United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)
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 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 which decreases the production of the hormone prolactin.
Quinagolide is used to treat conditions resulting from high levels of prolactin in the blood
excess production of breast milk
changes in menstrual bleeding patterns
reduced sexual drive.
2. Before you take Quinagolide
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 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.
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.
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.
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.
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
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:
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
3. How to take Quinagolide
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
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
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
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.
. 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):
Common side effects (affect between 1 and 10 of every 100 patients treated):
Loss of appetite
Constipation or diarrhoea
Increased water retention
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 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. Storing Quinagolide
Keep Quinagolide 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.
6. Further information
Your medicine is called Quinagolide Tablets. They are for oral use only.
Quinagolide contains the active ingredient, quinagolide (as quinagolide hydrochloride). It is available in
strengths of 25 micrograms, 50 micrograms and 75 micrograms quinagolide.
Quinagolide 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:
Aspire Pharma Ltd., Unit 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK
Ferring GmbH, Wittland 11,D-24109 Kiel,Germany.
Quinagolide Tablets 25 micrograms PL 35533/0062
Quinagolide Tablets 50 micrograms PL 35533/0063
Quinagolide Tablets 75 micrograms PL 35533/0064
This leaflet was last revised in September 2016.
Quinagolide 50 micrograms tablets
Summary of Product Characteristics Updated 11-Oct-2016 | Aspire Pharma Ltd
1. Name of the medicinal product
NORPROLAC®50 micrograms Tablets
Quinagolide 50 micrograms Tablets
2. Qualitative and quantitative composition
Quinagolide, as the hydrochloride, 50 micrograms.
3. Pharmaceutical form
Tablet for oral administration
4. Clinical particulars
4.1 Therapeutic indications
Hyperprolactinaemia (idiopathic or originating from a prolactin-secreting pituitary microadenoma or
4.2 Posology and method of administration
Since dopaminergic stimulation may lead to symptoms of orthostatic hypotension, the dosage of
NORPROLAC should be initiated gradually with the aid of the 'starter pack', and given only at bedtime.
The optimal dose must be titrated individually on the basis of the prolactin- lowering effect and
With the 'starter pack' treatment begins with 25 micrograms/day for the first 3 days, followed by 50
micrograms/day for a further 3 days. From day 7 onwards, the recommended dose is 75 micrograms/day.
If necessary, the daily dose may then be increased stepwise until the optimal individual response is
attained. The usual maintenance dosage is 75 to 150 micrograms/day.
Daily doses of 300 micrograms or higher doses are required in less than one- third of the patients.
In such cases, the daily dosage may be increased in steps of 75 to 150 micrograms at intervals not shorter
than 4 weeks until satisfactory therapeutic effectiveness is achieved or reduced tolerability, requiring the
discontinuation of treatment, occurs.
Experience with the use of NORPROLAC in elderly patients is not available.
Experience with the use of NORPROLAC in children is not available.
Method of Administration
NORPROLAC should be taken once a day with some food at bedtime.
Hypersensitivity to the drug.
Impaired hepatic or renal function
For procedure during pregnancy, (see section 4.6 Pregnancy and lactation).
4.4 Special warnings and precautions for use
Fertility may be restored by treatment with NORPROLAC. Women of child-bearing age who do not wish
to conceive should therefore be advised to practice a reliable method of contraception.
Since orthostatic hypotension may result in syncope, it is recommended to check blood pressure both
lying and standing during the first days of therapy and following dosage increases.
In a few cases, including patients with no previous history of mental illness, treatment with
NORPROLAC has been associated with the occurrence of acute psychosis, usually reversible upon
discontinuation. Particular caution is required in patients who have had psychotic episodes in their
To date no data is available with the use of NORPROLAC in patients with impaired renal or hepatic
function (see Section 4.3 Contraindications).
NORPROLAC has been associated with somnolence. Other dopamine agonists can be associated with
sudden sleep onset episodes, particularly in patients with Parkinson's disease. Patients must be informed
of this and advised to exercise caution whilst driving or operating machines during treatment with
Patients who have experienced somnolence must not drive or operate machines. Furthermore, a reduction
of dosage or termination of therapy may be considered (see Section 4.7 Effects on the ability to drive and
Impulse control disorders
Patients should be regularly monitored for the development of impulse control disorders. Patients and
carers should be made aware that behavioural symptoms of impulse control disorders including
pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and
compulsive eating can occur in patients treated with dopamine agonists including NORPROLAC. Dose
reduction/tapered discontinuation should be considered if such symptoms develop.
NORPROLAC should be kept out of the reach and sight of children.
4.5 Interaction with other medicinal products and other forms of interaction
No interactions between NORPROLAC and other drugs have so far been reported. On theoretical
grounds, a reduction of the prolactin-lowering effect could be expected when drugs (e.g. neuroleptic
agents) with strong dopamine antagonistic properties are used concomitantly. As the potency of
NORPROLAC for 5-HT
receptors is some 100 times lower than that for D
interaction between NORPROLAC and 5-HT
receptors is unlikely. However, care should be taken
when using these medicaments concomitantly.
The tolerability of NORPROLAC may be reduced by alcohol.
4.6 Pregnancy and lactation
Animal data provide no evidence that NORPROLAC has any embryotoxic or teratogenic potential, but
experience in pregnant women is still limited. In patients wishing to conceive, NORPROLAC should be
discontinued when pregnancy is confirmed, unless there is a medical reason for continuing therapy. No
increased incidence of abortion has been observed following withdrawal of the drug at this point.
If pregnancy occurs in the presence of a pituitary adenoma and NORPROLAC treatment has been
stopped, close supervision throughout pregnancy is essential.
Breast-feeding is usually not possible since NORPROLAC suppresses lactation. If lactation should
continue during treatment, breast-feeding cannot be recommended because it is not known whether
quinagolide passes into human breast milk.
4.7 Effects on ability to drive and use machines
Since, especially during the first days of treatment, hypotensive reactions may occasionally occur and
result in reduced alertness, patients should be cautious when driving a vehicle or operating machinery.
Patients being treated with NORPROLAC and presenting with somnolence must be advised not to drive
or engage in activities where impaired alertness may put themselves or others at risk of serious injury or
death (e.g. operating machines) unless patients have overcome such experiences of somnolence (see 4.4
Special warnings and precautions for use).
4.8 Undesirable effects
Frequency estimate: very common ≥10%, common ≥1% to <10%, uncommon ≥0.1% to <1%, rare
≥0.01% to <0.1%, very rare <0.01%.
The adverse reactions reported with the use of NORPROLAC are characteristic for dopamine receptor
agonist therapy. They are usually not sufficiently serious to require discontinuation of treatment and tend
to disappear when treatment is continued.
Very common undesirable effects are nausea, vomiting, headache, dizziness and fatigue. They occur
predominantly during the first few days of the initial treatment or, as a mostly transient event, following
dosage increase. If necessary, nausea and vomiting may be prevented by the intake of a peripheral
dopaminergic antagonist, such as domperidone, for a few days, at least 1 hour before ingestion of
Common undesirable effects include anorexia, abdominal pain, constipation or diarrhoea, insomnia,
oedema, flushing, nasal congestion and hypotension. Orthostatic hypotension may result in faintness or
syncope (see 4.4 Special warnings and precautions for use).
Rarely NORPROLAC has been associated with somnolence.
In very rare cases, treatment with NORPROLAC has been associated with the occurrence of acute
psychosis, reversible upon discontinuation.
Impulse control disorders
Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and
compulsive eating can occur in patients treated with dopamine agonists including NORPROLAC. (See
section 4.4. 'Special warnings and precautions for use').
Symptoms: Acute overdosage with NORPROLAC tablets has not been reported. It would be expected to
cause severe nausea, vomiting, headache, dizziness, drowsiness, hypotension and possibly collapse.
Hallucinations could also occur.
Treatment: Should be symptomatic.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: prolactin inhibitors (ATC code G02C B04)
Quinagolide, the active ingredient of NORPROLAC, is a selective dopamine D
-receptor agonist not
belonging to the chemical classes of ergot or ergoline compounds. Owing to its dopaminergic action, the
drug exerts a strong inhibitory effect on the secretion of the anterior pituitary hormone prolactin, but does
not reduce normal levels of other pituitary hormones. In some patients the reduction of prolactin secretion
may be accompanied by short- lasting, small increases in plasma growth hormone levels, the clinical
significance of which is unknown.
As a specific inhibitor of prolactin secretion with a prolonged duration of action, NORPROLAC has been
shown to be effective and suitable for once-a day oral treatment of patients presenting with
hyperprolactinaemia and its clinical manifestations such as galactorrhoea, oligomenorrhoea,
amenorrhoea, infertility and reduced libido.
5.2 Pharmacokinetic properties
After oral administration of radiolabelled drug, quinagolide is rapidly and well absorbed. Plasma
concentration values obtained by a non-selective radio- immunoassay (RIA), measuring quinagolide
together with some of its metabolites, were close to the limit of quantification and gave no reliable
The apparent volume of distribution of quinagolide after single oral administration of radiolabelled
compound was calculated to be approx. 100 L. For the parent drug, a terminal half-life of 11.5 hours has
been calculated under single dose conditions, and of 17 hours at steady state.
Quinagolide is extensively metabolised during its first pass. Studies performed with
quinagolide revealed that more than 95% of the drug is excreted as metabolites. About equal amounts of
total radioactivity are found in faeces and urine.
In blood, quinagolide and its N-desethyl analogue are the biologically active but minor components. Their
inactive sulphate or glucuronide conjugates represent the major circulating metabolites. In urine, the main
metabolites are the glucuronide and sulphate conjugates of quinagolide and the N-desethyl, N,N-
didesethyl analogues. In the faeces the unconjugated forms of the three components were found.
The protein binding of quinagolide is approximately 90% and is non-specific.
The results, obtained in pharmacodynamic studies, indicate that with the recommended therapeutic
dosage a clinically significant prolactin-lowering effect occurs within 2 hours after ingestion, reaches a
maximum within 4 to 6 hours and is maintained for about 24 hours.
A definite dose-response relationship could be established for the duration, but not for the magnitude, of
the prolactin-lowering effect which, with a single oral dose of 50 micrograms was close to maximum.
Higher doses did not result in a considerably greater effect but prolonged its duration.
5.3 Preclinical safety data
of quinagolide was determined for several species after single oral administration: mice 357 to
> 500 mg/kg; rats > 500 mg/kg; rabbits > 150 mg/kg
Decreased cholesterol levels of treated female rats suggest that quinagolide influences lipid metabolism.
Since similar observations have been made with other dopaminergic drugs, a causal relationship with low
prolactin levels is assumed. In several chronic studies with rats, enlarged ovaries resulting from an
increased number of corpora lutea and, additionally, hydrometra and endometritis were observed. These
changes were reversible and reflect the pharmacodynamic effect of quinagolide: suppression of prolactin
secretion inhibits luteolysis in rats and thus influences the normal sexual cycle. In humans, however,
prolactin is not involved in luteolysis.
Carcinogenic and mutagenic potential
In comprehensive in vitro and in vivo mutagenic studies there was no evidence of a mutagenic effect.
The changes which were observed in carcinogenicity studies reflect the pharmacodynamic activity of
quinagolide. The drug modulates the prolactin level as well as, specially in male rats, the level of
luteinizing hormone and, in female rodents, the ratio of progesterone to oestrogen.
Long-term studies with high doses of quinagolide revealed Leydig cell tumours in rats and mesenchymal
uterine tumours in mice. The incidence of Leydig cell tumours in a carcinogenicity study in rats was
increased even at low doses (0.01 mg/kg). These results were without relevance for the therapeutic
application in humans since there are fundamental differences between humans and rodents in the
regulation of the endocrine system.
Animal studies in rats and rabbits showed no evidence for embryotoxic or teratogenic effects. The
prolactin inhibiting effect led to a decrease of milk production in rats, which was associated with an
increased loss of rat pups. Possible post-natal effects of exposure during fetal development (2nd and 3rd
trimester) and effects on female fertility are not sufficiently investigated.
6. Pharmaceutical particulars
6.1 List of excipients
Indigotine lake, silica, colloidal anhydrous; magnesium stearate; methyldroxypropylcellulose; maize
starch; cellulose microcrystalline; lactose.
6.3 Shelf life
The shelf life is 5 years. The expiry date is printed on the box. On the blister the expiry date is marked
with the letters EXP.
6.4 Special precautions for storage
The expiry date refers to original unopened boxes, which were stored below 25°C. No special warning
with respect to light sensitivity or humidity is necessary because the tablets are protected by the
6.5 Nature and contents of container
The 'starter pack' (NORPROLAC 25/50) consists of 3 tablets of 25 micrograms and 3 tablets of 50
micrograms. These tablets are packed in an aluminium PVC/PVDC blister which is sealed in a moisture-
proof aluminium bag.
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
Aspire Pharma Ltd
Unit 4 Rotherbrook Court
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
Company Contact Details
Aspire Pharma Ltd
4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK
+44 (0)1730 231148
Customer Care direct line
+44 (0)1730 231148
Medical Information Direct Line
+44 (0)1730 231148