Neurolipon-mip 600

Package Leaflet: Information for the Patient

Neurolipon-MIP 600, 600 mg, soft capsules
Acidum thiocticum
Read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

• This leaflet should be kept in case it needs to be read again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Neurolipon-MIP 600 and what is it used for
• 2. Important information before using Neurolipon-MIP 600
• 3. How to use Neurolipon-MIP 600
• 4. Possible side effects
• 5. How to store Neurolipon-MIP 600
• 6. Contents of the package and other information

1. What is Neurolipon-MIP 600 and what is it used for

Neurolipon-MIP 600 is available in the form of soft capsules containing thioctic acid (also known as alpha-lipoic acid). Thioctic acid is endogenously produced by higher organisms and affects metabolic processes in the body.
Indications
Conditions associated with diabetic polyneuropathy.

2. Important information before using Neurolipon-MIP 600

When not to use Neurolipon-MIP 600

• -if the patient is allergic to thioctic acid or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Patients with a specific human leukocyte antigen genotype (more common in patients from Japan and Korea, but also found in people of white race) are more prone to the development of autoimmune insulin syndrome (disorders related to hormones regulating blood glucose levels with a visible decrease in these levels) during treatment with thioctic acid.

Children and adolescents

The medicine should be used with special caution in children and adolescents, as no clinical trials have been conducted in this patient group.

Neurolipon-MIP 600 and other medicines

Concomitant use of thioctic acid may lead to a decrease in the effectiveness of cisplatin.
The action of insulin or other oral antidiabetic medicines may be enhanced when used with thioctic acid. For this reason, frequent monitoring of blood glucose levels is recommended during the initial phase of treatment with thioctic acid.
In individual cases, to prevent hypoglycemia, it may be necessary to reduce the dose of insulin or oral antidiabetic medicines.

Using Neurolipon-MIP 600 with food, drink, and alcohol

During treatment with thioctic acid, alcohol should be avoided at all costs. Alcohol and its metabolites weaken the action of thioctic acid

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
No safety studies have been conducted on the use of thioctic acid during pregnancy. The medicine may only be used in pregnant women after careful consideration by the doctor of the benefit-risk ratio.
During breastfeeding, thioctic acid should not be used, as no relevant studies have been conducted.

Driving and using machines

The medicine has no influence or negligible influence on the ability to drive and use machines.
Neurolipon-MIP 600 contains amaranth –a dye that may cause allergic reactions and 72 mg of sorbitol in each capsule.

3. How to use Neurolipon-MIP 600

This medicine should always be used in accordance with the doctor's or pharmacist's recommendations. In case of doubts, consult a doctor or pharmacist.
Adults, in conditions caused by diabetic polyneuropathy, 1 capsule per day.
In severe conditions caused by severe diabetic polyneuropathy, the doctor may initially decide to use parenteral therapy.
The medicine can be taken regardless of meals, washed down with an appropriate amount of liquid.
Diabetic polyneuropathy is a chronic disease, and it may be necessary to constantly take the medicine.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
No side effects have been observed after oral administration of thioctic acid.
Side effects are known after intravenous administration. The frequency of side effects after intravenous administration is defined as follows:
unknown frequency: cannot be determined based on available data.
Blood and lymphatic system disorders:
unknown frequency: thrombocytopenia (platelet disorders).
General disorders and administration site conditions:
unknown frequency: headache, breathing difficulties, hives or rash at the injection site, cramps.
Immune system disorders:
unknown frequency: anaphylactic shock (acute, sometimes life-threatening, generalized allergic reaction of the body), disorders related to hormones regulating blood glucose levels with a visible decrease in these levels (autoimmune insulin syndrome).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. 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, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Neurolipon-MIP 600

The medicine should be stored in a place that is out of sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the blister pack and carton:
Expiry date. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Neurolipon-MIP 600 contains

• -The active substance of the medicine is thioctic acid
• -The other ingredients are: solid fat, triglycerides of saturated fatty acids with a medium chain length, dry substance obtained from 70% liquid sorbitol, non-crystallizing, glycerol 85%, gelatin, titanium dioxide (E 171), amaranth (E 123)

What Neurolipon-MIP 600 looks like and what the package contains

The medicine is in the form of soft capsules.
The capsules are packaged in HPVC/Aluminum blisters.
The package contains 10, 30, or 100 soft capsules, along with the patient information leaflet, in a cardboard box.
Not all pack sizes may be marketed.

Responsible entity and manufacturer

Responsible entity

MIP Pharma Polska Sp. z o.o.
ul. Orzechowa 5
80-175 Gdańsk
Tel: 58 303 93 62
Fax.: 58 322 16 13
e-mail: [email protected]

Manufacturer

Chephasaar GmbH
Mühlstrasse 50
D-66386 St. Ingbert
Germany

Date of the last update of the leaflet: