Package leaflet: Information for the patient

Nicergolin
10 mg, tablets
Nicergolinum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Nicergolin is and what it is used for
Important information before taking Nicergolin
How to take Nicergolin
Possible side effects
How to store Nicergolin
Contents of the pack and other information

1. What Nicergolin is and what it is used for

Nicergoline, the active substance in this medicine, affects cerebral and peripheral circulation, reduces vascular resistance, inhibits platelet aggregation (clumping), and increases blood flow in blood vessels. Nicergoline stimulates metabolic processes in brain cells and enhances oxygen and glucose utilization. Due to these properties, it improves impaired brain function caused by hypoxia.
Indications
Nicergolin is used in mild to moderate dementia.
Nicergolin is indicated for use in adults.

2. Important information before using Nicergolin

When not to use Nicergolin

if the patient is allergic to nicergoline or any of the other ingredients of this medicine (listed in section 6),
if the following conditions are present: acute bleeding, shock, acute phase of myocardial infarction or recent myocardial infarction, severe bradycardia (slowed heart rate below 50 beats per minute), hypotension or tendency to sudden drop in blood pressure upon changing position from lying to standing,
if the patient is concurrently using alpha- or beta-adrenolytic drugs (used in the treatment of hypertension and ischemic heart disease),
during pregnancy,
during childbirth,
during breastfeeding,
if the patient has current or past history of fibrotic reactions (fibrosis) affecting the heart muscle, lungs, peritoneum or retroperitoneal space.

Warnings and precautions
Before starting treatment with Nicergolin, consult a doctor:

if the patient has cardiac rhythm disorders, e.g. bradycardia,
if the patient has impaired kidney function (serum creatinine concentration > 2 mg%), in which case the doctor will recommend a reduced dose,
if the patient has elevated uric acid levels or a past history of gout,
if the patient is being treated with drugs that may affect metabolism and excretion of uric acid, e.g. allopurinol, probenecid,
if the patient is concurrently using anticoagulant, antiplatelet drugs or antihypertensive medications.

If blood pressure decreases during treatment with Nicergolin, the doctor will recommend discontinuation of the drug.
In patients receiving long-term nicergoline therapy, the doctor will check heart, lung and kidney function before initiating treatment. During treatment, the doctor will pay special attention to any signs potentially indicating fibrosis development. Appropriate tests will be performed if necessary. Treatment will be discontinued if fibrosis occurs.
During treatment with Nicergolin, symptoms typical of ergot alkaloid poisoning (ergotism) may occur, such as: nausea, vomiting, diarrhea, abdominal pain, numbness and tingling in fingers and toes, confusion, muscle pain in limbs, cyanosis (see also "Use of higher than recommended dose of Nicergolin" in section 3 of the leaflet). In such cases, immediate medical advice should be sought.

Nicergolin and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient intends to take.

Nicergoline enhances the effect of antihypertensive drugs. It should not be administered concurrently with other alpha- or beta-adrenolytic drugs (used in the treatment of hypertension and heart disease), as this may lead to bradycardia (slowed heart rate) and excessive drop in blood pressure.
Nicergoline may interact with antiarrhythmic drugs, beta-blockers used in the treatment of hypertension and certain heart conditions, and tricyclic antidepressants.
Caution is advised when using concurrently with drugs affecting uric acid metabolism (e.g. for gout).
Nicergoline enhances the anticoagulant effect of antiplatelet drugs, anticoagulants and acetylsalicylic acid, thus prolonging bleeding time.

Taking Nicergolin with food, drink and alcohol
See section 3.
Alcohol should not be consumed during treatment with Nicergolin, as it may intensify adverse effects on the nervous system.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Nicergolin should not be used during pregnancy. It is unknown whether nicergoline passes into human breast milk; therefore, Nicergolin should not be used during breastfeeding.

Driving and operating machinery
Nicergolin may cause drowsiness, fatigue, dizziness and reduced reaction speed.
Patients should avoid driving and operating machinery until they are certain that the medicine does not cause the aforementioned adverse effects.

Nicergolin contains lactose
One tablet contains 167.2 mg of lactose (equivalent to 176 mg of monohydrate lactose). If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Nicergolin

This medicine should always be used as prescribed by the physician. In case of doubt, consult
your doctor.
Usually, the medicine is used as described below.
Adults
The recommended initial dose is from 30 mg of nicergoline to 60 mg of nicergoline per day, i.e.
from 3 to 6 tablets per day in 2 or 3 divided doses.
Treatment is continued using the initial dose or by reducing the dose depending on the patient's
condition.
The medicine should be taken orally before meals; in case of gastrointestinal discomfort, during
meals. Swallow the tablet whole with water.
Patients with impaired renal and (or) hepatic function
In patients with renal insufficiency (serum creatinine concentration > 2 mg%), the physician will
recommend reducing the dose of the medicine.
Elderly patients
There is no need to modify the method of administration or dosage of the medicine in elderly
patients.
If you feel that the effect of Nicergolin is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Nicergolin
If you have taken more than the recommended dose, seek immediate medical advice.
Symptoms of overdose:
Slight decrease in blood pressure, which usually does not require treatment. Nicergoline poisoning,
similar to that caused by other ergot alkaloids, manifests as disturbances in peripheral circulation
such as decreased arterial pressure (dizziness, fainting), cold skin. There is no specific antidote.
Symptomatic treatment should be administered. In acute poisoning, gastric lavage and administration
of activated charcoal are indicated.
Missed dose of Nicergolin
Do not take a double dose to make up for a missed dose.
Stopping Nicergolin
If you have any further questions regarding the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Common adverse reactions (occur in 1 to 10 out of 100 patients): abdominal discomfort.
Uncommon adverse reactions (occur in 1 to 10 out of 1,000 patients): agitation, confusion, insomnia, drowsiness, dizziness, headache, hypotension, facial flushing, constipation, diarrhoea, nausea, pruritus, increased blood uric acid concentration.
Frequency not known (cannot be estimated from available data): feeling of warmth, rash.
With long-term use of nicergoline, reactions in the form of fibrosis (scarring) of the heart muscle, lungs, peritoneal and retroperitoneal tissues may occur.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store the medicine Nicergolin

Keep the 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 stated month.
Store below 25ºC.
Keep in the original packaging to protect from light and moisture.
Medicines must 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. Each tablet contains 10 mg of nicergoline.
The other components are: monohydrate lactose, potato starch, magnesium stearate, talc.

What Nicergolin looks like and contents of the pack
Nicergolin is an oral tablet.
Packaging:
In a cardboard box there is 1 glass bottle made of amber glass containing 30 tablets.
Marketing Authorisation Holder and Manufacturer
Farmaceutyczna Spółdzielnia Pracy FILOFARM
ul. Pułaskiego 39
85-619 Bydgoszcz
For further information regarding this medicinal product, please contact the representative of the Marketing Authorisation Holder.
Farmaceutyczna Spółdzielnia Pracy FILOFARM
ul. Pułaskiego 39, 85-619 Bydgoszcz
Tel.: 52 342 67 88
Information for blind and partially sighted people: The package leaflet of Nicergolin is available in the Audio Leaflet system via the nationwide free telephone number 800 706 848.