Dostinex

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Dostinex(ДОСТИНЕКС)
0.5 mg,tablets
Cabergoline
Dostinex and ДОСТИНЕКС are the same names of the same drug written in Polish and Bulgarian.

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 to a specific person. It should not be given 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 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 packaging and other information

1. What is Dostinex and what is it used for

Dostinex is an ergoline derivative with dopaminergic activity, strongly and long-lasting 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, 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 of the other ingredients 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, 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 Dostinex 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 have symptoms of respiratory or cardiovascular disorders related to fibrotic processes 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) 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,
• you should inform your doctor if you or your relatives notice unusual behaviors due to irresistible impulse, compulsion, or repetitive behavior 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. 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. 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 tell their doctor.
Dostinex 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 contraceptives during treatment with Dostinex and after discontinuation of the medicine until the resumption of anovulation.
Women who become pregnant should be monitored for signs of pituitary tumor growth, as pregnancy may cause 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 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 it is 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 limit fetal exposure to the medicine.
Given 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 machinery).
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 take Dostinex

This medicine should always be taken according to the doctor's recommendations. In case of doubts, you should consult a 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 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, 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 increased gradually, preferably by 0.5 mg per week at monthly intervals, until optimal therapeutic effect is achieved. The therapeutic dose is from 0.25 mg to 2 mg per week, on average 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 tolerance to the medicine.
The doctor will determine the smallest effective dose, after which the therapeutic effect is achieved. 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 Dostinex 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 "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 of Dostinex, you should contact your 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 use 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

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

Discontinuation of Dostinex

The decision to discontinue treatment is made by the doctor.
In case of any further doubts related to the use of this medicine, you should consult a 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 the 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.
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 the data from 6-month clinical trials with Dostinex administered at a dose of 1 to 2 mg per week (administered in two doses per week). 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 is rarely reported.
As an ergot derivative, Dostinex may exhibit vasoconstrictive properties.
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 impulse, temptation, or compulsion to perform actions that may be harmful to the patient or others; this includes:
• strong impulse or uncontrolled gambling, despite serious personal or family consequences,
• altered or increased sexual interests and behaviors of great importance to the patient or others, e.g., activities related to increased sexual drive,
• compulsive, uncontrolled spending or buying,
• sudden, uncontrolled eating (consuming more food than usual 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)

• 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 (more than 1 in 1,000, 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 1,000 people)

• epigastric pain.

Very rare (less than 1 in 10,000 people)

• pleural fibrosis.

Unknown: frequency cannot be estimated from available data

• angina pectoris,
• respiratory disorders, respiratory failure, pericarditis, 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 and/or suppress lactation.
**Common in patients treated for hyperprolactinemia; uncommon in patients treated to inhibit and/or suppress lactation.
***Very common in patients treated for hyperprolactinemia; very common in patients treated to inhibit and/or suppress lactation.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. 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, 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.
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 packaging 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 pack

Dostinex is a flat, white, capsule-shaped tablet with dimensions of 4x8 mm, with a scored line.
The tablet can be divided into two equal parts.
The tablets are packaged in an orange glass type I bottle with an aluminum cap with a desiccant or an HDPE bottle with a polypropylene child-resistant cap, in a cardboard box.
The packaging contains 2 or 8 tablets.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Pfizer Europe МА EEIG
Boulevard de la Plaine 17, 1050 Brussels, Belgium

Manufacturer:

Pfizer Italia S.r.l.
Via del Commercio, 63100 Marino del Tronto, Ascoli Piceno (AP), Italy

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in Bulgaria, the country of export:20030572

Parallel import authorization number: 374/22 Date of leaflet approval: 11.10.2022

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