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.
• If you have any further questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on to others.
• It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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 pack 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 can 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 can 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 you are allergic to quinagolide or any of the other ingredients of this medicine (listed in section 6). If you have severe liver or kidney problems.

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 a "starter pack". Since a decrease in blood pressure can cause fainting, it is recommended to measure blood pressure while lying down and standing during the first few days of treatment and after increasing the dose. The medicine can cause dizziness, so it should be taken before bedtime. You should remember this, especially when taking the first few doses of the medicine. You should inform your doctor about any liver or kidney problems. In women with prolactin-dependent infertility, treatment with Norprolac may restore fertility. Therefore, women of childbearing age who do not want to become pregnant should use effective contraception. You should exercise special caution in patients with a history of psychotic episodes. You should inform your doctor if you or your loved ones notice unusual behavior resulting from 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 sleepiness should not drive vehicles or operate machines. Additionally, your doctor may consider reducing the dose or stopping the 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 the medicines you are taking now or have taken recently, 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:You should 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 using machines

Norprolac can cause sleepiness and (or) sudden sleep attacks, especially in the first few days of treatment. You should not drive vehicles or perform activities (e.g., operate machines) that require attention, as this may put you 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 exactly as prescribed by your doctor. If you are unsure, consult your 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, your doctor may recommend gradual dose increase 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.

What to do if you take more Norprolac than you should

If you take more Norprolac than you should, tell your doctor immediately. The main symptoms of overdose may include: nausea, vomiting, pain, dizziness, sleepiness, low blood pressure, and sometimes fainting. Hallucinations (seeing, hearing, or feeling things that are not there) may also occur.

What to do if you miss a dose of Norprolac

If you miss a dose, take it as soon as possible. However, if it is less than 4 hours until the next dose, skip the missed dose. 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 patients treated: dizziness, headache, nausea, vomiting, fatigue. The following common side effectsaffect between 1 and 10 in every 100 patients treated: loss of appetite, insomnia, orthostatic hypotension (decrease in blood pressure when changing position from lying down to standing), nasal congestion, abdominal pain, constipation, diarrhea, muscle weakness. The following rare side effectsaffect between 1 and 10 in every 10,000 patients treated: transient acute psychosis, sleepiness. Frequency not known- cannot be estimated from the available data: The following side effects may occur: inability to resist impulse, urge, or compulsion to perform certain actions that may be harmful to you or others; this includes: 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. You should 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. It is not possible to exclude the risk of hypersensitivity reactions. Taking the medicine before bedtime reduces the risk of side effects.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 pack and other information

What Norprolac contains

• The active substance 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, anhydrous colloidal silica. 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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