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Package leaflet: Information for the user

Cabergoline ratiopharm 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 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 ratiopharm is and what it is used for

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

Cabergoline ratiopharm 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 ratiopharm

Do not take Cabergoline ratiopharm if you

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

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

• have ever been diagnosed in the past with problems described as fibrotic reactions affecting the lungs, back of the abdomen and kidneys or heart

• will be treated with Cabergoline ratiopharm 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 mustinform your doctor before taking Cabergoline ratiopharm 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)

• History of serious mental disease, particularly psychotic disorders

• Impaired liver or kidney function

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

• Low blood pressure

• Swelling of the hands and feet and a high blood pressure during pregnancy (preeclampsia, eclampsia)

• High blood pressure after childbirth

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

• Fibrotic reactions (scar tissue) affecting your heart, lungs or abdomen. In case you are treated with Cabergoline ratiopharm 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.

• If you are receiving Cabergoline ratiopharm to treat a certain type of brain tumour (prolactin-producing adenoma). Fluid discharge through the nose may occur. If this happens, consult your doctor immediately. He will then decide whether to continue or stop your treatment.

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 ratiopharm, 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. Suitable means of contraception should therefore be used during treatment with Cabergoline ratiopharm and also after discontinuation of treatment until recurrence of anovulation(see section “Pregnancy and breast-feeding”).

Children and adolescents

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

Other medicines and Cabergoline ratiopharm

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

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 ratiopharm can interfere with the effects of cabergoline. The treating doctor should therefore be aware of such simultaneous medication.

There are other medicines such as otherergot alkaloids (e.g. pergolide, bromocriptine, lisuride, ergotamine, dihydroergotamine, ergometrine or methysergide), medicines against vomiting (metoclopramide), and macrolide antibiotics (such as erythromycin) that may affect the activity and tolerability of Cabergoline ratiopharm.

Cabergoline ratiopharm with food and drink

Cabergoline ratiopharm should preferably be taken with mealsto help reduce the side effects.

Pregnancy and breast-feeding

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

If you are being treated with Cabergoline ratiopharm and become pregnant during this time you should contact your doctor as soon as possible. Before you can start using cabergoline you have to exclude that you are pregnant. Additionally you should take care not becoming pregnant for at least one month once you have stopped treatment with cabergoline.

As Cabergoline ratiopharm will stop you producing milk for your baby, you should not take Cabergoline ratiopharm if you plan to breastfeed. If you need to take Cabergoline ratiopharm you should use another method of feeding your baby.

Driving and using machines

Cabergoline ratiopharm 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. You should be careful when performing actions which require fast and accurate reaction during treatment initiation.

Cabergoline ratiopharm 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 episodes and somnolence have resolved.

Cabergoline ratiopharm contains 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.

3. How to take Cabergoline ratiopharm

Always take this medicine exactly as your doctor has told you. 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.

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

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.

The tablet can be divided into equal doses.

If you take more Cabergoline ratiopharm 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, 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 ratiopharm

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 using Cabergoline ratiopharm

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.

4. Possible side effects

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

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.

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

• Heart valve and related disorders e.g. inflammation (pericarditis) or leaking of fluid in the pericardium (pericardial effusion). The early symptoms may be one or more of the following: difficulty breathing, shortness of breath, chest or back pain and swollen legs. These may be the first signs of a condition called fibrosis, which can affect the lungs, heart/heartvalves or back. If you experience any one of these symptoms you must tell your doctor immediately.

• Dizziness/vertigo, headache

• Tiredness, lack of bodily strength

• Nausea, abdominal pain, indigestion, inflammation of the stomach lining (gastritis)

Common side effects (may affect up to 1 in 10 people):

• Low blood pressure (which can result in dizziness particularly on standing up)

• Depression

• Somnolence (extreme drowsiness)

• Vomiting, constipation

• Hot flushes/facial redness

• Breast pain

Uncommon side effects (may affect up to 1 in 100 people):

• Allergic reaction (hypersensitivity)

• Increased libido

• Temporary partial vision loss, fainting, crawling/prickling sensations in the body

• Palpitations (increase in heart rate)

• Vasospasm (tightening in your blood vessels) in fingers and toes

• Leg cramps

• Decrease in haemoglobin in amenhorrheic women

• Shortness of breath

• Nosebleeds

• Fibrotic reactions (including fibrosis affecting the lungs)

• Fluid in the layers of the membrane lining the lungs and chest cavity

• Rash, hair loss

• Swelling due to the accumulation of fluid (especially in the legs and arms)

Rare side effects (may affect up to 1 in 1.000 people):

Very rare side effect (may affect up to 1 in 10.000 people):

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

• Aggression, delusions, hypersexuality, pathologic gambling, psychotic disorder, hallucinations

• Sudden sleep attacks, tremor

• Visual impairment

• Chest pain (angina pectoris)

• Respiratory disorder and failure, pleuritis, chest pain

• Abnormal liver function

• Abnormal liver function test

• Increased blood values of a specific enzyme called creatinine phosphokinase

Side effects when treating certain brain tumours:

Fluid discharge through the nose is possible (see section 2 “Warnings and precautions”). If this happens, consult your doctor immediately.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Cabergoline ratiopharm

Keep out of the sight and reach of children

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

Do not store above 25 °C.

Store in the original package in order to protect from moisture. The drying bag with silica gel must not be removed from the bottle.

Do not throw away any medicines via wastewater of household waste. Ask you 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 ratiopharm contains

The active substance is cabergoline.

Each tablet contains 0.5mg cabergoline.

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

What Cabergoline ratiopharm looks like and contents of the pack

White, oval-shaped flat bevelled tablets. Each tablet is scored on one side and has „CBG“ on one side and „0.5“ on the other side of the breakline.

Cabergoline ratiopharm 0.5 mg is available in packs of 2, 8, 14, 15, 16, 20, 28, 30, 32, 40, 48, 50, 60, 90, 96 and 100 tablets.

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 revised in

2014-04-23

[To be completed nationally]