Vitaminum C Sviss2care

Leaflet attached to the packaging: patient information

Vitaminum C Swiss2Care

100 mg/ml, solution for injection

Ascorbic acid

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, 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 Vitaminum C Swiss2Care and what is it 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 packaging and other information

1. What is Vitaminum C Swiss2Care 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 gastrointestinal tract, and participates in the production of hemoglobin and the maturation of red blood cells (erythrocytes).

Indication for use:

• treatment of scurvy and other conditions of vitamin C deficiency requiring 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 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 stones (oxalate).

Warnings and precautions

Particular caution should be exercised when using Vitaminum C Swiss2Care in 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 iron deposits 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 patients taking high doses, tolerance to ascorbic acid may develop. Vitamin C administered in high doses (from 1 g per day) may interfere with the results of some laboratory tests performed using oxidation-reduction methods (e.g., glucose concentration in urine, ethinyl estradiol 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).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine. Pregnancy: High doses of vitamin C should not be used during pregnancy, as the effect of such doses on the fetus is unknown. During pregnancy, vitamin C should not be used in doses higher than the recommended daily intake (80-100 mg per day). Breastfeeding: The medicine passes into breast milk, but there is no evidence of its harmful effect on breastfed infants. During breastfeeding, vitamin C should not be used in doses higher than the recommended daily intake (80-100 mg per day).

Driving and using machines

The medicine is unlikely to affect the ability to drive and use machines.

Vitaminum C Swiss2Care and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Substances that reduce tissue saturation with ascorbic acid include: acetylsalicylic acid, nicotine in cigarettes, alcohol, some appetite suppressants, iron, phenytoin, some anticonvulsants, estrogen - a component of oral contraceptives, and tetracycline. Vitamin C administered in high doses acidifies the urine, which reduces the excretion of acidic drugs and increases the excretion of basic drugs, thereby weakening their effect. High doses of vitamin C may weaken the effect of oral anticoagulants. When administered with ascorbic acid, the concentration of flufenazine (a medicine used, among others, in schizophrenia) in serum may decrease. Ascorbic acid administered as an auxiliary with deferoxamine in patients who have overdosed on iron (to improve its excretion) 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 one month after starting deferoxamine treatment. In patients with impaired renal function using antacids containing aluminum and oral citrates, life-threatening encephalopathy may develop due to a significant increase in aluminum concentrations in the blood. It is suspected 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. 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.

Vitaminum C Swiss2Care contains sodium

The medicine contains 14.239 mg of sodium (the main component of common salt) per 1 ml of solution, which corresponds to 71.195 mg of sodium per ampoule. In doses up to 100 mg of ascorbic acid per day, this medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free". When administering higher doses of ascorbic acid, up to a 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 intake of sodium in the diet for adults.

3. How to use Vitaminum C Swiss2Care

This medicine should always be used as directed by the doctor. In case of doubts, consult a doctor. The medicine is administered in the form of intramuscular or intravenous injections. The doctor will determine the dosage individually, depending on the vitamin C deficiency assessed based on 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 Vitaminum C Swiss2Care is too strong or too weak, consult a doctor.

Using a higher dose of Vitaminum C Swiss2Care than recommended

Symptoms of vitamin C overdose may include gastrointestinal disorders, 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 the formation of oxalate kidney stones. Daily doses of 600 mg and higher may have a diuretic effect. If symptoms of overdose occur, discontinue the medicine, and the doctor will administer symptomatic treatment. If you have taken a higher dose of the medicine than recommended, consult a doctor or pharmacist immediately.

Missing a dose of Vitaminum C Swiss2Care

Take the prescribed dose as soon as possible. Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Vitaminum C Swiss2Care can cause side effects, although not everybody gets them. High doses of vitamin C may cause stomach and intestinal disorders, such as 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 oxalate 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 when the dose is reduced, deficiency symptoms may occur. Intramuscular administration may cause transient pain at the injection site. Some people may experience other side effects when using Vitaminum C Swiss2Care.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, 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 Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder or parallel importer. By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Vitaminum C Swiss2Care

Keep the medicine out of the sight and reach of children. Store in a temperature below 25°C. Store the ampoules in the outer packaging to protect them from light. Use the solution immediately after opening the ampoule. Discard any unused solution. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste. 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 Vitaminum C Swiss2Care contains

• The active substance of the medicine is ascorbic acid. 1 ml of solution contains 100 mg of ascorbic acid. 1 ampoule with a capacity of 5 ml contains 500 mg of ascorbic acid (100 mg/ml).
• The excipients are: sodium bicarbonate, sodium hydroxymethanesulfinate, trisodium hedetinate dihydrate, water for injections.

What Vitaminum C Swiss2Care looks like and what the packaging contains

Vitaminum C Swiss2Care, 100 mg/ml, solution for injection is a clear, colorless to light greenish-yellow solution, practically free from particulate matter. The medicine is packaged in 5 ml (500 mg/5 ml) colorless glass ampoules, 10 ampoules per cardboard box. For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

BB Pharma a.s. Durychova 101/66 142 00 Prague 4 - Lhotka Czech Republic

Manufacturer:

HBM Pharma s.r.o. Sklabinska 30 036 80 Martin Slovak Republic

Parallel importer:

Swiss2Care Sp. z o.o. Sp. k. ul. Mostowa 38/1 78-100 Toruń

Repackaged by:

CEFEA Sp. z o.o. Sp. k. ul. Działkowa 56 02-234 Warsaw Permit number in the Czech Republic, the country of export: 86/799/92-S/C Permit number for parallel import: 130/23

Date of leaflet approval: 06.07.2023