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BROMOCRIPTINE 2.5 MG TABLETS

Active substance(s): BROMOCRIPTINE MESILATE / BROMOCRIPTINE MESYLATE

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Patient Information Leaflet

Parlodel 2.5 mg Tablets
(bromocriptine mesylate)
Read all of this leaflet carefully before you start taking this
medicine.
• 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. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
• In this leaflet, Parlodel 2.5 mg Tablets will be called Parlodel.
Your medicine is available in other strengths.
In this leaflet:
1. What Parlodel is for
2. Before you take Parlodel
3. How to take Parlodel
4. Possible side effects
5. How to store Parlodel
6. Further information
1. What Parlodel is for
Parlodel belongs to a group of medicines called dopamine agonists
and prolactin inhibitors.
It works by increasing the release of dopamine in the brain, which
treats diseases where you need more of this substance. It also works
by decreasing the release of prolactin and growth hormone in the
body, which treats diseases where you need less of these substances.
Parlodel may be used for:
• For the 1mg and 2.5mg strengths. Stopping breast milk production
for medical reasons only, and when you and your doctor have
decided that it is necessary. Parlodel should not routinely be used
to stop breast milk production. It should also not be used to relieve
symptoms of painful breast engorgement after giving birth if these
can be adequately treated with non-medical means (such as firm
breast support, ice application) and/or a painkiller.
• Treating fertility and period problems usually caused by not having
the right amount of prolactin. This includes polycystic ovary
syndrome (reduces prolactin levels)
• Treating non-cancerous tumours in the brain called prolactinomas
(reduces prolactin levels)
• Treating diseases where too much growth hormone is made,
which causes people to be very tall or to have large hands and
feet. This is called acromegaly (reduces growth hormone levels)
• Treating Parkinson’s Disease (increases dopamine levels).
2. Before You Take Parlodel
Do not take Parlodel if:
• You are allergic to bromocriptine mesilate or other ergot alkaloids
such as ergotamine
• You are allergic to any of the other ingredients in Parlodel (see
Section 6)
• You have high blood pressure
• You have ever had blood pressure problems during pregnancy or
after giving birth, such as eclampsia, pre-eclampsia, pregnancyinduced high blood pressure, high blood pressure after giving birth
• You have, or have ever had, heart disease, or other severe blood
vessel disease
• You have, or have ever had, fibrotic reactions (scar tissue)
affecting your heart
• You have, or have ever had, serious mental health problems
• You are breast-feeding.
If any of the above applies to you, talk to your doctor or pharmacist.
Warnings and precautions
Talk to your doctor before taking Parlodel if
• For the 1mg and 2.5mg strengths; you have just given birth as you
may be more at risk of certain conditions. These are very rare but
may include high blood pressure, heart attack, convulsions, stroke
or mental problems. Therefore your doctor will need to check your
blood pressure regularly during the first days of 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.
• You have, or have ever had stomach ulcers and bleeding
• You have liver disease
• You have, or have ever had a condition called fibrosis.
Fibrosis causes thickening and stiffening of the heart, lungs and
abdomen which can stop them working properly. Before you are
given Parlodel your doctor will check that your heart, lungs and
kidneys are in good condition. The doctor may also do an
ultrasound (an echocardiogram) of your heart for check for scar
tissue






You are pregnant or planning to become pregnant. If so, tell your
doctor immediately
You have recently given birth, had a miscarriage or an abortion
You have premenstrual problems or non-cancerous breast disease
You have a non-cancerous tumour. You may need a full medical
check-up first.

Do not give Parlodel to children under 7 years old.
Take special care with Parlodel
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, and abnormally high
sex drive or an increase in sexual thoughts or feelings. Your doctor
may need to adjust or stop your dose.
Tell your doctor if you are taking any of the following medicines:
• Any medicine used to change your blood pressure, such as
diuretics (‘water tablets’), beta-blockers, calcium channel blockers
or ACE inhibitors
• Ergot alkaloids such as ergometrine (used to stop blood loss after
giving birth) and ergotamine tartrate (used to treat migraines). This
is especially important if you have just given birth or had an
abortion
• Erythromycin or any other macrolide antibiotics (used to treat
infections)
• Azole anti-fungals (used to treat fungal infections)
• Protease inhibitors (used to treat HIV)
• Octreotide (used to treat growth disorders)
• Antipsychotics such as phenothiazines, butyrophenones,
thioxanthenes (used to treat mental disorders)
• Metoclopramide and domperidone (used to stop you feeling and
being sick)
• Any other medicine, including medicines obtained without a
prescription.
Taking Parlodel with food and drink
You must take this medicine with a meal.
Avoid drinking alcohol as it may make the side effects of this medicine
worse.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant or are planning to become
pregnant.
You must not breast-feed. This medicine stops or slows down your
breasts making milk.
Remember: Taking this medicine may increase or bring back your
chances of getting pregnant. If you do not wish to get pregnant, ask
your doctor for advice.
Driving and using machines
You must not drive or operate machines if you feel dizzy or faint. This
may mean you have low blood pressure.
This is most likely to happen in the first few days. You may also feel
very tired or suddenly fall asleep during the day whilst taking this
medicine, if this happens you should not drive.
Warnings about the ingredients in Parlodel
This medicine contains lactose which 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 medicine.
3. How To Take Parlodel
Always take Parlodel exactly as your doctor has told you.
Important:
Your doctor will choose the dose that is right for you or your
child. The dose will be shown clearly on the label that your
pharmacist puts on the medicine. If it does not, or you are not
sure, ask your doctor or pharmacist.
Remember: Always take this medicine with a meal.
Adults and Children between 7 and 17 years old:
For most diseases, your doctor will start you or your child on a low
dose of Parlodel, and then gradually increase the dose as necessary.
This will help the body adjust to the new medicine and stop you or your
child from getting so many side effects. You should always follow the
advice of your doctor about increasing the dose of the medicine.
As the dose changes, tablets and capsules may need to be taken
together to get to the right dose. You may also need to break the
tablets in half along the line down the middle. Your doctor or
pharmacist will tell you how to do this. Never break the capsules in half.

The maximum dose for children aged 7-12 years is 5 to 10 mg,
depending on the condition they are being treated for. The maximum
dose for children aged 13-17 years is 20 mg.
If you are a woman, your doctor will advise you when in your menstrual
cycle you should start to take this medicine.
The elderly:
If you are elderly, your doctor may suggest you take a slightly lower
dose than the usual adult dose. This is because you are more likely to
have kidney, liver and heart problems or be taking other medicines,
which will change how well Parlodel works.
Patients with liver problems:
Your doctor will tell you how much to take.
Medical check-ups
When you are taking this medicine, your doctor may ask you to come
for check-ups which may include:
• An ultrasound of your heart (an echocardiogram). This is to ensure
that your heart is working properly and to check for fibrotic
reactions. If fibrotic reactions occur, your doctor may stop your
treatment with Parlodel
• Blood pressure checks. This is important when you first start to
take this medicine
• If you are a woman and you have been taking Parlodel for a long
time you may have six monthly gynaecological exams and cervical
smear tests
• Eye sight checks
• If you are taking Parlodel for a disease involving a tumour, the
size, shape and type of tumour may be checked regularly.
If you take more Parlodel than you should
Do not take more Parlodel than you should. If you accidentally take too
much of your medicine, immediately tell your doctor or go to the
nearest hospital casualty department. Taking too much Parlodel may
make you feel or be sick, have a fever or become abnormally tired.
If you forget to take Parlodel
Do not take a double dose to make up for a forgotten dose. Simply
take the next dose as planned.
If you stop taking Parlodel
It is important to talk to your doctor if you want to stop taking your
medicine. If you stop suddenly, you may get withdrawal symptoms
including confusion, a reduced attention span and stiffness.
If you have any further questions about taking this medicine, ask your
doctor or pharmacist.
4. Possible Side Effects
Like all medicines, Parlodel can cause side effects, although not
everybody gets them.
Seek immediate medical help if you have any of the following
symptoms:
• You have a headache which does not go away, or is severe
• You get any problems with your eyesight after giving birth
• You feel faint, dizzy or have blurred vision
• You have blood in your stools. They may look black and tarry
• You vomit blood or dark particles that look like coffee granules
• You have severe pains in your stomach
• You have difficulty breathing, shortness of breath, swollen
legs, chest or back pain.
Common side effects
(affect less than 1 in 10 people):
• Headache
• Dizziness
• Drowsiness
• Feeling and being sick
• Constipation
• Blocked nose.
Uncommon side effects
(affect less than 1 in 100 people):
• Restlessness
• Confusion or hallucinations
• Dry mouth
• Dizziness or light-headedness upon standing which may cause
you to collapse (you may have low blood pressure)
• Leg cramps
• Itchy, red or swollen skin
• Hair loss
• Tiredness.
Rare side effects
(affect less than 1 in 1000 people):
• Extreme drowsiness
• Insomnia (trouble sleeping)
• Pins and needles











Mental health problems
Diarrhoea
Inability to pass water and back pain
Irregular heart beat including an abnormally slow or fast beating of
the heart
Lung problems that may cause difficulty breathing, a shortness of
breath, pain when you breath in, or a cough that doesn’t go away
Swelling of the ankles
Disturbed or blurred vision
Watery discharge from your nose
Ringing in your ears.

Very rare side effects
(affect less than 1 in 10,000 people):
• Heart valve disorders such as inflammation or leaking of fluid in
the heart - these may cause difficulty breathing, chest pains,
weakness and swelling of the legs and ankles
• Extreme drowsiness during the day or falling asleep unexpectedly
• Pale or white fingers and toes, caused by cold temperatures.
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
• 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.
If you have just given birth you may be more at risk of certain
conditions. These are very rare, but may include high blood pressure,
heart attack, convulsion, stroke or mental problems.
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 any 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 Parlodel
• Keep out of the sight and reach of children.
• Do not use Parlodel after the expiry date stated on the label or
carton. The expiry date refers to the last day of that month.
• Store the tablets in the original package in order to protect from
light.
• Do not store above 25°C.
Medicines should not be thrown away in waste water or in household
waste. Return any medicine you no longer need to your pharmacist.
If your tablets show any signs of deterioration or discolouration, seek
the advice of your pharmacist who will advise you.
6. Further Information
What Parlodel contains
The active substance in Parlodel is bromocriptine mesylate
Each tablet contains 2.87 mg bromocriptine mesylate (equivalent to
2.5 mg bromocriptine base).
The tablets also contain lactose, maize starch, disodium edetate,
maleic acid, colloidal anhydrous silica, and magnesium stearate.
What Parlodel looks like
Round, white, flat tablets, with a bevelled edge, angle-scored on one
side with ‘2.5’ above the scoreline and ‘MG’ below and plain on the
other side. The tablets come in a blister strips containing 30 tablets
Manufacturer:
Meda Manufacturing GmbH,
Cologne, Germany.
Procured within the EU
Product Licence holder:
Ecosse Pharmaceuticals Limited.
3 Young Place, East Kilbride G75 0TD.
Re-packaged by:
Munro wholesale Medical Supplies Limited
3 Young Place East Kilbride G75 0TD.
PL 19065/0430
This leaflet was last revised 15/06/2015
E0430/2(P)

POM

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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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