NORPROLAC 75 mcg. 30 tablets

What is Norprolac and what it is used
Norprolac contain hinagolid who belongs to a group of medicines known as inhibitors of prolactin. Honagolid reduced secretion of the hormone prolactin.
Norprolac be used for treatment of elevated levels of the hormone prolactin in the blood as a result of the prolactin-secreting pituitary tumor or unknown origin.

2. What you need to know before taking Norprolac
Do not take Norprolac:
if you are allergic to hinagolid or any of the other ingredients of this medicine (listed in section 6);
if you have impaired kidney or liver function.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Norprolac:
if you have a prolactin-induced infertility, since fertility can be restored by treatment with Norprolak. Women of childbearing age who do not wish to become pregnant should use reliable method of contraception during treatment with Norprolak (see also section "Pregnancy and lactation");
If any of the following conditions: mental illness or dysfunction of the liver or kidneys;
if you are a child or adolescent under 18 years of age;
if you are elderly.
Tell your doctor if you or someone in your family / caregiver notice that you develop a strong desire to behave in ways unusual for you, and you can not resist the impulse, the urge or temptation to perform certain activities that can harm you and others. These are disorders of impulse control and may include behaviors such as addiction to gambling, excessive eating and spending, unusually increased sex drive, enhance sexual thoughts or feelings. You may need your doctor to adjust the dose or discontinue treatment.
Norprolak can cause a temporary decrease in blood pressure upon standing. You may experience dizziness, which in rare cases can lead to loss of consciousness. It is recommended that your doctor to measure your blood pressure during the first few days of treatment and after dose increases.
Blood pressure monitoring is more appropriate if you have severe heart disease.

Other medicines and Norprolac
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.

Other medicines may affect the effectiveness and tolerability of Norprolak:
drugs that block dopamine receptors (eg. antipsychotic drugs) may reduce the prolactin-inhibiting effect of Norprolak;
drugs that affect serotonin receptors (eg. antidepressants) or dopamine receptors (eg. drugs for the treatment of Parkinson's disease, severe migraine, etc.);
drugs which have been proven as potent inhibitors of the enzymes involved in the metabolism of drugs.

Norprolac with food, drinks and alcohol
Tolerability Norprolac may be reduced by alcohol intake.

Pregnancy and lactation
Data for Norprolac intake during pregnancy are limited. If you become pregnant or plan to become pregnant during treatment with Norprolak, talk to your doctor. Norprolak therapy should be discontinued at the confirmation of pregnancy, unless your doctor has recommended otherwise.
Breast-feeding is usually not possible because Norprolac suppresses lactation. You should not breastfeed, even if it is possible because it is not known whether hinagolid passes into breast milk.
Ask your doctor or pharmacist before taking this medicine.

Driving and using machines
In some patients, Norprolac can cause reduced ability to react during the first days of taking what should be considered when caution is required, eg. when driving or performing a precise activity.
In rare cases, patients can fall asleep suddenly without feeling tired before. If this applies to you, you should not drive or participate in activities in which reduced alertness could put you and others at risk of serious injury (eg. Using machines).

Norprolac contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Norprolac
Always take this medicine exactly as you have been told by your doctor or pharmacist. If you're not sure, ask your doctor or pharmacist.

Adults
Norprolac should be taken with food once daily in the evening.
Dosage is individual and your doctor will prescribe a suitable dose for you.
Treatment is usually started with a dose of 25 micrograms once daily for the first 3 days followed by 50 micrograms once daily for the next 3 days. On day 7, the dose is 75 micrograms per day, which may be increased until the optimal dosage. The recommended dose is 75-150 micrograms a day. Some patients may need 300 micrograms or more per day.

Use in children and adolescents
Experience in children and adolescents is limited.

Use in Elderly
Experience in elderly patients is limited.

If you take more than the amount Norprolac
If you take more than you should or if a child has taken this medicine by accident, please contact your doctor or go to the nearest hospital.
Expected symptoms of overdose are nausea, vomiting, headache, dizziness, drowsiness, fall in blood pressure and hallucinations.

If you forget to take Norprolac
If you forget to take Norprolac one day then continue in the normal dose the next day.
Do not take a double dose to make up the missed dose as it can cause side effects.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects are dose dependent, therefore, do not change the prescribed dose without the knowledge of your doctor. Most side effects occur during the first day of therapy and subside during therapy.

Very common (may affect more than 1 in 10 patients):
dizziness;
headache;
nausea;
vomiting;
fatigue.
Common (may affect up to 1 in 10 patients):
temporary decrease in blood pressure on standing up (in rare cases can lead to loss of consciousness);
anorexia (loss of appetite);
trouble sleeping;
nasal congestion;
stomach ache;
constipation;
diarrhea;
muscle weakness.
Rare (may affect up to 1 in 1000 patients):
acute psychosis which resolved upon discontinuation of therapy;
somnolence (extreme drowsiness).
Other (frequency can not be estimated from the available data):
inability to resist the impulse, the desire or temptation to perform activities that can harm you and others, like this include:
a strong impetus to excessive betting on gambling, despite serious family and personal effects;
altered or increased sexual interest and behavior is essential for you and others around you, for example. increased sexual desire;
uncontrolled excessive shopping and spending;
binge eating (receiving large amounts of food in a short period of time) or compulsive eating (taking more than the normal amount of food and more than is necessary for satiation of hunger).
If you get any of these behaviors, discuss with your doctor how to deal with them or reducing them.
Should not exclude the risk of hypersensitivity reactions.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Norprolac
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
Store in the original container to protect from light and moisture. Do not store above 25 ° C
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information
What Norprolac
Tablets 25 micrograms:
The active substance is 25 micrograms hinagolid hinagolid as hydrochloride.
The other ingredients are lactose monohydrate, iron oxide red (E172), microcrystalline cellulose, corn starch, hypromellose, magnesium stearate, silica colloidal anhydrous.

Tablets 50 micrograms:
The active substance is 50 micrograms hinagolid as hinagolid hydrochloride.
The other ingredients are lactose monohydrate, indigo carmine (E132), microcrystalline cellulose, corn starch, hypromellose, magnesium stearate, silica colloidal anhydrous.

Tablets 75 micrograms:
The active substance is 75 micrograms hinagolid hinagolid as hydrochloride.
The other ingredients are lactose monohydrate, microcrystalline cellulose, corn starch, hypromellose, magnesium stearate, silica colloidal anhydrous.

Tablets 150 micrograms:
The active substance is 150 micrograms hinagolid hinagolid as hydrochloride.
The other ingredients are lactose monohydrate, microcrystalline cellulose, corn starch, hypromellose, magnesium stearate, silica colloidal anhydrous.

Norprolac looks like and contents of the pack
Norprolac 25 microgram tablets:
Pale pink with isolated pigment spots, circular, flat with bevelled edges, with a diameter of 7 mm.
Inscriptions: "NORPROLAC", a circular on one side and "25" linear on the other side.

Norprolac 50 microgram tablets:
Pale blue with isolated pigment spots, circular, flat with bevelled edges, with a diameter of 7 mm.
Inscriptions: "NORPROLAC", a circular on one side and "50" linear on the other side.

Norprolac 75 microgram tablets:
White, round, flat with bevelled edges, with a diameter of 7 mm.
Inscriptions: "NORPROLAC", a circular on one side and "75" linear on the other side.

Norprolac 150 microgram tablets:
White, round, flat with bevelled edges, with a diameter of 7 mm.
Inscriptions: "NORPROLAC", a circular on one side and "150" linear on the other side.

Package Contents
Packing for dose titration: +50 25 micrograms: 3+ 3 tablets
Packaged in a blister of ALU / PVC / PVDC, sealed in moisture-proof aluminum bag.
The outer packaging is a cardboard box.

75 microgram: 30 tablets.
150 microgram: 30 tablets.
Packaged in blisters of ALU / ALU.
The outer packaging is a cardboard box.
Not all pack sizes may be marketed.

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