DOSTINEX 0.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Dostinex 0.5mg tablets

Cabergoline

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4).

Contents of the package leaflet:

• What is Dostinex and what is it used for
• 1. What you need to know before you take Dostinex
  2. How to take Dostinex
  3. Possible side effects
  4. Storage of Dostinex
  5. Contents of the pack and other information

1. What is Dostinex and what is it used for

Dostinex is a medicine used to prevent milk production, immediately after childbirth, as well as for the withdrawal of milk, in the following situations:

• After childbirth, once the mother decides not to breastfeed her child
• After childbirth, when breastfeeding is contraindicated for medical reasons for the mother or the newborn.
• After giving birth to a stillborn baby or after an abortion.

In addition, Dostinex is indicated for the treatment of disorders related to increased prolactin levels in the blood (hyperprolactinemic disorders), including absence of menstruation (amenorrhea), infrequent menstruation (oligomenorrhea), menstrual cycles in which there is no ovulation (anovulation), and milk secretion in the breast not associated with the lactation period (galactorrhea).

Dostinex is also indicated in patients with pathologies associated with hyperprolactinemic disorders, such as pituitary tumors that secrete prolactin (pituitary adenomas - micro and macroprolactinomas), increased prolactin without a known cause (idiopathic hyperprolactinemia), or empty sella syndrome.

2. What you need to know before you take Dostinex

Do not take Dostinex

• If you are allergic (hypersensitive) to any ergot alkaloid, cabergoline, or any of the other components of this medicine (listed in section 6)
• If you are going to be treated with Dostinex for a prolonged period and have any of the heart valves affected.
• If you have severe liver disease (severe hepatic insufficiency).
• If you have a history of postpartum psychosis (postpartum syndrome characterized by depression, delirious ideas, and thoughts of harming yourself and/or the baby).
• If you have high blood pressure during pregnancy associated with fluid retention (edema) and protein in the urine (toxemia of pregnancy).
• If you have or have had fibrotic disorders (scarring tissue) that have affected your lungs, heart, or abdomen.
• If you are being treated with medications used to treat mental illnesses (antipsychotic medication).

Warnings and precautions

• If you have a severe heart or circulatory disease, pain and/or sudden changes in color in the extremities (Raynaud's syndrome), stomach ulcers, or gastrointestinal bleeding.
• If you have severe liver insufficiency, you may need a lower dose.
• If you have had or have severe mental illnesses (especially of a psychotic type).
• If you are taking medications that lower blood pressure. Dostinex may cause a drop in blood pressure when changing positions (postural hypotension).
• In case you are being treated with Dostinex for a prolonged period, before starting treatment and regularly during treatment, your doctor will assess whether your heart, lungs, and kidneys are functioning properly. Your doctor will also perform an echocardiogram (a heart ultrasound) before starting treatment and regularly during treatment. If a heart valve disorder is detected, treatment with Dostinex will not be initiated or if the disorder occurs during treatment, it will be interrupted.
• If you experience or develop during treatment signs and/or symptoms of respiratory, cardiac, or renal disorders.
• If during treatment you develop an increased desire for sex or obsessive sexual desire.
• If during treatment you notice altered behavior related to gambling.
• If during treatment you make compulsive purchases.
• If during treatment you eat compulsively.
• If during treatment you notice a sensation of sleep or the sudden onset of sleep.
• If you are pregnant or think you may be pregnant.

If you are in any of the above cases, consult your doctor.

Tell your doctor immediately if you notice or someone notices in you:

If you have just given birth, you may be at a higher risk of suffering from certain conditions. These can include high blood pressure, heart attack, seizures, strokes, or mental health problems. Therefore, your doctor will need to monitor your blood pressure frequently during treatment. Talk to your doctor immediately if you experience high blood pressure, chest pain, or unusually intense or persistent headache (with or without vision problems).

Before administering Dostinex, pregnancy should be ruled out. In the case of patients of childbearing age, the use of barrier contraceptives is recommended.

Before starting treatment, your doctor may perform tests to evaluate pituitary function. During prolonged treatments with Dostinex, your doctor may perform periodic gynecological checks and liver function tests.

Using Dostinex with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Certain medications may interact with Dostinex; in these cases, it may be necessary for your doctor to change the dose or interrupt treatment with one of them.

It is especially important that you inform your doctor if you are taking any of the following medications:

• Medications called dopamine antagonists (such as phenothiazines, butyrophenones, thioxanthenes, metoclopramide), as they may decrease the effect of Dostinex.
• A type of antibiotic called macrolides (such as erythromycin), as they may increase the adverse effects of Dostinex.
• Other ergot-derived medications, such as bromocriptine, pergolide, ergotamine, dihydroergotamine, etc.

Taking Dostinex with food and drinks

It is recommended that Dostinex be administered with food, as it improves tolerance.

Pregnancy, breastfeeding, and fertility

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Before administering Dostinex, pregnancy should be ruled out. After treatment, women who wish to become pregnant should wait at least one month after stopping treatment. If pregnancy occurs during treatment, the administration of Dostinex should be interrupted.

Dostinex should not be administered to mothers who decide to breastfeed their children, as this medication is used to prevent milk secretion, and it is unknown whether it passes into breast milk. If milk secretion is maintained during treatment with Dostinex, you should not breastfeed your child.

Driving and using machines

Dostinex may cause drowsiness and even sudden sleep. If you notice any of these symptoms, at the start or during treatment, do not drive or use machines or perform activities that require concentration until the symptoms disappear, as you could put your life and the lives of others at risk.

Dostinex contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Dostinex

Follow the instructions for administration of Dostinex indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Dostinex is administered orally. It is recommended to take Dostinex with food.

To prevent milk production: The recommended dose is 1 mg (2 tablets of 0.5 mg) administered as a single dose on the first day postpartum.

To withdraw milk: It is recommended to administer 0.25 mg (half a tablet of 0.5 mg) every 12 hours for two days (total dose of 1 mg).

For disorders related to increased prolactin levels in the blood (hyperprolactinemic disorders): The initial recommended dose is 0.5 mg per week, administered in one or two doses (half a tablet of 0.5 mg) per week (e.g., Monday and Thursday). The weekly dose should be gradually increased, preferably by adding 0.5 mg (1 tablet) per week at monthly intervals until your doctor establishes the adequate dose.

Use in children and adolescents

The use of Dostinex is not recommended in patients under 16 years of age.

Use in elderly patients

Although the information from both studies and post-marketing experience is very limited, Dostinex does not appear to pose a special risk for the elderly.

Use in patients with impaired renal function

No dose adjustment is necessary in this group of patients.

Use in patients with non-severe impaired liver function

No dose adjustment is necessary in this group of patients.

If you take more Dostinex than you should

Immediately contact your doctor, go to the nearest emergency room, or consult the Toxicology Information Service, phone 91 562 04 20.

If you have taken more Dostinex than you should, the following symptoms may appear: nausea, vomiting, stomach discomfort, low blood pressure, and alterations in thinking or perception.

If you forget to take Dostinex

Do not take a double dose to make up for forgotten doses.

If you stop taking Dostinex

Do not stop treatment before your doctor tells you to, as the desired effect will not be achieved.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dostinex can cause side effects, although not everybody gets them.

Very common side effects (may affect more than 1 in 10 people):

• Dizziness
• Vertigo
• Headache
• Abdominal pain
• Gastric discomfort (dyspepsia), stomach inflammation (gastritis)
• Nausea
• Weakness (asthenia) and fatigue
• Heart valve disorders (valvular heart disease), inflammation of the membranes that cover the heart (pericarditis), and fluid accumulation in the membranes that cover the heart (pericardial effusion)

Common side effects (may affect up to 1 in 10 people):

• Decrease in blood pressure in patients with long-term treatments
• Decrease in blood pressure when changing positions (postural hypotension)
• Drowsiness (somnolence)
• Decrease in blood pressure without symptoms
• Depression
• Hot flashes
• Constipation
• Vomiting
• Breast pain

Uncommon side effects (may affect up to 1 in 100 people):

• Narrowing of the blood vessels in the fingers (digital vasospasm) and fainting
• Leg cramps
• Decrease in hemoglobin values after restoration of menstruation in women with amenorrhea
• Transient loss of vision that affects half of the visual field (transient hemianopsia)
• Sudden loss of consciousness (syncope)
• Heartbeat more frequent than normal (palpitations)
• Nosebleeds (epistaxis)
• Feeling of tingling (paresthesia)
• Increased sexual desire
• Feeling of difficulty breathing (dyspnea)
• Hair loss (alopecia)
• Rash
• Fluid retention (edema)
• Exaggerated allergic reaction (hypersensitivity reaction)
• Formation of fibrotic tissue in an organ (fibrosis), including in the lung
• Fluid accumulation in the membranes that cover the lung (pleural effusion)

Rare side effects (may affect between 1 and 10 in 10,000 people):

• Pain in the upper abdomen

Very rare side effects (may affect up to 1 in 10,000 people):

• Formation of fibrotic tissue in the lung (pleural fibrosis)

Side effects of unknown frequency (cannot be estimated from the available data):

• Chest pain and feeling of oppression, usually centered behind the sternum, and sometimes radiating (angina pectoris)
• Aggressive behavior, delirium
• Obsessive sexual desire (hypersexuality)
• Pathological gambling
• Loss of contact with reality (psychotic disorder)
• Hallucinations

• Visual disturbances
• Respiratory disorders, decreased ability to breathe (respiratory failure), inflammation of the membranes that cover the lung, chest pain
• Sudden onset of sleep, tremors

• Liver function disorders
• Increased levels of a type of enzyme (creatine phosphokinases) in the blood, alterations in liver function tests

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dostinex

Store at a temperature below 25°C.

Keep out of sight and reach of children.

Do not use Dostinex after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dostinex

• The active ingredient is cabergoline. Each tablet contains 0.5 mg of cabergoline.
• The other ingredients are lactose and leucine.

Appearance of the product and packaging contents

Dostinex is presented in the form of white, capsule-shaped tablets with a score line in the center that allows the tablet to be divided into two equal halves.

Dostinex is presented in packs of 2 and 8 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

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

Date of last revision of this leaflet:10/2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/.