Thioctic acid farmak

Package leaflet: Information for the patient

Thioctic acid Farmak, 600 mg, coated tablets
Acidum thiocticum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

1. What Thioctic acid Farmak is and what it is used for

The active substance in Thioctic acid Farmak, thioctic acid, is produced naturally by the body and influences certain metabolic processes. Thioctic acid has antioxidant properties that protect nerve cells against damage caused by free radicals (harmful chemical substances naturally produced by the body as a by-product of metabolism).
Thioctic acid Farmak is used in the treatment of symptoms of diabetic peripheral neuropathy, a condition involving nerve damage which may cause pain, loss or reduced sensation, particularly in the arms and legs.

2. Important information before taking Thioctic acid Farmak

Do not take Thioctic acid Farmak if:

• you are allergic to thioctic acid or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Thioctic acid Farmak, please discuss with your doctor or pharmacist if:

• you have liver disease,
• you have thyroid problems,
• you have vitamin B1 deficiency (also known as thiamine deficiency),
• you are elderly (aged 65 years or older),
• you consume large amounts of alcohol.

Patients with a certain human leukocyte antigen genotype (more common in Japanese and Korean populations, but also present in Caucasian populations) are more susceptible to developing autoimmune insulin syndrome (a hormonal disorder affecting glucose regulation, characterized by a marked decrease in blood sugar levels) during treatment with thioctic acid.
While taking Thioctic acid Farmak, urine may have a different odour; however, this does not require treatment.

Children and adolescents
Thioctic acid Farmak should not be used in children and adolescents, as the safety and efficacy of the medicine have not been established in this age group.

Thioctic acid Farmak with other medicines
Please inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
This is particularly important if you are taking any of the following medicines:

• cisplatin (used in cancer treatment). Concomitant use of Thioctic acid Farmak with cisplatin may reduce the effectiveness of cisplatin;
• medicines or dietary supplements containing metal compounds (e.g. preparations containing iron or magnesium) and dairy products (due to calcium content). Thioctic acid binds metal ions and may therefore neutralize their effects. If you take Thioctic acid Farmak 30 minutes before breakfast, preparations containing iron and/or magnesium may be taken at lunchtime or in the evening;
• antidiabetic medicines (e.g. insulin and/or other oral antidiabetic drugs). Concomitant use of Thioctic acid Farmak with antidiabetic medicines may enhance the blood glucose-lowering effect, therefore regular monitoring of blood glucose levels is required, especially at the beginning of treatment with Thioctic acid Farmak. Your doctor may also adjust the dose of your antidiabetic medicines to avoid low blood glucose levels (hypoglycaemia).

Thioctic acid Farmak with food, drink, and alcohol
Regular alcohol consumption is an important risk factor for the development and progression of neuropathy and may therefore negatively affect the outcome of treatment with Thioctic acid Farmak. For this reason, patients with diabetic neuropathy are advised to avoid alcohol consumption, including during treatment breaks.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, please consult your doctor or pharmacist before taking this medicine.
Do not take Thioctic acid Farmak during pregnancy unless otherwise advised by your doctor.
It is not known whether thioctic acid passes into breast milk. The risk to the nursing infant cannot be excluded. Do not take Thioctic acid Farmak while breastfeeding.

Driving and using machines
Dizziness and visual disturbances may occur while taking Thioctic acid Farmak. These may impair your ability to drive or operate machinery.

3. How to take Thioctic acid Farmak

Always take this medicine exactly as your doctor or pharmacist has instructed. If in doubt, consult your doctor or pharmacist.
The recommended dose is 1 tablet once daily. The tablet should be taken on an empty stomach, swallowed whole with a large amount of liquid. Do not chew the tablet.
Taking the medicine with food may reduce the absorption of thioctic acid. Therefore, it is recommended that the full daily dose (1 coated tablet) be taken 30 minutes before breakfast, especially in patients with prolonged gastrointestinal transit (i.e. delayed gastric emptying).

Duration of treatment
As diabetic peripheral neuropathy is a chronic condition, long-term or even lifelong treatment with Thioctic acid Farmak may be necessary. Your doctor will inform you how long you should continue taking this medicine.
If you feel that the effect of Thioctic acid Farmak is too weak or too strong, please consult your doctor or pharmacist.

If you take more Thioctic acid Farmak than you should
If you take too much of this medicine, nausea, vomiting, and headache may occur.
In isolated cases, severe and even life-threatening symptoms of overdose, including generalized seizures, acid-base imbalance (acidosis) manifesting as fatigue, disorientation, lethargy, and increased respiratory rate, and serious blood coagulation disorders, have been observed after ingestion of more than 10 g of thioctic acid, particularly when combined with alcohol.
Therefore, if you have taken an excessive dose (e.g. more than 10 tablets) or if a child accidentally swallows the tablets (more than 50 mg/kg body weight), contact the nearest emergency department immediately, as treatment may be necessary (e.g. induction of vomiting, gastric lavage, administration of activated charcoal).

If you forget to take Thioctic acid Farmak
Do not take a double dose to make up for a missed dose.

If you stop taking Thioctic acid Farmak
Please consult your doctor before deciding to stop treatment, as symptoms may worsen otherwise.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.

Common adverse reactions (may occur in less than 1 in 10 patients):

• dizziness,
• nausea.

Very rare adverse reactions (may occur in less than 1 in 10,000 patients):

• allergic reactions (including skin rash, urticaria, and itching). If any symptoms of an allergic reaction occur, discontinue use of this medicine immediately and contact your doctor without delay.
• low blood glucose levels (hypoglycemia),
• taste disturbances,
• headache,
• excessive sweating,
• visual disturbances,
• vomiting,
• abdominal pain,
• diarrhea.

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Frequency not known (frequency cannot be estimated from available data):

• sleep disorders,
• anxiety,
• low blood pressure (hypotension),
• sudden spasm of the vocal cords which may lead to problems with speaking and breathing (laryngospasm),
• hormonal disorders affecting hormones regulating blood glucose levels, with a noticeable decrease in blood glucose (autoimmune insulin syndrome),
• decreased concentration of thyroid hormones in blood (detectable in blood tests),
• decreased iron concentration in blood (detectable in blood tests).

If any of the above-mentioned adverse reactions occur,
discontinue use of Thioctic acid Farmak.
Inform your doctor, who will assess their severity and take any necessary
appropriate actions.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: +48 22 49 21 301,
fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the Marketing Authorisation Holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Thioctic acid Farmak

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister pack following:
EXP. The expiry date refers to the last day of the specified month.
Do not store above 25°C.
Store in the original packaging to protect from light.

6. Contents of the package and other information

What Thioctic acid Farmak contains

• The active substance is thioctic acid. One coated tablet contains 600 mg of thioctic acid.
• The other ingredients are: low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172).

What Thioctic acid Farmak looks like and contents of the pack
Dull, yellow-orange, elongated, biconvex coated tablets with bevelled edges and a division line.
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The tablets are packed in PVC/PVDC/Aluminium blisters with white, two-layer polymer foil and printed, lacquered aluminium foil, with 10 tablets per blister. The blisters are placed in cardboard boxes.
Pack sizes: 30, 60 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel. +48 22 822 93 06
[email protected]

Importer
Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw

This medicinal product is authorised in the European Economic Area under the following names:
Latvia: Diahit 600 mg apvalkotās tablets
Poland: Thioctic acid Farmak
LV/H/0251/001/DC