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Package Leaflet: Information for the User

Cabergoline Teva 0.5 mg, tablets

Cabergoline

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 signs of illness are the same as yours.

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.See section 4.

What is in this leaflet:

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

Cabergoline Teva belongs to a group of medicines known as prolactin inhibitors. Cabergoline Teva prevents lactation (production of milk) by decreasing levels of a hormone known as prolactin.

Cabergoline Teva can also be used to reduce abnormal quantities of the hormone prolactin in the blood.

2. What you need to know before you take Cabergoline Teva

Do not take Cabergoline Teva if you:

• are allergic to cabergoline or other ergot alkaloids (e.g. bromocriptine), or any of the other ingredients of this medicine (listed in section 6)

• have (or have had in the past) psychosis or you are at risk of psychosis after childbirth

• have severely impaired liver function

• have swelling of the hands, feet and a high blood pressure during pregnancy (preeclampsia, eclampsia)

• have uncontrolled high blood pressure or high blood pressure after childbirth

• have ever been diagnosed in the past with problems described as fibrotic reactions affecting the lungs, back of the abdomen and kidneys or heart

• will be treated with Cabergoline Teva for a long period and have or had been diagnosed in the past with a problem described as fibrotic reactions (scar tissue) affecting your heart

Warnings and precautions

If you have any of the following health problems you mustinform your doctor before taking Cabergoline Teva as the medicinal product may be unsuitable for you.

• Cardiovascular disease

• Stomach ulcer or bleeding in the gastrointestinal tract. (This condition can cause black faeces or vomiting with blood)

• Impaired kidney function

• Raynaud’s disease. (When it is cold the fingers and toes become bluish white, with no pulse, cold, insensitive and fumbling).

• Low blood pressure

• Serious chest complaint (e.g. pain in the chest when breathing, fluid in the lungs, inflammation or infection of the lungs)

• If you have or had fibrotic reactions (scar tissue) affecting your heart, lungs or abdomen.
  In case you are treated with Cabergoline Teva for a long period, your physician will check before starting treatment whether your heart, lungs and kidneys are in good condition. He/she will also have an echocardiogram (an ultrasound test of the heart) taken before treatment is started and at regular intervals during treatment. If fibrotic reactions occur treatment will have to be discontinued.

• History of serious mental disorder, particularly psychotic disorders.

• If you are pregnant and develop high blood pressure during pregnancy.

Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.

The effect of alcohol on the tolerability of cabergoline is unknown

Infertility can be reversed in women taking Cabergoline Teva, and pregnancy can occur before the menstrual cycle has normalised. Therefore a pregnancy test is recommended at least every 4 weeks until menses are reinitiated, and from then on every time a menstrual period is delayed by more than 3 days. Suitable means of contraception should therefore be used during treatment with Cabergoline Teva and also after discontinuation of treatment until recurrence of anovulation (See section “Pregnancy”).

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Children and adolescentsThe safety and efficacy of Cabergoline Teva has not been established in children and adolescents less than 16 years of age.

Other medicines and Cabergoline Teva

Certain medicines used for reducing blood pressure and certain medicinal products (e.g. phenothiazines, butyrophenones, thioxanthene) used for the treatment of psychological illnesses (schizophrenia or psychoses), if taken at the same time as Cabergoline Teva can interfere with the effects of cabergoline. The treating doctor should therefore be aware of such simultaneous medication.

There are other medicines such as otherergot alkaloids, medicines against vomiting (metoclopramide), and macrolide antibiotics (such as erythromycin) that may affect the activity and tolerability of Cabergoline Teva.

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

Cabergoline Teva with food and drink

Cabergoline Teva should be taken by mouth, preferably with meals.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There are no adequate and well-controlled studies of the use of Cabergoline Teva during pregnancy. If you are being treated with Cabergoline Teva and become pregnant during this time you should discontinue the treatment and contact your doctor as soon as possible. Before you can start using cabergoline you have to exlude that you are pregnant. Additionally you should take care not becoming pregnant for at least one month once you have stopped treatment with cabergoline.

Breast-feeding

It is not known whether cabergoline passes into breast milk. Cabergoline Teva should not be taken by mothers who intend to breast feed as it prevents lactation.

As Cabergoline Teva will stop you from producing milk for your baby, you should not take Cabergoline Teva if you plan to breastfeed. If you need to take Cabergoline Teva you should use another method of feeding your baby

Fertility

If you are planning to become pregnant the Cabergoline Teva should be discontinued one month before intended pregnancy. You should therefore consult your doctor if you are pregnant or plan to become pregnant before the treatment is started.

Driving and using machines

Cabergoline Teva can negatively affect the ability to react in some people and this should be considered in cases where a high level of alertness is required, e.g. driving a car and in precision work.

Cabergoline Teva can cause somnolence (extreme drowsiness) and sudden sleep onset. Persons affected by this should therefore not drive or take part in activities in which reduced alertness could incur a risk of serious harm (e.g. using machines), until such recurrent episodes and somnolence have resolved.

Cabergoline Teva contains lactose

Cabergoline Teva 0.5mg tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars you should contact your doctor before taking this medicine.

3. How to take Cabergoline Teva

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The dose is determined by your doctor who adjusts it individually for you.

The tablets should be taken with meals to reduce certain side effects such as nausea, vomiting and stomach pains.

The usual dose is 1 mg (as a single dose)within 24 hours after giving birth.

Usually the treatment is started with 0.5 mg per week, but higher doses may then be necessary. Your doctor will tell you for how long you must take your tablets.

The tablet can be divided into equal doses.

If you take more Cabergoline Teva than you should

It is important not to take too many tablets. Contact your nearest hospital Accident and Emergency department or a doctor for advice, if you have taken too many tablets orif you think a child has swallowed any. Symptoms of overdose may include nausea, vomiting, reduced blood pressure, stomach pain, changes in behaviour, confusion or hallucinations (seeing things). Take this leaflet and any tablets that you still have to show the doctor.

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 it.

If it is almost time to take the next dose, skip the forgotten dose and take the next dose as usual.

If you stop using Cabergoline Teva

If you stop using cabergoline the symptoms of your illness may become more severe and you should discuss with your doctor before you discontinue therapy. Cabergoline takes many days to be cleared from the bloodstream and effects may worsen over a 2 week period resulting in increased lactation.

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 everyone gets them.

You may experience the following side effects:

Inability to resist the impulse, drive 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.

• Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.

• Uncontrollable excessive shopping or spending

• Binge eating (eating large amounts of food in a short time period) 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; they will discuss ways of managing or reducing the symptoms.

When used for stopping the production of breast milk approx. 14 in 100 patients have some form of side effects. The most common are low blood pressure, dizziness and headache. In treatment of increased prolactin levels side effects are more common as the tablets are taken for a longer period of time. Approximately 70 in 100 patients then experience side effects, but the side effects mostly disappear or decrease after approx. 2 weeks.

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

Heart valve and related disorders eg, inflammation (pericarditis) or leaking of fluid in the pericardium (pericardial effusion). The early symptoms may be one or more of the following: difficulty breathing, shortness of breath, chest or back pain and swollen legs. If you experience any one of these symptoms you must tell your doctor immediately.

Dizziness, vertigo (a feeling of dizziness or spinning), headache; nausea (feeling sick), stomach pain, inflammation of the stomach lining (gastritis)

Weakness (asthenia) and fatigue (tiredness),

Common: (may affect up to1 in10 people):

Somnolence (extreme drowsiness), low blood pressure (which can result in dizziness, particularly on standing up), depression, sleep disturbances, vomiting (being sick), constipation, breast pain, facial redness, hot flushes.

Uncommon :(may affect up to1 in100 people):

Problems with your blood vessels, changes in your vision, nosebleeds, cramps in your legs, fainting, crawling, tingling and or prickling sensations in the body, palpitations (feeling your heart beat), rash, hair loss, increased libido, swelling due to accumulation of fluid in the tissues, allergic reactions (development of a widespread itchy rash, difficulty breathing with or without wheezing, feeling faint, unexplained swelling of the body or tongue or any other symptoms which appear to come on rapidly after taking this medication and make you feel unwell), low haemoglobin values in blood (your doctor will tell you this from blood test results), fibrosis of the lung, pleural effusion (excess fluid in the space around the lung).

You can develop excess fibrous connective tissue (fibrosis) e.g. in the heart, lungs, and kidneys has been reported. You should become aware of this as difficulty breathing, chest pain, back pain and swelling of the legs.

Rare :(may affect up to1 in 1,000 people):

Pain in the upper central abdomen

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

Sudden sleep attacks, hallucinations, delusions, psychotic disorder,chest pain,tremor, problems with your vision, angina pectoris, abnormal liver and abnormal blood tests of liver function, breathing problems with inadequate intake of oxygen, an increase in the level of some enzymes in the blood, abnormal vision and aggression.

Reporting of side effects

If you get 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 package after EXP

Do not store above 30°C. Store in the original package in order to protect from moisture. The drying capsule or bag with silica gel must not be removed from the bottle.

Do not throw away any medicines via wastewater of household waste. Ask you pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Cabergoline Teva contains

The active substance is cabergoline.

Each tablet contains 0.5mg cabergoline.

The other ingredients are anhydrous lactose, L-leucin and magnesium stearate.

What Cabergoline Teva looks like and contents of the pack

White, oval, flat tablets with bevelled edges. One side is smooth and the other side has a dividing score line and is debossed with ‘CBG’ and ‘0.5’ on either side of the score.

Cabergoline Teva 0.5 mg is available 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 Authorisation Holder and Manufacturer

[To be completed nationally]

Manufacturer:

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:

Sweden: Cabergoline Teva 0.5mg Tablet

Belgium: Cabergoline TEVA 0.5 mg Tabletten

Germany: Cabergolin-TEVA 0.5mg Tabletten.

Luxembourg: Cabergoline TEVA 0.5mg comprimés

Netherlands: Cabergoline 0.5 PCH, Tabletten 0.5mg

Slovakia: Cabest 0.5mg Tablet

This leaflet was last revised in2014-06-16