Cebion

Package Leaflet: Information for the Patient

Cebion

100 mg/ml, oral drops, solution, Acidum ascorbicum

Read the package leaflet carefully before using 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 Cebion and what is it used for
• 2. Important information before taking Cebion
• 3. How to take Cebion
• 4. Possible side effects
• 5. How to store Cebion
• 6. Package contents and other information

1. What is Cebion and what is it used for

Cebion oral drops contain ascorbic acid (vitamin C), a substance essential for humans.
Vitamin C participates in many enzymatic reactions (including collagen synthesis, catecholamine synthesis, steroid hydroxylation, tyrosine, and exogenous substances), increases iron salt absorption, and inhibits chain reactions of free radicals. Its antioxidant action is closely related to the antioxidant action of vitamin E, vitamin A, and carotenoids.
Cebion is intended for the prevention and treatment of vitamin C deficiency states when a suitable diet is not sufficient.

2. Important information before taking Cebion

When not to take Cebion

Do not take the medicine if:

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

Warnings and precautions

Caution should be exercised in the case of:

• enzyme deficiency of red blood cells, e.g., erythrocyte glucose-6-phosphate dehydrogenase deficiency - high doses of ascorbic acid (4 g per day) should not be taken

VV-LAB-019237 v3.0

• severe or terminal kidney failure - high doses of ascorbic acid may contribute to the formation of kidney stones.

Cebion and other medicines

Inform your doctor if you are taking antacids (containing aluminum, especially in the case of existing kidney failure, as ascorbic acid increases aluminum absorption in the gastrointestinal tract).
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 its failure.
High concentrations of ascorbic acid may affect the results of various laboratory tests (glucose, uric acid, creatinine, inorganic phosphates). Such concentrations can be achieved in urine after doses above 1g. Also, the detection of occult blood in stool may give false-negative results after doses above 1g.
Other chemical detection methods based on color reactions may also be falsified.

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.
The medicine should not be taken by pregnant women without medical supervision.
Ascorbic acid passes through the placental barrier and into human milk.
Do not exceed the recommended dose during breastfeeding.

Driving and using machines

No effect of vitamin C on the ability to drive and use machines has been observed.

3. How to take Cebion

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor.
In case of doubt, consult a doctor or pharmacist.
In small children under 3 years of age, the medicine should be administered after consulting a doctor.
If there is no need for a different dosage:

• infants and young children (from 28 days to 23 months) should be given 5-8 drops per day, preferably adding drops to a bottle or a spoon of milk, tea, or fruit juice
• children (from 24 months to 11 years) should take 10 drops per day
• adolescents (from 12 years) and adults 15-20 drops per day.

In case of higher vitamin requirements, the recommended doses can be taken twice a day.

Taking a higher dose of Cebion than recommended

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 a case, the medicine should be discontinued.
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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In individual cases, skin hypersensitivity reactions and respiratory system reactions have been observed.
Especially when taking high doses, headache, gastrointestinal disorders (e.g., nausea, vomiting, diarrhea, abdominal pain, indigestion), and polyuria have been observed.
Long-term use of increased doses may cause kidney stones.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should inform your 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: [email protected]. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cebion

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.
The expiry date refers to the last day of the given month.
Store in a temperature below 25°C.
The medicine can be used for 3 months after opening the packaging. After this period, the remainder should be discarded.

6. Package contents and other information

What Cebion contains

• The active substance of the medicine is ascorbic acid (vitamin C).
• The other ingredient is: glycerol 87%.

What Cebion looks like and what the package contains

Cebion is in the form of drops.
Packaging 30 ml, glass bottle with a dropper.

Responsible entity

P&G Health Germany GmbH
Sulzbacher Str. 40
65824 Schwalbach am Taunus
Germany

Manufacturer

Lusomedicamenta Sociedade Técnica Farmacȇutica, S.A.
Estrada Consiglieri Pedroso, n.̊ 66, 69-B
Queluz de Baixo
VV-LAB-019237 v3.0
2730-055 Barcarena
Portugal
Procter & Gamble Manufacturing GmbH
Procter & Gamble Strasse 1
64521 Gross Gerau, Hessen
Germany

Date of the last update of the leaflet:

VV-LAB-019237 v3.0