Nilogrin

Package Leaflet: Information for the Patient

Nilogrin, 10 mg, Film-Coated Tablets

Nilogrin, 30 mg, Film-Coated Tablets

Nicergoline

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Have Any Further Questions, Ask Your Doctor or Pharmacist.
• This Medication 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 Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.

Package Leaflet Contents:

• 1. What is Nilogrin and What is it Used For
• 2. Important Information Before Taking Nilogrin
• 3. How to Take Nilogrin
• 4. Possible Side Effects
• 5. How to Store Nilogrin
• 6.Package Contents and Other Information

1. What is Nilogrin and What is it Used For

Nilogrin Contains Nicergoline as the Active Substance – a Synthetic Derivative of Ergoline Alkaloids with a Multidirectional Effect on Brain Metabolism and Cerebral and Peripheral Circulation.
Indications for Use: Mild and Moderate Dementia.

2. Important Information Before Taking Nilogrin

When Not to Take Nilogrin:

If You are Allergic to Nicergoline or Any of the Other Ingredients of this Medication (Listed in Section 6).
Acute Cerebral Hemorrhage.
Arterial Hypotension or a Tendency to Orthostatic (Related to Standing) Decreases in Blood Pressure.
Pregnancy and Breastfeeding.
Recent Myocardial Infarction.
Severe Bradycardia (Slow Heart Rate).
Concomitant Use of β-Adrenergic Agonists (e.g., Adrenaline).

Warnings and Precautions

Nicergoline May Enhance the Effect of Concomitantly Administered Antihypertensive Medications. Patients Taking Such Medications Should Exercise Caution in the Initial Period of Nicergoline Administration, as Excessive Blood Pressure Reduction May Occur.
Caution Should be Exercised in Patients with Elevated Uric Acid Levels in the Blood, a History of Gout, and Those Treated with Medications 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 Medications, Patients Taking Such Medications Concomitantly Should Exercise Particular Caution.
Due to the Possibility of Enhanced Adverse Reactions on the Central Nervous System, Alcohol Should Not be Consumed During Treatment with Nicergoline.
If Any Other Concerning Symptoms Occur During Treatment with Nilogrin, the Medication Should be Discontinued and the Doctor Consulted.
Consult a Doctor, Even if the Above Warnings Refer to Past Situations.
Exercise Particular Caution in Certain Special Groups Taking the Medication:

Children and Adolescents

The Medication Should Not be Used in Children.
Using Nilogrin in Patients with Renal and/or Hepatic Impairment:
In Patients with Renal Insufficiency (Serum Creatinine Above 2 mg/dl), the Dose of the Medication Should be Reduced.
No Dose Adjustment is Necessary in Patients with Hepatic Insufficiency.
Using Nilogrin in the Elderly:
No Dose Adjustment is Necessary.

Nilogrin and Other Medications

Tell Your Doctor About All Medications You are Currently Taking or Have Recently Taken, as Well as Those You Plan to Take.
Nicergoline May Enhance the Effect of Antihypertensive Medications, Antiplatelet Medications (e.g., Acetylsalicylic Acid), and Anticoagulants.
Alcohol May Enhance the Adverse Effects of Nicergoline on the Central Nervous System.

Nilogrin with Food and Drink

The Medication Should be Taken Before Meals.

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 Medication.
The Medication Should Not be Used During Pregnancy and Breastfeeding.

Driving and Operating Machinery

Since Nicergoline May Cause Adverse Reactions on the Central Nervous System (e.g., Drowsiness and Dizziness), Do Not Drive or Operate Machinery if Such Symptoms Occur.

Nilogrin Contains Sodium

The Medication Contains Less than 1 mmol (23 mg) of Sodium per Tablet, Which Means the Medication is Considered "Sodium-Free".

3. How to Take Nilogrin

Always Take this Medication Exactly as Your Doctor has Told You.
In Case of Doubt, Consult Your Doctor.
Adults:
The Dose is Determined Individually, Depending on the Response to Treatment.
Daily Doses of Nicergoline Range from 10 to 60 mg. Most Often, 30 mg per Day (3 Times 1 Tablet of 10 mg) or 60 mg per Day (2 Times 1 Tablet of 30 mg) are Administered.
In Sensitive Patients Who Experience Difficulty Falling Asleep or Insomnia Due to Nicergoline, it is Recommended to Administer the Medication in Two Daily Doses, Omitting the Evening Dose Before Going to Bed. In Patients Requiring Once-Daily Administration of Nicergoline, the Entire Daily Dose Should be Administered in the Morning.
If You Feel that the Effect of Nilogrin is Too Strong or Too Weak, Consult Your Doctor.

Taking a Higher Dose of Nilogrin than Recommended

In Case of Taking a Higher Dose of the Medication than Recommended, Consult Your Doctor Immediately.
After Taking High Doses of Nicergoline, a Decrease in Arterial Blood Pressure May Occur, Which Usually Does Not Require Any Special Treatment, Apart from Placing the Patient in a Horizontal Position. In Severe Cases, the Use of Medications that Increase 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

In Case of Missing a Dose, Take it as Soon as Possible.
However, if the Time for the Next Dose is Approaching, Take the Next Dose at the Regular Time.
Do Not Take a Double Dose to Make Up for the Missed Dose.

4. Possible Side Effects

Like All Medications, Nilogrin Can Cause Side Effects, Although Not Everybody Gets Them.
Nicergoline is Generally Well-Tolerated; Most Side Effects are Mild and Transient, Usually Not Requiring Discontinuation of Treatment. The Following Possible Side Effects of Nicergoline are Listed According to System and Organ Class.
Cardiac Disorders, Vascular Disorders
Hypotension, Bradycardia (Rare).
Nervous System Disorders
Excessive Sweating, Sleep Disturbances, Fainting, Excitement, Drowsiness, Dizziness, Insomnia, Anxiety, Hot Flashes (Feeling of Heat and Facial Redness), Increased Appetite.
Gastrointestinal Disorders
Nausea, Vomiting, Gastric Acid Hypersecretion, Heartburn.
Reproductive System and Breast Disorders
Impotence (a Known Side Effect of α-Adrenergic Blocking Agents).
Respiratory, Thoracic, and Mediastinal Disorders
Changes in the Pleura and Lungs. Symptoms Usually Resolve Within a Few Months After Discontinuation of the Ergoline Derivative.
Skin and Subcutaneous Tissue Disorders
Flush, Urticaria.
Immune System Disorders
Hypersensitivity Reactions.
General Disorders and Administration Site Conditions
Malaise.
In Some Individuals, Other Side Effects May Occur During Treatment with Nilogrin.
If You Experience Any Side Effects Not Listed in this Package Leaflet, Consult Your Doctor.

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Listed in the Package Leaflet, Tell Your Doctor, Pharmacist, or Nurse. Side Effects Can be Reported Directly to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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 the Medication.

5. How to Store Nilogrin

Keep the Medication Out of Sight and Reach of Children.
Do Not Use the Medication After the Expiration Date Stated on the Packaging.
The Expiration Date Refers to the Last Day of the Specified Month.
Store at a Temperature Not Exceeding 25°C.

6. Package Contents and Other Information

What Nilogrin Contains

• The Active Substance is Nicergoline.
• The Other Excipients are: Microcrystalline Cellulose, Anhydrous Calcium Hydrogen Phosphate, Polyvinyl Alcohol, Sodium Carboxymethylcellulose (Type A), Magnesium Stearate.
• Coating: Hypromellose E 15, Hypromellose E 5, Macrogol 8000, Hydroxypropylcellulose, Titanium Dioxide (E 171).

What Nilogrin Looks Like and Contents of the Package

Nilogrin 10 mg Film-Coated Tablets: 30, 50, 60, 90, or 120 Tablets
Nilogrin 30 mg Film-Coated Tablets: 30 Tablets

Marketing Authorization 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

Date of the Last Update of the Package Leaflet: