Package Insert: Information for the User

Dostinex 0.5 mg Tablets

Cabergoline

Read this package insert carefully before starting to take the medication.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert (see section 4)

Dostinex is a medication used to prevent milk production, immediately after delivery as well as for its removal, in the following situations:

-After delivery, once the mother decides not to breastfeed her child

-After delivery, when breastfeeding is contraindicated for medical reasons for the mother or for the newborn.

-After giving birth to a stillborn fetus or after an abortion.

Additionally, Dostinex is indicated in the treatment of disorders related to the increase of prolactin hormone in the blood (hyperprolactinemic disorders), including absence of menstruation (amenorrhea), menstruation that is very spaced out in time (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 tumors of the pituitary gland that secrete the prolactin hormone (hypophyseal adenomas – micro and macroprolactinomas), increases in the prolactin hormone without a known cause (idiopathic hyperprolactinemia) or empty sella syndrome.

Do not take Dostinex

-If you are allergic (hypersensitive) to any ergot alkaloid, cabergoline, or any of the other components of this medication (listed in section 6)

-If you are to be treated with Dostinex for a prolonged period and have any of your heart valves affected

-If you have severe liver disease (severe hepatic insufficiency)

-If you have a history of postpartum psychosis (a post-partum syndrome characterized by depression, delirious ideas, and thoughts of harming yourself and/or your child)

-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 tissues) 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 severe heart or circulation disease, pain, or sudden changes in color in your extremities (Raynaud's syndrome), stomach ulcers, or gastrointestinal bleeding

-If you have severe liver disease, you may need a lower dose

-If you have a history of 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).

-During prolonged treatment with Dostinex, your doctor will evaluate if 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 any valve abnormalities are detected, treatment with Dostinex will not be initiated or will be discontinued if the abnormality occurs during treatment.

-If you experience or develop during treatment clinical signs and/or symptoms of respiratory, cardiac, or renal alterations

-If during treatment you develop an increased sex drive or obsessive sex drive

-If during treatment you notice altered behavior related to gaming

-If during treatment you make compulsive purchases

-If during treatment you eat compulsively

-If during treatment you experience drowsiness 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.

Inform 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 developing certain conditions. These may 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 severe and persistent headaches (with or without vision problems).

Before administering Dostinex, pregnancy must be ruled out. In fertile patients, the use of barrier contraceptives is recommended.

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

Use of Dostinex with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Certain medications may interact with Dostinex; in these cases, your doctor may need to change your dose or discontinue one of them.

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

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

Taking Dostinex with food and drinks

Dostinex should be taken with food, as it improves tolerance.

Pregnancy, breastfeeding, and fertility

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

Pregnancy must be ruled out before administering Dostinex. After treatment, women who wish to become pregnant should wait at least a month after treatment is discontinued. If pregnancy occurs during treatment, Dostinex administration should be discontinued.

Dostinex should not be administered to mothers who decide to breastfeed their children, as this medication is used to prevent milk secretion and its passage into breast milk is unknown. If milk secretion persists during Dostinex treatment, do not breastfeed your children.

Driving and operating machinery

Dostinex may cause drowsiness and even sudden onset of sleep. If you experience any of these symptoms, do not drive, operate machinery, or perform activities that require concentration until the symptoms disappear, as you may put your life and the lives of others at risk.

Dostinex contains lactose

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

Follow exactly the administration instructions for Dostinex as 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 post-partum.

For the withdrawal of breast 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 the increase of prolactin hormone 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 (example: 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 appropriate dose.

Use in children and adolescents

It is not recommended to use Dostinex in patients under 16 years old.

Use in elderly patients

Despite the very limited information from both studies and post-marketing experience, it does not seem that Dostinex poses a special risk for the elderly.

Use in patients with kidney function impairment

No dose adjustment is necessary in this group of patients.

Use in patients with mild liver function impairment

No dose adjustment is necessary in this group of patients.

If you take more Dostinex than you should

Get in touch with your doctor immediately, go to the nearest emergency service or consult the Toxicological 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 thought or perception.

If you forget to take Dostinex

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Dostinex

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

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

Like all medicines, Dostinex may cause side effects, although not everyone will experience them.

Very common side effects (may affect more than one in 10 patients):

• Dizziness
• Dizziness
• Headache
• Abdominal pain
• Uncomfortable stomach (dyspepsia), stomach inflammation (gastritis)
• Nausea
• Weakness (asthenia) and fatigue
• Alterations in heart valve function (cardiac valvulopathy), inflammation of the membranes covering the heart (pericarditis), and accumulation of fluid in the membranes covering the heart (pericardial effusion)

Common side effects (may affect up to one in 10 patients):

• Decreased blood pressure in patients on long-term treatment
• Decreased blood pressure when changing position (postural hypotension)
• Sleepiness (somnolence)
• Decreased blood pressure without symptoms
• Depression
• Hot flushes
• Constipation
• Vomiting
• Breast pain

Rare side effects (may affect up to one in 100 patients):

• Narrowing of the blood vessels in the fingers (digital vasospasm) and fainting
• Cramps in the legs
• Decreased hemoglobin values after menstruation restoration in amenorrheic women
• Transient loss of vision affecting half of the visual field (transient hemianopsia)
• Sudden loss of consciousness (syncope)
• Abnormal heart rhythm (palpitations)
• Nasal bleeding (epistaxis)
• Prickling sensation (paresthesia)
• Increased libido
• Sensation of difficulty breathing (dyspnea)
• Hair loss (alopecia)
• Rash
• Fluid retention (edema)
• Exaggerated allergic reaction (hypersensitivity reaction)
• Fibrosis formation in some organs, including the lung
• Accumulation of fluid in the membranes covering the lung (pleural effusion)

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

• Upper abdominal pain

Very rare side effects (may affect up to one in 10,000 patients):

• Fibrosis formation in the lung (pleural fibrosis)

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

• Acute and oppressive chest pain, often centered behind the sternum, and sometimes radiated (angina pectoris)
• Aggressive behavior, delirium
• Obsessive sexual desire (hypersexuality)
• Pathological gambling
• Loss of contact with reality (psychotic disorder)
• Hallucinations

• Visual disturbances
• Respiratory alterations, decreased ability to breathe (respiratory insufficiency), inflammation of the membranes covering the lung, chest pain
• Sudden and abrupt sleep, tremor

• Liver function alteration
• Increase of a type of enzyme (creatine phosphokinases) in the blood, alterations in liver function tests

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Store at a temperature below 25°C.

Keep out of sight and reach of children.

Do not use Dostinexafter the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGREpoint of thePharmacy. If in doubt, ask yourpharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

Composition of Dostinex

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

Appearance of the product and contents of the packaging

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

Dostinex is presented in packaging of 2 and 8 tablets.

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder of the marketing authorization:

Pfizer, S.L.

Avda. de Europa, 20-B,

Parque Empresarial La Moraleja.

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing:

Pfizer Italia S.r.L.

Marino del Tronto – 63100

Ascoli Piceno (AP)

Italy

Last review date of this leaflet:10/2020

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.