Norprolac

PATIENT INFORMATION LEAFLET

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Leaflet accompanying the packaging: patient information

NORPROLAC, 25 micrograms, 50 micrograms, tablets

NORPROLAC, 75 micrograms, tablets

Quinagolide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor.
• This medicine has been prescribed specifically for you. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor. See section 4.

Table of contents of the leaflet:

• 1. What is Norprolac and what is it used for
• 2. Important information before taking Norprolac
• 3. How to take Norprolac
• 4. Possible side effects
• 5. How to store Norprolac
• 6. Contents of the packaging and other information

1. What is Norprolac and what is it used for

Norprolac inhibits the release of a hormone called prolactin from the pituitary gland. Under normal conditions, the level of prolactin in the blood increases after childbirth, causing milk production by the breast. Sometimes, the level of prolactin in the blood may become very high, even in men or women who have not given birth. This can cause unwanted milk production, infrequent or absent menstrual periods, infertility, and decreased libido. An increase in prolactin levels may be caused by the presence of a pituitary tumor (Prolactinoma). Norprolac is indicated for the treatment of hyperprolactinemia (idiopathic or caused by a micro- or macroprolactinoma).

2. Important information before taking Norprolac

When not to take Norprolac

If the patient is allergic to quinagolide or any of the other ingredients of this medicine (listed in section 6). If the patient has severe liver or kidney function disorders.

Warnings and precautions

Before starting treatment with Norprolac, discuss it with your doctor. The side effects of Norprolac include dizziness, which occurs most frequently during the first few days of treatment. Therefore, the dose of the medicine should be increased gradually with the help of the "starter pack". Since a decrease in blood pressure may cause fainting, it is recommended to measure blood pressure in a lying and standing position during the first few days of treatment and after increasing the dose. The medicine may cause dizziness, so it should be taken before bedtime. Remember this, especially when taking the first few doses of the medicine. Inform your doctor about liver or kidney function disorders. In women with fertility disorders related to prolactin, treatment with Norprolac may restore fertility. Therefore, women of childbearing age who do not want to become pregnant should use effective contraception. Particular caution should be exercised in patients with a history of psychotic episodes. Inform your doctor if you or your loved ones notice unusual behavior resulting from an irresistible impulse, compulsion, or urge to perform certain actions that may be harmful to you or others. Such behaviors are called impulse control disorders and may include a strong impulse to gamble uncontrollably, despite significant personal or family consequences, changed or increased sexual interests and behaviors of great importance to you or others, e.g., activities related to increased libido, compulsive or binge eating, or uncontrolled spending. Your doctor may decide to adjust the treatment or discontinue the medicine. Patients who experience somnolence should not drive vehicles or operate machines. Additionally, your doctor may consider reducing the dose or discontinuing treatment. Alcohol may decrease the body's tolerance to Norprolac.

Children and adolescents

Experience with the use of Norprolac in children is limited.

Elderly

Experience with the use of Norprolac in the elderly is limited.

Norprolac and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Norprolac with food, drink, and alcohol

Norprolac should be taken once a day before bedtime with a small amount of food. Consuming alcohol during treatment with Norprolac may increase the risk of side effects or their severity.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine. Pregnancy:Inform your doctor about pregnancy or planned pregnancy. Experience with the use of Norprolac in pregnant women is very limited. In case of pregnancy, the medicine should be discontinued unless the doctor recommends continued treatment. No increased frequency of miscarriages has been observed after discontinuation of the medicine. Breastfeeding:Women taking Norprolac should not breastfeed, as the medicine inhibits milk production. If milk production is not completely inhibited, breastfeeding is not recommended, as it is not known whether quinagolide passes into breast milk.

Driving and operating machines

Norprolac may cause somnolence and/or sudden sleep attacks, especially during the first few days of treatment. The patient should not drive vehicles or perform activities (e.g., operate machines) that require unimpaired ability, as this may put themselves or others at risk of serious injury or death.

Norprolac contains lactose monohydrate

If you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Norprolac

This medicine should always be taken according to the doctor's recommendations. In case of doubts, consult a doctor. Norprolac should be taken once a day before bedtime with a small amount of food. Treatment usually starts with a "starter pack", taking one 25 microgram tablet for the first 3 days and one 50 microgram tablet for the next 3 days. From the seventh day, the recommended dose is 75 micrograms per day. If necessary, the doctor may recommend gradual dose increases until a satisfactory treatment effect is achieved. The average daily dose is 75 micrograms or 150 micrograms. Some patients may require daily doses of 300 micrograms or more.

Taking a higher dose of Norprolac than recommended

In case of taking a higher dose of the medicine than recommended, inform your doctor immediately. The main symptoms of overdose may include: nausea, vomiting, pain, dizziness, somnolence, decreased blood pressure, and sometimes fainting. Hallucinations (seeing, hearing, or feeling things that are not there) may also occur.

Missing a dose of Norprolac

If a dose is missed, take it as soon as possible. However, do not take the medicine if there are less than 4 hours until the next dose. In this case, take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Norprolac can cause side effects, although not everybody gets them. Most side effects are dose-dependent and temporary. Side effects are rarely severe enough to require discontinuation of treatment. The following very common side effectsaffect more than 10 in every 100 treated patients: dizziness, headache, nausea, vomiting, fatigue. The following common side effectsaffect between 1 and 10 in every 100 treated patients: loss of appetite, insomnia, orthostatic hypotension (decrease in blood pressure when changing position from lying to standing), impaired nasal passage, abdominal pain, constipation, diarrhea, muscle weakness. The following rare side effectsaffect between 1 and 10 in every 10,000 treated patients: transient acute psychosis, somnolence. Frequency not known- cannot be estimated from the available data: The following side effects may occur: impulse control disorders, such as a strong impulse to gamble uncontrollably, despite significant personal or family consequences, changed or increased sexual interests and behaviors of great importance to you or others, e.g., activities related to increased libido, compulsive or binge eating, or uncontrolled spending. Inform your doctor if you experience any of these behaviors to discuss ways to control or limit these symptoms. Orthostatic hypotension may rarely lead to fainting. An allergic reaction cannot be excluded. Taking the medicine before bedtime reduces the risk of side effects.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, inform your doctor. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Aleje Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Norprolac

Keep the medicine out of the sight and reach of children. Store in a temperature not exceeding 25°C. Do not use this medicine if you notice that the packaging is damaged or shows signs of opening. Do not use this medicine after the expiry date stated on the packaging after the words "Expiry date". The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Norprolac contains

• The active substance of the medicine is quinagolide in the form of quinagolide hydrochloride. One tablet contains 25, 50, or 75 micrograms of quinagolide.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, maize starch, hypromellose, magnesium stearate, silicon dioxide, anhydrous colloidal. The 25 microgram tablets also contain red iron oxide. The 50 microgram tablets also contain indigo carmine.

What Norprolac looks like and contents of the pack

The 25 microgram tablets are pink. On one side, there is a circular inscription "NORPROLAC", on the other side, a linear inscription "25". The 50 microgram tablets are blue. On one side, there is a circular inscription "NORPROLAC", on the other side, a linear inscription "50". The 75 microgram tablets are white. On one side, there is a circular inscription "NORPROLAC", on the other side, a linear inscription "75". One pack of Norprolac 25 micrograms, 50 micrograms ("starter pack") contains 3 tablets of 25 micrograms and 3 tablets of 50 micrograms. One pack of Norprolac 75 micrograms contains 30 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Ferring GmbH, Wittland 11, D-24109 Kiel, Germany. For more detailed information, please contact the representative of the marketing authorization holder: Ferring Pharmaceuticals Poland Sp. z o.o., ul. Szamocka 8, 01-748 Warsaw, Tel.: +48 22 246 06 80, Fax: +48 22 246 06 81

Date of last revision of the leaflet:

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