PARLODEL 5MG CAPSULES

Active substance: BROMOCRIPTINE

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Patient Information Leaflet

Parlodel 1 mg & 2.5 mg Tablets
Parlodel 5 mg & 10 mg Capsules
Bromocriptine mesilate
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 1 mg & 2.5 mg Tablets and
Parlodel 5 mg & 10 mg Capsules will be called
Parlodel.
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:
• Stopping or delaying breast milk being made for
medical reasons. This may be needed after you have
given birth or had a miscarriage.
• 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).

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

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
• 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.
Check with your doctor before you take Parlodel if:
• 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

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.
If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist immediately.
5. How To Store Parlodel
Keep out of the reach and sight 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 and capsules in the original package in
order to protect from light.
1 mg and 2.5 mg Tablets - Store below 25°C.
5 mg and 10 mg Capsules - Store below 30°C.
Medicines should not be thrown away in waste water or
in household waste. Return any medicine you no longer
need to your pharmacist.
6. Further Information
What Parlodel contains
The active substance in Parlodel is bromocriptine
mesilate
Parlodel Tablets come in two strengths: 1 mg and
2.5 mg:
• Each 1 mg tablet contains 1 mg bromocriptine
mesilate. Each 2.5 mg tablet contains 2.5 mg
bromocriptine mesilate.
• The tablets also contain lactose, maize starch,
disodium edetate, maleic acid, colloidal anhydrous
silica, and magnesium stearate.
Parlodel Capsules come in two strengths: 5 mg and
10 mg:
• Each 5 mg capsule contains 5 mg bromocriptine
mesilate. Each 10 mg capsule contains 10 mg
bromocriptine mesilate.
• The capsules also contain lactose, maize starch,
maleic acid, magnesium stearate, colloidal anhydrous
silica, titanium dioxide (E171) (white-colouring
agent) and gelatin. The 5 mg capsules also contain
indigo carmine (E132) (blue colouring agent). The
capsules are imprinted using the printing inks shellac
(E904) and black iron oxide (E172).
What Parlodel looks like
Parlodel 1 mg Tablets are round, white and marked with
a break line on one side and ‘1 MG’ on the other side.
The tablets come in an amber glass bottle containing
30 or 100 tablets.
Parlodel 2.5 mg Tablets are round, white and marked
with a groove on one side and ‘2.5 MG’ on the other
side. The tablets come in a blister strip containing
30 tablets or in an amber glass bottle containing 100 or
500 tablets.
Parlodel 5 mg Capsules are blue, white, oblong and
imprinted with ‘5 mg’. The capsules come in either a
blister strip containing 30 capsules or an amber glass
bottle containing 100 capsules.
Parlodel 10 mg Capsules are plain white, oblong and
imprinted with ’10 mg’. The capsules come in an amber
glass bottle containing 100 capsules.
Not all pack-sizes are marketed.
Marketing Authorisation Holder:
Meda Pharmaceuticals Ltd, trading as Meda
Pharmaceuticals, Skyway House, Parsonage Road,
Takeley, Bishop’s Stortford, CM22 6PU, UK.
Manufacturer:
Meda Manufacturing GmbH, Neurather Ring 1,
51063 Cologne, Germany.
This leaflet was last updated November 2012.

If this leaflet is difficult to see or read or you would like it in a different format,
please contact Meda Pharmaceuticals, Skyway House, Parsonage Road,
Takeley, Bishop’s Stortford, CM22 6PU, UK.

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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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