Package leaflet: Information for the patient

Alatic, 600 mg/24 ml, solution for injection
Acidum thiocticum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Alatic is and what it is used for
Important information before using Alatic
How to use Alatic
Possible side effects
How to store Alatic
Contents of the package and other information

1. What Alatic is and what it is used for

Thioctic acid, the active substance in Alatic, is a substance naturally produced in the body that affects certain metabolic processes. In addition, thioctic acid exhibits antioxidant properties, protecting nerve cells against reactive breakdown products.
Alatic is used in the treatment of sensory-motor peripheral diabetic polyneuropathy.

2. Information before using Alatic

Do not use Alatic 600 mg/24 ml, solution for injection:

if the patient is allergic (hypersensitive) to thioctic acid or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Alatic, please discuss this with your doctor or pharmacist.
Allergic reactions (hypersensitivity), including life-threatening anaphylactic shock (sudden cardiovascular collapse), have been reported following administration of thioctic acid as solution for injection or infusion (see section 4, "Possible side effects"). Therefore, the patient's condition will be monitored during administration of Alatic for early signs of such reactions (e.g. itching, nausea, malaise, etc.). If such symptoms occur, treatment must be stopped immediately; other therapeutic measures may be required.
During treatment with Alatic, urine may have a different odour, but this is not clinically significant.
Patients with a specific human leukocyte antigen genotype (more commonly found in patients from Japan and Korea, but also present in Caucasian individuals) may be more susceptible to developing autoimmune insulin syndrome (a disorder affecting hormones regulating blood glucose levels, with marked decrease in blood glucose concentration) during treatment with thioctic acid, the active substance in Alatic.

Children and adolescents
This medicine should not be given to children and adolescents under 18 years of age, as the safety and efficacy have not yet been established in this age group.

Alatic with other medicines
Inform your doctor or pharmacist about any other medicines the patient is currently taking, has recently taken, or plans to take.
Concomitant use of Alatic and cisplatin (an anticancer medicine) may lead to loss of cisplatin efficacy.
Thioctic acid, when used together with antidiabetic medicines (insulin or oral antidiabetic drugs), may enhance their hypoglycaemic effect. Therefore, blood glucose levels should be closely monitored when starting treatment with Alatic. In some cases, to prevent episodes of hypoglycaemia, the dose of insulin or antidiabetic medicines may need to be reduced, according to the doctor's recommendations.

Use of Alatic with alcohol
Regular alcohol consumption is an important risk factor for the development and worsening of diseases related to nerve damage and may therefore affect the effectiveness of treatment with Alatic. For this reason, patients with diabetic neuropathy are generally advised to avoid alcohol consumption. This also applies during treatment breaks.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnant women and those who are breastfeeding should not take Alatic without medical advice, as there are currently no data available on use in such patients.

Driving and using machines
Very rarely, dizziness, headache and double vision (symptoms of hypoglycaemia) have occurred. If these symptoms occur, the patient should not drive or operate machinery.

3. How to use Alatic

Follow all your doctor's instructions carefully.
If in doubt, consult your doctor.
Dose:
The recommended dose for adults with diabetic sensory-motor polyneuropathy
is 1 vial (24 ml of injection solution) of Alatic (600 mg of thioctic acid) per day.
Method of administration
Alatic can be administered intravenously as an undiluted injection or as a short infusion after mixing with physiological saline solution.
Alatic should be administered over a period of not less than 12 minutes.
Due to the photosensitivity of the active substance, the infusion solution must be prepared immediately before administration and protected from light (e.g. by using aluminium foil).
Duration of treatment
Injections will be administered by a doctor for a period of two to four weeks during the initial phase of treatment. Your doctor will inform you when to switch to oral thioctic acid for maintenance therapy.
If you feel that the effect of Alatic 600 mg/24 ml, solution for injection, is too strong or too weak, consult your doctor.
Taking more Alatic than prescribed
In case of overdose, nausea, vomiting and headache may occur.
In some cases, after ingestion of more than 10 grams of thioctic acid, especially when combined with large amounts of alcohol, severe, sometimes life-threatening symptoms of poisoning have been observed (such as generalized seizures, acid-base imbalance and acidosis, severe blood coagulation disorders). Therefore, in case of suspected significant overdose of Alatic, immediate hospitalization is required and standard overdose treatment measures should be applied. Management of any symptoms should be carried out in an intensive care unit.
Missing a dose of Alatic
Your doctor will determine the dosing schedule. If you suspect that a dose has been missed, contact your doctor.
Stopping Alatic treatment
Do not discontinue treatment without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everybody gets them.
Possible adverse reactions:
Common (may occur in no more than 1 in 10 people):
Increased intracranial pressure (intracranial hypertension; headache) and dyspnea may occur frequently after rapid intravenous administration; these symptoms resolve spontaneously.
Uncommon (may occur in no more than 1 in 100 people):
Taste disturbances such as a metallic taste in the mouth, nausea, vomiting.
**Very rare (occur in less than 1 in 10,000 people):
Platelet-related disorder (thrombopathy), hypoglycemia (low blood glucose concentration) with symptoms such as dizziness, sweating, headache, visual disturbances, double vision, convulsions, petechiae (purpura), injection site reactions.
**Frequency not known (frequency cannot be estimated from available data):
Disorders related to hormones regulating blood glucose levels with marked reduction in blood glucose concentration (autoimmune insulin syndrome).
Generalized allergic reactions (including anaphylactic shock).
Skin allergic reactions including urticaria, pruritus, eczema, erythema, and rash.

Reporting of adverse reactions
If any adverse reactions occur in a patient, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can also be reported directly via the Department of Monitoring Adverse Drug Reactions at 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 responsible entity. By reporting adverse reactions, additional information regarding the safety of the medicine's use can be collected.

5. How to store Alatic

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or on the vial labels after EXP. The expiry date refers to the last day of the stated month.
Store below 25°C.
Keep in the original packaging to protect from light. Do not freeze.

After opening the vial:

Undiluted solution: The infusion solution should be protected from light (e.g. by using aluminium foil). Vials are intended for single use only; any unused content should be discarded after use. From a microbiological point of view, the product should be used immediately after first puncture of the rubber stopper.
After dilution: The infusion solution should be protected from light (e.g. by using aluminium foil). Chemical and physical stability of the prepared infusion solution diluted with 0.9% sodium chloride solution has been demonstrated for up to 6 hours under in-use conditions, provided it is stored below 25°C and protected from light. From a microbiological standpoint, the medicinal product should be used immediately. If the product is not used immediately, the user is responsible for ensuring the storage period and conditions prior to use, which generally should not exceed 6 hours at 2–8°C.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Alatic contains

The active substance is thioctic acid. Each 24 ml vial of solution for injection contains 600 mg of thioctic acid (in the form of trometamol salt).
The other components are: trometamol, 1M solution of trometamol (for pH adjustment), and water for injections.

What Alatic looks like and contents of the pack
Alatic is a clear, yellowish sterile solution, practically free from visible particles.
Vials containing 24 ml of solution for injection are packed in cardboard boxes.
Pack sizes:
Alatic is available in packs containing 1 vial or 5 vials. One cardboard box containing 1 vial or one cardboard box containing 5 vials in a protective tray made of PVC foil.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Solinea Sp. z o.o.
Elizówka, Szafranowa 6 Street
21-003 Ciecierzyn
Poland
tel.: +48 81 463 48 82
Manufacturer:
Rompharm Company S.R.L.
1A Eroilor Street, 075100, Otopeni, Ilfov county, Romania
This medicinal product is authorised for sale in the European Economic Area under the following names:
Romania: Acid tioctic Rompharm 600 mg/24 ml soluţie injectabilă
Bulgaria: Тиоктова киселина РОМФАРМ 600 mg/24 ml инжекционен разтвор
Hungary: Tioktánsav Rompharm 600mg/24ml oldatos injekció
Poland: Alatic, 600 mg/24 ml, solution for injection