Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is 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 medicinal product.
Please read this leaflet carefully before using the 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 questions, please consult your doctor, pharmacist or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

What is Acidum ascorbicum Aga Kommerz and what is it used for
Important information before using Acidum ascorbicum Aga Kommerz
How to use Acidum ascorbicum Aga Kommerz
Possible side effects
How to store Acidum ascorbicum Aga Kommerz
Contents of the pack and other information

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

The active substance of this medicine is ascorbic acid, also known as vitamin C, which belongs to the group of water-soluble vitamins. It plays a role in the formation of collagen and intercellular substance, and is therefore essential for the proper development of cartilage, bones, teeth, and also 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 formation of hemoglobin and maturation of erythrocytes (red blood cells).
The indications for use of this medicine are:

Treatment of scurvy and other conditions of vitamin C deficiency requiring supplementation. The medicine administered by parenteral route is used 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 to any of the other ingredients of this medicine (listed in section 6);
in oxalate kidney stone disease (nephrolithiasis).

Warnings and precautions
Special caution should be exercised when using Acidum ascorbicum Aga Kommerz in the following cases:

excessive amounts of oxalic acid or oxalates in urine,
predisposition to mineral deposits in the urinary tract,
haemochromatosis (an inherited metabolic disorder characterized by iron deposition in tissues),
diabetes,
thalassaemia (sickle cell anaemia),
sideroblastic anaemia,
glucose-6-phosphate dehydrogenase deficiency, as high doses of vitamin C may then cause haemolysis (breakdown of red blood cells).

Tolerance to ascorbic acid may develop in patients receiving high doses.
Vitamin C administered in high doses (≥1 g daily) may interfere with the results of certain laboratory tests performed by redox methods (e.g. urinary glucose concentration, ethinylestradiol concentration in plasma, lactate dehydrogenase activity, liver aminotransferases in serum, occult blood test in faeces, bilirubin concentration, urine pH, urinary content of uric acid and oxalates, serum iron and ferritin concentrations).

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.

Pregnancy
High-dose vitamin C is not recommended during pregnancy, as the effect of such doses on the foetus is unknown.
During pregnancy, vitamin C should not be used in doses exceeding the recommended daily intake (80–100 mg daily).

Breastfeeding
The medicine passes into breast milk, but there is no evidence of harmful effects on breastfed infants.
During breastfeeding, vitamin C should not be used in doses exceeding the recommended daily intake (80–100 mg daily).

Driving and operating machinery
The medicine probably has no influence on the ability to drive or operate machinery.

Acidum ascorbicum Aga Kommerz and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines planned for future use.

Substances that may reduce tissue saturation with ascorbic acid include: acetylsalicylic acid, nicotine in cigarettes, alcohol, certain appetite suppressants, iron, phenytoin, certain anticonvulsants, oestrogen (a component of oral contraceptives), and tetracycline.

High-dose vitamin C acidifies urine, thereby decreasing the excretion of acidic drugs and increasing the excretion of basic drugs, which may lead to reduced efficacy of the latter.

High doses of vitamin C may reduce the effect of oral anticoagulants. Concurrent administration with ascorbic acid may decrease plasma concentrations of fluphenazine (a medicine used, among others, in schizophrenia).

Ascorbic acid administered as an adjunct to deferoxamine in patients with iron overdose (to enhance iron excretion) may increase its toxic effects, particularly on the myocardium, especially in the early phase of treatment when tissue iron levels are excessive. Therefore, this combination should not be used in patients with impaired cardiac function. In patients with normal cardiac function, the physician may administer additional vitamin C no earlier than one month after starting deferoxamine therapy.

In patients with impaired renal function receiving antacids containing aluminium and oral citrates, life-threatening encephalopathy due to markedly increased serum aluminium concentrations may develop. There is a suspicion that vitamin C may have a similar effect.

Oral contraceptives reduce ascorbic acid concentration in plasma. Concurrent use of these agents with vitamin C may result in increased plasma oestradiol concentrations.

Incompatibilities with other medicines
Vitamin C is incompatible with iron salts, oxidizing agents, and heavy metal salts, especially copper.

Incompatibilities have been reported between vitamin C solution and: aminophylline, bleomycin sulphate, cefazolin (sodium salt), cephapirin, chlordiazepoxide, conjugated oestrogens, dextran, doxapram (hydrochloride), erythromycin lactobionate, methicillin (sodium salt), nafcillin (sodium salt), nitrofurantoin (sodium salt), diethanolamine sulfafurazole, penicillin G (potassium salt), phytomenadione, sodium bicarbonate, and warfarin.

Occasionally, depending on pH and concentration, incompatibility may occur with sodium chloramphenicol succinate.

Acidum ascorbicum Aga Kommerz contains sodium metabisulphite and sodium

Sodium metabisulphite
This medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

Sodium
This 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 according to the doctor's instructions. If in doubt, consult your
doctor.
This medicine is administered by intramuscular or intravenous injection.
The doctor will determine the dosage individually, depending on the vitamin C deficiency assessed
based on symptoms.
Adults:
treatment: 500 mg to 1000 mg per day, in divided doses;
Children:
treatment: 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, consult your doctor.
Use of a higher than recommended dose of Acidum ascorbicum Aga Kommerz
Symptoms of vitamin C overdose may include gastrointestinal disturbances 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 formation of oxalate kidney stones. Daily doses of 600 mg and higher may have a diuretic effect. If symptoms of overdose occur, administration of the medicine should be discontinued and the doctor will initiate symptomatic treatment.
If a higher than recommended dose has been taken, seek immediate advice from a doctor or
pharmacist.
Missed dose of Acidum ascorbicum Aga Kommerz
Take the missed dose as soon as possible.
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
High doses of vitamin C may cause gastrointestinal disturbances, including diarrhoea, vomiting, heartburn,
skin flushing, headache, and insomnia. High doses may also cause
hyperoxaluria (increased excretion of oxalic acid in urine) and formation of calcium oxalate kidney stones,
if the urine becomes acidic. 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 symptoms of deficiency may occur when the dosage is reduced.
Intramuscular administration may cause transient pain at the injection site.
Other adverse reactions may occur in some individuals during treatment with Acidum ascorbicum Aga Kommerz.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Acidum ascorbicum Aga Kommerz

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Store in the original packaging to protect from light.
The solution should be used immediately after opening the ampoule. Any unused portion of the solution must 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 stated month.

6. Contents of the packaging and other information

What Acidum ascorbicum Aga Kommerz contains

The active substance is ascorbic acid. 1 ml of solution contains 100 mg of ascorbic acid. One 5 ml ampoule contains 500 mg of ascorbic acid (100 mg/ml).
Excipients: sodium hydroxide, sodium pyrosulfite, water for injections.

What Acidum ascorbicum Aga Kommerz looks like and contents of the pack
Acidum ascorbicum Aga Kommerz, 100 mg/ml, solution for injection is a colourless or slightly yellowish, clear liquid.
The medicine is packed in brown glass ampoules with a capacity of 5 ml (500 mg/5 ml), 5 or 10 units per cardboard box.
For further information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation 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 Český Těšín, Czech Republic
Repackaged in:
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warszawa
Euceryna Pharmaceutical Laboratory COEL S.J. E.Z.M. KONSTANTY, ul. Wł. Żeleńskiego 45, 31-353 Kraków
Marketing Authorisation Number in Italy, country of export: 008194045
Parallel Import Licence Number: 248/23