Prospecto: information for the user

Cabergolina Teva 0.5 mg tablets EFG

cabergolina

Read this prospect carefully before starting to take the medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Cabergolina Teva and for what it is used

2.What you need to know before starting to take Cabergolina Teva

3.How to take Cabergolina Teva

4.Possible adverse effects

5.Storage of Cabergolina Teva

6. Contents of the package and additional information

This medication contains cabergoline, which belongs to a group of medications called prolactin inhibitors. Prolactin is a hormone formed in the pituitary gland of your brain. Cabergoline decreases the levels of the prolactin hormone.

Cabergolina Teva is used:

• to interrupt or inhibit milk production for medical reasons
• to treat hormonal disorders resulting from high prolactin levels, such as ovulation failure or irregular ovulation, infertility, or non-pregnancy-related milk secretion.
• to treat high prolactin levels due to a pituitary gland tumor.
• to treat high prolactin levels due to an unknown cause
• to treat high prolactin levels due to the empty Turkish saddle syndrome

Do not take Cabergolina Teva if

• You are allergic to cabergolina or any other ergolike alkaloid (e.g. bromocriptina), or to any of the other components of this medication (listed in section 6).
• You have (or have had in the past) psychosis or are at risk of developing psychosis after delivery.
• You have been diagnosed with problems described as fibrotic reactions (scar tissue) that affect the lungs, posterior abdomen, kidneys, or heart.
• You are going to be treated with cabergolina for a long period of time and have or have had a heart valve disorder determined by echocardiogram.

Warnings and precautions

If you suffer from any of the following health problems, inform your doctor before taking Cabergolina as the medication may not be suitable for you:

• History of severe mental disorder, particularly psychotic disorders
• Alteration in liver or renal function
• Cardiovascular disease
• Stomach ulcer or gastrointestinal bleeding (this condition may cause black stools or vomiting with blood)
• Raynaud's disease, when cold fingers and toes turn white, blue, and are cold, insensitive, and weak
• Low blood pressure, which may cause dizziness, especially when standing up
• Swelling of hands and feet and high blood pressure during pregnancy (preclampsia, eclampsia)
• High blood pressure after delivery
• Severe chest pain (e.g. chest pain when breathing, fluid in the lungs, inflammation or infection of the lungs)
• Fibrotic reactions (scar tissue) that affect the heart, lung, or abdomen. If you are treated with Cabergolina Teva for a long period of time, your doctor will check your heart, lungs, and kidneys before starting treatment and at regular intervals during treatment. If fibrotic reactions occur, treatment should be interrupted.

Consult your doctor if you or your family/caregiver notice that you are developing impulses or cravings to behave in an unusual way and cannot resist the impulse, temptation to carry out certain activities that may harm you or others. These are known as impulse control disorders and may include behaviors such as addictive gambling, excessive eating or spending, abnormally elevated sexual desire, or an increase in sexual thoughts or feelings.Your doctor will adjust or interrupt your dose.

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. Immediately consult your doctor if you experience high blood pressure, chest pain, or unusual and persistent headache (with or without vision problems).

The effect of hormonal contraceptives may be reduced in women taking cabergolina, and pregnancy may occur before the menstrual cycle has normalized. Therefore, it is recommended to perform a pregnancy test at least every 4 weeks until menstruation is resumed and, from then on, every time the menstrual period is delayed by more than 3 days. Therefore, effective non-hormonal contraceptives should be used during treatment with cabergolina and at least for a month after treatment is discontinued (see section "Pregnancy, breastfeeding, and fertility").

Children and adolescents

The safety and efficacy of cabergolina have not been established in children and adolescents under 16 years of age.

Taking Cabergolina Teva with other medications

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

Certain medications used to reduce blood pressure, certain medications (e.g. phenothiazines, butyrophenones, thioxanthenes) used to treat mental health disorders (schizophrenia or psychosis), other ergolike alkaloids, medications to treat vomiting (metoclopramide), and macrolide antibiotics (such as erythromycin) may interfere with the effects of cabergolina. Your doctor should be aware of such simultaneous medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor before using this medication.

Pregnancy

There is limited experience with the use of Cabergolina Teva during pregnancy.

Before you can start taking cabergolina, you must ensure that you are not pregnant. You must also be careful not to become pregnant during treatment and at least for a month after treatment with cabergolina is discontinued.

Effective non-hormonal contraceptives should be used. Discuss the choice of contraceptive method with your doctor.

If you are being treated with cabergolina and become pregnant during this time, you should discontinue treatment and contact your doctor as soon as possible.

Breastfeeding

It is unknown whether cabergolina passes into breast milk. Since Cabergolina Teva will prevent you from producing milk for your baby, you should not take Cabergolina if you plan to breastfeed. If you need to take Cabergolina, you should use another method to feed your baby.

Mothers who are breastfeeding should be aware that milk production may be reduced or interrupted.

Fertility

Fertility may be reversible, and pregnancy may occur before the menstrual cycle has normalized in women taking cabergolina (see section "Warnings and precautions").

Driving and operating machinery

Cabergolina Teva may negatively affect your reaction time in some people, and this should be taken into account in cases where a high level of alertness is required, e.g. driving vehicles and precision work.

Cabergolina may cause drowsiness (extreme sleepiness) and the sudden appearance of sleep.

Therefore, affected individuals should not drive or participate in activities where decreased alertness implies a high risk of damage (e.g. operating machinery), until such episodes and drowsiness have resolved. If you are affected, consult your doctor.

Cabergolina Teva contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, ask your doctor or pharmacist.

Your doctor will determine the dosage and adjust it individually for you.

The tablets can be divided into equal doses.

The tablets should be taken with meals to reduce certain adverse effects such as nausea, vomiting, and stomach pain.

• To prevent/inhibit milk production (lactation):

You should take 2 tablets (1 mg) as a single dose within 24 hours after giving birth.

• To interrupt lactation once breastfeeding has started:

You should take ½ (half) tablet (0.25 mg) every 12 hours for two days.

• To reduce prolactin concentration in the body:

Generally, treatment starts with 0.5 mg per week, but higher doses may be necessary. Your doctor will evaluate your response to the medication and adjust your treatment accordingly; they will also indicate the duration of treatment.

If you take more Cabergolina Teva than you should

If you have taken too many tablets or if you think a child has ingested any, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 915 620 420. The symptoms of an overdose may include nausea, vomiting, decreased blood pressure, dizziness, stomach pain, mood changes, confusion, or hallucinations (seeing things that do not exist). Bring this leaflet and any remaining tablets to show your doctor at the nearest hospital.

If you forget to take Cabergolina Teva

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose as usual. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Cabergolina Teva

Consult your doctor before stopping or suspending treatment with cabergolina. If you have been treated for high prolactin levels, your symptoms will generally reappear. In some patients, a decrease in prolactin levels has been observed for several months after stopping cabergolina treatment.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

When used tointerruptbreast milk production, approximately 14out of100patientsexperiencesomeside effect.The most common arelow blood pressure, dizzinessandheadache.In the treatmentofincreased prolactin levels, sideeffectsare more commonsincetabletsare takenfor a longer periodof time.Approximately 70out of every 100 patientsexperience side effects, but most sideeffects disappear or decrease after approximately 2 weeks.

Severe side effects

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

• Cardiac valve disorders and related disorders, for example, inflammation (pericarditis) orfluid loss in the pericardium (pericardial effusion). The first symptoms may be one or more of the following: difficulty breathing, shortness of breath, palpitations, feeling of fainting, chest or back pain, pelvic or swollen legs.Seek medical attention or contact the nearest hospital emergency department immediately if you experience any of these symptoms.

Uncommon(may affect up to 1 in 100 people)

• Chest pain, difficulty breathing, cough and fever due to fluid in the layers of the membrane that covers the lungs and thoracic cavity (pleural effusion).Seek immediate medical attention or contact the nearest hospital emergency department.
• Increased difficulty breathing due to the formation of scar tissue in the lungs (pulmonary fibrosis that affects the lungs).Seek immediate medical attention or contact the nearest hospital emergency department.
• Development of a generalized rash with itching, difficulty breathing with or without wheezing, feeling of fainting, unexplained swelling of the body or tongue, or any other symptom that appears quickly after taking this medicine and makes you feel unwell. These may be indicative of an allergic reaction.Seek immediate medical attention or contact the nearest hospital emergency department.

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

• Difficulty breathing and cough due to the formation of scar tissue in the layers of the membrane that covers the lungs and thoracic cavity (pleural fibrosis).Seek immediate medical attention or contact the nearest hospital emergency department.

Unknown(frequency cannot be estimated from available data)

• Chest pain, possibly with radiation of pain to the arm and neck and difficulty breathing due to inadequate blood supply to the heart muscle.Seek immediate medical attention or contact the nearest hospital emergency department.
• Weakened breathing, blue lips and nails.Seek immediate medical attention or contact the nearest hospital emergency department.
• Mental disorders (aggressive behavior, hallucinations, delirium, psychotic disorder).Seek medical attention.

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

• Dizziness/dizziness, headache
• Nausea, indigestion, stomach pain, inflammation of the stomach wall (gastritis)
• Weakness, fatigue

Common(may affect up to 1 in 10 people)

• Depression
• Somnolence (extreme sleepiness)
• Low blood pressure (which may cause dizziness, particularly when standing up)
• Palpitations, facial flushing
• Vomiting, constipation
• Chest pain (mastodynia)

Uncommon(may affect up to 1 in 100 people)

• Difficulty breathing.It may become severe. Consult your doctor.
• Loss of consciousness, fainting.It may become severe. Normal heart rate, normal breathing, and rapid recovery. Consult your doctor. In all other cases, call an ambulance.
• Swelling due to fluid accumulation in tissues (edema), swelling in feet, ankles, and hands.In some people, severe conditions may occur. Consult your doctor.
• Severe daytime fatigue and tendency to fall asleep suddenly.It may become severe. Consult your doctor.
• Increased libido
• Temporary partial vision loss,
• Itching/tingling sensationsin thebody
• A strong heartbeat that may be rapid and irregular
• Problems with blood vessels in the fingers and toes (vasospasm)
• Nasal bleeding
• Acne, itching, skin rash, hair loss
• Crampsin the legs
• Decreased hemoglobin valuesin women whose periods had stopped and then restarted

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

• Chest pain in the upper central part of the abdomen

Unknown(frequency cannot be estimated from available data)

• Tremor
• Visual problems
• Respiratory problems with inadequate oxygen intake, inflammation, and pain of the membrane surrounding the lungs (pleuritis), chest pain
• Abnormal liver function, abnormal liver function tests
• Increased values in the blood of a specific enzyme called creatine phosphokinase

You may experience the following side effects:

Inability to resist the impulse, impulse, or temptation to perform an action that could be harmful to you or others, which may include:

• Strong impulse to gamble excessively despite severe personal or family consequences.
• Altered or increased sex drive and behavior of great concern to you or others, for example, an increase in sexual desire.
• Uncontrollable excessive or uncontrolled spending.
• Eating excessively (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger)

Inform your doctor if you experience any of these behaviors; they will discuss ways to control or reduce symptoms.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly throughSistema Español de Farmacovigilancia de Medicamentos de Uso Humano, Website: https://www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above30°C. Store in the original packaging to protect it from moisture. Do not remove the capsule or the silica gel desiccant bag from the bottle.

You must discard the tablets of this medication that have not been taken 30 days after the first opening of the bottle.

Medications should not be thrown down the drains or in the trash.Deposit the packaging and the medication that you no longer need at the SIGRE point of the pharmacy.If in doubtask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

Composition of Cabergolina Teva

• The active ingredient is cabergolina.Each tablet contains 0.5 mg of cabergolina.
• The other components are: lactose, L-leucine, and magnesium stearate.

Appearance of Cabergolina Teva and contents of the packaging

White, smooth, bisected oval-shaped tablets. Each tablet is scored on one face and marked with “CBG” on one side and “0.5” on the other side of the score.

It is available in packaging sizes of 2, 8, 14, 15, 16, 20, 28, 30, 32 (2x16), 40 (2x20), 48 (3x16), 50, 60 (3x20), 90 (3x30), 96 (6x16), and 100 (5x20) tablets.

Only some packaging sizes may be commercially marketed.

Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor.

28108 Alcobendas, Madrid

Spain

Responsible for manufacturing:

Teva Czech Industries s.r.o.

Ostravská 29, indication number 305

Opava, Komárov, postal code 747 70

Czech Republic

O

GALIEN LPS

98 rue Bellocier

89100 Sens

France

Last review date of this leaflet:May 2024

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

You can access detailed and updated information on this medicine by scanning the QR code included in the carton with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/69669/P_69669.html

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