0.5 mg tablets
cabergoline
1. What Cabergoline Teva is and what it is used for
Cabergoline Teva belongs to a group of medicines called prolactin inhibitors. Cabergoline Teva prevents lactation (breast milk production) by reducing the levels of a hormone called prolactin .
Cabergoline Teva can also be used to reduce abnormal levels of the hormone et prolactin in the blood.
Cabergoline contained in Cabergoline Teva may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
2. What you need to know before using Cabergoline Teva
Do not use Cabergoline Teva if you:
- Is allergic to cabergoline, other ergot alkaloids (eg bromocriptine) or any of the other ingredients of this medicine (listed in section 6).
- Has or has had psychosis or has an increased risk of psychosis after childbirth.
- Has swollen hands and feet and high blood pressure during pregnancy (pregnancy poisoning).
- Has uncontrolled high blood pressure or high blood pressure after childbirth.
- Ever before has been diagnosed with problems described as fibrotic reactions that affect the lungs, back of the abdomen and kidneys or heart.
- Will be treated with Cabergoline Teva for a long time and have or have had fibrotic reactions (scar tissue) in the heart.
Warnings and cautions
If you have any of the following health problems, you must inform your doctor before taking Cabergoline Teva, as this medicine may not be suitable for you:
- Cardiovascular disease.
- Gastric ulcer or bleeding in the gastrointestinal tract (may cause black stools or bloody vomiting).
- Previously serious mental illness, especially psychotic illness.Hepatic or renal impairment.
- Raynaud’s disease (when cold, fingers and toes become bluish white, pulseless, cold, insensitive and numb).
- Low blood pressure (which can cause dizziness – especially when you get up).
- Severe chest problems (eg chest pain when breathing, fluid in the lungs, infectionor inflammation in the lungs).
- Fibrotic reactions (scar tissue) in the heart, lungs or abdomen.
If you are being treated with Cabergoline Teva for a long time, your doctor will check that your heart, lungs and kidneys are in good condition before starting treatment. He / she will also take an echocardiogram (an ultrasound examination of the heart) before starting treatment and at regular intervals during treatment. If fibrotic reactions occur, treatment will be discontinued.
Tell your doctor if you or your family / carer notices that you develop a strong desire or desire to behave in a way that is unusual for you or that you can not resist the impulse, drive or temptation to perform certain activities that can harm you or others. These behaviors are called impaired impulse control and may include gambling addiction, compulsive eating, compulsive buying, an abnormally high sexual drive, or an increase in sexual thoughts and feelings. Your doctor may need to adjust dose one or discontinue treatment .
If you have just given birth, you may be at higher risk for certain medical problems. This can be high blood pressure , heart attack, seizures, strokes or mental problems. Therefore, your doctor must check your blood pressure regularly during treatment. Contact a doctor immediately if you get high blood pressure , chest pain or unusually severe or persistent headaches (with or without vision problems).
Infertility can be reversed in women taking Cabergoline Teva, and pregnancy may occur before the menstrual cycle normalizes. Therefore, a pregnancy test is recommended at least every four weeks during the period before menstruation returns and thereafter, each time a period is delayed by more than three days.
Appropriate contraception should therefore be used during treatment with Cabergoline Teva and also from the end of treatment until ovulation has stopped (see section Pregnancy and lactation).
Children and young people
The safety and efficacy of Cabergoline Teva have not been established in children and adolescents under 16 years of age.
Other medicines and Cabergoline Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Certain antihypertensive drugs and certain drugs (eg phentiazine derivatives, butyrophenone derivatives, thioxanthene derivatives) for mental illness (schizophrenia or psychosis ) can affect the treatment effect of cabergoline if taken at the same time as Cabergoline Teva. The treating physician therefore needs to be aware of such concomitant medication.
Other drugs such as other ergot alkaloids, antiemetics (metoclopramide) and macrolide antibiotics (eg erythromycin) may affect the efficacy and sensitivity of Cabergoline Teva.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Pregnancy
There is only limited experience with the use of Cabergoline Teva during pregnancy.
If you are planning to become pregnant, treatment with Cabergoline Teva should be stopped one month before you intend to become pregnant. Therefore, consult your doctor if you are pregnant or planning to become pregnant before starting treatment.
Before you start taking Cabergoline Teva, make sure you are not pregnant. In addition, you should avoid becoming pregnant for at least one month after stopping treatment with Cabergoline Teva. Effective non-hormonal contraceptives should be used, discuss the choice of contraceptive method with your doctor. If you are being treated with Cabergoline Teva and become pregnant during this time, you should stop treatment and contact your doctor as soon as possible.
Breast-feeding
It is not known if cabergoline turns into breast milk.
As Cabergoline Teva will prevent you from producing breast milk for your baby, you should not take Cabergoline Teva if you are planning to breast-feed. If you need to take Cabergoline Teva, feed your baby in a different way.
Fertility
Infertility can be reversed in women taking Cabergoline Teva, and pregnancy may occur before the menstrual cycle normalizes. (see section Warnings and Precautions).
Driving and using machines
Cabergoline Teva can impair the reactivity of some people, which should be considered at times when sharper attention is required, e.g. while driving and precision work.
Cabergoline Teva can cause somnolence (pronounced fatigue) and sudden sleep attacks. The person affected by this should therefore not drive or participate in activities where reduced attention may lead to a risk of serious injury (eg use of machinery) until the somnolence and sleep attacks have disappeared. If you are affected, consult your doctor.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Cabergoline Teva contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to use Cabergoline Teva
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by your doctor who adjusts it individually for you.
The tablet can be divided into two equal doses .
The tablets should be taken with a meal to reduce certain side effects such as nausea, vomiting and abdominal pain.
- To stop breast milk production : The
recommended dose is 1 mg cabergoline (as a single dose) within 24 hours after delivery. - To reduce the concentration of prolactin in your body:
Usually start treatment with 0.5 mg cabergoline (per week, but a higher dose may be needed. Your doctor will tell you how long to take your tablets
If you forget to take Cabergoline Teva
If you forget to take a dose at the right time, you can take it as soon as you remember.
If it is almost time to take the next dose , skip the missed dose and take the next doseas usual. Do not take a double dose to make up for a forgotten dose .
If you stop using Cabergoline Teva
If you stop using Cabergoline Teva, your symptoms may get worse and you should always consult your doctor before stopping your treatment. It takes many days before cabergoline has disappeared from the body and the symptoms can worsen over a 2 week period, which can result in increased breast milk production.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately if you experience any of the following symptoms after taking this medicine. These symptoms can be severe:
- Impact on the heart valves and related disorders, e.g. pericarditis or fluid in the sac surrounding the heart (pericardial effusion). This is a very common side effect(may affect more than 1 user in 10). The early symptoms may be one or more of the following: difficulty breathing, shortness of breath, palpitations, fainting, chest pain, back pain, pelvic pain and swelling in the legs. These can be the first signs of a disease called fibrosis that can affect the lungs, heart / heart valves or back.
- Development of widespread skin rash with itching , difficulty breathing with or without wheezing, fainting, unexplained swelling of the body or tongue or other symptoms that appear shortly after taking the medicine and make you feel unwell. This may be a sign of an allergic reaction . This is a less common side effect (may affect up to 1 in 100 people.)
When breast milk production is stopped, about 14 out of 100 patients get some form of side effect. The most common are low blood pressure , dizziness and headaches. In the treatment of elevated prolactin levels, side effects are more common, as the tablets are taken for a longer period of time. About 70 out of 100 patients then get side effects , but the side effects usually disappear or subside after about 2 weeks.
During treatment, you may also notice the following side effects:
Very common (may affect more than 1 in 10 people):
- Dizziness, headache,
- nausea, indigestion, abdominal pain, inflammation of the gastric mucosa ( gastritis ),
- weakness ( asthenia ) and fatigue.
Common (may affect up to 1 in 10 people):
- Somnolence (extreme fatigue),
- low blood pressure (which can cause dizziness especially when you get up),
- Depression,
- vomiting, constipation,
- chest pain,
- flushing, hot flashes.
Uncommon (may affect up to 1 in 100 people):
temporary partial loss of vision, loss of consciousness,
- creeps, tickling and / or
- crawling, stinging sensation in the body,
- nosebleeds,
- leg cramps,
- palpitation er (that you feel your heartbeat),
- problems with blood vessels in fingers and toes (vasospasm),
- fainting spells,
- skin rash, hair loss,
- increased sex drive,
- swelling due to accumulation of fluid in the tissues ( edema ),
- decrease in hemoglobin levels in women whose menstruation has stopped and then resumed,
- difficulty breathing, fibrotic reactions (including pulmonary fibrosis ), fluid leakage into the pleura ( pleural effusion).
Rare (may affect up to 1 in 1,000 people):
- pain in the upper abdomen,
- cramps in the fingers.
Very rare (may affect up to 1 in 10,000 people):
Formation of scar tissue in the membrane surrounding the lungs (pleural fibrosis)
No known frequency (cannot be calculated from the available data):
- sudden sleep attacks,
- tremors,
- aggressive behavior, hallucinations, delusions, psychotic disorder,
- vision problems,
- angina ( angina pectoris ),
- abnormal liver function, liver function tests,
- respiratory problems with insufficient oxygen intake, inflammation and pain in the membrane surrounding the lungs (pneumonia), chest pain,
- elevated blood levels of a specific enzyme called creatinine phosphokinase.
- Inability to resist an impulse to perform an action that can be harmful such as:
- A strong impulse to excessive gambling despite serious consequences for you personally or for your family
- Altered or increased sexual interest or behavior that makes you or others noticeably concerned, e.g. an increased sexual drive
- Uncontrollable and excessive need to buy things and spend money
- Binge eating (eating large amounts of food in a short time) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)
Tell your doctor if you experience any of these behaviors to discuss ways to manage or reduce the symptoms.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store 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 expiration date is the last day of the specified month.
Do not store above 30 ° C. Store in the original package. Moisture sensitive. The capsule or bag with desiccant (silica gel) must not be removed from the jar.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is cabergoline
Each tablet contains 0.5 mg cabergoline.
Other ingredients: Anhydrous lactose , L-leucine and magnesium stearate.
What the medicine looks like and contents of the pack
White, oval, flat tablets with a bevelled edge. One side is smooth and the other side has a break notch. The tablet is marked with ‘CBG’ and ‘0.5’ on each side of the breaker notch.
Cabergoline Teva 0.5 mg is supplied in packs of 2, 8, 14, 15, 16, 20, 28, 30, 32, 40, 48, 50, 60, 90, 96 and 100 tablets.
Not all pack sizes may be marketed
Marketing Authorization Holder / Information provided by:
Manufacturer:
Teva Czech Industries sro, Ostravská 29, cp 305, 747 70 Opava, Komárov, Czech Republic