Thiogamma Turbo-set

Package Leaflet: Information for the Patient

Thiogamma Turbo-Set,

600 mg/50 ml, solution for infusion
(Acidum thiocticum)

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

• Keep this leaflet, you may need to read it again.
• Ask your doctor, pharmacist, or nurse if you have any further questions.
• This medicine has been prescribed for you only. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Thiogamma Turbo-Set and what is it used for
• 2. Important information before using Thiogamma Turbo-Set
• 3. How to use Thiogamma Turbo-Set
• 4. Possible side effects
• 5. How to store Thiogamma Turbo-Set
• 6. Contents of the pack and other information

1. What is Thiogamma Turbo-Set and what is it used for

The active substance of Thiogamma Turbo-Set is thioctic acid. This substance is produced naturally in the human and animal body. Thioctic acid has an effect on many metabolic processes. Additionally, thioctic acid acts as an antioxidant.
Thiogamma Turbo-Set is used to treat pain and paresthesia (sensory symptoms such as burning, stabbing, itching, or tingling) in diabetic nerve damage (polyneuropathy).

2. Important information before using Thiogamma Turbo-Set

When not to use Thiogamma Turbo-Set

• if you are allergic to thioctic acid or any of the other ingredients of this medicine (listed in section 6).
• if you have liver or kidney failure.
• in children and adolescents.

Warnings and precautions

• During parenteral administration of Thiogamma Turbo-Set, hypersensitivity reactions, including anaphylactic shock, have occurred. For this reason, the doctor will order appropriate monitoring of the patient. In case of early symptoms (e.g., itching, nausea, malaise), the doctor will order the treatment to be discontinued and, if necessary, other treatment to be applied.
• Thioctic acid may cause hypoglycemia. In diabetic patients, the doctor will order blood glucose monitoring.
• In patients with uncontrolled or poorly controlled diabetes and in poor general condition, severe anaphylactic reactions may occur during treatment with the medicine.
• Thioctic acid may induce autoimmune insulin syndrome and cause cholestatic hepatitis.
• Patients with a specific human leukocyte antigen genotype (more common in patients from Japan and Korea, but also found in white people) are more prone to autoimmune insulin syndrome (disorders of hormones regulating blood glucose levels with visible decrease in these levels) during thioctic acid treatment.

regarding the hormones regulating blood glucose levels with a visible decrease in these levels) during thioctic acid treatment.

Children and adolescents

Thiogamma Turbo-Set should not be used in children and adolescents due to the lack of clinical trials in this patient group.

Other medicines and Thiogamma Turbo-Set

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Be particularly careful if you are taking any of the following medicines:

• cisplatin (a medicine used in anticancer chemotherapy) - concomitant use of Thiogamma Turbo-Set with cisplatin reduces the effect of cisplatin.
• insulin and other oral antidiabetic medicines - the effect of antidiabetic medicines lowering blood sugar levels may be enhanced. Close monitoring of blood sugar levels is recommended, especially at the beginning of treatment with Thiogamma Turbo-Set. To avoid symptoms of excessive lowering of blood sugar levels, it may be necessary to reduce the dose of insulin or other oral antidiabetic medicine in individual cases.

Thiogamma Turbo-Set with food, drink, and alcohol

While taking Thiogamma Turbo-Set, you should absolutely avoid consuming alcohol.
Alcohol increases the risk of disease progression and may cause nerve damage and reduce the effect of the medicine. This also applies to periods between treatments.

Pregnancy, breastfeeding, and fertility

There are no data on the use of thioctic acid in pregnant women. Thiogamma Turbo-Set is not recommended for use in pregnant women and women of childbearing age not using effective contraception methods.
It is not known whether thioctic acid passes into breast milk. Thiogamma Turbo-Set should not be used during breastfeeding.

Driving and using machines

No studies have been conducted on the effect of thioctic acid on the ability to drive and operate machinery.

3. How to use Thiogamma Turbo-Set

This medicine should always be used according to the doctor's instructions. The doctor will determine the dose and treatment method suitable for the individual patient. If you have any doubts, ask your doctor.
Treatment of diabetic polyneuropathy should be started and supervised by specialist doctors experienced in diagnosing and treating neuropathy, according to current standards.
Detailed dosing and administration instructions are provided at the end of the leaflet, in the section "Information intended exclusively for healthcare professionals".
The primary requirement for the treatment of diabetic polyneuropathy is optimal metabolic control of diabetes.
If the effect of Thiogamma Turbo-Set is too strong or too weak, contact your doctor or pharmacist.

Using a higher dose of Thiogamma Turbo-Set than recommended

If you suspect that you have received too high a dose of the medicine, inform your doctor immediately.
In case of overdose, nausea, vomiting, and headache may occur.
After significant overdose of thioctic acid, especially in combination with alcohol, severe poisonings have been observed, some of which were fatal. Clinical symptoms of poisoning include initial psychomotor agitation or impaired consciousness, followed by generalized seizures and lactic acidosis. As a consequence of thioctic acid overdose, cases of hypoglycemia, shock, rhabdomyolysis, hemolysis, disseminated intravascular coagulation (DIC), bone marrow disorders, and multi-organ failure have also been observed.
Procedure in case of poisoning
Even if there is only a suspicion of significant thioctic acid overdose, you should immediately go to the hospital, where general procedures for poisoning will be applied.

Missing a dose of Thiogamma Turbo-Set

If you suspect that you have missed a dose of Thiogamma Turbo-Set, tell your doctor as soon as possible.
Do not take a double dose to make up for the missed dose.
If you have any further doubts about using this medicine, ask your doctor.

Stopping treatment with Thiogamma Turbo-Set

Do not stop using Thiogamma Turbo-Set without consulting your doctor.
If you have any further doubts about using the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Thiogamma Turbo-Set can cause side effects, although not everybody gets them.
After intravenous administration of thioctic acid, the following side effects may occur:

Side effects that occur very rarely (less than 1 in 10,000 patients):

• coagulation disorders,
• excessive lowering of blood glucose levels (hypoglycemia) (described symptoms: dizziness, excessive sweating, headaches, vision disturbances),
• taste changes or disorders,
• seizures,
• double vision,
• petechiae,
• reactions at the injection site.

Side effects of unknown frequency:

• systemic allergic reactions, including anaphylactic shock,
• feeling of pressure in the head (after rapid intravenous administration),
• autoimmune insulin syndrome,
• allergic skin reactions with urticaria, itching, rash, and hives,
• respiratory failure (after rapid intravenous administration),
• dizziness,
• disorders of hormones regulating blood glucose levels with a visible decrease in these levels (autoimmune insulin syndrome).

During the use of products containing thioctic acid, cases of autoimmune insulin syndrome and cholestatic hepatitis have been reported.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist or nurse. 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 181 C
02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
e-mail: [email protected]
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 this medicine.

5. How to store Thiogamma Turbo-Set

There are no special recommendations for storage temperature.
The medicine should be stored out of sight and reach of children.
Due to the high sensitivity to light of the solution for infusion, it must be protected by storing it in the original packaging!
Due to the high sensitivity to light of thioctic acid, the vials should be removed from the box only immediately before use! After removal, the vial should be immediately placed in a protective bag!
Do not use this medicine after the expiry date stated on the label and carton after:
Exp. The expiry date refers to the last day of the given month.
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 pack and other information

What Thiogamma Turbo-Set contains

• The active substance of Thiogamma Turbo-Set is thioctic acid. One vial of 50 ml solution for infusion contains: 1167.70 mg thioctic acid with meglumine, corresponding to 600 mg thioctic acid.
• The other ingredients are: meglumine, Macrogol 300, water for injections.

What Thiogamma Turbo-Set looks like and contents of the pack

50 ml vial made of brown glass, closed with a bromobutyl rubber stopper and protected with a "flip off cap" (aluminum part + polypropylene part). The packaging consists of a cardboard box containing 1 or 10 vials and 1 or 10 polyurethane bags protecting the vial from light during injection.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Wörwag Pharma GmbH & Co. KG
Flugfeld-Allee 24
71034 Böblingen
Germany

Manufacturer

Solupharm Pharmazeutische Erzeugnisse GmbH
Industriestrasse 3
34212 Melsungen
Germany
Wörwag Pharma GmbH & Co. KG
Flugfeld-Allee 24
71034 Böblingen
Germany
To obtain more detailed information, please contact the representative of the marketing authorization holder:
Woerwag Pharma Polska sp. z o.o.
ul. Józefa Piusa Dziekońskiego 1
00-728 Warsaw
tel. (+48) 22 863 72 81
fax (+48) 22 877 13 70

Date of last revision of the leaflet: October 2021

Information intended exclusively for healthcare professionals:

Detailed information is provided in the Summary of Product Characteristics.

Thiogamma Turbo-Set,

600 mg/50 ml, solution for infusion
(Acidum thiocticum)

Dosing and administration

Treatment of diabetic polyneuropathy should be started and supervised by specialist doctors experienced in diagnosing and treating neuropathy, according to current standards.
Dosing
Adults:In the case of severe sensory disturbances associated with diabetic polyneuropathy, the recommended dose is 600 mg thioctic acid per day (corresponding to 1 vial of Thiogamma Turbo-Set).
Children and adolescents:Due to the lack of clinical experience in this age group, Thiogamma Turbo-Set should not be used.
Renal impairment:Due to the lack of clinical trials, Thiogamma Turbo-Set should not be used in patients with renal impairment.
Hepatic impairment:Due to the lack of clinical trials, Thiogamma Turbo-Set should not be used in patients with hepatic impairment.
Administration and treatment duration
Thiogamma Turbo-Set is administered intravenously.
It is recommended to use it for a period of 2 to 4 weeks in the initial phase of treatment.
The intravenous solution should be administered slowly, in the form of a short infusion over at least 30 minutes. The product should be administered directly from the vial, using standard infusion equipment and the provided light-protective bag. If necessary, before administration, the product can be diluted with physiological saline solution. Due to the sensitivity to light of the active substance, the vials should be removed from the box only immediately before use and, after removal, protected from light. A minimum infusion time of 30 minutes should be ensured.
Treatment should be continued using thioctic acid in the form of oral tablets.
The primary requirement for the treatment of diabetic polyneuropathy is optimal metabolic control of diabetes.

Overdose

In case of overdose, nausea, vomiting, and headache may occur. After oral administration of a dose of 10 to 40 grams of thioctic acid in combination with alcohol, severe poisonings have been observed (some of which were fatal). Symptoms of poisoning may include: initial psychomotor agitation or impaired consciousness, followed by generalized seizures and lactic acidosis. There have been reports of hypoglycemia, shock, rhabdomyolysis, hemolysis, disseminated intravascular coagulation (DIC), bone marrow disorders, and multi-organ failure as consequences of thioctic acid overdose.
Procedure in case of overdose
Even if there is only a suspicion of thioctic acid poisoning, it is recommended to immediately hospitalize the patient and apply the procedures used in case of poisoning.
Treatment of seizures, lactic acidosis, and all life-threatening consequences of poisoning should primarily take place in the intensive care unit and be adapted to the symptoms occurring in the patient. So far, no proven benefits have been confirmed for the use of hemodialysis, hemoperfusion, and filtration techniques as forced elimination of thioctic acid.

Incompatibilities

Thioctic acid reacts in vitrowith metal ion complexes (e.g., cisplatin). With sugar molecules (e.g., levulose solution), thioctic acid forms poorly soluble complex compounds.
Thiogamma Turbo-Set is incompatible with glucose solutions, Ringer's solution, and solutions reacting with SH groups and disulfide bridges.
Thiogamma Turbo-Set is compatible with physiological saline solution.

Special precautions for storage

Due to the high sensitivity to light, Thiogamma Turbo-Set must be protected by storing it in the original packaging!
Due to the high sensitivity to light of thioctic acid, the vials should be removed from the box only immediately before use! After removal, the vial should be immediately placed in a protective bag!
There are no special recommendations for storage temperature.