Dostinex

Package Leaflet: Information for the Patient

DOSTINEX, 0.5 mg, tablets
Cabergoline

Read the package 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.
• If you have any doubts, consult your 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 you experience any side effects, including those not listed in this leaflet, tell your 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 receptors D 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 tumors, idiopathic hyperprolactinemia, or empty sella syndrome associated with hyperprolactinemia.

2. Important information before taking DOSTINEX

When not to take DOSTINEX

• if you are allergic to cabergoline or any other ingredient of this medicine (listed in section 6);
• if you are allergic to other ergot derivatives;
• if you have or have had fibrotic reactions in the heart, lungs, or abdomen;
• if you will be taking DOSTINEX long-term and have currently or had in the past fibrotic reactions (fibrosis) of the heart muscle.

Warnings and precautions

Before starting treatment with DOSTINEX, discuss with your doctor:

• if you have severe cardiovascular disorders,
• if you have Raynaud's syndrome,
• if you have peptic ulcer or gastrointestinal bleeding,
• if you have a history of serious psychiatric disorders, particularly psychosis,
• if you have severe liver dysfunction - a lower dose of DOSTINEX may be considered,
• if you are taking blood pressure-lowering medications, as orthostatic hypotension may occur after taking cabergoline (especially in the first few days of treatment),
• if you have symptoms of respiratory or cardiovascular disorders related to fibrosis or a history of such disorders,
• if you have Parkinson's disease, as sudden episodes of sleepiness may occur - consider reducing the dose or stopping treatment,
• if you have currently or had in the past fibrotic reactions (fibrosis) of the heart muscle, lungs, or abdominal organs. For patients taking DOSTINEX long-term, the doctor will check if heart, lung, and kidney function is normal 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 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 intense sexual thoughts and feelings. Your doctor may decide to adjust 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 you experience high blood pressure, chest pain, or extremely severe or persistent headache (with or without vision disturbances), you should immediately tell your doctor.
Do not take DOSTINEX if you have 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 DOSTINEX, a detailed assessment of pituitary function is recommended.
Since DOSTINEX restores ovulation and fertility in women with hyperprolactinemia-associated hypogonadism, it is recommended to perform a pregnancy test at least every 4 weeks during the premenstrual period and thereafter whenever 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 until the return of anovulation. Women who become pregnant should be monitored for signs of pituitary tumor growth, as pregnancy may cause an increase in existing pituitary tumors.
Patients treated with dopamine agonists, including cabergoline, have reported pathological gambling, increased libido, and hypersexuality. 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

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 it is not recommended to take these medicines together 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 taken 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 taken with food, so it is recommended to take DOSTINEX with meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, 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 stopping treatment with 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 to the medicine.
Given 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 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 you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take DOSTINEX

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
DOSTINEX is 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).
Lactation inhibition
The recommended dose is: 1 mg of cabergoline (2 tablets of 0.5 mg) on the first day after childbirth.
Milk production cessation
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 initial recommended 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).
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 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 stopping 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 stopping 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 dysfunction

In patients with severe liver dysfunction, a reduced dose of DOSTINEX should be considered (see section: When to exercise special caution when taking 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, 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 apply supportive measures to remove unabsorbed medicine and stabilize blood pressure values. Additionally, the doctor may use dopamine antagonists.

Missed dose of DOSTINEX

If you forget to take DOSTINEX, take it as soon as possible, unless it is almost time for the next dose. In this case, take the next dose at the scheduled time. Do not take a double dose to make up for the 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.
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). 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 stopping the medicine.
General information:
Side effects depend mainly on the dose.
DOSTINEX may cause a decrease in blood pressure when taken long-term, although orthostatic hypotension or fainting are rare.
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 resuming menstruation.
The following side effects may occur:

• inability to resist an impulse, temptation, or compulsion to perform actions that may be harmful to you or others; this includes:

strong impulse or uncontrolled gambling, despite serious personal or family consequences,
changed or increased sexual interests and behaviors of great importance to you 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(may affect 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(may affect 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 affect up to 1 in 100 people)

• palpitations
• shortness of breath, pleural effusion, fibrosis (including pulmonary fibrosis), nosebleeds
• hypersensitivity reactions
• transient hemianopia, fainting, 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 resuming 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

Frequency not known(cannot be estimated from the 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 the blood, abnormal liver function test results

*Very common in patients treated for hyperprolactinemia; common in women treated for lactation inhibition and (or) suppression
**Common in patients treated for hyperprolactinemia; uncommon in women treated for lactation inhibition and (or) suppression
***Very common in patients treated for hyperprolactinemia; very common in women treated for lactation inhibition and (or) suppression

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, 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
Jerozolimskie Avenue 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
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 sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after (EXP).
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 that are no longer needed. This will help protect the environment.

6. Contents of the pack 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, anhydrous lactose.

What DOSTINEX looks like and contents of the pack

DOSTINEX is a white, flat, elongated tablet with a score line and engraved with "PU" on one side and "700" on the other side.
The tablets are packaged in a glass bottle with an aluminum cap or an HDPE bottle with a PP cap, containing a desiccant in an LDPE container. The bottle is placed in a cardboard box.
The pack contains 2, 4, or 8 tablets.

Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Manufacturer

Pfizer Italia S.r.l., 63100 Marino Del Tronto, Ascoli Piceno, Italy
To obtain more detailed information, contact the local representative of the marketing authorization holder:
Pfizer Polska Sp. z o.o.
tel. 22 335 61 00

Date of last revision of the leaflet:

Detailed and up-to-date information about this product can be obtained by scanning the QR code on the outer packaging using a mobile device. The same information is also available at the URL: https://pfi.sr/ulotka-dostinex and on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products http://www.urpl.gov.pl .