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Cabergoline 1mg Tablets

Document: leaflet MAH BRAND_PLPI 10383-0980 change

Cabaser® 1mg Tablets/Cabergoline 1mg Tablets Cabaser® 2mg Tablets/Cabergoline 2mg Tablets

(cabergoline)

Your medicine is known by either of the above names, but will be referred to as Cabaser throughout the following:

Patient Information Leaflet

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 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

Cabaser is used to treat the symptoms of Parkinson's disease.

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.

Cabergoline belongs to a group of medicines called dopamine agonists.

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

2)    What you need to know before you take Cabaser 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.

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.

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).

Side-effects may be increased by other medicines, these include:

•    Antibiotics (e.g. erythromycin).

•    Drugs used for migraines (e.g. ergotamine).

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.

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.

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.

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.

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 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.

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 behaviours; they will discuss ways of managing or reducing the symptoms.

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.

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 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 all medicines out of the sight and reach of children.

•    Do not use Cabaser after the expiry date which is printed on the carton or the bottle label 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.

•    If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

•    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 What Cabaser contains

-    The active substance is Cabergoline.

Each tablet contains either 1mg or 2mg cabergoline.

-    The other ingredients are anhydrous lactose and leucine.

What Cabaser looks like and the contents of the pack

1mg Tablet: Each Tablet is white, oval-shaped, and is coded ‘7 breakline 01' on one side and plain on the reverse.

2mg Tablet: Each Tablet is white, oval-shaped, and is coded ‘7 breakline 02' on one side and plain on the reverse.

The tablets are packed in glass bottles of 20 tablets. Each bottle has a special cap which absorbs moisture.

PL No: 10383/0980    Cabaser 1mg Tablets/Cabergoline 1mg Tablets

PL No: 10383/0981    Cabaser 2mg Tablets/Cabergoline 2mg Tablets

Who makes and repackages your medicine:

Your medicine is manufactured by Pfizer Italia S.r.l., Localita Marino del Tronto, 63100 Ascoli Piceno, Italy. Procured from within the EU and repackaged by the Product Licence holder: Primecrown Ltd., 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

Leaflet date: 14.08.2015

Cabaser is a trade mark of the Pfizer group of companies