Vitaminum C Teva

Leaflet attached to the packaging: patient information

Vitaminum C Teva,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, you may need to read it again.
• In case of 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 Teva and what is it used for
• 2. Important information before using Vitaminum C Teva
• 3. How to use Vitaminum C Teva
• 4. Possible side effects
• 5. How to store Vitaminum C Teva
• 6. Package contents and other information

1. What is Vitaminum C Teva 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, and also in 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 erythrocytes (red blood cells).
The indication for the use of the medicine is:

• treatment of scurvy and other deficiency states 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 Vitaminum C Teva

When not to use Vitaminum C Teva:

• 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 Tevain 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 red blood cell disorder),
• sideroblastic anemia,
• 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, ethinyl estradiol concentration in serum, lactate 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 are not recommended during pregnancy, as their effect 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 Teva 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 used 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 simultaneously with ascorbic acid, the concentration of flufenazine (a medicine 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 (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, a 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. Simultaneous 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 Teva contains sodium metabisulfite and sodium

Sodium metabisulfite

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 ampoule (5 ml).
This corresponds to 3.5% of the maximum recommended daily sodium intake in the diet for adults.

3. How to use Vitaminum C Teva

This medicine should always be used as directed by a 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 the patient feels that the effect of Vitaminum C Teva is too strong or too weak, they should consult a doctor.

Using a higher dose of Vitaminum C Teva 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.
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, the patient should immediately consult a doctor or pharmacist.

Missing a dose of Vitaminum C Teva

The prescribed dose should be used as soon as possible.
A double dose should not be used to make up for a 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 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 patients using Vitaminum C Teva may experience other side effects.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Vitaminum C Teva

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

6. Package contents and other information

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

What Vitaminum C Teva looks like and what the package contains

Vitaminum C Teva, 100 mg/ml, solution for injection is a colorless or slightly yellowish, clear liquid.
The medicine is packaged in 5 ml (500 mg/5 ml) colorless glass ampoules, 10 pieces in a cardboard box.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
phone: (22) 345 93 00

Manufacturer

Merckle GmbH
Ludwig-Merckle Str. 3
89143 Blaubeuren, Germany

Date of the last update of the leaflet: