Cabergoline Ratiopharm

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cabergolina ratiopharm 0.5 mg, tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Cabergolina ratiopharm is and what it is used for
2. What you need to know before taking Cabergolina ratiopharm
3. How to take Cabergolina ratiopharm
4. Possible side effects
5. How to store Cabergolina ratiopharm
6. Contents of the pack and other information

1. What Cabergolina ratiopharm is and what it is used for
Cabergolina ratiopharm belongs to a group of medicines called prolactin inhibitors. Cabergolina ratiopharm prevents lactation (milk production) by reducing levels of a hormone called prolactin.
Cabergolina ratiopharm can also be used to reduce abnormally high levels of the hormone prolactin in the blood.

2. What you should know before taking Cabergoline ratiopharm

Do not take Cabergoline ratiopharm:

• if you are allergic to cabergoline or to other ergot alkaloids (e.g. bromocriptine), or to any of the excipients of this medicine (listed in section 6)
• if you currently suffer from (or have previously suffered from) psychosis or are at risk of developing postpartum psychosis
• if you have previously been diagnosed with fibrotic reactions affecting the lungs, the back of the abdomen, kidneys, or heart
• if you require long-term treatment with Cabergoline ratiopharm and currently suffer or have previously suffered from fibrotic reactions (scar tissue) affecting the heart.

Warnings and precautions
If you suffer from any of the following health conditions, inform your doctor before taking Cabergoline ratiopharm, as this medicine may not be suitable for you.

• Cardiovascular diseases
• Gastric ulcer or gastrointestinal bleeding (this condition may cause black stools or vomiting blood)
• History of severe mental illness, particularly psychotic disorders
• Impaired liver or kidney function
• Raynaud’s disease (when exposed to cold, fingers and toes become bluish, weak, poorly circulated, cold, numb, and tingling)
• Low blood pressure
• Swelling of the hands and feet with high blood pressure (preeclampsia, eclampsia)
• High blood pressure after childbirth
• Severe chest disorders (e.g. chest pain on breathing, presence of fluid in the lungs, lung inflammation or infection)
• Fibrotic reactions (scar tissue) affecting the heart, lungs, or abdomen. If long-term treatment with Cabergoline ratiopharm is required, your doctor will first check that your heart, lungs, and kidneys are in good condition. An echocardiogram (an ultrasound test of the heart) will be performed before starting treatment and at regular intervals during treatment. If fibrotic reactions occur, treatment must be discontinued.
• If you are being treated with Cabergoline ratiopharm for a certain type of brain tumour (prolactin-secreting adenoma), it is possible that cerebrospinal fluid leakage from the nose may occur. If this happens, contact your doctor immediately, who will decide whether you should continue or discontinue treatment.

Inform your doctor if you, or someone in your family or caregiver, notice the development of impulses or urges to behave in ways that are unusual for you and that you cannot resist the impulse or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorders and may include behaviours such as gambling addiction, compulsive eating or excessive spending, abnormally increased sexual desire, or increased sexual thoughts or feelings. Your doctor may consider it necessary to adjust or discontinue the dose.
The effect of alcohol on the tolerability of cabergoline is unknown.
Infertility is reversible in women taking Cabergoline ratiopharm, so pregnancy may occur even before menstrual cycles have become regular. Therefore, a pregnancy test is recommended at least every 4 weeks until menstruation resumes, and thereafter whenever a menstrual period is more than 3 days late.
During treatment with Cabergoline ratiopharm, appropriate contraceptive methods must be used, even after stopping treatment, until anovulatory cycles are restored. (See section "Pregnancy and breastfeeding")
Children and adolescents
The safety and efficacy of Cabergoline ratiopharm in children and adolescents under 16 years of age have not been established.
Other medicines and Cabergoline ratiopharm
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines used to lower blood pressure and certain drugs (e.g. phenothiazines, butyrophenones, thioxanthenes) used to treat psychiatric disorders (schizophrenia or psychosis), if taken concomitantly with Cabergoline ratiopharm, may interfere with the effects of cabergoline. Your treating physician must therefore be aware of the concomitant use of such drugs.
Other medicines, such as other ergot alkaloids (e.g. pergolide, bromocriptine, lisuride, ergotamine, dihydroergotamine, ergometrine or methysergide), anti-nausea drugs (metoclopramide), and macrolide antibiotics (such as erythromycin) may affect the activity and tolerability of Cabergoline ratiopharm.
Cabergoline ratiopharm with food and drink
Cabergoline ratiopharm should be taken orally, preferably with food, to reduce undesirable effects.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.
If you become pregnant during treatment with Cabergoline ratiopharm, contact your doctor as soon as possible. Before starting cabergoline treatment, ensure you are not pregnant. Furthermore, avoid pregnancy for at least one month after stopping cabergoline treatment.
Since Cabergoline ratiopharm will stop your milk production, you must not take Cabergoline ratiopharm if you wish to breastfeed your baby. If you need to take Cabergoline ratiopharm, you must use an alternative method to feed your baby.
Driving and using machines
Cabergoline ratiopharm may negatively affect reaction ability in some individuals, and this should be considered in activities requiring high alertness, such as driving vehicles or performing precision work. Be cautious when performing tasks requiring rapid and accurate responses during treatment.
Cabergoline ratiopharm may cause drowsiness (extreme lethargy) and sudden sleep attacks. Patients experiencing these symptoms should not drive or engage in activities that, due to reduced alertness, could result in serious harm (e.g. operating machinery), until these episodes and drowsiness have resolved.
Cabergoline ratiopharm contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. HOW TO TAKE CABERGOLINE RATIOPHARM

Always take this medicine exactly as instructed by your doctor.
If you have any doubts, consult your doctor or pharmacist.
The dose will be determined by your doctor, who will adjust it individually according to your needs.
The tablets should be taken with food to reduce certain side effects such as nausea, vomiting, and stomach pain.

• To stop milk production: The recommended dose is 1 mg (as a single dose) within 24 hours after childbirth.
• To reduce prolactin levels in the body: Treatment usually starts with 0.5 mg per week, but higher doses may be required. Your doctor will inform you how long you need to take the tablets.

The tablet may be divided into equal parts.
If you take more Cabergoline ratiopharm than you should
It is important not to take too many tablets. If you have taken too many tablets or if you suspect that a child has ingested some, contact the emergency department of the nearest hospital or a doctor immediately. Symptoms of overdose include nausea, vomiting, low blood pressure, stomach pain, behavioural changes, confusion, or hallucinations (seeing things that are not real). Take this leaflet and any remaining tablets with you to show the doctor.
If you forget to take Cabergoline ratiopharm
If you forget to take a dose at the usual time, take it as soon as you remember.
If it is almost time for the next dose, skip the missed dose and take the next one at the regular time.
If you stop taking Cabergoline ratiopharm
If you stop taking cabergoline, symptoms of your condition may worsen; therefore, you should discuss with your doctor before stopping treatment. It takes several days for cabergoline to be cleared from the bloodstream, and effects may worsen over a period of 2 weeks, increasing lactation.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not
everyone experiences them.
The following adverse effects may occur:
Inability to resist the impulse to perform actions that could be harmful, which
may include:

• Strong urge to gamble excessively, despite serious personal or family consequences.
• Altered or increased sexual interest and behaviour causing significant concern to you or others, for example, increased sexual desire.
• Uncontrollable shopping or excessive spending
• Compulsive eating (eating large amounts of food in a short period of time) or bulimia (eating more food than normal and more than needed to satisfy your hunger)

Inform your doctor if any of these behaviours occur, so that he/she can
decide how to manage or reduce the symptoms.
Very common adverse effects (may affect more than 1 in 10 people):

• Heart valve disease and related disorders, for example, inflammation (pericarditis) or leakage of fluid into the pericardium (pericardial effusion). One or more of the following preliminary symptoms may occur: difficulty breathing, shortness of breath, chest or back pain, and swelling in the legs. These may be early signs of a condition called fibrosis, which may affect the lungs, heart/heart valves, or back. If you experience any of these symptoms, contact your doctor immediately.
• Dizziness/vertigo, headache
• Fatigue, lack of physical strength
• Nausea, abdominal pain, indigestion, inflammation of the stomach lining (gastritis)

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

• Low blood pressure (which may cause dizziness, especially when standing)
• Depression
• Drowsiness (excessive drowsiness)
• Vomiting, constipation
• Hot flushes, facial flushing
• Chest pain

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

• Allergic reactions (hypersensitivity)
• Increased libido
• Temporary partial loss of vision, fainting, sensation of itching/tingling in the body
• Palpitations (increased heart rate)
• Vasospasm (constriction of blood vessels) in the fingers and toes
• Leg cramps
• Decrease in haemoglobin in women during amenorrheic periods
• 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 fluid accumulation (especially in the arms and legs)

Rare adverse effects (may affect up to 1 in 1,000 people):

• Pain in the upper part of the stomach

Very rare adverse effect (may affect up to 1 in 10,000 people):

• Fibrotic reactions (includes fibrosis affecting the pleura)

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

• Aggression, delirium, hypersexuality, pathological gambling, psychotic disorders, hallucinations
• Sudden attacks of sleep, tremors
• Reduced vision
• Chest pain (angina pectoris)
• Respiratory disorders and respiratory failure, pleuritis, chest pain
• Abnormal liver function
• Abnormal liver function tests
• Increase in blood levels of a specific enzyme called creatine phosphokinase.

Adverse effects during treatment of certain types of brain tumour:
It is possible to experience leakage of fluid from the nose (see section 2: "Warnings and
precautions"). If this occurs, inform your doctor immediately.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this
leaflet, consult your doctor or pharmacist. You can also report adverse
effects directly via the national reporting system at:
http://www.agenziafarmaco.gov.it/it/responsabili. Reporting adverse
effects helps provide more information on the safety of this medicine.

5. How to store Cabergolina ratiopharm

Keep Cabergolina ratiopharm out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack. The expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original packaging to protect the medicine from moisture. The desiccant sachet containing silica gel must not be removed from the bottle.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Cabergoline ratiopharm contains
The active substance is cabergoline.
Each tablet contains 0.5 mg of cabergoline.
The excipients are anhydrous lactose, L-leucine and magnesium stearate.

Description of the appearance of Cabergoline ratiopharm and the contents of the pack
White, flat, oval-shaped tablets with bevelled edges. Each tablet is scored on one side and marked with 'CBG' on one side of the break line and '0.5' on the other side.
Cabergoline ratiopharm 0.5 mg is available in packs containing 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 Authorization Holder and Manufacturer
ratiopharm GmbH
DE-89079 Ulm
Germany

Marketing Authorization Holder for Italy: Teva Italia Srl - Milan
Batch release:
TEVA Czech Industries s.r.o., Ostravaska 29, 747 70 Opava-Komarov, Czech Republic
Merckle GmbH – Graf Arco Strasse 3 – 89079 Ulm – Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
Sweden: Cabergoline ratiopharm 0.5mg Tablet.

Package leaflet: Information for the user

Cabergoline ratiopharm 1 mg and 2 mg tablets

Generic medicine
Please read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Cabergoline ratiopharm is and what it is used for
2. What you need to know before taking Cabergoline ratiopharm
3. How to take Cabergoline ratiopharm
4. Possible side effects
5. How to store Cabergoline ratiopharm
6. Contents of the pack and other information

1. What Cabergoline ratiopharm is and what it is used for
Cabergoline ratiopharm belongs to a group of medicines called dopamine agonists. Cabergoline ratiopharm works in a way similar to a chemical substance naturally present in the nervous system, called dopamine. Patients with Parkinson's disease do not have sufficient levels of this important chemical.
Cabergoline ratiopharm 1 mg and 2 mg tablets are used to treat Parkinson's disease. It can be used alone or in combination with levodopa plus decarboxylase inhibitors, as a second-line therapy following treatment with non-ergot derived agents.
Treatment must be supervised by a specialist physician.

2. What you should know before taking cabergoline ratiopharm

Do not take Cabergoline ratiopharm:

• if you are allergic to cabergoline or to other ergot alkaloids (e.g. bromocriptine), or to any of the other ingredients of this medicine (listed in section 6)
• if you have previously been diagnosed with conditions known as fibrotic reactions affecting the lungs, the back of the abdomen, kidneys, or heart
• if you are to be treated with Cabergoline ratiopharm for a long period and you currently have or have previously had fibrotic reactions (scar tissue) affecting the heart.

Warnings and precautions
If you suffer from any of the following health problems, you must inform your doctor before taking Cabergoline ratiopharm, as this medicine may not be suitable for you.

• Cardiovascular diseases
• Gastric ulcer or gastrointestinal bleeding (this condition may cause black stools or vomiting blood)
• History of severe mental disorders, particularly psychotic disorders
• Impaired liver or kidney function
• If you currently suffer (or have previously suffered) from psychosis or are at risk of postpartum psychosis
• Raynaud's disease (when exposed to cold, fingers and toes become bluish, poorly circulated, cold, numb, and tingling)
• Low blood pressure
• Severe chest problems (e.g. chest pain on breathing, fluid in the lungs, lung inflammation or infection)
• If you currently have or have previously had fibrotic reactions (scar tissue) affecting the heart, lungs, or abdomen. If you need to be treated with Cabergoline ratiopharm for a prolonged period, your doctor will first check that your heart, lungs, and kidneys are in good condition. An echocardiogram (an ultrasound test of the heart) will be performed before starting treatment and at regular intervals during treatment. If fibrotic reactions occur, treatment must be discontinued.

Inform your doctor if you or someone in your family or caregiver notices the development of urges or desires to behave in ways that are unusual for you and that you cannot resist the impulse or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorders and may include behaviors such as gambling addiction, compulsive eating or spending, abnormally increased sexual desire, or increased sexual thoughts or feelings. Your doctor may consider it necessary to adjust or discontinue the dose.

Infertility is reversible in women taking Cabergoline ratiopharm, so pregnancy may occur even before menstrual cycles have become regular. Therefore, if necessary, adequate contraceptive measures must be used during treatment.

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

Other medicines and Cabergoline ratiopharm
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines used to lower blood pressure and certain psychiatric drugs (e.g. phenothiazines, butyrophenones, thioxanthenes) used to treat psychiatric conditions (such as schizophrenia or psychosis), when taken concomitantly with Cabergoline ratiopharm, may interfere with the effects of cabergoline. Your treating physician must therefore be aware of the concomitant use of such drugs.

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

Cabergoline ratiopharm with food and drink
Cabergoline ratiopharm should be taken orally, preferably with meals, to reduce side effects.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.

Experience with the use of Cabergoline ratiopharm during pregnancy is limited. If you become pregnant while being treated with Cabergoline ratiopharm, contact your doctor as soon as possible. Contraception should be continued for at least 4 weeks after stopping treatment with cabergoline.

Since Cabergoline ratiopharm will stop your milk production, you must not take Cabergoline ratiopharm if you intend to breastfeed your baby. If you need to take Cabergoline ratiopharm, you should use an alternative method to feed your baby.

Driving and using machines
Cabergoline ratiopharm may negatively affect the reaction ability in some individuals, and this should be considered in activities requiring a high degree of alertness, such as driving vehicles or performing precision work. Be cautious when carrying out tasks that require rapid and accurate responses during treatment.

Cabergoline ratiopharm may cause drowsiness (extreme somnolence) and sudden sleep attacks. Individuals experiencing these symptoms should therefore not drive or engage in activities that, due to reduced alertness, could result in serious harm (e.g. operating machinery), until these episodes and drowsiness have resolved. If you experience these symptoms, inform your doctor.

Cabergoline ratiopharm contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Cabergolina ratiopharm

Take this medicine exactly as directed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
The tablets should be taken with meals to reduce certain side effects such as
nausea, vomiting, and stomach pain.
Adult and elderly patients .
The dose will be determined by your doctor, who will adjust it individually according to your needs. The recommended starting dose at the beginning of treatment is 0.5–1 mg of
cabergoline per day. The dose is then gradually increased, as directed by your doctor, until an appropriate maintenance dose is reached.
The recommended maintenance dose ranges from 2 mg to 3 mg of cabergoline per day.
The tablet may be divided into equal parts.
If you take more Cabergolina ratiopharm than you should
It is important not to take too many tablets. If you have taken too many tablets or if you think a child has ingested some, contact the emergency department of the nearest
hospital or consult a doctor immediately. Symptoms of overdose may include nausea, vomiting,
lowering of blood pressure, stomach pain, behavioural changes,
confusion, or hallucinations (seeing non-existent things). Take this leaflet and any remaining tablets with you to show the doctor.
If you forget to take Cabergolina ratiopharm
If you forget to take a dose at the usual time, take it as soon as you remember.
If it is almost time for your next dose, skip the missed dose and take the next one at the usual time.
If you stop taking Cabergolina ratiopharm
If you stop taking cabergoline, the symptoms of your illness may worsen; therefore, you should discuss with your doctor before stopping treatment. It takes several days for cabergoline to be eliminated from the bloodstream, and effects may worsen over a period of 2 weeks, resulting in a worsening of Parkinson's disease symptoms.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not
everyone experiences them.
The following adverse reactions may occur:
Inability to resist the impulse to carry out actions that could be harmful, which
may include:

• Strong urge to gamble excessively, despite serious personal or family consequences.
• Altered or increased interest in sex and behaviour causing considerable concern to you or others, for example, increased sexual desire.
• Uncontrollable shopping or excessive spending
• Compulsive eating (eating large amounts of food in a short period of time) or bulimia (eating more food than normal and more than needed to satisfy your hunger)

Inform your doctor if any of these behaviours occur, so that he/she can
decide how to manage or reduce the symptoms.
Very common adverse reactions (may affect more than 1 in 10 people):
Heart valve disease and related disorders, for example, inflammation (pericarditis) or
fluid leakage into the pericardium (pericardial effusion).
One or more of the following preliminary symptoms may occur: breathing difficulty,
shortness of breath, chest or back pain, and swelling of the legs. These may
be the first signs of a condition called fibrosis, which may affect the lungs, the
heart/heart valves, or the back. If you experience any of these symptoms, contact your
doctor immediately.
Nausea, swelling of arms and legs due to fluid retention.
Common adverse reactions (may affect up to 1 in 10 people):

• Vomiting, indigestion, constipation, inflammation of the stomach lining (gastritis)
• Chest pain (angina pectoris) (when levodopa is used concomitantly)
• Hallucinations, confusion, sleep disorders, increased libido
• Headache, drowsiness (extreme drowsiness), dizziness/vertigo, involuntary movements
• Lack of physical strength
• Low blood pressure (which may cause dizziness, especially when standing)
• Shortness of breath
• Blood disorders, including low blood cell count (symptoms may include fatigue), abnormal liver function tests

Uncommon adverse reactions (may affect up to 1 in 100 people):

• Redness, swelling and pain in the arms and legs (erythromelalgia)
• Fluid accumulation in the membranes lining the lungs and chest cavity
• Fibrotic reactions affecting the lungs
• Skin rash
• Swelling due to fluid accumulation, fatigue
• Allergic reactions (hypersensitivity)
• Delirium, psychotic disorders
• Abnormal liver function

Very rare (may affect up to 1 in 10,000 people)

• Fibrotic reactions (includes fibrosis affecting the pleura)

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

• Aggression, hypersexuality, pathological gambling
• Sudden sleep attacks, fainting, tremors
• Visual impairment
• Vasospasm (constriction of blood vessels) in fingers and toes
• Respiratory disorders and respiratory failure, pleuritis, chest pain
• Hair loss
• Leg cramps
• Increase in blood levels of a specific enzyme called creatine phosphokinase

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this
leaflet, talk to your doctor or pharmacist. You can also report adverse
reactions directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you
can help provide more information on the safety of this medicine.

5. How to store Cabergolina ratiopharm

Keep Cabergolina ratiopharm out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original packaging to protect the medicine from moisture. The desiccant sachet containing silica gel must not be removed from the bottle.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cabergoline ratiopharm contains
The active substance is cabergoline.
Cabergoline ratiopharm 1 mg tablets
Each tablet contains 1 mg of cabergoline.
Cabergoline ratiopharm 2 mg tablets
Each tablet contains 2 mg of cabergoline.
The excipients are: anhydrous lactose, L-leucine and magnesium stearate.

Description of the appearance of Cabergoline ratiopharm and contents of the pack
Cabergoline ratiopharm 1 mg tablets are white, oval-shaped, biconvex tablets. Each tablet is scored on both sides, with 'CBG' on one side and '1' on the other side of the break line.
Cabergoline ratiopharm 2 mg tablets are white, capsule-shaped, biconvex tablets with a break line on both sides. On one side of the break line the tablet is marked with 'CBG', and on the other side with '2'.
Cabergoline ratiopharm 1 mg is available in packs containing 2, 8, 14, 15, 16, 20, 28, 30, 32, 40, 48, 50, 60, 90, 96 and 100 tablets.
Cabergoline ratiopharm 2 mg is available in packs containing 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 Authorization Holder and Manufacturer
ratiopharm GmbH
DE-89079 Ulm
Germany

Marketing Authorization Holder for sale: Teva Italia Srl - Milan

Batch release:
TEVA Czech Industries s.r.o., Ostravaska 29, 747 70 Opava-Komarov, Czech Republic
Merckle GmbH – Graf Arco Strasse 3 – 89079 Ulm – Germany.

This medicinal product is authorized in the European Economic Area countries under the following names:
Sweden: Cabergoline ratiopharm 1mg Tablet
Cabergoline ratiopharm 2mg Tablet.
Germany: Cabergolin-ratiopharm 1mg Tabletten
Cabergolin-ratiopharm 2mg Tabletten