Nicergolin

Package Leaflet: Information for the Patient

Nicergolin

10 mg, tablets

Nicergolinum

Read the package 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 or pharmacist.
• 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Nicergolin and what is it used for

Nicergoline, the active substance of the medicine, affects cerebral and peripheral circulation, reduces vascular resistance, inhibits platelet aggregation, and increases blood flow in blood vessels. Nicergoline stimulates metabolic processes in brain cells, increases oxygen and glucose utilization. Thanks to these properties, it improves impaired brain function due to hypoxia.

Indications for Use

Nicergolin is used for mild and moderate dementia.
Nicergolin is indicated for use in adults.

2. Important information before taking Nicergolin

When not to take Nicergolin

• if you are allergic to nicergoline or any of the other ingredients of this medicine (listed in section 6),
• if you have: acute bleeding, shock, acute phase of myocardial infarction and recent myocardial infarction, severe bradycardia (heart rate below 50 beats per minute), hypotension or tendency to sudden decrease in blood pressure when changing body position from lying to standing,
• if you are taking alpha- or beta-adrenergic blockers (used to treat hypertension and coronary heart disease),
• in pregnancy,
• during childbirth,
• during breastfeeding,
• if you have currently or in the past had reactions in the form of fibrosis (scarring) of the heart muscle, lungs, peritoneum, or retroperitoneum.

Warnings and precautions

Before starting treatment with Nicergolin, discuss it with your doctor:

• if you have heart rhythm disorders, such as bradycardia,
• if you have impaired kidney function (serum creatinine > 2 mg%), your doctor will recommend a dose reduction,
• if you have increased uric acid levels, a history of gout,
• if you are taking medications that may affect uric acid metabolism and excretion, such as allopurinol, probenecid.
• if you are taking anticoagulant, anti-aggregant, and blood pressure-lowering medications.

If, during treatment with Nicergolin, your blood pressure drops, your doctor will recommend stopping the medicine.
In the case of patients taking nicergoline for a long time, before starting treatment, the doctor will check if the heart, lungs, and kidneys are functioning properly. During treatment, the doctor will pay special attention to any signs potentially related to the occurrence of fibrosis. If necessary, appropriate tests will be performed. If fibrosis occurs, treatment will be discontinued.
During treatment with Nicergolin, symptoms typical of ergot alkaloid poisoning (ergotism) may occur, such as: nausea, vomiting, diarrhea, abdominal pain, numbness and tingling in the fingers and toes, confusion, muscle pain in the limbs, cyanosis (see also "Taking a higher dose of Nicergolin than recommended" in section 3 of the leaflet). You should then immediately consult a doctor.

Nicergolin and other medicines

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

• Nicergoline enhances the effect of antihypertensive medicines. The medicine should not be administered simultaneously with other alpha- and beta-adrenergic blockers (used to treat hypertension and heart disease), as bradycardia (slow heart rate) and excessive blood pressure reduction may occur.
• Nicergoline may interact with anti-arrhythmic medications, beta-adrenergic receptor blockers used to treat hypertension and certain heart diseases, and tricyclic antidepressants.
• Caution should be exercised when taking medications that affect uric acid metabolism (e.g., against gout).
• Nicergoline enhances the anticoagulant effect of anti-aggregant, anticoagulant medications, and acetylsalicylic acid, so the bleeding time may be prolonged.

Taking Nicergolin with food, drink, and alcohol

See section 3.
Do not drink alcohol while taking Nicergolin, as it may enhance the undesirable effects of the medicine on the nervous system.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Nicergolin should not be taken during pregnancy. It is not known whether nicergoline passes into breast milk, so Nicergolin should not be taken during breastfeeding.

Driving and using machines

Nicergolin may cause drowsiness, fatigue, dizziness, and reduced reaction speed.
Avoid driving and operating machines until you are sure that the medicine does not cause these effects.

Nicergolin contains lactose

1 tablet contains 167.2 mg of lactose (which is 176 mg of lactose monohydrate). If you have been diagnosed with intolerance to some sugars, contact your doctor before taking the medicine.

3. How to take Nicergolin

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Normally, the medicine is taken as described below.

Adults

The recommended initial dose is 30 mg to 60 mg of nicergoline per day, which is 3 to 6 tablets per day in 2 or 3 divided doses.
Treatment is continued with the initial dose or the dose is reduced depending on the patient's condition.
The medicine should be taken orally before a meal, and if gastrointestinal disorders occur, during a meal. Swallow the tablet whole with water.
Patient with renal and/or hepatic impairment
In patients with renal impairment (serum creatinine > 2 mg%), the doctor will recommend a dose reduction.
Elderly patients
There is no need to modify the administration and dosage of the medicine in elderly patients.
If you feel that the effect of Nicergolin is too strong or too weak, consult your doctor.

Taking a higher dose of Nicergolin than recommended

If you have taken more than the recommended dose, consult your doctor immediately.
Overdose symptoms:
Slight decrease in blood pressure, which usually does not require treatment. Nicergoline poisoning, like other ergot alkaloids, manifests as peripheral circulation disorders in the form of decreased blood pressure (dizziness, fainting), skin cooling. There is no specific antidote. Symptomatic treatment should be used. In acute poisoning, gastric lavage and activated charcoal are used.

Missing a dose of Nicergolin

Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Nicergolin

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects(occurring in 1 to 10 in 100 patients): discomfort in the abdominal cavity.
Uncommon side effects(occurring in 1 to 10 in 1,000 patients): excitement, confusion, insomnia, drowsiness, dizziness, headache, hypotension, facial flushing, constipation, diarrhea, nausea, itching, increased uric acid levels in the blood.
Frequency not known(cannot be estimated from the available data): feeling of heat, rash.
During long-term treatment with nicergoline, fibrotic reactions (scarring) of the heart muscle, lungs, peritoneum, and retroperitoneum may occur.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nicergolin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
Store in a temperature below 25°C.
Store in the original packaging to protect from light and moisture.
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 Nicergolin contains

• The active substance is nicergoline. 1 tablet contains 10 mg of nicergoline.
• The excipients are: lactose monohydrate, potato starch, magnesium stearate, talc.

What Nicergolin looks like and contents of the pack

Nicergolin is an oral tablet.
Packaging:
A cardboard box contains 1 glass vial made of orange glass, containing 30 tablets.

Marketing authorization holder and manufacturer

Pharmaceutical Cooperative FILOFARM
ul. Pułaskiego 39
85-619 Bydgoszcz
For more detailed information on this medicine, contact the representative of the marketing authorization holder.
Pharmaceutical Cooperative FILOFARM
ul. Pułaskiego 39, 85-619 Bydgoszcz
Phone: 52 342 67 88
Information for the blind and visually impaired: The content of the Nicergolin leaflet is available in the Ulotka Audio system under the national free phone number 800 706 848.

Date of last revision of the leaflet: