CEBION 100 mg /Ml Oral Drops, Solution

Зміст інструкції

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

CEBION

500 mg chewable tablets
1 g effervescent tablets
1 g granules
Vitamin C

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if you feel worse.

Contents of this leaflet:

• 1. What CEBION is and what it is used for
• 2. What you need to know before you take 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 you take 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
Consult your doctor or pharmacist before taking CEBION.
Vitamin C should be used with caution by subjects who suffer from, or have suffered in the past, from
nephrolithiasis (kidney stones) and by those affected by:

• G6PD deficiency (Glucose-6-phosphate dehydrogenase), anemia due to the destruction of red blood cell walls;
• Hemochromatosis, a disease due to the accumulation of considerable amounts of iron in various organs and tissues;
• Thalassemia (a genetic blood disease caused by reduced or absent hemoglobin synthesis);
• Sideroblastic anemia (anemia caused by the body's inability to accumulate iron in red blood cells). Subjects who suffer from diabetes or who follow low-calorie diets (with few calories to lose weight) should consider that the 1 g lemon and orange effervescent tablets and the orange granules contain approximately 810 and 7950 mg of sucrose, respectively. For these subjects, it is recommended to take Cebion Sugar-Free (sweetened with sorbitol, not containing glucose), which is more suitable for them. Subjects following low-sodium diets should consider that Cebion chewable tablets contain approximately 40 mg of sodium per tablet, corresponding to approximately 0.1 g of table salt; Cebion

effervescent tablets contain approximately 285 mg of sodium per tablet, corresponding to approximately 0.7 g of table
salt.
Vitamin C can interfere, at high doses, with the results of some diagnostic tests, particularly the search for
glucose in the urine with non-specific means. It is therefore advisable to discontinue taking vitamin C
a few days before proceeding with this examination.

Other medicines and CEBION
Tell 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 are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
It does not alter the ability to drive vehicles and use machinery.

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

Cebion 1 g granules orange flavor contains sucrose.This medicine contains 7.950 g of
sucrose per dose. To be taken into consideration in people affected by diabetes mellitus.
For these subjects, it is recommended to take Cebion sweetened with sorbitol, not containing glucose and
therefore more manageable.

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. To be taken into consideration in people with reduced kidney function or
following a low-sodium diet.

3. How to take CEBION

Take this medicine following exactly as indicated 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 compensate for an intense vitamin C deficiency, 2-3 or even more tablets per day.
The chewable tablet can also be dissolved slowly in the mouth or swallowed, after breaking it, with a little water, tea or fruit juice.

Cebion 1 g effervescent tablets:
The recommended dose is 1 tablet per day.
Adults and children can take one or more effervescent tablets of Cebion, one or more 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-flavored granules:
The recommended dose is one or more times a day for several consecutive days.
Dissolve the contents of one sachet of orange-flavored granules in half a glass of water and drink immediately afterwards. To shorten the dissolution time, it is advisable to stir the liquid. With Cebion orange-flavored granules you obtain a particularly pleasant drink.
Do not exceed the indicated doses without the advice of your doctor.
Use only for short-term treatment periods.

If you take more CEBION than you should
In case of accidental ingestion/intake of an excessive dose of Cebion, immediately notify your doctor or go to the nearest hospital.
Administration of very high quantities can occasionally cause mild gastrointestinal disturbances, consisting mainly of laxative-like phenomena. In such cases, it is appropriate to discontinue treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In predisposed individuals, hypersensitivity reactions may occur.
At higher doses than recommended, headache and gastrointestinal disorders have been reported.

Reporting of side effects
If you experience any side effects, 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 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 which is stated on the packaging.

Cebion effervescent tablets:
The medicine is sensitive to humidity. The cap of the tube contains a desiccant substance which serves to
protect the tablets from moisture that could penetrate; therefore, the packaging must be carefully
resealed each time.
Store in the original packaging to protect the medicine from humidity.
Do not store at a temperature above 25°C.

Cebion 1 g granules:
Do not store at a temperature above 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What CEBION contains

Cebion 500 mg chewable tablets orange flavour:

• the active ingredient 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 ingredients are: sucrose CD, glycerol monostearate, sodium cyclamate, magnesium stearate, mandarin aroma, orange aroma, Yellow Orange S (E 110) - lacquer.

Cebion 500 mg chewable tablets lemon flavour:

• The active ingredient 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 ingredients are: sucrose CD, glycerol monostearate, sodium cyclamate, magnesium stearate, lemon aroma, Quinoline Yellow (E 104) - lacquer.

Cebion 500 mg chewable tablets blueberry flavour:

• The active ingredient 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 ingredients are: sucrose CD, glycerol monostearate, sodium cyclamate, magnesium stearate, blueberry aroma, Indigo Carmine (E 132) - lacquer, Erythrosine (E 127) - lacquer.

Cebion 1 g effervescent tablets orange flavour:

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

Cebion 1 g effervescent tablets lemon flavour:

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

Cebion 1 g granules orange flavour:

• The active ingredient is vitamin C. One sachet contains ascorbic acid (vit. C) 1 g.
• The other ingredients are: orange granular, lyophilized orange, citric acid, sucrose.

Cebion 500 mg sugar-free chewable tablets:

• The active ingredient is vitamin C. One tablet contains sodium ascorbate (equivalent to 320 mg of ascorbic acid) 360 mg; ascorbic acid 180 mg.
• The other ingredients are: glycerol monostearate, magnesium stearate, sodium cyclamate, berry aroma, Erythrosine (E 127) - lacquer, hydrated colloidal silica, sorbitol.

Cebion 1 g sugar-free effervescent tablets:

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

Marketing Authorisation Holder and Manufacturer
Procter & Gamble s.r.l., Viale Giorgio Ribotta, 11 – 00144 Rome.
Manufacturers

For chewable tablets:

Famar Italia S.p.a. –Via Zambeletti, 25 20021 Baranzate (MI)
Bracco SpA Via C. Di Marcinelle, 13 Milan, Italy

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 Milan, Italy

For granules

Famar Italia S.p.a. –Via Zambeletti, 25 20021 Baranzate (MI)
Bracco SpA Via C. Di Marcinelle, 13 Milan, Italy

BEFORE USE
READ ALL THE INFORMATION CONTAINED IN THE PACKAGE LEAFLET CAREFULLY
This is a self-medication medicine that you can use to treat mild and transient disorders
easily recognizable and resolvable without resorting to the help of a doctor.
It can therefore be purchased without a prescription but must be used correctly to ensure its effectiveness and
reduce its side effects.

• for more information and advice ask your pharmacist
• consult your doctor if the disorder does not resolve after a short period of treatment

CEBION100 mg/ml oral drops solution 10 ml bottle
Vitamin C
COMPOSITION
100 ml contain:

Active ingredient:ascorbic acid (vitamin C) 10 g.

Excipients:glycerol, purified water.

WHAT IT LOOKS LIKE
Cebion is available in the form of oral drops, 10% solution. The pack contains 1 dropper bottle of 10 ml.

WHAT IT IS
Cebion is vitamin C.

AIC Holder
Procter & Gamble s.r.l., Viale Giorgio Ribotta, 11 – 00144 Rome

Production, packaging, control and release
FAMAR S.A.63 Ag. Dimitriou str. 174 56 Alimos, Athens, Greece.

Alternatively only for batch release

Bracco s.p.a. -Via E. Folli, 50 – Milan

Alternatively

only for secondary packaging
Silvano Chiapparoli Logistica S.p.A., Via delle Industrie snc, 26814 Livraga (LO)

WHY IT IS USED
Cebion is used for vitamin C deficiencies.

WHEN IT SHOULD NOT BE USED
Hypersensitivity to the components or other substances closely related from a chemical point of view.
What to do during pregnancy and breastfeeding
Ask your doctor for advice.

PRECAUTIONS FOR USE
Vitamin C should be used with caution by subjects who suffer from, or have suffered in the past, from
nephrolithiasis (kidney stones) and those affected by G6PD deficiency (Glucose-6-phosphate dehydrogenase),
hemochromatosis, thalassemia or sideroblastic anemia.

WHICH MEDICINES OR FOODS CAN MODIFY THE EFFECT OF THE MEDICINE
If you are using other medicines ask your doctor or pharmacist for advice.
IT IS IMPORTANT TO KNOW THAT
Ascorbic acid can interfere, at high doses, with the results of some diagnostic tests, in particular the search
for glucose in urine with non-specific means. It is therefore advisable to suspend the assumption of vitamin
C a few days before proceeding with such an examination.

HOW TO USE THIS MEDICINE
HOW MUCH
Unless otherwise prescribed by your doctor, it is recommended for infants and young children on average 5-8
drops; for small children, 10 drops; for school children and adults, 15-20 drops per day.
In case of very high vitamin needs, Cebion drops can be administered several times a day.

Caution: do not exceed the indicated doses without the advice of your doctor.
WHEN AND FOR HOW LONG
Consult your doctor if the disorder occurs repeatedly or if you have noticed any
recent change in its characteristics.
Caution: use only for short periods of treatment.
HOW
Cebion drops are administered diluted, added for example to the bottle, milk, tea, fruit juice.

WHAT TO DO IF YOU HAVE TAKEN TOO MUCH MEDICINE
In case of accidental ingestion/intake of an excessive dose of Cebion, immediately
inform your doctor or go to the nearest hospital.
Administration of very high quantities can occasionally determine mild gastrointestinal disorders, consisting mainly of phenomena of a laxative type. In such cases it is appropriate to interrupt
the treatment.

UNDESIRABLE EFFECTS
In predisposed subjects, hypersensitivity reactions may occur.
At doses higher than those recommended, headache and gastrointestinal disturbances have been reported.

These side effects are generally transient. When they occur, however, it is
advisable to consult your doctor or pharmacist.
It is important to communicate to the doctor or pharmacist the appearance of undesirable effects not described
Request and fill in the Adverse Effects Reporting form available in pharmacies
(Model B).
EXPIRY AND STORAGE
Store at a temperature not exceeding 25°C
Caution: do not use the medicine after the expiry date indicated on the packaging.
Keep the medicine out of the reach and sight of children.
It is important to always have the information on the medicine available, so keep both the