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QUINAGOLINE 75 MICROGRAMS TABLETS

Active substance(s): QUINAGOLIDE HYDROCHLORIDE

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504151/PL1b

®

Norprolac 75 micrograms Tablets
(quinagolide hydrochloride)
Patient Information Leaflet
The name of your medicine is Norprolac 75 micrograms
Tablets. It will be referred to as Norprolac throughout this
leaflet. Other strengths are available.
Read all of this leaflet carefully before you start
taking this medicine.
- Keep this leaflet, you may need to use it again
- If you have further questions, please ask your doctor
or pharmacist
- This medicine has been prescribed for you personally
and you should not pass it on to others.
It may harm them, even if their symptoms are the
same as yours.
In this leaflet:
1. What Norprolac is and what it is used for
2. Before you take Norprolac
3. How to take Norprolac
4. Possible side effects
5. How to store Norprolac
6. Further information
1. WHAT NORPROLAC IS AND WHAT IT IS USED FOR
Norprolac is for oral use only. It is available in strengths of 25
micrograms, 50 micrograms and 75 micrograms. Norprolac
contains quinagolide which decreases the production of the
hormone prolactin.
Norprolac is used to treat conditions resulting from high levels
of prolactin in the blood (hyperprolactinaernia) including:
• excess production of breast milk
• changes in menstrual bleeding patterns
• infertility
• reduced sexual drive.
2. BEFORE YOU TAKE NORPROLAC
Do not take Norprolac:
• if you have a medical condition affecting your liver or
kidneys
• if you are allergic to any of the ingredients listed in
Section 6
If you are pregnant or planning a pregnancy, please refer to
the pregnancy section of this leaflet.
Before taking Norprolac:
• please consult your doctor if you have ever had any
mental illness.
• Norprolac may cause your blood pressure to drop
when you stand up, particularly for the first few days of
treatment or following an increase in your dosage. This
may result in reduced alertness or fainting. To avoid
this, stand up slowly from a sitting or lying down
position. Your doctor will normally check your blood
pressure during the first few days of treatment and
when increasing your dosage.
• Inform 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.
Taking/using other medicines:
Please inform your doctor or pharmacist if you are taking or
have recently taken or used any other medicines - even those
not prescribed.

Taking Norprolac with drink:
Drinking alcohol may increase the side effects of Norprolac. If
this happens, you should avoid drinking alcohol while you are
on treatment with Norprolac.
Pregnancy:
• Fertility may be restored while you are on Norprolac,
so women of child-bearing age who do not wish to
become pregnant should use a reliable method of
contraception.
• If you are planning a pregnancy, it is recommended
that Norprolac is stopped when pregnancy is
confirmed. However, some patients may need to
continue treatment with Norprolac during pregnancy. If
you become pregnant while you are on Norprolac, tell
your doctor as soon as possible.
Breast-feeding:
Norprolac reduces production of breast-milk, so it is not
normally possible to breast-feed while you are taking it. You
should not breast-feed even if it is possible to do so. This is
because it is not known whether the active ingredient in
Norprolac passes into breast-milk.
Driving and using machines:
While you are on Norprolac, caution is advised if you drive or
operate machinery. This is because Norprolac:
• may cause your blood pressure to drop, particularly
during the first few days of treatment or following
dosage increase. This may result in reduced alertness
or fainting.
• may also cause somnolence (drowsiness or
sleepiness).
If you experience any of these effects, please do not drive or
engage in any other activity (e.g. operating machinery) where
impaired alertness may put you or others at risk of serious
injury or death and please consult your doctor, as your dose
may need to be adjusted.
Important information about some of the ingredients in
Norprolac:
Norprolac contains the ingredient, lactose monohydrate.
Therefore, if you have been told by your doctor that you have
an intolerance to some sugars (including lactose), contact
your doctor before taking this medicinal product.
3. HOW TO TAKE NORPROLAC
Adults:
It is important to take your medicine as directed by your
doctor. The label on your medicine should tell you how much
to take and when to take it. If it does not, or you are not sure,
ask your doctor or pharmacist.
Elderly:
Take this medicine only if your doctor has decided that this is
appropriate for you. Follow the instructions given to you very
carefully.
The tablets should only be removed from the blister when it is
time to take your medicine.






Your treatment will normally begin with the ‘starter
pack’ and you will take one 25 micrograms tablet daily
(one light pink tablet) for the first three days (marked
Day 1, Day 2 and Day 3 on the blister strip).
This is followed by one 50 micrograms tablet daily (one
very pale blue tablet) for the next three days (marked
Day 4, Day 5 and Day 6 on the blister strip).
From Day 7, the recommended dose is one 75
micrograms tablet daily (one whitish tablet). Most
patients require a daily dose of 75 to 150 micrograms.
Some patients require a daily dose of 300 micrograms
or higher. Your doctor will tell you if you need a higher
dose. You should not change the dose yourself.
Continued overleaf

Norprolac should be taken once daily at bedtime preferably
with a snack. Remove the tablet from the blister by pushing it
through the foil and place it in your mouth. Swallow it with a
mouthful of water.
If you take more Norprolac than you should:
If you take more Norprolac than you should, tell your doctor
immediately or go to your nearest casualty department.
If you forget to take Norprolac:
If you forget to take a dose, take it as soon as you remember.
However, if you do not remember until it is nearly time for the
next dose, take your next dose as usual and carry on as
before. Do not take double doses to make up for a dose that
you miss.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Norprolac can have side effects.
These are most common during the first few days of treatment
and tend to go away on continuing treatment.
Very common side effects (affect more than 10 of every
100 patients treated):
• Nausea
• Vomiting
• Headache
• Dizziness
• Tiredness
Common side effects (affect between 1 and 10 of every
100 patients treated):
• Loss of appetite
• Abdominal pain
• Constipation or diarrhoea
• Insomnia
• Increased water retention
• Flushing
• Nasal congestion and a drop in blood pressure, which
may result in fainting.
Rare side effects (affect between 1 and 10 of every 10,000
patients treated):
• Somnolence (drowsiness or sleepiness).

5. STORING NORPROLAC
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Store in the original package.
• Do not take the tablets past the expiry date on the
packaging.
• If you are unsure about the storage, ask your
pharmacist. It is best to return all old and unused
medicines to your pharmacist for safe disposal.
• If you notice any signs of discolouration or
deterioration, please tell your pharmacist immediately.
6. FURTHER INFORMATION
Your medicine is called Norprolac Tablets. They are for oral
use only.
• Each tablet contains 81.9 micrograms of quinagolide
hydrochloride equivalent to 75 micrograms of the
active ingredient, quinagolide.
• Norprolac also contains: colloidal anhydrous silica,
hypromellose, maize starch, magnesium stearate,
microcrystalline cellulose and lactose monohydrate.
• Norprolac tablets are white, round tablets with 75 on
one side and NORPROLAC on the other. They come
in packs of 30 tablets.
Product Licence Holder:
Procured from within the EU. Product Licence Holder Ginova
Ltd, repackager Ginova UK Ltd, both of St James' House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer:
Ferring GmbH, Wittland 11, D-24109 Kiel, Germany.
®

Norprolac 75 micrograms Tablets
PL No: 18067/0428

POM

®

Norprolac is a registered trademark of Ferring B.V.
th

This leaflet was last approved on 9 July 2015.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

Very rare side effects (affect less than 1 of every 10,000
patients treated):
• Treatment with Norprolac has been associated with a
change in mental status, which is reversible when
treatment is stopped.
Other side effects include:
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 behaviors; they
will discuss ways of managing or reducing the symptoms.
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.
504151/PL1b

504153/PL1b

Quinagolide 75 micrograms Tablets
(quinagolide hydrochloride)
Patient Information Leaflet
The name of your medicine is Quinagolide 75 micrograms
Tablets. It will be referred to as Quinagolide throughout this
leaflet. Other strengths are available.
Read all of this leaflet carefully before you start
taking this medicine.
- Keep this leaflet, you may need to use it again
- If you have further questions, please ask your doctor
or pharmacist
- This medicine has been prescribed for you personally
and you should not pass it on to others.
It may harm them, even if their symptoms are the
same as yours.
In this leaflet:
1. What Quinagolide is and what it is used for
2. Before you take Quinagolide
3. How to take Quinagolide
4. Possible side effects
5. How to store Quinagolide
6. Further information
1. WHAT QUINAGOLIDE IS AND WHAT IT IS USED FOR
Quinagolide is for oral use only. It is available in strengths of
25 micrograms, 50 micrograms and 75 micrograms.
Quinagolide contains quinagolide which decreases the
production of the hormone prolactin.
Quinagolide is used to treat conditions resulting from high
levels of prolactin in the blood (hyperprolactinaernia)
including:
• excess production of breast milk
• changes in menstrual bleeding patterns
• infertility
• reduced sexual drive.
2. BEFORE YOU TAKE QUINAGOLIDE
Do not take Quinagolide:
• if you have a medical condition affecting your liver or
kidneys
• if you are allergic to any of the ingredients listed in
Section 6
If you are pregnant or planning a pregnancy, please refer to
the pregnancy section of this leaflet.
Before taking Quinagolide:
• please consult your doctor if you have ever had any
mental illness.
• Quinagolide may cause your blood pressure to drop
when you stand up, particularly for the first few days of
treatment or following an increase in your dosage. This
may result in reduced alertness or fainting. To avoid
this, stand up slowly from a sitting or lying down
position. Your doctor will normally check your blood
pressure during the first few days of treatment and
when increasing your dosage.
• Inform 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.
Taking/using other medicines:
Please inform your doctor or pharmacist if you are taking or
have recently taken or used any other medicines - even those
not prescribed.

Taking Quinagolide with drink:
Drinking alcohol may increase the side effects of Quinagolide.
If this happens, you should avoid drinking alcohol while you
are on treatment with Quinagolide.
Pregnancy:
• Fertility may be restored while you are on Quinagolide,
so women of child-bearing age who do not wish to
become pregnant should use a reliable method of
contraception.
• If you are planning a pregnancy, it is recommended
that Quinagolide is stopped when pregnancy is
confirmed. However, some patients may need to
continue treatment with Quinagolide during pregnancy.
If you become pregnant while you are on Quinagolide,
tell your doctor as soon as possible.
Breast-feeding:
Quinagolide reduces production of breast-milk, so it is not
normally possible to breast-feed while you are taking it. You
should not breast-feed even if it is possible to do so. This is
because it is not known whether the active ingredient in
Quinagolide passes into breast-milk.
Driving and using machines:
While you are on Quinagolide, caution is advised if you drive
or operate machinery. This is because Quinagolide:
• may cause your blood pressure to drop, particularly
during the first few days of treatment or following
dosage increase. This may result in reduced alertness
or fainting.
• may also cause somnolence (drowsiness or
sleepiness).
If you experience any of these effects, please do not drive or
engage in any other activity (e.g. operating machinery) where
impaired alertness may put you or others at risk of serious
injury or death and please consult your doctor, as your dose
may need to be adjusted.
Important information about some of the ingredients in
Quinagolide:
Quinagolide contains the ingredient, lactose monohydrate.
Therefore, if you have been told by your doctor that you have
an intolerance to some sugars (including lactose), contact
your doctor before taking this medicinal product.
3. HOW TO TAKE QUINAGOLIDE
Adults:
It is important to take your medicine as directed by your
doctor. The label on your medicine should tell you how much
to take and when to take it. If it does not, or you are not sure,
ask your doctor or pharmacist.
Elderly:
Take this medicine only if your doctor has decided that this is
appropriate for you. Follow the instructions given to you very
carefully.
The tablets should only be removed from the blister when it is
time to take your medicine.






Your treatment will normally begin with the ‘starter
pack’ and you will take one 25 micrograms tablet daily
(one light pink tablet) for the first three days (marked
Day 1, Day 2 and Day 3 on the blister strip).
This is followed by one 50 micrograms tablet daily (one
very pale blue tablet) for the next three days (marked
Day 4, Day 5 and Day 6 on the blister strip).
From Day 7, the recommended dose is one 75
micrograms tablet daily (one whitish tablet). Most
patients require a daily dose of 75 to 150 micrograms.
Some patients require a daily dose of 300 micrograms
or higher. Your doctor will tell you if you need a higher
dose. You should not change the dose yourself.
Continued overleaf

Quinagolide should be taken once daily at bedtime preferably
with a snack. Remove the tablet from the blister by pushing it
through the foil and place it in your mouth. Swallow it with a
mouthful of water.
If you take more Quinagolide than you should:
If you take more Quinagolide than you should, tell your doctor
immediately or go to your nearest casualty department.
If you forget to take Quinagolide:
If you forget to take a dose, take it as soon as you remember.
However, if you do not remember until it is nearly time for the
next dose, take your next dose as usual and carry on as
before. Do not take double doses to make up for a dose that
you miss.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Quinagolide can have side effects.
These are most common during the first few days of treatment
and tend to go away on continuing treatment.
Very common side effects (affect more than 10 of every
100 patients treated):
• Nausea
• Vomiting
• Headache
• Dizziness
• Tiredness
Common side effects (affect between 1 and 10 of every
100 patients treated):
• Loss of appetite
• Abdominal pain
• Constipation or diarrhoea
• Insomnia
• Increased water retention
• Flushing
• Nasal congestion and a drop in blood pressure, which
may result in fainting.
Rare side effects (affect between 1 and 10 of every 10,000
patients treated):
• Somnolence (drowsiness or sleepiness).

5. STORING QUINAGOLIDE
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Store in the original package.
• Do not take the tablets past the expiry date on the
packaging.
• If you are unsure about the storage, ask your
pharmacist. It is best to return all old and unused
medicines to your pharmacist for safe disposal.
• If you notice any signs of discolouration or
deterioration, please tell your pharmacist immediately.
6. FURTHER INFORMATION
Your medicine is called Quinagolide Tablets. They are for oral
use only.
• Each tablet contains 81.9 micrograms of quinagolide
hydrochloride equivalent to 75 micrograms of the
active ingredient, quinagolide.
• Quinagolide also contains: colloidal anhydrous silica,
hypromellose, maize starch, magnesium stearate,
microcrystalline cellulose and lactose monohydrate.
• Quinagolide tablets are white, round tablets with 75 on
one side and NORPROLAC on the other. They come
in packs of 30 tablets.
Product Licence Holder:
Procured from within the EU. Product Licence Holder Ginova
Ltd, repackager Ginova UK Ltd, both of St James' House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer:
Ferring GmbH, Wittland 11, D-24109 Kiel, Germany.
Quinagolide 75 micrograms Tablets
PL No: 18067/0428

POM

th

This leaflet was last approved on 9 July 2015.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

Very rare side effects (affect less than 1 of every 10,000
patients treated):
• Treatment with Quinagolide has been associated with
a change in mental status, which is reversible when
treatment is stopped.
Other side effects include:
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 behaviors; they
will discuss ways of managing or reducing the symptoms.
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.

504153/PL1b

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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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