Package leaflet: Information for the patient

Vitaminum C Teva, 100 mg/ml, solution for injection
(Acidum ascorbicum)
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, 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.

Leaflet contents

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

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

The active substance 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, teeth, and for 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 indication for use of this medicine is:

Treatment of scurvy and other conditions associated with vitamin C deficiency requiring supplementation. The drug is administered parenterally in severe cases or when oral administration is not feasible.

2. Information before using Vitaminum C Teva

When not to use Vitaminum C Teva:

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

Warnings and precautions
Special caution is needed when using Vitaminum C Teva in the following cases:

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

Tolerance to ascorbic acid may develop in patients taking high doses.
Vitamin C used in high doses (from 1 g daily) may interfere with the results of certain laboratory tests performed by redox methods (e.g. glucose concentration in urine, ethinylestradiol concentration in plasma, lactate dehydrogenase activity, liver aminotransferases in serum, occult blood test in faeces, bilirubin concentration, urine pH, urinary excretion 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 has no influence on the ability to drive or operate machinery.

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

Substances that may reduce tissue saturation with ascorbic acid include: acetylsalicylic acid, nicotine in cigarettes, alcohol, some appetite suppressants, iron, phenytoin, some anticonvulsants, oestrogen (a component of contraceptive drugs), and tetracycline.

High-dose vitamin C acidifies urine, thereby reducing the excretion of acidic drugs and increasing the excretion of basic drugs, consequently weakening their effect.

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

Concomitant 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 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 aluminium and oral citrates, life-threatening encephalopathy due to markedly increased serum aluminium concentrations may develop. There are suspicions that vitamin C may act similarly.

Oral contraceptives reduce plasma concentrations of ascorbic acid. Concurrent use of these agents with vitamin C may result in increased plasma oestradiol concentrations.

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 sulphate, cefazolin (sodium salt), cepapirin, chlordiazepoxide, conjugated oestrogens, 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 pH and concentration, incompatibility may occur with sodium chloramphenicol succinate.

Vitaminum C Teva contains sodium metabisulphite and sodium

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

Sodium
The medicine contains 69.74 mg of sodium (the main component of table salt) in each 5 ml ampoule.
This corresponds to 3.5% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Vitaminum C Teva

This medicine should always be used as directed by a physician. If in doubt, consult a doctor.
The medicine is administered by intramuscular or intravenous injection.
The physician will determine the dosage individually, depending on the degree of 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 Teva is too strong or too weak, consult a doctor.
Use of a higher than recommended dose of Vitaminum C Teva
Symptoms of vitamin C overdose may include gastrointestinal disturbances such as diarrhoea, vomiting, heartburn, as well as skin redness, headache, and insomnia. High doses may lead to 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 initiate symptomatic treatment.
In case of ingestion of a dose higher than recommended, seek immediate medical advice from a doctor or pharmacist.
Missed dose of Vitaminum C Teva
Take the missed dose as soon as possible.
Do not take 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 everyone will experience them.
High doses of vitamin C may cause gastrointestinal and intestinal disturbances, including diarrhoea, vomiting, heartburn, skin flushing, 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.
Rapid intravenous administration may cause dizziness and a feeling of weakness.
After prolonged use of high doses, tolerance to ascorbic acid may develop, and if the dose is reduced, deficiency symptoms may occur.
Intramuscular administration may cause transient pain at the injection site.
Other adverse reactions may occur in some individuals during treatment with Vitaminum C Teva.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Vitaminum C Teva

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

6. Contents of the packaging and other information

What Vitaminum C Teva 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).
The excipients are: sodium hydroxide, disodium edetate, sodium pyrosulfite, water for injections.

What Vitaminum C Teva looks like and contents of the pack
Vitaminum C Teva, 100 mg/ml, solution for injection is a colourless or slightly yellowish,
clear liquid.
The medicine is packed in colourless glass ampoules with a capacity of 5 ml (500 mg/5 ml), with 10 ampoules
in a cardboard box.
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel.: (22) 345 93 00
Manufacturer
Merckle GmbH
Ludwig-Merckle Str. 3
89143 Blaubeuren, Germany