Dropice

Package Leaflet: Information for the Patient

DropiCe

100 mg/ml, Oral Drops, Solution

Acidum ascorbicum
Vitamin C in drops

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet or as directed 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 or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

1. What is DropiCe and what is it used for

DropiCe is an oral drop solution containing ascorbic acid (vitamin C). Vitamin C is a substance necessary for the proper functioning of the human body.
Vitamin C participates in many enzymatic reactions, including collagen synthesis, catecholamine synthesis, steroid hydroxylation, tyrosine, and exogenous substances. Vitamin C increases iron salt absorption and inhibits chain reactions of free radicals.
The antioxidant effect of vitamin C is closely biochemically related to the antioxidant effects of vitamins E and A and carotenoids.

Indications

DropiCe is intended for the prevention and treatment of vitamin C deficiency states, in cases where a suitable diet is not sufficient.

2. Important information before taking DropiCe

When not to take DropiCe:

• if the patient is allergic to ascorbic acid or any other component of this medicine (listed in section 6),
• if the patient has kidney stones,
• if the patient has a history of increased uric acid levels,
• if the patient has iron storage disorders,
• if the patient has gastric ulcer disease.

Warnings and precautions

Before starting to take DropiCe, the patient should discuss it with their doctor or pharmacist.
Caution should be exercised in the case of:

• enzyme deficiency of red blood cells, e.g., erythrocyte glucose-6-phosphate dehydrogenase deficiency. In such cases, high doses of ascorbic acid (4 g per day) should not be taken;
• severe or terminal kidney failure. High doses of ascorbic acid may contribute to the formation of kidney stones.

DropiCe 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 patient should inform their doctor if they are taking antacids containing aluminum (anti-heartburn and anti-reflux medicines), especially in the case of existing kidney failure (ascorbic acid increases aluminum absorption in the gastrointestinal tract).
Concomitant use of antacids containing aluminum may increase aluminum excretion in the urine.
Concomitant use of salicylates may increase renal excretion of ascorbic acid.
Concomitant use of deferoxamine may enhance the toxic effects of iron on tissues, especially the heart, leading to heart failure.
High levels of ascorbic acid may affect the results of some laboratory tests (glucose, uric acid, creatinine, inorganic phosphates). Such levels may be achieved in urine after doses exceeding 1 g of ascorbic acid. Detection of occult blood in stool may give false-negative results after doses exceeding 1 g of ascorbic acid.
Other chemical detection methods based on color reactions may also be falsified.
High doses of ascorbic acid may decrease the concentration of indinavir in blood plasma.

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.
Pregnancy
The medicine should not be taken by pregnant women without medical supervision. Ascorbic acid crosses the placental barrier.
Breastfeeding
Ascorbic acid passes into breast milk. The established dose should not be exceeded during breastfeeding.

Driving and using machines

DropiCe has no influence or negligible influence on the ability to drive and use machines.

3. How to take DropiCe

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.

Recommended dose

1 ml of solution is approximately 22 drops.
Children and adolescents
Small children under 3 years of age should be given the medicine after consulting a doctor.
If there is no need for a different dosage:

• infants and small children (from 28 days to 23 months) should be given 5 to 8 drops per day,
• children from 24 months to 11 years should be given 10 drops per day,
• adolescents from 12 years should be given 15 to 20 drops per day.

Adults
15 to 20 drops per day
In case of higher vitamin C requirements, the above doses can be taken twice a day.

Method of administration

Oral administration.
Infants and small children should be given drops by adding them to a bottle or a spoon with milk, tea, or fruit juice.

Overdose

After taking a single dose of 3 g or more, transient osmotic diarrhea with characteristic abdominal symptoms may occasionally occur. Diarrhea almost always occurs after taking doses of 10 g or higher. In such cases, the medicine should be discontinued.

4. Possible side effects

Like all medicines, DropiCe can cause side effects, although not everybody gets them.
In individual cases, skin hypersensitivity reactions and respiratory system reactions have been observed.
Headache, gastrointestinal disorders (e.g., nausea, vomiting, diarrhea, abdominal pain, indigestion), and polyuria, especially after taking high doses of ascorbic acid, have been reported.
Long-term use of high doses of ascorbic acid may cause kidney stones.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, e-mail: ndl@urpl.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 DropiCe

Store below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: Expiry date. The expiry date refers to the last day of the specified month.
Shelf life after first opening the bottle: 6 months.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What DropiCe contains

• The active substance is ascorbic acid (vitamin C). 1 ml of solution contains 100 mg of ascorbic acid.
• The other ingredients are glycerol and purified water.

What DropiCe looks like and contents of the pack

DropiCe is available as oral drops. The drops are clear, colorless, or slightly yellow.
Available packaging
Bottle made of orange glass type III, closed with a screw cap with a vertical dropper and a tamper-evident seal, in a cardboard box. The screw cap is made of HDPE, the dropper is made of LDPE. The bottle contains 30 ml of solution.

Marketing authorization holder and manufacturer

Marketing authorization holder:
"Polski Lek – Dystrybucja" Sp. z o.o.
ul. Chopina 10
34-100 Wadowice
Poland
Manufacturer:
Farmaceutyczna Spółdzielnia Pracy „GALENA”
ul. Krucza 62
53-411 Wrocław
Poland

Date of last revision of the leaflet: