Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Acidum ascorbicum Delfarma, 100 mg/ml, solution for injection
Acidum ascorbicum
Please read the entire 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 doubts, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. 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 adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What Acidum ascorbicum Delfarma is and what it is used for

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

Treatment of scurvy and other conditions involving vitamin C deficiency requiring supplementation. The medicine is administered parenterally in severe cases or when oral administration is difficult.

2. Important information before using Acidum ascorbicum Delfarma

When not to use Acidum ascorbicum Delfarma:

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

Warnings and precautions
Exercise special caution when using Acidum ascorbicum Delfarma in the following cases:

presence of excessive amounts of oxalic acid or oxalates in urine,
tendency to form mineral deposits in the urinary system,
haemochromatosis (an inherited metabolic disorder characterized by deposition of iron in tissues),
diabetes,
thalassaemia (sickle cell anaemia),
sideroblastic anaemia, Page 1 of 5
glucose-6-phosphate dehydrogenase deficiency, since high doses of vitamin C may cause haemolysis (breakdown of red blood cells).

Tolerance to ascorbic acid may develop in patients taking high doses.
Vitamin C administered in high doses (from 1 g per day) may interfere with the results of certain laboratory tests based on redox methods (e.g. urinary glucose concentration, ethinylestradiol concentration in plasma, lactate dehydrogenase activity, hepatic serum aminotransferases, 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 per day).

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 per day).

Driving and operating machinery:
The medicine probably does not affect the ability to drive or operate machinery.

Interaction of Acidum ascorbicum Delfarma with other medicines
Inform your doctor about all medicines currently taken or recently used, as well as any medicines planned for future use.

Substances that may reduce tissue saturation with ascorbic acid include: acetylsalicylic acid, nicotine contained in cigarettes, alcohol, some 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 consequently reduce their effectiveness.

High doses of vitamin C may reduce the effect of oral anticoagulants.

Concurrent administration with ascorbic acid may reduce serum concentrations of fluphenazine (a drug used, among others, in schizophrenia).

Ascorbic acid administered as an adjunct to deferoxamine in patients with iron overdose (to enhance iron excretion) may enhance 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 taking aluminium-containing antacids and oral citrates, life-threatening aluminium-induced encephalopathy due to significantly increased serum aluminium concentrations may develop. There are suspicions that vitamin C may have a similar effect.

Oral contraceptives reduce serum ascorbic acid concentration. Concurrent use of these agents with vitamin C may result in increased serum estradiol concentration.

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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), cefapirin, chlordiazepoxide, conjugated oestrogens, dextran, doxapram (hydrochloride), erythromycin lactobionate, methicillin (sodium salt), nafcillin (sodium salt), nitrofurantoin (sodium salt), sulfafurazole diethanolamine salt, penicillin G (potassium salt), phytomenadione, sodium bicarbonate, warfarin.

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

Acidum ascorbicum Delfarma contains sodium metabisulphite and sodium

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

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

3. How to use Acidum ascorbicum Delfarma

This medicine should always be used exactly as directed by the physician. In case of doubt, consult
your doctor.
This medicine is administered by intramuscular or intravenous injection.
The physician will determine the dosage individually, depending on the vitamin C deficiency assessed
based on symptoms.
Adults:
Therapeutic dose: 500 mg to 1000 mg per day, in divided doses;
Children:
Therapeutic dose: 100 mg to 300 mg per day in 2–3 divided doses.
If you feel that the effect of Acidum ascorbicum Delfarma is too strong or too weak,
consult your doctor.
Use of a higher than recommended dose of Acidum ascorbicum Delfarma:
Symptoms of vitamin C overdose may include gastrointestinal disturbances such as diarrhea,
vomiting, heartburn, as well as skin redness, headache, and insomnia. Large doses may
cause excessive excretion of oxalic acid in 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 physician
will initiate symptomatic treatment.
In case of ingestion of a higher than recommended dose, seek immediate medical advice from a doctor or
pharmacist.
Missed dose of Acidum ascorbicum Delfarma
Take the missed dose as soon as possible.
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
High doses of vitamin C may cause gastrointestinal disturbances, including diarrhoea, vomiting, heartburn,
skin redness, 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 if the dose is reduced.
Intramuscular administration may cause transient pain at the injection site.
Other adverse effects may occur in some individuals during treatment with Acidum ascorbicum Delfarma.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects
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
By reporting adverse effects, additional information on the safety of this medicine can be collected.

5. How to store Acidum ascorbicum Delfarma

Keep this medicine out of 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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the packaging and other information

What Acidum ascorbicum Delfarma contains

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

What Acidum ascorbicum Delfarma looks like and contents of the pack
Acidum ascorbicum Delfarma 100 mg/ml solution for injection is a colourless or slightly yellow, clear liquid.
The medicine is packed in 5 ml amber glass ampoules (500 mg/5 ml), with 5 ampoules in a cardboard pack.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Italy, the country of export:
S.A.L.F. S.p.A. Laboratorio Farmacologico, Via Marconi, 2 – 24069 Cenate Sotto (BG), Italy
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Manufacturer:
S.A.L.F. S.p.A. Laboratorio Farmacologico, Via Marconi, 2 – 24069 Cenate Sotto (BG), Italy
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged by:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Italian marketing authorisation number, country of export: 008194045
Parallel import licence number: 195/24
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