Neurolipon-mip 600
Poland
Table of Contents
Package leaflet: Information for the patient
Neurolipon-MIP 600, 600 mg, soft capsules
Acidum thiocticum
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.
- Keep this leaflet so that you can read it again if necessary.
- If you have any doubts, 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 any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents of the leaflet
- What Neurolipon-MIP 600 is and what it is used for
- Important information before taking Neurolipon-MIP 600
- How to take Neurolipon-MIP 600
- Possible side effects
- How to store Neurolipon-MIP 600
- Contents of the pack and other information
1. What Neurolipon-MIP 600 is and what it is 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 in higher organisms and influences metabolic processes occurring in the body.
Indications
Symptoms associated with diabetic polyneuropathy.
2. 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 genotype of human leukocyte antigens (more common in patients from Japan and Korea, but also found in white individuals) are more susceptible to developing autoimmune insulin syndrome (disorders affecting hormones regulating blood glucose levels, with a noticeable decrease in glucose concentrations) during treatment with thioctic acid. Children and adolescents Neurolipon-MIP 600 should be used with particular caution in children and adolescents, as clinical studies have not been conducted in this patient group. Neurolipon-MIP 600 with other medicines Concomitant use of thioctic acid may reduce the effectiveness of cisplatin.
The action of insulin or other oral antidiabetic medicines may be enhanced when used simultaneously with thioctic acid. For this reason, frequent monitoring of blood glucose levels is recommended at the beginning of treatment with thioctic acid. In individual cases, to prevent hypoglycaemia, it may be necessary to reduce the dose of insulin or oral antidiabetic medicines.
Taking Neurolipon-MIP 600 with food, drink and alcohol
During treatment with thioctic acid, alcohol consumption must be strictly avoided. Alcohol and its metabolites reduce the effectiveness of thioctic acid.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The safety of thioctic acid use during pregnancy has not been established. The medicine may be used in pregnant women only after careful consideration by the physician of the benefit-risk ratio.
Thioctic acid should not be used during breastfeeding, as adequate studies have not been conducted.
Driving and operating machinery
This medicine has no effect or has a negligible effect on the ability to drive and operate machinery.
Neurolipon-MIP 600 contains amaranth – a dye which may cause allergic reactions – and 72 mg of sorbitol in each capsule.
3. How to use Neurolipon-MIP 600
This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Adults, for symptoms caused by diabetic polyneuropathy: 1 capsule per day.
In severe symptoms caused by severe diabetic polyneuropathy, the doctor may initially
decide to use parenteral therapy.
The medicine may be taken regardless of meals, with an adequate amount of fluid.
Diabetic polyneuropathy is a chronic disease, and continuous use of the medicine may be necessary.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
No adverse reactions have been observed so far following oral administration of thioctic acid.
Adverse reactions are known following intravenous administration. The frequency of adverse reactions after intravenous administration is defined as follows:
Frequency not known: cannot be estimated from the available data.
Blood and lymphatic system disorders:
Frequency not known: purpura, thrombocytopathy (platelet function disorders).
General disorders and administration site conditions:
Frequency not known: headache, breathing difficulties, urticaria or rash at injection site, spasms.
Immune system disorders:
Frequency not known: anaphylactic shock (acute, sometimes life-threatening, generalized allergic reaction), disorders affecting hormones regulating blood glucose concentration with evident reduction in blood levels of these hormones (autoimmune insulin syndrome).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of the medicine can be collected.
5. How to store Neurolipon-MIP 600
Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the blister and carton after:
Expiry date. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures will help protect the environment.
6. Contents of the pack and other information
What Neurolipon-MIP 600 contains
- The active substance is thioctic acid
- The other ingredients are: hard fat, medium-chain saturated triglycerides, dry substance obtained from 70% liquid non-crystallizing sorbitol, glycerol 85%, gelatin, titanium dioxide (E 171), amaranth (E 123)
What Neurolipon-MIP 600 looks like and contents of the pack
The medicine is in the form of soft capsules. The capsules are packed in blisters made of HPVC/Aluminium foil. The pack contains 10, 30 or 100 soft capsules together with the package leaflet in a cardboard box. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
MIP Pharma Polska Sp. z o.o.
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