Doxurra 0,5 mg Tablets

DOXURRA belongs to a group of medicines called dopamine agonists. Dopamine is produced naturally in the body and helps to transmit messages to the brain.

DOXURRA is used to:

• stop breast milk production (lactation) soon after childbirth, stillbirth, abortion or miscarriage. It can also be used if you do not want to continue to breastfeed your baby once you have started.
• treat other conditions caused by hormonal disturbance which can result in high levels of prolactin being produced. This includes lack of periods, infrequent and very light menstruation, periods in which ovulation does not occur and secretion of milk from your breast without breastfeeding. Also, in conditions in which high levels of prolactin are due to unknown causes (idiopathic hyperprolactinaemia) or are caused by tumours of the pituitary gland in both men and women.

Do not take DOXURRA:

• if you are hypersensitive (allergic) to cabergoline, any ergot alkaloid (e.g. pergolide, bromocriptine, ergotamine) or any of the other ingredients of DOXURRA (listed in section 6),
• if you are pregnant or breastfeeding your baby. You should stop breastfeeding your baby once you start taking DOXURRA (see section Pregnancy, breastfeeding and fertility),
• if you had high blood pressure, swelling of the hands and feet or protein in your urine in the second half of your pregnancy or soon after you have given birth to your baby (pre-eclampsia or toxaemia of pregnancy, post-partum hypertension),
• if you have had fibrotic reactions (scar tissue) affecting your abdomen, heart or lungs,
• if you have liver problems,
• if you are being treated with anti-psychotic medicines used to treat mental illnesses, or if you have a history of mental illness associated with childbirth (puerperal psychosis),
• if you will be treated with DOXURRA for a long time and have stiff and inflamed heart valves (cardiac valvulopathy).

Warnings and precautions

Take special care with DOXURRA:

• If you suffer from any of the following inflammatory disorders: inflammation of the linings around the lungs (pleuritis), build-up of fluid between the tissue that lines the lungs and the chest (pleural effusion), thickening and stiffening of the linings around the lungs (pleural fibrosis), a lung disease that occurs when lung tissue becomes damaged and scarred (pulmonary fibrosis), swelling and irritation of the thin, sac-like membrane surrounding the heart (pericarditis), the build-up of too much fluid in the double-layered, sac-like membrane around the heart (pericardial effusion), one or more of the valves in your heart doesn't work properly (cardiac valvulopathy involving one or more valves e.g. aortic, mitral and tricuspid) or a rare condition that occurs when excess fibrous tissue develops in the space behind your stomach and intestine (retroperitoneal fibrosis).
• Fibrotic reactions (scar tissue) affecting your heart, lungs or abdomen. In case you are treated with DOXURRA for a long period, your doctor will check before starting treatment whether your heart, lungs and kidneys are in good condition. They will also have an echocardiogram (an ultrasound test of the heart) taken before treatment is started and at regular intervals during treatment. If fibrotic reactions occur treatment will have to be discontinued.

Do not share medicines prescribed for you with any other person. Always take DOXURRA exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose of DOXURRA:

• To stop/prevent the production of milk: You should take 1 mg (two 0,5 mg tablets) on the first day after giving birth to your baby.
• To stop milk production once you have started to breastfeed: You should take 0,25 mg (one half of DOXURRA 0,5 mg tablet) every 12 hours for two days.
• To reduce the level of the hormone prolactin in other conditions: You should initially take one 0,5 mg tablet (to be taken in one or two doses) spread out over a week (e.g., half a tablet on Monday and the other half of the tablet on Thursday). Your dose can be increased gradually until you respond to treatment.

DOXURRA should be taken preferably with meals.

DOXURRA can have side effects. Not all side effects reported for DOXURRA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DOXURRA, please consult your healthcare provider for advice.

If any of the following happens, stop taking DOXURRA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to DOXURRA. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• changes in the way your heart beats, for example if you notice it beating faster or irregularly, heart problems such as heart valve and related disorders e.g. inflammation (pericarditis) or leaking of fluid in the sac around the heart (pericardial effusion). The early symptoms may be one or more of the following: difficulty breathing, shortness of breath, pounding heart, feeling faint, chest pain, back pain, pelvic pain or swollen legs. These may also be the first signs of a condition called pulmonary fibrosis, which can affect the lungs, heart/heart valves or lower back,
• chest pain (angina pectoris),
• fluid build-up in the lungs, causing difficulty in breathing (pleural effusion),
• abnormal liver function, which may cause yellowing of the skin and eyes (jaundice), abnormal tiredness or severe pain in the upper abdomen.

These are all serious side effects. You may need urgent medical attention.

Store all medicines out of reach of children. Store at or below 25 °C. Protect from light and moisture. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).