Dostinex

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Dostinex (Dostinex)
0.5 mg, tablets
Cabergolinum
Dostinex and Dostinex are the same brand names of the same medicinal product written in Polish and Bulgarian languages.
Please read this leaflet carefully 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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

1. What Dostinex is and what it is used for
2. What you need to know 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 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,
• 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 had fibrotic (scarring) disorders of 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 impairment – lower doses should be considered;
• when used concomitantly with antihypertensive medicines, 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, lungs, or abdominal organs. In 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, 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 behaviours caused by an irresistible urge, compulsion, or impulse to carry out certain actions that are harmful to you or others. These behaviours 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 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, your doctor will need to monitor your 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 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 detailed 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 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 medicine, until ovulation ceases again. Women who become pregnant should be monitored for symptoms of pituitary enlargement, as pre-existing pituitary tumours may grow during pregnancy.
In patients treated with dopamine agonists, including cabergoline, pathological gambling, 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
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

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

Dostinex with food and drink
Tolerance of dopaminergic medicines 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, consult your doctor or pharmacist before using this medicine.
Pregnancy must be excluded before starting treatment with Dostinex. Furthermore, 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 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 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 using machines
Patients should exercise caution when performing activities requiring rapid and precise reactions at the beginning of treatment with Dostinex.
Patients taking Dostinex who experience somnolence and/or sudden onset of sleep should not drive or perform activities where impaired alertness could put themselves or others at risk of serious injury or death (e.g. operating machinery), until somnolence and/or episodes of sudden sleep onset have resolved.

Dostinex contains lactose. If you have been previously diagnosed with an 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 intolerant to dopaminergic agents, 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, to improve drug tolerance, the physician 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 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. In patients with hyperprolactinemia, doses up
to 4.5 mg weekly have been used.
The physician will determine the appropriate regimen for weekly dosing—either as a single dose or
divided into two or more doses—depending on drug tolerance.
The physician will establish 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 lasting several months has been
observed. In most women, ovulatory cycles continued for at least 6 months after cessation of
therapy.

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: 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 higher than recommended dose of Dostinex
If an overdose of Dostinex is taken, contact your doctor immediately. Symptoms of overdose are
presumably 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 unabsorbed drug and
stabilize blood pressure. 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 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
The decision to discontinue treatment must 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

As with any medicine, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects observed during administration of the medicine to suppress lactation:
The adverse effects are listed by frequency of occurrence. They reflect data from clinical trials 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 effects were mostly transient and of mild to moderate 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 of disorders associated with excessive prolactin secretion:
The adverse effects are listed by 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 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, 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 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*, dizziness of central and/or peripheral origin*
• Nausea*, dyspepsia, gastritis*, abdominal pain*
• Asthenia***, 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, syncope, paresthesia
• Increased libido
• Vasoconstriction of the fingers
• Edema, peripheral edema
• Rash, alopecia
• Muscle cramps in the lower limbs
• Decreased hemoglobin concentration observed in non-menstruating women 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

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 levels, 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, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such practices 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, capsule-shaped tablet, 4 x 8 mm in size, with a score line.
The tablet can be divided into two equal doses.
The tablets are placed in a Type I amber glass bottle with an aluminium child-resistant cap and a silica gel desiccant, or in an HDPE bottle with a polypropylene child-resistant cap, all contained in a cardboard box.
The pack contains 2 or 8 tablets.
For more detailed 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:
Allpharm Sp. z o.o. sp.k.
M. Zdziechowskiego 11/4
02-659 Warsaw
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
spółka komandytowa
Forteczna 35-37
87-100 Toruń
Tymiankowa 24/28
95-054 Ksawerów
Działkowa 56
02-234 Warsaw
Poland

Marketing Authorisation Number in Bulgaria, country of export: 20030572
Parallel Import Licence Number: 2/25