Pill Identifier App

NORPROLAC TABLETS 25 MICROGRAMS

Active substance: QUINAGOLIDE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
Norprolac® Tablets
quinagolide

Patient Information

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:

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.

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.

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.

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.

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:

• Norprolac contains the active ingredient,
quinagolide (as quinagolide hydrochloride). It is
available in strengths of 25 micrograms, 50
micrograms and 75 micrograms quinagolide.
• 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.,
Drayton Hall,
Church Road,
West Drayton,
UB7 7PS, UK
Manufacturer:
Ferring GmbH,
Wittland 11,
D-24109 Kiel,
Germany.
Norprolac Tablets 25 micrograms PL 03194/0096
Norprolac Tablets 50 micrograms PL 03194/0097

• 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.

Norprolac Tablets 75 micrograms PL 03194/0098

This leaflet was last revised in September 2014.
Norprolac is a registered trademark.

• 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.

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.

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.

Hide
(web3)