THIOCTACID

THIOCTACID 600 HR film-coated tablets

Important notes (mandatory information)

Thioctacid 600 HR. Active ingredient: alpha-lipoic acid.

Indications

Thioctacid 600 HR is used for paraesthesia in diabetic neuropathy (polyneuropathy).

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


Patient information: Information for the user
Thioctacid 600 HR
Film-coated tablets with 600 mg alpha-lipoic acid For use in adults
Active ingredient: alpha-lipoic acid

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, to achieve the best possible treatment results, Thioctacid 600 HR must be used as directed.
. Keep the package leaflet. You may want to read it again later.
. Ask your pharmacist if you need more information or advice.
. If your symptoms worsen or do not improve after 14 days, you must consult a doctor.
. If any of the listed side effects affect you significantly or if you notice side effects that are not listed in this package leaflet, please inform your doctor or pharmacist.

This package leaflet includes

1. WHAT IS THIOCTACID 600 HR AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING THIOCTACID 600 HR?
3. HOW SHOULD THIOCTACID 600 HR BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD THIOCTACID 600 HR BE STORED?
6. FURTHER INFORMATION

1. WHAT IS THIOCTACID 600 HR AND WHAT IS IT USED FOR?

Alpha-lipoic acid, the active ingredient in Thioctacid 600 HR, is a substance produced in the body's own metabolism that influences certain metabolic functions of the body. In addition, alpha-lipoic acid has antioxidant properties that protect the nerve cell from reactive degradation products.

Indications

Thioctacid 600 HR is used for paraesthesia in diabetic neuropathy (polyneuropathy).

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING THIOCTACID 600 HR?

Thioctacid 600 HR must not be taken

- if you are hypersensitive (allergic) to alpha-lipoic acid or any of the other ingredients of Thioctacid 600 HR.

Special care should be taken when taking Thioctacid 600 HR

No special precautions are required.

After using Thioctacid 600 HR, a change in the smell of urine may be noticed, which has no clinical significance.

Children

Children and adolescents should not be treated with Thioctacid 600 HR, as there is insufficient experience for this age group.
When taking Thioctacid 600 HR with other medicines: Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines. Please note that this information may also apply to medicines that you have recently used.
It cannot be ruled out that the concomitant use of Thioctacid 600 HR will lead to the loss of effect of cisplatin (an anticancer drug).
Alpha-lipoic acid, the active ingredient in Thioctacid 600 HR, easily forms chemical compounds with metals (metal chelator) and should therefore not be given at the same time as metal compounds (e.g. iron preparations, magnesium preparations, dairy products due to their calcium content), as this can lead to loss of effect. If the entire daily dose of Thioctacid 600 HR is taken 30 minutes before breakfast, iron and magnesium preparations can be taken at midday or in the evening.

The blood sugar-lowering effect of antidiabetic agents (insulin or other antidiabetic agents taken orally) may be increased. Therefore, especially at the beginning of therapy with Thioctacid 600 HR, close monitoring of blood sugar levels is indicated. In individual cases, it may be necessary to reduce the insulin dose or the dose of the antidiabetic agent according to the instructions of the treating physician in order to avoid hypoglycaemic symptoms.

When taking Thioctacid 600 HR with food and drink

Regular alcohol consumption is a significant risk factor for the development and progression of diseases associated with nerve damage and can therefore also impair the success of treatment with Thioctacid 600 HR. Therefore, patients with diabetic neuropathy (polyneuropathy) are generally advised to avoid alcohol consumption as much as possible. This also applies to therapy-free intervals.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. It is in accordance with the general principles of drug therapy to use drugs during pregnancy and breast-feeding only after careful consideration of the benefits and risks. Pregnant and breast-feeding women should only undergo treatment with alpha-lipoic acid after careful recommendation and monitoring by a doctor, as there is no experience with this patient group to date. Special studies in animals have shown no evidence of impaired fertility or harmful effects on the foetus. Nothing is known about the possible transfer of alpha-lipoic acid into breast milk.

Driving and operating machinery

No special precautions are required.

3. HOW SHOULD THIOCTACID 600 HR BE TAKEN?

Always take Thioctacid 600 HR exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, the usual dose is

Unless otherwise prescribed, the daily dose is 3 Thioctacid 600 HR film-coated tablets (corresponding to 600 mg alpha-lipoic acid), which should be taken as a single dose approximately 30 minutes before the first meal.

Method of administration

Thioctacid 600 HR film-coated tablets should be swallowed whole and with sufficient liquid on an empty stomach. The simultaneous intake of food can hinder the passage of alpha-lipoic acid into the bloodstream. Therefore, it is especially important for patients who also have a prolonged gastric emptying time to take the medication half an hour before the first meal.

Duration of use

As diabetic neuropathy is a chronic disease, you may need to take Thioctacid 600 HR for a long period of time. In individual cases, your doctor will decide.

Please talk to your doctor or pharmacist if you have the impression that the effect of Thioctacid 600 HR is too strong or too weak.

If you have taken more Thioctacid 600 HR than you should

Overdosage may cause nausea, vomiting and headache. In individual cases, severe, sometimes life-threatening poisoning symptoms have been observed when taking more than 10 g of alpha-lipoic acid, especially when combined with heavy alcohol consumption (such as generalised seizures, acid-base imbalance with acidosis, severe blood clotting disorders). Therefore, if there is a suspicion of a significant overdose or accidental ingestion of Thioctacid 600 HR (e.g. more than 30 tablets of 600 mg in adults and more than 50 mg/kg body weight in children), immediate hospitalisation and initiation of measures according to the general principles of treatment of poisoning cases (e.g. induction of vomiting, gastric lavage, activated charcoal, etc.) is required. The treatment of any poisoning symptoms that may occur must be based on the principles of modern intensive care and be symptomatic.

If you forget to take Thioctacid 600 HR:
Do not take a double dose if you have forgotten to take the previous dose.

If you stop taking Thioctacid 600 HR

Please do not stop taking Thioctacid 600 HR without consulting your doctor. Your condition may worsen as a result.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Thioctacid 600 HR can have side effects, although not everybody gets them.

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 treated
Common:	1 to 10 in 100 treated
Uncommon:	1 to 10 in 1,000 treated
Rare:	1 to 10 in 10,000 treated
Very rare:	less than 1 in 10,000 treated
Not known:	frequency cannot be estimated from the available data.

Possible side effects

Gastrointestinal tract
Common: Nausea
Very rare: Vomiting, stomach, intestinal pain and diarrhoea.

Hypersensitivity reactions
Very rare: Allergic reactions such as rash, hives (urticaria) and itching.

Nervous system
Common: Dizziness
Very rare: Change or disturbance of taste sensation

General side effects

Very rare: Due to improved glucose utilisation, blood sugar levels may drop. Symptoms such as those of hypoglycaemia with dizziness, sweating, headache and visual disturbances have been described.

Countermeasures

If you experience any of the above side effects, Thioctacid 600 HR should not be taken again. Notify your doctor so that he/she can decide on the severity and any further measures that may be necessary. At the first signs of a hypersensitivity reaction, the medicine should be discontinued and a doctor should be contacted immediately.

Please inform your doctor or pharmacist if any of the listed side effects affect you significantly or if you notice side effects that are not listed in this package leaflet.

5. HOW SHOULD THIOCTACID 600 HR BE STORED?

Keep out of reach of children.

Do not use the medicine after the expiry date which is stated on the carton and container after "Use by".

Storage conditions
Do not store above 25°C

6. FURTHER INFORMATION

What Thioctacid 600 HR contains

The active ingredient is: alpha-lipoic acid

1 film-coated tablet contains 600 mg alpha-lipoic acid The other ingredients are

Poly(0-2-hydroxypropyl)cellulose (5.0-16.0% hydroxypropoxy groups), magnesium stearate, hydroxypropylcellulose, hypromellose, macrogol 6000, talc, titanium dioxide (E 171), quinoline yellow, aluminium salt (E 104),'lndigocarmin, aluminium salt (E 132)

What Thioctacid 600 HR looks like and contents of the pack

Container: Brown glass bottle, hydrolytic class III, with original polyethylene closure
Thioctacid 600 HR is available in packs of 30, 60 and 100 film-coated tablets.

Pharmaceutical entrepreneur
MEDA Pharma GmbH & Co. KG
Benzstraße 1
61352 Bad Homburg
Telephone: (06172) 888-01
Telefax: (06172) 888-2740
E-mail: medinfo@medapharma.de

This package leaflet was last revised in August 2007.

Source: Information from the package leaflet
Status: 08/2015
Active ingredient: alpha-lipoic acid. Indications: Thioctacid 600 HR is used for paraesthesia in diabetic neuropathy (polyneuropathy).