Dostinex

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language

Dostinex

0.5 mg, tablets

Cabergoline

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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 pack and other information

1. What is Dostinex and what is it used for

Dostinex is an ergoline derivative with dopaminergic activity, strongly and long-lastingly 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 periods), anovulation, and 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 long-term and has currently or has had fibrotic reactions (fibrosis) in the heart muscle.

Warnings and precautions

Before starting treatment with Dostinex, discuss the following with your 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 - a lower dose of Dostinex may be considered,
• in case of concomitant use of blood pressure-lowering medications, as orthostatic hypotension may occur after cabergoline administration (especially in the first few days of treatment),
• patients with symptoms of respiratory or cardiovascular disorders related to fibrotic processes or a history of such disorders,
• patients with Parkinson's disease may experience sudden episodes of sleep - the dose may need to be reduced or treatment discontinued,
• if the patient has currently or has had fibrotic reactions (fibrosis) in the heart, lungs, or abdominal organs. In patients taking Dostinex long-term, the doctor will check 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,
• inform your doctor if you or your relatives notice unusual behaviors due to irresistible impulses, compulsions, or repetitive behaviors that may be harmful to you or others. Such behaviors are called impulse control disorders and may include gambling addiction, compulsive or binge eating, excessive sexual drive, or increased sexual thoughts and feelings. Your doctor may decide to adjust the treatment or discontinue the medicine.

Women who have just given birth may be more susceptible to certain adverse events, including high blood pressure, heart attack, 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 vision 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, do not exceed a single dose of 0.25 mg of Dostinex 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 a pregnancy test at least every 4 weeks during the pre-menstrual period 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 discontinuation, until anovulation recurs. Women who become pregnant should be monitored for signs of pituitary tumor growth, as pregnancy may cause 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. Consult your doctor, even if the above warnings refer to past situations.

Dostinex and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you 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.
• Like other ergot derivatives, Dostinex 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your 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-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 treatment, treatment should be discontinued immediately after confirmation of pregnancy to minimize fetal exposure. Considering the mechanism of action of Dostinex, inhibition or reduction of lactation is expected during its use. Women taking Dostinex should not breastfeed.

Driving and using machines

When starting treatment with Dostinex, patients should be cautious when performing tasks that require quick and accurate reactions. Patients taking Dostinex who experience somnolence and/or sudden sleep attacks should not drive or operate machinery that may put themselves or others at risk of serious injury or death (e.g., when operating machinery). Until somnolence and/or sudden sleep attacks resolve, patients should not engage in activities that require alertness.

Dostinex contains lactose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Dostinex

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist. Dostinex is 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 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, given 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 gradually increased, 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, hyperprolactinemia usually recurs. 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 in patients under 16 years of age have not been evaluated.

Use in patients with liver disorders

In patients with severe liver impairment, a reduced dose of Dostinex should be considered (see section: When to be cautious with Dostinex).

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, consult a doctor. The symptoms of overdose are likely to be those associated with excessive stimulation of dopamine receptors, such as nausea, vomiting, gastrointestinal disorders, orthostatic hypotension, confusion, and/or psychosis or hallucinations. If necessary, the doctor will use supportive methods to remove unabsorbed medicine and stabilize blood pressure. Additionally, the doctor may use dopamine antagonists.

Missing a dose of Dostinex

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

Stopping treatment with Dostinex

The decision to stop treatment is made by the doctor. If you have any further doubts about the use of this medicine, consult your 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 at a dose of 1 mg and in breastfeeding women who received Dostinex at 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 at a dose of 1-2 mg per week (given 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 long-term; however, orthostatic hypotension or fainting is rare. As an ergot derivative, Dostinex 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:

• inability to resist an 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 serious 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 larger amounts of food than normal and more than needed to satisfy hunger).
Inform your doctor if you 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 affect 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 affect up to 1 in 10 people)

• sleepiness
• 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 affect 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 affect up to 1 in 1,000 people)

• epigastric pain

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

• pleural fibrosis

Not known(cannot be estimated from the 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 women treated to inhibit lactation
**Common in patients treated for hyperprolactinemia; uncommon in women treated to inhibit lactation
***Very common in patients treated for hyperprolactinemia; very common in women treated to inhibit lactation

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, you can help provide more information on the safety of this medicine.

5. How to store Dostinex

Store in a temperature below 25°C. Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Dostinex contains

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

What Dostinex looks like and contents of the pack

Dostinex is a white, flat, elongated tablet with a score line and the imprint "PU" on one side and "700" on the other. The tablet can be divided into two equal doses. The medicine is available in bottles with a child-resistant closure or in HDPE bottles with a PP cap, each containing 2 or 8 tablets, in a cardboard box.

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

Pfizer bv, Rivium Westlaan 142, 2909 LD Capelle a/d Ijssel, Netherlands

Manufacturer:

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

Parallel importer:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź

Repackaged by:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź, 02-234 Warsaw

Marketing authorization number in the Netherlands, the country of export: RVG 15375

Parallel import authorization number: 160/24

Date of leaflet approval: 22.04.2024

[Information about the trademark]