DOSTINEX 500MCG TABLETS

S740-1 LEAFLET Dostinex 20130125

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PACKAGE LEAFLET: INFORMATION FOR THE USER

DOSTINEX 500 micrograms TABLETS (cabergoline)
Your medicine is known as Dostinex 500 micrograms Tablets but will be referred to as Dostinex throughout the following patient information leaflet. Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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.

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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. Taking other medicines: 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).

In this leaflet: 1. What Dostinex is and what it is used for 2. Before you take Dostinex 3. How to take Dostinex 4. Possible side effects 5. How to store Dostinex 6. Further 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 in the body. This includes high levels of prolactin caused by tumours of the pituitary gland in both men and women. Dostinex is an oral tablet that 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.

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Some medicines can increase the amount of Dostinex in your blood and so could increase the side effects, these include: Medicines for Parkinsons disease; Medicines for severe migraine headaches (e.g. pergolide, bromocriptine, lisuride, ergotamine, dihydroergotamine, ergometrine or methysergide); Antibiotics (e.g. erythromycin).

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Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking Dostinex with food and drink Dostinex should preferably be taken with or after food to help reduce the side effects. The effect of alcohol is unknown and should therefore be avoided. Pregnancy

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2. 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 in the tablet (see Section 6 for further information); You have severe liver disease; You have high blood pressure in pregnancy associated with swelling and protein in the urine (toxaemia of pregnancy); You are being treated with anti-psychotics or have a history of mental illness associated with child-birth (puerperal psychosis); You are pregnant or breastfeeding. You will be treated with Dostinex for a long period and have or had fibrotic reactions (scar tissue) affecting your heart.

If you are pregnant or planning to get pregnant, discuss this with your doctor before treatment. Before you can start using Dostinex check that you are not pregnant. You should also take care not to become pregnant for at least one month once you have stopped taking Dostinex. Breastfeeding As Dostinex will stop you producing milk for your baby, you should not take Dostinex if you plan to breastfeed. If you need to take Dostinex you should use another method of feeding your baby. Driving and using machinery 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 Dostinex. Your doctor will decide if you can continue treatment on Dostinex if this occurs. Important information on some ingredients of Dostinex Dostinex contains lactose (a type of sugar). If you have been told you have an intolerance to sugars, consult your doctor before you take Dostinex.

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Take special care with Dostinex: Tell your doctor if you have or had any of the following conditions to help him or her decide if Dostinex is suitable for you: Disease that involves the heart and blood vessels (cardiovascular disease); Cold hands and feet (Raynauds 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.

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3. HOW TO TAKE DOSTINEX 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 1mg (two 0.5mg tablets) on the first day after delivery. To stop lactation once you have started to breastfeed: You should take 0.25mg (one half of Dostinex 0.5mg tablet) every 12 hours for two days. To reduce prolactin levels in other conditions: You should initially take one 0.5mg 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 4.5mg or until you have responded fully to treatment.

During treatment you may also notice the following effects: Very common (occurring in more than 1 in 10 patients): drowsiness, nausea, headache, dizziness, stomach pain, indigestion, inflamed stomach lining; fatigue, rash, lack of bodily strength; weakness. Common (occurring in less than 1 in 10 of patients): 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 (occurring in less than 1 in 100 patients): Episodes of sudden sleep onset, loss of hair, severe itching, shortness of breath, fainting, nosebleed, leg cramps , irregular or strong heartbeat (palpitations), pins and needles sensation, decrease in haemoglobin in amenhorrheic women, temporary partial vision loss. Rare (occurring in less than 1 in 1000 of patients): allergic skin reactions, muscle weakness, cold hands and feet. Not known (cannot be estimated from the available data): swelling due to accumulation of fluid in the tissues, 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.







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 Dostinex 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 too many Dostinex: If you take too many Dostinex tablets, contact your doctor immediately or go to the nearest hospital casualty department. If you miss a dose of Dostinex: It is important not to miss your dose. If you miss 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 missed 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 how to take this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Dostinex can sometimes have 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 (occurring in more than 1 in 10 patients). 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.



If you get any of the above side effects, or notice any other side effects not listed in this leaflet, tell your doctor or pharmacist. 5. HOW TO STORE DOSTINEX KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Dostinex should always be kept in the bottle. It is important that the desiccant is not removed from the cap. Do not store above 25C. Do not use after the expiry date printed on the carton or bottle label. If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to. If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.





6. FURTHER INFORMATION What Dostinex contains Each tablet contains 500 micrograms of the active ingredient, cabergoline. Dostinex also contains the following: lactose and leucine.

What Dostinex looks like and contents of the pack Dostinex Tablets are white capsule-shaped tablet marked P U on one side and 700 on the other with a score line on both sides. Dostinex Tablets are available in amber glass bottles with a desiccant-containing tamper-evident metal screw cap containing 8 tablets. Product Licence holder Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX. Manufacturer This product is manufactured by Pharmacia Italia SpA, Via Milano 68, 20014 Nerviano, Italy. Pfizer Italia S.r.I., Localita Marino del Tronto 63100, Ascoli Piceno (AP), Italy. PL No: 19488/0740 PL No: 19488/0741 Leaflet revision date: 25 January 2013 Dostinex is a registered trade mark of Pharmacia Italia SpA, Italy.
S740-1 LEAFLET Dostinex 20130125



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 o 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)

POM

o o

Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.

S740-1 LEAFLET Cabergoline 20130125

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PACKAGE LEAFLET: INFORMATION FOR THE USER

CABERGOLINE 500 micrograms TABLETS
Your medicine is known as Cabergoline 500 micrograms Tablets but will be referred to as Cabergoline Tablets throughout the following patient information leaflet. Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. -

Fibrotic reactions (scar tissue) affecting your heart, lungs or abdomen. In case you are treated with Cabergoline Tablets 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 Cabergoline Tablets for hormonal disorders should have regular gynaecological exams including smear tests. Your doctor will continue to monitor your medical condition while you are taking Cabergoline Tablets. Taking other medicines: Some medicines can reduce the effectiveness of Cabergoline Tablets, 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). -

In this leaflet: 1. What Cabergoline Tablets are and what they are used for 2. Before you take Cabergoline Tablets 3. How to take Cabergoline Tablets 4. Possible side effects 5. How to store Cabergoline Tablets 6. Further information 1. WHAT CABERGOLINE TABLETS ARE AND WHAT THEY ARE USED FOR Cabergoline Tablets are 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. Cabergoline Tablets can also be used to treat other conditions caused by hormonal disturbance which can result in high levels of prolactin being produced in the body. This includes high levels of prolactin caused by tumours of the pituitary gland in both men and women. Cabergoline Tablets are oral tablets that contain cabergoline and belong 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. Cabergoline Tablets should only be used in adults. It is not suitable for children under the age of 16 years.

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Some medicines can increase the amount of Cabergoline Tablets in your blood and so could increase the side effects, these include: Medicines for Parkinsons disease; Medicines for severe migraine headaches (e.g. pergolide, bromocriptine, lisuride, ergotamine, dihydroergotamine, ergometrine or methysergide); Antibiotics (e.g. erythromycin).

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Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking Cabergoline Tablets with food and drink Cabergoline Tablets should preferably be taken with or after food to help reduce the side effects. The effect of alcohol is unknown and should therefore be avoided. Pregnancy If you are pregnant or planning to get pregnant, discuss this with your doctor before treatment. Before you can start using Cabergoline Tablets check that you are not pregnant. You should also take care not to become pregnant for at least one month once you have stopped taking Cabergoline Tablets. Breastfeeding As Cabergoline Tablets will stop you producing milk for your baby, you should not take Cabergoline Tablets if you plan to breastfeed. If you need to take Cabergoline Tablets you should use another method of feeding your baby. Driving and using machinery Cabergoline Tablets 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 Cabergoline Tablets. Your doctor will decide if you can continue treatment on Cabergoline Tablets if this occurs. Important information on some ingredients of Cabergoline Tablets Cabergoline Tablets contain lactose (a type of sugar). If you have been told you have an intolerance to sugars, consult your doctor before you take Cabergoline Tablets.

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2. BEFORE YOU TAKE CABERGOLINE TABLETS Do not take Cabergoline Tablets 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 in the tablet (see Section 6 for further information); You have severe liver disease; You have high blood pressure in pregnancy associated with swelling and protein in the urine (toxaemia of pregnancy); You are being treated with anti-psychotics or have a history of mental illness associated with childbirth (puerperal psychosis); You are pregnant or breastfeeding. You will be treated with Cabergoline Tablets for a long period and have or had fibrotic reactions (scar tissue) affecting your heart.

-

Take special care with Cabergoline Tablets: Tell your doctor if you have or had any of the following conditions to help him or her decide if Cabergoline Tablets are suitable for you: Disease that involves the heart and blood vessels (cardiovascular disease); Cold hands and feet (Raynauds 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.

-

3. HOW TO TAKE CABERGOLINE TABLETS It is recommended you take Cabergoline Tablets with or after food to help reduce feelings of nausea or vomiting. To prevent milk production (lactation): You should take 1mg (two 0.5mg tablets) on the first day after delivery. To stop lactation once you have started to breastfeed: You should take 0.25mg (one half of Cabergoline 0.5mg tablet) every 12 hours for two days. To reduce prolactin levels in other conditions: You should initially take one 0.5mg 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 4.5mg or until you have responded fully to treatment.

During treatment you may also notice the following effects: Very common (occurring in more than 1 in 10 patients): drowsiness, nausea, headache, dizziness, stomach pain, indigestion, inflamed stomach lining; fatigue, rash, lack of bodily strength; weakness Common (occurring in less than 1 in 10 of patients): 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 (occurring in less than 1 in 100 patients): Episodes of sudden sleep onset, loss of hair, severe itching, shortness of breath, fainting, nosebleed, leg cramps , irregular or strong heartbeat (palpitations), pins and needles sensation, decrease in haemoglobin in amenhorrheic women, temporary partial vision loss Rare (occurring in less than 1 in 1000 of patients): allergic skin reactions, muscle weakness, cold hands and feet. Not known (cannot be estimated from the available data): swelling due to accumulation of fluid in the tissues, 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







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 Cabergoline Tablets 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 too many Cabergoline Tablets: If you take too many Cabergoline tablets, contact your doctor immediately or go to the nearest hospital casualty department.



If you get any of the above side effects, or notice any other side effects not listed in this leaflet, tell your doctor or pharmacist. 5. HOW TO STORE CABERGOLINE TABLETS

If you miss a dose of Cabergoline Tablets: It is important not to miss your dose. If you miss 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 missed dose. If you stop taking Cabergoline Tablets: Your doctor will advise you how long to take Cabergoline Tablets. You should not stop until your doctor tells you. If you have any further questions on how to take this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Cabergoline Tablets can sometimes have 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 (occurring in more than 1 in 10 patients). 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.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Cabergoline Tablets should always be kept in the bottle. It is important that the desiccant is not removed from the cap. Do not store above 25C. Do not use after the expiry date printed on the carton or bottle label. If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to. If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.





6. FURTHER INFORMATION What Cabergoline Tablets contain Each tablet contains 500 micrograms of the active ingredient, cabergoline. Cabergoline Tablets also contain the following: lactose and leucine.

What Cabergoline Tablets look like and contents of the pack Cabergoline Tablets are white capsule-shaped tablet marked P U on one side and 700 on the other with a score line on both sides. Cabergoline Tablets are available in amber glass bottles with a desiccant-containing tamper-evident metal screw cap containing 8 tablets. Product Licence holder Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX. Manufacturer This product is manufactured by Pharmacia Italia SpA, Via Milano 68, 20014 Nerviano, Italy. Pfizer Italia S.r.I., Localita Marino del Tronto 63100, Ascoli Piceno (AP), Italy. PL No: 19488/0740 PL No: 19488/0741 Leaflet revision date: 25 January 2013
S740-1 LEAFLET Cabergoline 20130125



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 o 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)

POM

o o

Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms