Thiogamma

Leaflet attached to the packaging: patient information

Thiogamma,600 mg, coated tablets
(Thioctic acid)

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.
• Consult a doctor or pharmacist if you have any doubts.
• 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 you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Thiogamma and what is it used for

The active substance of Thiogamma is thioctic acid. This substance is produced naturally in the human and animal body. Thioctic acid has an effect on many metabolic processes. In addition, thioctic acid acts as an antioxidant. Thiogamma 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 taking Thiogamma

When not to take Thiogamma

In case of allergy (hypersensitivity) to thioctic acid or any other component of Thiogamma. Children and adolescents: Thiogamma should not be given to children and adolescents due to the lack of data on the use of thioctic acid in this age group. Patients with renal impairment: Thiogamma should not be used due to insufficient data on the use of the medicine in patients with renal impairment. Patients with hepatic impairment: Thiogamma should not be used due to the lack of data on the use of thioctic acid in patients with hepatic impairment.

Warnings and precautions

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 developing autoimmune insulin syndrome (a disorder of hormones regulating blood glucose levels with a noticeable decrease in these levels) during treatment with thioctic acid.

Other medicines and Thiogamma

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Concurrent use of Thiogamma with cisplatin (a medicine used in anticancer chemotherapy) weakens the effect of cisplatin. Thioctic acid, the active substance of Thiogamma, easily forms chemical compounds with metals and therefore cannot be used simultaneously with dairy products (containing calcium) and preparations containing metal compounds (preparations containing iron, magnesium), as their effect may be disrupted. If Thiogamma is taken 30 minutes before breakfast, preparations containing iron and magnesium can be taken during lunch or in the evening. The effect of antidiabetic medicines (insulin and other oral antidiabetic medicines) that lower blood sugar levels may be enhanced. Close monitoring of blood sugar levels is recommended, especially at the beginning of treatment with Thiogamma. To avoid symptoms of low blood sugar, it may be necessary to reduce the dose of insulin or other antidiabetic medicine in individual cases.

Thiogamma with food, drink, and alcohol

Thiogamma should be taken approximately 30 minutes before the first meal of the day. The tablets should be taken with a sufficient amount of water on an empty stomach (see section 3). During treatment with Thiogamma, alcohol should be avoided at all costs. Alcohol increases the risk of disease progression, can cause nerve damage, and weaken the effect of Thiogamma. 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 is not recommended for use in pregnant women and women of childbearing age who are not using effective contraception. It is not known whether thioctic acid passes into breast milk. Thiogamma should not be used during breastfeeding.

Children and adolescents

Since there are no clinical trial results available for children and adolescents, Thiogamma should not be used in this patient group.

Driving and using machines

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

Thiogamma contains lactose and sodium

This medicine contains lactose. If you have intolerance to some sugars, consult your doctor before taking the medicine. The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means that the medicine is considered "sodium-free".

3. How to take Thiogamma

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. Treatment of diabetic polyneuropathy should be initiated and supervised by specialists experienced in the diagnosis and treatment of neuropathy, according to current standards. Unless otherwise prescribed by your doctor, the usual daily dose is one coated tablet of Thiogamma (equivalent to 600 mg of thioctic acid) taken approximately 30 minutes before the first meal of the day. Concurrent food intake may disrupt the absorption of thioctic acid into the bloodstream. The tablet should be taken on an empty stomach. Swallow whole, with a sufficient amount of water. The primary requirement for the treatment of diabetic polyneuropathy is optimal metabolic control of diabetes.

Duration of treatment

Since diabetic polyneuropathy is a chronic disease, the use of Thiogamma may be prescribed for an extended period. Your doctor will decide how long you should take the medicine.

Taking a higher dose of Thiogamma than recommended

In case of accidental ingestion of too high a dose of Thiogamma, contact your doctor or go to the hospital 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 dysfunction, and multi-organ failure have also been observed. Procedure in case of poisoning: Even if only suspected significant overdose of thioctic acid, go to the hospital immediately, where general procedures in case of poisoning will be applied.

Missing a dose of Thiogamma

In case of a missed dose, do not take a double dose to make up for the missed dose. If you have any further doubts about the use of the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Thiogamma can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking Thiogamma and consult your doctor. This is very rare, but may require medical attention.

Side effects can be defined according to the following categories:

Frequent:

• dizziness
• nausea

Very rare:

• taste disorders
• vomiting, stomach and intestinal pain, diarrhea
• allergic reactions such as skin rash, urticaria, and itching
• excessive lowering of blood glucose levels (hypoglycemia), with symptoms such as dizziness, excessive sweating, headaches, and vision disturbances.

Frequency not known:

• shock
• disorders related to hormones regulating blood glucose levels with a noticeable decrease in these levels (autoimmune insulin syndrome)

During the use of products containing thioctic acid in the form of intravenous administration, additional side effects have been reported: double vision, seizures, thrombopathy, petechiae, respiratory disorders. 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 the 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: ndl@urpl.gov.pl. 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 the medicine.

5. How to store Thiogamma

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton after Exp. The expiry date refers to the last day of the month stated. Store in a temperature below 25°C. Store in the original packaging. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Thiogamma contains

The active substance is thioctic acid. One coated tablet contains 600 mg of thioctic acid. Excipients: Tablet core: hypromellose, colloidal anhydrous silica, microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, talc, dimethicone (viscosity n=350), magnesium stearate; Coating: macrogol 6000, hypromellose, talc, sodium lauryl sulfate. Note for diabetics: 1 coated tablet contains less than 0.0041 bread units.

What Thiogamma looks like and contents of the pack

Yellow coated tablets with a dividing line on both sides. Thiogamma is available in packs of 30, 60, or 100 coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

Dragenopharm Apotheker Püschl GmbH, Göllstr. 1, 84529 Tittmoning, Germany, Wörwag Pharma GmbH & Co. KG, Flugfeld-Allee 24, 71034 Böblingen, Germany, Wörwag Pharma Operations Sp. z o.o., ul. Gen. Mariana Langiewicza 58, 95-050 Konstantynów Łódzki, Poland. For 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: