Ibuvit C

Package Leaflet: Information for the User

Ibuvit C, 100 mg/ml, Oral Drops, Solution

Acidum ascorbicum
(Vitamin C)

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

This medicine should always be used 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 further information, consult a pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, contact your doctor.

Table of Contents of the Leaflet

• 1. What is Ibuvit C and what is it used for
• 2. Important information before using Ibuvit C
• 3. How to use Ibuvit C
• 4. Possible side effects
• 5. How to store Ibuvit C
• 6. Contents of the pack and other information

1. What is Ibuvit C and what is it used for

Ibuvit C are oral drops containing ascorbic acid (vitamin C) as the active substance.
This form of the medicine is particularly recommended for use in infants and children, as it facilitates the administration of the correct amount of vitamin C.
Vitamin C is a water-soluble vitamin. It is easily degraded by numerous external factors, such as light, high temperature, and oxygen in the air.
Vitamin C participates in the formation of many body tissues (including cartilage, bones, and teeth), and also affects the healing process of wounds and bone fractures, as well as the functioning of the immune system.
Ibuvit C is used to prevent and treat vitamin C deficiency states, in cases where a suitable diet is not sufficient.

2. Important information before using Ibuvit C

When not to use Ibuvit C:

• if the patient is allergic to vitamin C or any of the other ingredients of this medicine (listed in section 6);
• if the patient has kidney stones caused by oxalate;
• if the patient has increased iron levels in the body due to, for example, excessive iron intake (hemochromatosis), sickle cell anemia, quantitative disorders of hemoglobin synthesis (thalassemia), and poisoning with iron-containing products.

Warnings and precautions

Before starting to use Ibuvit C, discuss it with your doctor or pharmacist.
Particular caution should be exercised when using Ibuvit C before laboratory tests. Vitamin C taken in large doses can falsify the results of some tests, such as glucose or creatinine measurements in blood and urine.

Ibuvit C and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Consult your doctor if you are using Ibuvit C at the same time as:

• iron-containing products. Vitamin C significantly increases the absorption of iron ions in the gastrointestinal tract, especially in people with low iron levels in the body;
• deferoxamine (a medicine used in iron poisoning). In patients with elevated iron levels in the body taking deferoxamine in combination with vitamin C, increased iron toxicity may occur in the initial treatment phase;
• acetylsalicylic acid. High doses of acetylsalicylic acid reduce the absorption of vitamin C;
• vitamin E. Vitamin C enhances the antioxidant effect of vitamin E;
• paracetamol. Ascorbic acid prolongs the half-life of paracetamol;
• tricyclic antidepressants, phenothiazine derivatives (medicines used to treat mental disorders), and aminoglycoside antibiotics (e.g., streptomycin). Ascorbic acid used in doses greater than 1 g per day may reduce their effectiveness.

Ibuvit C with food and drink

Ibuvit C can be used with food and drink. In the case of children, it is recommended to dissolve the appropriate dose of Ibuvit C in water, tea, or juice, or add it to food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
The recommended daily intake of vitamin C for pregnant women (including the amount of vitamin taken with food) is 80 mg (which corresponds to 16 drops of Ibuvit C).
Breastfeeding
The recommended daily intake of vitamin C for breastfeeding women (including the amount of vitamin taken with food) is 100 mg (which corresponds to 20 drops of Ibuvit C). Vitamin C passes into breast milk. Taking too high doses by the mother during breastfeeding increases the risk of vitamin C overdose in the child.

Driving and using machines

Ibuvit C does not affect the ability to drive and use machines.

3. How to use Ibuvit C

This medicine should always be used exactly as described in the package leaflet or as directed by a doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The medicine is used orally once a day or in divided doses, preferably during meals.
In the case of children, it is recommended to dissolve the appropriate dose of Ibuvit C in water, tea, or juice, or add it to food. Do not give the medicine directly from the packaging (bottle) to the child's mouth.

Use in children and adolescents

In children under 3 years of age, the medicine should be given after consulting a doctor.
Recommended dose of Ibuvit C (unless the doctor recommends otherwise):

• in infants and children up to 2 years: 5 to 8 drops per day, added to a drink or food;
• in children from 2 to 11 years: 10 drops per day;
• in adolescents from 12 to 17 years: 15 to 20 drops per day.

Using a higher dose of Ibuvit C than recommended

Using a higher dose of Ibuvit C than recommended is practically not associated with the risk of side effects. High doses of vitamin C are quickly excreted in the urine unchanged.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ibuvit C can cause side effects, although not everybody gets them.
The medicine used in recommended doses is well tolerated by the body. Side effects concern cases of using high doses of vitamin C (over 1,000 mg = 200 drops per day).
Using high doses of vitamin C in people with a deficiency of glucose-6-phosphate dehydrogenase (a rare genetic disease) may lead to the breakdown of red blood cells (erythrocytes).
In the case of oral daily doses of vitamin C of 1 g or more, gastrointestinal disorders, such as diarrhea, may occur.
Vitamin C in high doses can cause excessive excretion of oxalic acid with urine, crystallization of urates and citrates, which increases the risk of stone formation in the urinary tract.
Long-term use of high doses may lead to the development of tolerance, which, after withdrawal of the medicine, may manifest as a deficiency of vitamin C in the body.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. 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 181C
02-222 Warsaw
Phone: +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 Ibuvit C

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect from light.
Keep the bottle tightly closed.
After opening the bottle, the product is stable for at least 6 months if stored as recommended.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ibuvit C contains

• The active substance of the medicine is ascorbic acid. Each ml contains 100 mg of ascorbic acid. Each drop contains 5 mg of ascorbic acid.
• The other ingredients are: glycerol, purified water.

What Ibuvit C looks like and what the pack contains

30 ml solution in a brown glass bottle with a dropper, in a cardboard box.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz

Date of last revision of the leaflet: