Gestodene may increase the chances of developing blood clots or cancers such as breast or cervical cancer. However, it may provide some protection against ovarian and endometrial cancer. You and your prescriber will need to weigh up the risks and benefits of taking Gestodene.

Hormonal contraceptives will only prevent a pregnancy if they are taken regularly. It is important you take this medicine at the same time each day. If you want immediate contraceptive cover then start to take Gestodene on the first day of your menstrual period. If you do not start taking Gestodene on the first day of your menstrual period you will need to take extra contraceptive precautions for at least seven days until Gestodene starts to work. For more information about starting Gestodene and if you need to take extra contraceptive precautions ask your prescriber, family planning nurse or read the patient information leaflet that comes with your medicine.

Once you have started to take Gestodene, you should take it once a day for 21 days. After this you should not take any more tablets for the next seven days. Start a new strip of Gestodene immediately after the seven day tablet-free break. During this break you will usually have a withdrawal bleed. If you do not have a withdrawal bleed during the tablet-free break and you have taken all your pills properly, you are very unlikely to be pregnant. But, if you miss two withdrawal bleeds in a row you should immediately contact your prescriber or family planning nurse. This is because there is a possibility that you could be pregnant and you must not take Gestodene during pregnancy.

In certain situations the effectiveness of Gestodene may be reduced and you will need to take extra contraceptive precautions. These situations include: missing a dose by more than 12 hours; taking other medicines that interact with Gestodene; having diarrhea, vomiting or any medical condition which interferes with the absorption of your medicine. If any of these situations occur during the last seven days of your tablet strip you should not have a tablet-free break between strips of tablets. Start taking the next strip of tablets without a break.

As there is no gap between strips you will not have a withdrawal bleed at the end of the first strip. But you may have some menstrual bleeding while you are taking the second strip and you should have a withdrawal bleed once you finish the second strip. For more information about situations when the effectiveness of Gestodene may be reduced and when to take additional contraceptive precautions ask your prescriber, family planning nurse or read the patient information leaflet that comes with your medicine.

Other information about Gestodene:

-you may have light and irregular periods or no periods at all when you stop taking Gestodene

Gestodene contains two hormones that are similar to the hormones estrogen and progesterone that are produced by the body. Gestodene comes in a strip of 21 tablets. Each strip contains three types of tablets?six beige, five dark brown and ten white tablets. These tablets contain different amounts of estrogen and progestogen. Gestodene is used to prevent women from becoming pregnant. It works by preventing the release of eggs from the ovary and changes the lining of the uterus which makes it difficult for an egg to develop. It also increases the thickness of vaginal fluid which can stop a sperm from reaching an egg.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

-are allergic or sensitive to or have had a reaction to any of the ingredients in the medicine

-are obese

-are pregnant or think you may be pregnant

-have a bleed in the brain

-have a movement disorder

-have a problem such as otosclerosis that became worse during pregnancy or after taking oral contraceptives

-have an inflammatory bowel disease such as Crohn's disease or ulcerative colitis

-have asthma

-have blood problems

-have cardiovascular problems

-have chloasma

-have diabetes or have risk factors for developing diabetes

-have epilepsy

-have gallstones

-have had certain problems during pregnancy such as jaundice, rashes or itching

-have high blood pressure

-have kidney problems

-have lupus or a lupus-like problem

-have metabolic problems

-have migraines

-have multiple sclerosis

-have or have had benign breast disease, breast cancer or a family history of breast cancer

-have or have had depression

-have or have had endometrial cancer

-have or have had liver problems such as jaundice or liver tumors

-have or have had phlebitis

-have otosclerosis

-have porphyria

-have risk factors for developing blood clots such as smoking, having a personal or family history of blood clots, being over 35 years of age, being immobile for a long period of time, having thrombophlebitis, having problems with blood clotting, have had recent surgery or trauma, are about to have surgery or have given birth in the last six to eight weeks

-have sickle cell anaemia

-have tetany

-have uterine problems such as fibroids

-have vaginal bleeding and the cause of the bleeding is not known

-have varicose veins

Hormonal contraceptives will only prevent a pregnancy if they are taken regularly. It is important you take this medicine at the same time each day. When you first start to take Gestodene you may need to take extra contraceptive precautions until it starts to work. You may also need to take extra contraceptive precautions in certain situations. These situations include missing a dose by more than 12 hours or vomiting within three to four hours of taking Gestodene. Ask your prescriber, family planning nurse or read the patient information leaflet that comes with your medicine for more information about when to take additional contraceptive precautions.

Other information about Gestodene:

-for information about when you should start to take this medicine you should ask your prescriber, pharmacist or read the patient information leaflet that comes with your medicine

What happens if I miss a Gestodene dose?

What happens if I overdose?

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

-Possibly Pregnant

-Severe disturbances of liver function, jaundice or persistent itching during a previous pregnancy, Dubin-Johnson syndrome, Rotor syndrome, previous or existing liver tumors.

-History of confirmed venous thromboembolism (VTE). Family history of idiopathic VTE. Other known risk factors for VTE.

-Existing or previous arterial thrombotic or embolic processes, conditions which predispose to them e.g. disorders of the clotting processes, valvular heart disease and atrial fibrillation.

-Sickle-cell anemia.

-Mammary or endometrial carcinoma, or a history of these conditions.

-Severe diabetes mellitus with vascular changes.

-Disorders of lipid metabolism.

-History of herpes gestationis.

-Deterioration of otosclerosis during pregnancy.

-Undiagnosed abnormal vaginal bleeding.

The frequency of these side-effects is unknown

-breast tenderness

-cervical cancer - this has been reported in women who have taken combined estrogen and progestogen contraceptives for a long period of time

-changes in libido

-changes to menstruation or bleeding patterns such as lighter menstrual periods, irregular spotting or bleeding in between menstrual periods, irregular menstrual periods or not having a menstrual period at all. Seek immediate medical advice if you do not have two withdrawal bleeds in a row or if you have any spotting or bleeding in between menstrual periods after taking Gestodene for some time

-changes to weight

-changes to your awareness - seek immediate medical advice if you suddenly develop hearing or eye problems

-chloasma - this may be worsened if you expose your skin to sunlight. If you are prone to chloasma do not expose your skin to sunlight while taking Gestodene

-depressed mood

-epilepsy - you or your carer must seek immediate medical advice if you have seizures more often

-headaches?seek immediate medical advice if you have an unusually bad headache or if your headaches occur more often

-intolerance to contact lenses - seek medical advice if you develop an intolerance to wearing contact lenses

-liver problems such as liver tumors - some liver tumors may be life-threatening. Seek medical advice if you develop jaundice, itching or if you have pain or discomfort in the upper part of your stomach

-may affect the results for certain tests

-migraine?seek immediate medical advice if you get a migraine-type headache for the first time or if your migraine-type headaches become worse

-nausea

-reduced glucose tolerance  - people with diabetes may be advised to adjust their anti-diabetic therapy

-some conditions may occur for the first time or get worse during treatment with Gestodene. If any of these happen to you, seek medical advice. Examples include: diabetes, raised blood pressure, varicose veins, phlebitis, otosclerosis, multiple sclerosis, depression, porphyria, tetany, chorea, kidney problems, obesity, systemic lupus erythematosus, fibroids in the uterus, gall-stones, heart and circulation problems, asthma, breast cancer or other breast problems

-stomach upsets such as diarrhea or vomiting - if you have diarrhea or vomiting after taking Gestodene you may need to take extra contraceptive precautions. For more information speak to your prescriber, family planning nurse or read the patient information leaflet that comes with this medicine

-thromboembolic problems such as heart attacks, strokes, deep vein thromboses or pulmonary embolisms - some of these problems may be fatal. Seek immediate medical advice if you have feelings of pain and tightness in the chest, pain on breathing or coughing, painful or swollen legs

Hormonal contraceptives may also increase the chances of developing breast cancer. You and your prescriber will need to weigh up the benefits and risks of taking Gestodene before you start to take it. Women who take Gestodene need to regularly examine their breasts for any changes or lumps.

The following medicines may interact with Gestodene:

-carbamazepine

-griseofulvin

-phenobarbital

-phenylbutazone

-phenytoin

-primidone

-rifampicin

The following types of medicine may interact with Gestodene:

-antibiotics

-barbiturates

-liver enzyme inducers

If pregnancy occurs during medication with oral contraceptives, the preparation should be withdrawn immediately. Pregnancy is a reason for stopping immediately because it has been suggested by some investigations that oral contraceptives taken in early pregnancy may slightly increase the risk of fetal malformations. Other investigations have failed to support these findings. The possibility therefore cannot be excluded, but it is certain that if a risk exists at all, it is very small.