Vita-gem C

Leaflet included in the packaging: information for the user

VITA-GEM C

1000 mg, effervescent powder
Acidum ascorbicum
Raspberry flavor
Read the leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist,
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after a few days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is V-C and what is it used for
• 2. Important information before using V-C
• 3. How to use V-C
• 4. Possible side effects
• 5. How to store V-C
• 6. Package contents and other information

1. What is V-C and what is it used for

• V-C is an effervescent powder containing vitamin C, which participates in oxidation and reduction processes in cells, e.g., in cellular respiration. It is involved in amino acid metabolism, the synthesis of steroid hormones in the adrenal cortex, and insulin synthesis. It is essential for the production of collagen and intercellular substances in many tissues (skin, bones, teeth, cartilage, tendons, vascular endothelium). Increased demand for vitamin C occurs in the following cases: AIDS, alcoholism, gastrointestinal diseases (e.g., prolonged diarrhea - associated loss of ascorbic acid, achlorhydria - reduced absorption, resection of the ileum), prolonged exposure to low temperatures, prolonged fever, chronic hemodialysis, certain infectious diseases (pneumonia, tonsillitis) and recovery period, prolonged stress, wound healing and bone fractures, hyperthyroidism, burns, smoking, cancer, surgical procedures.

Indications for use of the medicine are:

• states of vitamin C deficiency (e.g., inflammatory conditions of mucous membranes, scurvy);
• states of increased demand for vitamin C (e.g., colds, recurrent infections of the upper respiratory tract, reduced immunity, convalescence).

2. Important information before using V-C

When not to use V-C

• if the patient is allergic (hypersensitive) to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if the patient has:
• urolithiasis or excessive excretion of oxalates in the urine;
• excessive absorption of iron from the gastrointestinal tract.

Warnings and precautions

Before starting to use this medicine, the patient should discuss it with their doctor or pharmacist.
The medicine should be used with caution if the patient has:

• tendency to form mineral deposits in the urinary system;
• cystinuria (excretion of increased amounts of cystine in the urine);
• gout - a disorder of uric acid metabolism;
• thalassemia - disorders of hemoglobin synthesis;
• deficiency of glucose-6-phosphate dehydrogenase, as administration of doses higher than recommended may cause red blood cell lysis.

Children

Do not use in children under 12 years of age.

V-C and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or plan to take.
Vitamin C contained in the medicine:

• reduces the effectiveness of amphetamine derivatives and tricyclic antidepressants;
• enhances the effect of paracetamol, coumarin anticoagulants (e.g., acenocoumarol);
• when used with sulfonamides (antibacterial medicines), it may cause the formation of their crystals in the urine;
• may enhance the adverse effect of acetylsalicylic acid on the stomach;
• increases iron absorption from the gastrointestinal tract. If it is necessary to take doses above 1 g per day, the patient should inform their doctor about all medicines they are currently taking, as vitamin C may affect their action. In higher doses, the use of vitamin C may falsify the results of blood, urine, and stool tests, so if such tests are necessary, the patient should inform their doctor about the use of the medicine
• V-C.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Do not exceed the recommended dose of the medicine during pregnancy, due to the risk of vitamin C deficiency in the child. Do not exceed the recommended dose of the medicine during breastfeeding, due to increased tolerance to vitamin C in the mother and child.

Driving and using machines

Ascorbic acid does not affect the ability to drive and use machines.

Important information about some ingredients of V-C

The medicine contains a source of phenylalanine (aspartame). It may be harmful to patients with phenylketonuria.
The medicine contains sodium (156 mg per dose), which should be taken into account in patients with reduced renal function and in patients controlling their sodium intake.
The medicine contains sucrose (2.35 g per dose). This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to use V-C

This medicine should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Adults and adolescents over 12 years: 1 sachet per day.
The medicine is taken orally, after dissolving the contents of the sachet in boiled, cooled water (3/4 cup).

Using a higher dose of V-C than recommended

Mild gastrointestinal symptoms (e.g., diarrhea) may occur, without systemic toxicity.
The patient should consult their doctor or pharmacist.

Missing a dose of V-C

The patient should take the next dose. They should not take a double dose to make up for the missed dose.

Stopping the use of V-C

In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Prolonged use of preparations containing ascorbic acid in a dose above 1 g per day may cause:

• gastrointestinal disorders (heartburn, diarrhea);
• urinary system disorders (due to facilitated formation of uric acid, cystine, or oxalate stones);
• increased tolerance to vitamin C and, after withdrawal, may lead to scurvy.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store V-C

Keep out of the reach and sight of children.
Store in a temperature below 25°C. Store in the original packaging to protect from light and moisture.
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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed.

6. Package contents and other information

What V-C contains

• The active substance of the medicine is ascorbic acid (vitamin C). 1 sachet (5 g) contains 1000 mg of ascorbic acid.
• The medicine also contains: aspartame 50 mg, sucrose 2.35 g, sodium hydroxide 400 mg (sodium content 156 mg), citric acid, flavor and aroma enhancer raspberry.

What V-C looks like and what the package contains

10 sachets of 5 g of powder, which after dissolution in water takes the form of an effervescent solution.

Marketing authorization holder and manufacturer

Przedsiębiorstwo Produkcji Farmaceutycznej „GEMI” Grzegorz Nowakowski
ul. Mickiewicza 36
05-480 Karczew
tel. +48 22 780 83 05 w. 70
e-mail: gemi@gemi.pl

Date of the last update of the leaflet: