Dostinex

Package leaflet: Information for the patient

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

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
• 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 persistently reduces prolactin levels. It acts by directly stimulating dopamine D receptors in the anterior pituitary cells, thereby inhibiting prolactin secretion.
Dostinex is indicated:

• to suppress lactation immediately after childbirth or to stop milk secretion,
• for the treatment of disorders associated with excessive prolactin secretion (hyperprolactinemia), including menstrual disorders (absent, scanty or irregular menstruation), anovulation, and galactorrhea,
• for 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 (scarring) 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 hepatic insufficiency – lower doses should be considered;
• when concomitantly using antihypertensive drugs, as orthostatic hypotension may occur after administration of cabergoline (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 treatment with Dostinex, 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 due to irresistible impulses, compulsions, or impulsive performance of certain activities that may be harmful to the patient or others. These behaviors are called impulse control disorders and may include gambling addiction, compulsive or binge eating, increased sex drive, or intense sexual thoughts and feelings. Your doctor may decide to adjust or discontinue treatment.

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 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 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 treatment with Dostinex, a thorough assessment 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 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 drug until ovulation ceases again. Women who become pregnant should
be monitored for symptoms of pituitary enlargement, as pre-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 drug.
Consult your doctor, even if the above warnings relate to conditions that occurred in the past.

Dostinex with other medicines
Inform your doctor about all medicines you have recently taken, including those available without a prescription.

• There is no information on interactions between cabergoline and other ergot alkaloids; therefore, concomitant use of these drugs is not recommended during long-term treatment with Dostinex.
• Dostinex should not be taken together with phenothiazines, butyrophenones, thioxanthenes (antipsychotic drugs), or metoclopramide (a drug used for upper 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 drugs.

Dostinex with food and drink
Tolerance of dopaminergic drugs 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, you should consult your doctor or pharmacist before using this medicine.
Before starting treatment with Dostinex, pregnancy must be excluded. 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 potential fetal 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 drug and limited data on fetal exposure, women planning pregnancy should discontinue Dostinex one month before planned conception.
If conception occurs during therapy, treatment 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 using machines
Patients should exercise caution when performing tasks requiring rapid and precise reactions, especially at the beginning of treatment with Dostinex.
Patients taking Dostinex who experience somnolence and/or sudden sleep attacks must not drive or operate machinery, or perform any activities where impaired alertness could put themselves or others at risk of serious injury or death, until such symptoms resolve.

Dostinex contains lactose. If you have been previously diagnosed with intolerance to certain sugars, you should consult your 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 intended for oral administration. It is recommended to take Dostinex during meals.
In patients who are intolerant to dopaminergic agents, 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, in order to reduce the likelihood of adverse effects.
If persistent or severe adverse effects occur, the doctor may decide to temporarily reduce the dose to
improve tolerability, 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 delivery.

Cessation of milk secretion
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 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. Doses up to 4.5 mg weekly have been used in patients with hyperprolactinemia.
The doctor will determine the appropriate regimen for administering the weekly dose—either as a single dose or divided into two or more doses—depending on the patient's tolerability.
The doctor will establish the lowest effective dose that provides the desired 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 typically 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 have not been evaluated in patients under 16 years of age.

Use in patients with hepatic impairment
In patients with severe liver dysfunction, dose reduction of Dostinex should be considered (see section: Warnings and precautions).

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

Use of a higher than recommended dose of Dostinex
If an overdose of Dostinex is taken, contact a 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 may employ supportive measures to remove 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 a dose of Dostinex, they should take it as soon as possible, unless it is almost time for the next scheduled dose. In that case, the patient should take the next dose at the usual time. A double dose should not be taken to make up for a missed dose.

Discontinuation of 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects observed during use of the medicine to suppress lactation:
The adverse effects are listed according to their frequency. They reflect data from clinical trials using Dostinex at a dose of 1 mg, and from trials in breastfeeding women who received Dostinex at a dose of 0.25 mg every 12 hours to suppress lactation.
Reported adverse effects 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 effects observed during use of the medicine in the treatment of disorders associated with excessive prolactin secretion:
The adverse effects are 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 effects were mostly mild or 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.
Long-term use of Dostinex may cause lowering of arterial blood pressure, although orthostatic hypotension and fainting have been reported rarely.
Dostinex is an ergot derivative and may therefore 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:
  • Strong impulse or uncontrollable gambling behaviour, despite serious personal or family consequences,
  • Altered or increased sexual interests and behaviours of significance to the patient or others, e.g. activities related to increased sexual drive,
  • Compulsive, uncontrolled spending or shopping,
  • Binge eating (eating larger amounts of food than normal and more than needed to satisfy hunger).

Patients should inform their doctor if they experience any of these behaviours, so that ways of managing or reducing these symptoms can be discussed.
Adverse effects are listed according to their frequency of occurrence.

Very common (affects more than 1 in 10 people)

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

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

• Palpitations
• Dyspnoea, pleural effusion, fibrosis (including pulmonary fibrosis), epistaxis
• Hypersensitivity reactions
• Transient hemianopia, fainting, paraesthesia
• Increased libido
• Vasoconstriction of the fingers
• Edema, peripheral edema
• Rash, alopecia
• Muscle cramps in lower limbs
• Decreased hemoglobin concentration observed in non-menstruating women during the first few months after resumption of menstruation

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

• Epigastric pain

Very rare (affects 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, 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 this 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 packaging. 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 in use. Such measures 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, oblong tablet, embossed with the mark "PU" divided by a score line on one side, and the mark "700" with a small notch above and below the central "0" on the other side.
The container is an orange type I glass bottle with an aluminium child-resistant cap and a moisture-absorbing agent in the form of silica gel, or a HDPE bottle with a polypropylene child-resistant cap, contained 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 Bulgaria, the country of export:
Pfizer Europe MA 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation Number in Bulgaria, the country of export: 20030572
Parallel Import Licence Number: 38/24