Cebion

Package leaflet: Information for the user

Cebion
100 mg/ml, oral drops, solution,
Acidum ascorbicum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken 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 contact your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, you should inform your doctor or pharmacist. See section 4.
• If your condition does not improve or if you feel worse, you should consult your doctor.

Table of contents of the leaflet

1. What Cebion is and what it is used for
2. What you need to know before taking Cebion
3. How to take Cebion
4. Possible side effects
5. How to store Cebion
6. Contents of the pack and other information

1. What Cebion is and what it is used for

Cebion oral drops contain ascorbic acid (vitamin C), a substance essential for humans.
Vitamin C participates in numerous enzymatic reactions (including collagen synthesis, catecholamine synthesis, hydroxylation of steroids, tyrosine and exogenous substances), enhances iron absorption, and inhibits chain free-radical reactions. Its antioxidant effect is biochemically closely related to the antioxidant effects of vitamin E, vitamin A and carotenoids.
Cebion is intended for the prevention and treatment of vitamin C deficiency states, in cases where an appropriate diet is insufficient.

2. Important information before using Cebion

When not to use Cebion
Do not use this medicine if:

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

Warnings and precautions
Exercise caution in the following cases:

• enzymatic defect of red blood cells, e.g. glucose-6-phosphate dehydrogenase deficiency – high doses of ascorbic acid (4 g per day) should not be used,

VV-LAB-019237 v3.0

• severe or end-stage renal failure – high doses of ascorbic acid may contribute to the formation of urinary stones.

Interaction of Cebion with other medicines
Inform your doctor if you are taking agents that neutralize gastric acid (antacids) containing aluminium, particularly in the presence of concomitant renal impairment (ascorbic acid increases gastrointestinal absorption of aluminium).
Concomitant use of salicylates may increase renal excretion of ascorbic acid.
Concomitant use of deferoxamine may enhance iron-induced tissue toxicity, especially in the heart, leading to cardiac failure.
High concentrations of ascorbic acid may interfere with various laboratory tests (determination of glucose, uric acid, creatinine, inorganic phosphates). Such concentrations may occur in urine after doses exceeding 1 g. Also, occult blood testing in stool may yield false-negative results after doses above 1 g.
Other chemical methods of detection based on color reactions may also be distorted.

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.
This medicine should not be used during pregnancy without medical supervision.
Ascorbic acid crosses the placental barrier and is excreted into human milk.
The recommended dose should not be exceeded during breastfeeding.

Driving and operating machinery
No influence of vitamin C on the ability to drive or operate machinery has been observed.

3. How to use Cebion

This medicine should always be used exactly as described in the patient information leaflet or as advised by your doctor.
If in doubt, consult your doctor or pharmacist.
In children under 3 years of age, this medicine should be given only after consultation with a doctor.
If there is no need for a different dosage:

• infants and young children (from day 28 of life up to the end of month 23) should receive 5 - 8 drops per day, preferably added to a bottle or spoonful of milk, tea or fruit juice
• children (from month 24 of life up to the end of year 11) should receive 10 drops per day
• adolescents (from year 12) and adults should receive 15-20 drops per day.

If there is an increased need for vitamin C, the above doses may be taken twice daily.
Use of a higher than recommended dose of Cebion medicine
After ingestion of a single dose of 3 g or more, transient osmotic diarrhoea with characteristic abdominal symptoms may occasionally occur. Diarrhoea occurs almost invariably after doses of 10 g or higher.
In such a case, the medicine should be discontinued.
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4. Possible adverse effects

Like all medicinal products, this medicine can cause adverse effects, although not everybody will experience them.
In isolated cases, skin hypersensitivity reactions and respiratory system reactions have been observed.
Especially when high doses are used, headache, gastrointestinal disturbances (e.g. nausea, vomiting, diarrhoea, abdominal pain, dyspepsia) and polyuria have been observed.
Long-term use of increased doses may lead to kidney stones.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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; e-mail: [email protected]. Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Cebion

Keep the medicine 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 stated month.
Store below 25 °C.
The medicine may be used for 3 months after opening the container. After this period, any remaining medicine must be discarded.

6. Contents of the pack and other information

What Cebion contains

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

What Cebion looks like and contents of the pack
Cebion is a solution for oral drops.
30 ml pack, glass bottle with dropper.
Marketing Authorisation Holder
P&G Health Germany GmbH
Sulzbacher Str. 40
65824 Schwalbach am Taunus
Germany
Manufacturer
Lusomedicamenta Sociedade Técnica Farmacêutica, 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
VV-LAB-019237 v3.0