Ascorgem

Leaflet attached to the packaging: patient information

ASCORGEM

100 mg/ml, oral drops, solution
Acidum ascorbicum
Vitamin C in drops

Please read carefully the contents of the leaflet 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 according to the doctor's or pharmacist's instructions.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.
• If after a few days there is no improvement or the patient feels worse, the doctor should be contacted.

Table of contents of the leaflet:

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

1. What is A and what is it used for

A is an oral drop containing vitamin C. This vitamin is involved in oxidation and reduction processes in cells, e.g., in cellular respiration.
It also participates in amino acid metabolism, the synthesis of steroid hormones in the adrenal cortex, and insulin synthesis.
It is also necessary for the production of collagen and intercellular substance in many tissues (skin, bones, teeth, cartilage, tendons, vascular endothelium).
The demand for vitamin C is increased in the following cases: AIDS, alcoholism, gastrointestinal diseases (e.g., prolonged diarrhea - increased loss of ascorbic acid, achlorhydria - reduced absorption, resection of the ileum), prolonged exposure to low temperatures, prolonged fever, chronic hemodialysis, some infectious diseases (pneumonia, tuberculosis) and recovery period, prolonged stress, wound healing and bone fractures, hyperthyroidism, burns, smoking, cancer, surgical procedures.
The indication for using A is:

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

2. Important information before using A

When not to use A

• 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 doctor or pharmacist should be consulted.
Use 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 breakdown;
• diabetes.

Children

The medicine is particularly recommended for use in children.

A and other medicines

The doctor should be informed about all medicines currently being used by the patient or recently used, as well as medicines that the patient plans to use.
The vitamin C contained in the medicine:

• reduces the effectiveness of amphetamine derivatives and tricyclic antidepressants;
• enhances the effect of paracetamol, anticoagulant coumarin derivatives (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. When it is necessary to take doses above 1 g per day, the doctor should be informed about all currently used medicines, as vitamin C may affect their action. The use of vitamin C in high doses may distort the results of blood, urine, and stool tests, so in case of necessity to perform such tests, the doctor should be informed about the use of A.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
The recommended doses of the medicine should not be exceeded during pregnancy, due to the risk of later vitamin C deficiency in the child.
The recommended doses of the medicine should not be exceeded during breastfeeding.

Driving and operating machinery

Ascorbic acid does not affect psychophysical fitness or the ability to drive vehicles and operate machinery.

A contains sucrose

10 drops contain 0.25 g of sucrose. This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to some sugars, the patient should contact the doctor before taking the medicine.

3. How to use A

This medicine should always be used exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions. In case of doubts, the doctor or pharmacist should be consulted.
Oral administration
In infants (under 2 years), the medicine can only be used according to the doctor's instructions.
Children from 2 to 6 years: 10 drops per day.
Children over 6 years and adults: 15 to 20 drops per day.
Drops can be taken undiluted or in a teaspoon of milk, juice, etc.
If it feels like the effect of the medicine is too strong or too weak, the doctor should be consulted.

Using a higher dose of A than recommended

In case of overdose, side effects may occur in the form of mild gastrointestinal symptoms (e.g., diarrhea), without systemic toxicity.
In case of taking a higher dose of the medicine than recommended, the doctor or pharmacist should be consulted.

Missing a dose of A

The next dose of the medicine should be taken. A double dose should not be used to make up for a missed dose.

Stopping the use of A

In case of any further doubts related to the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although they may not occur in everyone.
Prolonged use of medicines containing vitamin C in doses above 1 g per day may cause:

• gastrointestinal disorders (heartburn, diarrhea);
• urinary system disorders (as a result of facilitating the formation of uric acid, cystine, and oxalate stones);
• increased tolerance to vitamin C, which after withdrawal of the medicine may lead to deficiency and scurvy.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to 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.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store A

Store in a place inaccessible and invisible to children.
Store at a temperature below 25°C.
Do not use the medicine A after the expiration date stated on the packaging. The expiration date means the last day of the given month.
The shelf life after opening the bottle is 3 months. After this period, the remainder should be discarded.
Medicines should not be disposed of in the sewage system or household waste containers. The pharmacist should be asked what to do with medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What A contains

• The active substance of the medicine is ascorbic acid (vitamin C). 1 ml (approx. 20 drops) contains 100 mg of ascorbic acid.
• The medicine also contains: sucrose, citric acid, purified water.

What A looks like and what the package contains

A brown glass bottle with a dropper, in a cardboard box, containing 20 ml of a colorless to slightly yellowish liquid with a slightly acidic taste.

Responsible entity and manufacturer

Gemipharma Sp. z o.o.
ul. Mickiewicza 36
05-480 Karczew
tel. +48 (22) 780 83 05 w. 70
e-mail: [email protected]
Date of last update of the leaflet:07/2024