Alatic

Package Leaflet: Information for the Patient

Alatic, 600 mg/24 ml, Solution for Injection

Thioctic Acid

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Alatic and what is it used for

Thioctic acid, the active substance of Alatic, is a substance produced in the body that affects certain metabolic functions of the body. Additionally, thioctic acid has antioxidant properties, which protect nerve cells from reactive breakdown products. Alatic is used to treat the symptoms of diabetic peripheral neuropathy.

2. Important information before using Alatic

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

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

Warnings and precautions

Before starting treatment with Alatic, discuss it with your doctor or pharmacist. Allergic reactions (hypersensitivity), including life-threatening shock (sudden cardiovascular collapse), have been reported after administration of thioctic acid in the form of a solution for injection or infusion (see section 4 "Possible side effects"). Therefore, during administration of Alatic, the patient's condition will be monitored for early signs of these reactions (e.g., itching, nausea, malaise, etc.). If such symptoms occur, treatment should be discontinued immediately; other therapeutic measures may be taken. During treatment with Alatic, urine may have a different odor, but this is not clinically significant. Patients with a specific genotype of human leukocyte antigen (more common in patients from Japan and Korea, but also occurring in people of Caucasian origin) may be more prone to developing autoimmune insulin syndrome (a disorder affecting hormones regulating blood glucose levels with a significant decrease in blood glucose levels) during treatment with thioctic acid, the active substance of Alatic.

Children and adolescents

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

Alatic and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take. Concomitant use of Alatic and cisplatin (an anticancer medicine) may lead to a loss of cisplatin efficacy. Thioctic acid used concomitantly with antidiabetic medicines (insulin or oral antidiabetic medicines) may enhance their hypoglycemic effect. Therefore, when starting treatment with Alatic, blood glucose levels should be closely monitored. In some cases, to prevent episodes of hypoglycemia, it may be necessary to reduce the dose of insulin or antidiabetic medicines in accordance with the doctor's recommendations.

Using Alatic with alcohol

Regular consumption of alcohol is a significant risk factor for the development and exacerbation of nerve damage-related diseases, and thus may affect the efficacy of treatment with Alatic. Therefore, patients with diabetic nerve damage (peripheral neuropathy) are generally advised to avoid consuming alcohol. This also applies to breaks in treatment.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Women who are pregnant or breastfeeding should not use Alatic without a doctor's recommendation, as there is currently no data on such patients.

Driving and using machines

In very rare cases, dizziness, headaches, and double vision (hypoglycemic symptoms) have occurred. If you experience these symptoms, do not drive or operate machinery.

3. How to use Alatic

Follow the doctor's instructions carefully. If you have any doubts, ask your doctor. Recommended dose:The recommended dose for adults with diabetic peripheral neuropathy is 1 vial (24 ml solution for injection) of Alatic (600 mg thioctic acid) per day. Method of administrationAlatic can be administered intravenously as an undiluted solution for injection or as a short infusion after mixing with a physiological saline solution. Alatic should be administered over a period of not less than 12 minutes. Due to the sensitivity of the active substance to light, the infusion solution should be prepared immediately before administration and protected from light (e.g., with aluminum foil). Duration of treatmentInjections will be administered by a doctor for a period of 2 to 4 weeks in the initial phase of treatment. The doctor will inform the patient when to switch to thioctic acid administered orally as part of maintenance treatment. If you feel that the effect of Alatic 600 mg/24 ml, solution for injection is too strong or too weak, tell your doctor.

Overdose of Alatic

In case of overdose, nausea (vomiting), vomiting, and headache may occur. In some cases, after taking more than 10 grams of thioctic acid, especially with concurrent consumption of large amounts of alcohol, severe, sometimes life-threatening symptoms of poisoning (such as generalized seizures, acid-base imbalance, and acidosis, severe blood coagulation disorders) have been observed. Therefore, in case of suspected significant overdose of Alatic, immediate hospitalization and standard treatment for overdose are necessary. Treatment of any symptoms should be carried out in the intensive care unit.

Missed dose of Alatic

The dose will be determined by the doctor. If you suspect a missed dose, contact your doctor.

Stopping treatment with Alatic

Do not stop treatment without consulting your doctor. If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects

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

Possible side effects: Frequent (may affect up to 1 in 10 people):

Frequent intravenous administration may cause increased intracranial pressure (intracranial hypertension; headache) and shortness of breath; these symptoms resolve on their own. Uncommon (may affect up to 1 in 100 people): Taste disturbances in the form of a metallic taste in the mouth, nausea, vomiting. Rare (may affect up to 1 in 10,000 people): Blood platelet disorders (thrombopathy), hypoglycemia (low blood glucose levels) with symptoms such as dizziness, sweating, headache, vision disturbances, double vision, seizures, petechiae (small spots), injection site reactions. Frequency not known (cannot be estimated from the available data): Disorders affecting hormones regulating blood glucose levels with a significant decrease in blood glucose levels (autoimmune insulin syndrome). Systemic allergic reactions (including anaphylaxis). Skin allergic reactions including urticaria, itching, eczema, redness, and rash.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can also be reported directly to the Department of Pharmacovigilance 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. 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 this medicine.

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 label after EXP. The expiry date refers to the last day of that month. Store in a temperature below 25°C. Store in the original package to protect from light. Do not freeze. After opening the vial:

• Undiluted solution:The infusion solution should be protected from light (e.g., with aluminum foil). The vials are intended for single use only, and any unused contents should be discarded after use. From a microbiological point of view, the product should be used immediately after the first piercing of the rubber stopper.
• After dilution:The infusion solution should be protected from light (e.g., with aluminum foil). The chemical and physical stability of the prepared infusion solution with the addition of 0.9% sodium chloride solution has been demonstrated under conditions of use for up to 6 hours, provided that it is stored below 25°C and protected from light. From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user, and these times normally should not exceed 6 hours at 2-8°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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 (as trometamol salt).
• The other ingredients are trometamol, 1M trometamol solution (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 film. Not all pack sizes may be marketed.

Marketing authorization holder

Solinea Sp. z o.o., Elizówka, ul. Szafranowa 6, 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 authorized in the Member States of 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, roztwór do wstrzykiwań

Date of last revision of the leaflet