Quinagolide 50microgram tablets and Quinagolide 25microgram tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Dostupné z:

Aspire Pharma Ltd

ATC kód:

G02CB04

Forma lieku:

Not applicable

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 06070100; GTIN: 5060209731414

Príbalový leták

PACKAGE LEAFLET
QUINAGOLIDE TABLETS
NORPROLAC® TABLETS
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:
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
(hyperprolactinaemia) including:
• excess production of breast milk
• changes in menstrual bleeding patterns
• infertility
• 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

Súhrn charakteristických

OBJECT 1
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
macroadenoma).
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.
Adults
The optimal dose must be titrated individually on the basis of the
prolactin- lowering effect and
tolerability.
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.
Elderly
Experience with the use of NORPROLAC in elderly patients is not
available.
Children
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.
4.3 Contraindications
Hypersensitivity to the drug.
Impaired hepatic or renal function
For procedure during pregnancy, (see section 4.6 Pregnancy and
lactation).
4.4 Special warnings an