VITAMIN 100 mg /Ml Solution

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Vitamin C Zentiva, 100 mg/mL, solution for injection/infusion
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Vitamin C Zentiva and what is it used for
4. Important information before using Vitamin C Zentiva
   1. When not to use Vitamin C Zentiva:
   2. Warnings and precautions
   3. Vitamin C Zentiva and other medicines
   4. Tell your doctor or nurse if you are taking any of the following medicines:
   5. Vitamin C Zentiva with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Vitamin C Zentiva contains sodium sulfite anhydrous (E221) and sodium
5. How to use Vitamin C Zentiva
   1. Children and adolescents
   2. Using more than the recommended dose of Vitamin C Zentiva
   3. Missing a dose of Vitamin C Zentiva
6. Possible side effects
   1. Reporting side effects
7. How to store Vitamin C Zentiva
8. Contents of the packaging and other information
   1. What Vitamin C Zentiva contains
   2. What Vitamin C Zentiva looks like and what the pack contains
   3. Marketing authorization holder
   4. Manufacturer
   5. For more information, contact the local representative of the marketing authorization holder:
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   8. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Vitamin C Zentiva, 100 mg/mL, solution for injection/infusion

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 or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Vitamin C Zentiva and what is it used for

Vitamin C is a water-soluble vitamin that plays a role in many important processes in the body.
Vitamin C Zentiva is used to treat scurvy and to prevent ascorbic acid (vitamin C) deficiency. Vitamin C Zentiva is used in all age groups when oral administration is not possible or when absorption after oral administration is insufficient.

2. Important information before using Vitamin C Zentiva

When not to use Vitamin C Zentiva:

• in hyperoxaluria (increased oxalate content in urine);
• in kidney stone disease (including oxalate stone disease).

Warnings and precautions

Before starting treatment with Vitamin C Zentiva, discuss it with your doctor or nurse:

Intravenous administration of ascorbic acid can be painful and may occasionally cause thrombophlebitis. Rapid intravenous injection of ascorbic acid should be avoided, and particular caution should be exercised to avoid potential extravasation during infusion.
Intramuscular administration is recommended for patients with venous system disorders, thrombophlebitis, those undergoing anticoagulant therapy, and those with a tendency to thrombosis.

Vitamin C Zentiva and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
The active substance of Vitamin C Zentiva is ascorbic acid, also known as vitamin C.
Concomitant use with other medicines may affect their action or they may affect the action of Vitamin C Zentiva.

Tell your doctor or nurse if you are taking any of the following medicines:

• salicylates (anti-inflammatory medicines) such as aspirin (acetylsalicylic acid) - when used concomitantly, the amount of vitamin C in the body may decrease due to possible reduced absorption and increased excretion in the urine. It has been found that salicylates reduce vitamin C absorption by about one-third;
• corticosteroids, as they increase the oxidation of vitamin C;
• anticoagulant medicines, as vitamin C may affect the intensity and duration of action of coumarin derivatives (e.g., warfarin, dicumarol);
• oral contraceptives, as they lower the concentration of vitamin C in serum. When used concomitantly with products containing estrogen, vitamin C may increase estrogen levels;
• iron-containing medicines, as vitamin C may increase iron absorption from the gastrointestinal tract;
• deferoxamine (treatment of iron or aluminum overload in the body) - vitamin C may increase iron excretion when used concomitantly with deferoxamine. However, cases of cardiomyopathy and congestive heart failure have been observed in patients taking both medicines. It may happen that ascorbic acid causes the release of iron from the spleen and other reticuloendothelial tissues, leading to increased iron deposition in visceral organs.
• isoprenaline (medicine used to treat heart block and cardiac arrest), as concomitant administration with vitamin C weakens the action of isoprenaline;
• disulfiram (supportive treatment of alcoholism), as chronic use or high doses of vitamin C may reduce the effectiveness of disulfiram used in antialcoholic therapy;
• mexiletine (treatment of irregular heart rhythm), as high doses of vitamin C may accelerate the excretion of mexiletine in the urine;
• barbiturates or primidone (treatment of epileptic seizures), as concomitant use may increase the excretion of vitamin C in the urine;
• fluphenazine, other phenothiazine derivatives (treatment of schizophrenia), as concomitant use with vitamin C reduces their therapeutic effect;
• amphetamines (central nervous system stimulants) and tricyclic antidepressants (treatment of depression), as vitamin C reduces the reabsorption of amphetamines and tricyclic antidepressants in the renal tubules;
• aluminum-containing products, as vitamin C may increase aluminum absorption and enhance its adverse effects;
• alcohol, as it reduces the concentration of vitamin C.

Vitamin C Zentiva affects many laboratory tests. The effect of Vitamin C Zentiva on laboratory test results depends on several factors.
Consult specialized literature to obtain detailed information on the falsification of laboratory test results caused by the use of vitamin C.
Vitamin C in high doses may falsify the results of aminotransferase, lactate dehydrogenase, and bilirubin tests.
Vitamin C, as a reducing-oxidizing agent, affects the results of laboratory tests performed using oxidation-reduction methods to determine glucose concentration in urine and serum. Vitamin C intake should be discontinued 1-2 days before the test. Patients with diabetes taking more than 500 mg of vitamin C per day may obtain false urine glucose test results.
According to reports, vitamin C may falsify the results of screening tests for the presence of paracetamol in urine, resulting in negative results in the presence of paracetamol.
High doses of vitamin C (i.e., more than 500 mg per day) may affect the concentration of carbamazepine measured by the Ames ARIS method.
Using vitamin C (in a dose of more than 1 g per day) may cause a false-negative result in the guaiac test for occult blood in stool. If a false test result is suspected, Vitamin C Zentiva administration should be discontinued.
Vitamin C is incompatible in solution with aminophylline, bleomycin, erythromycin, lactobionate, nafcillin, nitrofurantoin (sodium salt), conjugated estrogens, sodium bicarbonate, sulfafurazole, diethanolamine, sodium succinate of chloramphenicol, chlorothiazide (sodium salt), and sodium succinate of hydrocortisone.
Vitamin C undergoes rapid oxidation in an alkaline environment, in the presence of copper and iron ions, and other oxidizers.

Vitamin C Zentiva with food, drink, and alcohol

Alcohol causes a decrease in vitamin C concentration.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine.
Pregnancy
Administration of Vitamin C Zentiva to pregnant women should be considered only when absolutely necessary.
Breastfeeding
Vitamin C passes into breast milk, so breastfeeding mothers should be treated with caution.
Fertility
There is no data on the effect of vitamin C on fertility.

Driving and using machines

Vitamin C Zentiva does not affect the ability to drive and use machines.

Vitamin C Zentiva contains sodium sulfite anhydrous (E221) and sodium

The presence of sodium sulfite anhydrous in the medicine may rarely cause a severe hypersensitivity reaction and bronchospasm.
This medicine contains 27.56 mg of sodium (the main component of table salt) in each 2 mL ampoule.
This corresponds to 1.4% of the recommended maximum daily intake of 2 g of sodium for adults.
This medicine contains 68.9 mg of sodium (the main component of table salt) in each 5 mL ampoule.
This corresponds to 3.45% of the recommended maximum daily intake of 2 g of sodium for adults.

3. How to use Vitamin C Zentiva

This medicine should always be used as directed by a doctor. In case of doubts, consult a doctor or nurse.
Vitamin C Zentiva, solution for injection/infusion, is administered intramuscularly or intravenously.
Intramuscular administration is recommended. The doctor will determine the dosage and duration of treatment. Intravenous administration should be performed by a doctor or a qualified healthcare professional (nurse).
Recommended dosage
Adults (including elderly patients)
Adults (including elderly patients) with renal impairment
In patients with a tendency to form kidney stones, the daily dose of vitamin C should not exceed 100 mg (1 mL) to 200 mg (2 mL).
Patients with severe renal impairment or end-stage renal disease (dialysis patients) should receive no more than 50 mg (0.5 mL) to 100 mg (1 mL) per day.

Children and adolescents

Vitamin C Zentiva can be administered to adolescents under 18 years of age, children, infants, and newborns. The doctor will determine the dosage and duration of treatment.
Adolescents under 18 years of age, children, infants, newborns with renal impairment
Patients should be treated with lower, individually adjusted doses.
Method of administration
Preparation and administration of intramuscular injection
Take the required dose of Vitamin C Zentiva and inject it slowly into the upper part of the buttock, 5 cm below the iliac crest. The injection site should be changed for subsequent injections.
Preparation and administration of intravenous injection
Rapid intravenous injection of the medicine may cause transient dizziness and should not be performed. Since undiluted Vitamin C Zentiva is hypertonic, it is recommended to dilute the solution before intravenous injection, in at least an equal volume of solvent, such as 9 mg/mL (0.9%) sodium chloride solution or 50 mg/mL (5%) glucose solution, and inject slowly intravenously.

Take the required dose of Vitamin C Zentiva and dilute it to 100 mL with 9 mg/mL (0.9%) sodium chloride solution or 50 mg/mL (5%) glucose solution. Administer by intravenous infusion over

• 15 - 30 minutes.

The solution should be administered immediately after mixing.

Using more than the recommended dose of Vitamin C Zentiva

No cases of severe overdose with serious consequences have been reported.
In high doses, vitamin C may cause allergic reactions.
In case of significant overdose, vitamin C may cause kidney failure.
Overdose of vitamin C may cause acidosis (increased blood acidity) and hemolytic anemia (abnormal breakdown of red blood cells) in susceptible individuals, e.g., patients with glucose-6-phosphate dehydrogenase deficiency.
In case of taking more than the recommended dose, consult a doctor immediately.

Missing a dose of Vitamin C Zentiva

In case of suspected missed dose, tell your doctor or nurse.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Vitamin C Zentiva is well tolerated. In rare cases, it may cause side effects.
Rare (may affect up to 1 in 1000 people):

• nausea;
• vomiting;
• intestinal colic;
• diarrhea;
• high doses of the medicine may cause an allergic reaction;
• polyuria (increased urine production);
• kidney stones;
• in some patients with pre-existing kidney disease, kidney failure has been reported after treatment with high doses of vitamin C;
• transient, mild pain and induration at the site of intramuscular injection.

Frequency not known (frequency cannot be estimated from the available data):

• headache;
• insomnia;
• transient fainting or dizziness (due to too rapid intravenous administration);
• hot flashes;
• fatigue;
• rebound effect in the form of vitamin C deficiency after discontinuation of therapy with high doses.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your 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:
Jerozolimskie Avenue 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 its representative.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Vitamin C Zentiva

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not freeze.
Do not use this medicine after the expiry date stated on the blister pack and carton after the abbreviation "EXP". The expiry date refers to the last day of the 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 Vitamin C Zentiva contains

The active substance of the medicine is ascorbic acid. 1 mL of the solution contains 100 mg of ascorbic acid.
Each 2 mL ampoule contains 200 mg of ascorbic acid.
Each 5 mL ampoule contains 500 mg of ascorbic acid.
Excipients: sodium bicarbonate, sodium sulfite anhydrous, edetic acid, and water for injections.

What Vitamin C Zentiva looks like and what the pack contains

Clear, colorless to light brown-yellow solution.
2 mL or 5 mL ampoule made of colorless glass type I, with a colored ring marking the opening point. Each ampoule is accompanied by a self-adhesive label.
10 ampoules in a blister pack made of rigid PVC foil. 1 blister pack in a carton box with an attached leaflet.
Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva k.s.
U kabelovny 130
Dolni Mecholupy
102 37 Prague 10
Czech Republic

Manufacturer

SOPHARMA AD
16, Iliensko Shosse Str.
1220 Sofia, Bulgaria

For more information, contact the local representative of the marketing authorization holder:

Zentiva Polska Sp. z.o.o.
Bonifraterska Street 17
00-203 Warsaw, Poland
tel.: +48 22 375 92 00

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Latvia:
Vitamin C Zentiva 100 mg/ml solution for injection/infusion
Estonia:
VITAMIN C SOPHARMA
Poland:
Vitamin C Zentiva
Romania:
Vitamina C Zentiva 100 mg/ml solution for injection/infusion

Date of last revision of the leaflet: