PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet – the information on the immediate packaging is in a foreign language!
Vitaminum C Neupharm (vici)
100 mg/ml, solution for injection
Acidum ascorbicum
Vitaminum C Neupharm and vici are different trade names of 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. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What Vitaminum C Neupharm is and what it is used for
Important information before using Vitaminum C Neupharm
How to use Vitaminum C Neupharm
Possible side effects
How to store Vitaminum C Neupharm
Contents of the pack and other information

1. What Vitaminum C Neupharm is and what it is used for

The active substance of Vitaminum C Neupharm is ascorbic acid, i.e. vitamin C, which belongs to the group of water-soluble vitamins. It participates in collagen and intercellular substance formation and is therefore essential for the proper development of cartilage, bones, teeth, and wound healing. It also plays a very 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 indication for use of this medicinal product is:

Treatment of scurvy and other conditions associated with vitamin C deficiency requiring supplementation. The parenteral form of the medicine is administered in severe cases or when oral administration is difficult.

2. Important information before using Vitaminum C Neupharm

When not to use Vitaminum C Neupharm

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

Warnings and precautions
Special caution is required when using Vitaminum C Neupharm in the following
cases:

presence of excessive oxalic acid or oxalates in urine,
tendency to form mineral deposits in the urinary system,
hemochromatosis (an inherited metabolic disorder characterized by iron deposition in tissues),
diabetes,
thalassemia (sickle cell anemia),
sideroblastic anemia,
glucose-6-phosphate dehydrogenase deficiency, because high doses of vitamin C may cause red blood cell breakdown in such cases.

Tolerance to ascorbic acid may develop in patients taking high doses.
Vitamin C administered in high doses (from 1 g daily) may interfere with the results of certain
laboratory tests based on redox methods (e.g. urinary glucose concentration, ethinylestradiol plasma concentration, lactate dehydrogenase activity, liver aminotransferases in serum, occult blood test in stool, bilirubin concentration, urine pH, urinary uric acid and oxalate levels, 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 become pregnant, she should consult a doctor before using this medicine.
Pregnancy:
High-dose vitamin C is not recommended during pregnancy, as the effects of such doses on the fetus are unknown.
During pregnancy, vitamin C should not be used in doses exceeding the recommended daily intake (80–100 mg per day).
Breastfeeding:
The drug 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.
Vitaminum C Neupharm with other medicines
Inform your doctor about all medicines currently used or recently used, as well as any medicines you plan to take.
Substances that may reduce tissue saturation with ascorbic acid include: acetylsalicylic acid, nicotine from cigarettes, alcohol, certain appetite suppressants, iron, phenytoin, certain anticonvulsants, estrogen (a component of contraceptive drugs), and tetracycline.
High-dose vitamin C acidifies urine, thereby decreasing the excretion of acidic drugs and increasing the excretion of basic drugs, consequently weakening their effects.
High doses of vitamin C may reduce the effectiveness of oral anticoagulants.
Concurrent administration with ascorbic acid may reduce plasma concentrations of fluphenazine (a drug used, among others, in schizophrenia).
Ascorbic acid administered concomitantly with deferoxamine in patients with iron overdose (to enhance iron excretion) may increase its toxic effects, particularly on the heart muscle, especially in the early treatment phase when tissue iron levels are excessive. Therefore, such 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 antacids containing aluminum and oral citrates, life-threatening encephalopathy due to significantly increased serum aluminum levels may develop. There are suspicions that vitamin C may act similarly.
Oral contraceptives reduce plasma ascorbic acid concentration. Concurrent use of these agents with vitamin C may result in increased plasma estradiol concentration.
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), cephalothin, chlordiazepoxide, conjugated estrogens, dextran, doxapram (hydrochloride), erythromycin lactobionate, methicillin (sodium salt), nafcillin (sodium salt), nitrofurantoin (sodium salt), sulfafurazole diethanolamine salt, penicillin G (potassium salt), phytonadione, sodium bicarbonate, warfarin.
Occasionally, depending on pH and concentration, incompatibility may occur with chloramphenicol sodium succinate.
Vitaminum C Neupharm contains sodium metabisulfite and sodium
Sodium metabisulfite
The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.
Sodium
The medicine contains 65 mg of sodium (main component of table salt) in each 5 ml ampoule.
This corresponds to 3.25% of the maximum recommended daily sodium intake in the adult diet.

3. How to use Vitaminum C Neupharm

This medicine should always be used as directed by a physician. In case of doubt, consult your
doctor.
This medicine is administered by intramuscular or intravenous injection.
The dosage will be determined individually by the physician, 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 Vitaminum C Neupharm is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Vitaminum C Neupharm:
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 urine and formation of calcium 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 Vitaminum C Neupharm
Take the missed dose as soon as possible.
Do not use 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 and intestinal disturbances, including diarrhoea, vomiting, heartburn, skin redness, headache, and insomnia. High doses may also lead to 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 upon dose reduction.
Intramuscular administration may cause transient pain at the injection site.
Other adverse reactions may occur in some individuals during treatment with Vitaminum C Neupharm.

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 also be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 this medicine.

5. How to store Vitaminum C Neupharm

Keep in the original packaging to protect from light.
The medicine should be stored out of sight and reach of children.
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.
The solution should be used immediately after opening the ampoule. Any unused portion of the solution must be discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Vitaminum C Neupharm 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 hydrogen carbonate, sodium metabisulfite, water for injections.

What Vitaminum C Neupharm looks like and contents of the pack
Vitaminum C Neupharm, 100 mg/ml, solution for injection is a colourless or slightly yellowish,
clear, transparent liquid.
The medicine is packed in amber glass ampoules with a capacity of 5 ml (500 mg/5 ml), with 5 ampoules in a cardboard box.
For further information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Italy, country of export:
Monico spa
Via Ponte di Pietra 7
30173 Venice/Mestre
Italy
Manufacturer:
Monico spa
Via Ponte di Pietra 7
30173 Venice/Mestre
Italy
Parallel Importer:
NEUPHARM Sp. z o.o.
ul. Chełmska 30/34
00-725 Warsaw
Repackaged by:
LABOR Pharmaceutical and Chemical Enterprise sp. z o.o.
ul. Długosza 49
51-162 Wrocław
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing Authorisation Number in Italy, country of export: 007112016
Parallel Import Licence Number: 221/23