Dostinex

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep this leaflet. Information on the immediate packaging is 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 possible future reference.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse effects, including those not listed in this leaflet, inform the doctor, pharmacist, or nurse. 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 for a prolonged period reduces prolactin levels. It acts by directly stimulating dopamine receptors D in the anterior pituitary gland 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), lack of ovulation, and 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 had fibrotic (fibrous tissue) 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, please 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 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 with a history suggestive of such disorders;
• in patients with Parkinson's disease, sudden episodes of sleep 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 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 behaviors due to an irresistible impulse, compulsion, or obsessive performance of certain actions that are 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. 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, during treatment, your doctor will need to monitor your blood pressure regularly. If
you develop high blood pressure, chest pain, or an unusually severe or persistent headache (with
or without visual disturbances), inform your 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 should not exceed 0.25 mg when
suppressing established lactation in breastfeeding women.
Before starting treatment with Dostinex, a detailed 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 until 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. 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 refer to conditions from the past.

Dostinex with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently
taken, as well as any medicines you plan to take.

• 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 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 drugs 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 the benefit-risk ratio.
Due to the long half-life of the drug and limited data on fetal exposure, women planning pregnancy 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
Patients should exercise caution when performing tasks requiring rapid and precise reactions at the beginning of treatment with Dostinex.
Patients taking Dostinex who experience somnolence and/or sudden sleep attacks must not drive or perform activities where impaired alertness could endanger themselves or others (e.g., operating machinery) until somnolence and/or sudden sleep attacks 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 according to the doctor's instructions. 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. 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 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. 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 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 Dostinex, they should take it as soon as possible, unless it is almost
time for the next dose. In that case, the next dose should be taken at the scheduled time. A
double dose should not be taken to make up for a missed dose.

Discontinuation of Dostinex
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 reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everyone experiences them.

Adverse reactions observed during use of the medicine to suppress lactation:
The adverse reactions are listed according to frequency. They reflect data from clinical trials using Dostinex administered at a dose of 1 mg, and in breastfeeding women who received 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 excessive prolactin secretion:
The adverse reactions are listed according to 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 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, 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. In non-menstruating women, a decrease in hemoglobin has been observed during 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 may be harmful to the patient or others; this includes:
  • 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 according to frequency of occurrence.

Very common (may occur in more than 1 in 10 people)

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

Common (may occur in no more 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 reduction in blood pressure (systolic ≥20 mmHg and diastolic ≥10 mmHg)

Uncommon (may occur in no more 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
• In non-menstruating women, decreased hemoglobin concentration has been observed during the first few months after resumption of menstruation

Rare (may occur in no more than 1 in 1,000 people)

• Upper abdominal pain

Very rare (may occur in no more than 1 in 10,000 people)

• Pleural fibrosis

Frequency not known (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, pharmacist, or nurse. 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
Phone: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Dostinex

Store below 25°C.
Keep the medicine in a place 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 in use. This will help protect the environment.

6. Contents of the packaging 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" on one side and the mark "700" with a fine notch above and below the central "0" on the other side.
The tablets are packed in amber type I glass bottles with a moisture-absorbing cap or in HDPE bottles with a child-resistant PP cap, containing a moisture-absorbing agent, and placed 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 Spain, the country of export:
Pfizer, S.L.
Avda. de Europa, 20-B
Parque Empresarial La Moraleja
28108 Alcobendas (Madrid)
Spain
Manufacturer:
Pfizer Italia S.r.L.
Località Marino del Tronto – 63100
Ascoli Piceno (AP), Italy
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Spanish marketing authorisation numbers, country of export: 683052.9
683045.1
710401.8
710402.5
Parallel Import Licence Number: 397/15