each day following the direction of the arrows until all 21 white tablets have gone;
• Then take one red tablet each day for the next 7 days;
• You will have a ‘withdrawal’ bleed, similar to having a period, during the week of red tablets.

If you do not bleed and there is any chance that you have not followed all the advice in this leaflet, contact your doctor to check if you are pregnant.

Switching from a progestogen-only contraceptive

You can stop taking a progestogen-only contraceptive tablet any day and start taking Minulet the next day, at the same time.

If you have been using a progestogen-only implant, start taking Minulet on the day the implant is removed.

If you have been using a progestogen-only injection, start taking Minulet on the day the next injection would be due.

In all cases start Minulet by taking a white tablet from the purple shaded section that matches the day of the week.

You must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) until a white tablet has been taken daily for 7 days without a break.

After having a baby

If you have just had a baby, talk to your doctor before you start taking Minulet.

After a miscarriage or abortion

Your doctor will advise you how to take Minulet after a miscarriage or abortion.

How long to take Minulet

Your doctor may prescribe Minulet for long periods until you no longer need or want contraception.

If you are not sure how long you should be taking Minulet, ask your doctor.

If you forget to take your tablets

If you forget to take Minulet every day it may not work as well in protecting you from becoming pregnant.

Do not try to make up for missed doses by taking more than one tablet at a time.

Forgetting one white tablet

• If you forget one white tablet but it is less than 12 hours late, take the missed tablet immediately. Take the next tablet at your usual time, even if this means taking two tablets in one day.
  • If you do not take the missed tablet within 12 hours, Minulet may not work as well in protecting you from becoming pregnant;
• If one white tablet is missed and is more than 12 hours late, skip the missed white tablet and take the next white tablet at the usual time. Continue to take tablets at your usual time but you must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm but not the rhythm or temperature methods) until a white tablet has been taken daily for 7 days without a break. If you come to the end of the white tablets during the 7 days after a missed tablet, start the next pack straight away. Skip the 7 red tablets.

Forgetting more than one white tablet

Contact your doctor for advice on what to do.

Forgetting a red tablet

• If you miss one or more red tablets, leave them in the pack and do not worry;
• However, if you miss red tablets and then forget to start the next pack on time, start as soon as you remember by taking a white tablet that matches the day of the week from the purple shaded section. You must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm but not the rhythm or temperature methods) until a white tablet has been taken daily for 7 days without a break.

If you are not sure what to do, ask your doctor or pharmacist.

If you are having trouble remembering to take Minulet, ask your pharmacist for some hints.

If you vomit or have diarrhoea after taking Minulet

If you have vomiting or diarrhoea within 4 hours of taking a white tablet, you must use an additional non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) until a white tablet has been taken daily for 7 days without a break. If you come to the end of the white tablets during these 7 days, start the next pack straight away. Skip the 7 red tablets.

The tablet may not have time to be absorbed properly and may not protect you from becoming pregnant.

If you have vomiting or diarrhoea after taking a red tablet, do not worry.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital if you think you or anyone else may have taken too much Minulet. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too much Minulet, some of the symptoms you may have included:

• Feeling sick or vomiting;
• Dizziness;
• Feeling sleepy or tired.

Women may also experience menstrual bleeding.

While you are taking Minulet

Things you must do

Tell all doctors, dentists, and pharmacists who are treating you that you are taking Minulet.

If you are about to start taking any new medicines, tell the doctor or pharmacist that you are taking Minulet.

If you become pregnant while taking Minulet, see your doctor immediately.

If you miss a period and you have taken your tablets correctly, continue taking your tablets as you would normally. Sometimes you might not have a menstrual period while taking Minulet.

If you miss a period and you have not taken your tablets correctly, keep taking your tablets and see your doctor immediately. Not taking your tablets correctly includes missing one or more tablets or starting a new pack later than you should have.

If you miss two menstrual periods, stop taking your tablets and see your doctor, even if you have taken the tablets correctly. You must use a non-hormonal method of contraception, (such as condoms or a diaphragm) during this time. Your doctor should make sure you are not pregnant before you start taking Minulet again.

Have regular check-ups from your doctor, including a Pap smear. Oral contraceptives should not be prescribed for longer than one year without your doctor carrying out a check-up. Your doctor will advise you how often you need a Pap smear. A Pap smear can detect abnormal cells lining the cervix. Sometimes abnormal cells can progress to cervical cancer. The most important risk factor for cervical cancer is persistent human papillomavirus (HPV) infection. However, cervical cancer has been reported to occur more often in women using an oral contraceptive for a long time. This finding may not be caused by the oral contraceptive but may be related to sexual behaviour and other reasons.

Perform regular breast self-examination. Risk factors for the development of breast cancer include increasing age, family history, obesity, never having had a baby, and late age for first full-term pregnancy. Breast cancer has also been found slightly more often in women who use oral contraceptives than in women of the same age who do not use them. This slight increase in the number of breast cancer cases gradually disappears during the course of the 10 years after stopping the use of oral contraceptives. It is not known whether the oral contraceptive causes the difference. It may be that the women were examined more often so that the breast cancer was noticed earlier.

If you are concerned about contracting a sexually transmitted disease (STD), ask your partner to wear a condom when having sexual intercourse with you. Minulet will not protect you from HIV-AIDS or any other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B, human papillomavirus, and syphilis. To help protect yourself from STDs, you need to use a barrier contraceptive such as a condom.

Tell your doctor you are using Minulet at least 4 weeks before any planned hospitalisation or surgery. Your doctor may tell you to stop taking Minulet several weeks before surgery or at the time of immobilisation. Your doctor will tell you when you can start taking Minulet after you are back on your feet. To avoid pregnancy during this time you must use a non-hormonal method of contraception such as condoms or a diaphragm.

Things you must not do

Do not give Minulet to anyone else even if they have the same condition as you.

Do not use Minulet to treat any other complaints unless your doctor tells you to.

Do not stop taking Minulet, or change the dosage, without checking with your doctor. If you stop taking Minulet or do not take a tablet every day, without using another form of contraception, you may become pregnant.

After taking Minulet

Storage

Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the blister pack they may not keep well.

Keep Minulet in a cool, dry place where the temperature stays below 25°C and is away from light. Do not store Minulet or any other medicine, in a bathroom or near a sink. Do not leave Minulet in the car on hot days or on window sills. Heat and dampness can destroy some medicines.

Keep Minulet where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking Minulet, or the tablets have passed their expiry date, ask your pharmacist what to do with any left over.

After stopping Minulet

If your periods do not return within 2 to 3 months of stopping Minulet tell your doctor. Some women have short-term problems getting pregnant after stopping Minulet, especially if they had irregular menstrual cycles before starting to use an oral contraceptive.

If you are planning to become pregnant after stopping Minulet, use a non-hormonal method of contraception such as condoms or a diaphragm for 3 months before trying to get pregnant.

Ask your doctor or pharmacist for advice about taking folate if you plan to become pregnant.

Schedule of Minulet

Minulet is an S4 – prescription only medicine.

Side effects of Minulet

Tell your doctor or pharmacist as soon as possible if you do not feel well while taking Minulet. When used correctly, Minulet is an effective contraceptive but may have unwanted side effects in some people. All medicines can have side effects. Sometimes they are serious, most of the time they are not.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you have.

Tell your doctor if

Tell your doctor if you notice any of the following and they worry you.

Reproductive or breast problems such as:

• Changes in bleeding patterns, including breakthrough bleeding/ spotting;
• Painful periods;
• Missed periods, but if you have not taken Minulet as directed you should check whether you are pregnant;
• Changes in mucus from the vagina;
• Changes in the cervix;
• Vaginal thrush (candida);
• Breast pain, tenderness, enlargement, possible milk secretion;
• Changes in sex drive.

Stomach problems such as:

• Nausea or vomiting;
• Abdominal pain, cramps or bloating.

Difficulties thinking or working because of:

• Mood changes, including depression;
• Headache, including migraines;
• Nervousness;
• Dizziness;
• Contact lenses becoming uncomfortable to wear.

Changes to your appearance such as:

• Weight change (increase or decrease) or changes in appetite;
• Swelling of the hands, ankles or feet;
• Acne;
• Rash;
• Darkening of the skin, which may persist after stopping your medicine;
• Loss of scalp hair;
• Increase in body hair.

The above list includes the more common side effects of your medicine.

Tell your doctor as soon as possible if

Tell your doctor as soon as possible if you notice any worsening of conditions that you may already have such as:

• Chorea;
• Porphyria;
• Systemic lupus erythematosus;
• Varicose veins;
• Gallbladder disease;
• Hereditary angioedema.

Go to hospital if

Tell your doctor immediately, or go to accident and emergency at your nearest hospital if you notice any of the following:

• Unexplained or persistent pains in the head, chest, arm or below the breastbone;
• Severe pain, swelling or discolouration in either of your legs;
• Shortness of breath;
• Rapid or irregular heartbeat;
• Blurred or double vision;
• Partial or complete loss of sight;
• Eye protrusion, swelling of the eye or eye lesions;
• Dizziness or fainting, sometimes with loss of balance;
• Sweating, nausea or vomiting;
• An unusual cough;
• Weakness or numbness in any part of your body;
• Discomfort radiating to the back, jaw, throat or stomach;
• Confusion, trouble speaking or understanding;
• Bloody diarrhoea;
• Abdominal pain;
• Fever;
• Feeling of indigestion or choking;
• Rectal bleeding;
• Feeling tired;
• Lose your appetite or lose weight;
• Breast lumps;
• Jaundice or a yellowing of the skin or eyeballs, often with fever, fatigue, loss of appetite, dark coloured urine or light coloured bowel movements. Taking oral contraceptives has been associated with an increased risk of having a benign liver tumour and, in very rare cases, liver cancer. The risk appears to increase the longer oral contraceptives are taken.
• Migraine headaches for the first time;
• More frequent migraines if you already suffer from them;
• Itchy rash;
• You are an epileptic and your fits become more frequent;
• Rise in blood pressure. You may experience headache, blurred vision or palpitations. Sometimes your blood pressure may rise without you experiencing any of these symptoms. It is important to keep your routine doctor’s appointments so that your blood pressure can be checked;
• Swelling around eyes or mouth.

Whilst these side effects are rare, they are serious. You may need urgent medical attention or hospitalisation.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

For further information talk to your doctor.

References

1. Minulet Consumer Medicine Information (CMI). West Ryde, NSW: Pfizer Australia Pty Ltd. February 2018. [PDF]
2. Minulet Product Information (PI). West Ryde, NSW: Pfizer Australia Pty Ltd. January 2018. [PDF]