Acidum ascorbicum Aga Kommezh

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Acidum ascorbicum Aga Kommerz (Vitamina C SALF)

100 mg/ml, solution for injection
Acidum ascorbicum
Acidum ascorbicum Aga Kommerz and Vitamina C SALF are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Acidum ascorbicum Aga Kommerz and what is it used for

The active substance of the medicine is ascorbic acid, i.e., vitamin C, which belongs to water-soluble vitamins. It participates in the production of collagen and intercellular substance and is therefore necessary for the proper development of cartilage, bones, teeth, as well as for wound healing. It also plays a very important role in the conversion of folic acid to folinic acid, facilitates the absorption of iron from the gastrointestinal tract, and participates in the production of hemoglobin and the maturation of red blood cells (erythrocytes).
The indication for use of the medicine is:

• treatment of scurvy and other states of deficiency requiring vitamin C supplementation. The medicine in the form of a parenteral solution is administered in severe cases or when oral administration is difficult.

2. Important information before using Acidum ascorbicum Aga Kommerz

When not to use Acidum ascorbicum Aga Kommerz:

• if the patient is allergic to vitamin C or any of the other ingredients of this medicine (listed in section 6);
• in kidney stones (oxalate).

Warnings and precautions

Particular caution should be exercised when using Acidum ascorbicum Aga Kommerzin the following cases:

• excessive amounts of oxalic acid or oxalates in the urine,
• tendency to form mineral deposits in the urinary system,
• hemochromatosis (a congenital metabolic disorder characterized by the deposition of iron in tissues),
• diabetes,
• thalassemia (a hemolytic anemia),
• sideroblastic anemia,
• glucose-6-phosphate dehydrogenase deficiency, as high doses of vitamin C may cause red blood cell breakdown in this case.

In patients taking high doses, tolerance to ascorbic acid may develop. Vitamin C used in high doses (from 1 g per day) may interfere with the results of certain laboratory tests performed using oxidation-reduction methods (e.g., glucose concentration in urine, ethinylestradiol concentration in serum, lactic dehydrogenase activity, liver transaminases in serum, occult blood test in stool, bilirubin concentration, urine pH, uric acid and oxalate content in urine, iron and ferritin concentration in serum).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine.
Pregnancy
High doses of vitamin C are not recommended during pregnancy, as the effect of such doses on the fetus is not known.
During pregnancy, vitamin C should not be used in doses higher than the recommended daily intake (80-100 mg per day).
Breastfeeding
The medicine passes into breast milk, but there is no evidence of its harmful effect on breastfed infants.
During breastfeeding, vitamin C should not be used in doses higher than the recommended daily intake (80-100 mg per day).

Driving and using machines

The medicine is unlikely to affect the ability to drive and use machines.

Acidum ascorbicum Aga Kommerz and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as about medicines they plan to take.
Substances that reduce tissue saturation with ascorbic acid include: acetylsalicylic acid, nicotine contained in cigarettes, alcohol, some appetite suppressants, iron, phenytoin, some anticonvulsant medicines, estrogen - a component of oral contraceptives, and tetracycline.
Vitamin C used in high doses acidifies the urine, which reduces the excretion of acidic medicines and increases the excretion of basic medicines, thereby weakening their effect.
High doses of vitamin C may weaken the effect of oral anticoagulant medicines. When administered together with ascorbic acid, the concentration of flufenazine (a medicine used, among others, in schizophrenia) in serum may decrease.
Ascorbic acid administered as an auxiliary agent with deferoxamine in patients who have taken an overdose of iron (to improve its excretion) may increase its toxic effect, especially on the heart muscle, especially in the early stages of treatment, when the amount of iron in tissues is excessive. Therefore, such a combination should not be used in patients with impaired heart function, while in patients with normal heart function, the doctor will use vitamin C no earlier than one month after the start of deferoxamine treatment.
In patients with impaired renal function using antacids containing aluminum and oral citrates, life-threatening encephalopathy may develop, caused by a significant increase in aluminum concentrations in the blood. There are suspicions that vitamin C may interact similarly.
Oral contraceptives reduce the concentration of ascorbic acid in serum. Concurrent use of these agents with vitamin C may result in increased estradiol concentration in serum.
Incompatibilities with other medicines
Vitamin C is incompatible with iron salts, oxidizing agents, and heavy metal salts, especially copper.
Incompatibilities of vitamin C solution have been reported with: aminophylline, bleomycin sulfate, cefazolin (sodium salt), cefapirin, chlordiazepoxide, conjugated estrogens, dextran, doxapram (hydrochloride), erythromycin lactobionate, methicillin (sodium salt), nafcillin (sodium salt), nitrofurantoin (sodium salt), sulfafurazole diethanolamine, penicillin G (potassium salt), phytomenadione, sodium bicarbonate, warfarin.
Occasionally, depending on pH and concentration, incompatibility with sodium succinate may occur.

Acidum ascorbicum Aga Kommerz contains sodium metabisulfite and sodium

Sodium metabisulfite

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

Sodium

The medicine contains more than 1 mmol (23 mg) of sodium (the main component of table salt) per dose.

3. How to use Acidum ascorbicum Aga Kommerz

This medicine should always be used as directed by the doctor. In case of doubts, the doctor should be consulted.
The medicine is administered in the form of intramuscular or intravenous injections .
The doctor will determine the dosage individually, depending on the vitamin C deficiency assessed based on symptoms.
Adults:
therapeutically:from 500 mg to 1000 mg per day, in divided doses;
Children:
therapeutically:from 100 mg to 300 mg per day, in 2-3 divided doses.
If you feel that the effect of Acidum ascorbicum Aga Kommerz is too strong or too weak, you should consult a doctor.

Using a higher dose of Acidum ascorbicum Aga Kommerz than recommended

Symptoms of vitamin C overdose may include gastrointestinal disorders, such as diarrhea, vomiting, heartburn, as well as skin redness, headache, and insomnia. High doses may cause excessive excretion of oxalic acid in the urine and the formation of oxalate stones in the kidneys. Daily doses of 600 mg and higher may have a diuretic effect. If symptoms of overdose occur, the administration of the medicine should be discontinued, and the doctor will use symptomatic treatment.
In case of taking a higher dose of the medicine than recommended, you should immediately consult a doctor or pharmacist.

Missing a dose of Acidum ascorbicum Aga Kommerz

The prescribed dose should be used as soon as possible.
A double dose should not be used to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
High doses of vitamin C may cause gastrointestinal disorders, such as diarrhea, vomiting, heartburn, as well as skin redness, headache, and insomnia. High doses may also cause hyperoxaluria (increased excretion of oxalic acid in the urine) and the formation of oxalate kidney stones, if the urine becomes acidified. Daily doses of 600 mg and higher may have a diuretic effect.
Too rapid intravenous administration may cause dizziness and a feeling of weakness. After prolonged use of high doses, tolerance to ascorbic acid may develop, and when the dose is reduced, symptoms of deficiency may occur.
Intramuscular administration may cause transient pain at the injection site.
In some people, other side effects may occur during the use of Acidum ascorbicum Aga Kommerz.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Acidum ascorbicum Aga Kommerz

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Store in the original packaging to protect from light.
The solution should be used immediately after opening the ampoule. Any unused solution should be discarded.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

6. Contents of the packaging and other information

What Acidum ascorbicum Aga Kommerz contains

• The active substance of the medicine is ascorbic acid. 1 ml of the solution contains 100 mg of ascorbic acid .1 ampoule with a capacity of 5 ml contains 500 mg of ascorbic acid (100 mg/ml).
• The excipients are: sodium hydroxide, sodium metabisulfite, water for injections.

What Acidum ascorbicum Aga Kommerz looks like and what the packaging contains

Acidum ascorbicum Aga Kommerz, 100 mg/ml, solution for injection is a colorless or slightly yellowish, clear liquid.
The medicine is packaged in brown glass ampoules with a capacity of 5 ml (500 mg/5 ml), 5 or 10 pieces in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Italy, country of export, and manufacturer:

S.A.L.F. S.p.A. Laboratorio Farmacologico
Via Marconi, 2 – 24069 Cenate Sotto (BG), Italy

Parallel importer:

Aga Kommerz spol. s r.o., Frydecka 2006, 737 01 Czeski Cieszyn, Czech Republic

Repackaged by:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
Wytwórnia Euceryny Laboratorium Farmaceutyczne COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45, 31-353 Kraków
Marketing authorization number in Italy, country of export:008194045

Parallel import authorization number: 248/23

Date of leaflet approval: 31.10.2023