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QUINAGOLIDE 75 MICROGRAMS TABLETS

Active substance(s): QUINAGOLIDE / QUINAGOLIDE

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Ref: 1703/160317/1/F

Quinagolide 75 micrograms Tablets
Patient Information Leaflet
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.
Your medicine is called Quinagolide Tablets 75 micrograms Tablets but will
be refered to as Quinagolide Tablets throughout this leaflet.
In this leaflet:
1 What Quinagolide Tablets is and what it is used for
2 Before you take Quinagolide Tablets
3 How to take Quinagolide Tablets
4 Possible side effects
5 How to store Quinagolide Tablets
6 Further information

1

What Quinagolide Tablets is and what it is used for

Quinagolide Tablets is for oral use only. It is available in strengths of 25
micrograms, 50 micrograms and 75 micrograms. Quinagolide Tablets
contains quinagolide which decreases the production of the hormone
prolactin. Quinagolide Tablets is used to treat conditions resulting from high
levels of prolactin in the blood (hyperprolactinaemia) including:

* excess production of breast milk
* changes in menstrual bleeding patterns
* infertility
* reduced sexual drive.

Pregnancy:
* Fertility may be restored while you are on Quinagolide Tablets, 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
Tablets is stopped when pregnancy is confirmed. However, some patients
may need to continue treatment with Quinagolide Tablets during pregnancy.
If you become pregnant while you are on Quinagolide Tablets, tell your
doctor as soon as possible.
Breast-feeding:
Quinagolide Tablets 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 Tablets passes into breast-milk.
Driving and using machines:
While you are on Quinagolide Tablets, caution is advised if you drive or
operate machinery. This is because Quinagolide Tablets:
* 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 Quinagolide
Tablets:
Quinagolide Tablets 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
2

Before you take Quinagolide Tablets

Do not take Quinagolide Tablets:
* 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 Quinagolide Tablets:
* please consult your doctor if you have ever had any mental illness.
* Quinagolide Tablets 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.
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 Tablets with drink:
Drinking alcohol may increase the side effects of Quinagolide Tablets. If this
happens, you should avoid drinking alcohol while you are on treatment with
Quinagolide Tablets.

How to take Quinagolide Tablets

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.
Quinagolide Tablets 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 Tablets than you should:
If you take more Quinagolide Tablets than you should, tell your doctor
immediately or go to your nearest casualty department.
If you forget to take Quinagolide Tablets:
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.

Ref: 1703/160317/1/B

Quinagolide 75 micrograms Tablets
Patient Information Leaflet (continued)
4

Possible side effects

Like all medicines, Quinagolide Tablets 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 Tablets has been associated with a change in
mental status, which is reversible when treatment is stopped.

If the tablets becomes discoloured or shows any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines that are no longer
required. These measures will help to protect the environment.

6

Further information

What Quinagolide contain:
Each tablet contains 81.9 micrograms of quinagolide hydrochloride
equivalent to 75 micrograms of the active ingredient quinagolide
Other ingredients are colloidal anhydrous silica, magnesium stearate,
methylhydroxypropylcellulose, maize starch, microcrystalline cellulose and
lactose
What Quinagolide look like and contents of the pack
White round tablets with 75 embossed on one side and NORPROLAC on
the other side .
Each pack contains 30 Tablets.
Manufacturer and Licence Holder
Manufactured by Ferring GmbH, Wittland 11, D-24109 Kiel, Germany and is
procured from within the EU and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM
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 behaviours; they will discuss
ways of managing or reducing the symptoms.
Reporting of side effects
If you get any side effects, talk to your doctor or 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
(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 Tablets

Keep out of the sight and reach of children.
Do not store above 25°C.
Do not take Quinagolide Tablets after the expiry date which is stated on the
blister label and carton. The expiry date refers to the last day of the month.
If your doctor tells you to stop taking this medicine, return any unused
tablets to your pharmacist (chemist) for safe disposal. Only keep this
medicine if your doctor tells you to.

PL 15184/1703

Quinagolide 75 micrograms Tablets

Revision date: 16/03/17

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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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