Cabergoline Teva 2 mg tablets EFG
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Cabergoline Teva 2 mg tablets EFG
Read the entire leaflet carefully before you start taking this medicine, because 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 effects, consult your doctor or pharmacist, even if they are
adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Cabergoline Teva is and what it is used for
- What you need to know before taking Cabergoline Teva
- How to take Cabergoline Teva
- Possible side effects
- How to store Cabergoline Teva
- 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 levels of this important chemical substance.
Cabergolina Teva is used to treat Parkinson's disease. It may be taken alone or in combination with levodopa, as a second-line treatment following non-ergot-derived therapy.
This 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 and kidneys, or the 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 confirmed by echocardiography.
Before starting treatment with Cabergoline Teva, your doctor will perform tests to assess your heart condition. Your doctor will monitor you throughout the treatment with Cabergoline Teva.
Warnings and precautions
If you suffer from 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 disorders, particularly psychotic disorders
? Impaired liver or kidney function
? Raynaud's disease, in which cold causes fingers and toes to turn pale or bluish, become pulseless, cold, numb, and weak
? Low blood pressure, which may cause dizziness, especially when standing up
? Severe 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 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/carer 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 could harm you or others. These are known as impulse control disorders and may include behaviors such as compulsive gambling, eating, or spending, abnormally increased sexual desire, or increased thoughts or feelings about sex. Your doctor may adjust or stop your dose.
Infertility may be reversed 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 every time a menstrual period is delayed by more than three days. Adequate contraceptive methods should therefore be used during treatment with cabergoline and for at least one month after stopping treatment (see section “Pregnancy, breastfeeding and fertility”) if necessary.
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 should 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 plan to become pregnant, consult your doctor before using this medicine.
Pregnancy
Experience with the use of cabergoline during pregnancy is limited.
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 should 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.
Breastfeeding mothers should be aware that milk production may be reduced or stopped.
Fertility
Infertility may be reversed and pregnancy may occur before menstrual cycles have normalized in women taking Cabergoline Teva (see section "Warnings and precautions").
Driving and use of machines
Cabergoline Teva may negatively affect reaction ability in some people, and this should be taken into account in situations requiring a high level of alertness, e.g. driving vehicles and 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 could pose a high risk of harm (e.g. operating machinery) until repeated episodes and drowsiness have resolved.
If you are affected, 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 with him before taking this medicine.
3. How to take Cabergoline Teva
Follow exactly the instructions for use of 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 of treatment is 0.5 mg to 1 mg of cabergoline per day. Afterwards, your doctor will gradually increase the 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 may have swallowed some, contact your doctor or pharmacist immediately, or call the Poison 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 real). Take this leaflet and any remaining tablets with you to show to 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 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 a missed dose.
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 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 insufficient blood flow 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 may 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 in blood), 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 (constriction 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 perform an action that could be harmful to yourself or others, which may include:
- Strong urge to gamble excessively despite serious personal or family consequences.
- Altered or increased sexual interest and significant related behaviors, for example, increased sexual drive.
- Uncontrollable excessive spending or shopping.
- Overeating (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 manage or reduce the symptoms.
Reporting of adverse effects
If you experience any kind of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 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. Keep in the original packaging to protect from moisture. Do not remove the capsule or the silica gel desiccant bag from the bottle.
Any unused Cabergoline Teva capsules should be discarded 30 days after opening the bottle.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. 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 2 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, capsule-shaped tablets containing 2 mg of cabergoline. Each tablet is scored on both sides and marked with "CBG" on one side and "2" on the other side of the score.
Cabergoline Teva is available in packs containing 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 review of this leaflet: May 2024
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69686/P_69686.html
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