OPTOVITE B12 1000 micrograms Injectable Solution

Introduction

Leaflet: information for the user

Optovite B121,000 micrograms injectable solution

Cyanocobalamin

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

• Keep this 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 not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Optovite B12 1,000 micrograms is and what it is used for
2. What you need to know before taking Optovite B12 1,000 micrograms
3. How to take Optovite B12 1,000 micrograms
4. Possible side effects
5. Storage of Optovite B12 1,000 micrograms
6. Package contents and additional information

1. What Optovite B12 1,000 micrograms is and what it is used for

Optovite B12 is a vitamin, the active ingredient is cyanocobalamin. It is a clear red injectable solution.

This medication is indicated in states of vitamin B12 deficiency such as: pernicious anemia (reduction in the number of red blood cells due to vitamin B12 deficiency), pregnancy, malabsorption syndrome (difficulty in digesting nutrients from food that may be accompanied by diarrhea and colic), sprue (inflammation of the small intestine due to intolerance to gluten and other grains, causing diarrhea), regional enteritis (chronic inflammation of the digestive tract, small intestine, and colon), intestinal or pancreatic neoplasms (tumors), total or partial gastrectomy (removal of all or part of the stomach), and other conditions where there is a significant increase in the requirements of this vitamin. It is indicated in vegetarians. It is also indicated in diabetic and alcoholic polyneuritis (nerve damage due to diabetes mellitus) and trigeminal neuralgia (severe facial pain) or painful tics. Vitamin B12 is effective in allergic diseases (itching and skin peeling), and it has also been used in certain arthritic processes (joint degeneration) resistant to usual medications.

2. What you need to know before taking Optovite B12 1,000 micrograms

Do not use Optovite B12

If you are allergic (hypersensitive) to cobalt and/or vitamin B12.

Warnings and precautions

• If you have a predisposition to gout (joint pain due to elevated uric acid), cyanocobalamin may precipitate a gout crisis.
• If you have tabetic amblyopia (dim vision due to tobacco consumption) or hereditary optic nerve atrophy (Leber's disease), as they may worsen with cyanocobalamin administration.
• If you have been treated for megaloblastic anemia (reduction in the number of red blood cells with an increase in their size) and it is reversing, a decrease in blood potassium levels may occur, which can be fatal. This can also occur during the initial treatment of pernicious anemia.
• If you are sensitive to this vitamin, anaphylactic shock (acute allergic reaction) may occur after parenteral administration.
• If you take folic acid instead of cyanocobalamin, folic acid will resolve the anemia but not the neurological disorders.

The vitamin B12 deficiency must be confirmed before starting treatment because it could mask symptoms of spinal cord degeneration.

Consult your doctor, even if any of the above circumstances have occurred to you at any time.

Using Optovite B12with other medications

Tell your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription. Some medications may influence the action of others.

It is not recommended to administer with the following medications:

• Chloramphenicol and other bone marrow depressors: may decrease the effect of vitamin B12.
• Oral neomycin, colchicine, aminosalicylic acid, H2 histamine receptor antagonists: may decrease the oral absorption of vitamin B12.
• Oral contraceptives: may decrease serum vitamin B12 concentrations.
• Most antibiotics, methotrexate, and primethamine may invalidate folic acid and cyanocobalamin values in blood tests.

Pregnancy, breastfeeding, and fertility

Pregnancy

Consult your doctor or pharmacist before using any medication. Vitamin B12 can be administered to pregnant women when necessary. A daily dose of 4 micrograms is recommended.

Breastfeeding

Consult your doctor or pharmacist before using any medication. Vitamin B12 is excreted in breast milk, but its use is compatible with breastfeeding, and even recommended when the amount that passes to the infant is insufficient. The recommended dose for infants is 0.5-3 micrograms/day.

Driving and using machines

There is no evidence of effects on the ability to drive vehicles or use machines.

Optovite B12 contains sodium chloride: This medication contains less than 23 mg (1 mmol) of sodium per dose; therefore, it is considered essentially "sodium-free".

3. How to take Optovite B12 1,000 micrograms

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Your doctor will indicate the appropriate dose and duration of your treatment with Optovite B12. Do not stop treatment before.

If you think the action of this medication is too strong or too weak, tell your doctor or pharmacist.

Cyanocobalamin is administered by intramuscular routeand by deep subcutaneous routein case of gastrectomized patients. In both cases, the administration schedule is 1,000 micrograms/day for 1 week at the beginning of treatment, 1,000 micrograms/week for the next 4-8 weeks, and 1,000 micrograms/month as a maintenance dose.

In the case of patients who do not tolerate the intramuscular route (hemophiliacs), consult your doctor for oral administration. In these cases, the normal dose is 500 to 1,000 micrograms/day.

Intravenous administration is not recommended, although in exceptional cases (such as extreme thrombocytopenia) cyanocobalamin may be administered by this route.

If you take more Optovite B12than you should

Consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Phone 915 620 420, indicating the medication and the amount used.

If you forget to take Optovite B12

You should not take a double dose to make up for forgotten doses.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Optovite B12 can cause side effects, although not everyone will experience them.

In exceptional cases, the following side effects have been observed:

• Blood and lymphatic system disorders: polycythemia vera. At the start of treatment, cases of peripheral vascular thrombosis have been described.
• Immune system disorders: anaphylactic shock and death.
• Metabolism and nutrition disorders: hypokalemia.
• Eye disorders: optic nerve atrophy.
• Cardiac disorders: at the start of treatment, cases of congestive heart failure have occurred.

• Respiratory, thoracic, and mediastinal disorders: at the start of treatment, cases of pulmonary edema have occurred.
• Gastrointestinal disorders: mild transient diarrhea.
• Skin and subcutaneous tissue disorders: pruritus, transient exanthema, urticaria.
• General disorders and administration site conditions: pain at the injection site, feeling of inflammation throughout the body.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

If you observe any of these reactions or any other reaction not described in this leaflet, consult your doctor or pharmacist.

5. Storage of Optovite B12 1,000 micrograms

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use Optovite B12 after the expiration date shown 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 in the pharmacy's SIGRE point. If in 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 Optovite B121,000 micrograms

The active ingredient is cyanocobalamin. Each ampoule contains 1,000 micrograms of cyanocobalamin.

The other components are: sodium chloride and water for injectable preparations.

Appearance of the product and package contents

Clear red injectable solution, presented in a package containing 5 ampoules of 2 ml each.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last revision of this leaflet:December 2004

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

Information for healthcare professionals

Intramuscular injection will be performed in a large muscle mass.

Intravenous administration is exceptional and will be performed by diluting small amounts of cyanocobalamin in a parenteral administration solution. Administration of large amounts of cyanocobalamin would result in almost total loss through urine.