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• leaflet MAH GENERIC_PL 00289-1395

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Package leaflet: Informationforthe us

BROMOCRIPTINE 2.5 mg TABLETS

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.

♦    Ifyou have anyfurtherquestions, askyour 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.

♦    Ifyou get any side effects, talkto your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.

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

OWhat bromocriptine is and what it is used for

BromocriptineTablets belong to a group of drugs known as dopamine-receptor stimulants, which stopthe 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 ifthese can be adequatelytreated with non-medical means (such as firm breast support, ice application) and/or a painkiller.

You must talkto a doctor ifyou do not feel betteror if you feel worse within a few days oftaking this medicine.

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) orany ofthe 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

♦    ifyou have high blood pressure

♦    if you have ever had blood pressure problems during pregnancy or after giving birth, such as eclampsia, pre-eclampsia, pregnancy-induced high blood pressure, high blood pressure after giving birth

♦    ifyou have, or have ever had, heart disease, or other severe blood vessel disease

♦    ifyouwill betreatedwith bromocriptinefor a long period and have or had fibrotic reactions (scartissue) 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 Tablets

♦    Yourdoctorwillperformbaseline investigations such as blood tests, chest x-ray, lung and kidney function tests prior to commencing treatment with BromocriptineTablets

♦    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 BromocriptineTablets for a long period, your physician will check before starting treatment whetheryour heart, lungs and kidneys are in good condition. He/she will also have an echocardiogram (an ultrasound test ofthe 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 occurtreatment will have to be discontinued.

♦    In women, BromocriptineTablets can cause ovulation (where eggs are produced in the ovaries). Ifyou do not wantto become pregnant, you should use an effective barrier method of contraception. If you will be taking BromocriptineTablets fora long time, yourdoctor 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 checkyour blood pressure regularly during the first days oftreatment. Speak immediately to yourdoctor ifyou experience high blood pressure, chest pain

or unusually severe or persistent headache (with or without vision problems).

Tell your doctor if you or yourfamily/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 ortemptation to carry out certain activities that could harm yourselforothers. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating orspending, an abnormally high sex drive or an increase in sexual thoughts or feelings. Your doctor may need to adjust or stopyour dose.

Talk to your doctor or pharmacist before taking bromocriptine

♦    ifyou have a history of mental disorders

♦    ifyou have problems with your heart or circulation

♦    ifyou have Parkinson's disease, as you are more likely to suffer from certain side effects (read section 4, Possible side effects)

♦    ifyou have lung, kidney or heart problems

♦    ifyou are taking yourtablets for infertility. You will need to tell your doctoras soon as you miss a period.

♦    ifyou are pregnant or planning to become pregnant. If so tell your doctor immediately.

♦    ifyou have recently given birth, had a miscarriage or an abortion

♦    ifyou have a tumour of the pituitary gland

♦    if you are having treatment to lower the amount ofgrowth 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.

♦    ifyou have ever been diagnosed in the past with a problem known as fibrosis affecting the lungs, lower backand kidneys or heart. You must tell your doctor as Bromocriptine Tablets may not be appropriate foryou.

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 ('watertablets'), 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 doctoror 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 drinkalcohol while you are taking BromocriptineTablets.

Pregnancy and breast-feeding

♦    Ifyou are taking this medicine to treat infertility and you become pregnant, you should talkto yourdoctor as soon as possible, as it is advisable to stop BromocriptineTablets after missing your first menstrual period

♦    Women of childbearing age who are taking this medicine to treat otherconditions and who do not wish to become pregnant should use a barrier method of contraception

Ifyou are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, askyour doctor or pharmacist for advice before taking this medicine.

Driving and using machines BromocriptineTablets can cause effects that may make it dangerous foryou 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 oroperate machinery.

♦    BromocriptineTablets can cause excessive daytime drowsiness, and sudden sleep onsetepisodes. 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 Tablets.

Bromocriptine tablets contain lactose

♦    Patients who are intolerant to lactose should note that BromocriptineTablets contain a small amount of lactose. Ifyour doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take bromocriptine

Always take this medicine exactly as your doctoror pharmacist has told you. Checkwith your doctor or pharmacist ifyou 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 riskof side effects, your doctor will introduce your treatment with BromocriptineTablets gradually.

1 mg to 1.25 mg at bedtime. After 2to3 days, this dose may be increased to 2 mg to 2.5 mg at bedtime.Your doctor may then increase your dose by another 1 mg to 2.5 mg every 2to3 days until you are taking 2.5 mg twice a day. Yourdoctor may continue to increase your dose if necessary. For some conditions, you may have to take up to 30 mg a day. The dosage for treatment of some specific conditions is given below:

*    To stop milk production (lactation)

The usual dose is 2.5 mg on the first day increasing after 2to3 days to 2.5 mg twice a day for 14 days.

*    To prevent milk production (lactation) after you have had a baby

The usual dose is 2.5 mg on the day your baby is born, followed by 2.5 mg twice a day for 14 days.

*    To treat abnormal milk secretion or infertility caused by high prolactin hormone levels

Yourtreatment will start with the gradual introduction described above.

The usual dose fortreatment of excessive milk production is 7.5 mg per day in divided doses, but your doctor may decide to give you as much as 30 mg daily.

For infertilitytreatment,the usual dose is 2.5 mg, twice daily.

*    To treat a tumour of the pituitary gland or excessive growth hormone production

Yourtreatment will start with the gradual introduction described above until you are taking 2.5 mg twice a day.

Yourdose may then be increased by 2.5 mg perday everytwo to three days, and may be increased up to as much as 30 mg per day given in divided doses.

*    To treat cyclical breast disease and/or breast pain or disorders of the menstrual period

Yourtreatment will start with the gradual introduction described above until you are taking 2.5 mg twice a day.

*    To treat acromegaly (a growth disorder)

Yourtreatment will start with the gradual introduction described above until you are taking 2.5 mg twice a day.

Yourdose may then be increased by 2.5 mg perday everytwo to three days, and may be increased up to as much as 30 mg per day given in divided doses.

*    For Parkinson's disease

Your treatment will start with a dose of 1 mg to 1.25 mg daily taken at bedtime. Your doctor will then increase your dose weekly until he finds the correct dose foryou.

This is usually between 10 mg and 30 mg a day.

*    Use in children under 15 years of age

BromocriptineTablets should not be used in children under 15 years of age.

If you take more Bromocriptine Tablets than you should

If you (or someone else) swallow a lot ofthe tablets all together, orifyouthinka child has swallowed any ofthe tablets, contact your nearest hospital casualty department oryour 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 Tablets

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 upfor a forgotten dose.

If you stop taking Bromocriptine Tablets DO NOT stop taking your medicine without talking to yourdoctor first even ifyou feel better.

If you have any furtherquestions on the use of this medicine, askyour doctoror pharmacist.

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 upto 1 in 10 people

*    headache

*    dizziness

*    drowsiness

*    feeling and being sick

*    constipation

*    blocked nose.

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 uptolin 1000 people

♦    extreme drowsiness

♦    insomnia (trouble sleeping)

♦    pins and needles

♦    mental health problems

♦    diarrhoea

♦    inability to pass waterand back pain

♦    irregular heart beat including an abnormally slow orfast beating ofthe 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 ofthe ankles

♦    disturbed or blurred vision

♦    watery discharge from your nose

♦    ringing in your ears.

Very rare; may affect upto 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 orwhite 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 orfamily consequences

♦    Altered or increased sexual interest and behaviourofsignificant 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 Ifyou get any side effects, talkto your doctor or pharmacist.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via theYellow 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 this medicines out of the sight and reach of children.

You should keepthese tablets below25^sC and away from light and moisture. Keepthem in the packthey came in. Do not put them into anothercontainer.

Do not use this medicine afterthe expiry date which is stated on the carton.The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Askyour pharmacist how to throw away medicines you no longer use.These measures will help protect the environment.

©Contents of the pack and other information

What Bromocriptine Tablets contain

♦ BromocriptineTablets contain

bromocriptine mesylate, equivalent to bromocriptine base 2.5 milligrams (mg)

♦ The other ingredients are lactose, corn starch, maleic acid, colloidal silicon dioxide, magnesium stearate and polyvinyl pyrrolidone.

What Bromocriptine Tablets look like and contents of the pack

BromocriptineTablets are white round tablets embossed BCE 2.5 with a breakline on one side and plain on the reverse.

♦ They come in packs of 7,14, 21, 28,30, 50, 56, 60, 84, 90, 100, 112, or 120 tablets.

Not all packsizes may be marketed. Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder and company responsible for batch release is TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised in January 2015

PL 00289/1395

Uncommon; may affect upto 1 in 100 people

♦    restlessness

♦    confusion or hallucinations

♦    dry mouth

♦    dizziness or light-headedness upon