Package leaflet: Information for the user

VITA-GEM C
1000 mg, effervescent powder
Acidum ascorbicum
Raspberry flavour
Please read carefully all of this leaflet before taking the medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient information leaflet or as directed by the physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after a few days, or if you feel worse, you should contact your doctor.

Contents of the leaflet:

What V-C is and what it is used for
Important information before taking V-C
How to take V-C
Possible side effects
How to store V-C
Contents of the package and other information

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

V-C is an effervescent powder containing vitamin C, which participates in oxidation and reduction processes occurring in cells, e.g. cellular respiration. It is involved in amino acid metabolism, synthesis of adrenal cortical steroid hormones, and insulin synthesis. It is essential for collagen and intercellular substance formation in many tissues (skin, bones, teeth, cartilage, tendons, capillary endothelium).

Increased demand for vitamin C occurs in the following conditions: AIDS, alcoholism, gastrointestinal diseases (e.g. prolonged diarrhoea – increased loss of ascorbic acid, achlorhydria – reduced absorption, resection of the small intestine), prolonged exposure to low temperatures, prolonged fever, chronic haemodialysis, certain infectious diseases (pneumonia, tuberculosis) and during convalescence, prolonged stress, wound healing and bone fractures, hyperthyroidism, burns, smoking, cancer, and surgical procedures.

Indications for use of the medicine include:

Conditions associated with vitamin C deficiency (e.g. mucosal inflammation, scurvy);
Conditions with increased requirement for vitamin C (e.g. colds, recurrent upper respiratory tract infections, decreased body resistance, convalescence).

2. Important information before using the medicine V-C

When not to use V-C

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

Warnings and precautions
Before starting treatment with this medicine, discuss it with your doctor or pharmacist.
Use this medicine with caution if the patient has:

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

Children
Do not use in children under 12 years of age.
V-C and other medicines
You must tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient intends to take.
Vitamin C contained in this medicine:

reduces the effectiveness of amphetamine derivatives and tricyclic antidepressants;
enhances the effect of paracetamol and coumarin anticoagulants (e.g. acenocoumarol);
when used together with sulfonamides (antibacterial agents) may cause crystallization of these drugs in urine;
may intensify the adverse effects of acetylsalicylic acid on the stomach;
increases the absorption of iron from the gastrointestinal tract. When it is necessary to take doses exceeding 1 g per day, inform the doctor about all currently taken medicines, because vitamin C may affect their action. In higher doses, vitamin C may interfere with blood, urine and stool test results; therefore, if such tests are required, inform the doctor about the use of V-C.

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 or pharmacist before using this medicine.
Do not exceed the recommended doses during pregnancy due to the risk of vitamin C deficiency in the child. Do not exceed the recommended doses during breastfeeding due to increased tolerance to vitamin C in both mother and child.

Driving and operating machinery
Ascorbic acid does not affect the ability to drive or operate machinery.

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 impaired kidney function and in patients controlling sodium intake in their diet.
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 certain sugars, the patient should consult a doctor before taking the medicine.

3. How to use V-C

This medicine should always be taken exactly as described in the patient leaflet or according to the instructions of a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults and adolescents over 12 years of age: 1 sachet per day.
The medicine is administered orally, after dissolving the contents of the sachet in boiled, cooled water (3/4 of a glass).

Use of a higher than recommended dose of V-C
Adverse effects may occur in the form of mild gastrointestinal symptoms (e.g. diarrhoea), without systemic toxicity.
Consult a doctor or pharmacist.

Missed dose of V-C
Take the next dose as scheduled. Do not take a double dose to make up for the missed dose.

Discontinuation of V-C treatment
If you have any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not in everyone.
Prolonged use of preparations containing ascorbic acid in doses exceeding 1 g daily may cause, in some individuals:

gastrointestinal disturbances (heartburn, diarrhoea);
urinary system disturbances (due to increased risk of formation of uric acid, cystine, and oxalate stones);
increased tolerance to vitamin C, and subsequent withdrawal may lead to scurvy.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Tel.: +48 22 4921301
Fax: +48 22 4921309
e-mail: [email protected].
Reporting adverse reactions enables further collection of information on the safety of the medicine's use.

5. How to store V-C

Store in a place inaccessible and out of sight of children.
Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use.

6. Contents of the pack and other information
What V-C contains

The active substance is ascorbic acid (vitamin C). One sachet (5 g) contains 1000 mg of ascorbic acid.
Other ingredients: aspartame 50 mg, sucrose 2.35 g, sodium bicarbonate 400 mg (Na+ content 156 mg), citric acid, raspberry flavouring.

What V-C looks like and contents of the pack
10 sachets of 5 g of powder, which when dissolved in water forms an effervescent solution.

Marketing Authorisation Holder and Manufacturer
Pharmaceutical Production Company „GEMI” Grzegorz Nowakowski
Mickiewicza 36
05-480 Karczew
tel. +48 22 780 83 05 ext. 70
e-mail: [email protected]