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 this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are similar.
• 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 long-lastingly reduces prolactin levels. It acts by directly stimulating dopamine D2 receptors 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) 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 DOSTINEX is used concomitantly with 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;
• in patients with current or past history of fibrotic (scarring) reactions of the heart muscle, lungs, or abdominal organs. For patients receiving long-term treatment with DOSTINEX, the doctor will check before starting treatment whether heart, lung, and kidney function 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 close relatives notice unusual behaviors due to irresistible impulses, 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 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, blood pressure should 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 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 used to suppress ongoing lactation in breastfeeding women should not exceed 0.25 mg.
  Before starting treatment with DOSTINEX, a detailed 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 period before menstruation resumes, and thereafter whenever menstrual bleeding 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 tendencies, 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 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, or thioxanthenes (antipsychotic drugs), or metoclopramide (a drug 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 drugs.

DOSTINEX with food and drink

Tolerance of dopaminergic drugs 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.
Pregnancy must be excluded before starting treatment with 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 to become pregnant should discontinue DOSTINEX one month before the planned 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, 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 activities requiring rapid and precise reactions.
Patients taking DOSTINEX who experience somnolence and/or sudden sleep attacks must not drive or perform activities where reduced alertness may pose a risk of serious injury or death to themselves or others (e.g., operating machinery) until such symptoms resolve.

DOSTINEX contains lactose

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

3. How to use DOSTINEX

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
DOSTINEX is intended for oral administration. It is recommended to take DOSTINEX with food.
In patients intolerant to dopaminergic drugs, to reduce the likelihood of adverse reactions, the
physician 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 physician 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 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 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 physician will decide on the appropriate regimen for weekly dosing—single dose or divided
into two or more doses—depending on drug tolerance.
The physician will determine the lowest effective dose that achieves the therapeutic effect. After
establishing the therapeutic dose, the physician 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, recurrence of hyperprolactinemia is usually
observed. 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 established 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: When to be cautious with 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 a higher than recommended dose of DOSTINEX
If an overdose of DOSTINEX is taken, contact a physician 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 physician may employ supportive measures to eliminate the unabsorbed drug
and stabilize blood pressure values. Additionally, the physician 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 scheduled dose. In that case, the patient should take the next dose at the
scheduled time. Do not take a double dose to make up for a missed dose.

Discontinuation of DOSTINEX treatment
The decision to discontinue treatment should be made by the physician.
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 medicinal product can cause adverse effects, although not everyone will experience them.
Adverse effects observed during treatment with this 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 from 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 treatment with this medicine for 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.
Long-term use of DOSTINEX may cause lowering of 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 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 gambling, despite serious personal or family consequences,
  • Changes or increases in sexual interests and behaviors of significant concern to the patient or others, such as 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 effects are listed 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 blood pressure reductions (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 non-menstruating women, decreased hemoglobin concentration 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

• Pleuritic chest pain
• Breathing 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 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 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 for Monitoring of 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
Adverse effects can also be reported to the marketing authorization holder or parallel importer.
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 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 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, anhydrous lactose.

What DOSTINEX looks like and contents of the pack
DOSTINEX is a white, capsule-shaped tablet with a score line, measuring 4 x 8 mm. The tablet can be divided into equal doses. The tablets are supplied in a type I amber glass bottle with a moisture-absorbing cap or in an HDPE bottle with a child-resistant PP cap containing a desiccant, all 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 Spain, country of export:
Pfizer, S.L., Avda. De Europa, 20-B, Business Park La Moraleja, 28108 Alcobendas (Madrid), Spain
Manufacturer:
Pfizer Italia S.r.L., Località Marino del Tronto – 63100, Ascoli Piceno (AP), Italy
Parallel Importer:
PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna
Repackaged in:
Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
IVA Pharm Sp. z o.o., ul. Drawska 14/1, 02-202 Warsaw
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o., ul. Długosza 49, 51-162 Wrocław
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź
Marketing Authorisation numbers in Spain, country of export: 683052.9
683045.1
710401.8
710402.5
Parallel Import Licence number: 110/17