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Package leaflet: Information for the patient

Cabarsuss 0.5 mg tablets

Cabergoline

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 Cabarsuss is and what it is used for

2. What you need to know before you take Cabarsuss

3. How to take Cabarsuss

4. Possible side effects

5. How to store Cabarsuss

6. Contents of the pack and other information

1. What Cabarsuss is and what it is used for

Cabarsuss belongs to a group of medicines known as prolactin inhibitors.

Cabarsuss prevents lactation (production of milk) by decreasing levels of a hormone known as prolactin.

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

2. What you need to know before you take Cabarsuss

Do NOT take Cabarsuss if you:

• are allergic to cabergoline or other ergot alkaloid medicines (e.g. bromocriptine) or any of the other ingredients of this medicine (see Section 6 and end of Section 2)

• have psychosis, or a history of psychosis, or you are at risk of psychosis after childbirth

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

• have ever been diagnosed in the past with a problem known as fibrosis affecting the lungs, lower back and kidneys or heart.

Warnings and precautions

Talk to your doctor before taking Cabarsuss

If you have any of the following health problems you must inform your doctor before taking Cabarsuss as this medicine may be unsuitable for you:

• cardiovascular disease

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

• liver or kidney problems

• Raynaud’s disease (a condition where fingers and toes become bluish white, with no pulse, cold, insensitive and fumbling on exposure to cold or stress)

• low blood pressure (which can result in dizziness - this usually happens on standing up)

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

• if you have a history of serious mental disorder, particularly psychotic disorders

• if you have swelling of the hands, feet and a high blood pressure during pregnancy (preeclampsia, eclampsia)

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

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 behaviours are called impulse control disorders and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or an increase in sexual thoughts or feelings. Your doctor may need to review your treatment.

Infertility can be reversed in women taking Cabarsuss, and pregnancy can occur before the menstrual cycle has normalised. Therefore a pregnancy test is recommended at least every 4 weeks until menses are reinitiated, and from then on every time a menstrual period is delayed by more than 3 days. Means of contraception should therefore be used during treatment with Cabarsussand also after discontinuation of treatment until recurrence of anovulation (see section “Pregnancy”).

Children and adolescents

The safety and efficacy of Cabarsuss has not been established in subjects less than 16 years of age.

Long term use

In case you are treated with Cabarsuss 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.

Other medicines and Cabarsuss

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, or herbal medicines.

Some medicines, if taken at the same time as Cabarsuss,can interfere with the effects of your tablets. These are medicines for:

• reducing blood pressure

• the treatment of psychological illnesses such as schizophrenia or psychoses (e.g. phenothiazines, butyrophenones, thioxanthene)

• other ergot alkaloids, medicines to prevent vomiting (e.g. metoclopramide)

• antibiotics (e.g. erythromycin)

The treating doctor should therefore be aware of all medicines you may be taking as some medicines should be avoided.

Cabarsuss with food, drink and alcohol

TakeCabarsuss preferably with meals to reduce side effects.

Avoid alcohol while you are taking Cabarsuss.

Pregnancy and breast-feeding

Pregnancy

Before you can start using cabergoline you must be checked to ensure that you are not pregnant. Additionally you should take care not to become pregnant for at least one month after you have stopped treatment with cabergoline. If you are being treated with Cabarsuss and become pregnant during this time you should stop the treatment and contact your doctor as soon as possible.

Breast-feeding

It is not known whether cabergoline passes into breast milk. AsCabarsuss will stop you from producing milk for your baby, you should not take Cabarsuss if you plan to breastfeed. If you need to take Cabarsussyou should use another method for feeding your baby.

Nursing mothers should be aware that the quantity of milk can be reduced.

Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Cabarsusscan reduce your ability to react quickly as it reduces blood pressure. This should be considered in cases where a high level of alertness is required, e.g. driving a car or in precision work.

Cabarsuss can cause extreme drowsiness and sudden sleep episodes can occur. If you are affected by these you should not drive or operate machinery. If affected, consult your doctor.

Cabarsusscontains lactose

If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicine.

3. How to take Cabarsuss

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Take the tablets with meals to reduce certain side effects such as nausea, vomiting and stomach pains.

The exact dose will be determined by your doctor to suit your needs. Cabarsuss 0.5 mg tablets can be broken into two equal halves if necessary.

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

To stop lactation once you have started to breastfeed: You should take 0.25 mg (one half of Cabarsuss 0.5 mg tablet) every 12 hours for two days. This dosage regimen should not be exceeded.

Usually the treatment is started with 0.5 mg per week given in one (single 0.5 mg) or two (separate 0.25 mg) doses, but higher doses may then be necessary. Your doctor will tell you how long you need to take your tablets.

Patients with hepatic or renal dysfunction

These tablets should be used with caution.

Elderly

No dose adjustment is necessary.

Children and adolescents

Cabarsuss is not recommended in patients under 16 years of age.

If you take more Cabarsuss 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. Take this leaflet and any remaining tablets with you.

Symptoms of overdose may include nausea, vomiting, reduced blood pressure, drop in blood pressure following a change of body position into a more upright position, stomach pain, changes in behaviour, confusion or hallucinations (seeing things).

If you forget to take Cabarsuss

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

If it is almost time to take the next dose, skip the forgotten dose and take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Cabarsuss

If you stop taking Cabarsussthe symptoms of your illness may become more severe and you should consult 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.

4. Possible side effects

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

When used for stopping the production of breast milk about 14 in 100 patients have some form of side effects. The most common are low blood pressure, dizziness and headache.

When used to reduce prolactin levels side effects are more common as the tablets are taken for a longer period of time. Approximately 70 in 100 patients can experience side effects, but these mostly disappear or decrease after about 2 weeks.

Tellyour doctorimmediatelyifyou experience any ofthefollowing symptomsafter takingthis medicine. These symptomscan besevere:

• Abnormalor unusualthoughts.

• Heartvalveand relateddisorderse.g. inflammation(pericarditis)orleakingof fluidin the sac that surrounds the heart (pericardialeffusion).Thisis averycommonside effect(mayaffect morethan 1in 10people).Theearlysymptomsmaybeone ormoreof thefollowing: difficultybreathing, shortnessofbreath,poundingheart,feelingfaint,chestpain,backpain, pelvicpain orswollenlegs.Thesemaybe thefirstsignsof acondition calledpulmonaryfibrosis,which canaffectthe lungs,heart/heartvalvesorlower back.

• Developmentof awidespreaditchyrash,difficultybreathingwith orwithout wheezing, feelingfaint, unexplainedswellingof the bodyor tongue orany other symptoms which appearto comeon rapidlyaftertakingthis medicationand make youfeel unwell.Thesemaybe indicativeof anallergicreaction.

Youmay experience thefollowing sideeffects:

• Inabilityto resisttheimpulse,driveor temptationto performan actionthatcouldbe harmfulto youor others,whichmayinclude:

Tell your doctorifyou experience any ofthese behaviours;they willdiscusswaysof managing or reducingthesymptoms.

Duringtreatmentyou mayalso noticethefollowingeffects:

• Very common (may affectmorethan 1 in 10 people)nausea,headache, dizziness, vertigo,stomachpain, inflammation of the stomach (dyspepsia/gastritis), fatigue, lackof bodilystrength,weakness.

• Common(may affect up to 1 in 10 people) constipation, low blood pressureafterchildbirthwhichmaynot haveany symptoms, drop in blood pressure following a change of body position into a more upright position, breastpain,depression,excessivedaytimedrowsiness/sleepiness,vomiting, low bloodpressure,hot flushes, facial redness, chest pain.

• Uncommon (may affectup to 1 in 100 people)lossof hair,shortnessof breath,fainting,nosebleed,leg cramps, swellingdue toaccumulationof fluidin the tissues(oedema),rash,irregularor strongheartbeat(palpitations),pinsandneedles sensation, decreasein haemoglobin in women whose periods had stopped and thenre- started,temporarypartialvisionloss, disorder of blood vessels (digital vasospasm), increased libido, fluid in the layers of the membrane lining the lungs and chest cavity, loss of consciousness (syncope)

• Rare (may affect up to 1in 1000 people) Pain in the upper stomach, cramp in fingers

• Not known (frequency cannot be estimatedfromthe available data) abnormalliver and abnormalbloodtests ofliverfunction,breathingproblems with inadequateintakeof oxygen,episodes of suddensleeponset,seeingor hearingthings thatarenot reallythere(hallucinations), delusions, psychoticdisorder, involuntary movements (tremor), chest pain (angina pectoris), inflammation and pain of the membrane surrounding the lungs (pleura), abnormal vision

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 national reporting system [to be completed nationally] By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Cabarsuss

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month. Theshelf life after the first opening is 3 months.

Keep the bottle tightly closed in order to protect from light and moisture.

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

6. Contents of the pack and other information

What Cabarsuss contains

The active substance is cabergoline. Each tablet contains 0.5 mg cabergoline.

The other ingredients are anhydrous lactose (see end of Section 2 for further information on lactose) and L-Leucine

What Cabarsuss looks like and contents of the pack

White, oval, uncoated tablet, scored and debossed with “C 1/2“ on one side.

The tablet can be divided into equal halves by a breakline.

Amber glass bottle with PP cap: 2, 4, 8, 30 and 90 tablets.

The bottle contains a silicagel capsule.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:

[To be completed nationally]

This leaflet was last approved in 2014-09-18

[To be completed nationally]