Ascorvita

1. WHAT IS ASCORVITA AND WHAT IS IT USED FOR

Ascorbic acid is involved in numerous metabolic processes, plays an important role in oxidation-reduction processes, facilitating, among other things, iron absorption, participating in hemoglobin synthesis, and is necessary for collagen and intercellular substance production, and thus for the proper development of cartilage, bones, and teeth.
Vitamin C participates in the wound healing process, maintains the mechanical resistance of blood vessel walls, exhibits antioxidant properties, and increases the body's resistance.
The indication for the use of Ascorvita is a state of vitamin C deficiency or increased demand.

2. IMPORTANT INFORMATION BEFORE TAKING ASCORVITA

When not to take Ascorvita:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• in children under 12 years of age;
• if the patient has kidney stones.

Warnings and precautions

Before starting to take Ascorvita, the patient should discuss it with their doctor or pharmacist.
Particular caution should be exercised and doses above 1 g of ascorbic acid per day should be avoided in people with a tendency to gout, in patients with cystinuria, in those taking tricyclic antidepressants and amphetamines (due to the inhibition of renal reabsorption), and in people with excessive iron absorption from the gastrointestinal tract.
Vitamin C, when used in therapeutic doses, may cause false-positive results in urine sugar tests and false-positive results in occult blood tests in stool.
Due to the presence of aspartame, it should not be taken by patients with phenylketonuria.
Due to the presence of sorbitol, it should not be taken by patients with rare hereditary fructose intolerance.
The medicine contains 400 mg of sorbitol in each tablet. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or hereditary fructose intolerance, a rare genetic disease, they should not take this medicine.
In patients with hereditary fructose intolerance, the body does not break down the fructose contained in this medicine, which can lead to severe side effects.
The medicine contains 294.5 mg of sodium (the main component of common salt) in each tablet.
This corresponds to 14.7% of the maximum recommended daily sodium intake in the diet for adults.
The medicine contains 30.4 mg of aspartame in each tablet. Aspartame is a source of phenylalanine.
It may be harmful to patients with phenylketonuria. This is a rare genetic disease in which phenylalanine accumulates in the body due to its impaired excretion.

Ascorvita and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The medicine enhances the effect and toxicity of oral anticoagulants derived from warfarin, sulfonamides, acts synergistically with flavonoid glycosides, and increases iron absorption.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Ascorbic acid passes into breast milk and crosses the placenta.

Driving and operating machinery

The medicine does not affect the ability to drive vehicles or operate machinery.

3. HOW TO TAKE ASCORVITA

This medicine should always be taken 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.
Usually, 1 tablet is taken once a day, dissolved in ½ glass of water or juice, in adults and adolescents.
The medicine does not contain sugar, so it can be taken by diabetic patients.

Taking a higher dose of Ascorvita than recommended

Doses exceeding 1 g per day may cause gastrointestinal disorders and skin rash.
Chronic administration of very high doses of ascorbic acid (above 4 g per day) may, apart from gastrointestinal disorders, lead to impaired absorption of vitamin C.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Ascorvita can cause side effects, although not everybody gets them.
Possible side effects:

• gastrointestinal disorders;
• nausea, vomiting, and stomach cramps;
• skin rash.

Ascorbic acid is partially metabolized to oxalic acid, and its high concentrations can lead to the crystallization of oxalates; acidification of urine can also cause the crystallization of urates or citrates, resulting in urinary tract stones.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor or pharmacist or nurse.
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 181 C, 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. HOW TO STORE ASCORVITA

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C, in a dry place.
Keep the package tightly closed.
Do not use this medicine after the expiry date stated on the tube. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Ascorvita contains

The active substance of the medicine is ascorbic acid (vitamin C).
The other ingredients are: citric acid, sodium bicarbonate, sorbitol, corn starch, lemon flavor, aspartame, riboflavin sodium phosphate (colorant).

What Ascorvita looks like and what the package contains

The medicine is in the form of effervescent tablets. 10 or 20 tablets are in a polypropylene tube. The tube is placed in a cardboard box.

Marketing authorization holder and manufacturer

Natur Produkt Pharma Sp. z o.o.
ul. Podstoczysko 30
07-300 Ostrów Mazowiecka
Tel. (029) 644 29 00
To obtain more detailed information, the patient should contact the marketing authorization holder.
Date of last update of the leaflet:July 2020