Dostinex

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is 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 so that you can read it again if necessary.
• If you have any questions, 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 other people, even if their symptoms are similar.
• 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. 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 on cells of the anterior pituitary gland, 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 turcica 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 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 impairment, lower doses of the medicine should be considered;
• when concomitantly using antihypertensive medicines, as orthostatic hypotension may occur after administration of cabergoline (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, episodes of sudden 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, 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 resulting from irresistible urges, compulsions, or impulsive, repetitive actions 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 blood pressure regularly. 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 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 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 medicine 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 medicine.
Consult your doctor, even if the above warnings relate to conditions that occurred in the past.

Dostinex and other medicines
Inform 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 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 medicines 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 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 plan to become pregnant, 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 benefit-risk ratio.
Due to the long half-life of the medicine and limited data on fetal exposure, women planning pregnancy should discontinue Dostinex one month before the intended conception.
If conception occurs during therapy, treatment should be discontinued immediately upon confirmation of pregnancy to minimize fetal exposure to the medicine.
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 activities 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 a patient has been previously 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 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
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 per week 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. After establishing the therapeutic dose, the doctor will decide on appropriate monitoring of blood 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 many months. In most women, ovulatory cycles continued for at least 6 months after the end of therapy.

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
No regular studies on the use of Dostinex have been conducted 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 caused by excessive stimulation of dopamine receptors, such as nausea, vomiting, gastrointestinal disturbances, orthostatic hypotension, confusion, and/or psychosis or hallucinations.

If necessary, the doctor will apply 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 the patient forgets to take a dose of 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. A double dose should not be taken to make up for a missed dose.

Stopping Dostinex treatment
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 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 categorized by frequency of occurrence. They reflect data from clinical trials using Dostinex 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 use of the medicine in the treatment of disorders associated with excessive prolactin secretion:
The adverse reactions have been categorized 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 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 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, decreased hemoglobin levels have been observed in non-menstruating women 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:
  • a strong impulse or uncontrollable urge to gamble, despite serious personal or family consequences,
  • altered or increased sexual interests and behaviors 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 behaviors, so that ways of managing or reducing these symptoms can be discussed.
Adverse reactions have been categorized according to their frequency of occurrence.

Very common (may occur in 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 (may occur in 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 occur in up to 1 in 100 people)

• Palpitations
• Dyspnea, pleural effusion, fibrosis (including pulmonary fibrosis), epistaxis
• Hypersensitivity reactions
• Transient hemianopia, syncope, paresthesia
• Increased libido
• Digital vasospasm
• Edema, peripheral edema
• Rash, alopecia
• Muscle cramps in lower limbs
• Decreased hemoglobin concentration observed in non-menstruating women during the first few months after resumption of menstruation

Rare (may occur in up to 1 in 1,000 people)

• Upper abdominal pain

Very rare (may occur in up to 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 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 required. This will help protect the environment.

6. Package contents 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 white, oval tablets with a central break-line.
The tablets are contained in an amber glass bottle with an aluminium child-resistant cap and a moisture-absorbing agent, or in an HDPE bottle with a PP cap and a moisture-absorbing agent, packed in a cardboard box. The pack contains either 2 or 8 tablets.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in the Netherlands, 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation number in the Netherlands, country of export: RVG 15375
Parallel import licence number: 136/24