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Package leaflet: Information for the patient

Cabarsuss 3 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 dopamine agonists. Itacts in a similar way to a chemical present in the nervous system called dopamine. Patients with Parkinson’s disease do not have enough of this important chemical in their body.

Cabarsuss is used to treat Parkinson’s disease. It can be used either taken alone or in combination with levodopa, as second choice following non-ergot derived therapies.

Treatment by a specialist is required with regular checks.

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)

• 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.

Before you are given Cabarsussyour doctor will arrange for you to have tests to assess the condition of your heart. Your doctor will continue to monitor your medical condition while taking Cabarsuss.

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)

• kidney problems

• liver problems

• psychosis (currently or in the past)

• 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)

• history of serious mental disorder, particularly psychotic disorders.

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.

Regular checks of blood pressure are recommended in the first 3-4 days after starting treatment.

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)

Cabarsuss with food and drink

Take Cabarsuss preferably with meals to reduce side effects.

Pregnancy, breast-feeding and fertility

Pregnancy

There is only limited experience of the use of Cabarsuss 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 Cabarsuss and become pregnant during this time you should contact your doctor as soon as possible; he will discuss the options with you. Contraception should be continued for at least 4 weeks after stopping Cabarsuss.

Fertility

Infertility can be reversed in women taking Cabarsuss, and pregnancy can occur before the menstrual cycle has normalised. Use contraception during treatment if necessary, and continue for at least 4 weeks after stopping Cabarsuss.

Breast-feeding

It is not known whether cabergoline passes into breast milk. As Cabarsuss might stop you from producing enough milk for your baby, you should not breastfeed while you take Cabarsuss.

Driving and using machines

Cabarsuss can 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.

Cabarsuss containslactose.

If you have been told by your doctor that you have an intolerance to some sugars contact your doctor beforetaking 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.

Open the closure, push and break through the liner to access the contents.

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

Adults and elderly patients:

The dose is determined by your doctor who adjusts it to suit your needs. The usual dose at the start of treatment is 0.5 -1 mg cabergoline daily. The dose is then increased gradually as directed by the doctor up to a suitable maintenance dose.

The usual maintenance dose is from 2 mg to a maximum of 3 mg cabergoline daily.

Cabarsuss 3 mg tablets can be broken into three equal parts.

Place the tablet on a hard, flat surface with the deeply scored side at the top. Press with the thumb on the middle of the tablet and the tablet will break into three parts.

Patients with hepatic or renal dysfunction

These tablets should be used with caution.

Children and adolescents

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

If you take more Cabarsussthan 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 worsening of symptoms of Parkinson's disease.

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.

Tell your doctor immediately if you experience any of the following symptoms. These

symptoms can be severe:

You may experience the following side effects:

Very common: may affect more than 1 in 10 people

Nausea, swelling of tissues in the lower limbs due to the accumulation of fluids (peripheral edema),

Common: may affect up to 1 in 10 people

Vomiting, digestive disturbances, constipation, inflammation of the stomach lining (gastritis), chest pain (angina), hallucinations, confusion, sleep disturbances, somnolence, dizziness, headache, increased libido, shortness of breath, weakness/lack of energy and motivation, involuntary movements (dyskinesias), drop in blood pressure following a change of body position into a more upright position, low blood pressure after treatment for a long time, decrease in the value of specific blood components (haemoglobin, hematocrit, and/or red blood cell), abnormal liver function tests.

Uncommon may affect up to 1 in 100 people

Redness, swelling and pain in the extremities of the arms and legs (erythromelalgia), excessive movements (hyperkinesia), fluid in the layers of the membrane lining the lungs and chest cavity, formation of scar tissue in the lung (pulmonary fibrosis), rash, fatigue, delusions, psychotic disorder, abnormal hepatic function, swelling of tissues due to the accumulation of fluids (edema).

Very rare mayaffect up to 1 in 10,000 people

Formation of scar tissue in the lung (fibrosis).

Not known: frequency cannot be estimated from the available data

Aggression, hypersexuality, pathological gambling, sudden sleep onset, fainting, hair loss, leg cramps, disorder of blood vessels (digital vasospasm), problems with the respiratory system, increased blood values of a specific enzyme called creatinine phosphokinase, tremor, problems with your eyesight, inflammation of the lining of the lung (pleuritis), chest pain

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 behaviors; they will discuss ways of managing or reducing the symptoms.

Reporting of side effects

If you get side effects , talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effect directly via [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 the 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 either 3 mg cabergoline.

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

What Cabarsuss looks like and contents of the pack

Cabarsuss 3 mg are white, round biconvex uncoated tablets with tripartite score line on both sides.Diameter 8.6 – 9.1 mm.

The tablets can be divided into three equal parts.

The tablets are packed in glass bottles with 8, 20, 30, 32, 40, 60, 64, 96, 100, 2x100 and 200 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 2014-11-26