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• Cabergoline Hexal 1 mg 2 mg tablet ENG PL

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Package leaflet: Information for the patient

Cabergoline Hexal 1 mg and 2 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 Cabergoline Hexal is and what it is used for

Cabergoline Hexal belongs to a group of medicines known as dopamine agonists. Cabergoline Hexal acts 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.

Cabergoline Hexal 1mg and 2mg 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 under a specialist is required.

2. What you need to know before you take Cabergoline Hexal

Do not take Cabergoline Hexal if you:

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

• will be treated with Cabergoline Hexal 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 Cabergoline Hexal your 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 Cabergoline Hexal.

Warnings and precautions

Talk to your doctor before taking Cabergoline Hexal

If you have any of the following health problems you must inform your doctor before taking Cabergoline Hexal 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 with blood)

• Impaired kidney function

• Have impaired liver function

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

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

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

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

• Have a history of serious mental disorder, particularly psychotic disorders.

In case you are treated with Cabergoline Hexal 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.

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.

Other medicines and Cabergoline Hexal

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

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

• to prevent vomiting (e.g. metoclopramide)

Cabergoline Hexal with food, drink and alcohol

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

Avoid alcohol while you are taking Cabergoline Hexal

Pregnancy, breast-feeding and fertility

Pregnancy

There is only limited experience of the use of Cabergoline Hexal 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 Hexal 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 cabergoline.

Fertility

Infertility can be reversed in women taking Cabergoline Hexal, 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 Cabergoline Hexal.

Breast-feeding

It is not known whether cabergoline passes into breast milk. As Cabergoline Hexal mightstop you from producing enough milk for your baby, you should not breastfeedwhile you take Cabergoline Hexal..

Driving and using machines

Cabergoline Hexal 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 Hexal 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. If affected, consult your doctor.

Cabergoline Hexal 1mg and 2mg contains 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 Cabergoline Hexal

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

The tablets should be taken 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 individually for you. 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 up to 3 mg cabergoline daily.

The maximum dose is 3 mg cabergoline per day.

Cabergoline Hexal 1mg and 2mg Tablets have a score and can be divided into two equal doses.

Patients with hepatic or renal dysfunction

These tablets should be used with caution.

Children and adolescents

Cabergoline Hexal is not recommended in children and adolescents under 18 years of age.

If you take more Cabergoline Hexal 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 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).Take this leaflet and any tablets that you still have to show the doctor.

If you forget to take Cabergoline Hexal

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. Do not take a double dose to make up for a forgotten dose.

If you stop taking Cabergoline Hexal

If you stop taking Cabergoline Hexal the 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 everyone 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:

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.

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: may affect up to 1 in 10,000 people

Formation of scar tissue (fibrosis)

Not known: frequency cannot be estimated from the available data

Aggression, , 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.

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 Cabergoline Hexal

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.

Do not store above 30ºC. Store in the original package in order to protect from moisture. The drying capsule or bag with silica gel must not be removed from the bottle.

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 Cabergoline Hexal contains

The active substance: is cabergoline.

Each tablet contains 1 mg and 2 mg cabergoline

The other ingredients are: anhydrous lactose, L-leucin and magnesium stearate

What Cabergoline Hexal looks like and contents of the pack

Cabergoline Hexal 1 mg tablets are white, oval-shaped biconvex tablets containing 1 mg cabergoline. Each tablet is scored on both sides and has “CBG” on one side and “1” on the other side of the breakline.

Cabergoline Hexal 2 mg tablets are white, capsule-shaped, biconvex tablets with a dividing score line on both sides of the tablet. One side of the tablet is marked ‘CBG’ and ‘2’ on either side of the dividing score line.

Cabergoline Hexal 1 mg are available in packs of 2, 8, 14, 15, 16, 20, 28, 30, 32, 40, 48, 50, 60, 90, 96, 100 and 200 (2x100) tablets.

Cabergoline Hexal 2 mg are available in packs of 2, 8, 14, 15, 16, 20, 28, 30, 32, 40, 48, 50, 60, 90, 96 , 100 and 200 (2x100) tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

<To be completed nationally>

Manufacturer

<To be completed nationally>

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

Sweden: Cabergoline Hexal 1 mg <2 mg> Tablet

Germany: Cabergolin HEXAL 1 mg <2 mg> Tabletten

This leaflet was last approved in 2015-02-13