DOSTINEX 0.5 MG TABLETS

Active substance: CABERGOLINE

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Dostinex® 0.5 mg Tablets

2595
04.04.14[2]

(Cabergoline)
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 available using the above name but will be referred to as
Dostinex throughout the following leaflet.
What is 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.

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.

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.

By reporting side effects you can help provide more information on the
safety of this medicine.

If you stop taking Dostinex
Your doctor will advise you how long to take Dostinex.
You should not stop until your doctor tells you.

5. HOW TO STORE DOSTINEX
Keep this medicine out of the sight and reach of children.
Do not store above 25 °C.
Keep the bottle tightly closed in order to protect from moisture.

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.

Do not use this medicine after the expiry date which is stated on the single
dose bottle label and the carton after EXP. The expiry date refers to the last
day of that month.
Dostinex 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.
If your tablets become discoloured or show any other signs of deterioration,
consult your doctor or pharmacist who will tell 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Dostinex contains
- The active substance is cabergoline
Each tablet contains 0.5 mg cabergoline
- The other ingredients are lactose anhydrous and leucine.
What Dostinex looks like and contents of the pack
Dostinex 0.5 mg Tablets are white, flat capsule-shaped with one side
scored engraved ‘P’ on the left and ‘U’ on the right and other side
engraved ‘700’.
The tablets are contained in amber glass bottles with tamper resistant
screw caps which contain silica gel desiccant.
Available in packsize of 8 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER:
Manufactured by Pfizer Italia S.r.l., Italy.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL No: 20636/2595

Leaflet revision and issue date (Ref) 04.04.14[2]
Dostinex is a trademark of Pfizer Italia S.r.l.

- 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 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.
- 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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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