ASCORBIC ACID BAYER 1000 mg/5 ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Ascorbic Acid Bayer 1000 mg/5 ml Solution for Injection

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

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

Contents of the Package Leaflet:

1. What Ascorbic Acid Bayer Solution for Injection is and what it is used for
2. What you need to know before using Ascorbic Acid Bayer Solution for Injection
3. How to use Ascorbic Acid Bayer Solution for Injection
4. Possible side effects
5. Storage of Ascorbic Acid Bayer Solution for Injection
6. Package Contents and Additional Information

1. What Ascorbic Acid Bayer Solution for Injection is and what it is used for

This medication contains ascorbic acid (vitamin C), which belongs 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 an 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 from 14 years of age.

2. What you need to know before using Ascorbic Acid Bayer Solution for Injection

Do not use Ascorbic Acid Bayer

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

Warnings and Precautions

Consult your doctor before starting to use Ascorbic Acid Bayer.

• This medication should not be administered in higher doses or for longer than recommended in section 3. How to use Ascorbic Acid Bayer, as long-term use of high doses may be harmful.
• If you have kidney disease, high doses of this medication could harm you.
• If you have or have had kidney stones or gout (uric acid deposits 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 (a hereditary disorder of red blood cell metabolism), hemolysis (destruction of red blood cells) may occur.
• Patient with sickle cell anemia (a hereditary disease that affects the shape of red blood cells) should be cautious, as they may experience a crisis.
• If you are taking anticoagulants, see the section Use of Ascorbic Acid Bayer with other medications.
• If you have any condition with iron overload (high iron levels in the blood), taking this medication could harm you.

Interference with Laboratory Tests:

If you are going to have any diagnostic tests (including blood, urine, etc.), 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 of age due to lack of safety data.

Use of Ascorbic Acid Bayer with other medications

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

Ascorbic acid may interact with the following medications:

• Deferoxamine (medication used for iron poisoning or overload)
• Indinavir (for the treatment of HIV or AIDS infection)
• Cyanocobalamin (vitamin B12): may decrease its levels
• Oral anticoagulant medications such as acenocoumarol and warfarin (for blood circulation)
• Cyclosporine (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 enhance or delay the elimination of some medications.

Pregnancy, Breastfeeding, and Fertility

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

As a precautionary measure, Ascorbic Acid Bayer Solution for Injection should not be used during pregnancy or breastfeeding.

Driving and Using Machines

This medication has a negligible effect on the ability to drive or operate machinery.

Ascorbic Acid Bayer contains Sodium

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

3. How to use Ascorbic Acid Bayer Solution for Injection

Follow your doctor's instructions for administering this medication exactly. If in doubt, consult your doctor again.

The recommended dose is:

Intravenous route

Adults and adolescents from 14 years of age: 1 ampoule per day.

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

Intravenous route.

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

Use in Children and Adolescents

Do not use this medication in children under 14 years of age due to lack of safety data.

If you use more Ascorbic Acid Bayer than you should

Prolonged use of high doses of ascorbic acid may be harmful.

If you have been administered more Ascorbic Acid Bayer than you should, i.e., excessive doses of ascorbic acid, kidney stones, elevated blood glucose, urinary tract irritation, acute gout attack; high doses of ascorbic acid may cause hemolysis (destruction of red blood cells) in patients with glucose-6-phosphate dehydrogenase deficiency (a hereditary disorder of red blood cell metabolism).

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

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

Treatment will be symptomatic, and administration of this medication should be discontinued.

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

4. Possible Side Effects

Like all medications, Ascorbic Acid Bayer Solution for Injection may cause side effects, although not everyone 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 recommended, whose frequency could not be established with accuracy:

• There have been reports of hypersensitivity reactions, with laboratory and clinical manifestations, including allergic asthma syndrome, mild to moderate reactions that may affect the skin, respiratory system, digestive tract, and cardiovascular system, including symptoms such as rash, urticaria (redness with itching), allergic edema, and angioedema (rapid swelling under the skin, especially on the face and in the mouth), itching, cardio-respiratory difficulties, and, very rarely, severe reactions, including anaphylactic shock (severe generalized allergic reaction).
• The administration of ascorbic acid in individuals predisposed to increased stone formation (those with higher risk are those with kidney disorders) 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 fainting or dizziness.
• In predisposed patients, gouty arthritis (uric acid deposits in the joints) may occur.
• Headache, insomnia.
• Gastrointestinal disorders such as diarrhea, nausea, vomiting, abdominal pain, and gastrointestinal disorders have been described with oral ascorbic acid.

Reporting of Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use, Website: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ascorbic Acid Bayer Solution for Injection

No special storage conditions are required.

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

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the Sigre Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ascorbic Acid Bayer Solution for Injection

• The active ingredient is Ascorbic Acid (Vitamin C). Each 5 ml ampoule contains 1000 mg of ascorbic acid.
• The other components (excipients) are: Sodium hydroxide and water for injectable preparations.

Appearance of the Product and Package Contents:

This medication is presented as a solution for injection; it is a clear, yellowish liquid. It is presented in packages containing 3 or 6 glass ampoules.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

BAYER HISPANIA, S.L.

Av. Baix Llobregat, 3 – 5

08970 Sant Joan Despí (Barcelona)

Manufacturer

Doppel Farmaceutici S.R.L.

Via Volturno, 48

20089 Quinto de’Stampi, MI (Italy)

Date of the Last Revision of this Package Leaflet:November 2015

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/