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Package Leaflet: Information for the User

Cabergoline Teva 1 mg and 2 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 dopamine agonists. Cabergoline Teva acts in a similar way to a chemical present in the nervous system called dopamine. Patients with Parkinson’s disease do not have enough of this important chemical.

Cabergoline Teva 1mg and 2mg is used to treat Parkinson’s disease. It can be used either taken alone or in combination with levodopa, as second choice following non-ergot derived therapies.

Treatment under a specialist is required.

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

• have uncontrolled high blood pressure

• 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 the lungs, back of the abdomen and kidneys or heart

• If you have previously experienced side effects affecting lung, such as fibrosis, associated with the use of dopamine agonists (e.g. bromocriptine, pergolide).”

• If you have ever been diagnosed in the past with a problem known as fibrosis affecting the lungs, lower back and kidneys or heart

Before you are given Cabergoline Teva your doctor will arrange for you to have tests to assess the condition of your heart. Your doctor will continue to monitor your medical condition while taking Cabergoline Teva.

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

• Have impaired liver function

• Have or had fibrotic reactions (scar tissue) affecting your heart, lungs or abdomen

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

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

• Low blood pressure

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

• History of serious mental disorder, particularly psychotic disorders

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 a good condition. He/she will also have an echocardiogram (an ultrasoundtest of the heart) taken before treatment is started and at regular intervals during treatment. If fibrotic reactions occur, treatment will have to be discontinued.

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.

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”).

Children and adolescents

The 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 concomitant medication.

There are other medicines such as otherergot alkaloids, medicines to prevent 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. Contraception should be continued for at least 4 weeks after stopping 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. If affected, consult your doctor.

Cabergoline Teva contains lactose

Cabergoline Teva 1mg and 2mg 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 tablets should be taken with meals to reduce certain side effects such as nausea, vomiting and stomach pains.

Adults and elderly patients.

The dose is determined by your doctor who adjusts it individually for you. The usual dose at the start of treatment is 0.5 -1 mg cabergoline daily. The dose is then increased gradually as directed by the doctor up to a suitable maintenance dose.

The usual maintenance dose is from 2 mg up to 3 mg cabergoline daily.

The tablets 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 worsening of symptoms of Parkinson's disease.

If you have any other 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.

Side effects are listed below with the highest frequency reported, independent of what Cabergoline Teva is used for.

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. Nausea (feeling sick), swelling due to fluid accumulating (especially in the legs and arms).

Common : (may affect up to 1in 10 people):

Sleeping disturbances, hallucinations (seeing things that are not there) ), dizziness, low blood pressure (which can result in dizziness particularly on standing up), confusion, involuntary movements, constipation, upset stomach, digestive disturbances, inflammation of the stomach lining (gastritis), vomiting (being sick), blood problems including low blood count (symptoms may include tiredness), heart problems (chest pain), shortness of breath, headache, extreme drowsiness and a strong desire to sleep or sleepiness, increased libido, muscle weakness and fatigue, abnormal liver function tests.

Uncommon : (may affect up to 1 in 100 people):

Excessive abnormal movements, Redness, swelling and pain in the arms and legs (erythromelalgia). Fluid in the layers of the membrane lining the lungs and chest cavity, developing excess fibrous tissue in the lungs (pulmonary fibrosis), symptoms can include shortness of breath, limited chest movement and breathing difficulties. Hypersensitivity, fatigue, abnormal liver function, skin rash. Delusions or psychotic disorder

Very rare: (may affect up to 1 in 10,000 people)

Formation of fibrous tissues

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

Sudden sleep attacks , aggression, tremor, visual impairment, leg cramps, fainting, respiratory disorders and failure, vasospasm (tightening in your blood vessels) and alopecia (hair loss). Increases in blood creatinine phosphokinase test results.

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 or household waste. Ask you pharmacist how 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 1 mg and 2 mg cabergoline

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

What Cabergoline Teva looks like and contents of the pack

Cabergoline Teva 1 mg tablets are white, oval-shaped biconvex tablets with a dividing score line on both sides of the tablet. One side of the tablet is marked ‘CBG’ and ‘1’ on either side of the dividing score line.

Cabergoline Teva 2 mg tablets are white, capsule-shaped, biconvex tablets with a dividing score line on both sides of the tablet. One side of the tablet is marked ‘CBG’ and ‘2’ on either side of the dividing score line.

Cabergoline Teva 1 mg are available in packs of 2, 8, 14, 15, 16, 20, 28, 30, 32, 40, 48, 50, 60, 90, 96 and 100 tablets.

Cabergoline Teva 2 mg are 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 1mg Tablet.

Cabergoline Teva 2mg Tablet.

Belgium: Cabergoline TEVA 1mg Tabletten

Cabergoline TEVA 2mg Tabletten

Germany: Cabergolin-TEVA 1mgTabletten

Cabergolin-TEVA 2mgTabletten

Luxembourg: Cabergoline TEVA 1mg comprimes

Cabergoline TEVA 2mg comprimes

This leaflet was last revised in2014-06-16