Dostinex

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet – the information on the immediate packaging is in a foreign language!
Dostinex
0.5 mg, tablets
Cabergolinum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are identical.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Dostinex is and what it is 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 Dostinex is and what it is used for

Dostinex is an ergoline derivative with dopaminergic activity, which strongly and long-lastingly reduces prolactin levels. It acts by directly stimulating dopamine receptors D in the anterior pituitary gland cells, thereby inhibiting prolactin secretion.
Dostinex is indicated:

• to suppress lactation immediately after childbirth or to stop milk secretion,
• in the treatment of disorders associated with excessive prolactin secretion (hyperprolactinemia), including menstrual disorders (absent, scanty or irregular menstruation), anovulation, and galactorrhea,
• in the treatment of 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 of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to other ergot derivatives;
• if the patient currently has or has previously had fibrotic disorders affecting the heart, lungs, or abdomen;
• if the patient is to receive long-term treatment with Dostinex and has currently or previously experienced fibrotic (scar-like) reactions of the heart muscle.

Warnings and precautions
Before starting treatment with Dostinex, discuss the following with your doctor:

• in patients with severe cardiovascular disorders;
• in patients with Raynaud's syndrome;
• in patients with peptic ulcer disease or gastrointestinal bleeding;
• in patients with a history of serious psychiatric disorders, particularly psychosis;
• in patients with severe liver impairment – lower doses should be considered;
• when concomitantly using antihypertensive medicines, as orthostatic hypotension may occur after cabergoline administration (especially during the first days of treatment);
• in patients who have symptoms of respiratory or cardiovascular disorders related to fibrotic processes or with a history suggestive of such disorders;
• in patients with Parkinson’s disease, episodes of sudden sleep onset may occur – dose reduction or discontinuation of treatment should be considered;
• if the patient has current or past fibrotic (scar-like) reactions of the heart muscle, lungs, or abdominal organs. In patients receiving long-term Dostinex treatment, the doctor will check before starting treatment whether heart, lung, and kidney functions are normal. Before starting treatment and at regular intervals during treatment, echocardiographic examinations (ultrasound of the heart) will be performed. If fibrotic reactions occur, treatment will be discontinued;
• inform your doctor if you or your family members notice unusual behaviours caused by irresistible impulses, compulsions, or impulsive performance of certain actions that may be harmful to the patient or others. These behaviours are known as impulse control disorders and may include gambling addiction, compulsive or binge eating, increased sexual drive, or intense sexual thoughts and feelings. The doctor may decide to adjust the treatment or discontinue the medicine.

Women in the immediate postpartum period may be more susceptible to certain adverse events,
including high blood pressure, heart attack, seizures, stroke, and psychiatric disturbances. For this
reason, the doctor will need to monitor blood pressure regularly during treatment. If a woman
experiences high blood pressure, chest pain, or unusually severe or persistent headache (with or
without visual disturbances), she should inform her doctor immediately.
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 when used to suppress
ongoing lactation in breastfeeding women.
Before starting Dostinex, a thorough evaluation of pituitary function is recommended.
Since Dostinex restores ovulation and fertility in women with hyperprolactinemia-related
hypogonadism, a pregnancy test should be performed at least every 4 weeks during the period
before menstruation resumes, and thereafter whenever menstruation is delayed by more than 3
days. Women who wish to avoid pregnancy should use mechanical contraceptive methods during
treatment with Dostinex and for some time after discontinuation of the medicine, until ovulation
ceases again. Women who become pregnant should be monitored for symptoms of pituitary
enlargement, as pre-existing pituitary tumours may grow during pregnancy.
In patients treated with dopamine agonists, including cabergoline, pathological gambling
behaviour, increased libido, and hypersexuality have been observed. These symptoms were usually
reversible upon dose reduction or discontinuation of the medicine.
Consult your doctor, even if the above warnings relate to conditions that occurred in the past.

Dostinex and other medicines
Inform your doctor about all medicines you are currently taking, including those available without
prescription.

• There is no information on interactions between cabergoline and other ergot alkaloids; therefore, concomitant use of these medicines is not recommended during long-term Dostinex treatment.
• Dostinex should not be taken together with phenothiazines, butyrophenones, thioxanthenes (antipsychotic medicines), or metoclopramide (a medicine used for gastrointestinal motility disorders), as these may reduce the therapeutic effect of Dostinex.
• Dostinex, like other ergot derivatives, 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 antihypertensive medicines.

Dostinex with food and drink
Tolerance of dopaminergic medicines is improved when taken with food; therefore, it is recommended to take Dostinex with meals.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Before starting Dostinex, pregnancy must be excluded. In addition, measures to prevent pregnancy should be taken for at least one month after stopping Dostinex treatment.
There are no clinical data on the use of Dostinex in pregnant women. Animal studies have shown reduced fertility and potential foetal toxicity.
Dostinex should be used during pregnancy only if clearly indicated and after careful assessment of benefit versus risk.
Due to the long half-life of the medicine and limited data on foetal exposure, women planning pregnancy should discontinue Dostinex one month before attempting conception.
If conception occurs during treatment, therapy should be discontinued immediately upon confirmation of pregnancy to minimize foetal exposure.
Given the mechanism of action of Dostinex, suppression or reduction of lactation is expected during treatment. Women taking Dostinex must not breastfeed.

Driving and operating machinery
During the initial phase of treatment with Dostinex, patients should exercise caution when performing tasks requiring rapid and accurate responses.
Patients taking Dostinex who experience somnolence and/or sudden onset of sleep should not drive or perform activities where reduced alertness could place themselves or others at risk of serious injury or death (e.g. operating machinery), until such symptoms resolve.

Dostinex contains lactose.
If you have been previously diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to use Dostinex
This medicine should always be used exactly as prescribed by your doctor. In case of doubt, consult your doctor or pharmacist.
Dostinex is intended for oral use. It is recommended to take Dostinex with meals.
In patients intolerant to dopaminergic medicines, the doctor may decide to start treatment with a reduced dose (e.g. 0.25 mg once weekly) and gradually increase the dose until the therapeutic dose is reached, in order to reduce the likelihood of adverse effects.
If persistent or severe adverse effects occur, the doctor may temporarily reduce the dose to improve tolerance, then gradually re-escalate to the therapeutic dose (e.g. increasing by 0.25 mg weekly or every two weeks).

Suppression of lactation
Recommended dose: 1 mg of cabergoline (2 tablets of 0.5 mg) on the first day after delivery.

Cessation of milk secretion
Recommended dose: 0.25 mg (half a tablet) every 12 hours for two days.

Treatment of disorders related to excessive prolactin secretion
Recommended initial dose: 0.5 mg per week, administered as a single dose (1 tablet of 0.5 mg) or in two doses (twice weekly, half a tablet each time, e.g. on Monday and Thursday).
The weekly dose should be gradually increased, 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 weekly have been used.
The doctor will decide on the appropriate administration schedule – once weekly or divided into two or more doses – depending on drug tolerance.
The doctor will determine the lowest effective dose that achieves the therapeutic effect. After establishing the therapeutic dose, the doctor will arrange appropriate monitoring of blood prolactin levels.
Normalization of prolactin levels is usually achieved within 2–4 weeks.
After discontinuation of Dostinex therapy, hyperprolactinemia usually recurs. However, in some patients, a sustained reduction in prolactin levels has been observed for many 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 have not been established in patients under 16 years of age.

Use in patients with liver function disorders
In patients with severe liver impairment, dose reduction of Dostinex should be considered (see section: When not to use Dostinex).

Use in elderly patients
No formal studies on the use of Dostinex in elderly patients with disorders related to excessive prolactin secretion have been conducted.

Use of higher than recommended dose of Dostinex
If an overdose of Dostinex is taken, contact your doctor immediately. Symptoms of overdose are likely to be similar to those of excessive stimulation of dopamine receptors, such as nausea, vomiting, gastrointestinal disturbances, orthostatic hypotension, confusion, and/or psychosis or hallucinations.
If necessary, the doctor may use methods to support elimination of the unabsorbed medicine and stabilize blood pressure values. Additionally, the doctor may administer dopamine antagonists as treatment.

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

Stopping Dostinex treatment
The decision to discontinue treatment should be made by the doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions observed during the use of the medicine to suppress lactation:
The adverse reactions have been listed according to their frequency. They reflect data from clinical trials using Dostinex administered at a dose of 1 mg, as well as from breastfeeding women who received Dostinex at a dose of 0.25 mg every 12 hours to suppress lactation.
Reported adverse reactions were mostly transient and mild to moderate in intensity.
During the first 3–4 days after delivery, asymptomatic decreases in blood pressure (≥20 mmHg systolic and ≥10 mmHg diastolic) may occur.

Adverse reactions observed during treatment of disorders associated with excessive prolactin secretion:
The adverse reactions have been listed according to their frequency. They reflect data from 6-month clinical trials using Dostinex at weekly doses of 1 to 2 mg (administered in two weekly doses). Reported adverse reactions were mostly mild to moderate in intensity and occurred primarily during the first two weeks of treatment. Most of them resolved during continued treatment or within a few days after discontinuation of the medicine.

General information:
Adverse reactions are mainly dose-dependent.
Long-term use of Dostinex may lead to decreased arterial blood pressure, although orthostatic hypotension or fainting have been reported rarely.
Dostinex is an ergot derivative and therefore may have vasoconstrictive effects. With long-term use, abnormal results in standard laboratory tests are unlikely; however, in non-menstruating women, a decrease in hemoglobin has been observed within the first few months after resumption of menstruation.

The following adverse reactions may occur:

• Inability to resist an impulse, urge, or compulsion to perform actions that may be harmful to the patient or others; this includes: a strong impulse or uncontrollable urge to gamble, despite serious personal or family consequences; changes or increases in sexual interests and behaviors of significant concern to the patient or others, e.g., activities related to increased sexual drive; compulsive, uncontrolled spending or shopping; binge eating (consuming larger amounts of food than normal and more than needed to satisfy hunger).

Patients should inform their doctor if they exhibit any of these behaviors, so that ways to manage or reduce these symptoms can be discussed.
Adverse reactions have been categorized according to their frequency of occurrence.

Very common (occurs in more than 1 in 10 people)

• Heart valve disorders (including regurgitation) and associated conditions (pericarditis, pericardial effusion)
• Headache*, central and/or peripheral dizziness*
• Nausea*, dyspepsia, gastritis*, abdominal pain*
• Asthenia***, fatigue

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

• Somnolence
• Depression
• Decreased arterial blood pressure in patients undergoing long-term treatment; orthostatic hypotension, hot flushes**
• Constipation, vomiting**
• Breast pain
• Asymptomatic decreases in blood pressure (systolic ≥20 mmHg and diastolic ≥10 mmHg)

Uncommon (occurs in 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, fainting, paresthesia
• Increased libido
• Vasoconstriction of the fingers
• Edema, peripheral edema
• Rash, alopecia
• Muscle cramps in the lower limbs
• Decreased hemoglobin concentration observed in non-menstruating women during the first few months after resumption of menstruation

Rare (occurs in more than 1 in 10,000, but less than 1 in 1,000 people)

• Upper abdominal pain

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

• Pleural fibrosis

Not known: frequency cannot be estimated from available data

• Angina pectoris
• Respiratory disorders, respiratory failure, pleuritis, chest pain
• Sudden sleep attacks, tremor
• Visual disturbances
• Hepatic function disorders
• Increased blood creatine phosphokinase levels, abnormal liver function tests

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, patients should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Dostinex
Store 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. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the package and other information

What Dostinex contains

• The active substance is cabergoline. Each tablet contains 0.5 mg of cabergoline.
• Other ingredients: leucine, lactose.

What Dostinex looks like and contents of the pack
HDPE bottle with a child-resistant PP cap, containing a desiccant, in a cardboard box.
The pack contains 2 or 8 tablets.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation 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 in:
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 Authorisation numbers in Spain, the country of export: 710401.8
710402.5

Parallel Import Licence Number: 203/22