Dianette

How does it work?

Dianette tablets contain two active ingredients, cyproterone acetate and ethinylestradiol. This combination of medicines is also known as co-cyprindiol. (NB. Co-cyprindiol tablets are also available without a brand name, ie as the generic medicine.)

Cyproterone acetate is a type of medicine called an anti-androgen. Androgens are male hormones, and are produced by women as well as men. They are responsible for stimulating the growth of the skin, including the sebaceous glands that produce oil (sebum), and the hair that grows from the skin. However, if your body produces too much androgen, or if your skin is particularly sensitive to the effects of androgens, the sebaceous glands may produce too much sebum. This can cause the sebaceous glands to become blocked, resulting in infection, inflammation and acne spots. The androgens may also cause excessive growth of the hair on the face and body - a condition known as hirsutism. Both these problems are common in women with polycystic ovary syndrome.

Cyproterone acetate is used to prevent these actions of the androgens. It works by blocking the receptors in the body that the androgens normally work on. This means that the androgens can no longer affect the skin or the hair, and acne and hirsutism can improve. Cyproterone acetate also decreases the production of androgens by the ovaries, so that there are less of these male hormones circulating.

You should notice that your skin becomes less greasy within a few weeks of treatment with this medicine, but it may take a few months of treatment before you see a definite improvement in your acne or excessive hair growth.

This medicine is also an effective combined oral contraceptive. Cyproterone acetate is a progestogen derivative, and the other ingredient, ethinylestradiol, is a synthetic version of the naturally-occurring female hormone, oestrogen. The medicine works as a contraceptive by preventing the ripening and release of eggs from the ovaries, as well as increasing the thickness of the cervical mucus, which makes it more difficult for sperm to cross from the vagina into the womb. It also changes the lining of the womb so that it is less suitable for any fertilised eggs to successfully implant in.

Each tablet has the same dose of hormones in it. One tablet is taken every day for 21 days and you then have a seven day break from pill-taking. During your seven day break, the levels of the hormones in your blood drop, which results in a withdrawal bleed that is similar to your normal period. You start the next pack after the seven pill-free days are up, even if you are still bleeding.

The tablets come in a calender pack marked with days of the week to help you remember to take a pill every day for three weeks, followed by a week off. You will still be protected against pregnancy in your pill-free week, provided you took all the pills correctly, you start the next packet on time and nothing else happened that could make the pill less effective (eg sickness, diarrhoea, or taking certain other medicines - see below).

This medicine is as effective a contraceptive as any other combined hormonal contraceptive, but it should not be used solely for this purpose. It is used to treat severe acne and hirsutism in women, and has the advantage of also providing contraception. This means you do not need to use any other method of contraception while you are using this medicine, unless you miss a pill, have a stomach upset, or are prescribed certain other medicines as well. See below for more information about all of these scenarios.

What is it used for?

Severe acne in women that has not responded to treatment with oral antibiotics.

Abnormal hair growth in women as a result of excessive production of male sex hormones (hirsutism).

This medicine will also provide contraception for women taking it for acne or hirsutism, but it should not be used solely as a contraceptive.

It can take a few months of treatment before your acne or hirsutism has completely cleared up and it is recommended that you stop using this medicine three to four months after your skin has got better, rather than use it continuously just for contraception. If your acne or hirsutism flares up again, you can take repeat courses.

Warning!

If you are relying on this medicine for contraception it is important that you carefully follow the instructions for taking it provided in the pack. You should take your pill at the same time every day. If you are more than 12 hours late in taking a pill you will not be protected against pregnancy. Take the missed pill as soon as you remember and use an additional non-hormonal method of contraception (eg condoms) for the next seven days, while continuing to take your pills as normal. If the pill you missed was in the last seven days of a pack, you should start a new pack immediately without having a seven day break. Read the instructions in your pack carefully regarding missed pills.

Vomiting and severe diarrhoea may interfere with the absorption of this medicine from the gut and decrease its effectiveness as a contraceptive. You should use an additional method of contraception (eg condoms) during a stomach upset and for the next seven days after you have recovered. If the seven days overrun the end of a pack, you should start a new pack immediately without having a seven day break. Read the instructions in your pack carefully regarding this.

Women using this contraceptive for the first time may experience menstrual irregularities such as spotting, breakthrough bleeding or missed periods. Consult your doctor if any breakthrough bleeding persists. Your periods may become infrequent or stop after you stop taking this medicine.

If you do not have a withdrawal bleed during your pill-free week, you should do a pregnancy test or consult your doctor. Since this medicine should not be taken during pregnancy, it is important that you do not start your next pack until you are certain you are not pregnant. In the meantime, you should use a condom or a cap plus spermicide if you have sex.

This pill will not protect you against sexually transmitted infections, so you may still need to use condoms as well.

It is important to be aware that, compared with women who do not use these contraceptives, women taking combined pills appear to have a small increase in the risk of developing a blood clot in a vein, eg in the leg (deep vein thrombosis) or in the lungs (pulmonary embolism), or a blood clot in an artery, eg causing a stroke or a heart attack. This risk is greater in certain groups of women, particularly smokers and women who are obese - see cautions and not to be used in below). The risk of blood clots in the veins is slightly greater with this pill than with other pills. However, pregnancy carries a much higher risk of blood clots than any pill. The potential risks must be weighed against the potential benefits of this medicine. You should discuss this with your doctor.

The risk of blood clots forming in the veins (venous thromboembolism) while taking this medicine may be temporarily increased if you are immobile for prolonged periods of time, for example if you have a major accident or major surgery. For this reason, your doctor will usually recommend that you stop taking this pill for a period of time (usually six weeks) prior to any planned surgery, particularly abdominal surgery or orthopaedic surgery on the lower limbs (but not before minor surgery like teeth extraction). You will also need to stop taking this pill if you are going to be immobile for long periods, for example because you are confined to bed or have a leg in a plaster cast. You should not start taking the pill again until at least two weeks after you are fully mobile. There may also be an increased risk of blood clots in the veins if you are travelling for long periods of time where you will be sat still (over five hours). The risk of blood clots during long journeys may be reduced by appropriate exercise during the journey and possibly by wearing elastic hosiery. Discuss this with your doctor.

It is important to be aware that women using hormonal contraceptives appear to have a small increase in the risk of being diagnosed with breast cancer, compared with women who do not use these contraceptives. Women who use oral contraceptives for longer than five years may also have a small increase in the risk of being diagnosed with cervical cancer. However, these risks must be weighed against the benefits of using the contraceptive, which include a decrease in the risk of cancers of the ovaries and endometrium (womb). You should discuss the risks and benefits of the pill with your doctor before you start taking it.

Stop taking this medicine and inform your doctor immediately if you get any of the following symptoms while taking the medicine: stabbing pains and/or unusual swelling in one leg, pain on breathing or coughing, coughing up blood, sudden breathlessness, sudden severe chest pain, migraine or severe headaches, sudden disturbance in vision, hearing or speech, sudden weakness or numbness on one side of the body, fainting, collapse, epileptic seizure, significant rise in blood pressure, itching of the whole body, yellowing of the skin or whites of the eyes (jaundice), severe stomach pain, severe depression, or if you think you could be pregnant.

Use with caution in

Women aged over 35 years

Women whose parent, brother or sister had a stroke caused by a blood clot or a heart attack before the age of 45

Obesity

Smokers

Diabetes mellitus

High blood pressure

Women who use a wheelchair

Varicose veins

History of severe depression

History of migraines

Inflammatory bowel disease, eg Crohn's disease or ulcerative colitis

History of liver disease

Decreased kidney function

Heart failure

History of gallstones

Close family history of breast cancer (eg mother or sister has had the disease)

History of irregular brown patches appearing on the skin, usually of the face, during pregnancy or previous use of a contraceptive pill (chloasma). Women with a tendency to this condition should minimise their exposure to the sun or UV light while taking this medicine.

Not to be used in

Men

Known or suspected pregnancy

Breastfeeding

Personal or family history of a blood clot in a vein (venous thromboembolism), eg in the leg (deep vein thrombosis) or in the lungs (pulmonary embolism)

Blood disorders that increase the risk of blood clots in the veins, eg antiphospholipid syndrome or factor V Leiden

Long-term condition called systemic lupus erythematosus (SLE)

Excess of urea in the blood causing damaged red blood cells (haemolytic uraemic syndrome)

Hereditary blood disorder called sickle cell disease

Women with two or more other risk factors for getting a blood clot in a vein, eg obesity, varicose veins, long-term immobility

Women who have ever had a blood clot in an artery, eg a stroke or mini-stroke caused by a blood clot, or a heart attack

Angina

Heart valve disease

Irregular heartbeat caused by very rapid contraction of the top two chambers of the heart (atrial fibrillation)

Moderate to severe high blood pressure

High cholesterol levels

Severe diabetes with complications, eg affecting the eyes, kidneys or nerves

Women who smoke more than 40 cigarettes per day

Women over 50 years of age

Women with two or more other risk factors for getting a blood clot in an artery, eg family history of heart attack or stroke before the age of 45 (parent, brother or sister), diabetes, high blood pressure, smoking, age over 35 years, obesity, migraines

Women who get migraines with aura, severe migraines regularly lasting over 72 hours despite treatment, or migraines that are treated with ergot derivatives

History of breast cancer

Cancer involving the genital tract

Vaginal bleeding of unknown cause

Severe liver disease, eg liver cancer, hepatitis

History of liver disease when liver function has not returned to normal

Disorders of bile excretion that cause jaundice (eg Dubin-Johnson or Rotor syndrome)

Gallstones

History of jaundice, severe itching, hearing disorder called otosclerosis, or rash called pemphigoid gestationis during a previous pregnancy, or previous use of sex hormones

Hereditary blood disorders known as porphyrias.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine must not be used during pregnancy. This is because androgens are needed for the development of the sexual organs in a male foetus, and the anti-androgen action of this medicine could therefore prevent the normal development of a male foetus. The risk of this (known as feminisation) in humans is unknown, but because of the potential risk you must not take this medicine if you are pregnant. If you do not have a withdrawal bleed in your pill-free week you must make sure you are not pregnant before you start your new pack. Discuss this with your doctor.

This medicine should not be used by breastfeeding mothers. Discuss this with your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Change in menstrual bleeding

Menstrual spotting or breakthrough bleeding

Headache

Upset stomach

Nausea and vomiting

Breast tenderness

Weight changes

Decreased sex drive

Depressed mood

Retention of water in the body tissues (fluid retention)

Vaginal thrush (candidiasis)

Irregular brown patches on the skin, usually of the face (chloasma)

Steepening of corneal curvature which may make contact lenses uncomfortable

Rise in blood pressure

Disturbance in liver function

Gallstones

Blood clots in the blood vessels (eg, DVT, pulmonary embolism, heart attack, stroke - see warnings above)

The side effects listed above may not include all of the side effects reported by the drug's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

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