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CABASER 2 MG TABLETS

Active substance(s): CABERGOLINE

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Package leaflet: Information for the patient

If you forget to take Cabaser
If you forget to take your medicine at the usual time, take it as soon as you
remember then continue as usual. Do not take a double dose to make up
for a forgotten dose.

Cabaser 1 mg and 2 mg tablets

If you stop taking Cabaser
Your doctor will advise you how long to take Cabaser. Your condition may
return if you stop taking Cabaser before you are advised.

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.

If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

®

cabergoline

4. Possible side effects
Like all medicines, this medicine can cause side-effects, although not everybody
gets them.
Tell your doctor immediately if you experience any of the following
symptoms. These symptoms can be severe:
• Very common side effect (may affect more than 1 in 10 people) heart
valve and related disorders e.g. 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,
palpitations (pounding heart), feeling faint, 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.

What is in this leaflet
1. What Cabaser is and what it is used for
2. What you need to know before you take Cabaser
3. How to take Cabaser
4. Possible side effects
5. How to store Cabaser
6. Contents of the pack and other information
1. What Cabaser is and what it is used for

You may experience the following side effects
Cabaser is used to treat the symptoms of Parkinson’s disease.

Cabergoline belongs to a group of medicines called dopamine agonists.

• 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).

You must talk to a doctor or pharmacist if you do not feel better or if you
feel worse.

Tell your doctor if you experience any of these behaviours; they will
discuss ways of managing or reducing the symptoms.

2. What you need to know before you take Cabaser

Other side-effects that may occur are:
• Very common (may affect more than 1 in 10 people) Feeling sick (nausea)
• Common (may affect up to 1 in 10 people) Being sick (vomiting), indigestion,
stomach pain, inflamed stomach lining, constipation, involuntary or uncontrolled
movements of the limbs, hallucinations, sleep disturbances, increased
sexual energy, confusion, headache, dizziness, drowsiness, suddenly falling
asleep, vertigo, lack of bodily strength, weakness, chest pain (angina),
abnormal blood tests for liver function.
• Uncommon (may affect up to 1 in 100 people) Severe burning pain and skin
redness in the hands and feet, low blood pressure, sudden drop in blood
pressure on standing, swelling of the feet and ankles due to accumulation
of fluid in the tissues, fatigue, delusions, psychotic disorder.
• Not known (frequency cannot be estimated from the available data)
Abnormal vision, aggressive behaviour, hair loss, leg cramps, an increase
in the level of some enzymes in the blood.

It is used after your doctor has tried other treatments that have not worked
or for people who are already taking other medicines for this illness to help
control other symptoms.
This medicine contains cabergoline which acts in a similar way to a chemical
in the body called dopamine. Patients with Parkinson’s disease do not have
enough of this chemical.

Do not take Cabaser
• If you are allergic (hypersensitive) to cabergoline, to other medicines called
ergot alkaloids or any of the other ingredients of this medicine (listed in
section 6).
• If you will be treated with Cabaser for a long period and have or had
fibrotic reactions (scar tissue) affecting your heart.
• If you have been told you have a problem affecting your heart valves.
• If you have a previous history of respiratory or cardiac disorders linked to
fibriotic tissue disorders.
Warnings and precautions
Talk to your doctor or pharmacist before taking Cabaser if you have or had
any of the following conditions:
• Heart disease.
• Raynaud’s syndrome (causing cold hands and feet).
• Severe chest problems (such as pleurisy).
• Liver disease.
• Stomach ulcer, or bleeding from the stomach and intestines.
• Mental illness, in particular psychotic disorders.
• Low blood pressure (postural hypotension) or you are taking any medicines
to lower your blood pressure.
• Fibrotic reactions (scar tissue) affecting your heart, lungs or abdomen.
In case you are treated with Cabaser for a long period, your physician will
perform checks of your heart, lungs, kidneys and blood to determine if
this medicine is suitable for you. 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.
Low blood pressure (postural hypotension) can occur following administration
of this medicine, particularly during the first few days. Care should be taken
when taking Cabaser with other drugs known to lower blood pressure.
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.

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Cabaser
Keep this medicine out of the sight and reach of children.
Do not store above 25 °C.
Do not use this medicine after the expiry date which is stated on the singledose bottle label and the carton after EXP. The expiry date refers to the last
day of that month.
Cabaser tablets absorb moisture, so you should always replace the cap after
taking out your tablets. Do not remove the special granules from the cap,
and do not transfer your tablets to another container.
Do not throw away any medicines via wastewater or household waste. Ask
your 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

Other medicines and Cabaser
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines, including medicines obtained without a
prescription.

What Cabaser contains

The effectiveness of Cabaser can be reduced by some medicines, these
include:
• Drugs used to treat mental illness (e.g. phenothiazines, butyrophenones,
thioxanthenes).
• Drugs used to treat sickness (e.g. metoclopramide).

What Cabaser looks like and contents of the pack
Cabaser tablets are white, oval and concave with one side scored and engraved.

- The active substance is cabergoline.
- The other ingredients are lactose and leucine.

The engraving is 7/01 for 1 mg tablets and 7/02 for 2 mg tablets.
The tablets are packed in glass bottles of 20. Each bottle has a special cap
which absorbs moisture.

Side-effects may be increased by other medicines, these include:
• Antibiotics (e.g. erythromycin).
• Drugs used for migraines (e.g. ergotamine).

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer

Cabaser with food and drink
Please see section 3 for details.
Pregnancy
You are advised to use adequate contraception while you are taking this
medicine.
If you are pregnant, think you may be pregnant, or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.
Breast-feeding
Tell your doctor if you are breast-feeding. You should not breast-feed while
taking this medicine as this medicine may affect milk production (lactation).
Driving and using machines
Cabaser can cause drowsiness (somnolence) and sudden sleepy episodes.
Do not drive, use any tools or machines or engage in activities requiring
mental alertness or coordination if you experience these symptoms until
they have resolved completely.
Cabaser contains lactose
Lactose is a type of sugar, if you have been told that you have an intolerance
to some sugars, contact your doctor before taking this medicinal product.

Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
Manufacturer
Pfizer Italia S.r.l.
Marino Del Tronto
63100, Ascoli Piceno (AP)
Italy
Company Contact Address
For any information about this medicine, please contact Medical Information
at Pfizer Limited, Walton Oaks, Tadworth, Surrey, KT20 7NS; Tel 01304 616161.
This leaflet was last revised in 04/2015
Ref: CA 14_0

3. How to take Cabaser
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
The usual starting dose of Cabaser is 1 mg daily, preferably taken after food
to reduce the side-effects. Your doctor may then increase the dose until he
finds a suitable dose to control your symptoms. You should not take more
than 3 mg of this medicine in one day.
If you take more Cabaser than you should
If too many tablets are taken by accident, contact your doctor at once or
go to the nearest hospital casualty department.
4207645.02.6

4207645.02.6

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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