Patient Information Leaflet: Information for the Patient

Ascorvita, 1000 mg, effervescent tablets
Acidum ascorbicum
Please read carefully the entire leaflet before taking the medicine, because
it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or
as directed by a physician or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
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.

Table of contents:

What Ascorvita is and what it is used for
Important information before taking Ascorvita
How to take Ascorvita
Possible side effects
How to store Ascorvita
Contents of the pack and other information

1. WHAT ASCORVITA IS AND WHAT IT IS USED FOR

Ascorbic acid participates in numerous metabolic processes and plays an important role in redox reactions, facilitating, among others, iron absorption. It contributes to hemoglobin synthesis and is essential for collagen and intercellular substance formation, thus supporting proper development of cartilage, bones, and teeth. Vitamin C participates in wound healing, maintains mechanical resistance of capillary walls, exhibits antioxidant properties, and enhances body immunity.
Ascorvita is indicated in conditions involving vitamin C deficiency or increased vitamin C requirements.

2. IMPORTANT INFORMATION BEFORE USING THE MEDICINAL PRODUCT ASCORVITA

When not to use Ascorvita:

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

Warnings and precautions
Before starting to use Ascorvita, consult a doctor or pharmacist.
Exercise particular caution and avoid doses exceeding 1 g daily of ascorbic acid in patients with a tendency towards gout, in patients with cystinuria, in those taking tricyclic antidepressants and amphetamine (due to inhibition of renal tubular reabsorption), and in individuals with increased intestinal absorption of iron.
Vitamin C used in therapeutic doses may cause false positive results in urine glucose tests and false positive results in tests for occult blood in stool.
Due to the presence of aspartame, do not use in patients with phenylketonuria.
Due to the presence of sorbitol, do not use in patients with rare hereditary fructose intolerance.
The medicinal product contains 400 mg of sorbitol per tablet. Sorbitol is a source of fructose. If a patient has previously been diagnosed with intolerance to certain sugars or with hereditary fructose intolerance, a rare genetic disorder, the patient must not take this medicinal product.
In patients with hereditary fructose intolerance, the body cannot break down the fructose contained in this medicinal product, which may lead to severe adverse reactions.
The medicinal product contains 294.5 mg of sodium (main component of table salt) per tablet. This corresponds to 14.7% of the maximum recommended daily dietary intake of sodium for adults.
The medicinal product contains 30.4 mg of aspartame per tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.

Ascorvita with other medicinal products
Inform your doctor or pharmacist about all medicinal products currently or recently taken, as well as any medicinal products you plan to take.
This medicinal product enhances the action 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, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicinal product.
Ascorbic acid crosses the placenta and is excreted in breast milk.

Driving and operating machinery
Ascorvita has no influence on the ability to drive motor vehicles or operate mechanical equipment.

3. HOW TO USE THE MEDICINE ASCORVITA

This medicine should always be taken exactly as described in the patient leaflet or as directed by a physician.
If in doubt, consult a doctor or pharmacist.
The usual dose for adults and adolescents is 1 tablet dissolved in ½ glass of water or juice, taken once daily.
The medicine does not contain sugar and therefore may be used by diabetic patients.
Use of a higher than recommended dose of Ascorvita
Doses exceeding 1 g daily may cause gastrointestinal disturbances and skin rash.
Chronic intake of very high doses of ascorbic acid (above 4 g daily) may, apart from gastrointestinal disorders, lead to impaired absorption of vitamin C.

4. POSSIBLE ADVERSE REACTIONS

Like any medicine, this medicine can cause adverse reactions, although not everybody experiences them.
Possible adverse reactions:

Gastrointestinal disturbances;
Nausea, vomiting, and stomach cramps;
Skin rash.

Ascorbic acid is partially metabolized to oxalic acid and high concentrations may lead to oxalate crystallization; urine acidification may also cause crystallization of urates or citrates and consequently lead to urolithiasis.
Reporting of adverse reactions
If any adverse reactions 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 Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. HOW TO STORE THE MEDICINE ASCORVITA

Keep the medicine out of the sight and reach of children.
Store below 25°C, in a dry place.
Keep the container 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 specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Ascorvita contains
The active substance is Acidum ascorbicum (vitamin C).
The other ingredients are: acidum citricum, natrium hydrogencarbonicum, sorbitol, starch maize,
lemon flavour, aspartame, phosphorus sodium riboflavin (colouring agent).

What Ascorvita looks like and contents of the pack
Ascorvita is in the form of effervescent tablets. Each pack contains 10 or 20 effervescent tablets in a polypropylene tube. The tube is placed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Natur Produkt Pharma Sp. z o.o.
ul. Podstoczysko 30
07-300 Ostrów Mazowiecka
Tel. (029) 644 29 00
For further information, please contact the Marketing Authorisation Holder.

Date of latest revision of the leaflet: July 2020