How does it work?

This medicine is a combined oral contraceptive often referred to as 'The Pill'. It contains a combination of two synthetic derivatives of naturally occuring sex hormones, oestrogen and progesterone, found in the female body. Ethinylestradiol is a synthetic version of oestrogen and levonorgestrel is a synthetic form of progesterone. During a woman's normal menstrual cycle, the levels of these sex hormones change. Oestrogen levels rise causing an egg to ripen (maturation) and be released from the ovaries (ovulation). This causes levels of progesterone in the body to increase, preventing the release of more eggs from the ovary and preparing the lining of the womb for a possible pregnancy. Combined oral contraceptives work by over-riding the normal menstrual cycle. Ethinylestradiol prevents the ripening and release of an egg from the ovary. Levonorgestrel works by tricking the body processes into thinking that ovulation has already occurred. In addition, levonorgestrel affects the natural mucus at the neck of the womb. It increases the thickness of this mucus making it more difficult for sperm to cross from the vagina into the womb. Levonorgestrel also acts to change the quality of the womb lining (endometrium). This prevents the successful implantation of any fertilised eggs onto the wall of the womb. When the blood levels of these hormones decrease at the end of each 'cycle' in the packet, a menstrual period occurs. Different brands of combined oral contraceptives may contain a different type of progesterone and/or a different strength of ethinylestradiol - Low Strength (20 micrograms), Standard Strength (30 to 40 micrograms) or High Strength (50 micrograms). There may also be differences in the tablets taken during the monthly cycle. The most widely used preparations are known as 'Monophasic'. In these, all 21 tablets are the same and a seven day pill-free gap is left between packets, during which time a period occurs. Preparations known as 'Bi- or Tri-Phasic' have different coloured tablets which contain different strengths of oestrogen and progesterone. These tablets must be taken in the order specified on the pack for each cycle. 'ED' (Every Day) preparations contain 28 tablets (21 active tablets and 7 inactive tablets). This allows a woman to take a tablet every day of the 28 day cycle rather than having to remember the 7 day break at the end of each pack of 21 tablets. Again, these tablets must be taken in the order specified on the pack.

What is it used for?

Contraception

Disorders of the menstrual cycle

Warning!

Missed pill: if you forget to take a pill, take it as soon as you remember, and the next one at your normal time. If you are 12 hours or more late, another contraceptive method (e.g. condoms) should be used for the next seven days, whilst continuing with normal pill taking. Read the instructions on your pack carefully regarding missed pills.

Women taking this contraceptive pill for the first time may experience menstrual irregularities such as spotting and missed periods. If two consecutive menstrual periods are missed, a test must be done to exclude pregnancy.

Women taking oral contraceptives should have regular medical check-ups.

It is important to be aware that women taking the combined oral contraceptive pill appear to have a small increase in the risk of developing a blood clot in a vein or artery (thrombosis), compared with women who do not use the pill. This risk is greater in certain groups of women, particularly smokers. However, this risk must be weighed against the benefits of taking the pill. Discuss this with your doctor.

This medicine may need to be discontinued four weeks prior to planned surgery and during periods of immobility, and not restarted until two weeks after return to mobility. Discuss this with your doctor.

Women who suffer from a condition called chloasma, which causes yellowish-brown patches of colouring on the skin, particularly the face, should avoid prolonged exposure to sunlight or ultraviolet radiation, eg sunbeds or UV lamps, while using this medicine, as they can make this condition worse.

It is important to be aware that all women taking the oral contraceptive pill appear to have a small increase in the risk of being diagnosed with breast cancer, compared with women who do not use the pill. However, this risk must be weighed against the benefits of taking the pill which can be discussed with your doctor.

Vomiting and severe diarrhoea may interfere with the absorption of this medicine, thereby decreasing its effectiveness as a contraceptive. If you vomit or have severe diarrhoea within three to four hours of taking a pill, you should take another as soon as possible. If this is more than 12 hours later, an additional method of contraception (eg condoms) should be used for the next seven days. Read the instructions in your pack carefully regarding this.

Stop taking this medicine and inform your doctor immediately if any of the following occur whilst taking this medicine: migraine or severe headaches, disturbance in vision, stabbing pains and/or unusual swelling in one leg, pain on breathing or coughing, sudden breathlessness, sudden severe chest pain, significant rise in blood pressure, itching of the whole body, yellowing of the skin (jaundice), severe abdominal complaints, severe depression, worsening of epilepsy or if you become pregnant.

Use with caution in

Asthma

Contact lens wearers

Decreased kidney function

Decreased liver function

Diabetes

Disease involving the heart and blood vessels

Disorder causing deafness in adult life (otosclerosis)

Epilepsy

Family history of blood clotting disorders

Family history of breast cancer

Family history of heart attack, stroke or deep vein thrombosis at a young age

Fibroids of the uterus

Gall stones

High blood pressure

History of benign breast disease

History of depression

History of inflammation of a vein wall (phlebitis)

Irregular brown skin patches on the face and elsewhere often due to pregnancy or the use of oral contraceptives (chloasma)

Life long inherited blood diseases which can cause a variety of symptoms, including mental health problems (porphyrias)

Long-term inflammation of skin and some internal organs (systemic lupus erythematosus)

Migraine

Multiple sclerosis

Muscle twitching, especially of the face, caused by low blood calcium levels (tetany)

Nervous system disorder in young persons causing involuntary, irregular, jerky movement of the muscles of the face, neck, and limbs (Sydenham's chorea or chorea minor)

Obesity

Smokers

Varicose veins

Not to be used in

Anaemia caused by a hereditary blood disorder where abnormal haemoglobin is produced (sickle cell anaemia)

Blood clot in the blood vessels (thromboembolism) or a history of this

Blood clotting disorders

Current or previous breast cancer

Current or previous cancer of the lining of the womb

Current or previous liver cancer

Deterioration of a disorder causing worsening deafness (otosclerosis) during a previous pregnancy

Disorders of lipid metabolism

Heart valve disease

History of herpes infection during pregnancy

History of jaundice or generalised itch during pregnancy

Inherited disorder of bile excretion that causes jaundice (Rotor syndrome)

Irregular heart beats in a chamber of the heart (atrial fibrillation)

Metabolic disorder that runs in families and causes mild jaundice (Dubin-Johnson syndrome)

Pregnancy

Severe diabetes associated with circulatory problems

Severely decreased liver function

Vaginal bleeding of unknown cause

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 should not be used in pregnancy. Seek medical advice from your doctor.

There may be small amounts of this medicine present in breast milk and it may also reduce the amount of milk produced. Seek medical advice from 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.

Headache

Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain

Breast tenderness/swelling

Spotting of blood between menstrual periods in women

Fluctuation in sex drive

Weight changes

Depressed mood

Irregular brown patches on the skin of the face and elsewhere (chloasma)

Change in menstrual bleeding

Discomfort when wearing contact lenses

Stopping of periods or infrequent periods after discontinuing the pill

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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