Label: information for the user

Ascorbic Acid Bayer 1000 mg/5 ml injectable solution

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label.See section 4.

This medication containsascorbic acid (vitamin C), whichbelongs to the group of water-soluble vitamins.This vitamin is important, among other functions, for the formation of collagen and intercellular material (between cells) and is antioxidant.

This medication is indicated for the treatment of severe vitamin C deficiency states, when oral administration is not feasible or in cases of absorption disorders, in adults and adolescents 14 years and older.

Do not use Bayer Ascorbic Acid

• If you are allergic to ascorbic acid or any of the other components of this medication (listed in section 6).
• If you have kidney stones or a history of kidney stones (formation of stones in the kidneys).
• If you have hyperoxaluria (increased rate of oxalic acid in the urine).
• If you have severe kidney disease.
• If you have hemochromatosis (presence of too much iron in the body).

Warnings and precautions

Consult your doctor before starting to use Bayer Ascorbic Acid.

• This medication should not be administered in higher doses or for a longer period than recommended in section 3, as long-term use of high doses may be harmful.How to use Bayer Ascorbic Acid.
• If you have any kidney disease, high doses of this medication may damage you.
• If you have or have had kidney stones or gout (deposits of uric acid in the joints, especially in the feet), you should be cautious as they may recur.
• If you have a deficiency of glucose-6-phosphate dehydrogenase (hereditary alteration of red blood cell metabolism), hemolysis (destruction of red blood cells) may occur.
• Patients with sickle cell anemia (hereditary disease affecting the shape of red blood cells) should be cautious, as they may experience a crisis.
• If you are being treated with anticoagulants, see the sectionUse of Bayer Ascorbic Acid with other medications.
• If you have any condition with iron overload (elevated iron levels in the blood), the consumption of this medication may harm you.

Interference with diagnostic tests:If you are to undergo any diagnostic test (including blood, urine, etc. tests), inform your doctor that you are using this medication, as it may alter the results.

Children and adolescents

Do not administer this medication to children under 14 years due to lack of data on its use in this population.

Use of Bayer Ascorbic Acid with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Bayer Ascorbic Acid may interact with the following medications:

• Deferoxamine (medication used for iron intoxication or overload)
• Indinavir (for the treatment of HIV or AIDS infection)
• Cyanocobalamin (vitamin B12): may decrease its levels
• Oral anticoagulant medicationssuch as acenocoumarol and warfarin(for blood circulation)
• Ciclosporin (medication used to prevent transplant rejection)
• Disulfiram (medication used to treat chronic alcoholism)
• Iron (medication used to treat iron deficiency)

The administration of ascorbic acid, especially in high doses, may facilitate or delay the elimination of some medications.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

As a precaution, Bayer Ascorbic Acid injectable solution should not be used during pregnancy or lactation.

Driving and operating machinery

This medicationhas no or insignificant effect onthe ability to drive or operate machinery.

Bayer Ascorbic Acid contains sodium

This medication contains 130.5 mg of sodium (main component of table salt/for cooking) in each ampule. This is equivalent to 6.5% of the recommended daily maximum sodium intake for an adult.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

The recommended dose is:

By intravenous route

Adults and adolescents 14 years and older:1 vial per day.

Do not exceed this dose (1000 mg of vitamin C per day).

By intravenous route.

This medication should only be administered by qualified healthcare personnel. The administration of the product and the handling of needles should be done with caution.

Use in children and adolescents

Do not use in children under 14 years old due to lack of safety data.

If you use more Bayer Ascorbic Acid than you should

Prolonged use of large doses of ascorbic acid can be harmful.

If you have been administered more Bayer Ascorbic Acid than you should, that is, excessive doses of ascorbic acid, the following may occur: kidney stones, elevated blood glucose, urinary tract irritation, acute gout attack; large doses of ascorbic acid may cause hemolysis (destruction of red blood cells) in patients with glucose-6-phosphate dehydrogenase deficiency (hereditary alteration).

Other disorders are gastrointestinal, such as: diarrhea or constipation, nausea, vomiting, abdominal cramps or colic.

If these symptoms appear, stop taking the medication immediately and consult a healthcare professional.

The treatment will be symptomatic, and the administration of this medication should be discontinued.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, Teléfono 91 562 04 20, indicating the medication and the amount taken (or go to a medical center).

Like all medications, Bayer Ascorbic Acid injectable can produce adverse effects, although not all people may experience them.

During the period of use of the active ingredient of this medication, the following adverse reactions have been reported, especially at doses higher than those recommended, whose frequency has not been established with precision:

• There have been reports of hypersensitivity reactions, with laboratory and clinical manifestations, including allergic asthma syndrome, mild to moderate reactions that could affect the skin, respiratory system, digestive tract, and cardiovascular system, including symptoms such as rash, urticaria (red itchy rash), allergic edema, and angioedema (rapid swelling under the skin, especially on the face and in the mouth), itching, cardio-respiratory difficulty, and, very rarely, severe reactions, including anaphylactic shock (severe generalized allergic reaction).
• The administration of ascorbic acid in individuals predisposed to an increase in the formation of stones (those who have a higher risk are those with renal alteration), has been associated with the production of stones or precipitation of medications in the urinary tract.
• Reactions at the injection site, such as redness; rapid intravenous administration may cause transient dizziness or dizziness.
• In predisposed patients, gouty arthritis (deposition of uric acid in the joints) could be produced.
• Headache, insomnia.
• There have been describedtdigestive disturbances such as diarrhea, nausea, vomiting, abdominal and gastrointestinal pain, with oral ascorbic acid.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, Website:www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

No special storage conditions are required.

Keep this medication out of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the pharmacy's Sigre Point. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Bayer Ascórbico Solution for Injection

- The active ingredient is Ascorbic Acid (Vitamin C). Each 5 ml ampoule contains 1,000 mg of ascorbic acid.

- The other components (excipients) are: Sodium Hydroxide and Water for Injection.

Appearance of the product and contents of the packaging:

This medicine is presented in the form of a solution for injection; it is a clear, yellowish liquid. It is presented in containers that contain 3 or 6 glass ampoules.

Not all packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

BAYER HISPANIA, S.L.

Av. Baix Llobregat, 3 – 5

08970 Sant Joan Despí (Barcelona)

Responsible for manufacturing

Doppel Farmaceutici S.R.L.

Via Volturno, 48

20089 Quinto de’Stampi, MI (Italy)

Date of the last review of this leaflet:November 2015

The detailed and updated information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/