CABERGOLINE TEVA 2 mg TABLETS

Introduction

Package Leaflet: Information for the User

Cabergoline Teva 2 mg Tablets EFG

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 symptoms are the same as yours.

• If you experience 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

Cabergoline Teva contains cabergoline which belongs to a group of medicines called dopamine agonists. Cabergoline Teva works in a similar way to dopamine, a chemical substance in the nervous system. Patients with Parkinson's disease do not have enough of this important chemical substance.

Cabergoline Teva is used to treat Parkinson's disease. It can be taken alone or in combination with levodopa, as a second choice following a therapy of non-ergoline derivatives.

Treatment requires medical supervision.

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 ever been diagnosed with problems described as fibrotic reactions (scar tissue) that affect the lungs, the back of the abdomen and the 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 determined by echocardiography.

Before taking Cabergoline Teva, your doctor will perform tests to assess the condition of your heart. Your doctor will monitor you while you are taking Cabergoline Teva.

Warnings and precautions

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

? Cardiovascular disease

? Stomach ulcer or bleeding in the gastrointestinal tract (this condition can cause black stools or vomiting with blood)

? History of severe mental disorder, in particular psychotic disorders

? Impaired liver or kidney function

? Raynaud's disease, when the fingers of the hands and feet turn blue-white, without pulse, cold, insensitive and weakened

? Low blood pressure, which can cause dizziness, especially when standing up

? Severe chest disease (e.g. chest pain when breathing, fluid in the lungs, inflammation or infection of the lungs)

? Fibrotic reactions (scar tissue) that affect the heart, lungs or abdomen. In case you receive treatment with cabergoline for a prolonged period, your doctor will check if your heart, lungs and kidneys are in good condition before starting treatment. You will also have an echocardiogram (an ultrasound test of the heart) 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 impulses or cravings to behave in an unusual way and you 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 gambling, overeating or excessive spending, an abnormally high sexual desire or an increase in sexual thoughts or feelings. Your doctor will adjust or interrupt your dose.

Infertility may be reversed in women taking Cabergoline Teva and pregnancy may occur before the menstrual cycle has normalized. Therefore, it is recommended to perform a pregnancy test every four weeks until menstruation resumes, and thereafter whenever the menstrual period is delayed by more than three 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") 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 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, anti-emetic medicines (metoclopramide), macrolide antibiotics (such as erythromycin) and itraconazole may interfere with the effects of cabergoline. Therefore, the doctor treating you should be aware of such 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 have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

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

Before starting to take cabergoline, you must make sure you are not pregnant. Also, you must be careful 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; consult the choice of contraceptive method with your doctor.

If you become pregnant while being treated with Cabergoline Teva, consult your doctor as soon as possible.

Breastfeeding

It is not known whether cabergoline passes into breast milk. As cabergoline will prevent milk production, you should not take cabergoline if you intend to breastfeed your baby. 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 Teva (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 Teva may cause somnolence (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 somnolence have been resolved.

If you are affected, consult your doctor.

Cabergoline Teva contains lactose

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 exactly the administration instructions of this medicine given by your doctor. In case of doubt, ask your doctor or pharmacist.

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

Cabergoline Teva tablets can be divided into equal doses.

Adults and elderly:

Your doctor will determine the dose and adjust it individually for you. The recommended dose at the start of treatment is 0.5 mg to 1 mg of cabergoline per day. Then, your doctor will gradually increase the dose until an adequate maintenance dose is reached.

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 if you think a child has swallowed some, contact your doctor or pharmacist or call the Toxicology Information Service, telephone 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 to your 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 forgotten doses.

If you stop taking Cabergoline Teva

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

If you have any further questions on 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.

Serious side effects

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

• Heart valve 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, back pain, pelvic pain or swollen legs. These may be the first signs of a condition called fibrosis, which can affect the lungs, heart/heart valves or back. If you experience any of these symptoms, contact a doctor or the emergency department of your nearest hospital immediately.

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• Development of rash with generalized 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. This may be indicative of an allergic reaction. Contact a doctor or the emergency department of your nearest hospital immediately.
• 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 department of your nearest hospital immediately.
• Increased difficulty breathing due to the formation of scar tissue in the lungs (pulmonary fibrosis). Contact a doctor or the emergency department of your nearest hospital 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 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 department of your nearest hospital immediately.

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

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

Otherside 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
• sleepiness (extreme drowsiness)
• dizziness/vertigo
• involuntary movements
• low blood pressure (which can cause dizziness, especially when standing up)
• shortness of breath
• vomiting, indigestion, inflammation of the stomach wall (gastritis), constipation
• weakness
• blood disorders (decrease in hemoglobin, hematocrit and/or red blood cell count in the blood), changes in liver function tests.

Uncommon(may affect up to 1 in 100 people)

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

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

• aggressive behavior
• tremor, loss of consciousness
• visual disturbance
• vasospasm (contraction of blood vessels) in the fingers of the hands and feet
• respiratory disorders and failure, chest pain
• hair loss
• leg cramps
• increase in blood values of a specific enzyme called creatine phosphokinase

You may experience the following side effects:

Inability to resist the 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.
• Alteration or increase in sexual interest and significant related behavior towards you or others, for example, increased sexual desire
• Uncontrollable excessive spending or shopping
• 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 yourdoctorif you experience anyof these behaviors, he/she will discuss the way tomanage orreduce thesymptoms.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance 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 Cabergoline Teva

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Do not store above 30°C. Store in the original package to protect from moisture. Do not remove the capsule or the silica gel desiccant from the bottle.

You should discard the Cabergoline Teva tablets that have not been used 30 days after opening the bottle.

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

6. Packaging Content and Additional Information

Composition of Cabergolina Teva

The active ingredient is cabergoline.

Each tablet contains 2 mg of cabergoline.

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

Product Appearance and Packaging Content

White, biconvex, capsule-shaped tablets containing 2 mg of cabergoline. Each tablet is scored on both sides and bears the inscription “CBG” on one side and “2” on the other side of the score.

Cabergolina 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 some pack sizes may be marketed.

Marketing Authorization Holder:

Teva Pharma, S.L.U.

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

28108 Alcobendas. Madrid.

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 Last Revision of this Leaflet: May 2024

Detailed and updated information on this medicinal product 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 medicinal product 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/69686/P_69686.html

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