Dostinex

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

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

Dostinex

0.5 mg, tablets

Cabergoline

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• 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 using Dostinex
• 3. How to use Dostinex
• 4. Possible side effects
• 5. How to store Dostinex
• 6. Contents of the package 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 cells, 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, galactorrhea,
• to treat pituitary adenoma, idiopathic hyperprolactinemia, or empty sella syndrome associated with hyperprolactinemia.

2. Important information before using Dostinex

When not to use 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 using Dostinex for a long time and has currently or has had fibrotic reactions (fibrosis) in the heart muscle.

Warnings and precautions

Before starting treatment with Dostinex, you should discuss it with your doctor:

• in patients with severe cardiovascular disorders,
• in patients with Raynaud's syndrome,
• in patients with peptic ulcer or gastrointestinal bleeding,
• in patients with a history of serious psychiatric disorders, particularly psychosis,
• in patients with severe liver impairment - a lower dose of the medicine should be considered,
• in case of concomitant use of blood pressure-lowering medicines, as orthostatic hypotension may occur after administration of cabergoline (especially in the first few days of treatment),
• in patients who experience symptoms of respiratory or cardiovascular disorders related to fibrosis or have a history of such disorders,
• in patients with Parkinson's disease, sudden episodes of sleepiness may occur - the dose should be reduced or treatment discontinued,
• if the patient has currently or has had fibrotic reactions (fibrosis) in 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,
• you should inform your doctor if you or your relatives notice unusual behaviors resulting from irresistible impulses, compulsions, or urges to perform certain actions 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 intense sexual thoughts and feelings. The 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 mental disorders. For this reason, during treatment, the doctor will regularly check blood pressure. If the patient experiences high blood pressure, chest pain, or extremely 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, 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 a pregnancy test at least every 4 weeks during the period before the onset of menstruation and then every time 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 enlargement, 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. You should consult your doctor, even if the above warnings refer to situations that have occurred in the past.

Dostinex and other medicines

You should inform your doctor about all medicines you have taken recently, including those that are available without a prescription.

• There is no information on interactions between cabergoline and other ergot alkaloids, so it is not recommended to use these medicines concomitantly 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 concomitantly with macrolide antibiotics (e.g., erythromycin) due to increased bioavailability of cabergoline.
• Dostinex may cause orthostatic hypotension in patients taking blood pressure-lowering medicines.

Dostinex with food and drink

Tolerance to dopaminergic medicines is better when they are 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, you should consult your doctor or pharmacist before using 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 it is 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 therapy, treatment should be discontinued immediately after confirmation of pregnancy to limit fetal exposure to the medicine. 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

When starting 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, as impaired alertness may put them or others at risk of serious injury or death (e.g., when operating machines). Until sleepiness and/or sudden sleep attacks resolve, patients should not engage in activities where reduced alertness may pose a risk.

Dostinex contains lactose

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to use Dostinex

This medicine should always be used as directed by your doctor. In case of doubts, you should consult your doctor or pharmacist. Dostinex is intended for oral use. It is recommended to take Dostinex with meals. In patients with intolerance to dopaminergic medicines, to reduce the likelihood of side effects, the doctor may decide to start treatment with a reduced dose of the medicine (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, to improve tolerance to the medicine, 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). 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 to the medicine. 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 therapy 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 therapy.

Use in children and adolescents

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

Use in patients with liver function disorders

In patients with severe liver impairment, a reduced dose of Dostinex should be considered (see section: When not to use 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.

Use of a higher than recommended dose of Dostinex

In case of overdose, you should contact your 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 the unabsorbed medicine and stabilize blood pressure values. Additionally, the doctor may use dopamine antagonists.

Missing a dose of Dostinex

If you miss a dose of Dostinex, you should take it as soon as possible, unless it is almost time for the next dose. In this case, you should take the next dose at the scheduled time. Do 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 you have any further doubts about the use of this medicine, you should 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 use of the medicine to inhibit lactation: Side effects have been ranked according to frequency. They reflect the 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, mild to moderate in 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 use of the medicine to treat disorders associated with excessive prolactin secretion: Side effects have been ranked according to frequency. They reflect the data from 6-month clinical trials with Dostinex administered in a dose of 1 to 2 mg per week (administered in two doses per week). The reported side effects were mostly mild to moderate in severity 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 are rarely reported. 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:

• inability to resist an impulse, temptation, or urge to perform actions that may be harmful to you 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 you 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).

You should 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 (more than 1 in 10 people)

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

Common (more than 1 in 100, but less than 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 (more than 1 in 1000, but less than 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 (more than 1 in 10,000, but less than 1 in 1000 people)

• epigastric pain

Very rare (less than 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
• vision disorders
• liver function disorders
• increased creatine phosphokinase levels in blood, abnormal liver function test results

*Very common in patients treated for hyperprolactinemia; common in women treated to inhibit and/or suppress lactation **Common in patients treated for hyperprolactinemia; uncommon in women treated to inhibit and/or suppress lactation ***Very common in patients treated for hyperprolactinemia; very common in women treated to inhibit and/or suppress lactation

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. 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 stated. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Dostinex contains

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

What Dostinex looks like and contents of the package

HDPE bottle with a PP cap, a desiccant, and a cardboard box. The package contains 2 or 8 tablets. For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

Pfizer, S.L., Avda. de Europa, 20-B, Parque Empresarial La Moraleja, 28108 Alcobendas (Madrid), Spain

Manufacturer:

Pfizer Italia S.r.L., Località Marino del Tronto – 63100, Ascoli Piceno (AP), 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, CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw, Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw, Synoptis Industrial Sp. z o.o., ul. Szosa Bydgoska 58, 87-100 Toruń, CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź, Marketing authorization number in Spain, the country of export: 710401.8

• 710402.5

Parallel import authorization number: 203/22 Date of leaflet approval: 11.05.2022

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