Cabaser 1 mg tablets – patient leaflet, side effects, dosage

1. What Cabaser is and what it is used for

Cabaser contains the active substance cabergoline. This medicine belongs to a group of medicines called dopamine agonists.

This medicine is used to treat the symptoms of Parkinson’s disease in adults.

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.

Cabergoline 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.

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 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 fi brotic disorders (scar tissue) affecting your heart valves.
• If you have been told you have a problem affecting your heart valves.
• If you have a history of abdominal, respiratory or cardiac fi brotic (scar 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
• 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. An echocardiogram (an ultrasound test of the heart) will be taken before treatment is started and at regular intervals during treatment. If fi brotic reactions occur treatment will have to be discontinued.

Low blood pressure (postural hypotension) can occur following administration of this medicine, particularly during the fi rst 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

See section 3 ‘How to take Cabaser’.

Pregnancy, breast-feeding and fertility

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). If you need to take Cabaser you should use another method of feeding your baby.

Driving and using machines

Cabaser can cause drowsiness (somnolence) and sudden sleepy episodes, in some cases without any warning signs or awareness. 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 by your doctor 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 fi nds a suitable dose to control your symptoms. Cabergoline should be taken as a single daily dose. You should not take more than 3 mg of this medicine in one day.

If you take more Cabaser than you should

If you take too many tablets, contact your doctor immediately or go to the nearest hospital A&E department. Symptoms of overdose may include nausea, vomiting, gastric complaints, low blood pressure when standing, confusion/psychosis or hallucinations.

Cabaser^® 1 mg and 2 mg Tablets

cabergoline

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. infl ammation (pericarditis) or leaking of fl uid in the pericardium (pericardial effusion). The early symptoms may be one or more of the following: diffi culty breathing, shortness of breath, palpitations (pounding heart), feeling faint, chest pain, back pain, pelvic pain or swollen legs. These may be the fi rst signs of a condition called fi brosis, 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:

  o Strong impulse to gamble excessively despite serious personal or family consequences

  o Altered or increased sexual interest and behaviour of signifi cant concern to you or to others, for example, an increased sexual drive

  o Uncontrollable excessive shopping or spending

  o 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), swelling of the feet and ankles due to accumulation of fl uid in the tissues
• Common: may affect up to 1 in 10 people: Being sick (vomiting), indigestion, stomach pain, infl amed stomach lining, constipation, involuntary or uncontrolled movements of the limbs, low blood pressure, sudden drop in blood pressure on standing, hallucinations, sleep disturbances, increased libido, confusion, headache, dizziness, drowsiness, vertigo, lack of bodily strength, weakness, chest pain (angina), diffi culty breathing, abnormal blood tests for liver function, decreased haemoglobin and/or red blood cells
• Uncommon: may affect up to 1 in 100 people: Hypersensitivity reactions, rash, severe burning pain and skin redness in the hands and feet, swelling due to accumulation of fl uid in the tissues (oedema), muscle spasms, fatigue, delusions, psychotic disorder, abnormal liver function
• Not known: frequency cannot be estimated from the available data: Respiratory disorder, respiratory failure, pleuritis (infl ammation of the linings around the lungs), chest pain, abnormal vision, suddenly falling asleep, fainting, tremor, aggressive behaviour, hair loss, leg cramps, cold hands and feet, 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 or pharmacist. This includes any possible side effects not listed in this leafl et. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 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

What Cabaser contains

• The active substance is cabergoline. Each tablet contains 1 mg or 2 mg cabergoline.
• The other ingredients are lactose and leucine (see section 2 ‘Cabaser contains lactose’).

What Cabaser looks like and contents of the pack

Cabaser tablets are white, oval and concave with one side scored and engraved with 7/01 for 1 mg tablets and 7/02 for 2 mg tablets.

The tablets are contained in either amber glass bottles with an aluminium tamper-evident screw cap or high-density polyethylene bottles with a child-resistant polypropylene cap. The caps of both bottles contain a silica gel insert.

Each bottle contains 20 or 30 tablets and is enclosed in an outer cardboard carton.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Pfi zer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

Manufacturer

Pfi zer 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 Pfi zer Limited, Walton Oaks, Tadworth, Surrey, KT20 7NS; Tel 01304 616161.

This leafl et was last revised in 01/2018.

Ref: CA 18_0