Bromocriptine 2.5mg Tablets
Bromocriptine 2.5mg Tablets
(bromocriptine mesilate)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is available using the name Bromocriptine 2.5mg Tablets but will be referred to as Bromocriptine throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
■ Keep this leaflet. You may need to read it again.
■ If you have any further questions, ask your doctor or pharmacist.
■ This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
■ If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Bromocriptine is and what it is used for
2. What you need to know before you take Bromocriptine
3. How to take Bromocriptine
4. Possible side effects
5. How to store Bromocriptine
6. Contents of the pack and other information
1. What Bromocriptine is and what it is used for
Bromocriptine belongs to a group of drugs known as dopamine-receptor stimulants, which stop the hormone prolactin being produced by the pituitary gland.
Bromocriptine may be used for:
■ stopping breast milk production for medical reasons only, and when you and your doctor have decided that it is necessary
■ to stop the production of milk in men and women who produce too much prolactin hormone, and also in women who have recently had a baby
■ to treat tumours which release prolactin, breast disease or breast pain, problems with the menstrual cycle, or infertility
■ to reduce the amount of growth hormone in the blood
■ occasionally to treat Parkinson's disease.
Bromocriptine should not routinely be used to stop breast milk production. It should also not be used to relieve symptoms of painful breast engorgement after giving birth if these can be adequately treated with non-medical means (such as firm breast support, ice application) and/or a painkiller.
You must talk to your doctor if you do not feel better or if you feel worse within a few days of taking this medicine.
2. What you need to know before you take Bromocriptine
Do not take Bromocriptine:
■ if you are allergic (hypersensitive) to bromocriptine, any other ergot alkaloids (such as ergotamine or ergometrine) or any of the other ingredients of this medicine (listed in section 6)
■ if you are suffering from pregnancy toxaemia, which is a condition during pregnancy where you have high blood pressure, and protein present in your urine
■ if you have high blood pressure
■ if you have ever had blood pressure problems during pregnancy or after giving birth, such as eclampsia, preeclampsia, pregnancy-induced high blood pressure, high blood pressure after giving birth
■ if you have, or have ever had, heart disease, or other severe blood vessel disease
■ if you will be treated with Bromocriptine for a long period and have or had fibrotic reactions (scar tissue) affecting your heart
■ if you have, or have ever had, serious mental health problems
■ if you are breast-feeding.
Warnings and precautions
Take special care with Bromocriptine
■ Your doctor will perform baseline investigations such as blood tests, chest x-ray, lung and kidney function tests prior to commencing treatment with Bromocriptine
■ If you have liver problems, tell your doctor as it may be necessary to give you a lower dose
■ If you have or had fibrotic reactions (scar tissue) affecting your heart, lungs or abdomen. In case you are treated with Bromocriptine 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. During treatment your physician will pay special attention to any signs which may be related to fibrotic reactions. If necessary he/she will have an echocardiogram taken. If fibrotic reactions occur treatment will have to be discontinued.
■ In women, Bromocriptine can cause ovulation (where eggs are produced in the ovaries). If you do not want to become pregnant, you should use an effective barrier method of contraception. If you will be taking Bromocriptine for a long time, your doctor will want you to have regular check ups, including smear tests.
■ If you have just given birth you may be more at risk of certain conditions. These are very rare, but may include high blood pressure, heart attack, convulsion, stroke or mental problems. Therefore, your doctor will need to check your blood pressure regularly during the first days of treatment. Speak immediately to your doctor if you experience high blood pressure, chest pain or unusually severe or persistent headache (with or without vision problems).
Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others.
These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.
Talk to your doctor or pharmacist before taking Bromocriptine
■ if you have a history of mental disorders
■ if you have problems with your heart or circulation
■ if you have Parkinson's disease, as you are more likely to suffer from certain side effects (read section 4, Possible side effects)
■ if you have lung, kidney or heart problems
■ if you are taking your tablets for infertility. You will need
to tell your doctor as soon as you miss a period.
■ if you are pregnant or planning to become pregnant. If so tell your doctor immediately.
■ if you have recently given birth, had a miscarriage or an abortion
■ if you have a tumour of the pituitary gland
■ if you are having treatment to lower the amount of
growth hormone in your blood. Your doctor should assess you for peptic ulceration before you start treatment with this medicine, and advise you to tell them as soon as possible if you start to have stomach upsets and pain when you are taking this medicine.
■ if you have ever been diagnosed in the past with a problem known as fibrosis affecting the lungs, lower back and kidneys or heart. You must tell your doctor as Bromocriptine may not be appropriate for you.
Other medicines and Bromocriptine
Talk to your doctor if you are taking any of the
following:
■ macrolides, e.g. erythromycin, azithromycin, clarithromycin, used to treat infections
■ isometheptene, or ergot alkaloids e.g. ergotamine, used to treat migraine
■ medicines to lower your blood pressure such as diuretics ('water tablets'), beta-blockers, calcium channel blockers or ACE inhibitors
■ azole anti-fungals (used to treat fungal infections)
■ protease inhibitors (used to treat HIV)
■ antipsychotic medicines e.g. chlorpromazine, haloperidol, promazine, used to treat schizophrenia, or movement disorders such as tremor or restlessness
■ domperidone or metoclopramide, used to treat feeling sick (nausea), being sick (vomiting), or to help move food faster through your digestive system
■ octreotide, used to inhibit the release of growth hormone and some gut hormones and secretions
■ memantine, used to treat Alzheimer's disease
■ methyldopa, used to lower blood pressure
■ phenylpropanolamine, used in some cold and decongestant medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Bromocriptine with food and drink
You must take this medicine with a meal.
DO NOT drink alcohol while you are taking Bromocriptine.
Pregnancy and breast-feeding
■ If you are taking this medicine to treat infertility and you become pregnant, you should talk to your doctor as soon as possible, as it is advisable to stop Bromocriptine after missing your first menstrual period
■ Women of childbearing age who are taking this medicine to treat other conditions and who do not wish to become pregnant should use a barrier method of contraception
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Bromocriptine can cause effects that may make it dangerous for you to drive or use machines:
■ When you first start to take your tablets, your blood pressure may drop. This may make you feel dizzy and light-headed. If you are affected, DO NOT drive or operate machinery.
■ Bromocriptine can cause excessive daytime drowsiness, and sudden sleep onset episodes. If you ever experience these effects while you are taking this medicine, you must NOT drive or operate machinery while you continue your treatment with Bromocriptine.
Bromocriptine contains lactose
■ Patients who are intolerant to lactose should note that Bromocriptine contain a small amount of lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Bromocriptine
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The tablets should always be taken during a meal.
The recommended dose is:
■ Adults including older people
For the best result with the least risk of side effects, your doctor will introduce your treatment with Bromocriptine gradually.
1mg to 1.25mg at bedtime. After 2 to 3 days, this dose may be increased to 2mg to 2.5mg at bedtime. Your doctor may then increase your dose by another 1mg to 2.5mg every
2 to 3 days until you are taking 2.5mg twice a day. Your doctor may continue to increase your dose if necessary. For some conditions, you may have to take up to 30mg a day.
The dosage for treatment of some specific conditions is given below:
■ To stop milk production (lactation)
The usual dose is 2.5mg on the first day increasing after 2 to 3 days to 2.5mg twice a day for 14 days.
■ To prevent milk production (lactation) after you have had a baby
The usual dose is 2.5mg on the day your baby is born, followed by 2.5mg twice a day for 14 days.
■ To treat abnormal milk secretion or infertility caused by high prolactin hormone levels
Your treatment will start with the gradual introduction described above.
The usual dose for treatment of excessive milk production is 7.5mg per day in divided doses, but your doctor may decide to give you as much as 30mg daily. For infertility treatment, the usual dose is 2.5mg, twice daily.
■ To treat a tumour of the pituitary gland or excessive growth hormone production
Your treatment will start with the gradual introduction described above until you are taking 2.5mg twice a day. Your dose may then be increased by 2.5mg per day every two to three days, and may be increased up to as much as 30mg per day given in divided doses.
■ To treat cyclical breast disease and/or breast pain or disorders of the menstrual period
Your treatment will start with the gradual introduction described above until you are taking 2.5mg twice a day.
■ To treat acromegaly (a growth disorder)
Your treatment will start with the gradual introduction described above until you are taking 2.5mg twice a day. Your dose may then be increased by 2.5mg per day every two to three days, and may be increased up to as much as 30mg per day given in divided doses.
■ For Parkinson's disease
Your treatment will start with a dose of 1mg to 1.25mg daily taken at bedtime. Your doctor will then increase your dose weekly until he finds the correct dose for you. This is usually between 10mg and 30mg a day.
■ Use in children under 15 years of age
Bromocriptine should not be used in children under 15 years of age.
If you take more Bromocriptine than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.
An overdose is likely to cause vomiting (being sick), confusion, hallucinations, and lowering of blood pressure.
Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you forget to take Bromocriptine
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Bromocriptine
DO NOT stop taking your medicine without talking to your doctor first even if you feel better.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seek immediate medical help if you have any of the following symptoms:
■ You have a headache which does not go away, or is severe
■ You get any problems with your eyesight after giving birth
■ You feel faint, dizzy or have blurred vision
■ You have blood in your stools. They may look black and tarry
■ You vomit blood or dark particles that look like coffee granules
■ You have severe pains in your stomach
■ You have difficulty breathing, shortness of breath, swollen legs, chest or back pain.
Common; may affect up to 1 in 10 people
■ headache
■ dizziness
■ drowsiness
■ feeling and being sick
■ constipation
■ blocked nose.
Uncommon; may affect up to 1 in 100 people
■ restlessness
■ confusion or hallucinations
■ dry mouth
■ dizziness or light-headedness upon standing which may cause you to collapse (you may have low blood pressure)
■ leg cramps
■ itchy, red or swollen skin
■ hair loss
■ tiredness.
Rare; may affect up to 1 in 1000 people
■ extreme drowsiness
■ insomnia (trouble sleeping)
■ pins and needles
■ mental health problems
■ diarrhoea
■ inability to pass water and back pain
■ irregular heart beat including an abnormally slow or fast beating of the heart
■ lung problems that may cause difficulty breathing, a shortness of breath, pain when you breathe in, or a cough that doesn't go away
■ swelling of the ankles
■ disturbed or blurred vision
■ watery discharge from your nose
■ ringing in your ears.
Very rare; may affect up to 1 in 10,000 people
■ heart valve disorders such as inflammation or leaking of fluid in the heart - these may cause difficulty breathing, chest pains, weakness and swelling of the legs and ankles
■ extreme drowsiness during the day or falling asleep unexpectedly
■ pale or white fingers and toes, caused by cold temperatures.
You may experience the following side effects:
Not known: frequency cannot be estimated from the available data
Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
■ Strong impulse to gamble excessively despite serious personal or family consequences
■ Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive
■ Uncontrollable excessive shopping or spending
■ Binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger).
Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Bromocriptine
Keep out of the sight and reach of children.
Do not use Bromocriptine after the expiry date that is stated on the carton and blister label (Exp). The expiry date refers to the last day of that month.
Do not store above 25°C.
Protect from light and moisture.
If your doctor decides to stop treatment, return any leftover tablets to the pharmacist. Only keep them if the doctor tells you to.
If your medicine appears to be discoloured or shows any other signs of deterioration, please return to your pharmacist.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Bromocriptine contains
Each tablet contains bromocriptine mesilate 2.87mg, equivalent to 2.5mg bromocriptine base.
Also contains: lactose, maize starch, povidone, maleic acid, magnesium stearate and colloidal silicon dioxide.
What Bromocriptine looks like and contents of the pack
Bromocriptine are white, round tablets with a breakline on one side, embossed with 'BCE' above the breakline and '2.5' below the breakline, and plain on the reverse.
Bromocriptine is available in packs of 30 tablets.
Manufacturer
Manufactured by: DOPPEL FARMACEUTICI S.r.l., Stabilimento de Quinto de' Stampi, Rozzano (MI), Italy.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd.,
7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0579 POM
Leaflet issue and revision date (Ref): 23.07.15
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