THIOCTIC ACID DELFARMA

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Thioctic acid Delfarma (Tiotop), 600 mg, coated tablets
Acidum thiocticum
Thioctic acid Delfarma and Tiotop are different brand names of the same medicinal product.
Please read carefully the entire 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 questions, please 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 identical.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Alpha-lipoic acid, the active substance in Thioctic acid Delfarma, is a substance produced by the body and influences certain metabolic processes. Alpha-lipoic acid has antioxidant properties that protect nerve cells from breakdown products.
Thioctic acid Delfarma is used in the treatment of symptoms of peripheral (sensory-motor) diabetic neuropathy.

2. Important information before using Thioctic acid Delfarma

When not to use Thioctic acid Delfarma

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

Warnings and precautions
Before starting treatment with Thioctic acid Delfarma, discuss this with your doctor or
pharmacist.
Patients with a certain human leukocyte antigen genotype (more common in Japanese and Korean populations, but also present in Caucasians) are more susceptible to developing autoimmune insulin syndrome (a disorder affecting hormones regulating serum glucose levels, leading to a significant decrease in blood sugar) during treatment with thioctic acid.
The patient may notice a different odour of urine after administration of thioctic acid; however, this has no clinical significance.
Children and adolescents
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Thioctic acid Delfarma must not be used in children and adolescents due to insufficient clinical data in this age group.
Thioctic acid Delfarma and other medicines
Inform your doctor or pharmacist about any medicines currently taken or recently taken, as well as any medicines that may be taken in the future.
Treatment with Thioctic acid Delfarma may neutralize the effect of cisplatin (an anticancer drug). Alpha-lipoic acid, the active substance in Thioctic acid Delfarma, chemically interacts with metal ions; therefore, it must not be administered simultaneously with substances containing these metals (e.g., iron-containing products, magnesium-containing products, dairy products due to their calcium content). If the patient takes the medicine 30 minutes before breakfast, iron- and magnesium-containing products may be taken at lunchtime or in the evening.
Thioctic acid Delfarma enhances the effect of antidiabetic drugs (insulin and/or other oral antidiabetic drugs) that lower blood serum glucose concentration; therefore, constant monitoring of blood glucose levels is required, especially after starting treatment with Thioctic acid Delfarma. In individual cases, it may be necessary to reduce the dose of insulin and/or other oral antidiabetic drugs to avoid symptoms of hypoglycaemia.
Taking Thioctic acid Delfarma with food and drink
Regular alcohol consumption is an important risk factor for the development and progression of neuropathy and therefore also negatively affects the outcome of treatment with Thioctic acid Delfarma. For this reason, patients with diabetes are generally advised to avoid alcohol consumption as much as possible, including during treatment breaks.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Animal studies have not shown direct or indirect toxic effects on reproduction. Thioctic acid Delfarma should be used during pregnancy only after careful assessment of the benefit-risk ratio. A pregnant woman may be treated with Thioctic acid Delfarma only in exceptional cases and only under medical supervision.
Breastfeeding
It is not known whether thioctic acid or its metabolites pass into human milk. A decision should be made whether to discontinue breastfeeding or to discontinue therapy with Thioctic acid Delfarma, taking into account the benefits of breastfeeding for the child and the benefits of therapy for the woman.
Fertility
Reproductive toxicity studies have not indicated any risk to fertility.
Driving and operating machinery
There are no data indicating that Thioctic acid Delfarma may impair the ability to drive or operate machinery.
Thioctic acid Delfarma contains lactose monohydrate
Thioctic acid Delfarma contains lactose (34.79 mg per tablet) as an excipient. If the patient has been diagnosed by a doctor as having intolerance to certain sugars, consult a doctor before starting treatment with this medicine.

3. How to use Thioctic acid Delfarma

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This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
The recommended dose is 1 coated tablet of Thioctic acid Delfarma (600 mg of alpha-
lipoic acid) per day. Thioctic acid Delfarma should be taken whole, with liquid, on an empty
stomach. Taking the medicine with food may reduce the absorption of alpha-
lipoic acid. Therefore, it is recommended that the total daily dose be taken 30 minutes before
breakfast, especially in patients with prolonged digestion.
Since peripheral polyneuropathy is a chronic condition, long-term treatment with Thioctic acid Delfarma
is required.
The physician will decide on treatment individually.
If the patient feels that the effect of treatment with Thioctic acid Delfarma is too weak or too strong,
consult a physician or pharmacist.
Taking more Thioctic acid Delfarma than recommended
If too high a dose is taken, nausea, vomiting, and headache may occur.
In isolated cases, serious, partly life-threatening symptoms of poisoning (including generalized
seizure, acid-base imbalance with accompanying acidosis, and/or severe coagulation disorders)
have been observed after ingestion of more than 10 g of alpha-
lipoic acid, particularly in combination with alcohol.
In case of any suspicion of overdose of Thioctic acid Delfarma (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 hospital and standard poisoning treatment procedures initiated (induction of vomiting, gastric lavage, administration of activated charcoal).
Seizures, symptoms resulting from acid-base imbalance, and other life-threatening symptoms require intensive therapy.
Missed dose of Thioctic acid Delfarma
Do not take a double dose to make up for a missed dose. Take the next dose at the regular time and continue treatment as directed by the physician.
Stopping treatment with Thioctic acid Delfarma
Consult a physician before deciding to discontinue treatment, otherwise symptoms may worsen.
If you have any further doubts concerning the use of this medicine, consult a physician or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Common (may affect up to 1 in 10 people): nausea, dizziness.
Very rare (may affect up to 1 in 10,000 people): vomiting, abdominal pain, diarrhoea, taste disturbances, headache, sweating, visual disturbances, allergic skin reactions (including skin rash, urticaria and itching).
In very rare cases, blood glucose concentration may decrease due to improved glucose utilization. In such cases, symptoms resembling hypoglycaemia have been observed, including dizziness, sweating, headache and visual disturbances.
Frequency not known: disturbances related to hormones regulating serum glucose concentration leading to a marked decrease in these concentrations (autoimmune insulin syndrome).
If any of the adverse effects listed above occur, discontinue use of Thioctic acid Delfarma.
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Inform your doctor, who will assess their severity and take any further appropriate actions.
In case of the first signs of an allergic reaction, stop using the medicine and contact your doctor immediately.
If you notice that any adverse effect becomes severe or is not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects 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,
tel.: +48 22 49 21 301,
fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Reporting adverse effects allows the collection of further information on the safety of using the medicine.

5. How to store Thioctic acid Delfarma

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store below 25°C in the original packaging.
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 packaging and other information

What Thioctic acid Delfarma contains

• The active substance is alpha-lipoic acid (thioctic acid) at a dose of 600 mg per tablet.
• Other components are: tablet core: microcrystalline cellulose, hypromellose, magnesium stearate, colloidal anhydrous silica, lactose monohydrate, simethicone, sodium croscarmellose.
  tablet coating (Opadry 200 Optimized Performance Coating 200F210038 Green): polyethylene glycol 3350, polyethylene glycol 4000, titanium dioxide (E 171), talc, quinoline yellow, aluminium lake (E 104), polyvinyl alcohol – partially hydrolysed, methacrylic acid and ethyl acrylate copolymer (1:1), FD&C blue No. 2 indigo carmine, aluminium lake (E 132), sodium hydrogen carbonate.

What Thioctic acid Delfarma looks like and contents of the pack
Green, elongated, biconvex coated tablets.
The tablets are packed in PVC/PE/PVDC-Al blisters containing 10 tablets, placed in a cardboard box of appropriate size, together with the patient leaflet.
Pack sizes: 30, 60, 90.
For more detailed information, please contact the responsible party or the parallel importer.
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Marketing Authorisation Holder in Bulgaria, country of export:
World Medicine Europe Ltd., Bul. Simeonovsko Shose 130, fl. 3, 1700 Sofia, Bulgaria
Manufacturer:
World Medicine Europe Ltd., Bul. "Bulgaria" No 110, BX. A, ap. 8, 1618 Sofia, Bulgaria
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation Number in Bulgaria, country of export: 20220272
Parallel Import Licence Number: 34/26
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