Package leaflet: Information for the patient

Nilogrin, 10 mg, film-coated tablets
Nilogrin, 30 mg, film-coated tablets
Nicergoline
Please read this leaflet carefully before using the medicine, because
it contains important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. 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 adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What Nilogrin is and what it is used for

Nilogrin contains nicergoline as the active substance – a synthetic derivative of ergot alkaloids with multiple effects on brain metabolism and cerebral and peripheral circulation.
Indications: Mild to moderate dementia.

2. Important information before using Nilogrin

When not to use Nilogrin:
If the patient is allergic to nicergoline or to any of the other ingredients of this
medicine (listed in section 6).
Acute cerebral haemorrhage.
Arterial hypotension or tendency to orthostatic (posture-related) drops in blood pressure.
Pregnancy and breastfeeding.
Recent myocardial infarction.
Severe bradycardia (slow heart rate).
Concomitant use of β-adrenomimetic drugs (e.g. adrenaline).

Warnings and precautions
Nicergoline may enhance the effect of antihypertensive medicines taken concomitantly. Patients taking such medicines should exercise caution during the initial period of nicergoline treatment, as excessive lowering of blood pressure may occur.

Caution is advised in patients with increased blood uric acid levels, history of gout, or those treated with drugs that may affect uric acid metabolism and excretion.

Since nicergoline reduces platelet aggregation and blood viscosity, and may enhance the effect of antiplatelet and anticoagulant drugs, particular caution is required in patients taking such medicines concomitantly.

Due to the possibility of increased adverse effects on the central nervous system, alcohol should not be consumed during treatment with nicergoline.

If any other disturbing symptoms occur during treatment with Nilogrin, the medicine should be discontinued and medical advice sought.
Medical advice should be sought, even if the above warnings refer to conditions that occurred in the past.

Exercise special caution in certain specific patient groups:
Children and adolescents
Nilogrin should not be used in children.

Use of Nilogrin in patients with renal and/or hepatic impairment:
Dosage should be reduced in patients with renal insufficiency (serum creatinine above 2 mg/dL).
Dosage adjustment is not required in patients with hepatic insufficiency.

Use of Nilogrin in elderly patients:
Dosage adjustment is not required.

Nilogrin and other medicines
Inform your doctor about all medicines currently taken or recently taken, as well as any medicines planned for use.
Nicergoline may enhance the effect of antihypertensive drugs, antiplatelet drugs (e.g. acetylsalicylic acid), and anticoagulants.
Alcohol may increase the undesirable effects of nicergoline on the central nervous system.

Nilogrin with food and drink
The medicine should be taken before meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
The medicine should not be used during pregnancy and breastfeeding.

Driving and operating machinery
Since nicergoline may cause adverse effects on the central nervous system (e.g. drowsiness and dizziness), patients should not drive or operate machinery if such symptoms occur.

Nilogrin contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to use Nilogrin

This medicine should always be taken exactly as directed by your doctor.
If in doubt, consult your doctor.
Adults:
The dose should be individually adjusted according to the response to treatment.
The daily dose of nicergoline ranges from 10 to 60 mg. The most commonly used dose is 30 mg per day
(3 times 1 tablet of 10 mg) or 60 mg per day (2 times 1 tablet of 30 mg).
In sensitive patients in whom nicergoline causes difficulty falling asleep or insomnia,
administration in two daily doses is recommended, omitting the evening dose taken before bedtime.
In patients requiring once-daily administration of nicergoline, the entire daily dose should be taken in the morning.
If you feel that the effect of Nilogrin is too strong or too weak, consult your doctor.
Taking more Nilogrin than recommended
If you take more than the recommended dose, contact your doctor immediately.
After ingestion of large doses of nicergoline, a decrease in arterial blood pressure may occur,
which usually does not require any specific treatment other than placing the patient in a horizontal position.
In severe cases, administration of drugs to raise blood pressure and monitoring of blood pressure and other vital functions may be necessary.
To remove unabsorbed nicergoline from the gastrointestinal tract, the doctor may perform gastric lavage and administer activated charcoal.
Missing a dose of Nilogrin
If you miss a dose, take it as soon as possible.
However, if it is almost time for the next dose, take the next dose at the regular time.
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Nicergoline is generally well tolerated; most adverse effects are mild and transient in nature, usually not requiring discontinuation of treatment. The possible adverse effects of nicergoline are listed below, classified by system organ class.

Cardiac disorders, vascular disorders
Hypotension, bradycardia.

Central and peripheral nervous system disorders
Excessive sweating, sleep disturbances, fainting, agitation, drowsiness, dizziness, insomnia, restlessness, hot flushes (feeling of warmth and facial flushing), increased appetite.

Gastrointestinal disorders
Nausea, vomiting, gastric hyperacidity, heartburn.

Reproductive system and breast disorders
Inability to achieve ejaculation (this effect is a known adverse reaction of α-adrenolytic drugs).

Respiratory, thoracic and mediastinal disorders
Changes in the pleura and lungs. Symptoms usually resolve after several months of discontinuing the ergoline derivative.

Skin and subcutaneous tissue disorders
Erythema, urticaria.

Immune system disorders
Hypersensitivity reactions.

General disorders and administration site conditions
Malaise.

In some individuals during treatment with Nilogrin, other adverse effects may occur.

If any adverse symptoms not mentioned in this leaflet occur, consult a physician.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions at 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
Adverse effects may also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Nilogrin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Store below 25 °C.

6. Contents of the packaging and other information

What Nilogrin contains

The active substance is nicergoline.
The other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate anhydrous, polyvinyl alcohol, sodium carboxymethyl starch (type A), magnesium stearate.
Coating composition: hypromellose E 15, hypromellose E 5, macrogol 8000, hydroxypropylcellulose, titanium dioxide (E 171).

What Nilogrin looks like and contents of the pack
Nilogrin 10 mg coated tablets: 30, 50, 60, 90 or 120 tablets
Nilogrin 30 mg coated tablets: 30 tablets

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów