THIOGAMMA TURBOSET 600 mg. / 50 ml. 5 ampules

WHAT THIOGAMMA TURBO-SET AND WHAT IT IS USED
Thioctic (alpha-lipoic) acid is a substance that is generated by the metabolism of higher organisms, and affects certain metabolic processes in the body. Furthermore, thioctic acid has antioxidant, protecting neuronal cells properties.

indications
Tiogamma Turbo-Set is used for:
Sensory disturbances in diabetic polyneuropathy (sensory nerve damage, which are caused by diabetes).

2. Before applying THIOGAMMA TURBO-SET
Do not use Tiogamma Turbo Seth
Tiogamma Turbo Seth should not be used in known hypersensitivity to thioctic (alpha-lipoic) acid or any of the excipients in the formulation of Tiogamma Turbo Seth.

Take special care with Tiogamma Turbo Seth
There have been reports of hypersensitivity reactions, including anaphylactic shock (sudden circulatory collapse) during application of Tiogamma Turbo Seth in the form of solution for injection or infusion solutions (see. Pt. 4). For this reason, your doctor will closely monitor you during the implementation of Tiogamma Turbo Seth occurrence of early symptoms (eg. Itching, nausea, anxiety, etc.). If this occurs, therapy should be discontinued immediately and, if necessary to take appropriate measures.
In some cases, patients with decompensated or inadequately controlled diabetes and impaired general condition may develop severe hypersensitivity reactions associated with the use of Tiogamma Turbo Seth.
Thioctic acid reacts in vitro with a metal ion complexes (e.g., cisplatin). Thioctic acid interacts with a sugar molecule (e.g., a solution of laevulose) and forms a sparingly soluble complex compounds. Tiogamma Turbo-Set is incompatible with the glucose solution, Ringer's solution, and solutions which have been known to react with SH-groups (sulfhydryl groups) or disulfide bridges.
Administered as an infusion Tiogamma Turbo Seth as a solvent can be used only saline.
In children and adolescents should be conducted therapy Tiogamma Turbo Seth due to lack of clinical experience in this age group.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
It is not excluded concomitant use of Tiogamma Turbo Seth to reduce the effect of cisplatin (a chemotherapy medicine to treat cancer).
Hypoglycaemic effect of antidiabetic agents (insulin and other medicines to treat diabetes) may be increased. For this reason it is necessary, careful monitoring of blood sugar levels, especially in the initial phase of therapy Tiogamma Turbo Seth. In individual cases, in order to avoid symptoms of hypoglycaemia may be necessary to medical indication to reduce the insulin dose or the dose of oral antidiabetic agents.

Use of Tiogamma Turbo-Set with food and drink
Regular use of alcohol is an important risk factor for the development and progression of nerve damage and therefore could compromise the success of treatment with Tiogamma Turbo Seth. In general, patients with diabetic neuropathy is recommended to avoid the use of alcohol. This also applies for the time in which not conducted a therapeutic course.

Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
Fundamental principle of pharmacotherapy is: during pregnancy and lactation, medicinal products to be used only after careful evaluation of the risks and benefits of treatment.
Since no information is available for this period in this patient group, treatment with alpha-lipoic acid in pregnant and nursing women should be carried out only after careful medical evaluation and monitoring by the physician. Special animal studies have shown no impairment of fertility or development of the embryo.
It is not known whether the passage of thioctic (alpha-lipoic) acid in the maternal milk. In principle, the use of Tiogamma Turbo Seth during lactation should be avoided.

Children and adolescents (under 18 years)
In children and adolescents should be conducted therapy Tiogamma Turbo Seth due to lack of clinical experience in this age group.

Driving and using machines
No special precautions.

3. HOW TO USE THIOGAMMA TURBO-SET
Always Tiogamma Turbo Seth exactly as your doctor tells you. If you are not sure, ask your doctor or pharmacist.
Tiogamma Turbo Seth should always be applied in accordance with the instructions in this leaflet.
Please follow the instructions for use, otherwise Tiogamma Turbo Seth will not have the desired therapeutic effect.

If your doctor advises otherwise, the usual dose is:
In severe paresthesia, resulting in severe diabetic polyneuropathy, the dose in the initial treatment phase includes 600 mg of alpha-lipoic acid daily (corresponding to 1 vial Tiogamma Turbo-Seth). The solution for injection is administered for 2-4 weeks in the initial phase of treatment.
Intravenous administration should be carried out slowly, in which content should be introduced for at least thirty minutes as a short infusion. The infusion is done directly from the vial using a standard system for intravenous infusion and applied svetozashtitno bag.
Due to the sensitivity of the drug, the vial should be removed from the carton only immediately prior to use. Should certainly be noted that a minimum duration of infusion 30 minutes.
Therapy should be continued with 300 mg to 600 mg thioctic (alpha-lipoic) acid in pharmaceutical forms suitable for oral administration.

If you take more dose Tiogamma Turbo Seth
Overdose might occur: nausea, vomiting and headache.
In individual cases, when taking more than 10 g of thioctic acid, especially with consumption and a large quantity of alcohol, serious and sometimes life-threatening toxic symptoms (such as generalized seizures disorders in acid-base balance of the induction of lactic tsidoza, serious bleeding disorders).
Therefore, even in case of a suspected overdose significantly Tiogamma Turbo Seth, must be carried out immediate hospitalization and initiation according to the general principles for the treatment of intoxication.

If you forget to use Tiogamma Turbo Seth
Do not take a double dose to make up.

If you stop using Tiogamma Turbo Seth
Do not interrupt or stop treatment with Tiogamma Turbo Seth without prior consultation with your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Tiogamma Turbo Seth can cause side effects, although they do not necessarily occur in any patient.
In assessing the adverse reactions following data are used for the frequency of their occurrence:
Very common: more than 1 in 10 treated;
Common: less than 1 in 10 but more than 1 in 100;
Uncommon: less than 1 in 100 but more than 1 in 1,000;
Rare: less than 1 in 1,000, but more than 1 in 10,000 treated;
Very rare: less than 1 in 10 000 treated, incl. isolated cases.
General disorders and administration site conditions:
Very rare:
Adverse reactions at the injection site.
Hypersensitivity reactions:
Possible allergic reactions of the skin such as urticaria, pruritus and rash and systemic reactions including shock.
Nervous system disorders:
Very rare: changes or disturbances in sensory processing, seizures and double vision.
Blood and lymphatic system:
Bleeding into the skin (purpura), disturbances in platelet function, respectively. bleeding disorders (trombopatiya).
General disorders and administration site conditions:
Common: After rapid intravenous injection may occur feeling of tension in the head and difficulty breathing, which resolved spontaneously;
Very rare: Due to enhanced glucose uptake in isolated cases can reduce blood sugar levels, as described symptoms resembling hypoglycemia: dizziness, sweating, headaches and impaired vision.
If you get any of the events above side effects, you should stop taking Tiogamma Turbo Seth. Tell your doctor who will determine the severity of events at your side effects and take appropriate action.
At the first sign of hypersensitivity, the product should be stopped and inform your doctor immediately.

If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE THIOGAMMA TURBO-SET
Keep the medicinal product out of the reach of children!
The expiry date is printed on the vial label and carton. Do not use this medicine after the expiry of the said period of life!

Storage conditions:
Do not store above 25 ° C.
As thioctic acid is a very strong light sensitive, solution for injection should be protected in the package svetozashtitna bag (bag).
Due to the sensitivity of the thioctic acid,  vials should be removed from the pack just before use! Then immediately be placed (to be wrapped) in svetozashtitnoto bag!
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What Tiogamma Turbo Seth
Active substance: alpha-lipoic acid (Thioctic acid).
One vial of 50 ml solution for injection contains:
1167,70 mg of alpha-lipoic acid, meglumine salt; corresponding to 600 mg of thioctic acid.
Excipients:
Meglumine, macrogol 300, water for injections.

Looks Tiogamma Turbo Seth and contents of the pack
Original packaging:
1 vial of 50 ml solution for injection and 1 svetozashtitno bag.
10 vials of 50 ml of solution for injection and 10 svetozashtitni bags.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Worwag Pharma