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QUINAGOLIDE 75MICROGRAMS TABLETS

Active substance(s): QUINAGOLIDE

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Package leaflet: Information for the user

Norprolac® 75 micrograms tablets

(quinagolide hydrochloride)

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.
The name of your medicine is Norprolac 75
micrograms tablets but will be referred to as
Norprolac throughout this leaflet.
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 hydrochloride 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.

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:




2. Before you take 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).

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 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.

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.

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



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.

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 to150 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):

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).
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 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 take your tablets after the expiry date which is
stated on the carton/blister label after „Exp‟. The
expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original package in order to protect from
light and moisture.
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
The active ingredient is quinagolide (as quinagolide
hydrochloride). Each tablet contains 81.9 micrograms
quinagolide hydrochloride equivalent to 75 micrograms of
the active ingredient, quinagolide.
The other ingredients are:
lactose monohydrate, microcrystalline cellulose, maize
starch, hypromellose, magnesium stearate, colloidal
anhydrous silica.
Norprolac are white, round tablets marked with
“NORPROLAC” on one side and “75”on the other side.
Norprolac is available in blister packs containing 30
tablets.
Manufactured by: Ferring GmbH, Wittland 11, D-24109
Kiel,Germany.
Procured from within the EU & repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Norprolac 75 micrograms tablets
PL No- 18799/2361

POM

Leaflet date: 05.12.2014
Norprolac is registered trademark of Ferring
Pharmaceuticals.

Package leaflet: Information for the user

Quinagolide 75 micrograms tablets
(quinagolide hydrochloride)

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.
The name of your medicine is Quinagolide 75
micrograms tablets but will be referred to as
Quinagolide throughout this leaflet.
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 hydrochloride 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.

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:




2. Before you take 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).

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 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.

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.

Important information about some of the
ingredients in Quinagolide:
Quinagolide 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 Quinagolide



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.

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 to150 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.

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).
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 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 Quinagolide






Keep out of the sight and reach of children.
Do not take your tablets after the expiry date which is
stated on the carton/blister label after „Exp‟. The
expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original package in order to protect from
light and moisture.
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
The active ingredient is quinagolide (as quinagolide
hydrochloride). Each tablet contains 81.9 micrograms
quinagolide hydrochloride equivalent to 75 micrograms of
the active ingredient, quinagolide.
The other ingredients are:
lactose monohydrate, microcrystalline cellulose, maize
starch, hypromellose, magnesium stearate, colloidal
anhydrous silica.
Quinagolide are round tablets marked with
“NORPROLAC” on one side and “75”on the other side.
Quinagolide is available in blister packs containing 30
tablets.
Manufactured by: Ferring GmbH, Wittland 11, D-24109
Kiel,Germany.
Procured from within the EU & repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Quinagolide 75 micrograms tablets
PL No- 18799/2361
Leaflet date: 05.12.2014

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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