Nicerin

Package Leaflet: Information for the Patient

Nicerin, 10 mg, Film-Coated Tablets

Nicergoline

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. 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 or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Nicerin and what is it used for

Nicerin belongs to a group of medicines called peripheral vasodilators. Nicergoline, the active substance of this medicine, improves blood flow in the brain and has anti-aggregating properties (prevents platelet aggregation).
Nicerin is indicated for the treatment of patients with mild and moderate dementia.

2. Important information before taking Nicerin

When not to take Nicerin:

• if you are allergic to nicergoline, other ergotamine derivatives, or any of the other ingredients of this medicine (listed in section 6);
• in patients with recent myocardial infarction;
• in case of bleeding;
• in case of severe bradycardia (slow heart rate);
• in patients with arterial hypotension or orthostatic hypotension in history (decrease in blood pressure associated with a change in body position from lying to standing);
• in case of concomitant use of alpha or beta-mimetic drugs (e.g., drugs used in asthma and rhinitis).

Warnings and precautions

Before starting treatment with Nicerin, discuss it with your doctor or pharmacist:

• if you have increased uric acid levels in your blood;
• if you have a history of gout;
• if you are taking medicines that may affect uric acid metabolism and excretion.

Nicergoline may lower systolic blood pressure, and to a lesser extent, diastolic blood pressure in patients with normal and elevated blood pressure.

• diastolic blood pressure in patients with normal and elevated blood pressure.

The use of ergotamine derivatives may cause fibrotic reactions (e.g., lungs, heart, heart valves, retroperitoneal space).
If there are any doubts about the use of the medicine, you should consult a doctor or pharmacist.
In case of severe nausea, vomiting, diarrhea, abdominal pain, and peripheral vasoconstriction, you should contact a doctor or pharmacist, as these symptoms may indicate ergotamine poisoning.

Nicerin with other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Nicerin may enhance the effects of blood pressure-lowering medicines.
Nicerin may interact with anti-arrhythmic medicines, beta-adrenergic receptor blockers used to treat hypertension and certain heart diseases, and tricyclic antidepressants.
Nicerin may increase the negative inotropic effects (inhibiting heart activity) of beta-adrenergic receptor blockers.
Concomitant use of Nicerin and anti-aggregant or anticoagulant medicines (including acetylsalicylic acid) may prolong bleeding time.
The use of medicines that affect uric acid metabolism and excretion (e.g., those used to treat gout) may alter uric acid metabolism and excretion.

Nicerin with food, drink, and alcohol

See section 3.
As with other medicines that act on the nervous system, concurrent consumption of alcohol may enhance the nervous system-related side effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Nicerin should not be used during pregnancy. If administration is unavoidable, it should be done under the direct supervision of a doctor.
It is not known whether nicergoline passes into breast milk. Nicerin should not be used during breastfeeding.

Driving and using machines

No studies have been conducted on the effects of the medicine on the ability to drive and use machines.
However, when driving or operating machinery, you should take into account the possibility of dizziness or drowsiness.

Nicerin contains 60 mg of lactose monohydrate

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Nicerin

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Your doctor will determine the dose and duration of treatment.
Nicergoline is administered in doses of 10 mg to 60 mg per day. The medicine should be taken in two doses: during breakfast and lunch.
The film-coated tablets of Nicerin should be swallowed whole with water during breakfast and lunch. The tablets should not be chewed.
Long-term administration of Nicerin is recommended; after 6 months, your doctor will assess whether treatment should be continued.

Elderly patients

In elderly patients, there is no need to adjust the dosage.

Patients with renal impairment

In patients with renal impairment, the doctor will reduce the dose.

Overdose of Nicerin

In case of overdose and symptoms indicating significant lowering of blood pressure (dizziness, fainting), the doctor will prescribe appropriate symptomatic treatment if necessary.
In acute poisoning, gastric lavage should be performed and activated charcoal administered.
In case of overdose, you should immediately consult a doctor or pharmacist.

Missed dose of Nicerin

Take the missed dose as soon as possible, except when the next dose is near. Do not take a double dose to make up for the missed dose. If in doubt, consult your doctor.

Stopping treatment with Nicerin

Do not stop treatment without consulting your doctor.

4. Possible side effects

Like all medicines, Nicerin can cause side effects, although not everybody gets them.
The side effects listed below are classified by system organ class and frequency of occurrence.
Common side effects(may affect up to 1 in 10 people): abdominal discomfort.
Uncommon side effects(may affect up to 1 in 100 people): 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, fibrosis (e.g., lungs, heart, heart valves, retroperitoneal space).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 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 Nicerin

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

• The active substance of Nicerin is nicergoline. Each tablet contains 10 mg of nicergoline.
• The other ingredients are: Tablet core: lactose monohydrate, maize starch, microcrystalline cellulose PH-101, povidone K 25, crospovidone, magnesium stearate. Tablet coating: hypromellose E5-LV, hypromellose E15-LV, eudragit E100, glycerol, propylene glycol, polysorbate 80, titanium dioxide (E 171).

What Nicerin looks like and contents of the pack

Nicerin, 10 mg: white or almost white, round, biconvex film-coated tablets.
Available pack sizes:
Nicerin, 10 mg is packaged in blisters placed in a carton containing 30, 50, or 60 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert Str. 23
40764 Langenfeld
Germany

Manufacturer

Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic

For further information, please contact the marketing authorization holder:

Neuraxpharm Polska Sp. z o.o.
ul. Domaniewska 37
02-672 Warsaw

Date of last revision of the leaflet: