DOSTINEX 0.5 MG TABLETS, CABERGOLINE 0.5 MG TABLETS - patient leaflet, side effects, dosage

Patient leaflet - DOSTINEX 0.5 MG TABLETS, CABERGOLINE 0.5 MG TABLETS

J^Bwhat Dostinex is and what it is used for

Dostinex contains the active ingredient cabergoline. This medicine belongs to a class of medicines called ‘dopamine agonists’. Dopamine is produced naturally in the body and helps to transmit messages to the brain.
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 breast-feed 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 lack of periods, infrequent and very light menstruation, periods in which ovulation does not occur and secretion of milk from your breast without breast-feeding. Also in conditions in which high levels of prolactin are due to unknown causes (idiopathic hyperprolactinaemia) or are caused by tumours of the pituitary gland in both men and women.
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.

r^Hwhat you need to know before you take Dostinex

Do not take Dostinex:

If you are 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 breast-feeding
If you will be treated with Dostinex for a long period and have stiff and inflamed heart valves (cardiac valvulopathy)
If you have had fibrotic reactions (scar tissue) affecting your abdomen, heart or lungs.

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
Reduced liver function
Kidney function abnormality or kidney disease
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. They 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.

If you have just given birth you may be more at risk of certain conditions. These may include high blood pressure, heart attack, convulsion, stroke or mental health problems. Therefore, your doctor will need to check your blood pressure regularly during the treatment. Speak immediately to your doctor if you experience high blood pressure, chest pain or unusually severe or persistent headache (with or without vision problems).

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 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

See section 3 ‘How to take Dostinex’.

Pregnancy, breast-feeding and fertility 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. If you become pregnant during treatment with Dostinex, stop taking Dostinex and inform your doctor who will then monitor your pregnancy as 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 breastfeed. 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

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 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 per week or until you have responded fully to treatment. The maximum dose should not exceed 3 mg per day.

Dostinex® 0.5mg Tablets

(cabergoline)

Patient Information Leaflet (continued)

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.

^■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, hypersensitivity reaction, shortness of breath, fainting, nosebleed, leg cramps, swelling due to accumulation of fluid 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, cold hands and feet.
Rare: may affect up to 1 in 1000 people: pain in the stomach.
* 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, chest pain, tremor, 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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.

^HHow to store Dostinex

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C.
Keep container tightly closed in order to protect from moisture.
Do not take this medicine after the expiry date shown on the bottle, carton label and carton. If your doctor tells you to stop using this medicine, take any remaining medicine back to the pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
The bottle caps contain desiccant granules. Do not remove desiccant granules from the cap or transfer tablets to another container.
If your medicine becomes discoloured or shows any signs of deterioration, ask your pharmacist who will advise you what to do.
* Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

^■Contents of the pack and other information

What Dostinex contains

Each tablet contains 0.5mg cabergoline as the active ingredient. The other ingredients are lactose and leucine.

What Dostinex looks like and contents of the pack

Dostinex are flat, capsule-shaped, white tablets scored, with a letter P on one side of the score and letter U on the other side.

The other side of the tablet is marked “700”. The tablet can be divided into equal halves. Each bottle contains 8 tablets and is enclosed in an outer cardboard carton. The capsules are packed in a white HDPE container with a white polypropylene child resistant cap, an activated slica gel desiccant, within the HDPE canister is included in each bottle.

Manufacturer and Licence Holder:

This medicine is manufactured by Pfizer Italia S.r.L, Localita Marino del Tronto –63100 Ascoli Piceno (AP), Italy and procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

POM PL 15184/1423

Dostinex is a registered trademark of Pfizer Italia S.r.l.

Revision date: 24/06/2021

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: 01527 505414 to obtain the leaflet in a format suitable for you

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is called Cabergoline 0.5mg Tablets but will be referred to as Cabergoline throughout this Patient Information Leaflet.

What is in this leaflet

What Cabergoline is and what it is used for

^2^B What you need to know before you take Cabergoline

^3^B How to take Cabergoline

j4^H Possible side effects

^5¹ How to store Cabergoline
[6¹ Contents of the pack and other information

jHWhat Cabergoline is and what it is used for

Cabergoline contains the active ingredient cabergoline. This medicine 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 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 breast-feed your baby once you have started.
Cabergoline can also be used to treat other conditions caused by hormonal disturbance which can result in high levels of prolactin being produced. This includes lack of periods, infrequent and very light menstruation, periods in which ovulation does not occur and secretion of milk from your breast without breast-feeding. Also in conditions in which high levels of prolactin are due to unknown causes (idiopathic hyperprolactinaemia) or are caused by tumours of the pituitary gland in both men and women.
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 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.

^HWhat you need to know before you take Cabergoline

Do not take Cabergoline:

If you are 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 breast-feeding
If you will be treated with Cabergoline for a long period and have stiff and inflamed heart valves (cardiac valvulopathy)
If you have had fibrotic reactions (scar tissue) affecting your abdomen, heart or lungs.

Warnings and precautions

Talk to your doctor or pharmacist before taking Cabergoline 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
Reduced liver function
Kidney function abnormality or kidney disease
Increased blood pressure after giving birth
Fibrotic reactions (scar tissue) affecting your heart, lungs or abdomen. In case you are treated with Cabergoline for a long period, your physician will check before starting treatment whether your heart, lungs and kidneys are in good condition. They 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.

It is recommended that women on long term treatment with Cabergoline 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

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.

Some medicines can reduce the effectiveness of Cabergoline, these include: 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 Cabergoline 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).

Cabergoline with food and drink

See section 3 ‘How to take Cabergoline’.

Pregnancy, breast-feeding and fertility 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. If you become pregnant during treatment with Cabergoline, stop taking Cabergoline and inform your doctor who will then monitor your pregnancy as Cabergoline can result in congenital abnormalities if you use it during pregnancy.

Breast-feeding

As Cabergoline will stop you producing milk for your baby, you should not take this medicine if you plan to breastfeed. 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. 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 Cabergoline if this occurs.

Dostinex contains lactose

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.

It is recommended you take Cabergoline 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 Cabergoline 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 per week or until you have responded fully to treatment. The maximum dose should not exceed 3 mg per day.

Patient Information Leaflet (continued)

If you take more Cabergoline than you should

If you take too many Cabergoline 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 Cabergoline

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 Cabergoline

Your doctor will advise you how long to take Cabergoline. 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.

r^HPossible 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, hypersensitivity reaction, shortness of breath, fainting, nosebleed, leg cramps, swelling due to accumulation of fluid 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, cold hands and feet.
Rare: may affect up to 1 in 1000 people: pain in the stomach.
* 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, chest pain, tremor, 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

^5^B

How to store Cabergoline

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C.
Keep container tightly closed in order to protect from moisture.
Do not take this medicine after the expiry date shown on the bottle, carton label and carton. If your doctor tells you to stop using this medicine, take any remaining medicine back to the pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
The bottle caps contain desiccant granules. Do not remove desiccant granules from the cap or transfer tablets to another container.
If your medicine becomes discoloured or shows any signs of deterioration, ask your pharmacist who will advise you what to do.
* Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

^■Contents of the pack and other information

What Cabergoline contains

Each tablet contains 0.5mg cabergoline as the active ingredient. The other ingredients are lactose and leucine.

What Cabergoline looks like and contents of the pack

Cabergoline are flat, capsule-shaped, white tablets scored, with a letter P on one side of the score and letter U on the other side.

Manufacturer and Licence Holder:

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

POM PL 15184/1423

Revision date: 24/06/2021

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: 01527 505414 to obtain the leaflet in a format suitable for you

DOSTINEX 0.5 MG TABLETS, CABERGOLINE 0.5 MG TABLETS - patient leaflet, side effects, dosage

Table of contents

Patient leaflet - DOSTINEX 0.5 MG TABLETS, CABERGOLINE 0.5 MG TABLETS

3 How to take Dostinex

(cabergoline)

Patient Information Leaflet (continued)

Patient Information Leaflet

3 How to take Cabergoline

Patient Information Leaflet (continued)

^5^B