Diane-35 ED is a hormonal preparation used in the treatment of women who have a problem with severe acne, facial or chest hair.

Diane-35 ED is also an effective oral contraceptive, commonly known as a Birth Control Pill or The Pill. Diane-35 ED prevents pregnancy in several ways:-

• inhibiting the egg release by stopping it maturing

• changing the cervical mucus consistency making it difficult for the sperm to reach the egg

• changing the lining of the uterus making it less suitable for implantation

When taken as directed Diane-35 ED is very effective at preventing pregnancy. Oral contraceptives such as Diane-35 ED may have many beneficial effects including:

• a decrease in the amount of blood you lose each month during your period

• a decrease in anemia

• a decrease in period pain

• a decrease in pelvic inflammatory disease

• a decrease in developing ovarian cysts

• an improvement in acne

• a reduced risk of tubal (ectopic) pregnancy

• a reduced risk of benign breast disease (breast lumpiness)

• a reduced risk of getting cancer of the uterus (womb) lining and ovaries.

• Diane-35 ED is not for use in men.

• Checklist before using Diane-35 ED

It is important to remember that Diane-35 ED tablets are a PRESCRIPTION ONLY MEDICINE - you should only use Diane-35 ED tablets as directed by your doctor.

Special precautions

The use of Oral Contraceptives such as Diane-35 ED by cigarette smokers may increase the risk of cardiovascular disease. This risk increases with heavy smoking and advancing age and is quite marked in women over the age of 35 years. You should therefore stop smoking if you want to use an oral contraceptive such as Diane-35 ED.

You must not use Diane-35 ED if any of the following apply to you:

• you are pregnant, or think you may be pregnant

• you are breastfeeding

• you have a history of or currently have blood clots in the legs, brain, lungs or heart

• you have known or suspected cancer of the breast or lining of the womb

• you have previous or existing liver tumors

• you have jaundice or suffer from severe disturbances of liver function, including jaundice and itch associated with pregnancy

• you suffer from diabetes and associated vascular complications

• you have undiagnosed abnormal vaginal bleeding

• you suffer from disturbances in blood lipid (fat) levels or have high cholesterol levels

• you suffer from otosclerosis (hearing loss), which deteriorates during pregnancy

• you have a history of herpes of pregnancy

• you have sickle-cell anemia

• You should advise your doctor if any of the following apply to you before commencing Diane-35 ED:

• you suffer from migraine

• you have a history of depression

• you have high blood-pressure

• you have any other medical conditions

• you are taking other medications you have been prescribed or bought yourself without prescription

Side effects

Most side effects of Diane-35 ED are not serious. The most common side effects are nausea and vomiting, which may decrease with continued use. Less common are abdominal cramps and bloating, bleeding between periods which usually disappears with the first three months of pill taking, weight gain, breast tenderness, vaginal infection and depression.

In predisposed women, use of the tablets can sometimes cause brownish patches on the face which are made worse by long exposure to the sun. Women who have this tendency should therefore avoid spending too long in the sun.

In individual cases poor tolerance of contact lenses has been reported.

You should immediately stop using Diane-35 ED and immediately consult your doctor if you experience:

• migraine headaches for the first time

• more frequent unusually severe headaches

• disturbance of hearing or vision (for example flickering in front of the eyes)

• first signs of blood clots in the leg (for example unusual pains or swelling of the leg) or chest (stabbing pains on breathing or coughing for no apparent reason)

• a feeling of pain or tightness in the chest

• pending operation (six weeks beforehand)

• immobilization (for example following accidents)

• onset of jaundice, hepatitis or generalized itching

• increase in epileptic seizures

• Pregnancy.

Your doctor will probably advise you to stop using Diane-35 ED if a significant rise in your blood pressure is detected.

Should you have any questions on the use of Diane-35 ED you should discuss these with your doctor.

Keep allappointments with your doctor.

Don’tlet anyone else take your medicines.