Patient leaflet - Cabergoline 1 mg tablets

1. What Cabergoline is and what it is used for

Cabergoline 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 Cabergoline

Do not take Cabergoline:

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 Cabergoline for a long period and have or had fibrotic 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 fibrotic (scar tissue) disorders.

Warnings and precautions

Talk to your doctor or pharmacist before taking Cabergoline 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 Cabergoline 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 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 Cabergoline 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 Cabergoline

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 Cabergoline 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)

Cabergoline with food and drink

See section 3 ‘How to take Cabergoline’.

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 Cabergoline you should use another method of feeding your baby.

Driving and using machines

Cabergoline 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.

Cabergoline 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 Cabergoline

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 Cabergoline 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. 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 Cabergoline 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.

If you forget to take Cabergoline

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 Cabergoline

Your doctor will advise you how long to take Cabergoline. Your condition may return if you stop taking Cabergoline 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.

225 x 290 mm Package leaflet: Information for the patient Cabergoline 1 mg and 2 mg Tablets

Cabergoline

QR Code 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:
o Strong impulse to gamble excessively despite serious personal or family
consequences
o Altered or increased sexual interest and behaviour of significant 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 fluid in the tissues
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, 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), difficulty 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 fluid 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 (inflammation 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 leaflet. 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 Cabergoline

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage condition.

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.

Cabergoline 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 Cabergoline contains

The active substance is cabergoline. Each tablet contains 1 mg or 2 mg
cabergoline.
- The other ingredients are lactose, l-leucine and magnesium stearate (see section 2 ‘Cabergoline contains lactose’).

What Cabergoline looks like and contents of the pack

Cabergoline 1 mg tablets are 7.5 × 4 mm, oval shaped, white coloured tablets, having scored on one side ‘c’ on left, ‘2’ on right and plain on other side.

Cabergoline 2 mg tablets are 10 × 5 mm, oval shaped, white coloured tablets, having scored on one side ‘c’ on left, ‘3’ on right and plain on other side.

The tablets are contained in high-density polyethylene bottles with a child-resistant polypropylene cap and silica gel pillow packs inside.

Each bottle contains 20, 30 or 100 tablets and is enclosed in an outer cardboard carton.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Renata (UK) Limited

Greenway Business Centre

Harlow Business Park, Harlow

CM19 5QE

United Kingdom

Manufacturer:

Crescent Pharma Limited

Key house, Sarum Hill

Basingstoke, RG21 8SR