Dostinex

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language.
Dostinex
0.5 mg, tablets
Cabergoline
Please read carefully the entire leaflet 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 doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, 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 persistently lowers 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, 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 (scarring) disorders affecting the heart, lungs, or abdomen;
• if the patient is to receive long-term treatment with Dostinex and has current or past history of fibrotic reactions (scarring) 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 hepatic insufficiency – lower doses should be considered;
• when concomitantly using antihypertensive drugs, 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 a history suggestive of such disorders;
• in patients with Parkinson's disease, sudden sleep episodes may occur – dose reduction or discontinuation of treatment should be considered;
• if the patient has current or past history of fibrotic (scarring) 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 behaviors caused by an irresistible impulse, compulsion, or obsessive performance of certain actions, harmful to the patient or others. These behaviors are called impulse control disorders and may include gambling addiction, compulsive or binge eating, increased sexual drive, or intensified sexual thoughts and feelings. The doctor may decide to adjust the treatment or discontinue the medicine.

Women immediately after childbirth may be more susceptible to certain adverse events,
including high blood pressure, heart attack, seizures, stroke, and psychiatric disorders. For this
reason, the doctor will need to monitor blood pressure regularly during treatment. If a woman
experiences high blood pressure, chest pain, or an 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
suppressing ongoing lactation in breastfeeding women.
Before starting Dostinex, a thorough assessment of pituitary function is recommended.
Since Dostinex restores ovulation and fertility in women with hypogonadism due to
hyperprolactinemia, a pregnancy test should be performed at least every 4 weeks during the
premenstrual period, 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 after discontinuation of the medicine until ovulation ceases again.
Pregnant women should be monitored for symptoms of pituitary enlargement, as existing
pituitary tumors may grow during pregnancy.
In patients treated with dopamine agonists, including cabergoline, pathological gambling
behavior, 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 or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

• There is no information on interactions between cabergoline and other ergot alkaloids; therefore, concomitant use of these drugs is not recommended during long-term Dostinex treatment.
• Dostinex should not be taken together with phenothiazines, butyrophenones, thioxanthenes (antipsychotic drugs), or metoclopramide (a medicine used for upper gastrointestinal motility disorders), as these drugs 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 better when taken with food; therefore, it is recommended to take Dostinex with meals.

Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, 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 possible fetal toxicity.
Dostinex should be used during pregnancy only if clearly indicated and after careful benefit-risk assessment.
Due to the long half-life of the drug and limited data on fetal exposure, women planning pregnancy should discontinue Dostinex one month before the intended conception.
If conception occurs during treatment, therapy should be discontinued immediately upon confirmation of pregnancy to minimize fetal exposure to the drug.
Considering the mechanism of action of Dostinex, inhibition or suppression of lactation is expected during treatment. Women taking Dostinex must not breastfeed.

Driving and operating machinery
Patients should exercise caution when performing activities requiring rapid and precise reactions at the beginning of Dostinex treatment.
Patients taking Dostinex who experience somnolence and/or sudden sleep attacks must not drive or perform activities where impaired alertness could endanger themselves or others (e.g., operating machinery) until somnolence and/or sudden sleep attacks have resolved.

Dostinex contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, they should contact their doctor before taking this medicine.

3. How to use Dostinex

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Dostinex is for oral use. It is recommended to take Dostinex with food.
For patients who are intolerant to dopaminergic drugs, the doctor may decide to initiate treatment with a reduced dose (e.g. 0.25 mg once weekly), gradually increasing the dose until the therapeutic dose is reached.
If persistent or severe adverse reactions occur, the doctor may decide to temporarily reduce the dose to improve drug tolerance, then return to the therapeutic dose by gradually increasing it (e.g. 0.25 mg weekly, every two weeks).

Inhibition 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 associated with excessive prolactin secretion
Recommended initial dose: 0.5 mg weekly, 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 weekly at monthly intervals, until optimal therapeutic effect is achieved. The therapeutic dose ranges from 0.25 mg to 2 mg weekly, with an average of 1 mg weekly. Doses up to 4.5 mg weekly have been used in patients with hyperprolactinemia.
The doctor will decide on the appropriate regimen for administering the weekly dose—either as a single dose 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 decide on appropriate monitoring of serum 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 several months. In most women, ovulatory cycles continued 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 established.

Use in patients with hepatic impairment
In patients with severe liver dysfunction, dose reduction of Dostinex should be considered (see section: When to be cautious while using Dostinex).

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

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 associated with excessive stimulation of dopamine receptors, such as nausea, vomiting, gastrointestinal disturbances, orthostatic hypotension, confusion and/or psychosis or hallucinations.
If necessary, the doctor will employ supportive measures to eliminate unabsorbed drug and stabilize blood pressure. Additionally, the doctor may administer dopamine antagonists as treatment.

Missed dose of Dostinex
If a patient forgets to take Dostinex, they should take it as soon as possible, unless it is almost time for the next dose. In that case, the patient should take the next dose 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 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 effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects observed during the use of the medicine to suppress lactation:
The adverse effects are listed according to frequency of occurrence. They reflect data from clinical trials using 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 suppress lactation.
Reported adverse effects were in most cases transient and mild to moderate in intensity.
During the first 3–4 days after childbirth, asymptomatic decreases in blood pressure (≥20 mmHg systolic and ≥10 mmHg diastolic) may occur.

Adverse effects observed during the use of the medicine in the treatment of disorders related to excessive prolactin secretion:
The adverse effects are listed according to frequency of occurrence. 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 effects 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 effects are mainly dose-dependent.
Dostinex, when used long-term, may cause a decrease in arterial blood pressure, although orthostatic hypotension and 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 effects 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,
  • altered or increased 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,
  • episodes of 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 effects are listed according to frequency of occurrence.

Very common (may affect 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*
• Exhaustion***, fatigue

Common (may affect up to 1 in 10 people)

• Somnolence
• Depression
• Decreased 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 (may affect up to 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 lower limbs
• In non-menstruating women, decreased hemoglobin concentration has been observed during the first few months after resumption of menstruation

Rare (may affect up to 1 in 1,000 people)

• Upper abdominal pain

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

• Pleural fibrosis

Not known (frequency cannot be estimated from available data)

• Painful dyspnea
• Respiratory disorders, respiratory failure, pleuritis, chest pain
• Sudden sleep attacks, tremor
• Visual disturbances
• Liver function disorders
• Increased blood creatine phosphokinase concentration, abnormal liver function tests

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, patients should inform their doctor or pharmacist. Adverse effects 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 effects helps to provide more information on the safety of the medicine.

5. How to store Dostinex

Store 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 stated month.
Medicines must 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, marked with "PU" on one side divided by a score line, and marked with "700" with a small notch above and below the central "0" on the other side.
The container is an amber glass bottle with an aluminium child-resistant cap and a moisture-absorbing agent, or a HDPE bottle with a PP cap and a moisture-absorbing agent, packed in a cardboard box. The pack contains 2 or 8 tablets.
For more detailed information, please contact the responsible entity or the parallel importer.

Responsible entity in the Netherlands, country of export:
Pfizer bv
Rivium Westlaan 142
2909 LD Capelle a/d Ijssel
The Netherlands

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

Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
02-234 Warsaw
Poland

Dutch Marketing Authorisation Number (country of export): RVG 15375
Parallel Import Licence Number: 160/24