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4.1. Therapeutic indications

CABASER® is used as monotherapy in second-line treatment of patients who cannot tolerate non-ergot compounds in the treatment of signs and symptoms of Parkinson's disease or treatment with such compounds, or as additive therapy in patients treated with levodopa / carbidopa.

4.2. Posology and administration

Posology / administration frequency and duration:

CABASER® is indicated for chronic and long-term treatment.

Adults and geriatric population: In

terms of efficacy and safety balance in dopamine agonists, the optimal dose seems to be due primarily to individual sensitivity, and therefore the optimum dose should be determined starting with daily doses of 1 mg by the degree of adjustment.

The dose of CABASER® can be gradually increased and the dose of levodopa may be gradually reduced until the optimal balance in patients receiving levodopa is reached simultaneously.

With regard to the long half-life of the compound, if necessary, the daily dose may be increased by 0.5-1 mg at weekly or two-week intervals until the optimum dose is reached (during the first few weeks).

Recommended therapeutic dose; Addition with levodopa / peripheral decarboxylase inhibitor istreatment or

®

a maximum of 3 mg per day when administered asmonotherapy. CABASER should be given once daily as a single dose.

Application:

CABASER® is used orally. It is recommended that CABASER® is preferably taken with the meal, since dopaminergic agents can be better tolerated when given with food.

Additional information on special populations:

Renal / hepatic impairment: Although

renal failure has been shown to have no effect on cabergoline kinetics, severe hepatic failure has been associated with a high curve area (EAA). Therefore, lower doses of CABASER® should be considered in patients with severe hepatic impairment (see section 4.4).

Pediatric population:

4.3. Contraindications

Cabergoline is contraindicated in case of hypersensitivity to other substances or ergot alkaloids in the formula.

History of pulmonary, retroperitoneal, pericardial fibrotic disease, anatomical data of valvulopathy in any cardiac valve (eg thickening of the valve in echocardiography, valve restriction, mixed restriction-stenosis in valve)

Cardiac valvulopathy determined by echocardiography before treatment

4.4. Specific use warnings and precautions

Fibrosis / cardiac valvulopathy and possible associated clinical phenomenon: long-term use of ergo derivatives showing agonist activity at serotonin 5HT2B receptor such as cabergoline followed by prolonged use of pleural effusions, pleural effusion, pleural fibrosis, pulmonary fibrosis, pericarditis, pericardial effusion, one or more valvular (aortic, mitral and tricuspid) involvement including fibrotic and serosal inflammatory disorders such as cardiac valvulopathy or retroperitoneal fibrosis.

There is also an abnormal increase in erythrocyte sedimentation rate (ESR) associated with pleural effusion / fibrosis. If there is an increase in ESR values ​​that cannot be attributed to another morbidity, a chest x-ray is recommended.

Serum creatinine measurements may be useful in the diagnosis of fibrotic disorders.

Valvulopathy has been associated with cumulative doses. Therefore, patients should be treated with the lowest effective dose. The risk-benefit profile of cabergoline treatment should be reassessed at each visit for the suitability of the patient to continue treatment with cabergoline. The risk of fibrosis increases when the daily treatment dose exceeds 3 mg.

The results of a large-scale retrospective cohort study among patients with Parkinson's disease and involving more than one European country were compared to patients who had been treated with levodopa for the first treatment. (see sections 4.8 and 5.1).

Before starting treatment:

Before starting treatment with cabergoline, patients should undergo cardiovascular evaluation, including echocardiography, to determine the likelihood of potential asymptomatic valvular disease. It would be appropriate to evaluate the erythrocyte sedimentation rate or other inflammation indicators, lung function / chest radiography and renal functions before starting treatment.

It is not known whether cabergoline treatment will worsen the underlying disease in patients with valvular regurgitation. If fibrotic valvular disease is detected, the patient should not be treated with cabergoline (see section 4.3).

During treatment:

Fibrotic disorders may be insidious onset and patients should be monitored regularly for the development of fibrotic symptoms.

Therefore, the following symptoms and symptoms should be considered during the treatment:

• Pulmonary-pulmonary diseases such as chest pain, persistent cough, dyspnoea, shortness of breath

• Abdominal masses or tenderness, which may indicate possible retroperitoneal fibrosis; kidney failure or ureteral / abdominal vascular obstruction with pain in the waist / side and edema in the legs.

• Heart failure; cases of valvular and pericardial fibrosis have often shown symptoms as heart failure. Therefore, if these symptoms are observed, the possibility of valvular fibrosis (and constrictive pericarditis) should be eliminated.

Clinical diagnostic follow-up is required for the development of valvular disease or fibrotic disorders. The first echocardiography should be performed within 6 ilk6 months after the beginning of treatment and in 6 ek12 months following the clinical evaluation of signs and symptoms.

If echocardiography reveals new or deteriorating valvular regurgitation, valvular restriction or thickening of the valvular valve sheets (see Section 4.3), the use of cabergoline should be discontinued.

Clinical monitoring needs (eg, physical examination, chest X-ray, computed tomography (CT)), including cardiac auscultation, should be evaluated individually.

Other appropriate studies, such as erythrocyte sedimentation rate and serum creatinine measurement, should be performed if needed to support the diagnosis of fibrotic disorder.

Somnolans / sudden falling asleep: It has been found that cabergoline is associated with somnolence and sudden sleep-on periods, especially in people with Parkinson's disease.

Sudden sleep drowsiness was reported when performing normal day-to-day activities, sometimes very rarely, without patient awareness or without any prior warning. Patients receiving cabergoline treatment should be informed about these possibilities and patients should be warned to be cautious when using a vehicle or machine. Patients who experience somnolence and / or sudden sleepiness should avoid using vehicles and machinery. The possibility of reducing the dose or terminating the treatment may be considered.

Hepatic impairment: The pharmacokinetic parameters of cabergoline did not show variations in patients with renal insufficiency, whereas in patients with severe hepatic impairment (Child-Pugh, score> 10, maximum score 12) the value of AUC was increased. Therefore, in patients with severe hepatic failure, dose adjustment should be made in Parkinson's patients.

Psychiatric: Pathological level gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists, including cabergoline. These conditions were generally reversible by dose reduction or termination of treatment.

General: As in other ergot derivatives; Cabergoline should be used with caution in people with severe cardiovascular disease, Raynaud's syndrome, peptic ulcer or gastrointestinal bleeding, or who have a history of serious, psychotic disorders.

Postural hypotension: After the use of cabergoline, postural hypotension may occur especially in the first days. Therefore, caution should be exercised when cabergoline is given with other drugs known to reduce blood pressure.

Currently, the effects of alcohol on the tolerability of the drug are unknown.

4.5. Interactions with other medicinal products and other forms of interaction

®

CABASER® should not be used in conjunction with these drugs, since the therapeutic effect of direct stimulation of dopamine receptors and drugs with dopamine antagonist activity (such as phenothiazines, butyrophenones, thioxanthenes, metoclopramide) may reduce the therapeutic effect of CABASER®. .

Similarly, also with other ergot derivatives, systemic bioavailability, and thusadverse

®

will be an increase ineffects in mindCABASER with macrolide antibiotics

(eg erythromycin) must not be given.

®

CABASER, and there is information on possible interactions between other ergot alkaloids. Therefore, co-administration of cabergoline is not recommended during long-term treatment.

The

simultaneous use of CABASER with other drugs, especially other Parkinson's medications that are not dopamine agonists, seems not to cause interactions that alter their tolerability and efficacy.

4.6. Pregnancy and lactation

General recommendation

Pregnancy category: B

Women with childbearing potential / Contraception (Contraception)

Up to now, more than 100 pregnancies have been observed in the treatment of women treated for hyperprolactinemia problems in clinical trials with cabergoline. In general, the drug continued to be taken for the first 8 weeks after conception. While 85% of the pregnancies that could be evaluated up to now have resulted in live births, approximately 10% had spontaneous abortion.

In addition, three cases of congenital anomalies (Down syndrome, hydrocephalus, malformations in lower extremities) and live births were found to have three minor anomalies. These incidences are comparable to those of the normal population and women treated with ovulation-inducible drugs. Based on the above data, the use of cabergoline does not seem to be related to an increase in the number of low, premature birth, multiple pregnancy, or congenital anomalies.

However, since the current clinical experience is still limited, women who wish to become pregnant as a safety precaution should interrupt cabergoline treatments at least one month in order to prevent the possibility of the fetus being exposed to the drug.

Pregnancy

Cabergoline can pass the placental barrier in rats; it is still not known whether this happened in humans.

If pregnancy occurs during the course of treatment, treatment should be discontinued as soon as it is learned that the patient is pregnant.

Lactation In

rats, cabergoline and / or derivatives pass into breast milk. It is estimated that lactation in humans is inhibited / suppressed due to the dopamine agonist effect of cabergoline. Since there is no information about whether or not the drug is excreted in breast milk, it is advisable for women treated with CABASER® not to breastfeed. This also applies in cases where medication does not inhibit or suppress lactation.

Reproductive ability / Fertility

4.7. Effects on ability to drive and use machines

4.8. Undesirable effects

Cabergoline may cause dizziness. In some cases, cabergoline has been associated with excessive daytime sleepiness and sudden falling asleep.

Patients Receiving Adjuvant Levodopa Treatment

During clinical trials, at least one adverse effect was observed in 74% of approximately 1070 patients treated with L-Dopa for cabergoline treatment. These effects were generally transient and mild to moderate. In a few cases the drug had to be discontinued.

Adverse effects for each system organ class are listed under headings indicating the frequency of the most common reactions using the following rules.

Very common (> 1/10); common (> 1/100 to <1/10); non-common (> 1/1000 to <1/100); sparse (> 1/10000 to <1/1000); very rare (<1/10000), unknown (unpredictable).

Nervous system disorders

Very common: Dyskinesia, hyperkinesis, hallucinations and confusion

Cardiac disorders

Very common: dizziness and postural hypotension, cardiac valvulopathy (including regurgitation) and related disorders (pericarditis and pericardial effusion)

Vascular disorders

Very Common: Peripheral edema

Common: Anjina

Common Non-erectromelalgia

Respiratory, chest disorders and mediastinal disorders

Very common: Conditions associated with the respiratory system

Common: Pleural effusion, pulmonary fibrosis, pleuritis, pleural fibrosis

Gastrointestinal disorders

Very common: Nausea, vomiting, dyspepsia and gastritis.

Diseases related to general disorders and site of practice

Common: Retroperitoneal fibrosis

Newly Diagnosed Parkinson's Patients

During clinical trials, approximately 200 patients with newly diagnosed Parkinson's patients received cabergoline and 79% of patients had at least one adverse effect. These effects were generally transient and mild to moderate.

Adverse effects for each system organ class are listed under headings indicating the frequency of the most common reactions using the following rules.

Very common (> 1/10); common (> 1/100 to <1/10); non-common (> 1/1000 to <1/100); sparse (> 1/10000 to <1/1000); very rare (<1/10000), unknown (unpredictable).

Nervous system disorders

Very common: Sleep disorder Common: Dyskinesia and hallucinations.

Gastrointestinal disorders

Very common: nausea, vomiting, dyspepsia, gastritis and constipation.

Cardiac disorders

Very common: dizziness and / or postural hypotension.

Vascular disorders

Very common: Peripheral edema.

In both patient populations, a decrease in blood pressure was observed in a minority of patients, clinically compatible, weighted orthostatic. This effect was found to be more pronounced in the first week of treatment. There were no consistent changes in heart rate or ECG tracings during treatment with cabergoline.

Cases with routine laboratory tests with long-term treatment with cabergoline have rarely been reported.

Post-marketing experience:

associated with Cabergoline, aggression, alopecia, asthenia, increased blood creatinine phosphokinase, delusion, dyspnea, edema, exhaustion, fibrosis, headache, hepatic function abnormalities, hypersensitivity reaction, hypersexuality, increased libido, abnormal liver function tests , pathological level gambling, psychotic disorder, rash, respiratory disorder, respiratory failure somnolence, sudden sleepiness, syncope and valvulopathy have been reported (see section 4.4 -Fibrosis / Cardiac valvulopathy, Somnolans / Sudden Sleeping, Psychiatric, section 4.7).

The prevalence of asymptomatic valvular regurgitation is significantly higher than that seen with non-ergot derivatives (see sections 4.3 and 4.4).

4.9. Overdose and treatment The

acute toxicity studies conducted in animals show that the product has a very low level of toxicity and therefore has a wide range of safety at pharmacologically effective doses. Clinical manifestations and causes of death in experimental animals in high doses have been attributed to stimulation of the Central Nervous System.

Information on overdosage of people with cabergoline is not available in the recommended indications. However, symptoms such as nausea, vomiting, gastric pain, hypotension, confusion / psychosis and hallucinations may be associated with excessive stimulation of dopaminergic receptors.

Treatment:

Emetic properties of dopamine agonists are expected to facilitate the removal of the unabsorbed product from the body.

Supportive treatment should be applied when necessary to keep blood pressure under control. In addition, it is recommended to administer dopamine antagonist drugs against significant central nervous system effects (hallucinations).

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