25 micrograms + 50 micrograms, 75 micrograms, 150 micrograms quinagolid tablets
What Norprolac is and what it is used for
Norprolac contains quinagolide, which belongs to a group of medicines called prolactin inhibitors. Quinagolide reduces the secretion of the hormone prolactin.
Norprolac is used for elevated levels of the hormone et prolactin of either unknown cause or derived from prolactin- secreting tumor in the pituitary gland.
What you need to know before you use Norprolac
Do not take Norprolac
- if you are allergic to quinagolide or any of the other ingredients of this medicine (listed in section 6).
- if you have severe hepatic or renal impairment
Warnings and cautions
Talk to your doctor or pharmacist before taking Norprolac
- if you have fertility problems related to prolactin as fertility may increase during treatment with Norprolac. Women of childbearing potential who do not wish to become pregnant must use a reliable method of contraception during treatment with Norprolac. (See also section Pregnancy, lactation and fertility ).
- if you have any of the following diseases; psychotic disorders or impaired liver or kidney function
- if you are a child or adolescent under 18 years of age
- if you are older
Tell your doctor if you or your family/caregiver notice that you develop a strong desire or desire to behave in ways that are unusual for you, or if you can not resist the impulse, drive, or temptation to perform certain activities. which may harm you or others. These behaviors are called impaired impulse control and may include gambling addiction, compulsive eating, compulsive buying, an abnormally high sex drive, or an increase in sexual thoughts and feelings. Your doctor may need to adjust your dose or discontinue treatment.
Norprolac can cause a temporary drop in blood pressure when you get up quickly. You may experience symptoms such as intoxication, and this can in rare cases result in fainting.
It is recommended that you get your blood pressure checked by a doctor during the first days of treatment and after increasing the dose.
Blood pressure control is especially important if you have severe heart disease.
Children and young people
Experience with the use of Norprolac in children is limited.
Other medicines and Norprolac
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Other medicines may affect the effect and tolerance of Norprolac;
- Dopamine receptor antagonists (eg antipsychotics ) may reduce the prolactin-lowering effect of Norprolac
- drugs that affect the serotonin receptors (eg drugs for depression) or dopamine receptors (eg drugs for Parkinson’s disease , severe migraine )
- drugs that effectively inhibit enzymes that break down drugs
Norprolac with food, drink and alcohol
Alcohol may reduce the tolerance of Norprolac.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Experience with the use of this medicine during pregnancy is limited.
Treatment with Norprolac should be discontinued when pregnancy is determined unless your doctor tells you otherwise.
Breast-feeding is usually not possible as Norprolac reduces the excretion of breast milk. You should not breastfeed even if it is possible as it is not known if quinagolide passes into breast milk.
Fertility can be regained with Norprolac treatment. If you do not wish to become pregnant, use a reliable contraceptive (See section 2 above).
Driving and using machines
In some people, Norprolac may impair its ability to react during the first day of treatment, which should be taken into account when increased attention is required, for example when driving or working with precision.
In rare cases, some users may suddenly fall asleep without any previous feeling of fatigue. If you suffer from this symptom, you should refrain from driving or participating in activities where impaired attention may expose yourself or others to danger or the risk of serious injury (eg when using machines).
You are always responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Norprolac contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Norprolac
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Adults
Norprolac should be taken with food once daily in the evening.
Dose one is determined by the doctor who adjusts it individually for you.
Treatment is usually started with a dose of 25 micrograms once daily for 3 days, followed by 50 micrograms once daily for 3 days. From day 7, the dose is 75 micrograms daily, the dose can be increased gradually until the correct dose is reached. The usual dose is 75-150 micrograms daily. Some patients may need 300 micrograms per day or more.
Children and young people
Experience in children and adolescents is limited.
Older
Experience in the elderly is limited.
If you take more Norprolac than you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice.
Expected symptoms of an overdose are; nausea, vomiting, headache, dizziness, drowsiness, decreased blood pressure, and hallucinations.
If you forget to take Norprolac
If you forget to take Norprolac one day, continue to take the medicine, as usual, the next day. Do not take a double dose the next day to make up for a forgotten dose, as this may cause unwanted side effects.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects are dose-dependent, so do not change the dose without consulting a doctor. Most side effects occur during the first days of treatment and usually disappear with continued treatment.
Very common (may affect more than 1 user in 10)
- dizziness
- headache
- nausea
- vomiting
- fatigue
Common (may affect less than 1 user in 10)
- temporary drop in blood pressure when getting up quickly (may in rare cases cause fainting)
- anorexia (loss of appetite)
- difficulty sleeping
- nasal congestion
- abdominal pain
- constipation
- diarrhea
- muscle weakness
Rare (may affect less than 1 in 1000 people)
- acute psychosis which ceases if treatment is discontinued
- somnolence (extreme drowsiness)
No known frequency (can not be determined from the available data)
- Inability to resist an impulse to perform an action that can be harmful such as:
- A strong impulse to excessive gambling despite serious consequences for you personally or for your family
- Changed or increased sexual interest or behavior that makes you or others noticeably worried, such as increased sexual drive
- Uncontrollable and excessive need to buy things and spend money
- Binge eating (eating large amounts of food in a short time) 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 to discuss ways to manage or reduce the symptoms.
The risk of hypersensitivity reactions can not be ruled out.
How to store Norprolac
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
Store in the original package. Sensitive to moisture and light. Do not store above 25 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
25 microgram tablets
The active substance is quinagolide 25 micrograms as quinagolide hydrochloride.
The other ingredients are lactose monohydrate, red iron oxide (E172), microcrystalline cellulose, corn starch, hypromellose, magnesium stearate, colloidal anhydrous silica.
50 microgram tablets
The active substance is quinagolide 50 micrograms as quinagolide hydrochloride.
The other ingredients are lactose monohydrate, indigo carmine (E132), microcrystalline cellulose, corn starch, hypromellose, magnesium stearate, colloidal anhydrous silica.
Tablets 75 micrograms
The active substance is quinagolide 75 micrograms as quinagolide hydrochloride.
The other ingredients are lactose monohydrate, microcrystalline cellulose, corn starch, hypromellose, magnesium stearate, colloidal anhydrous silica.
Tablets 150 micrograms
The active substance is quinagolide 150 micrograms as quinagolide hydrochloride.
The other ingredients are lactose monohydrate, microcrystalline cellulose, corn starch, hypromellose, magnesium stearate, colloidal anhydrous silica.
What the medicine looks like and contents of the pack
Norprolac 25 micrograms tablets
Slightly pink spotted, round, flat with a beveled edge, diameter 7 mm. Embossing “NORPROLAC” circularly on one side and “25” linearly on the other side.
Norprolac 50 micrograms tablets
Slightly blue-spotted, round, flat with a beveled edge, diameter 7 mm. Embossing “NORPROLAC” circularly on one side and “50” linearly on the other side.
Norprolac 75 micrograms tablets
White, round, flat with a beveled edge, diameter 7 mm. Embossing “NORPROLAC” circularly on one side and “75” linearly on the other side.
Norprolac 150 micrograms tablets
White, round, flat with a beveled edge, diameter 9 mm. Embossing “NORPROLAC” circularly on one side and “150” linearly on the other side.
Pack sizes
Escalator pack 25 + 50 micrograms: 3 + 3 tablets.
Blister of ALU / PVC / PVDC packed in a moisture-proof aluminum foil bag.
The outer packaging is cardboard.
75 micrograms: 30 tablets
150 micrograms. 30 tablets
Blister of ALU / ALU
The outer packaging is cardboard.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Ferring Läkemedel AB
Box 4041
203 11 Malmö
tel: 040-691 69 00
Manufacturer
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany