Cabergoline 2 Mg Tablets
CABERGOLINE 2MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
Cabergoline Tablets are available in the following strengths: 1mg and 2mg. Cabergoline 2mg Tablets will be referred to as Cabergoline throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
■ 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
■ If any of the side effects gets serious or if you notice any side effects not listed in this information leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Cabergoline is and what it is used for
2. Before you take Cabergoline
3. How to take Cabergoline
4. Possible side effects
5. How to store Cabergoline
6. Further information
1. What Cabergoline is and what it is used for
Cabergoline belongs to a group of medicines known as dopamine agonists. Cabergoline 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 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. Before you take Cabergoline
DO NOT take Cabergoline if you:
■ are hypersensitive to cabergoline or other ergot alkaloids (e.g. bromocriptine), or to any of the other ingredients in Cabergoline
■ 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
■ are pregnant or breastfeeding
■ have previously experienced side effects affecting lung, such as fibrosis, associated with the use of dopamine agonists (e.g. bromocriptine, pergolide)
■ will be treated with Cabergoline for a long period and have or had fibrotic reactions (scar tissue) affecting your heart.
Take special care with Cabergoline
If you have any of the following health problems you must inform your doctor before taking Cabergoline 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
■ liver or kidney disease
■ history of serious mental disease, particularly psychotic
disorders
■ Raynaud's disease (when it is cold the fingers and toes become bluish white, with no pulse, cold, insensitive and numb)
■ low blood pressure or you are taking medicines to lower blood pressure
■ increased blood pressure after giving birth
■ serious chest complaint (e.g. pain in the chest when breathing, fluid in the lungs, inflammation or infection of the lungs)
■ if you have ever been diagnosed in the past with a problem known as fibrotic disease (scar tissue) affecting the lungs, lower back and kidneys or heart.
In case you are treated with Cabergoline for a long period, your doctor will check before starting treatment whether your heart, lungs and kidneys are in a 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.
Use of Cabergoline has been associated with pathologic gambling, increased libido and hypersexuality.
The effect of alcohol on the tolerability of cabergoline is unknown. Infertility can be reversed in women taking Cabergoline, and pregnancy can occur before the menstrual cycle has normalised. Suitable means of contraception should therefore be used during treatment if necessary.
It is recommended that women on long term treatment with Cabergoline for hormonal disorders should have regular gynaecological exams including smear tests. Your doctor will continue to monitor your medical condition while you are taking Cabergoline tablets.
The safety and efficacy of Cabergoline has not been established in subjects less than 16 years of age.
Taking other medicines
■ 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, can interfere with the effects of cabergoline.
The treating doctor should therefore be aware of such concomitant medication.
■ There are other medicines such as other ergot alkaloids, medicines to prevent vomiting (metoclopramide), medicines for reducing high blood pressure, and macrolide antibiotics (such as erythromycin) that may affect the activity and tolerability of Cabergoline.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicinal products, including those obtained without a prescription and natural medical products/natural products.
Taking Cabergoline with food and drink
■ Cabergoline should be taken by mouth, preferably with meals.
Pregnancy
■ There is only limited experience of the use of Cabergoline during pregnancy. You should therefore consult your doctor if you are pregnant or plan to become pregnant before the treatment is started.
■ If you are being treated with Cabergoline 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 should not be taken by mothers who intend to breast feed as it prevents lactation. Nursing mothers should note that the quantity of milk can diminish.
Driving and using machines
■ Cabergoline 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 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.
Important information about some of the ingredients of Cabergoline
■ Cabergoline 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
Always take Cabergoline exactly as your doctor has told you. You should 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 0.5-1mg 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 2mg up to 3mg cabergoline daily.
Cabergoline 1mg and 2mg Tablets have a score and can be divided into two equal halves.
When you first start taking the tablet, it is recommended you slowly change position when trying to sit, stand or lie down, this is because Cabergoline may cause a drop in blood pressure that could make you dizzy when you move from a position. It is also recommended that you avoid alcohol and other medicines that cause drowsiness as this could increase the risk of dizziness.
During treatment your doctor may need to check your blood pressure, particularly in the first few days of treatment. A gynaecological assessment may also be carried out on the cells of your cervix or womb lining.
If you take more Cabergoline 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 or if 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
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
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 further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Cabergoline can cause side effects, although not everyone gets them.
When used for stopping the production of breast milk approximately 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.
Tell your doctor immediately if you experience any of the following symptoms after taking this medicine. These symptoms can be severe:
■ abnormal or unusual thoughts
■ heart valve and related disorders e.g. inflammation (pericarditis) or leaking of fluid in the pericardium (pericardial effusion). This is a very common side effect (occurring in more than 1 in 10 patients). The early symptoms may be one or more of the following: difficulty breathing, shortness of breath, pounding heart, feeling faint, chest pain, back pain, pelvic pain or swollen legs. These may be the first signs of a condition called pulmonary fibrosis, which can affect the lungs, heart/heart valves or lower back.
■ 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. These may be indicative of an allergic reaction.
■ strong impulse to gamble despite serious personal or family consequences.
■ aggression and increased sexual drive, which is of significant concern to the individual or to others.
During treatment you may also notice the following side effects:
Very common side effects (occur in more than 1 in 10 users):
■ dizziness/vertigo, headache, nausea, stomach pain, indigestion, inflammation of the stomach lining (gastritis), asthenia/fatigue (tiredness).
Common side effects (occur in more than 1 in 100 users):
■ low blood pressure (which can result in dizziness), depression, sleep disturbances, excessive daytime sleepiness, blurred vision, vomiting, constipation, breast pain, hot flushes, low blood pressure after childbirth which may not have any symptoms.
Uncommon side effects (occur in fewer than 1 in 100 users):
■ changes in vision, nosebleeds, cramps in the fingers and calves, fainting, crawling/prickling sensations in the body, temporary partial loss of vision, palpitations (irregular or strong heartbeat), low haemoglobin values in blood, fibrosis of the lung, pleural effusion (excess fluid in the space around the lung).
Rare side effects (occur in fewer than 1 in 1000 users):
■ pain in the upper central abdomen.
Not known (cannot be estimated from the available data):
■ abnormal vision.
Development of 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.
Cabergoline has been linked with somnolence and sudden sleep attacks.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Cabergoline
Keep out of the reach and sight of children.
Do not use the tablets after the expiry date indicated on the package.
Store in the original package in order to protect from moisture. The drying capsule with silica gel must not be removed from the bottle.
If your doctor decides to stop treatment, return any remaining tablets to your pharmacist for safe disposal. Only keep them if your doctor tells you to.
If the tablets become discoloured or show any signs of deterioration, you should seek the advice of your pharmacist. 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. Further information
What Cabergoline contains
The active substance is cabergoline. Each tablet contains 2mg cabergoline.
The other ingredients are: lactose anhydrous, magnesium stearate and L-leucine.
What Cabergoline looks like and contents of the pack
The tablets are white, oval, flat with bevelled edges, with a score line on both sides. One side is debossed with 'CBG' and '2' on either side of the score line.
Cabergoline is available in bottles of 20 tablets.
Manufacturer
Cabergoline is manufactured by: TEVA Czech Industries s.r.o., Ostravska 29, c.p. 305, 747 70 Opava-Komarov, Czech Republic or
RPG Life Sciences Ltd., 310A G.I.D.C. Estate, Ankleshwar,
Gujarat, India.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0339 POM
Leaflet revision date: 08.06.12
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