Patient Information Leaflet

Cabaser® 1 mg

Cabaser® 2 mg

Cabaser® 4 mg

Cabergoline tablets

Please read this carefully before you use your medicine. This leaflet provides some useful information for you on your medicine. If you have any questions, or are not sure about anything, please ask your doctor or pharmacist.

Remember this medicine is for you. Only a doctor can prescribe it for you. Never give it to others. It may harm them, even if their symptoms are the same as yours.

What is in your medicine?

The name of your medicine is Cabaser 1 mg, 2 mg or 4 mg tablets. The active ingredient in Cabaser tablets is a substance called cabergoline. Each tablet contains either 1 mg, 2 mg or 4 mg cabergoline. The other ingredients are lactose and leucine. Cabaser tablets are packed in glass bottles with a special cap which absorbs any moisture. Each bottle of the 1 mg or 2 mg strength contains 20 tablets, each bottle of the 4 mg strength contains 16 tablets.

Cabaser is one of a group of medicines known as dopamine agonists.

What is your medicine for?

Cabaser is used to treat the symptoms of Parkinson's disease after your doctor has tried an alternative medicine. It is given to patients who are already taking other medicines for this illness that have levodopa in them to help control their symptoms better.

How does your medicine work?

Cabaser 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.

Before taking your medicine -

Make sure it is safe for you to take Cabaser. Before you are given Cabaser 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 you are taking Cabaser tablets.

(1) General

During treatment with cabergoline take special care when you drive or operate a machine. If you experience excessive drowsiness or even a sudden sleep onset episode, refrain from driving and operating machines, and contact your physician.

(2) Your doctor should know

• If you have ever had an allergic reaction after taking medicines known as ergot alkaloids before. These may be found in certain other medicines for Parkinson's disease or some medicines for migraine.
• If you are taking any medicines known as phenothiazines, butyrophenones or thioxanthenes (which may be found in certain tranquillisers), metoclopramide (given to stop you feeling sick), an antibiotic known as erythromycin, or any medicine to lower your blood pressure. Ask your doctor or pharmacist if you are unsure.
• If you have any liver problems, heart disease, a condition known as Raynaud's syndrome, a stomach ulcer, or if you have suffered from any mental illness.
• If you have had any serious chest complaint (such as pleurisy).
• If you are pregnant, or trying to become pregnant. Also tell your doctor if you are breastfeeding, since this medicine may affect lactation (milk production).
• If you have ever been diagnosed in the past with a problem known as fibrosis affecting the lungs, lower back and kidneys or heart, you must tell your doctor as Cabaser may not be appropriate for you.
• If you have ever been diagnosed with a problem affecting your heart or heart valves.

Taking your medicine

You should normally take your medicine once each day, preferably with a meal. You will usually start on a low dose of Cabaser (1 mg), which will then be slowly increased. Meanwhile, your doctor may tell you to reduce the dose of your other medicines. The usual maintenance dose of Cabaser is 2 to 6 mg daily. Your doctor will decide the best dose for you to continue on. The label on the bottle will tell you exactly how many tablets to take and how often. Sometimes your doctor may tell you to break the tablets in half so you can take the exact amount needed.

What side effects might happen while you are taking your medicine?

As with other similar medicines used to treat Parkinson's disease, Cabaser may cause some unwanted effects. These effects may include uncontrolled movements and confusion, or your senses may be disturbed. Some patients may suffer from sickness, indigestion, stomach pain, dizziness, somnolence (excessive drowsiness) and sudden sleep onset episodes. In rare cases some patients have developed chest problems, angina, or swelling of the feet or ankles.

Some patients may experience fibrosis affecting the lungs, heart/heart valves or lower back. Early symptoms may be one or more of the following - difficulty in breathing, shortness of breath, palpitations (pounding heart), feeling faint, chest, back or pelvic pain and swollen legs. If you begin to experience any one of these symptoms, you must tell your doctor immediately.

Some patients may experience failure to resist gambling impulses despite serious personal or family consequences. Some patients may suffer from increased sexual drive and a desire for sexual behavior which is of significant concern to the individual or to others. If you experience any of these symptoms, you must tell your doctor immediately.

If you find that this medicine slows your reactions, do not drive or work machinery until this effect wears off.

If you suffer from any other unwanted effects while taking this medicine please tell your doctor or pharmacist.

Storing your medicine

Keep your tablets at room temperature (below 25 °C), in a safe place where children cannot reach them. 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 use the tablets after the expiry date printed on the container.