CABERGOLINA 0.5 мг Таблетка

Содержание инструкции

1. Cabergolina ratiopharm 0,5 mg, tablets
   1. What you need to know before taking Cabergolina ratiopharm
   2. HOW TO TAKE CABERGOLINA RATIOPHARM
   3. POSSIBLE SIDE EFFECTS
   4. How to store Cabergolina ratiopharm
   5. Contents of the pack and other information
2. Cabergolina ratiopharm 1 mg and 2 mg tablets
   1. What you need to know before taking Cabergolina ratiopharm
   2. How to take Cabergolina ratiopharm
   3. POSSIBLE SIDE EFFECTS
   4. How to store Cabergolina ratiopharm
   5. Contents of the pack and other information

Cabergolina ratiopharm 0,5 mg, tablets

Generic medicine

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. Do not pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What is Cabergolina ratiopharm and what it is used for
• 2. What you need to know before you take 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 is Cabergolina ratiopharm and what it is used for

Cabergolina ratiopharm belongs to a group of medicines called prolactin inhibitors.
Cabergolina ratiopharm prevents lactation (milk production) by decreasing the levels of a hormone called prolactin.

Cabergolina ratiopharm can also be used to reduce abnormal amounts of the hormone prolactin in the blood.

2. What you need to know before taking Cabergolina ratiopharm

Do not take Cabergolina ratiopharm:

• if you are allergic to cabergoline or other ergot alkaloids (e.g. bromocriptine), or to any of the excipients of this medicine (listed in section 6)
• if you suffer (or have suffered in the past) from psychosis or are at risk of developing psychosis after childbirth
• if you have been diagnosed in the past with problems defined as fibrotic reactions affecting the lungs, the back of the abdomen, the kidneys or the heart
• if you are to be treated for a long period with Cabergolina ratiopharm and suffer or have suffered from fibrotic reactions (scarred tissue) at the heart level.

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

• Cardiovascular diseases
• Gastric ulcer or bleeding of the gastrointestinal tract (this condition can cause the production of black stools or vomiting with blood)
• History of severe mental illness, especially psychotic disorders
• Impaired liver or kidney function
• Raynaud's disease (when it is cold, the fingers of the hands and feet become bluish, weak, lacking blood circulation, cold, insensitive and numb)
• Low blood pressure
• Swelling of the hands and feet and have high blood pressure (preeclampsia, eclampsia)
• High blood pressure after childbirth
• Severe chest disorders (e.g. chest pain with breathing, presence of fluid in the lungs, inflammation or lung infection)
• Fibrotic reactions (scarred tissue) at the heart, lung or abdominal level. If you need to be treated with Cabergolina ratiopharm for a long period of time, before starting treatment the doctor will check that your heart, lungs and kidneys are in good condition. He will also perform an echocardiogram (an ultrasound test for the heart) before the start of therapy and at regular intervals during treatment. If fibrotic reactions occur, treatment must be discontinued.
• If you are being treated with Cabergolina ratiopharm to treat a certain type of brain tumor (prolactin-secreting adenoma). It is possible that fluid may leak from your nose. If this happens, consult your doctor immediately, who will decide whether to continue or stop treatment.

Inform your doctor if you or someone in your family / or who takes care of the
patient notices that you are developing urges or desires to behave in ways
that are unusual for you and you cannot resist the urge or temptation to perform
certain activities that could harm yourself or others. These are called
impulse control disorders and may include behaviors such as gambling addiction,
excessive eating or spending excessively, an abnormal,
exaggerated sexual desire or an increase in sexual thoughts or feelings. The doctor may
need to adjust or stop the dose.
The effect of alcohol on the tolerability of cabergoline is not known.
Infertility is reversible in women taking Cabergolina ratiopharm, so
pregnancy may occur before the menstrual cycle has regularized.
Therefore, a pregnancy test is recommended at least every 4 weeks until
menstruation resumes, and from then on whenever a menstrual cycle is delayed by more
than 3 days.
During treatment with Cabergolina ratiopharm, adequate contraceptive methods must be used even after discontinuation of treatment until the restoration of anovulatory cycles. (See section "Pregnancy and breastfeeding")

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

Other medicines and Cabergolina ratiopharm
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Some medicines used to lower blood pressureand some drugs (e.g.
phenothiazines, butyrophenones, thioxanthenes) used for the treatment of psychiatric
diseases(schizophrenia or psychosis), if taken at the same time as Cabergolina
ratiopharm, can interfere with the effects of cabergoline. The treating doctor 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), drugs against
vomiting (metoclopramide), and macrolide antibiotics(such as erythromycin)

can affect the activity and tolerabilityof Cabergolina ratiopharm.

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

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are
breastfeeding, ask your doctor for advice before taking this
medicine
If you notice you are pregnant during treatment with Cabergolina ratiopharm
you should see your doctor as soon as possible. Before starting to take
cabergoline you must make sure you are not pregnant. You should also avoid a
pregnancy for at least one month after stopping treatment with cabergoline.
Since Cabergolina ratiopharm will stop your milk production, you should not
take Cabergolina ratiopharm if you want to breastfeed your baby. If you
need to take Cabergolina ratiopharm you should use another method to feed
your baby.

Driving and using machines
Cabergolina ratiopharm may negatively affect the ability to react of some
individuals, and this must be taken into consideration in activities that require a high
degree of vigilance, such as driving vehicles and precision work. Be careful
when performing operations that require a quick and accurate reaction during
treatment.
Cabergolina ratiopharm can cause drowsiness (extreme sleepiness) and sudden sleep
attacks. People who experience these symptoms should therefore not drive or
engage in activities that, due to reduced vigilance, could cause serious harm
(e.g. using machinery), until these episodes and sleepiness have
resolved.

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

3. HOW TO TAKE CABERGOLINA RATIOPHARM

Always take this medicine exactly as your doctor has instructed.
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 meals, to reduce some undesirable 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 of delivery.
• To reduce prolactin concentration in the body:Treatment usually starts with 0.5 mg per week, but higher doses may be necessary. Your doctor will tell you how long you need to take the tablets.

The tablet can 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 believe
that a child has ingested any, go to the emergency room of the nearest
hospital or to a doctor. Symptoms of overdose include nausea, vomiting,
lowering of blood pressure, stomach pain, behavioral changes,
confusion or hallucinations (seeing things that do not exist). Bring this leaflet and the
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 to take the next dose, skip the missed dose and take the
next one at the usual time.

If you stop taking Cabergolina ratiopharm
If you stop using cabergoline, the symptoms of your condition may worsen; you should
therefore discuss this with your doctor before stopping therapy. Many
days are needed before cabergoline is removed from the bloodstream, and the effects may
worsen over 2 weeks, increasing lactation.
If you have any doubts about using 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.
Not everyone will experience them.

The following side effects may occur:
Inability to resist the urge to perform actions that could be harmful, which
can include:

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

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

• Heart valve disease and related disorders, e.g. inflammation (pericarditis) or leakage of fluid into the pericardium (pericardial effusion). One or more of the following preliminary symptoms may occur: shortness of breath, difficulty breathing, chest or back pain, and swelling of the legs. These may be early signs of a condition called fibrosis, which can 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 inner wall of the stomach (gastritis)

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

• Low blood pressure (which can cause dizziness, especially when standing up)
• Depression
• Drowsiness (excessive torpor)
• Vomiting, constipation
• Hot flashes, facial flushing
• Chest pain

Uncommon side 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 heartbeat)
• Vasospasm (constriction of blood vessels) in the fingers and toes
• Leg cramps
• Decrease in hemoglobin in women during amenorrhea,
• Shortness of breath
• Nosebleeds
• Fibrotic reactions (including fibrosis affecting the lungs)
• Fluid in the layers of the lining membrane of the lungs and the chest cavity
• Skin rash, hair loss
• Swelling due to fluid retention (especially in the legs and arms)

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

• Pain in the upper abdomen

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

• Fibrotic reactions (includes fibrosis affecting the pleura)

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

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

Side effects during treatment of certain types of brain tumors:
Leakage of fluid from the nose is possible (see section 2: “Warnings and
precautions”). If this occurs, inform your doctor immediately.

Reporting of side effects
If you get any side effects, even those not listed in this
leaflet, tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system at:
http://www.agenziafarmaco.gov.it/it/responsabili. Reporting of side effects
helps to 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 which is stated on the pack. The expiry
date refers to the last day of that month.
Do not store at a temperature above 25°C
Store in the original package to protect the medicine from moisture. The
desiccant sachet containing silica gel must not be removed from the bottle.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Contents of the pack and other information

What the medicine containsCabergolina ratiopharm
The active ingredient 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 Cabergolina ratiopharm and contents of the pack
White, flat, oval-shaped tablets with rounded corners. Each tablet
is divided on one side and has ‘CBG’ on one side and ‘0.5’ on the other side of the fracture line.
Cabergolina 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
ratiopharm GmbH
DE-89079 Ulm
Germany

Distributor for sales: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 authorised in the Member States of the European
Economic Area with the following denominations:
Sweden: Cabergoline ratiopharm 0.5mg Tablet.

Cabergolina ratiopharm 1 mg and 2 mg tablets

Generic medicine
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. Do not pass it on to others, even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 7. What is Cabergolina ratiopharm and what it is used for
• 8. What you need to know before you take Cabergolina ratiopharm
• 9. How to take Cabergolina ratiopharm
• 10. Possible side effects
• 11. How to store Cabergolina ratiopharm

12. Contents of the pack and other information

1. What is Cabergolina ratiopharm and what it is used for

Cabergolina ratiopharm belongs to a group of medicines called dopamine agonists.
Cabergolina ratiopharm acts in a similar way to a chemical substance
present in the nervous system, called dopamine. Patients with Parkinson’s disease do not
have a sufficient amount of this important chemical substance.
Cabergolina ratiopharm 1 mg and 2 mg is used to treat Parkinson’s disease. It may
be used alone or in combination with levodopa plus decarboxylase inhibitors,
as a second-line therapy after treatments with non-ergotamine derivatives.
The treatment must be followed by a specialist doctor.

2. What you need to know before taking Cabergolina ratiopharm

Do not take Cabergolina 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)
• if you have been diagnosed in the past with problems defined as fibrotic reactions affecting the lungs, the back of the abdomen, the kidneys or the heart
• if you are to be treated for a long period with Cabergolina ratiopharm and you suffer from or have suffered from fibrotic (scarred) reactions to the heart.

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

• Cardiovascular diseases
• Gastric ulcer or gastrointestinal bleeding. (This condition can cause black stools or vomiting with blood)
• History of severe mental disorders, particularly psychotic disorders.
• Impaired liver or kidney function
• If you suffer (or have suffered in the past) from psychosis or are at risk of psychosis after childbirth
• Raynaud's disease (when it is cold, the fingers of the hands and feet become bluish, without blood circulation, cold, numb and tingling)
• Low blood pressure
• Severe chest disorders (e.g. chest pain during breathing, presence of fluid in the lungs, inflammation or lung infection)
• If you suffer from or have suffered from fibrotic (scarred) reactions to the heart, lungs or abdomen. If you need to be treated with Cabergolina ratiopharm for a long period of time, before starting treatment the doctor will check that your heart, lungs and kidneys are in good condition. He/she will also perform an echocardiogram (an ultrasound test of the heart) before starting therapy and at regular intervals during treatment. If fibrotic reactions occur, treatment should be discontinued.

Tell your doctor if you or someone in your family / or who cares for the
patient notices that you are developing urges or desires to behave in ways
that are unusual for you and you cannot resist the urge or temptation to perform
certain activities that could harm yourself or others. These are called
impulse control disorders and may include behaviors such as gambling
addiction, overeating or excessive spending, an abnormal,
exaggerated sexual desire or an increase in sexual thoughts or feelings. Your doctor may
need to adjust or stop your dose.
Infertility is reversible in women taking Cabergolina ratiopharm, so
pregnancy may occur before your menstrual cycle has returned to normal.
Therefore, if necessary, adequate contraceptive measures should be taken during
treatment.

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

Other medicines and Cabergolina ratiopharm
Tell your doctor or pharmacist if you are taking, have recently taken or may
take any other medicine.
Some medicines used to lower blood pressure and some drugs (e.g.
phenothiazines, butyrophenones, thioxanthenes) used to treat psychiatric illnesses (schizophrenia or psychosis), when taken at the same time as Cabergolina
ratiopharm, may interfere with the effects of cabergoline. Your doctor must
therefore be aware of the concomitant use of such medicines.
There are other medicines, such as other ergot alkaloids (e.g. pergolide, bromocriptine,
lisuride, ergotamine, dihydroergotamine, ergometrine or metisergide), drugs for
preventing vomiting (metoclopramide), and macrolide antibiotics (such as erythromycin) that
may affect the activity and tolerability of Cabergolina ratiopharm.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become
pregnant, or if you are breastfeeding, ask your doctor for advice before taking this
medicine
Experience with the use of Cabergolina ratiopharm during pregnancy is limited. If you notice you are pregnant during
treatment with Cabergolina ratiopharm, you should contact your
doctor as soon as possible. Contraception should be continued for at least 4
weeks after stopping treatment with cabergoline.
Because Cabergolina ratiopharm will stop your milk production, you should not
take Cabergolina ratiopharm if you wish to breastfeed your baby. If you
need to take Cabergolina ratiopharm, you should use another method to feed
your baby.

Driving and operating machinery
Cabergolina ratiopharm may negatively affect the reaction ability of some
individuals, and this must be taken into consideration in activities that require a high
degree of vigilance, such as driving vehicles and precision work. Be careful
when performing operations that require a quick and accurate reaction during
treatment.
Cabergolina ratiopharm can cause drowsiness (extreme sleepiness) and sudden sleep
attacks. People who experience these symptoms should therefore not drive or
engage in activities that, due to reduced vigilance, could cause serious harm
(e.g. the use of machinery), until such episodes and sleepiness have
resolved. If you experience these symptoms, tell your doctor.

Cabergolina ratiopharm contains lactose
If your doctor has told you that you have an intolerance to certain sugars, contact him/her before
taking this medicine.

3. How to take Cabergolina ratiopharm

Take this medicine following exactly the instructions of your doctor. If you have any
doubts, consult your doctor or pharmacist.
The tablets should be taken with meals, to reduce some undesirable effects such as
nausea, vomiting and stomach pain.

Adult and elderly patients.
The dose is determined by the doctor, who will adjust it individually according to your
needs. The recommended dose at the beginning of treatment is 0.5 -1 mg of
cabergoline per day. The dose is subsequently increased gradually, as
established by the doctor, until reaching a suitable maintenance dose.
The recommended maintenance dose ranges from 2 mg to 3 mg of cabergoline per day.
The tablet can 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 believe
that a child has ingested any, go to the emergency room of the nearest
hospital or to a doctor. Symptoms of overdose include nausea, vomiting,
lowering of blood pressure, stomach pain, behavioral changes,
confusion or hallucinations (seeing things that do not exist). Bring this leaflet and the
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 to take the next dose, skip the missed dose and take the
next one at the usual time.

If you stop taking Cabergolina ratiopharm
If you stop using cabergoline, the symptoms of your condition may worsen; you should
therefore discuss this with your doctor before stopping therapy. Many
days are needed before cabergoline is removed from the bloodstream, and the effects may
worsen over 2 weeks, with a consequent worsening of the symptoms of
Parkinson's disease.
If you have any doubts about 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 will experience them.
Not everyone will experience them.

The following side effects may occur:
Inability to resist the urge to perform actions that could be harmful, which
can include:

• A strong urge to gamble excessively, despite serious personal or family consequences.
• Altered or increased sexual interest and behavior that causes significant concern to you or others, for example, an increased sexual desire.
• Compulsive 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 is needed to satisfy your hunger)

Inform your doctor if any of these behaviors occur, so he can
decide how to intervene to manage or reduce the symptoms
Very common side effects (may affect more than 1 in 10 people):
Heart valve disease and related disorders, e.g., inflammation (pericarditis) or
leakage of fluid into the pericardium (pericardial effusion).
One or more of the following preliminary symptoms may occur: shortness of breath,
breathlessness, chest or back pain, and swelling of the legs. These may
be early signs of a disease called fibrosis, which can affect the lungs, the
heart/heart valves, or the back. If you experience any of these symptoms, contact your
doctor immediately.
Nausea, swelling of the legs and arms due to fluid retention.

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

• Vomiting, indigestion, constipation ,inflammation of the inner wall of the stomach (gastritis),
• Chest pain (angina pectoris) (when used with levodopa)
• Hallucinations, confusion, sleep disorders, increased libido .
• Headache, drowsiness (extreme torpor), dizziness/vertigo, involuntary movements.
• Lack of physical strength
• Low blood pressure (which can cause dizziness, especially when standing up).
• Shortness of breath
• Blood problems, including low number of white blood cells (symptoms may include fatigue) abnormal liver function tests

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

• Redness, swelling, and pain in the extremities of arms and legs (erythromelalgia)
• Presence of fluid in the membranes lining the lungs and the chest cavity
• Fibrotic reactions affecting the lungs
• Skin rash,
• Swelling due to fluid retention, fatigue
• Allergic reactions (hypersensitivity).
• Delusions, psychotic disorders
• Abnormal liver function

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

• Fibrotic reactions (includes fibrosis affecting the pleura)

Not known (frequency cannot be estimated based on available data)

• Aggression, hypersexuality, pathological gambling
• Sudden sleep attacks, fainting, tremors
• Reduced vision
• Vasospasm (contraction of blood vessels) in the fingers of the hands and feet
• Breathing difficulties and respiratory failure, pleurisy, chest pain.
• Hair loss
• Leg cramps
• Increased blood levels of a specific enzyme called creatine phosphokinase.

Reporting of side effects
If you experience any side effects, including those not listed in this
leaflet, please inform your doctor or pharmacist. You can also report side effects
directly through the national reporting system at:
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you
can contribute to providing 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 which is stated on the pack. The expiry
date refers to the last day of that month.
Do not store at a temperature above 25°C
Store in the original package to protect the medicine from moisture. The
desiccant sachet containing silica gel must not be removed from the bottle.
Do not dispose of any medicine in the wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Contents of the pack and other information

What the medicine containsCabergolina ratiopharm
The active ingredient 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 Cabergolina ratiopharm and contents of the pack
Cabergolina ratiopharm 1 mg tablets consist of white, oval biconvex tablets. Each tablet is divided on both sides and has ‘CBG’ on one side and ‘1’
on the other side of the fracture line.
Cabergolina ratiopharm 2 mg tablets consist of white, capsule-shaped, biconvex tablets with a fracture line on both sides of the tablet. On one half
of the fracture line there is the inscription ‘CBG’ while on the other half there is the inscription ‘2’.
Cabergolina ratiopharm 1 mg is available in packs of 2, 8, 14, 15, 16, 20, 28, 30,
32, 40, 48, 50, 60, 90, 96 and 100 tablets.
Cabergolina ratiopharm 2 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
ratiopharm GmbH
DE-89079 Ulm
Germany

Distributor for sales: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 authorised in the Member States of the European
Economic Area under the following denominations:
Sweden: Cabergoline ratiopharm 1mg Tablet
Cabergoline ratiopharm 2mg Tablet.

Germany: Cabergolin-ratiopharm 1mg Tablets
Cabergolin-ratiopharm 2mg Tablets