Vitaminum c swiss2care

Package leaflet: Information for the patient

Vitaminum C Swiss2Care
100 mg/ml, solution for injection
Acidum ascorbicum
Please read all of this leaflet carefully before using the medicine, because 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

1. What Vitaminum C Swiss2Care is and what it is used for
2. Important information before using Vitaminum C Swiss2Care
3. How to use Vitaminum C Swiss2Care
4. Possible side effects
5. How to store Vitaminum C Swiss2Care
6. Contents of the pack and other information

1. What Vitaminum C Swiss2Care is and what it is used for

The active substance of the medicine is ascorbic acid, i.e. vitamin C, which belongs to water-soluble vitamins. It participates in collagen and intercellular substance formation and is therefore essential for the proper development of cartilage, bones, teeth, as well as 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 indications for use are:

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

2. Important information before using Vitaminum C Swiss2Care

When not to use Vitaminum C Swiss2Care

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

Warnings and precautions
Special caution is required when using Vitaminum C Swiss2Care in the following cases:

• excessive oxalic acid or oxalates in urine,
• tendency to form mineral deposits in the urinary tract,
• hemochromatosis (an inherited metabolic disorder characterized by iron deposition in tissues),
• diabetes,
• thalassemia (sickle cell anemia),
• sideroblastic anemia,
• glucose-6-phosphate dehydrogenase deficiency, as 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 concentration in plasma, lactate dehydrogenase activity, liver aminotransferase activity 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 might be pregnant, or is planning to conceive, 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 fetus is 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:
Vitaminum C Swiss2Care probably does not affect the ability to drive or operate machinery.

Vitaminum C Swiss2Care and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines you plan to take.

Substances that reduce tissue saturation with ascorbic acid include: acetylsalicylic acid, nicotine in cigarettes, alcohol, certain appetite suppressants, iron, phenytoin, certain anticonvulsants, estrogen (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 efficacy.

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

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

Ascorbic acid administered adjunctively with 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 taking antacids containing aluminum and oral citrates, life-threatening encephalopathy due to markedly increased serum aluminum levels may develop. There is a suspicion 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 levels.

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 salt, penicillin G (potassium salt), phytonadione, sodium bicarbonate, warfarin.

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

Vitaminum C Swiss2Care contains sodium
The medicine contains 14.239 mg of sodium (main component of table salt) per 1 ml of solution, equivalent to 71.195 mg of sodium per ampoule.

At doses up to 100 mg of ascorbic acid per day, this medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

When higher doses of ascorbic acid are administered, up to the maximum dose of 2000 mg of ascorbic acid per day, this medicine contains up to 284.78 mg of sodium. This corresponds to 14.2% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Vitaminum C Swiss2Care

This medicine should always be used according to the doctor's instructions. If in doubt, consult
your doctor.
The 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 Vitaminum C Swiss2Care is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Vitaminum C Swiss2Care
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 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 provide 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 Swiss2Care
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 any medicine, this medicine can cause adverse reactions, although not everyone experiences 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 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 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 Swiss2Care.
Reporting adverse reactions
If any adverse symptoms occur, including any possible 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
Adverse reactions can also be reported to the marketing authorization holder or parallel importer.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Vitaminum C Swiss2Care

Keep the medicine out of sight and reach of children.
Store below 25°C.
Keep the ampoules in the outer packaging to protect from light.
The solution should be used immediately after opening the ampoule. Any unused portion 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Vitaminum C Swiss2Care 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 hydroxymethanesulfinate, trisodium edetate dihydrate, water for injections.

What Vitaminum C Swiss2Care looks like and contents of the pack
Vitaminum C Swiss2Care, 100 mg/ml, solution for injection is a clear, colourless to slightly greenish-yellow solution, practically free from particulate matter.
The medicine is packed in colourless glass ampoules with a capacity of 5 ml (500 mg/5 ml), 10 ampoules per cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Czech Republic, country of export:
BB Pharma a.s.
Durychova 101/66
142 00 Prague 4 - Lhotka
Czech Republic
Manufacturer:
HBM Pharma s.r.o.
Sklabinská 30
036 80 Martin
Slovak Republic
Parallel importer:
Swiss2Care Sp. z o.o. Sp. k.
Mostowa 38/1
78-100 Toruń
Repackaged in:
CEFEA Sp. z o.o. Sp. k.
Działkowa 56
02-234 Warsaw
Czech Republic marketing authorisation number: 86/799/92-S/C
Parallel import authorisation number: 130/23