Patient Information Leaflet

DropiCe
100 mg/ml, oral drops, solution
Acidum ascorbicum
Vitamin C in drops
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed
by your doctor 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.
If your symptoms do not improve or if you feel worse, you should contact your doctor.

Leaflet Contents

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

1. What DropiCe is and what it is used for

DropiCe is an oral drop formulation containing ascorbic acid (vitamin C). Vitamin C is a substance essential for the proper functioning of the human body.
Vitamin C participates in numerous enzymatic reactions, including collagen synthesis, catecholamine synthesis, hydroxylation of steroids, tyrosine, and exogenous substances. Vitamin C enhances the absorption of iron salts and inhibits chain free-radical reactions.
The antioxidant action of vitamin C is biochemically closely linked to the antioxidant effects of vitamin E, vitamin A, and carotenoids.
Indications
DropiCe is indicated for the prevention and treatment of vitamin C deficiency states, in cases where an appropriate diet alone is insufficient.

2. Important information before using DropiCe

When not to use DropiCe:

if the patient is allergic to ascorbic acid or to any of the other ingredients of this medicine (listed in section 6),
if the patient has kidney stones,
if the patient has been diagnosed with elevated uric acid levels (in medical history),
if the patient has disorders of iron storage in the body (iron storage disorders),
if the patient has peptic ulcer disease.

Warnings and precautions
Before starting treatment with DropiCe, discuss it with a doctor or pharmacist.
Exercise caution in the following cases:

enzymatic red blood cell disorders, e.g. glucose-6-phosphate dehydrogenase deficiency. In such cases, high doses of ascorbic acid (4 g per day) should not be used;
severe or end-stage renal failure. High doses of ascorbic acid may contribute to the formation of urinary stones.

DropiCe and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to use.
Inform the doctor if the patient is taking agents that neutralize gastric juice containing aluminium (antacids and anti-dyspeptic agents), particularly in the presence of concomitant renal failure (ascorbic acid increases aluminium absorption in the gastrointestinal tract).
Concomitant use of antacids containing aluminium may increase urinary excretion of aluminium.
Concomitant use of salicylates may increase renal excretion of ascorbic acid.
Concomitant use of deferoxamine may intensify iron-induced tissue toxicity, especially to the heart, leading to cardiac failure.
High concentrations of ascorbic acid may interfere with the results of certain laboratory tests (determination of glucose, uric acid, creatinine, inorganic phosphates). Such concentrations may be achieved in urine after doses exceeding 1 g of ascorbic acid. Occult blood detection in faeces may yield false-negative results after doses exceeding 1 g of ascorbic acid.
Other chemical detection methods based on color reactions may also be distorted.
High doses of ascorbic acid may reduce plasma concentrations of indinavir.

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 medicine.

Pregnancy
This medicine should not be used in pregnant women without medical supervision. Ascorbic acid crosses the placental barrier.

Breastfeeding
Ascorbic acid passes into breast milk. The recommended dose should not be exceeded during breastfeeding.

Driving and operating machinery
DropiCe has no effect or has a negligible effect on the ability to drive vehicles and operate machinery.

3. How to use DropiCe

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
1 ml of solution is approximately 22 drops.
Children and adolescents
In small children under 3 years of age, this medicine should be administered only after consultation with a doctor.
If there is no need for a different dosage:

for infants and young children (from day 28 of life up to 23 months of age) – 5 to 8 drops per day,
for children from 24 months of age up to 11 years of age – 10 drops per day,
for adolescents from 12 years of age – 15 to 20 drops per day.

Adults
15 to 20 drops per day
If there is a higher requirement for vitamin C, the above doses may be taken twice daily.
Method of administration
For oral use.
For infants and young children, the drops should be administered by adding them to a bottle or to a spoonful of milk, tea, or fruit juice.
Accidental overdose of DropiCe
After ingestion of a single dose of 3 g or more, transient osmotic diarrhoea with characteristic abdominal symptoms may occasionally occur. Diarrhoea occurs almost always after doses of 10 g or higher. In such a case, discontinue the medicine.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Skin hypersensitivity reactions and reactions affecting the respiratory system have been observed in isolated cases.
Headache, gastrointestinal disorders (e.g. nausea, vomiting, diarrhoea, abdominal pain, dyspepsia) and polyuria have been observed, particularly after administration of high doses of ascorbic acid.
Long-term use of high doses of ascorbic acid may lead to kidney stones.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables better monitoring of the medicine's safety.

5. How to store DropiCe medicine

Store below 25°C.
Keep the medicine in a place invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the packaging following: Expiry date:
The expiry date refers to the last day of the stated month.
Period of use after first opening the bottle: 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the package 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 an oral solution in dropper form. The drops are clear, colourless or slightly yellow.

Pack size available:
An amber glass bottle (Type III), closed with a screw cap incorporating a vertical dropper and a tamper-evident seal, placed in a cardboard box. The cap is made of HDPE polyethylene, the dropper is made of LDPE polyethylene. The bottle contains 30 ml of solution.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
"Polski Lek – Dystrybucja" Spółka z o.o.
ul. Chopina 10
34-100 Wadowice
Poland

Manufacturer:
Farmaceutyczna Spółdzielnia Pracy „GALENA”
ul. Krucza 62
53-411 Wrocław
Poland