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NORPROLAC 75 MICROGRAMS TABLETS

Active substance(s): QUINAGOLIDE / QUINAGOLIDE HYDROCHLORIDE

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T05564

Norprolac® 75 micrograms Tablets
(quinagolide hydrochloride)
Patient Information Leaflet

Your medicine is called Norprolac® tablets, but
will be referred to as Norprolac throughout the
following.
Norprolac is available in 25 µg, 50 µg and
75 µg strenghts.
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 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.
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.
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.
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.

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4. Possible side effects

Manufacturer and Product Licence Holder

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.

This product is manufactured by Ferring GmbH,
Wittland 11, D-24109 Kiel, Germany. It is
procured from within the EU by the Product
Licence Holder: Swinghope Limited, Brandon
House, Marlowe Way, Croydon CR0 4XS UK.
Repackaged by Interport Limited, Brandon
House, Marlowe Way, Croydon CR0 4XS UK.

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.

POM
PL No: 10380/1580
Leaflet revision date: 29/05/2015
Norprolac® is registered trademark of Ferring
B.V., Netherlands.

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.
If you experience one or more of these side
effects or any other undesirable effects, please
inform your doctor or pharmacist.
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 25ºC.
• 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.

6. Further information
• Each tablet contains 81.9 micrograms
quinagolide hydrochloride equivalent to 75
micrograms of the active ingredient,
quinagolide.
• It also contains: colloidal anhydrous silica,
maize starch, lactose, magnesiumstearate, microcrystalline cellulose and
methylhydroxypropylcellulose.
• Treatment usually starts with a 'starter pack'
containing 3 tablets of 25 micrograms
(light pink) and 3 tablets of 50 micrograms
(very pale blue) in a single blister strip.
This is then followed by treatment with
75 micrograms (white) tablets presented
in a pack of 30 tablets in blister strips of
10 tablets per strip.

T05564

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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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