Acidum ascorbicum Delfarma

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Acidum ascorbicum Delfarma, 100 mg/ml, solution for injection

Acidum ascorbicum

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.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. 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 tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Acidum ascorbicum Delfarma 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 digestive tract, and participates in the production of hemoglobin and the maturation of erythrocytes (red blood cells).
The indication for the 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 Delfarma

When not to use Acidum ascorbicum Delfarma:

• 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 Delfarmain 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, Page 1 5
• glucose-6-phosphate dehydrogenase deficiency, as high doses of vitamin C may then cause red blood cell breakdown.

In patients taking high doses, tolerance to ascorbic acid may develop.
Vitamin C used in high doses (from 1 g per day) may falsify the results of some 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).
High doses of vitamin C may weaken the effect of oral anticoagulant drugs.
During concurrent administration with ascorbic acid, the concentration of flufenazine (a drug 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 (in order to better eliminate it) 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 after a month from 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.
Page 2 5
Incompatibilities with other medicines
Vitamin C is incompatible with iron salts, oxidizing agents, and heavy metal salts, especially copper.
Incompatibilities of the 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 the pH and concentration, incompatibility with sodium succinate chloramphenicol may occur.

Acidum ascorbicum Delfarma 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 Delfarma

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, you should consult a doctor.
The medicine is used in the form of intramuscular or intravenous injections.
The doctor will determine the dosage individually, depending on the vitamin C deficiency assessed on the basis of 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 Delfarma is too strong or too weak, you should consult a doctor.

Using a higher dose of Acidum ascorbicum Delfarma than recommended:

Symptoms of vitamin C overdose may include gastrointestinal disorders, including 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.
In case of overdose symptoms, 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 Delfarma

You should take the prescribed dose as soon as possible.
You should not take a double dose to make up for the 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 stomach and intestinal disorders, including diarrhea, vomiting, heartburn, skin redness, headache, and insomnia. High doses may also cause hyperoxaluria (increased excretion of oxalic acid in the urine) and the formation of 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 long-term use of high doses, tolerance to ascorbic acid may develop, and in case of dose reduction, deficiency symptoms may occur.
Intramuscular administration may cause transient pain at the injection site.
In some people, during the use of Acidum ascorbicum Delfarma, other side effects may occur.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell 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 Delfarma

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. The unused amount of the solution should be discarded.
Do not use this medicine after the expiry date stated on the packaging. The expiry date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Acidum ascorbicum Delfarma 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).
• Excipients: sodium hydroxide, sodium metabisulfite, water for injections.

What Acidum ascorbicum Delfarma looks like and what the packaging contains

Acidum ascorbicum Delfarma, 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 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, the country of export:

S.A.L.F. S.p.A. Laboratorio Farmacologico, Via Marconi, 2 – 24069 Cenate Sotto (BG), Italy
Page 4 5

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, country of export marketing authorization number: 008194045

Parallel import authorization number: 195/24

Leaflet approval date: 09.05.2024

Page 5 5