Cabergoline Teva 1 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cabergoline Teva 1 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Cabergolina Teva contains cabergoline, which belongs to a group of medicines called dopaminergic agonists. Cabergolina Teva acts similarly to dopamine, a chemical substance present in the nervous system. Patients with Parkinson's disease do not have sufficient amounts of this important chemical substance.

Cabergolina Teva is used for the treatment of Parkinson's disease. It may be taken alone or in combination with levodopa, as a second-line treatment following non-ergot-derived therapy.

Treatment requires medical supervision

2. What you need to know before taking 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 ever been diagnosed with conditions described as fibrotic reactions (scar tissue) affecting the lungs, the back of the abdomen, 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 detected by echocardiography.

Before starting treatment with Cabergoline Teva, your doctor will perform tests to evaluate the condition of your heart. Your doctor will monitor you throughout the treatment with Cabergoline Teva.

Warnings and precautions

If you have any of the following health conditions, inform your doctor before taking Cabergoline Teva, as the medicine may not be suitable for you:

• Cardiovascular disease
• Stomach ulcer or gastrointestinal bleeding (this condition may cause black stools or vomiting blood)
• History of severe mental disorder, particularly psychotic disorders
• Impaired liver or kidney function
• Raynaud's disease, in which your fingers and toes turn bluish-white, become pulseless, cold, numb, and weak when exposed to cold
• Low blood pressure, which may cause dizziness, especially when standing up
• Serious chest illness (e.g. chest pain when breathing, fluid in the lungs, lung inflammation or infection)
• Fibrotic reactions (scar tissue) affecting your heart, lungs, or abdomen. If you are to receive cabergoline treatment for a prolonged period, your doctor will check that your heart, lungs, and kidneys are in good condition before starting treatment. An echocardiogram (an ultrasound test of the heart) will also be performed before starting treatment and at regular intervals during treatment. If fibrotic reactions occur, treatment must be discontinued.

Talk to your doctor if you or your family/caregiver notice that you are developing urges or cravings to behave in an unusual way and are unable to resist the impulse or 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 compulsive gambling, eating, or spending, abnormally increased sex drive, or increased thoughts or feelings about sex. Your doctor may adjust or discontinue your dose.

Infertility may reverse in women taking Cabergoline Teva, and pregnancy may occur before menstrual cycles have normalized. Therefore, a pregnancy test should be performed every four weeks until menstruation resumes, and thereafter whenever menstrual periods are delayed by more than three days. Adequate contraceptive methods should be used during treatment with cabergoline and for at least one month after stopping treatment (see section “Pregnancy, breastfeeding, and fertility”).

Children and adolescents

The safety and efficacy of cabergoline have not been studied in children and adolescents, as Parkinson’s disease does not affect this population.

Other medicines and Cabergoline Teva

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

Certain medicines used to lower blood pressure, certain medicines (e.g. phenothiazines, butyrophenones, thioxanthenes) used to treat psychiatric conditions (schizophrenia or psychosis), other ergot alkaloids, anti-nausea medicines (metoclopramide), macrolide antibiotics (such as erythromycin), and itraconazole may interfere with the effects of cabergoline. Therefore, your treating doctor must be aware of any concomitant medication.

Consult your doctor if you are taking other medicines for Parkinson’s disease.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

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

Before starting cabergoline, you must ensure that you are not pregnant. In addition, you must take care not to become pregnant during treatment and for at least one month after stopping treatment with cabergoline.

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

If you are being treated with Cabergoline Teva and become pregnant during treatment, consult your doctor as soon as possible.

Breastfeeding

It is unknown whether cabergoline passes into breast milk. Since cabergoline will inhibit milk production, you must not take cabergoline if you intend to breastfeed your baby. If you need to take cabergoline, you should use an alternative method to feed your baby.

Mothers who are breastfeeding should be aware that milk production may decrease or stop completely.

Fertility

Infertility may reverse and pregnancy may occur before menstrual cycles have normalized in women taking Cabergoline Teva (see section "Warnings and precautions").

Driving and using machines

Cabergoline Teva may negatively affect reaction ability in some individuals, and this should be considered in situations requiring a high level of alertness, e.g., driving vehicles or performing precision work.

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

Therefore, affected individuals must not drive or engage in activities where reduced alertness may pose a high risk of injury (e.g., operating machinery) until such recurrent episodes and somnolence have resolved.

If this affects you, consult your doctor.

Cabergoline Teva contains lactose

Cabergoline Teva contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Cabergoline Teva

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

The tablets should be taken with food to reduce certain adverse effects such as nausea, vomiting, and stomach pain. Take the medicine with a glass of water.

Cabergoline Teva tablets may be divided into equal doses.

Adults and elderly people:

Your doctor will determine the dose and adjust it individually for you. The recommended starting dose at the beginning of treatment is 0.5 mg to 1 mg of cabergoline per day. Afterwards, your doctor will gradually increase your dose until reaching an appropriate maintenance dose.

The recommended maintenance dose is 2 to 3 mg of cabergoline per day.

If you take more Cabergoline Teva than you should

If you have taken too many tablets or think that a child has swallowed any, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 915 620 420. Symptoms of overdose may include nausea, vomiting, low blood pressure, dizziness, stomach pain, mood changes, confusion, or hallucinations (seeing things that are not there). Take this leaflet and any remaining tablets with you to show your doctor at the 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 your next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Cabergoline Teva

If you stop treatment with cabergoline, your symptoms may return more intensely. You should consult your doctor before stopping treatment. Cabergoline takes several days to be eliminated from the blood, and its effects may worsen over a period of 2 weeks, resulting in a worsening of Parkinson's disease symptoms.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effects

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

• Heart valve and related disorders, for example inflammation (pericarditis) or fluid leakage into the pericardium (pericardial effusion). Early symptoms may include one or more of the following: difficulty breathing, shortness of breath, palpitations, feeling faint, chest pain, back pain, pelvic pain, or swollen legs. These may be the first signs of a condition called fibrosis, which may affect the lungs, heart/heart valves, or back. If you experience any of these symptoms, contact a doctor or the nearest hospital emergency department immediately.

Common (may affect up to 1 in 10 people)

• Chest pain, possibly radiating to the arm and neck, and difficulty breathing due to inadequate blood supply to the heart muscle. Contact the nearest hospital emergency department immediately.

Uncommon (may affect up to 1 in 100 people)

• Development of a widespread itchy rash, difficulty breathing with or without wheezing, feeling faint, unexplained swelling of the body or tongue, or any other symptom that appears rapidly after taking this medicine and makes you feel unwell. This could indicate an allergic reaction. Contact a doctor or the nearest hospital emergency department immediately.
• Chest pain, difficulty breathing, cough, and fever due to fluid accumulation in the layers of the membrane lining the lungs and chest cavity (pleural effusion). Contact a doctor or the nearest hospital emergency department immediately.
• Increased difficulty breathing due to scarring tissue formation in the lungs (lung fibrosis). Contact a doctor or the nearest hospital emergency department immediately.
• Psychotic disorders. Contact a doctor.
• Excessive abnormal movements. Contact a doctor.

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

• Difficulty breathing and cough due to scarring tissue formation in the layers of the membrane lining the lungs and chest cavity (pleural fibrosis). Contact a doctor or the nearest hospital emergency department immediately.

Not known (frequency cannot be estimated from available data)

• Weakened breathing, blue-colored lips and nails. Contact the nearest hospital emergency department immediately.
• Inflammation of the pleura, with chest pain, difficulty breathing, cough, and fever. Contact a doctor or the nearest hospital emergency department immediately.
• Fatigue, weight loss, fever, lower back or pelvic pain due to thickening of connective tissue in the abdominal cavity. Contact a doctor.

Other adverse effects

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

• nausea
• swelling of feet, ankles, and hands

Common (may affect up to 1 in 10 people)

• hallucinations, confusion, sleep disorders, increased libido

• headache

• somnolence (extreme drowsiness)

• dizziness/vertigo

• involuntary movements

• low blood pressure (which may cause dizziness, especially when standing up)

• shortness of breath

• vomiting, indigestion, inflammation of the stomach wall (gastritis), constipation

• weakness

• blood disorders (decreased hemoglobin, hematocrit, and/or red blood cell count), abnormalities in liver function tests

Uncommon (may affect up to 1 in 100 people)

• delusions
• extreme fatigue and sudden onset of sleep
• redness, swelling, and pain in the arms and legs (erythromelalgia)
• abnormal liver function
• skin rash
• tiredness
• fluid retention

Not known (frequency cannot be estimated from available data)

• aggressive behavior
• tremor, loss of consciousness
• visual disturbances
• vasospasm (contraction of blood vessels) in fingers and toes
• respiratory disorders and respiratory failure, chest pain
• hair loss
• leg cramps
• increased blood levels of a specific enzyme called creatine phosphokinase

You may experience the following adverse effects:

Inability to resist the impulse or temptation to carry out 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 interest in sexual activity and significant related behaviors, for example, increased sexual drive.
• Uncontrollable excessive spending or shopping.
• Overeating (consuming 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 manage or reduce the symptoms.

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: Website: https://www.notificaRAM.es

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

5. Storage of Cabergoline Teva

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store 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.

Dispose of any unused Cabergoline Teva tablets 30 days after opening the bottle.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cabergoline Teva

The active substance is cabergoline.

Each tablet contains 1 mg of cabergoline.

The other components are: lactose, L-leucine (E572) and magnesium stearate.

Appearance of the product and contents of the pack

White, biconvex, oval tablets containing 1 mg of cabergoline. Each tablet is scored on both sides and marked with "CBG" on one side and "1" on the other side of the score line.

Cabergoline Teva is available in packs of 2, 8, 14, 15, 16, 20, 28, 30, 32, 40 (2x20), 48, 50, 60 (3x20), 90 (3x30), 96 and 100 (5x20) tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder:

Teva Pharma, S.L.U.

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

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 most recent revision of this leaflet: May 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS): http://www.aemps.gob.es/

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69687/P_69687.html

QR Code + URL