Dostinex (Cabergoline)
Dostinex 0.5mg tablet
(Cabergoline)
1. What Dostinex is and what it is used for
Dostinex 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.
Dostinex can also be used to treat other conditions caused by hormonal disturbance which can result in high levels of prolactin being produced. This includes high levels of prolactin caused by tumours of the pituitary gland in both men and women.
Dostinex is an oral tablet that contains cabergoline and belongs to a class of medicines called ‘dopamine agonists’. Dopamine is produced naturally in the body and helps to transmit messages to the brain.
Cabergoline mimics the action of dopamine to reduce the production of prolactin in the blood.
Prolactin is the hormone which stimulates the breast to produce milk.
Dostinex should only be used in adults. It is not suitable for children under the age of 16 years.
2. Before you take Dostinex
Do not take Dostinex if:
- You are hypersensitive (allergic) to Cabergoline, to other medicines called ergot alkaloids, (e.g. pergolide, bromocriptine, lisuride, ergotamine or ergometrine) or to any of the other ingredients in the tablet (see Section 6 for further information); You have severe liver disease;
- You have high blood pressure in pregnancy associated with swelling and protein in the urine (toxaemia of pregnancy);
- You are being treated with anti-psychotics or have a history of mental illness associated with childbirth (puerperal psychosis); You are pregnant or breastfeeding.
- You will be treated with Dostinex for a long period and have or had fibrotic reactions (scar tissue) affecting your heart.
Take special care with Dostinex:
Tell your doctor if you have or had any of the following conditions to help him or her decide if Dostinex is suitable for you:
- Disease that involves the heart and blood vessels (cardiovascular disease);
- Cold hands and feet (Raynaud’s syndrome);
- Gnawing pain in the abdomen when hungry (peptic ulcer) or bleeding from the stomach and intestines (gastrointestinal bleeding);
- History of serious mental disease, particularly psychotic disorders.
- Liver or kidney disease;
- Kidney function abnormality;
- Increased blood pressure after giving birth.
- Fibrotic reactions (scar tissue) affecting your heart, lungs or abdomen. In case you are treated with
Dostinex for a long period, your physician will check before starting treatment whether your heart, lungs and kidneys are in good condition. He/she 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.
Low blood pressure (postural hypotension) or you are taking any medicines to lower your blood pressure.
It is recommended that women on long term treatment with Dostinex for hormonal disorders should have regular gynaecological exams including smear tests. Your doctor will continue to monitor your medical condition while you are taking Dostinex tablets.
Taking other medicines:
- Some medicines can reduce the effectiveness of Dostinex, these include:
- Medicines to lower your blood pressure;
- Medicines used to treat mental illness (e.g. antipsychotic medicines like chlorpromazine, haloperidol);
- Medicines for nausea and vomiting (e.g. domperidone, metoclopramide).
- Some medicines can increase the amount of Dostinex in your blood and so could increase the side effects, these include:
- Medicines for Parkinson’s disease;
- Medicines for severe migraine headaches (e.g. pergolide, bromocriptine, lisuride, ergotamine, dihydroergotamine, ergometrine or methysergide);
- Antibiotics (e.g. erythromycin).
Please tell your doctor or pharmacist if you are taking or have recently taking any other medicines, including medicines obtained without a prescription.
Taking Dostinex with food and drink
Dostinex should preferably be taken with or after food to help reduce the side effects. The effect of alcohol is unknown and should therefore be avoided.
Pregnancy
If you are pregnant or planning to get pregnant, discuss this with your doctor before treatment. Before you can start using Dostinex check that you are not pregnant. You should also take care not to become pregnant for at least one month once you have stopped taking Dostinex.
Breastfeeding
As Dostinex will stop you producing milk for your baby, you should not take Dostinex if you plan to breastfeed. If you need to take Dostinex you should use another method of feeding your baby.
Driving and using machinery
Dostinex can cause drowsiness (somnolence) and sudden sleepy episodes, in some cases without any warning signs or awareness. You are advised not to drive or operate machines or engage in activities requiring mental alertness or coordination during treatment with Dostinex. Your doctor will decide if you can continue treatment on Dostinex if this occurs.
Important information on some ingredients of Dostinex tablets
Dostinex contains lactose (a type of sugar). If you have been told you have an intolerance to sugars, consult your doctor before you take Dostinex.
3. How to take Dostinex
It is recommended you take Dostinex with or after food to help reduce feelings of nausea or vomiting.
• To prevent milk production (lactation): You should take lmg (two 0.5mg tablets) on the first day after delivery.
• To stop lactation once you have started to breastfeed: You should take 0.25mg (one half of Dostinex 0.5mg tablet) every 12 hours for two days.
• To reduce prolactin levels in other conditions: You should initially take one 0.5mg tablet (to be taken in 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 will be increased up to a maximum dose of 4.5mg or until you have responded fully to treatment.
When you first start taking the tablet, it is recommended you slowly change position when trying to sit, stand or lie down, this is because Dostinex may cause a drop in blood pressure that could make you dizzy when you move from a position. It is also recommended that you avoid alcohol and other medicines that cause drowsiness as this could increase the risk of dizziness.
During treatment your doctor may need to check your blood pressure, particularly in the first few days of treatment. A gynaecological assessment may also be carried out on the cells of your cervix or womb lining.
- If you take too many Dostinex tablets:
If you take too many Dostinex tablets, contact your doctor immediately or go to the nearest hospital casualty department.
- If you miss a dose of Dostinex:
It is important not to miss your dose. If you miss a dose take the next one as normal and tell your doctor if you have trouble remembering to take your tablets. Do not take a double dose to make up for a missed dose.
- If you stop taking Dostinex tablets:
Your doctor will advise you how long to take Dostinex. You should not stop until your doctor tells you.
If you have any further questions on how to take this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Dostinex can sometimes have side effects although not everybody gets them.
Tell your doctor immediately if you experience any of the following symptoms after taking this medicine. These symptoms can be severe:
• Abnormal or unusual thoughts
• Heart valve and related disorders e.g. inflammation (pericarditis) or leaking of fluid in the pericardium (pericardial effusion). This is a very common side effect (occurring in more than 1 in 10 patients). 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 be the first signs of a condition called pulmonary fibrosis, which can affect the lungs, heart/heart valves or lower back.
• Development of a widespread itchy rash, difficulty breathing with or without wheezing, feeling faint, unexplained swelling of the body or tongue or any other symptoms which appear to come on rapidly after taking this medication and make you feel unwell. These may be indicative of an allergic reaction.
• Strong impulse to gamble despite serious personal or family consequences.
• Aggression and increased sexual drive, which is of significant concern to the individual or to others.
During treatment you may also notice the following effects:
• Very common (occurring in more than 1 in 10 patients): drowsiness, nausea, headache, dizziness, stomach pain, indigestion, inflamed stomach lining; fatigue, rash, lack of bodily strength; weakness
• Common (occurring in less than 1 in 10 of patients): constipation, blurred vision, low blood pressure after childbirth which may not have any symptoms, breast pain, depression, sleep disturbances, excessive daytime drowsiness/sleepiness, vomiting, low blood pressure, hot flushes
• Uncommon (occurring in less than 1 in 100 patients): Episodes of sudden sleep onset, loss of hair, severe itching, shortness of breath, fainting, nosebleed, leg cramps , irregular or strong heartbeat (palpitations), pins and needles sensation, decrease in haemoglobin in amenhorrheic women, temporary partial vision loss
• Rare (occurring in less than 1 in 1000 of patients): allergic skin reactions, muscle weakness, cold hands and feet.
• Not known (cannot be estimated from the available data): swelling due to accumulation of fluid in the tissues, abnormal liver and abnormal blood tests of liver function, breathing problems with inadequate intake of oxygen, an increase in the level of some enzymes in the blood, abnormal vision
If you get any of the above side effects, or notice any other side effects not listed in this leaflet, tell your doctor or pharmacist.
5. How to store Dostinex
• Replace the cap after use as Dostinex tablets absorb moisture.
• The bottle caps contain desiccant granules. Do not remove desiccant granules from cap or transfer tablets to another container.
• Do not store above 25°C.
• Keep out of the reach and sight of children.
Dostinex should not be used after the expiry date printed on the box and on the bottle label. The expiry date refers to the last day of that month.
6.Further Information
- What Dostinex contains
The active substance is 0.5mg cabergoline. The other ingredients are lactose and leucine.
- What Dostinex looks like and contents of the pack
Dostinex is a flat capsule-shaped, scored, white tablet. The tablets are contained in an amber glass bottle with tamper resistant screw cap containing desiccant silica gel. Each bottle contains 2, 4 or 8 tablets and is enclosed in an outer cardboard carton.
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