Dostinex

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Dostinex (DOSTINEKS)
0.5 mg, tablets
Cabergolinum
Dostinex and DOSTINEKS are the same names of the same medicine written in Polish and
Bulgarian.
Please read the entire leaflet carefully before using the 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 doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are identical.
• If you experience any adverse effects, including any adverse effects 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,
• 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) conditions affecting the heart, lungs, or abdomen;
• if the patient is to receive Dostinex long-term 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 conditions;
• in patients with Parkinson’s disease, episodes of sudden sleep attacks 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 treatment initiation and at regular intervals during treatment, echocardiograms (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 urges to perform certain actions that may be harmful to yourself or others. These behaviors are known as impulse control disorders and may include gambling addiction, compulsive or binge eating, increased sexual drive, or intense sexual thoughts and feelings. Your 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, heart attack, seizures, stroke, and psychiatric disturbances. For this reason, your 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, single doses of Dostinex exceeding 0.25 mg should not be used to suppress ongoing lactation in breastfeeding women.
Before starting treatment with 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 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 and other medicines
Inform your doctor about all medications you are currently taking, including those available 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 treatment.
• 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 of dopaminergic drugs is improved when taken with food; therefore, Dostinex should be taken with meals.

Pregnancy, breastfeeding, and effects on fertility
If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy must be excluded before starting Dostinex. 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 attempting conception.
If conception occurs during treatment, therapy should be discontinued immediately upon confirmation of pregnancy to minimize fetal exposure to the drug.
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
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 impaired 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 intolerance to certain sugars, consult your 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 reactions.
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. by 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 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. 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. Once the therapeutic dose is established, 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 treatment, 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 formal 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 eliminate the 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. 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 any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions observed during use of the medicine to suppress lactation
The adverse reactions have been listed according to frequency. They reflect data from clinical studies using Dostinex administered at a dose of 1 mg, and in 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.
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 hyperprolactinemia
The adverse reactions have been listed according to frequency. They reflect data from 6-month clinical studies 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 blood pressure; however, 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 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 (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 behaviours, so that ways of managing or reducing these symptoms can be discussed.
Adverse reactions have been categorized 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*,
• 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,
• 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 amenorrheic women, decreased hemoglobin concentration has been observed 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 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 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 of the 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 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. This will help protect the environment.

6. Contents of the pack 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
Dostinex is a flat, white, capsule-shaped tablet measuring 4x8 mm, with a score line.
The tablet can be divided into two equal parts.
The tablets are placed in a type I amber glass bottle with an aluminium child-resistant cap and a desiccant containing silica gel, or in an HDPE bottle with a polpropylene child-resistant cap, all contained in a cardboard box.
The pack contains either 2 or 8 tablets.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Bulgaria, 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:
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 Bulgaria, country of export: 20030572
Parallel Import Authorisation Number: 374/22