Dostinex

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging 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 for future reference.
• Consult your doctor or pharmacist if you have any questions.
• 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 similar.
• If you experience any adverse reactions, including those 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 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, 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 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 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, episodes of sudden sleep onset 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 heart, lung, and kidney function before starting treatment. Before initiating therapy 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 urges, compulsions, or impulsive performance of certain actions 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 sexual drive, or intense sexual thoughts and feelings. The doctor may decide to adjust or discontinue treatment.

Women in the immediate postpartum period may be more susceptible to certain adverse events,
including high blood pressure, myocardial infarction, seizures, stroke, and psychiatric disturbances. For
this reason, blood pressure must be monitored regularly during treatment. If a woman develops high
blood pressure, chest pain, or unusually severe or persistent headache (with or without visual
disturbances), she should immediately inform her 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, single doses of Dostinex exceeding 0.25 mg should not be used
to suppress ongoing lactation in breastfeeding women.
Prior to initiating Dostinex therapy, 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 pre-menstrual
period, and thereafter whenever menstruation is delayed by more than 3 days. Women who wish to
avoid pregnancy should use mechanical contraceptive methods during Dostinex treatment and after
discontinuation of the drug until ovulation ceases again. Pregnant women 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 and other medicines
Inform your doctor about all medicines you are currently taking, including those obtained without a
prescription.

• There is no information available on interactions between cabergoline and other ergot alkaloids; therefore, concomitant use of these drugs is not recommended during long-term Dostinex therapy.
• 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 medications.

Dostinex with food and drink
Tolerance to 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, 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. Furthermore, 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 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 at least one month before attempting conception.
If conception occurs during treatment, therapy should be discontinued immediately upon confirmation of pregnancy to minimize fetal exposure.
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 tasks 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 reduced alertness could place themselves or others at risk of serious injury or death (e.g., operating machinery), until somnolence and/or sudden sleep attacks have resolved.

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

3. How to use Dostinex

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

Dostinex is intended for oral use. It is recommended to take Dostinex during meals.

In 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, 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, then return to the therapeutic dose by gradually increasing it (e.g. 0.25 mg weekly or 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 related to 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 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 decide on appropriate monitoring of serum prolactin levels.

Normalization of prolactin levels is usually achieved within 2 to 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 treatment ended.

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
There have been no regular studies 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 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 may employ supportive measures to remove unabsorbed drug and stabilize blood pressure. Additionally, the doctor may administer treatment with dopamine antagonists.

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. Do not take a double dose to make up for a missed dose.

Discontinuation of Dostinex
The decision to discontinue treatment must 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 medicinal product can cause adverse reactions, although not everyone experiences them.

Adverse reactions observed during use of the medicine to suppress lactation
The adverse reactions are listed below according to frequency, reflecting data from clinical trials using Dostinex at a dose of 1 mg, as well as from breastfeeding women receiving 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.
Asymptomatic decreases in blood pressure (≥20 mmHg systolic and ≥10 mmHg diastolic) may occur during the first 3–4 days postpartum.

Adverse reactions observed during treatment of disorders associated with excessive prolactin secretion
The adverse reactions are listed below according to frequency, reflecting 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 these reactions resolved during continued treatment or within a few days after discontinuation of the medicine.

General information
Adverse reactions are mainly dose-dependent.
Dostinex, when used long-term, may cause lowering of 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. In amenorrheic 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 could be harmful to the patient or others, including:
  • Strong impulse or uncontrollable gambling, 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,
  • Binge eating (consuming larger amounts of food than normal and more than needed to satisfy hunger).

Patients should inform their doctor if they experience any of these behaviors, so that ways to manage or reduce these symptoms can be discussed.

Adverse reactions are listed below according to frequency of occurrence.

Very common (affects 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 (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,
• Dyspnea, pleural effusion, fibrosis (including pulmonary fibrosis), epistaxis,
• Hypersensitivity reactions,
• Transient hemianopsia, fainting, paresthesia,
• Increased libido,
• Vasoconstriction of the fingers,
• Edema, peripheral edema,
• Rash, alopecia,
• Muscle cramps in lower limbs,
• Decreased hemoglobin concentration observed in amenorrheic 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)

• Upper abdominal pain.

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

• Pleural fibrosis.

Not known: frequency cannot be estimated from the 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 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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, elongated tablet, embossed with the mark "PU" bisected by a score on one side, and the mark "700" with a small notch above and below the central "0" on the other side.
The tablets are placed in an amber glass bottle with an aluminium child-resistant cap containing a desiccant, or in an HDPE bottle with a PP cap containing a desiccant, and packaged in a cardboard box.
The pack contains 2 or 8 tablets.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in the Netherlands, the country of export:
Pfizer bv
Rivium Westlaan 142
2909 LD Capelle aan den IJssel
The Netherlands
Manufacturer:
Pfizer Italia S.r.l.
Localita Marino del Tronto
63100 Ascoli Piceno
Italy
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in the Netherlands, the country of export: RVG 15375
Parallel Import Licence Number: 129/23