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NORPROLAC TABLETS 25 MICROGRAMS

Active substance: QUINAGOLIDE HYDROCHLORIDE

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Norprolac® Tablets
quinagolide

Patient Information

Read all of this leaflet carefully before you start taking this
medicine.


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.



Keep this leaflet, you may need to use it again





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.

4. Possible side effects

6. Further information

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.

Your medicine is called Norprolac® Tablets. They are for oral
use only.

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.

Very common side effects (affect more than 10 of every 100
patients treated):
• Nausea
• Vomiting
• Headache
• Dizziness
• Tiredness

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.



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.



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)



Norprolac also contains: colloidal anhydrous silica,
methylhydroxypropylcellulose, maize starch,
magnesium stearate, microcrystalline cellulose and
lactose. In addition, the 25 microgram tablets
contain indigotin lake as colouring agents.



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 (whitish) tablets
presented in a pack of 30 tablets in blister strips
of 10 tablets per strip.

Marketing Authorisation Holder:
Ferring Pharmaceuticals Ltd.,
The Courtyard,
Waterside Drive,
Langley, Birkshire
SL3 6EZ, UK
Manufacturer:
Ferring GmbH,
Wittland 11,
D-24109 Kiel,
Germany.
Norprolac Tablets 25 micrograms PL 03194/0096
Norprolac Tablets 50 micrograms PL 03194/0097

uncontrollable excessive shopping or spending



Norprolac contains the active ingredient,
quinagolide (as quinagolide hydrochloride). It is
available in strengths of 25 micrograms, 50
micrograms and 75 micrograms quinagolide.

Norprolac Tablets 75 micrograms PL 03194/0098

This leaflet was last revised in December 2012.
Norprolac is a registered trademark.

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.

5. Storing Norprolac
Keep Norprolac out of the reach and sight 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.

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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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