Thioctic acid Zentiva

Leaflet accompanying the packaging: patient information

Thioctic acid Zentiva, 600 mg, film-coated tablets
Acidum thiocticum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Thioctic acid Zentiva and what is it used for

Alpha-lipoic acid, the active substance of Thioctic acid Zentiva, is a substance produced by the body and has an effect on certain metabolic processes. Alpha-lipoic acid has antioxidant properties that protect nerve cells from breakdown products.
Thioctic acid Zentiva is used to treat the symptoms of peripheral (sensory-motor) diabetic neuropathy.

2. Important information before taking Thioctic acid Zentiva

When not to take Thioctic acid Zentiva

Warnings and precautions

Before starting treatment with Thioctic acid Zentiva, the patient should discuss it with their doctor or pharmacist.
Patients with a certain genotype of human leukocyte antigen (which is more common in Japanese and Korean races, but also occurs in Caucasian races) are more prone to developing autoimmune insulin syndrome (a disorder affecting hormones regulating blood sugar levels) during treatment with thioctic acid.
The patient may notice a different smell of urine after taking thioctic acid, but this has no clinical significance.

Children and adolescents

Thioctic acid Zentiva should not be used in children and adolescents due to the lack of sufficient clinical data for this age group.

Thioctic acid Zentiva and other medicines

The patient should inform their doctor or pharmacist about any medicines they are currently taking or have recently taken, as well as any medicines they may take.
Taking Thioctic acid Zentiva may neutralize the effect of cisplatin (an anticancer medicine). Alpha-lipoic acid, the active substance of Thioctic acid Zentiva, chemically interacts with metal ions, so it cannot be administered simultaneously with substances containing these metals (e.g., iron products, magnesium products, dairy products due to their calcium content). If the patient takes the medicine 30 minutes before breakfast, iron and magnesium products can be taken at lunchtime or in the evening.
Thioctic acid Zentiva enhances the effect of antidiabetic medicines (insulin and/or other oral antidiabetic medicines) that lower blood sugar levels, so constant monitoring of blood sugar levels is required, especially after starting treatment with Thioctic acid Zentiva. In individual cases, it may be necessary to reduce the dose of insulin and/or other oral antidiabetic medicines to avoid symptoms of hypoglycemia.

Taking Thioctic acid Zentiva with food and drink

Regular alcohol consumption is a significant risk factor for the development and progression of neuropathy and also has a negative impact on the outcome of treatment with Thioctic acid Zentiva. Therefore, patients with diabetes are advised to avoid consuming alcohol as much as possible, even during treatment breaks.

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 taking this medicine.
Pregnancy
Animal studies have not shown any indirect or direct toxic effects on reproduction. Thioctic acid Zentiva should be used during pregnancy only after a careful analysis of the risk to benefit ratio. A pregnant woman may be treated with Thioctic acid Zentiva only in exceptional cases and under medical supervision.
Breastfeeding
It is not known whether thioctic acid or its metabolites pass into breast milk. A decision should be made to either discontinue breastfeeding or discontinue Thioctic acid Zentiva, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the woman.
Fertility
Reproductive toxicity studies have not shown any risk related to fertility.

Driving and using machines

There are no data indicating that Thioctic acid Zentiva may impair the ability to drive or operate machines.

Thioctic acid Zentiva contains lactose

Thioctic acid Zentiva contains lactose (3.125 mg in one tablet) as an excipient.
If the patient has a medically confirmed intolerance to some sugars, they should consult their doctor before starting treatment with this medicine.

3. How to take Thioctic acid Zentiva

This medicine should always be taken exactly as advised by the doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
The recommended dose is one film-coated tablet of Thioctic acid Zentiva (600 mg of alpha-lipoic acid) per day. Thioctic acid Zentiva should be taken whole, with a liquid, on an empty stomach. Taking the medicine with food may reduce the absorption of alpha-lipoic acid.
Therefore, it is recommended to take the entire dose of the medicine 30 minutes before breakfast, especially in patients with prolonged digestion time.
Since peripheral neuropathy is a chronic disease, it requires long-term treatment with Thioctic acid Zentiva.
The doctor will decide on the treatment individually.
If the patient feels that the effect of Thioctic acid Zentiva is too weak or too strong, they should consult their doctor or pharmacist.

Taking a higher dose of Thioctic acid Zentiva than recommended

In case of taking too high a dose, nausea, vomiting, and headache may occur.
In single cases, serious, partly life-threatening symptoms of poisoning (including generalized tonic-clonic seizures, acid-base imbalance with accompanying acidosis, and/or severe coagulation disorders) have been observed after taking more than 10 g of alpha-lipoic acid, especially in combination with alcohol.
In case of suspected overdose of Thioctic acid Zentiva (e.g., >10 tablets of 600 mg in adult patients and >50 mg/kg body weight in children), the patient should be immediately referred to a hospital and standard treatment for poisoning should be initiated (induction of vomiting, gastric lavage, administration of activated charcoal).
Seizures, acid-base imbalance, and other life-threatening symptoms require intensive therapy.

Missing a dose of Thioctic acid Zentiva

A double dose should not be taken to make up for a missed dose. The next dose should be taken at the usual time and treatment should be continued as advised by the doctor.

Stopping treatment with Thioctic acid Zentiva

The patient should consult their doctor before deciding to stop treatment, otherwise, symptoms may worsen.
In case of any further doubts about the use of the medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Thioctic acid Zentiva can cause side effects, although not everybody gets them.
Frequent(may affect up to 1 in 10 people): nausea, dizziness.
Very rare(may affect up to 1 in 10,000 people): vomiting, abdominal pain, diarrhea, taste disorders, headache, sweating, vision disturbances, allergic skin reactions (including skin rash, urticaria, and itching).
In very rare cases, blood sugar levels may decrease due to improved glucose utilization. In such cases, symptoms similar to hypoglycemia have been observed, including dizziness, sweating, headache, and vision disturbances.
Frequency not known:disorders affecting hormones regulating blood sugar levels with a significant decrease in these levels (autoimmune insulin syndrome).
If any of the above side effects occur, the patient should stop taking Thioctic acid Zentiva.
The patient should inform their doctor, who will assess the severity of the side effects and take further appropriate action.
In case of the first symptoms of an allergic reaction, the patient should stop taking the medicine and immediately contact their doctor.
If the patient notices any side effects not mentioned in this leaflet, they should inform their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should inform their doctor or pharmacist. 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:
Aleje Jerozolimskie 181C,
02-222 Warsaw,
phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Thioctic acid Zentiva

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after EXP. The expiry date refers to the last day of the month.
Do not store above 25°C.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Thioctic acid Zentiva contains

• The active substance is alpha-lipoic acid (thioctic acid) in a dose of 600 mg in one tablet.
• The other ingredients are: tablet core: microcrystalline cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate, anhydrous colloidal silica, talc. tablet coating (Insta coat aqua III IA -III 40382 yellow): hypromellose 2910, macrogol 6000, lactose monohydrate, titanium dioxide (E171), talc, quinoline yellow (E104).

What Thioctic acid Zentiva looks like and what the pack contains

Yellow, oval, biconvex, film-coated tablet, smooth on both sides.
The tablets are packaged in 3 or 6 transparent blisters made of PVC/PVDC/Aluminum foil, containing 10 tablets, in an appropriate size cardboard box, with a patient information leaflet attached.
Pack sizes: 30, 60, 90.
Not all pack sizes may be marketed.

Marketing authorization holder

Marketing authorization holder:
Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer/Importer

S.C. Labormed Pharma S.A.
44B Theodor Pallady Blvd., 3 rd district
032266 Bucharest
Romania

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Bulgaria: Тиоктик ацид Зентива 600 mg филмирани таблетки
Poland: Thioctic acid Zentiva
Portugal: Ácido lipoico Zentiva
Romania: Thioctic acid Zentiva 600 mg comprimate filmate
Hungary: Thioctic acid Zentiva 600 mg filmtabletta

For further information about this medicine, please contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
Bonifraterska 17 street
00-203 Warsaw
phone: +48 22 375 92 00

Date of last revision of the leaflet: