Document: leaflet MAH BRAND_PLPI 10383-0956 change

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• leaflet MAH BRAND_PLPI 10383-0956
• leaflet MAH BRAND_PLPI 15184-1423
• leaflet MAH BRAND_PLPI 18799-2334

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Dostinex® 0.5mg Tablets/Cabergoline 0.5mg Tablets

(Cabergoline)

In this leaflet

1)    What Dostinex is and what it is used for

2)    What you need to know before you take Dostinex

3)    How to take Dostinex

4)    Possible side effects

5)    How to store Dostinex

6)    Contents of the pack and other information

1)    What Dostinex is and what it is used for

-    Dostinex is used to stop breast milk production (lactation) soon after childbirth, stillbirth, abortion or miscarriage. It can also be used if you do not want to continue to breastfeed your baby once you have started.

-    Dostinex can also be used to treat other conditions caused by hormonal disturbance which can result in high levels of prolactin being produced. This includes high levels of prolactin caused by tumours of the pituitary gland in both men and women.

-    This medicine contains cabergoline and belongs to a class of medicines called ‘dopamine agonists'. Dopamine is produced naturally in the body and helps to transmit messages to the brain.

-    Cabergoline mimics the action of dopamine to reduce the production of prolactin in the blood. Prolactin is the hormone which stimulates the breast to produce milk.

-    Dostinex should only be used in adults. It is not suitable for children under the age of 16 years.

-    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 Dostinex

Do not take Dostinex

-    If you are hypersensitive (allergic) to cabergoline, to other medicines called ergot alkaloids, (e.g. pergolide, bromocriptine, lisuride, ergotamine or ergometrine) or to any of the other ingredients of this medicine (listed in section 6);

-    If you have severe liver disease;

-    If you have high blood pressure in pregnancy associated with swelling and protein in the urine (toxaemia of pregnancy);

-    If you are being treated with anti-psychotics or have a history of mental illness associated with child-birth (puerperal psychosis);

-    If you are pregnant or breastfeeding.

-    If you will be treated with Dostinex for a long period and have or had fibrotic reactions (scar tissue) affecting your heart.

Warnings and precautions

Talk to your doctor or pharmacist before taking Dostinex if you have or had

any of the following conditions:

-    Disease that involves the heart and blood vessels (cardiovascular disease);

-    Cold hands and feet (Raynaud's syndrome);

-    Gnawing pain in the abdomen when hungry (peptic ulcer) or bleeding from the stomach and intestines (gastrointestinal bleeding);

-    History of serious mental disease, particularly psychotic disorders.

Liver or kidney disease;

-    Kidney function abnormality;

-    Increased blood pressure after giving birth.

-    Fibrotic reactions (scar tissue) affecting your heart, lungs or abdomen. In case you are treated with Dostinex for a long period, your physician will check before starting treatment whether your heart, lungs and kidneys are in good condition. 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) or you are taking any medicines to lower your 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.

It is recommended that women on long term treatment with Dostinex for hormonal disorders should have regular gynaecological exams including smear tests. Your doctor will continue to monitor your medical condition while you are taking Dostinex tablets.

Other medicines and Dostinex

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

Some medicines can reduce the effectiveness of Dostinex, these include:

-    Medicines to lower your blood pressure;

-    Medicines used to treat mental illness (e.g. antipsychotic medicines like chlorpromazine, haloperidol);

-    Medicines for nausea and vomiting (e.g. domperidone, metoclopramide).

Some medicines can increase the amount of Dostinex in your blood and so could increase the side effects, these include:

-    Medicines for Parkinson's disease;

-    Medicines for severe migraine headaches (e.g. pergolide, bromocriptine, lisuride, ergotamine, dihydroergotamine, ergometrine or methysergide);

-    Antibiotics (e.g. erythromycin).

Dostinex with food and drink

Please see section 3 for details.

Pregnancy

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. You should also take care not to become pregnant for at least one month once you have stopped taking this medicine.

Dostinex can result in congenital abnormalities if you use it during pregnancy.

Breast-feeding

As Dostinex will stop you producing milk for your baby, you should not take this medicine if you plan to breast-feed. If you need to take Dostinex you should use another method of feeding your baby.

Driving and using machines

Dostinex can cause drowsiness (somnolence) and sudden sleepy episodes, in some cases without any warning signs or awareness. You are advised not to drive or operate machines or engage in activities requiring mental alertness or coordination during treatment with this medicine. Your doctor will decide if you can continue treatment on Dostinex if this occurs.

Dostinex contains lactose

Lactose is a type of sugar, if you have been told you have an intolerance to sugars, consult your doctor before you take this medicine.

3) How to take Dostinex

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

It is recommended you take Dostinex with or after food to help reduce feelings of nausea or vomiting.

•    To prevent milk production (lactation): You should take 1 mg (two 0.5 mg tablets) on the first day after delivery.

•    To stop lactation once you have started to breastfeed: You should take 0.25 mg (one half of Dostinex 0.5 mg tablet) every 12 hours for two days.

•    To reduce prolactin levels in other conditions: You should initially take one 0.5 mg tablet (to be taken in two doses) spread out over a week (e.g. half a tablet on Monday and the other half of the tablet on Thursday). Your dose will be increased up to a maximum dose of 4.5 mg or until you have responded fully to treatment.

When you first start taking the tablet, it is recommended you slowly change position when trying to sit, stand or lie down, this is because this medicine may cause a drop in blood pressure that could make you dizzy when you move from a position. It is also recommended that you avoid alcohol and other medicines that cause drowsiness as this could increase the risk of dizziness.

During treatment your doctor may need to check your blood pressure, particularly in the first few days of treatment. A gynaecological assessment may also be carried out on the cells of your cervix or womb lining.

If you take more Dostinex than you should

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

If you forget to take Dostinex

If you forget to take a dose take the next one as normal and tell your doctor if you have trouble remembering to take your tablets. Do not take a double dose to make up for a forgotten dose.

If you stop taking Dostinex

Your doctor will advise you how long to take Dostinex.

You should not stop until your doctor tells you.

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 after taking this medicine.

These symptoms can be severe:

•    Abnormal or unusual thoughts.

•    Heart valve and related disorders e.g. inflammation (pericarditis) or leaking of fluid in the pericardium (pericardial effusion). This is a very common side effect (may affect more than 1 in 10 people). The early symptoms may be one or more of the following: difficulty breathing, shortness of breath, pounding heart, feeling faint, chest pain, back pain, pelvic pain or swollen legs. These may be the first signs of a condition called pulmonary fibrosis, which can affect the lungs, heart/heart valves or lower back.

•    Development of a widespread itchy rash, difficulty breathing with or without wheezing, feeling faint, unexplained swelling of the body or tongue or any other symptoms which appear to come on rapidly after taking this medication and make you feel unwell. These may be indicative of an allergic reaction.

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.

•    Aggression and 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.

During treatment you may also notice the following effects:

•    Very common (may affect more than 1 in 10 people) drowsiness, nausea, headache, dizziness, vertigo, stomach pain, indigestion, inflamed stomach lining, fatigue, lack of bodily strength, weakness.

•    Common (may affect up to 1 in 10 people) constipation, blurred vision, low blood pressure after childbirth which may not have any symptoms, breast pain, depression, sleep disturbances, excessive daytime drowsiness/sleepiness, vomiting, low blood pressure, hot flushes.

•    Uncommon (may affect up to 1 in 100 people) loss of hair, severe itching, shortness of breath, fainting, nosebleed, leg cramps, swelling due to accumulation of fl uid in the tissues (oedema), rash, irregular or strong heartbeat (palpitations), pins and needles sensation, decrease in haemoglobin in women whose periods had stopped and then re-started, temporary partial vision loss.

•    Rare (may affect up to 1 in 1000 people) allergic skin reactions, muscle weakness, cold hands and feet.

•    Not known (frequency cannot be estimated from the available data) abnormal liver and abnormal blood tests of liver function, breathing problems with inadequate intake of oxygen, an increase in the level of some enzymes in the blood, abnormal vision, episodes of sudden sleep onset, seeing or hearing things that are not really there (hallucinations), delusions, psychotic disorder.

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 Dostinex.

•    Keep all medicines out of the sight and reach of children.

•    Do not take this medicine after the expiry date (This is printed on the carton or bottle label).

•    Do not store above 25 °C.

•    Your Dostinex 0.5mg Tablets should always be kept in the bottle. It is important that the desiccant is not removed from the cap.

•    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 Dostinex contains

Each tablet contains 0.5mg cabergoline.

Each tablet also contains lactose and leucine.

What Dostinex looks like and the contents of the pack

Each tablet is white, capsule-shaped, and is coded ‘P breakline U' on one side and ‘700 with a short score' on the reverse.

Dostinex Tablets are available in packs of 8 tablets in an amber glass bottle.

PL 10383/0956    |pOM

Who makes and repackages your medicine:

Your medicine is manufactured by PFIZER ITALIA S.R.L 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: 03.07.2014

Dostinex is a trade mark of the Pfizer group of companies