CABERGOLINE TEVA 0.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Cabergoline Teva 0.5 mg Tablets EFG

cabergoline

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 pack

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

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

This medicine contains cabergoline which belongs to a group of medicines called prolactin inhibitors. Prolactin is a hormone that is produced in the pituitary gland in your brain. Cabergoline decreases the levels of the hormone prolactin.

Cabergoline Teva is used:

• to stop/inhibit milk production (lactation) for medical reasons
• to treat hormonal disorders as a result of high prolactin levels, such as lack of ovulation or irregular ovulation, infertility or milk secretion not associated with childbirth.
• to treat high prolactin levels due to a tumor in the pituitary gland.
• to treat high prolactin levels for unknown reasons
• to treat high prolactin levels due to the empty Turkish saddle syndrome

2. What you need to know before you take Cabergoline Teva

Do not take Cabergoline Teva if

• you are allergic to cabergoline or to any other ergoline alkaloid (e.g. bromocriptine), or to any of the other ingredients of this medicine (listed in section 6).
• you have (or have had in the past) psychosis or are at risk of suffering from psychosis after childbirth.
• you have been diagnosed in the past with problems described as fibrotic reactions (scar tissue) that affect the lungs, back of the abdomen and kidneys or heart.
• you are going to be treated with cabergoline for a long period of time and you have or have had a heart valve disorder determined by echocardiogram.

Warnings and precautions

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

• History of severe mental disorder, particularly psychotic disorders
• Alteration in liver or kidney function
• Cardiovascular disease
• Stomach ulcer or bleeding in the gastrointestinal tract (this condition can cause black stools or vomiting with blood)
• Raynaud's disease, when fingers and toes turn blue-white, pulseless, cold, numb, and weak when cold
• Low blood pressure, which can cause dizziness, especially when standing up
• Swelling of hands and feet and high blood pressure during pregnancy (pre-eclampsia, eclampsia)
• High blood pressure after childbirth
• Severe chest condition (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. In case of being treated with Cabergoline Teva for a long period of time, your doctor will check the condition of your heart, lungs, and kidneys before starting treatment. They will also perform an echocardiogram by ultrasound of the heart before starting treatment and at regular intervals during treatment. If fibrotic reactions occur, treatment should be discontinued.

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, the temptation to carry out certain activities that may harm you or others. These are called impulse control disorders and can include behaviors such as addictive gaming, overeating or overspending, abnormally high sexual desire, or an increase in sexual thoughts or feelings. Your doctor will adjust or discontinue your dose.

If you have just given birth, you may be at greater 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 severe or persistent headache (with or without vision problems).

The effect of hormonal contraceptives may be reduced in women who are taking cabergoline, and pregnancy may occur before the menstrual cycle has normalized. Therefore, it is recommended to have a pregnancy test at least every 4 weeks until menstruation resumes, and from that time on, whenever the menstrual period is delayed by more than 3 days. Therefore, adequate contraceptive methods should be used during treatment with cabergoline and for at least one month after discontinuation of treatment (see section "Pregnancy, breastfeeding, and fertility").

Children and adolescents

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

Taking Cabergoline Teva with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Certain medicines used to lower blood pressure, certain medicines (e.g. phenothiazines, butyrophenones, thioxanthenes) used to treat psychological disorders (schizophrenia or psychosis), other ergoline alkaloids, medicines to treat vomiting (metoclopramide), and macrolide antibiotics (such as erythromycin) may interfere with the effects of cabergoline. The doctor should be aware of such concurrent medication.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

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

Before you can start taking cabergoline, you must make sure you are not pregnant. Additionally, you must be careful not to become pregnant during treatment and for at least one month after discontinuing treatment with cabergoline.

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

If you become pregnant while being treated with cabergoline, you should discontinue treatment and contact your doctor as soon as possible.

Breastfeeding

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

Breastfeeding mothers should be aware that milk production may be reduced or interrupted.

Fertility

Infertility may be reversed and pregnancy may occur before the menstrual cycle has normalized in women taking cabergoline (see section "Warnings and precautions").

Driving and using machines

Cabergoline Teva may negatively affect the reaction ability 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.

Cabergoline may cause drowsiness (extreme drowsiness) and sudden onset of sleep.

Therefore, people affected should not drive or take part in activities where a decrease in alertness implies a high risk of damage (e.g. use of machines), until such repeated episodes and drowsiness have been resolved. If you are affected, consult your doctor.

Cabergoline Teva contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Cabergoline Teva

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. In case of doubt, ask your doctor or pharmacist.

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

The tablets can be divided into equal doses.

The tablets should be taken with meals to reduce certain side 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 stop breastfeeding once you have started breastfeeding:

You should take ½ (half) tablet (0.25 mg) every 12 hours for 2 days.

• To reduce prolactin levels in the body:

Treatment is usually started with 0.5 mg per week, but higher doses may be needed later. Your doctor will assess your response to the medicine and adjust the treatment accordingly; they will also indicate the duration of the treatment.

If you take more Cabergoline Teva than you should

If you have taken too many tablets or think a child has swallowed some, contact your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 915 620 420. The symptoms of an overdose may include nausea, vomiting, low 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 the doctor at your nearest hospital.

If you forget to take Cabergoline Teva

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

If you stop taking Cabergoline Teva

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

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

4. Possible side effects

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

When used to stop milk production, approximately 14 out of 100 patients experience some side effect. The most common are low blood pressure, dizziness, and headache. In the treatment of high prolactin levels, side effects are more common since the tablets are taken for a longer period of time. Approximately 70 out of 100 patients experience side effects, but most side effects disappear or decrease after about 2 weeks.

Serious side effects

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

• Heart valve disorders and related disorders, such as inflammation (pericarditis) or fluid accumulation in the pericardium (pericardial effusion). The first symptoms may be one or more of the following: difficulty breathing, shortness of breath, heart palpitations, feeling of fainting, chest pain or back pain, pelvic pain or swollen legs. If you experience any of these symptoms, contact a doctor or the emergency service of the nearest hospital immediately.

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 the thoracic cavity (pleural effusion). Contact a doctor or the emergency service of the nearest hospital immediately.
• Increased difficulty breathing due to the formation of scar tissue in the lungs (pulmonary fibrosis). Contact a doctor or the emergency service of the nearest hospital immediately.
• Development of a widespread 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 rapidly after taking this medicine and makes you feel unwell. These may be indicative of an allergic reaction. Contact a doctor or the emergency service of the nearest hospital immediately.

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

• Difficulty breathing and cough due to the formation of scar tissue in the layers of the membrane that covers the lungs and the thoracic cavity (pleural fibrosis). Contact a doctor or the emergency service of the nearest hospital immediately.

Not known(frequency cannot be estimated from the available data)

• Chest pain, possibly radiating to the arm and neck, and difficulty breathing due to poor blood flow to the heart muscle. Contact the emergency service of the nearest hospital immediately.
• Weak breathing, blue-tinged lips and fingernails. Contact the emergency service of the nearest hospital immediately.
• Mental disorders (aggressive behavior, hallucinations, delirium, psychotic disorder). Contact a doctor.

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

• dizziness/vertigo, headache
• nausea, indigestion, stomach pain, inflammation of the stomach wall (gastritis)
• weakness, fatigue

Common(may affect up to 1 in 10 people)

• depression
• drowsiness (extreme drowsiness)
• low blood pressure (which can lead to dizziness, especially when standing up)
• hot flashes, facial flushing
• vomiting, constipation
• breast pain (mastodynia)

Uncommon(may affect up to 1 in 100 people)

• difficulty breathing. This can become severe. Consult your doctor.
• loss of consciousness, fainting. This can become severe. With normal heart rate, normal breathing, and rapid recovery. Consult your doctor. In all other cases, call an ambulance.
• swelling due to fluid accumulation in the tissues (edema), swelling in feet, ankles, and hands. In some people, severe conditions may occur. Consult your doctor.
• pronounced fatigue during the day and tendency to fall asleep suddenly. This can become severe. Consult your doctor.
• increased libido
• temporary partial loss of vision,
• tingling/sensations of pricking in the body
• a strong heartbeat that can be rapid and irregular
• problems with blood vessels in the fingers and toes (vasospasm)
• nosebleeds
• acne, itching, skin rash, hair loss
• leg cramps
• decrease in hemoglobin values in women whose periods had stopped and then restarted

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

• upper central abdominal pain

Not known(frequency cannot be estimated from the available data)

• tremor
• vision problems
• breathing problems with inadequate oxygen intake, inflammation, and pain of the membrane surrounding the lungs (pleuritis), chest pain
• abnormal liver function, abnormal liver function tests
• increase in blood values 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 serious personal or family consequences.
• Altered or increased sexual interest and behavior of great concern to you or others, for example, an increased sexual desire.
• Uncontrollable excessive shopping or spending.
• Eating excessively (eating large amounts of food in a short period) or compulsive eating (eating more food than normal and more than necessary to satisfy hunger)

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use, Website: https://www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cabergolina Teva

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

Do not use this medicine 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 at a temperature above 30°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 should discard the tablets of this medicine that have not been taken 30 days after the first opening of the bottle.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Cabergolina Teva

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

Appearance of Cabergolina Teva and Package Contents

White, smooth, beveled tablets with an oval shape. Each tablet is scored on one side and marked with "CBG" on one side and "0.5" on the other side of the score.

It is available in package 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 package sizes may be marketed.

Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1ª planta.

28108 Alcobendas, Madrid

Spain

Manufacturer:

Teva Czech Industries s.r.o.

Ostravská 29, indication number 305

Opava, Komárov, postal code 747 70

Czech Republic

Or

GALIEN LPS

98 rue Bellocier

89100 Sens

France

Date of the Last Revision of this Leaflet:May 2024

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

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (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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