NORPROLAC Tablets
quinagolide
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 NORPROLAC Tablets.
It is for oral use only. It will be referred to as NORPROLAC in this leaflet.
- 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 iron oxide red and the 50 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 microgram (whitish) tablets presented a pack of 30 tablets in blister strips of 10 tablets per strip.
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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 reduces the secretion of the hormone prolactin.
NORPROLAC is used to treat conditions resulting from high levels of prolactin in the blood (hyperprolactinaemia). Prolactin is a hormone produced by the pituitary gland. High levels of prolactin may cause excess milk production, changes in menstrual bleeding patterns, infertility and reduced sexual drive.
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.
If you are pregnant or planning a pregnancy, please refer to the pregnancy section of this leaflet.
Before taking NOPROLAC:
- 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.
Driving or operating machinery:
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. Please consult your doctor.
Effects of alcohol:
Drinking alcohol may increase the side effects of NORPROLAC. If this happens, you should avoid drinking alcohol while you are on treatment with NORPROLAC.
While you are on NORPROLAC:
- fertility may be restored, so women of child-bearing age who do not wish to become pregnant should use a reliable method of contraception.
Pregnancy:
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.
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.
How to take NORPROLAC
Adults (excluding the elderly):
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.
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 25 micrograms 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 50 micrograms 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 75 micrograms 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 with some food.
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.
Possible side effects
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.
Very common side effects are nausea, vomiting, headache, dizziness and tiredness.
Other common side effects include loss of appetite, abdominal pain, constipation or diarrhoea, insomnia, increased water retention, flushing, nasal congestion and a drop in blood pressure.
Rarely, NORPROLAC may cause somnolence (drowsiness or sleepiness).
Very rarely, treatment with NORPROLAC has been associated with a change in mental status, which is reversible when treatment is stopped.
Patients treated for Parkinson’s disease including quinagolide have shown signs of pathological gambling (failure to resist gambling impulses despite serious personal or family consequences), Increased sex drive and hypersexuality (altered sexual interest and behaviour of significant concern to the patient or to others). Generally reversible upon reduction of the dose or treatment discontinuation.
If you experience one or more of these side effects or any other undesirable effects, please inform your doctor or pharmacist.
Storing NORPROLAC
Keep NORPROLAC out of the reach and sight of children.
Do not store above 25°C.
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.
NORPROLAC Tablets 25 micrograms PL 03194/0096
NORPROLAC Tablets 50 micrograms PL 03194/0097
NORPROLAC Tablets 75 micrograms PL 03194/0098
This leaflet was written in January 2007.
NORPROLAC is a registered trademark.
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