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NORPROLAC 75 MICROGRAM TABLETS

Active substance(s): QUINAGOLIDE

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(leaflet continued)
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 breastfeed 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:
x 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.
x 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.
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.

x

x

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.

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):
x Nausea
x Vomiting
x Headache
x Dizziness
x Tiredness

The tablets should only be removed from the
blister when it is time to take your medicine.
x 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).

Pregnancy:
x 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.
x 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.
(leaflet continued overleaf)

Common side effects (affect between 1 and
10 of every 100 patients treated):
x Loss of appetite
x Abdominal pain
x Constipation or diarrhoea
x Insomnia
x Increased water retention
x Flushing
x 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):
x Somnolence (drowsiness or sleepiness).
Very rare side effects (affect less than 1 of
every 10,000 patients treated):
x 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:
x strong impulse to gamble excessively
despite serious personal or family
consequences.
x altered or increased sexual interest and
behaviour of significant concern to you or to
others, for example, an increased sexual
drive.
x uncontrollable excessive shopping or
spending
x 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.

5. How to store Norprolac
KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN
Do not store above 25°C. Store in the original
package. Protect from light and moisture.
Do not take the tablets past the expiry date on
the packaging.
If the tablets show any signs of discolouration
or deterioration consult your pharmacist for
advice.
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.
6. Further information
Your medicine is called Norprolac Tablets.
They are for oral use only.
Each tablet contains 75 micrograms of the
active ingredient quinagolide (as quinagolide
hydrochloride).
Also contains lactose monohydrate,
microcrystalline cellulose, hypromellose, maize
starch, magnesium stearate and colloidal
anhydrous silica.
Norprolac 75 microgram tablets are white,
round tablets marked ‘NORPROLAC’
on one side and ‘75’ on the reverse.
Available in blister packs of 30 tablets.
PL 20774/1163 Norprolac 75 microgram
Tablets
POM
Manufactured by Ferring GmbH, Wittland 11,
D-24109 Kiel, Germany. Procured from within
the EU. Product Licence Holder: Quadrant
Pharmaceuticals Ltd, Lynstock House, Lynstock
Way, Lostock, Bolton, BL6 4SA. Repackaged
by Maxearn Ltd, Bolton, BL6 4SA.
Leaflet revision date: 15th May 2015
Norprolac is a registered trademark of Ferring
B.V.

2. Before you take Norprolac
Do not take Norprolac:
x if you have a medical condition affecting
your liver or kidneys
x 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.
Norprolac is used to treat conditions resulting
from high levels of prolactin in the blood
(hyperprolactinaemia) including:
x excess production of breast milk
x changes in menstrual bleeding patterns
x infertility
x reduced sexual drive.

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.

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.
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
Read all of this leaflet carefully before you
start taking this medicine.
x Keep this leaflet, you may need to use it
again
x If you have further questions, please ask
your doctor or pharmacist
x 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.
The name of your medicine is Norprolac 75
microgram Tablets but will be referred to as
Norprolac throughout the remainder of the
leaflet.

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.
Before taking Norprolac:
x please consult your doctor if you have ever
had any mental illness.
x 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.
x Inform your doctor if you or your
family/carer notices that your 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.

Patient Information Leafet
Norprolac® 75 microgram Tablets
quinagolide

PP3/1163/V1

x

(leaflet continued)
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 breastfeed 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:
x 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.
x 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.
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.

x

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.

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):
x Nausea
x Vomiting
x Headache
x Dizziness
x Tiredness

The tablets should only be removed from the
blister when it is time to take your medicine.
x 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).

Common side effects (affect between 1 and
10 of every 100 patients treated):
x Loss of appetite
x Abdominal pain
x Constipation or diarrhoea
x Insomnia
x Increased water retention
x Flushing
x 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):
x Somnolence (drowsiness or sleepiness).
Very rare side effects (affect less than 1 of
every 10,000 patients treated):
x 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:
x strong impulse to gamble excessively
despite serious personal or family
consequences.
x altered or increased sexual interest and
behaviour of significant concern to you or to
others, for example, an increased sexual
drive.
x uncontrollable excessive shopping or
spending
x 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.

5. How to store Norprolac
KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN
Do not store above 25°C. Store in the original
package. Protect from light and moisture.
Do not take the tablets past the expiry date on
the packaging.
If the tablets show any signs of discolouration
or deterioration consult your pharmacist for
advice.
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.
6. Further information
Your medicine is called Norprolac Tablets.
They are for oral use only.
Each tablet contains 75 micrograms of the
active ingredient quinagolide (as quinagolide
hydrochloride).
Also contains lactose monohydrate,
microcrystalline cellulose, hypromellose, maize
starch, magnesium stearate and colloidal
anhydrous silica.
Norprolac 75 microgram tablets are white,
round tablets marked ‘NORPROLAC’
on one side and ‘75’ on the reverse.
Available in blister packs of 30 tablets.
PL 20774/1163 Norprolac 75 microgram
Tablets
POM
Manufactured by Ferring GmbH, Wittland 11,
D-24109 Kiel, Germany. Procured from within
the EU. Product Licence Holder: Quadrant
Pharmaceuticals Ltd, Lynstock House, Lynstock
Way, Lostock, Bolton, BL6 4SA. Repackaged
by Maxearn Ltd, Bolton, BL6 4SA.
Leaflet revision date: 15th May 2015
Norprolac is a registered trademark of Ferring
B.V.

2. Before you take Norprolac
Do not take Norprolac:
x if you have a medical condition affecting
your liver or kidneys
x 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.
Norprolac is used to treat conditions resulting
from high levels of prolactin in the blood
(hyperprolactinaemia) including:
x excess production of breast milk
x changes in menstrual bleeding patterns
x infertility
x reduced sexual drive.
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.
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
Read all of this leaflet carefully before you
start taking this medicine.
x Keep this leaflet, you may need to use it
again
x If you have further questions, please ask
your doctor or pharmacist
x 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.
The name of your medicine is Norprolac 75
microgram Tablets but will be referred to as
Norprolac throughout the remainder of the
leaflet.

Pregnancy:
x 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.
x 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.
(leaflet continued overleaf)
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.
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.
Before taking Norprolac:
x please consult your doctor if you have ever
had any mental illness.
x 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.
x Inform your doctor if you or your
family/carer notices that your 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.

Patient Information Leafet
Norprolac® 75 microgram Tablets
quinagolide

PP3/1163/V1

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.

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