Cebion

Package leaflet: Information for the user

CEBION

500 mg chewable tablets
1 g effervescent tablets
1 g granules
Vitamin C
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.

• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not notice improvement or if your symptoms worsen.

Contents of this 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 contains vitamin C and is used to treat vitamin C deficiency.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking CEBION

Do not take CEBION

• if you are allergic to vitamin C or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking CEBION.
Vitamin C should be used with caution in individuals who suffer or have previously suffered from kidney stones (nephrolithiasis) and in those affected by:

• G6PD (Glucose-6-phosphate dehydrogenase) deficiency, anemia due to destruction of red blood cell membranes;
• Haemochromatosis, a disease caused by accumulation of significant amounts of iron in various organs and tissues;
• Thalassemia (a genetic blood disorder caused by reduced or absent hemoglobin synthesis);
• Sideroblastic anemia (anemia caused by the body's inability to incorporate iron into red blood cells).
  Individuals with diabetes or those following low-calorie diets (low in calories for weight loss) should be aware that the 1 g effervescent tablets with lemon and orange flavor and the orange-flavored granules contain approximately 810 mg and 7950 mg of sucrose, respectively. For these individuals, Cebion Sugar-Free (sweetened with sorbitol, free of glucose) is recommended, as it is more suitable.
  Individuals on low-sodium diets should be aware that Cebion chewable tablets contain approximately 40 mg of sodium per tablet, equivalent to about 0.1 g of table salt; Cebion effervescent tablets contain approximately 285 mg of sodium per tablet, equivalent to about 0.7 g of table salt.
  High doses of vitamin C may interfere with the results of certain diagnostic tests, particularly non-specific urine glucose testing. Therefore, it is advisable to discontinue vitamin C intake a few days before undergoing such tests.

Other medicines and CEBION
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Does not affect the ability to drive or operate machinery.

Cebion 500 mg chewable tablets (orange, lemon, blueberry flavors) and Cebion 1 g effervescent tablets (orange and lemon flavors) contain sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
Cebion 500 mg chewable tablets (orange, lemon, blueberry flavors) may be harmful to teeth.

Cebion 1 g orange-flavored granules contain sucrose. This medicine contains 7,950 mg of sucrose per dose. This should be taken into account in patients with diabetes mellitus.
For such patients, Cebion sweetened with sorbitol and free of glucose is recommended, as it is more suitable.

Cebion 500 mg chewable tablets and Cebion 1 g effervescent tablets contain sodium.
Cebion 500 mg chewable tablets contain 40 mg of sodium per dose; Cebion 1 g effervescent tablets contain 285 mg of sodium per dose. This should be taken into account in patients with impaired renal function or those on a low-sodium diet.

3. How to take CEBION

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Cebion 500 mg chewable tablets:
The recommended dose is 1–2 tablets per day. In severe cases, where it is necessary to correct an intense vitamin C deficiency, 2–3 or even more tablets per day may be taken.
The chewable tablet may also be slowly dissolved in the mouth or swallowed after breaking it up, with a little water, tea, or fruit juice.

Cebion 1 g effervescent tablets:
The recommended dose is one effervescent tablet per day.
Adults and adolescents may take one effervescent tablet once or several times a day.
Dissolve the effervescent tablet in half a glass of water or fruit juice and drink immediately after complete dissolution.

Cebion 1 g orange-flavoured granules:
The recommended dose is once or several times daily for several consecutive days.
Dissolve the contents of one sachet of orange-flavoured granules in half a glass of water and drink immediately afterwards. To shorten the dissolution time, it is advisable to stir the liquid. Cebion orange granules produce a particularly pleasant-tasting drink.

Do not exceed the recommended doses without medical advice.
Use only for short-term treatment.

If you take more CEBION than you should
In case of accidental ingestion/overdose of CEBION, contact your doctor immediately or go to the nearest hospital.
Occasionally, very high doses may cause mild gastrointestinal disturbances, mainly of a laxative nature. In such cases, it is advisable to discontinue treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Hypersensitivity reactions may occur in susceptible individuals.
At doses higher than those recommended, headache and gastrointestinal disturbances have been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at the following website: http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CEBION

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Cebion effervescent tablets:
This medicine is sensitive to moisture. The cap of the bottle contains a desiccant substance which protects the tablets from moisture that could penetrate into the container; therefore, the container must always be closed carefully after use.
Store in the original packaging to protect the medicine from moisture.
Do not store above 25°C.
Cebion 1 g granules:
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CEBION contains
Cebion 500 mg chewable tablets, Orange flavour:

• The active substance is vitamin C. One tablet contains sodium ascorbate (equivalent to 250 mg of ascorbic acid) 281 mg; ascorbic acid (vit. C) 250 mg.
• The other components are: sucrose CD, glyceryl palmitostearate, sodium cyclamate, magnesium stearate, tangerine flavour, orange flavour, Orange Yellow S (E 110) - lake.

Cebion 500 mg chewable tablets, Lemon flavour:

• The active substance is vitamin C. One tablet contains sodium ascorbate (equivalent to 250 mg of ascorbic acid) 281 mg; ascorbic acid (vit. C) 250 mg.
• The other components are: sucrose CD, glyceryl palmitostearate, sodium cyclamate, magnesium stearate, lemon flavour, Quinoline Yellow (E 104) - lake.

Cebion 500 mg chewable tablets, Blueberry flavour:

• The active substance is vitamin C. One tablet contains sodium ascorbate (equivalent to 250 mg of ascorbic acid) 281 mg; ascorbic acid (vit. C) 250 mg.
• The other components are: sucrose CD, glyceryl palmitostearate, sodium cyclamate, magnesium stearate, blueberry flavour, indigotine (E 132) - lake, erythrosine (E 127) - lake.

Cebion 1 g effervescent tablets, Orange flavour:

• The active substance is vitamin C. One tablet contains ascorbic acid (vit. C) 1 g.
• The other components are: tartaric acid, sodium bicarbonate, sodium cyclamate, orange flavour powder, adipic acid, Orange Yellow S (E 110), Orange Yellow S (E 110) - lake, sucrose CD, granulated sucrose.

Cebion 1 g effervescent tablets, Lemon flavour:

• The active substance is vitamin C. One tablet contains ascorbic acid (vit. C) 1 g.
• The other components are: tartaric acid, sodium bicarbonate, sodium cyclamate, lemon flavour powder, adipic acid, Quinoline Yellow (E 104), Quinoline Yellow (E 104) - lake, sucrose CD, granulated sucrose.

Cebion 1 g granules, Orange flavour:

• The active substance is vitamin C. One sachet contains ascorbic acid (vit. C) 1 g.
• The other components are: orange granules, freeze-dried orange, citric acid, sucrose.

Cebion 500 mg sugar-free chewable tablets:

• The active substance is vitamin C. One tablet contains sodium ascorbate (equivalent to 320 mg of ascorbic acid) 360 mg; ascorbic acid 180 mg.
• The other components are: glyceryl palmitostearate, magnesium stearate, sodium cyclamate, mixed berry flavour, erythrosine (E 127) - lake, hydrated colloidal silica, sorbitol.

Cebion 1 g sugar-free effervescent tablets:

• The active substance is vitamin C. One tablet contains ascorbic acid 1 g.
• The other components are: coated tartaric acid, sodium bicarbonate, adipic acid, sorbitol, sodium saccharin, sodium cyclamate, cedar flavour powder, Quinoline Yellow (E 104), hydrated colloidal silica.

Description of the appearance of CEBION and contents of the pack
Cebion is available as chewable tablets, effervescent tablets, or granules for oral use.
Pack contents:
Cebion 500 mg chewable tablets: 20 tablets, Orange flavour
Cebion 500 mg chewable tablets: 20 tablets, Lemon flavour
Cebion 500 mg chewable tablets: 20 tablets, Blueberry flavour
Cebion 1 g effervescent tablets: 10 tablets, Orange and Lemon flavour
Cebion 1 g granules: 10 sachets, Orange flavour
Cebion 500 mg chewable tablets: 20 sugar-free tablets
Cebion 1 g effervescent tablets: 10 sugar-free tablets

Marketing Authorization Holder
Procter & Gamble s.r.l., Viale Giorgio Ribotta, 11 – 00144 Roma.

Manufacturers
For chewable tablets:
Famar Italia S.p.A. – Via Zambeletti, 25 20021 Baranzate (MI)
Bracco SpA Via C. Di Marcinelle, 13 Milano, Italia

For effervescent tablets:
Famar Orléans – 5 avenue de Concyr, 45071 Orléans Cedex 02
E-Pharma Trento S.p.A. – Frazione Ravina, Via Provina 2 Trento (TN)
Bracco SpA Via C. Di Marcinelle, 13 Milano, Italia

For granules:
Famar Italia S.p.A. – Via Zambeletti, 25 20021 Baranzate (MI)
Bracco SpA Via C. Di Marcinelle, 13 Milano, Italia

BEFORE USING
READ CAREFULLY ALL THE INFORMATION CONTAINED IN THIS LEAFLET
This is a self-medication product intended for the treatment of mild and transient conditions that can be easily recognized and resolved without medical intervention.
It can therefore be purchased without a prescription, but must be used correctly to ensure efficacy and minimize potential adverse effects.

• For further information and advice, consult your pharmacist
• Consult a doctor if symptoms persist or worsen after a short period of treatment

CEBION 100 mg/ml oral drops solution Bottle 10 ml
Vitamin C

COMPOSITION
100 ml contains:
Active substance: ascorbic acid (vitamin C) 10 g.
Excipients: glycerol, purified water.

PRESENTATION
Cebion is supplied as 10% oral drops solution. The pack contains one 10 ml dropper bottle.

WHAT IS CEBION
Cebion is vitamin C.

MARKETING AUTHORIZATION HOLDER
Procter & Gamble s.r.l., Viale Giorgio Ribotta, 11 – 00144 Roma

Manufacture, packaging, quality control and batch release
FAMAR S.A. 63 Ag. Dimitriou str. 174 56 Alimos, Athens, Greece.
Alternatively, for batch release only:
Bracco s.p.a. - Via E. Folli, 50 – Milano
Alternatively, for secondary packaging only:
Silvano Chiapparoli Logistica S.p.A., Via delle Industrie snc, 26814 Livraga (LO)

INDICATIONS
Cebion is used for states of vitamin C deficiency.

CONTRAINDICATIONS
Hypersensitivity to the active substance, excipients, or to chemically related compounds.

Pregnancy and breastfeeding
Consult your doctor before use.

PRECAUTIONS FOR USE
Vitamin C should be used with caution in patients with, or with a history of, nephrolithiasis (kidney stones), G6PD (Glucose-6-phosphate dehydrogenase) deficiency, hemochromatosis, thalassemia, or sideroblastic anemia.

INTERACTIONS WITH OTHER MEDICINES OR FOODS
If you are taking other medicines, consult your doctor or pharmacist.

IMPORTANT INFORMATION
Ascorbic acid, especially at high doses, may interfere with certain diagnostic tests, particularly non-specific urine glucose tests. Therefore, it is advisable to discontinue vitamin C intake a few days before such testing.

DOSAGE AND ADMINISTRATION
Dosage
Unless otherwise prescribed by a physician:

• Infants and very young children: 5–8 drops
• Young children: 10 drops
• School-age children and adults: 15–20 drops per day

In cases of high vitamin requirement, Cebion drops may be administered multiple times daily.
Warning: Do not exceed the recommended dose without medical advice.

When and for how long
Consult your doctor if symptoms recur frequently or if you notice any recent changes in their characteristics.
Warning: Use only for short-term treatment.

Administration
Cebion oral drops should be diluted before use, for example, in a baby bottle, milk, tea, fruit juice, or baby food.

OVERDOSE
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
Very high doses may occasionally cause mild gastrointestinal disturbances, mainly with laxative effects. In such cases, treatment should be discontinued.

UNDESIRABLE EFFECTS
Hypersensitivity reactions may occur in susceptible individuals.
At doses higher than recommended, headache and gastrointestinal disturbances have been reported.
Following the instructions in this leaflet reduces the risk of adverse effects.
These adverse effects are generally transient. However, if they occur, it is advisable to consult your doctor or pharmacist.
It is important to inform your doctor or pharmacist of any adverse effects not listed in this leaflet.
Request and complete the adverse reaction reporting form available at pharmacies (Form B).

EXPIRY DATE AND STORAGE INSTRUCTIONS
Store below 25°C.
Warning: Do not use after the expiry date stated on the packaging.
Keep out of the reach and sight of children.
Keep both the packaging and the patient information leaflet for future reference.

REVISION OF THE PACKAGE LEAFLET BY AIFA: