Package Leaflet: Information for the User

Cabergolina Teva 2 mg Tablets EFG

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before taking Cabergolina Teva

3. How to take Cabergolina Teva

4. Possible side effects

5. Storage of Cabergolina Teva

6. Contents of the pack and additional information

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

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

Treatment requires medical supervision.

Do not take Cabergolina Teva if

• You are allergic to cabergolina or any other ergoline alkaloid (e.g. bromocriptina), or to any of the other components of this medication (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 the kidneys or the 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 echocardiography.

Your doctor will perform tests to evaluate the condition of your heart before you start taking Cabergolina Teva. Your doctor will monitor you while you are taking Cabergolina Teva.

Warnings and precautions

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

?Cardiovascular disease

?Stomach ulcer or gastrointestinal bleeding (this condition may cause black stools or vomiting with blood)

?History of severe mental disorder, particularly psychotic disorders

?Liver or kidney function impairment

?Raynaud's disease, when cold, the fingers of the hands and feet turn white, blue, and are cold, pulseless, insensitive, and weakened

Low blood pressure, which may cause dizziness, especially when standing up

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

?Fibrotic reactions (scar tissue) affecting your heart, lungs, or abdomen. If you are going to be treated with cabergolina for a long period of time, 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 suspended.

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 may include behaviors such as addictive gambling, excessive eating or spending, an abnormally elevated sex drive, or an increase in sexual thoughts or feelings.Your doctor will adjust or interrupt your dose.

Fertility may be reversed in women taking Cabergolina 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 then every time the menstrual period is delayed by more than three days. Therefore, suitable contraceptive methods should be used during treatment with cabergolina and for at least one month after treatment is discontinued (see section "Pregnancy, breastfeeding, and fertility") if necessary.

Children and adolescents

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

Other medications and Cabergolina Teva

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 illnesses (schizophrenia or psychosis), other ergoline alkaloids, anti-nausea medications (metoclopramide), macrolide antibiotics (such as erythromycin), and itraconazole may interfere with the effects of cabergolina. Therefore, your doctor should be aware of such simultaneous medication.

Consult your doctor if you are taking other medications for Parkinson's disease.

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 during pregnancy.

Before starting to take cabergolina, make sure you are not pregnant. You must also be careful not to become pregnant during treatment and for at least one month after stopping treatment with cabergolina.

Use effective non-hormonal contraceptive methods; consult your doctor about the choice of contraceptive method.

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

Breastfeeding

It is unknown whether cabergolina passes into breast milk.Since cabergolina will prevent milk production, you should not take cabergolina if you plan to breastfeed your baby. 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 reversed, and pregnancy may occur before the menstrual cycle has normalized in women taking Cabergolina Teva (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 Teva may cause drowsiness (extreme sleepiness) and the sudden onset of sleep.

Therefore, people affected 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

Cabergolina Teva contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. If you have any doubts, ask your doctor or pharmacist.

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

Cabergolina Teva tablets can be split into equal doses.

Adults and elderly people:

Your doctor will determine the dose and adjust it individually for you. The recommended starting dose is 0.5 mg to 1 mg of cabergolina per day. After that, your doctor will gradually increase the dose to reach a suitable maintenance dose.

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

If you take more Cabergolina Teva than you should

If you have taken too many tablets or if you think a child has swallowed one, 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 forgot to take Cabergolina Teva

If you forgot 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

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

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

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

Severe side effects

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

• Heart valve and related disorders, for example, inflammation (pericarditis) or fluid leakage 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 nearest hospital emergency department immediately.

Common (may affect up to 1 in 10 people)

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

Rare (may affect up to 1 in 100 people)

• Development of a rash with generalized pruritus, 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 nearest hospital emergency department immediately.
• 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). Contact a doctor or the nearest hospital emergency department immediately.
• Increased difficulty breathing due to the formation of scar tissue in the lungs (fibrosis affecting the lungs). 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 the formation of scar tissue in the layers of the membrane that covers the lungs and thoracic cavity (pleural fibrosis). Contact a doctor or the nearest hospital emergency department immediately.

Unknown (frequency cannot be estimated from available data)

• Weak breathing, blue lips and nails. Contact the nearest hospital emergency department immediately.
• Pleuritis, 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 side 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)

• Alucinations, confusion, sleep disorders, increased libido
• Headache
• Excessive somnolence
• Dizziness/dizziness
• Involuntary movements
• Low blood pressure (which may cause dizziness, especially when standing up)
• Shortness of breath
• Vomiting, indigestion, stomach wall inflammation (gastritis), constipation
• Weakness
• Blood disorders (decreased hemoglobin, hematocrit, and/or red blood cell count in the blood), liver function test abnormalities

Rare (may affect up to 1 in 100 people)

• Delirium
• Extreme fatigue and sudden onset of sleep
• Redness, inflammation, and pain in the arms and legs (erythromelalgia)
• Abnormal liver function
• Skin rash
• Fatigue
• Fluid retention

Unknown (frequency cannot be estimated from available data)

• Aggressive behavior
• Tremor, loss of consciousness
• Visual disturbances
• Vasospasm (contraction of blood vessels) in the fingers of the hands and feet
• Respiratory disorders and insufficiency, chest pain
• Hair loss
• Leg cramps
• Increased levels of a specific enzyme called creatine phosphokinase

You may experience the following side effects:

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

Inform your doctor if you experience any of these behaviors , they will discuss how to manage or reduce the 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 through the Spanish System for Pharmacovigilance of Medicines for Human Use, 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 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 must discard the unused Cabergolina Teva tablets 30 days after opening the bottle.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and unused

medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Cabergolina Teva Composition

The active ingredient 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 packaging

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 packaging 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 packaging sizes may be marketed.

Marketing Authorization Holder:

Teva Pharma, S.L.U.

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

28108 Alcobendas. Madrid.

Responsible for manufacturing:

Teva Czech Industries s.r.o.

Ostravská 29, indication number 305

Opava, Komárov, postal code 747 70

Republic of Czechia

or

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/69686/P_69686.html

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