Vitamin c zentiva

Package leaflet: Information for the patient

Vitamin C Zentiva, 100 mg/mL, solution for injection/infusion
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, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific person. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of the leaflet

1. What Vitamin C Zentiva is and what it is 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 pack and other information

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

Vitamin C is a water-soluble vitamin involved in many important processes in the body.
Vitamin C Zentiva is used in the treatment of scurvy and in the prevention of 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 inadequate.

2. Important information before using Vitamin C Zentiva

When not to use Vitamin C Zentiva:

• if the patient is allergic to ascorbic acid or any of the other ingredients of this medicine (listed in section 6);
• in hyperoxaluria (increased oxalate content in urine);
• in kidney stones (including oxalate kidney stones).

Warnings and precautions
Before starting treatment with Vitamin C Zentiva, discuss with your doctor or
nurse:

• If the patient has glucose-6-phosphate dehydrogenase deficiency (lack of enzyme in red blood cells);
• If the patient has kidney diseases, including kidney stones;
• If the patient has haemochromatosis (inherited metabolic disorder characterized by iron deposition in tissues), blood disorders – thalassaemia (sickle-shaped red blood cell anaemia), sickle cell anaemia (a condition in which haemoglobin, the oxygen-carrying protein in blood, is abnormal), sideroblastic anaemia (a type of anaemia caused by disturbances in iron metabolism in the body);
• If the patient is pregnant.

Intravenous administration of ascorbic acid may be painful and occasionally may cause thrombophlebitis. Rapid intravenous injection of ascorbic acid should be avoided, and particular care should be taken to prevent possible extravasation during infusion.
Intramuscular administration is recommended for patients with venous system disorders, thrombophlebitis, those on anticoagulant therapy, and those predisposed to thrombosis.

Vitamin C Zentiva and other medicines
You should tell your doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
The active substance in Vitamin C Zentiva is ascorbic acid, also known as vitamin C. Its concomitant use with other medicines may affect their action or they may affect the action of Vitamin C Zentiva.
You should tell your doctor or nurse if the patient is taking any of the following medicines:

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

Vitamin C Zentiva affects numerous laboratory tests. The effect of Vitamin C Zentiva on laboratory test results depends on several factors.
Refer to specialized literature for detailed information on how vitamin C may interfere with laboratory test results.
High-dose vitamin C may interfere with test results for aminotransferases, lactate dehydrogenase, and bilirubin.
Ascorbic acid, due to its reducing-oxidizing properties, affects laboratory tests performed by redox methods for measuring glucose concentration in urine and serum. Vitamin C intake should be discontinued 1–2 days before testing. Diabetic patients taking more than 500 mg of vitamin C per day may obtain false-negative results in urine glucose tests.
According to reports, vitamin C may interfere with urine screening tests for paracetamol, causing negative results despite the presence of paracetamol.
High doses of vitamin C (i.e. more than 500 mg per day) may affect carbamazepine concentration measured by the Ames ARIS® method.
Vitamin C use (at doses greater than 1 g per day) may cause a false-negative result in the guaiac test for occult blood in stool. If a false-negative test result is suspected, administration of Vitamin C Zentiva should be discontinued.
Vitamin C is incompatible in solution with aminophylline, bleomycin, erythromycin, lactobionate, nafcillin, nitrofurantoin (sodium salt), conjugated estrogens, sodium bicarbonate, sulfafurazole, diethanolamine, chloramphenicol sodium succinate, chlorothiazide (sodium salt), and hydrocortisone sodium succinate.
Vitamin C undergoes rapid oxidation in alkaline environments, in the presence of copper and iron ions, and other oxidizing agents.

Vitamin C Zentiva with food, drink, and alcohol
Alcohol reduces vitamin C concentration.

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
Administration of Vitamin C Zentiva to pregnant women should be considered only when absolutely necessary.

Breastfeeding
Vitamin C passes into breast milk; therefore, breastfeeding mothers should be treated with caution.

Fertility
There is no data available on the effect of vitamin C on fertility.

Driving and operating machinery
Vitamin C Zentiva has no influence on the ability to drive vehicles or operate machinery.

Vitamin C Zentiva contains anhydrous sodium sulfite (E221) and sodium
The presence of anhydrous sodium sulfite in this medicine may rarely cause severe hypersensitivity reactions and bronchospasm.
This medicine contains 27.56 mg of sodium (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 (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 your doctor. If you have any doubts, consult your
doctor or nurse.
Vitamin C Zentiva, solution for injection/infusion, is administered intramuscularly or intravenously.
Intramuscular administration is recommended. Your doctor will determine the dosage and duration
of treatment. Intravenous administration should be performed by a doctor or 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 physician will determine the dosage and duration of treatment.

Adolescents under 18 years of age, children, infants, neonates with impaired renal function
Patients should be treated with lower, individually adjusted doses.

Administration method

Preparation and administration of intramuscular injection
Withdraw the required dose of Vitamin C Zentiva and inject slowly into the upper outer quadrant of the gluteal muscle, 5 cm below the iliac crest. The injection site should be rotated for subsequent injections.

Preparation and administration of intravenous injection
Rapid intravenous injection of the drug may cause transient dizziness and should not be performed. Since undiluted Vitamin C Zentiva is hypertonic, dilution prior to intravenous administration is recommended. Dilute with 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 administer by slow intravenous injection.

Preparation and administration of intravenous infusion
Withdraw the required dose of Vitamin C Zentiva and dilute 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 used immediately after preparation.

Overdose of Vitamin C Zentiva
No cases of severe overdose with serious consequences have been reported.
High doses of vitamin C may cause allergic reactions.
In cases of significant overdose, renal failure may occur.
Vitamin C overdose may lead to acidosis (increased blood acidity) and hemolytic anemia (abnormal breakdown of red blood cells) in predisposed individuals, e.g. patients with glucose-6-phosphate dehydrogenase deficiency.
In case of ingestion of a dose higher than recommended, medical advice should be sought immediately.

Missed dose of Vitamin C Zentiva
If a dose is suspected to have been missed, inform the doctor or nurse.
For any further questions regarding the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this product can cause adverse reactions, although not everyone will experience them.
Vitamin C Zentiva is well tolerated. Adverse reactions may occur rarely.
Rare (may affect up to 1 in 1,000 people):

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

Frequency unknown (frequency cannot be estimated from available data):

• headache;
• insomnia;
• transient fainting or dizziness (due to too rapid intravenous administration);
• hot flushes;
• fatigue;
• rebound effect manifesting as vitamin C deficiency after discontinuation of high-dose therapy.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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 authorisation holder or its representative.
Reporting adverse reactions helps to provide 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 below 25°C.
Do not freeze.
Do not use this medicine after the expiry date stated on the blister and carton after the abbreviation "EXP". The expiry date refers to the last day of the stated month.
Medicines should 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 Vitamin C Zentiva contains
The active substance is Acidum ascorbicum. 1 mL of 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 hydrogen carbonate, anhydrous sodium sulfite, edetic acid and water for
injections.

What Vitamin C Zentiva looks like and contents of the pack
A clear, colourless to light brownish-yellow solution.
2 mL or 5 mL ampoules made of colourless type I glass, with a coloured ring indicating the break point. Each ampoule is supplied with a self-adhesive label.
10 ampoules in a blister made of rigid PVC foil. 1 blister in a cardboard carton with an enclosed leaflet.
Not all pack sizes may be marketed.

Marketing Authorisation 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 detailed information, please contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw, Poland
Tel.: +48 22 375 92 00

This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Latvia: Vitamin C Zentiva 100 mg/ml šķīdums injekcijām/infūzijām
Estonia: VITAMIN C SOPHARMA
Poland: Vitamin C Zentiva
Romania: Vitamina C Zentiva 100 mg/ml soluție injectabilă/perfuzabilă