THIOGAMMA ORAL 600 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Thiogamma Oral 600 mg Film-Coated Tablets

Thioctic Acid

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Thiogamma Oral and what is it used for
2. What you need to know before taking Thiogamma Oral
3. How to take Thiogamma Oral
4. Possible side effects
5. Storage of Thiogamma Oral
6. Contents of the pack and further information

1. What is Thiogamma Oral and what is it used for

Thiogamma Oral contains the active substance thioctic acid. Thioctic acid is produced naturally in the human body and protects against the degradation of nerve cells.

Thiogamma Oral is used in the symptomatic treatment of pain and other sensory disturbances in adults with mild to moderate diabetic polyneuropathy, which is nerve damage caused by diabetes. Other sensory disturbances are often described as a lack of sensitivity in the legs and/or arms.

This medicine is usually used as part of a complex treatment for controlling the underlying disease, diabetes, which includes diet and exercise and/or other therapies to provide sufficient blood sugar control and pain management.

2. What you need to know before taking Thiogamma Oral

Do not takeThiogamma Oral

• if you are allergic to thioctic acid or any of the other ingredients of this medicine (listed in section 6).
• if you are taking cisplatin (a medicine for cancer treatment).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Thiogamma Oral.

Patient with a certain human leukocyte antigen genotype (which is more frequent in Japanese and Korean patients but also found in Caucasians) are more prone to developing autoimmune insulin syndrome (a disorder of glucose-regulating hormones with a pronounced decrease in blood sugar levels) when treated with thioctic acid.

If you have liver problems, your doctor will consider whether to prescribe this medicine or not.

Children and adolescents

The use of this medicine in children and adolescents under 18 years of age is not recommended, as its efficacy and safety have not yet been established.

Other medicines and Thiogamma Oral

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The effect of cisplatin (a medicine for cancer treatment) may be reduced if used in combination with this medicine.

If you use medicines containing iron or magnesium or if you use dairy products containing calcium, do not take them at the same time as Thiogamma Oral, as it may reduce the effect of this medicine. If you take Thiogamma Oral half an hour before breakfast, you can take the iron and magnesium medicines (or dairy products) at lunchtime or in the evening.

When using insulin or other diabetes medicines and your doctor also prescribes Thiogamma Oral, you should frequently monitor your blood sugar levels. Your doctor may decide to reduce the dose of insulin and/or other diabetes medicines.

Taking Thiogamma Oral with food, drinks, and alcohol

Regular alcohol consumption is an important risk factor for the development and progression of neuropathic diseases and therefore also impairs the success of treatment with this medicine; alcohol consumption may also reduce the effect of this medicine. For this reason, patients with diabetic polyneuropathy are generally advised to avoid alcohol consumption as much as possible. This also applies to therapy-free intervals.

This medicine should not be taken with dairy products (see "Other medicines and Thiogamma Oral").

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You should not use Thiogamma Oral during pregnancy unless your doctor considers it essential for treatment.

Your doctor will also advise you whether to breastfeed, taking into account the benefit of breastfeeding for your child and the benefits of your treatment with this medicine.

Driving and using machines

The influence of Thiogamma Oral on the ability to drive and use machines is negligible.

This medicine contains lactose and sodium.

If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Thiogamma Oral

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 1 film-coated tablet (corresponding to 600 mg of thioctic acid) per day, approximately 30 minutes before the first meal.

If you experience severe symptoms, consult your doctor, who will decide on adequate therapeutic alternatives.

Method of administration

Thiogamma Oral is administered orally.

The tablets should be swallowed whole (not chewed) with plenty of water, on an empty stomach. Take this medicine half an hour before breakfast. Do not take this medicine with food, as it may reduce its effect.

The score line is only for breaking the tablet if you have difficulty swallowing it whole, but not for dividing it into equal doses.

Duration of treatment

Since diabetic polyneuropathy is a chronic disease, it may require prolonged treatment with this medicine.

Your doctor will decide on your treatment individually.

If you take more Thiogamma Oral than you should

In case of overdose, nausea, vomiting, and headache may occur.

In isolated cases, severe symptoms of poisoning, partly fatal (e.g., generalized seizures, acid-base balance disorders with lactic acidosis, severe coagulation disorders), have occurred after taking more than 10 g of thioctic acid, particularly when combined with alcohol.

If a significant overdose with Thiogamma Oral is suspected (e.g., more than 10 tablets of 600 mg in adults and more than 50 mg/kg body weight in children), immediate hospitalization and initiation of standard measures for the treatment of poisoning are required.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Thiogamma Oral

Do not take a double dose to make up for forgotten doses.

If you stop taking Thiogamma Oral

Before stopping treatment, consult your doctor, otherwise, your symptoms may worsen.

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

4. Possible side effects

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

Very rare (may affect up to 1 in 10,000 people):

• Gastrointestinal disorders such as nausea, vomiting, stomach pain, intestinal pain, and diarrhea
• Taste disturbances
• Allergic reactions such as skin rash, urticaria, itching
• The use of this medicine may cause a decrease in blood sugar levels, whose symptoms are dizziness, sweating, headache, and visual disturbances.

Frequency not known: cannot be estimated from the available data:

• Various allergic reactions that affect the whole body. It can cause:
• difficulty breathing
• collapse and loss of consciousness
• swelling of the lips, face, or throat (angioedema)
• Disorder of glucose-regulating hormones with a pronounced decrease in blood sugar levels (autoimmune insulin syndrome).
• Liver damage

Do not take this medicine again if you experience any of the above side effects. Inform your doctor so that he or she can decide on the severity of the condition and whether additional measures are required.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Thiogamma Oral

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Thiogamma Oral

• The active substance is thioctic acid.

Each film-coated tablet contains 600 mg of thioctic acid.

• The other ingredients are:
• Core of the tablet: hypromellose, colloidal anhydrous silica, microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, talc, dimethicone, magnesium stearate.
• Coating material: macrogol 6000, hypromellose, talc, sodium lauryl sulfate.

Appearance of the product and contents of the pack

Film-coated tablet, oblong, yellow, with a score line on both sides.

The score line is only for breaking the tablet if you have difficulty swallowing it whole, but not for dividing it into equal doses.

Thiogamma Oral is available in packs of 30, 60, and 100 film-coated tablets.

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

DRAGENOPHARM APOTHEKER PÜSCHL GMBH

Göllstraße 1

84529 Tittmoning, Germany

Or

Wörwag Pharma GmbH & Co. KG

Flugfeld-Allee 24

71034 Böblingen

Germany

Or

Wörwag Pharma Operations Sp. z o.o.

Ul. Gen. Mariana Langiewicza 58

95-050 Konstantynów Łódzki

Poland

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany Thioctsäure Wörwag Pharma 600 mg Filmtabletten

Austria Thiogamma 600 mg Filmtabletten

Italy Thiogamma

Spain Thiogamma Oral 600 mg film-coated tablets

Date of last revision of this package leaflet: June 2024

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).