Dostinex

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Dostinex, 0.5 mg, tablets

Cabergoline

Before taking the medicine, the patient should carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be passed on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Dostinex and what is it used for
• 2. Important information before taking Dostinex
• 3. How to take Dostinex
• 4. Possible side effects
• 5. How to store Dostinex
• 6. Contents of the packaging and other information

1. What is Dostinex and what is it used for

Dostinex is an ergoline derivative with dopaminergic activity, strongly and persistently lowering prolactin levels. It works by directly stimulating dopamine D receptors in the anterior pituitary gland, thereby inhibiting prolactin secretion. Dostinex is indicated:

• to inhibit lactation immediately after childbirth or to stop milk production,
• to treat disorders associated with excessive prolactin secretion (hyperprolactinemia), including menstrual disorders (absence, scarcity, or irregular menstruation), anovulation, galactorrhea,
• to treat pituitary tumors, idiopathic hyperprolactinemia, or empty sella syndrome associated with hyperprolactinemia.

2. Important information before taking Dostinex

When not to take Dostinex

• if the patient is allergic to cabergoline or any other component of this medicine (listed in section 6);
• if the patient is allergic to other ergot derivatives;
• if the patient has or has had fibrotic reactions in the heart, lungs, or abdomen;
• if the patient will be taking Dostinex for a long time and has currently or has had fibrotic reactions (fibrosis) of the heart muscle.

Warnings and precautions

Before starting treatment with Dostinex, the patient should discuss the following with their doctor:

• patients with severe cardiovascular disorders,
• patients with Raynaud's syndrome,
• patients with peptic ulcer or gastrointestinal bleeding,
• patients with a history of serious psychiatric disorders, particularly psychosis,
• patients with severe liver impairment should consider taking lower doses of Dostinex,
• in case of concomitant use of blood pressure-lowering medications, as orthostatic hypotension may occur after administration of cabergoline (especially in the first few days of treatment),
• patients with symptoms of respiratory or cardiovascular disorders related to fibrosis or a history of such disorders,
• patients with Parkinson's disease may experience episodes of sudden sleepiness - the dose should be reduced or treatment discontinued,
• if the patient has currently or has had fibrotic reactions (fibrosis) of the heart muscle, lungs, or abdominal organs. In patients taking Dostinex for a long time, the doctor will check the heart, lung, and kidney function before starting treatment. Before starting treatment and at regular intervals during treatment, echocardiographic examinations (heart ultrasound) will be performed. If fibrotic reactions occur, treatment will be discontinued,
• the patient should inform their doctor if they or their relatives notice unusual behaviors due to irresistible impulses, compulsions, or urges to perform certain actions that may be harmful to the patient or others. Such behaviors are called impulse control disorders and may include gambling disorder, compulsive or binge eating, excessive sexual drive, or increased sexual thoughts and feelings. The doctor may decide to adjust the treatment or discontinue the medicine.

Female patients after childbirth may be more susceptible to certain adverse events, including high blood pressure, myocardial infarction, seizures, stroke, and psychiatric disorders. Therefore, during treatment, the doctor will regularly monitor blood pressure. If the patient experiences high blood pressure, chest pain, or severe or persistent headache (with or without visual disturbances), they should immediately inform their doctor. The medicine should not be used in women with pregnancy-induced hypertension, pre-eclampsia, or postpartum hypertension, unless the potential benefits outweigh the risks. To avoid orthostatic hypotension, the single dose of Dostinex should not exceed 0.25 mg to inhibit ongoing lactation in breastfeeding women. Before starting treatment with Dostinex, a detailed assessment of pituitary function is recommended. Since Dostinex restores ovulation and fertility in women with hypogonadism associated with hyperprolactinemia, it is recommended to perform pregnancy tests at least every 4 weeks during the period before the onset of menstruation and thereafter whenever menstrual bleeding is delayed by more than 3 days. Women who want to avoid pregnancy should use mechanical contraceptive methods during treatment with Dostinex and after its discontinuation, until the resumption of anovulation. Women who become pregnant should be monitored for signs of pituitary tumor growth, as pregnancy may lead to the growth of pre-existing pituitary tumors. In patients treated with dopamine agonists, including cabergoline, pathological gambling, increased libido, and hypersexuality have been observed. These symptoms were usually reversible after dose reduction or discontinuation of the medicine. The patient should consult their doctor, even if the above warnings refer to past situations.

Dostinex and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• There is no information on interactions between cabergoline and other ergot alkaloids, so concomitant use of these medicines is not recommended during long-term treatment with Dostinex.
• Dostinex should not be taken with phenothiazines, butyrophenones, thioxanthenes (antipsychotic medicines), metoclopramide (a medicine used for disorders of the upper gastrointestinal tract), as these medicines may reduce the therapeutic effect of Dostinex.
• Dostinex, like other ergot derivatives, should not be used in combination with macrolide antibiotics (e.g., erythromycin) due to increased bioavailability of cabergoline.
• Dostinex may cause orthostatic hypotension in patients taking blood pressure-lowering medications.

Dostinex with food and drink

Tolerance to dopaminergic medicines is better when taken with food, so it is recommended to take Dostinex with meals.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Before starting treatment with Dostinex, pregnancy should be ruled out. Additionally, measures to prevent pregnancy should be taken for at least one month after discontinuation of Dostinex. There are no clinical data on the use of Dostinex in pregnant women. Animal studies have shown reduced fertility and possible toxicity to the fetus. Dostinex should be used during pregnancy only if clearly indicated and after a careful assessment of the benefit-to-risk ratio. Due to the long half-life of the medicine and limited data on fetal exposure, women planning to become pregnant should discontinue Dostinex one month before planned conception. If conception occurs during therapy, treatment should be discontinued immediately after confirmation of pregnancy to minimize fetal exposure. Considering the mechanism of action of Dostinex, it is expected to inhibit or reduce lactation during its use. Women taking Dostinex should not breastfeed.

Driving and using machines

During the initiation of treatment with Dostinex, patients should be cautious when performing tasks that require quick and accurate reactions. Patients taking Dostinex who experience sleepiness and/or sudden sleep attacks should not drive or operate machines that may put themselves or others at risk of serious injury or death (e.g., when operating machinery) until sleepiness and/or sudden sleep attacks have resolved. Dostinex contains lactose.If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Dostinex

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist. Dostinex is intended for oral use. It is recommended to take Dostinex with meals. In patients with intolerance to dopaminergic medicines, the doctor may decide to start treatment with a reduced dose of Dostinex (e.g., 0.25 mg once a week) and gradually increase the dose to achieve the therapeutic dose. In case of persistent or severe side effects, the doctor may decide to temporarily reduce the dose and then return to the therapeutic dose by gradually increasing it (e.g., 0.25 mg weekly, every two weeks). Inhibition of lactation The recommended dose is: 1 mg of cabergoline (2 tablets of 0.5 mg) on the first day after childbirth. Stopping milk production The recommended dose is: 0.25 mg (half a tablet) every 12 hours for two days. Treatment of disorders associated with excessive prolactin secretion The recommended initial dose is 0.5 mg per week, administered in one (1 tablet of 0.5 mg) or two doses (2 times a week, half a tablet, e.g., on Mondays and Thursdays). The weekly dose should be increased gradually, preferably by 0.5 mg per week at monthly intervals, until optimal therapeutic effects are achieved. The therapeutic dose ranges from 0.25 mg to 2 mg per week, with an average of 1 mg per week. In patients with hyperprolactinemia, doses up to 4.5 mg per week have been used. The doctor will decide on the appropriate administration of the weekly dose: once or in two or more portions, depending on the patient's tolerance. The doctor will determine the smallest effective dose that achieves the therapeutic effect. After determining the therapeutic dose, the doctor will decide on the appropriate control of prolactin levels in the blood. Normalization of prolactin levels is usually achieved within 2-4 weeks. After completion of treatment with Dostinex, a relapse of hyperprolactinemia is usually observed. However, in some patients, a persistent decrease in prolactin levels has been observed for several months. In most women, ovulatory cycles occurred for at least 6 months after completion of treatment.

Use in children and adolescents

The safety and efficacy of Dostinex have not been evaluated in patients under 16 years of age.

Use in patients with liver function disorders

In patients with severe liver impairment, the dose of Dostinex should be reduced (see section: Warnings and precautions).

Use in elderly patients

No regular studies have been conducted on the use of Dostinex in elderly patients with disorders associated with excessive prolactin secretion.

Overdose of Dostinex

In case of overdose, the patient should contact their doctor. The symptoms of overdose are presumably related to excessive stimulation of dopamine receptors, such as nausea, vomiting, gastrointestinal disorders, orthostatic hypotension, confusion, and/or psychosis or hallucinations. If necessary, the doctor will apply supportive methods to remove the unabsorbed medicine and stabilize blood pressure values. Additionally, the doctor may use treatment with dopamine antagonists.

Missing a dose of Dostinex

If the patient forgets to take a dose of Dostinex, they should take it as soon as possible, unless it is close to the time for the next dose. In this case, the patient should take the next dose at the scheduled time. The patient should not take a double dose to make up for the missed dose.

Discontinuation of Dostinex

The decision to discontinue treatment is made by the doctor. If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Dostinex can cause side effects, although not everybody gets them. Side effects observed during treatment with Dostinex to inhibit lactation: Side effects have been ranked according to frequency. They reflect data from clinical trials with Dostinex administered in a dose of 1 mg and in breastfeeding women who received Dostinex in a dose of 0.25 mg every 12 hours to inhibit lactation. The reported side effects were mostly transient, with mild to moderate severity. During the first 3-4 days after childbirth, asymptomatic decreases in blood pressure (≥20 mmHg systolic and ≥10 mmHg diastolic) may occur. Side effects observed during treatment with Dostinex for disorders associated with excessive prolactin secretion: Side effects have been ranked according to frequency. They reflect data from 6-month clinical trials with Dostinex administered in doses ranging from 1 to 2 mg per week (administered in two doses per week). The reported side effects were mostly mild to moderate and occurred mainly in the first two weeks of treatment. Most of them resolved during treatment or within a few days after discontinuation of the medicine. General information: Side effects depend mainly on the dose. Dostinex may cause a decrease in blood pressure when used for a long time; however, orthostatic hypotension or fainting has been reported rarely. Dostinex is an ergot derivative, so it may exhibit vasoconstrictive effects. With long-term use, abnormal results of standard laboratory tests are unlikely; in non-menstruating women, a decrease in hemoglobin has been observed during the first few months after resumption of menstruation. The following side effects may occur:

• irresistible impulse, temptation, or compulsion to perform actions that may be harmful to the patient or others; this includes: o strong impulse or uncontrolled gambling, despite significant personal or family consequences, o changed or increased sexual interests and behaviors of great importance to the patient or others, e.g., activities related to increased sexual drive, o compulsive, uncontrolled spending or buying, o binge eating (consuming more food than normal and more than needed to satisfy hunger).

The patient should inform their doctor if they experience any of these behaviors to discuss ways to control or limit these symptoms. Side effects have been ranked according to frequency. Very common(may occur in more than 1 in 10 people)

• valvular heart disease (including valve regurgitation) and associated conditions (pericarditis, pericardial effusion)
• headache*, dizziness of central or peripheral origin*
• nausea*, dyspepsia, gastritis*, abdominal pain*
• fatigue***, tiredness

Common(may occur in up to 1 in 10 people)

• drowsiness
• depression
• decreased blood pressure in patients undergoing long-term treatment, orthostatic hypotension, hot flashes**
• constipation, vomiting**
• chest pain
• asymptomatic decreases in blood pressure (systolic ≥20 mmHg and diastolic ≥10 mmHg)

Uncommon(may occur in up to 1 in 100 people)

• palpitations
• dyspnea, pleural effusion, fibrosis (including pulmonary fibrosis), epistaxis
• hypersensitivity reactions
• transient hemianopia, syncope, paresthesia
• increased libido
• digital vasospasm
• edema, peripheral edema
• rash, alopecia
• leg cramps
• in non-menstruating women, a decrease in hemoglobin has been observed during the first few months after resumption of menstruation

Rare(may occur in up to 1 in 1,000 people)

• epigastric pain

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

• pleural fibrosis

Frequency not known(cannot be estimated from available data)

• angina pectoris
• respiratory disorders, respiratory failure, pleuritis, chest pain
• sudden sleep attacks, tremors
• visual disturbances
• liver function disorders
• increased creatine phosphokinase levels in the blood, abnormal liver function test results

* Very common in patients treated for hyperprolactinemia; common in patients treated to inhibit lactation. ** Common in patients treated for hyperprolactinemia; uncommon in patients treated to inhibit lactation. *** Very common in patients treated for hyperprolactinemia; very common in patients treated to inhibit lactation.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 (22) 49 21 301, fax: +48 (22) 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Dostinex

Store at a temperature below 25°C. The medicine should be stored out of 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 the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Dostinex contains

• The active substance of Dostinex is cabergoline. One tablet contains 0.5 mg of cabergoline.
• The other ingredients are: leucine, lactose.

What Dostinex looks like and contents of the packaging

Dostinex is a white, oval, scored tablet. The tablets are packaged in a brown glass bottle with an aluminum cap with a desiccant or a HDPE bottle with a PP cap with a desiccant, in a cardboard box. The packaging contains 2 or 8 tablets. For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Pfizer bv, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands

Manufacturer:

Pfizer Italia S.r.l., Localita Marino del Tronto, 63100 Ascoli Piceno, Italy

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in the Netherlands, the country of export: RVG 15375

Parallel import authorization number: 136/24

Date of leaflet approval: 27.03.2024

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