Thioctic Tablets(alpha-lipoic)-为治疗糖尿病多发性周围神经病变新药
硫辛酸（阿尔法 - 硫辛酸）
适应症
治疗糖尿病多发性周围神经病变。
用法用量
口服，每日一次，每次600mg，早餐前半小时服用。对于较严重的症状，建议起始先采用注射治疗。由于糖尿病周围神经病变是慢性疾病，一般需长期服用，具体使用时间由医生根据个体特点决定。
包装规格
片
200mg*30  60

300mg*60
600mg*30  60

生产厂家：Worwag制药
THIOGAMMA 600mg. 30tablets
Thioctic (alpha-lipoic) acid, the active substance in 600 Tiogamma orally, 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 properties.
WHAT THIOGAMMA 600 ORAL AND WHAT IT IS USED
Substance or therapeutic group
Thioctic (alpha-lipoic) acid, the active substance in 600 Tiogamma orally, 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 properties.
Fields of application
Sensory disturbances in diabetic polyneuropathy (sensory nerve damage, which are caused by diabetes).
2. BEFORE YOU TAKE THIOGAMMA 600 oral
He plowed take Tiogamma 600
If you are hypersensitive (allergic) to alpha-lipoic (alpha-lipoic) acid or to any of the excipients of Tiogamma 600 plowed.
Take special care with Tiogamma 600 plowed
Please tell your doctor or pharmacist if you are taking / using or have recently taken / given, and other medicines, including medicines obtained without a prescription.
Taking other medicines
Please note that these data apply to drugs whose administration has ended recently.
It is not excluded Tiogamma 600 plowed cause reduction effect of cisplatin (chemotherapy medicinal product) during concomitant use.
Thioctic (alpha-lipoic) acid is a metal chelator, and therefore should not be administered concurrently with metallic compounds (e.g. iron and magnesium containing medicinal products, dairy food products - for calcium content). If the total daily dose of 600 Tiogamma plowed accepted 30 minutes before breakfast, iron and magnesium products can be taken at noon or afternoon.
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 600 plowed. 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.
Taking Tiogamma 600 plowed with food and drink
Regular use of alcohol is an important risk factor in the development and progression of nerve damage and therefore may compromise the success of the treatment with 600 Tiogamma orally. 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
According to the principles of pharmacotherapy during pregnancy and lactation, medicines are 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 (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.
What should be considered during lactation (breastfeeding)?
It is not known thioctic (alpha-lipoic) acid passes into breast milk. Use during lactation should in principle be avoided.
Children and adolescents (under 18 years)
In children and adolescents should be conducted therapy Tiogamma 600 plowed due to lack of clinical experience in this age group.
Driving and using machines
Tiogamma 600 plowed not affect your ability to drive and use machines.
Important information about some of the ingredients of Tiogamma 600 plowed
This medicinal product contains lactose. If you know that you have an intolerance to some sugars, you should take Tiogamma 600 plowed only after consulting your doctor.
3. HOW TO TAKE THIOGAMMA 600 oral
You must always take Tiogamma 600 plowed strictly according to the instructions given by your doctor. Please consult your doctor or pharmacist if anything you are not sure.
The following information Tiogamma 600 plowed you can take into account only if your doctor prescribes something different. Please follow the instructions and recommendations of your doctor! Otherwise Tiogamma 600 plowed will not have the desired therapeutic effect.
Method of administration
For oral administration.
If it is not otherwise specified, the dose comprises from 1 tablet Tiogamma 600 orally (containing 600 mg thioctic acid), which is taken approximately 30 minutes before the first meal of the day.
The film-coated tablets 600 Tiogamma plowed should be swallowed whole and with sufficient fluid. Take the tablets on an empty stomach, as concomitant use with food may prevent absorption (absorption). In this regard it is important, patients with prolonged gastric emptying to take the tablets in the morning, 30 minutes before breakfast.
Duration of dosing
Since diabetic polyneuropathy is a chronic disease, it is possible to impose a permanent conducting therapy Tiogamma 600 orally. The physician determines it appropriate.
If you take more dose Tiogamma 600 plowed
Overdose might occur: nausea, vomiting and headache.
In individual cases, when taking more than 10 g of thioctic (alpha-lipoic) acid, especially with consumption and a large quantity of alcohol, serious and sometimes life-threatening toxic symptoms (such as generalized seizures disorders acid-base balance with signs of lactic acidosis, severe bleeding disorders).
So even in case of a suspected overdose significantly Tiogamma 600 orally (eg more than 10 tablets of alpha-lipoic acid 600 mg and more than 50 mg / kg body weight in children) should be carried out immediate hospitalization and start procedures under general principles for the treatment of intoxication (e.g., emesis, gastric lavage, activated charcoal, etc.). Treatment of possible symptoms of intoxication must be in accordance with the principles of modern intensive care and is symptomatic.
If you forget to take Tiogamma 600 plowed
If you forget to take a dose, do not double the intake Tiogamma 600 plowed to make up for a forgotten tablet.
Keep taking the tablets Tiogamma 600 orally, as prescribed by your doctor and try in the future to take the preparation regularly.
If you stop taking Tiogamma 600 plowed
No special safety instructions.
To be successful therapy Tiogamma 600 plowed, you should take the preparation as possible on a regular basis. If you stop or wish to stop treatment prematurely, please talk about it with your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Tiogamma 600 plowed 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.
Significant side effects or symptoms that need to pay attention and measures to take if you are affected:
If you are affected by any of the following side effects, please stop taking Tiogamma 600 oral and consult your doctor as soon as possible.
Described isolated cases of gastrointestinal symptoms such as nausea, vomiting, gastrointestinal pain and diarrhea.
May occur isolated cases of allergic reactions such as skin rash, urticaria and pruritus.
Due to improved glucose uptake in isolated cases may be a decline in the level of blood sugar. Observed are similar to hypoglycemia symptoms such as dizziness, sweating, headache, and altered visual perception.
At the first signs of hypersensitivity reaction, taking the medicinal product should be discontinued immediately and seek medical help.
If you observe any of the above symptoms, stop taking Tiogamma 600 oral and tell your doctor. It will assess the severity of the reactions, the measures to be taken against them and whether it is necessary to take measures.
Please tell your doctor or pharmacist if any of these side effects cause considerable difficulties, or if you notice any side effects not listed in the patient information sheet.
5. HOW TO STORE THIOGAMMA 600 oral
Keep medicinal product carefully, out of the reach of children!
The expiry date is printed on the blister and carton. The length of time is the last day of that month.
Do not use this medicine after the expiry of the said period of life!
Storage conditions:
Be stored below 25 ° C
Protect from light.
6. FURTHER INFORMATION
What Tiogamma 600 plowed
Active substance: alpha-lipoic acid.
One tablet contains 600 mg of alpha-lipoic acid.
Excipients: methylhydroxypropyl cellulose, sodium carboxymethyl cellulose, dimethicone, lactose, magnesium stearate (Ph. Eur.), Macrogol 6000, talc, sodium dodecyl sulfate, microcrystalline cellulose, and highly disperse silica.
Does not contain gluten, contains lactose.
Advice for diabetics:
One tablet contains less than 0.0041 bakery units.
Looks Tiogamma 600 oral and contents of the pack
Yellow film-coated tablets scored on both sides of the tablet.
Packs of 30, 60 and 100 tablets. Not all pack sizes may be on sale in the market.
Marketing Authorisation Holder:
Worwag Pharma