Danol (danazol)

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How does it work?

Danol contains the active ingredient danazol, which is a synthetic steroid hormone resembling a group of natural hormones (androgens) found in the body. It acts on the pituitary gland in the brain, a gland that controls the amounts of hormones that are produced by the body.

Danazol inhibits the production of hormones called gonadotrophins by the pituitary gland. Gonadotrophins normally stimulate the production of sex hormones such as oestrogen and progestogen, which are responsible for body processes such as menstruation and ovulation.

By decreasing the production of these sex hormones, danazol can be used to treat disorders that are associated with disturbances in hormone production.

Danazol is used to treat endometriosis, a condition where the tissue that normally lines the womb grows on other organs outside the womb. The growth of endometriotic tissue is under hormonal influence, and danazol is used to control the fluctuations in hormone levels that stimulate the growth of this tissue.

Breast tissue is also under the control of sex hormones, and danazol is also used to relieve severe breast pain and tenderness in benign fibrocystic breast disease.

Danazol is only used for women who have not responded to other forms of treatment. It is also recommended that a treatment course should only last three to six months.

What is it used for?

- Endometriosis.
- Non-cancerous lumps in the breast.
- Hereditary angioedema.

Warning!

- People taking this medicine should have regular blood tests to check the levels of their blood components.
- Your liver function should be monitored while you are taking this medicine. Symptoms that may suggest a liver problem include persistent nausea and vomiting, abdominal pain, or the development of jaundice (a yellow colouring to the skin and the whites of the eyes). Consult your doctor if you experience any of these symptoms.
- Stop taking this medicine and consult your doctor immediately if you experience any of the following symptoms while taking this medicine: hair loss (especially like male baldness); marked increase in facial or body hair; voice change - hoarseness or pitch change; enlargement of the clitoris; altered vision; severe headache and vomiting; any other severe unexplained symptom.
- This medicine may be harmful to an unborn baby and should not be used during pregnancy. For this reason, treatment should be started during menstruation and women who could get pregnant should use a non-hormonal method of contraception, eg condoms, to prevent pregnancy while taking this medicine.
- People taking this medicine may find that alcohol makes you feel sick or short of breath.
- Danol may increase the risk of ovarian cancer in women treated for endometriosis. You can discuss this with your doctor.

Use with caution in

- Liver disease.
- Kidney disease.
- Any condition/state made worse by fluid retention.
- Diabetes mellitus.
- Disorders of blood lipoproteins (fats, eg cholesterol).
- Epilepsy.
- Excessive levels of red blood cells in the blood.
- High blood pressure.
- History of disease involving the heart and blood vessels.
- Malignant or cancerous disease.
- Migraine.

Not to be used in

- Severely decreased liver function.
- Severely decreased kidney function.
- Severe heart failure.
- Blood clot in the blood vessels (thromboembolism) or a history of this.
- Cancer which is dependent on male hormones for growth (androgen dependant).
- Life long inherited blood diseases which can cause a variety of symptoms, including mental health problems (porphyrias).
- Danol capsules contain lactose and may not be suitable for women with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
- Elderly people.
- Children.
- Pregnancy.
- Breastfeeding.
- 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 may be harmful to an unborn baby and should not be used during pregnancy. Women who could get pregnant should use a non-hormonal method of contraception, eg condoms, to prevent pregnancy while taking this medicine.
- It is not known whether this medicine passes into breast milk. It should not be used by breastfeeding women because of the potential harm it may cause to nursing infants. 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.

- Skin reactions, such as rash, changes in pigmentation or dermatitis.
- Backache. or muscle cramps.
- Nausea.
- Dizziness.
- Acne.
- Oily skin.
- Weight gain.
- Fluid retention or bloating.
- Increased hair growth (hirsutism).
- Headache.
- Visual disturbances.
- Vaginal dryness.

- Flushing.
- Changes in mood or anxiety.
- Change in menstrual bleeding.
- Stopping or absence of menstrual periods (amenorrhoea).
- Changes in sex drive (libido).
- Changes in blood sugar levels.
- Hair loss (alopecia).
- Reduction in breast size.
- Increased risk of abnormal blood clots within the blood vessels (thromboembolic disorders).

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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