Skip to Content

UK Edition. Click here for US version.

PARLODEL 2.5MG TABLETS/ BROMOCRIPTINE 2.5MG TABLETS

Active substance(s): BROMOCRIPTINE MESYLATE

View full screen / Print PDF » Download PDF ⇩
Transcript
PATIENT INFORMATION LEAFLET
PARLODEL® 2.5mg TABLETS / BROMOCRIPTINE 2.5mg TABLETS
(bromocriptine mesilate)
This medicine is available as either of the above names but will be referred to as Parlodel throughout the following
leaflet.
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.

Parlodel is also available as 1 mg strength tablets and 5 mg and 10 mg strength capsules.
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 1 mg and 2.5 mg 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, preeclampsia, pregnancy-induced 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 1 mg and 2.5 mg 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 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
• Leave your tablets in the blister. Only remove them when it is time to take your medicine.
• Do not store above 25°C. Protect from light. Store in the original package.
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date shown on the carton. The expiry date refers to the last day of that
month.
• If the tablets become discoloured or show signs of any deterioration, you should seek the advice of your
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. FURTHER INFORMATION
What’s in your medicine?
Your medicine is called Parlodel. The active ingredient contained in Parlodel is bromocriptine mesilate equivalent
to 2.5mg of bromocriptine.
Parlodel also contains the following inactive ingredients:
Lactose monohydrate, maize starch, maleic acid, magnesium stearate, disodium edetate, and colloidal anhydrous
silica. The tablets are white, round tablet bevelled edge marked ‘2.5’ breakline ‘MG’ on one side and plain on the
other. They are contained in blister strips of 10 tablets in packs of 30 tablets.
PL No: 15814/0870
POM
This product is manufactured by MEDA Manufacturing GmbH, Cologne, Germany and is procured from within the
EU and repackaged by the Product Licence holder: O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts
WD24 4PR.
Parlodel is a registered Trade Mark of Novartis AG, Switzerland.
Leaflet revision and issue date (ref) 21.05.2015.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

Expand view ⇕

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.

Hide