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Cabergoline 0.5mg Tablets

Document: leaflet MAH BRAND_PLPI 40739-0049 change

CABERGOLINE 0.5mg TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

Your medicine is known by the above name but will be referred to as Cabergoline 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 Cabergoline is and what it is used for

2.    What you need to know before you take Cabergoline

3.    How to take Cabergoline

4.    Possible side effects

5.    How to store Cabergoline

6.    Contents of the pack and other information

WHAT CABERGOLINE IS AND WHAT IT IS USED FOR

Cabergoline belongs to a group of medicines known as prolactin inhibitors. Cabergoline prevents lactation (production of milk) by decreasing levels of a hormone known as prolactin.

Cabergoline can also be used to reduce abnormal quantities of the hormone prolactin in the blood.

[2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE CABERGOLINE Do not take Cabergoline if you:

•    are allergic to cabergoline or other ergot alkaloids (e.g. bromocriptine), or to any of the other ingredients in this medicine (listed in section 6)

•    have (or have had in the past) psychosis or you are at risk of psychosis after childbirth

•    have severely impaired liver function

•    have swelling of the hands, feet and a high blood pressure during pregnancy (pre-eclampsia, eclampsia)

•    have uncontrolled high blood pressure or high blood pressure after childbirth

•    are pregnant or breast-feeding

•    have previously experienced side effects affecting lung, such as fibrosis, associated with the use of dopamine agonists (e.g. bromocriptine, pergolide)

•    will be treated with Cabergoline for a long period and have or had fibrotic reactions (scar tissue) affecting your heart.

Warnings and precautions

If you have any of the following health problems you must inform your doctor before taking Cabergoline as the medicinal product may be unsuitable for you:

•    cardiovascular disease

•    stomach ulcer or bleeding in the gastrointestinal tract, (this condition can cause black faeces or vomiting with blood)

•    impaired kidney function

•    liver or kidney disease

•    history of serious mental disease, particularly psychotic disorders

•    Raynaud's disease (when it is cold the fingers and toes become bluish white, with no pulse, cold, insensitive and numb)

•    low blood pressure or you are taking medicines to lower blood pressure

•    increased blood pressure after giving birth

•    serious chest complaint (e.g. pain in the chest when breathing, fluid in the lungs, inflammation or infection of the lungs)

•    if you have ever been diagnosed in the past with a problem known as fibrotic disease (scar tissue) affecting the lungs, lower back and kidneys or heart.

In case you are treated with Cabergoline for a long period, your doctor will check before starting treatment whether your heart, lungs and kidneys are in a 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.

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.

The effect of alcohol on the tolerability of cabergoline is unknown.

Infertility can be reversed in women taking Cabergoline and pregnancy can occur before the menstrual cycle has normalised. Suitable means of contraception should therefore be used during treatment if necessary.

It is recommended that women on long term treatment with Cabergoline for hormonal disorders should have regular gynaecological exams including smear tests. Your doctor will continue to monitor your medical condition while you are taking Cabergoline tablets.

Children and adolescents

The safety and efficacy of Cabergoline has not been established in children and adolescents less than 16 years of age.

Other medicines and Cabergoline

•    Certain medicines used for reducing blood pressure and certain medicinal products (e.g. phenothiazines,

butyrophenones, thioxanthene) used for the treatment of psychological illnesses (schizophrenia or psychoses), if taken at the same time as Cabergoline, can interfere with the effects of cabergoline. The treating doctor should therefore be aware of such simultaneous medication.

•    There are other medicines such as other ergot alkaloids, medicines to prevent vomiting (metoclopramide), medicines for reducing high blood pressure, and macrolide antibiotics (such as erythromycin) that may affect the activity and tolerability of Cabergoline.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicinal products, including those obtained without a prescription and natural medical products/natural products. Cabergoline with food and drink

•    Cabergoline should be taken by mouth, preferably with meals.

Pregnancy, breast-feeding and fertility

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.

Pregnancy

•    There is only limited experience of the use of Cabergoline during pregnancy. You should therefore consult your doctor if you are pregnant or plan to become pregnant before the treatment is started.

•    If you are being treated with Cabergoline and become pregnant during this time you should discontinue the treatment and contact your doctor as soon as possible.

•    Contraception should be continued for at least 4 weeks after stopping cabergoline.

Breast-feeding

•    It is not known whether cabergoline passes into breast milk.

•    Cabergoline should not be taken by mothers who intend to breast-feed as it prevents lactation. Nursing mothers should note that the quantity of milk can diminish.

Fertility

•    If you are planning to become pregnant the Cabergoline should be discontinued one month before intended pregnancy. You should therefore consult your doctor if you are pregnant or plan to become pregnant before the treatment is started.

Driving and using machines

•    Cabergoline can negatively affect the ability to react in some people and this should be considered in cases where a high level of alertness is required, e.g. driving a car and in precision work

•    Cabergoline can cause somnolence (extreme drowsiness) and sudden sleep onset. Persons affected by this should therefore not drive or take part in activities in which reduced alertness could incur a risk of serious harm (e.g. using machines), until such recurrent episodes and somnolence have resolved.

Cabergoline contains lactose

•    Cabergoline 0.5mg tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars you should contact your doctor before taking this medicine.

HOW TO TAKE CABERGOLINE

Always take Cabergoline exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The dose is determined by your doctor who adjusts it individually for you.

The tablets should be taken with meals to reduce certain side effects such as nausea, vomiting and stomach pains.

•    To stop the production of breast milk:

The usual dose is 1 mg (as a single dose) within 24 hours after giving birth

•    To reduce the concentration of prolactin in the body:

Usually the treatment is started with 0.5 mg per week, but higher doses may then be necessary. Your doctor will tell you for how long you must take your tablets.

Cabergoline 0.5mg Tablets have a score and can be divided into two equal halves. 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 Cabergoline 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 more Cabergoline than you should

It is important not to take too many tablets. Contact your nearest hospital Accident and Emergency department or a doctor for advice if you have taken too many tablets or if you think a child has swallowed any.

Symptoms of an overdose may include nausea, vomiting, reduced blood pressure, stomach pain, changes in behaviour, confusion or hallucinations (seeing things).

Take this leaflet and any tablets that you still have to show the doctor.

If you forget to take Cabergoline

If you forget to take a dose at the right time, you can take it as soon as you remember it.

If it is almost time to take the next dose, skip the forgotten dose and take the next dose as usual.

If you stop taking Cabergoline

If you stop using Cabergoline the symptoms of your illness may become more severe and you should discuss with your doctor before you discontinue therapy.

Cabergoline takes many days to be cleared from the bloodstream and effects may worsen over a 2 week period resulting in increased lactation.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone gets them.

When used for stopping the production of breast milk approximately 14 in 100 patients have some form of side effects. The most common are low blood pressure, dizziness and headache. In treatment of increased prolactin levels side effects are more common as the tablets are taken for a longer period of time. Approximately 70 in 100 patients then experience side effects, but the side effects mostly disappear or decrease after approx. 2 weeks.

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 (may affect 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.

This is an uncommon side effect (may affect 1 to 10 users in 1000).

You may experience the following side effects:

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.

During treatment you may also notice the following side effects:

Very common side effects (may affect more than 1 user in 10):

•    Dizziness or spinning feeling (vertigo), headache, feeling sick (nausea), stomach pain, upset stomach, inflammation of the stomach lining (gastritis), feeling weak, tired or fatigued.

Common side effects (may affect 1 to 10 users in 100):

•    low blood pressure upon standing (which can result in dizziness), depression, excessive daytime sleepiness, blurred vision, being sick (vomiting), constipation, breast pain, hot flushes, redness of the face, low blood pressure after childbirth which may not have any symptoms, low blood pressure (long term-treatment).

Uncommon side effects (may affect 1 to 10 users in 1000):

•    nosebleeds, leg cramps, fainting, your fingers or toes turn white or blue with a feeling of numbness after exposure to cold (digital vasospasm), crawling/prickling sensations in the body, loss of half of the vision in one or both eyes, pounding of the heart (palpitations), rash, hair loss, increased sex drive, swelling due to accumulation of fluid in the tissue (oedema), low haemoglobin values in blood, lung scar tissue, fluid in the space around the lung (pleural effusion).

Rare side effects (may affect 1 to 10 users in 10,000):

•    pain the upper central abdomen

•    cramps in fingers.

Not known (cannot be estimated from the available data):

•    sudden sleep attacks, seeing and hearing things that are not real (hallucinations), delusions, psychotic disorder, unintentional trembling or shaking movements (tremor), chest pain (angina), abnormal liver and abnormal blood tests of liver function, breathing problems with inadequate intake of oxygen, inflammation of the lining of the lung (pleuritis), an increase in the level of some enzymes in the blood, loss of vision and aggression.

Development of excess fibrous connective tissue (fibrosis) e.g. in the heart, lungs, and kidneys has been reported. You should become aware of this as difficulty breathing, chest pain, back pain and swelling of the legs.

Cabergoline has been linked with somnolence and sudden sleep attacks.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

^ HOW TO STORE CABERGOLINE Keep out of the sight and reach of children.

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

Do not store above 25°C. Store in the original package to protect from moisture. The drying bag with silica gel must not be removed from the bottle.

If your tablets show signs of deterioration or discolouration seek the advice of your pharmacist who will tell you what to do.

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.

contents of the pack and other information

What Cabergoline contains

Each tablet contains 0.5mg cabergoline.

Also includes lactose anhydrous, L-leucine and magnesium stearate.

What Cabergoline looks like and the contents of the pack

Each oval shaped, white flat tablet with bevelled edges has a dividing score line embossed with 'CBG' and '0.5' either side of the scoreline, and is plain on the reverse.

Available in bottles containing 8 tablets.

Who manufactured your medicine

Manufactured by Ratiopharm GmbH, DE 89079 Ulm, Germany. Procured from within the EU and repackaged by Product Licence Holder Ennogen Healthcare Ltd, Unit G4 Riverside Industrial Estate, Riverside Way, Dartford, Kent DA1 5BS.

PL 40739/ 0049    I POM I

Leaflet date: 3 December 2015 Ref: Cab0.5/v1