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1. What is Vitamina C Bayer and what is it used for
2. What you need to know before using Vitamina C Bayer
3. How to use Vitamina C Bayer
4. Possible side effects
5. How to store Vitamina C Bayer
6. Package Contents and Other Information
7. What is Vitamina C Bayer and what is it used for
8. What you need to know before using Vitamina C Bayer
9. How to use Vitamina C Bayer
10. Possible side effects
11. How to store Vitamina C Bayer
12. Contents of the pack and other information

Vitamina C Bayer 500 mg/5 ml injectable solution
vitamin C
Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Vitamina C Bayer and what is it used for

Vitamina C Bayer belongs to the category of vitamin supplements based on vitamin C.
Vitamina C Bayer is indicated in cases where a state of vitamin C deficiency is expected
(hypovitaminosis C) due to reduced nutritional intake or increased needs, such as during
pregnancy and breastfeeding, or in cases of rheumatic ailments and colds.

2. What you need to know before using Vitamina C Bayer

Do not use Vitamina C Bayer

• If you are allergic to ascorbic acid (vitamin C) or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from or have suffered in the past from kidney stones (nephrolithiasis);
• if you suffer from increased urinary excretion of calcium oxalate (hyperoxaluria);
• if your kidneys do not function properly (renal insufficiency) or you are on dialysis;
• if you suffer from abnormal iron accumulation in the body (hemochromatosis);
• if you are under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using Vitamina C Bayer.

• Do not exceed the recommended dose. Vitamin C should not be taken at doses higher or for longer periods than recommended, as an overdose can cause calcium oxalate deposits and acute renal failure (acute tubular necrosis) and/or reduced kidney function (see “If you use more Vitamina C Bayer than you should”).

Pay particular attention with Vitamina C Bayer:

• If your kidneys do not function properly (renal insufficiency); consult your doctor before taking high doses of vitamin C.
• If you suffer from or have suffered from kidney stones (nephrolithiasis); in this case, you should reduce the intake of vitamin C to 100-200 mg per day.
• If you suffer from reduced kidney function (severe renal insufficiency) or if you are on dialysis; in this case, the daily intake of vitamin C should not exceed 50 or 100 mg per day, respectively, due to the risk of increased urinary excretion of calcium oxalate (hyperoxalemia) and kidney stones (crystallization of oxalates in the kidneys).
• If you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase (an enzyme whose absence, genetically determined, involves a disease characterized by reduced survival of red blood cells), do not take doses higher than those recommended, as an overdose of vitamin C in your case could lead to a reduction in the number of red blood cells due to their excessive destruction (hemolytic anemia) (see “If you use more Vitamina C Bayer than you should”).
• If you are already taking other products containing vitamins or any other medicine, or if you are undergoing medical treatment, ask your doctor for advice before using this medicine (see “Other medicines and Vitamina C Bayer” and “If you use more Vitamina C Bayer than you should”).

High doses of vitamin C can interfere with the results of some diagnostic tests.
Vitamin C can interfere with tests for glucose, creatinine, carbamazepine, uric acid and inorganic phosphates in urine, serum and the search for occult blood in the stool.
Inform your doctor if you are taking Vitamina C Bayer and need to undergo diagnostic tests.
Vitamin C can interfere with tests that measure glucose in urine and blood, without
affecting blood glucose levels.
Consult the package insert included in the kit or glucose meter for information on
possible test interferences with vitamin C and the accuracy of reading the results.

Children and adolescents
Vitamina C Bayer is contraindicated in children and adolescents under 12 years of age (see
“Do not use Vitamina C Bayer” and “Use in children and adolescents”).

Other medicines and Vitamina C Bayer
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine, especially other products containing vitamins.
The following medicines can reduce the concentration of vitamin C in the blood and its effectiveness,
by increasing its inactivation or elimination, or by decreasing its absorption:

• medicines used in inflammatory states (corticosteroids, acetylsalicylic acid, salicylates),
• a medicine called calcitonin used to lower calcium levels in the blood,
• antiepileptic medicines (barbiturates),
• medicines used in bacterial infections (tetracyclines),
• medicines used to prevent pregnancy (oral contraceptives based on estrogens),
• iron (even a slight increase in iron can be important in patients with abnormal iron accumulation in the body (hereditary hemochromatosis) or carriers of the gene (heterozygotes) for this disease, as it could worsen iron overload),
• aluminum,
• amigdalin (a substance extracted from the seeds of some fruits, which releases cyanide); one case has been reported in which the risk of cyanide poisoning increased due to the concomitant ingestion of enormous doses of vitamin C and amygdalin.

Vitamin C can reduce the concentration in the blood and/or the effectiveness of the following medicines:

• a medicine used to prevent blood clotting (warfarin),
• medicines used in some disorders of the central nervous system (phenothiazines, flufenazine),
• a medicine used in AIDS (indinavir),
• a medicine used to treat alcoholism (disulfiram),
• a medicine used to remove excess iron from the body (desferoxamine); concomitant use with vitamin C can exacerbate iron toxicity in body tissues, particularly in the heart, causing heart failure,
• immunosuppressant medicine used in organ transplants (cyclosporine).

Vitamina C Bayer and alcohol
Drinking alcohol reduces vitamin C levels in the blood, so avoid drinking
alcoholic beverages during treatment with this medicine.

Pregnancy, breastfeeding and fertility
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 using this medicine.

Pregnancy
If you are pregnant, use this medicine only if absolutely necessary, under direct

Breastfeeding
If you are breastfeeding, use this medicine only if absolutely necessary, under direct
medical supervision and respecting the recommended doses in this

Fertility
There is no evidence to suggest that physiological levels of vitamin C cause adverse effects
on reproduction in humans

Driving and operating machinery
Vitamina C Bayer does not impair the ability to drive vehicles or operate machinery.

Vitamina C Bayer contains parabens
May cause allergic reactions (even delayed) and, exceptionally, bronchospasm.

Vitamina C Bayer containsSodium. This medicine contains 65.5 mg of sodium (component
mainly of table salt) per 500mg/5ml vial. This is equivalent to 3.3% of the maximum recommended daily intake with the diet of an adult.

3. How to use Vitamina C Bayer

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is: 1 vial of 500 mg per day by subcutaneous (under the skin),
intramuscular (into the muscle) or intravenous (into the vein) administration.
Do not exceed the dose of 1 g (2 vials) per day.

Instructions for use:

Use in children and adolescents
Vitamina C Bayer is contraindicated in children under 12 years of age (see “Do not use Vitamina C
Bayer”).

If you use more Vitamina C Bayer than you should
General symptoms of a Vitamina C overdose may include gastrointestinal disorders such as diarrhea, nausea and vomiting.
If you take an excessive dose of Vitamina C, the following may also occur:

• damage to blood cells (oxidative hemolysis), especially if you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase;
• blood clotting inside arteries and veins (disseminated intravascular coagulation);
• increased levels of substances called oxalates in the blood and urine, with the risk of their accumulation and predisposition to the formation of crystals (especially if you periodically undergo dialysis to purify the blood), which can cause tubulointerstitial nephropathy (syndrome characterized by renal insufficiency) and acute renal failure (reduction of kidney function);
• accumulation of a substance called calcium oxalate in the kidneys with serious damage, such as acute tubular necrosis and/or renal failure. If you experience these symptoms, stop taking the medicine and consult your doctor.

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The adverse reactions listed below are based on spontaneous reports and it is therefore not possible
to define their frequency.

Effects on the gastrointestinal system

• diarrhea
• nausea
• vomiting
• stomach ache (abdominal pain)
• digestive problems (dyspepsia).

Effects on the immune system
Allergic and anaphylactic reactions with their related clinical manifestations:
breathing problems (asthmatic syndrome);

• skin conditions: skin rashes, urticaria (itching and small spots on the skin), edema, angioedema (swelling of the face and mucous membranes), itching;
• cardiac and circulatory distress (cardiorespiratory distress);
• serious reactions such as anaphylactic shock.

Effects localized to the site of administration

• reactions at the injection and infusion site.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Vitamina C Bayer

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month. The expiry date indicated refers to the product in intact packaging, correctly stored.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in waste water 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 Vitamina C Bayer contains

• The active ingredient is ascorbic acid (vitamin C). One 5 ml vial contains 500 mg of ascorbic acid. The other components are methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium hydroxide, water for injections.

Description of the appearance of Vitamina C Bayer and contents of the pack
Vitamina C Bayer is presented as an injectable solution.
Vitamina C Bayer 500 mg/5 ml injectable solution: pack of 3 ampoules of 5 ml for
subcutaneous/intramuscular/intravenous administration.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bayer S.p.A.- Viale Certosa 130, 20156 Milan.

Manufacturer:
Cenexi S.A.S. - Fontenay-sous-Bois (France) manufacturing site.

Vitamina C Bayer 1 g/5 ml injectable solution
vitamin C
Read this leaflet carefully before you use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Vitamina C Bayer is and what it is used for
• 2. What you need to know before you use Vitamina C Bayer
• 3. How to use Vitamina C Bayer
• 4. Possible side effects
• 5. How to store Vitamina C Bayer
• 6. Package Contents and Other Information

1. What is Vitamina C Bayer and what is it used for

Vitamina C Bayer belongs to the category of vitamin products based on vitamin C.
Vitamina C Bayer is indicated in cases where a vitamin C deficiency
(hypovitaminosis C) is expected due to reduced nutritional intake or increased needs, such as during
pregnancy and breastfeeding, or in cases of rheumatic ailments and colds.

2. What you need to know before using Vitamina C Bayer

Do not use Vitamina C Bayer

• If you are allergic to ascorbic acid (vitamin C) or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from or have suffered in the past from kidney stones (nephrolithiasis);
• if you suffer from increased urinary excretion of calcium oxalate (hyperoxaluria);
• if your kidneys do not function properly (renal insufficiency) or you are on dialysis;
• if you suffer from abnormal iron accumulation in the body (hemochromatosis);
• if you are under 12 years of age

Warnings and precautions
Consult your doctor or pharmacist before using Vitamina C Bayer.

• Do not exceed the recommended dose. Vitamin C should not be taken at doses higher than or for longer periods than recommended, as an overdose may cause calcium oxalate deposits and acute renal failure (acute tubular necrosis) and/or reduced kidney function (see section “If you use more Vitamina C Bayer than you should”).

Pay particular attention with Vitamina C Bayer:

• If your kidneys do not function properly (renal insufficiency); consult your doctor before taking high doses of vitamin C.
• If you suffer from or have suffered from kidney stones (nephrolithiasis); in this case you should reduce the intake of vitamin C to 100-200 mg per day.
• If you suffer from severe renal insufficiency or are on dialysis; in this case the daily intake of vitamin C should not exceed 50 or 100 mg per day, respectively, due to the risk of increased urinary excretion of calcium oxalate (hyperoxalemia) and kidney stones (crystallization of oxalates in the kidneys).
• If you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase (an enzyme whose absence, genetically determined, results in a disease characterized by reduced survival of red blood cells), do not take doses higher than those recommended, as an overdose of Vitamina C in your case could lead to a reduction in the number of red blood cells due to their excessive destruction (hemolytic anemia) (see section “If you use more Vitamina C Bayer than you should”).
• If you are already taking other products containing vitamins or any other medicine, or if you are undergoing medical treatment; ask your doctor for advice before using this medicine (see “Other medicines and Vitamina C Bayer” and “If you use more Vitamina C Bayer than you should”).

High doses of vitamin C may interfere with the results of some diagnostic tests.
Vitamin C may interfere with tests for glucose, creatinine, carbamazepine, uric acid and inorganic phosphates in urine, serum and fecal occult blood research.
Inform your doctor if you are taking Vitamina C Bayer and need to undergo diagnostic tests.
Vitamin C may interfere with tests that measure glucose in urine and blood, without
affecting blood sugar levels.
Consult the leaflet included in the kit or the glucose meter for information on possible test interference with vitamin C and the accuracy of
reading the results.

Children and adolescents
Vitamina C Bayer is contraindicated in children and adolescents under 12 years of age
(see “Do not use Vitamina C Bayer” and “Use in children and adolescents”).

Other medicines and Vitamina C Bayer
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, especially products containing vitamins.
The following medicines may reduce the concentration in the blood and the effectiveness of vitamin C,
increasing its inactivation or elimination, or decreasing its absorption:

• medicines used in inflammatory states (corticosteroids, acetylsalicylic acid, salicylates),
• a medicine called calcitonin used to decrease calcium levels in the blood,
• antiepileptic medicines (barbiturates),
• medicines used in bacterial infections (tetracyclines),
• medicines used to prevent pregnancy (oral contraceptives based on estrogens),
• iron (even a slight increase in iron may be important in patients with abnormal iron accumulation in the body (hereditary hemochromatosis) or carriers of the gene (heterozygotes) for this disease, as it may worsen iron overload),
• aluminum,
• amigdalin (a substance extracted from the seeds of some fruits, which releases cyanide); one case has been reported in which the risk of cyanide poisoning increased due to the concomitant ingestion of huge doses of vitamin C and amygdalin.

Vitamin C may reduce the concentration in the blood and/or the effectiveness of the following
medicines:

• a medicine used to prevent blood clotting (warfarin),
• medicines used in some disorders of the central nervous system (phenothiazines, flufenazine),
• a medicine used in AIDS (indinavir),
• a medicine used to treat alcoholism (disulfiram),
• a medicine used to remove excess iron from the body (desferoxamine); concomitant use with vitamin C may exacerbate iron toxicity in body tissues, particularly in the heart, causing heart failure,
• immunosuppressant medicine used in organ transplantation (cyclosporine).

Vitamina C Bayer and alcohol
Drinking alcohol reduces vitamin C levels in the blood, so avoid drinking
alcoholic beverages during treatment with this medicine.

Pregnancy, breastfeeding and fertility
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 using this medicine.

Pregnancy
If you are pregnant, use this medicine only if absolutely necessary, under direct

Breastfeeding
If you are breastfeeding, use this medicine only if absolutely necessary, under direct
medical supervision and respecting the recommended doses in this

Fertility
There is no evidence to suggest that physiological levels of vitamin C cause adverse effects
on reproduction in humans

Driving and operating machinery
Vitamina C Bayer does not impair the ability to drive vehicles or operate machinery.

Vitamina C Bayer contains parabens
May cause allergic reactions (even delayed) and, exceptionally, bronchospasm.

Vitamina C Bayer contains sodium
This medicine contains 135.24 mg of sodium (the main component of table salt) per vial
of 1 g/5ml. This is equivalent to 6.8% of the recommended maximum daily intake with the diet
of an adult.

3. How to use Vitamina C Bayer

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is: 1 vial of 1 g per day by subcutaneous (under the skin), intramuscular
(into the muscle) or intravenous (into the vein) administration.
Do not exceed the dose of 1 g (1 vial) per day.

Instructions for use:

Use in children and adolescents
Vitamina C Bayer is contraindicated in children under 12 years of age (see “Do not use Vitamina C
Bayer”).

If you use more Vitamina C Bayer than you should
General symptoms of a Vitamina C overdose may include gastrointestinal
disorders such as diarrhea, nausea and vomiting.
If you take an excessive dose of Vitamina C, the following may occur:

• damage to blood cells (oxidative hemolysis), especially if you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase;
• blood clotting inside arteries and veins (disseminated intravascular coagulation);
• increased levels of substances called oxalates in the blood and urine, with the risk of their accumulation and predisposition to the formation of crystals (especially if you periodically undergo dialysis to purify the blood), which can cause tubulointerstitial nephropathy (syndrome characterized by renal failure) and acute renal failure (reduction of kidney function);
• accumulation of a substance called calcium oxalate in the kidneys with severe damage, such as acute tubular necrosis and/or renal failure.

If you experience these symptoms, stop taking the medicine and consult your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The adverse reactions listed below are derived from spontaneous reports and it is therefore not possible
to define their frequency.

Effects on the gastrointestinal system

• diarrhoea
• nausea
• vomiting
• stomach ache (abdominal pain)
• digestive problems (dyspepsia).

Effects on the immune system
Allergic and anaphylactic reactions with their related clinical manifestations:

• breathing problems (asthmatic syndrome);
• skin conditions: rashes, urticaria (itching and small spots on the skin), oedema, angioedema (swelling of the face and mucous membranes), itching;
• cardio-respiratory distress;
• severe reactions such as anaphylactic shock.

Effects localized to the site of administration

• reactions at the injection and infusion site.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Vitamina C Bayer

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month. The expiry date indicated refers to the
product in intact packaging, correctly stored.
Do not store at a temperature above 25°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 Vitamina C Bayer contains

• The active ingredient is ascorbic acid (vitamin C). One 5 ml vial contains 1 g of ascorbic acid. The other ingredients are: methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium hydroxide, water for injections.

Description of the appearance of Vitamina C Bayer and contents of the pack
Vitamina C Bayer is presented as an injectable solution.
Vitamina C Bayer 1 g/5 ml injectable solution: pack of 3 vials of 5 ml for administration
subcutaneously/intramuscularly/intravenously.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bayer S.p.A.- Viale Certosa 130, 20156 Milan.

Manufacturer:
Cenexi S.A.S. - Fontenay-sous-Bois (France) manufacturing site.