Label: information for the user

Optovite B121,000 micrograms injectable solution

Cyanocobalamin

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 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.

1. What is Optovite B121,000 micrograms and for what it is used

2. What you need to know before starting to use Optovite B121,000 micrograms

3. How to use Optovite B121,000 micrograms

4. Possible adverse effects

5. Storage of Optovite B121,000 micrograms

6. Contents of the package and additional information

Optovite B12is a vitamin, the active principle is cianocobalamina. It is a red and transparent injectable solution.

This medication is indicated in vitamin B12 deficiency states such as: pernicious anemia (decrease 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 cramps), sprue (inflammation of the small intestine due to intolerance to gluten and other grains, causing diarrhea), regional enteritis (chronic inflammation of the digestive tube, small intestine, and colon), intestinal or pancreatic neoplasms (tumors), total or partial gastrectomy (removal of all or part of the stomach), and other states in which there is a significant increase in the requirements of this vitamin. It is indicated in vegetarians. It is also indicated in diabetic (caused by diabetes mellitus) and alcoholic polyneuritis (affection of the nervous system), trigeminal neuralgias (intense facial pain) or painful tics. Vitamin B12 is effective in allergic diseases (itching and skin peeling), it has also been used in certain resistant arthritic processes (degeneration of the joints).

No 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 levels), cyanocobalamin may precipitate a gout crisis.

- If you have tobacco amblyopia (dark vision due to tobacco consumption) or hereditary optic nerve atrophy (Leber's disease), as they may worsen with the administration of cyanocobalamin.

- If you have been treated for megaloblastic anemia (decreased red blood cell count with increased cell size) and it is reversing, a decrease in serum 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.

Vitamin B12deficiency should be confirmed before starting treatment, as it may mask symptoms of spinal cord degeneration.

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

Use of Optovite B12with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription. Some medications may interact with each other.

Do not administer with the following medications:

- Chloramphenicol and other bone marrow depressants: may decrease the effect of vitamin B12.

- Oral neomycin, colchicine, salicylic acid, H2receptor antagonists: may decrease oral absorption of vitamin B12.

- Oral contraceptives: may decrease serum concentrations of vitamin B12.

- Most antibiotics, methotrexate, and primethamine may invalidate folic acid and cyanocobalamin values in blood tests.

Pregnancy, lactation, and fertility

Pregnancy

Consult your doctor or pharmacist before using any medication. Vitamin B12can be administered to pregnant women as needed. A daily dose of 4 micrograms is recommended.

Lactation

Consult your doctor or pharmacist before using any medication. Vitamin B12is excreted in breast milk, but its use is compatible with breastfeeding, and even recommended when the amount passed to the infant is insufficient. The recommended dose for infants is 0.5-3 micrograms/day.

Driving and operating machinery

No evidence of effects on the ability to drive vehicles or operate machines.

Optovite B12contains sodium chloride: This medication contains less than 23 mg (1 mmol) of sodium per dose; therefore, it is considered essentially "sodium-free".

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

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

Cyanocobalamin is administered by intramuscular route and by deep subcutaneous route in the case of patients who have undergone gastrectomy. In both cases, the administration schedule is 1,000 micrograms/day for the first week of treatment, 1,000 micrograms/week for the following 4-8 weeks, and 1,000 micrograms/month as 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.

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

If you take more Optovite B12 than you should

Consult your doctor or pharmacist immediately.

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

If you forgot to take Optovite B12

Do not administer a double dose to compensate for the missed doses.

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

Like all medications, Optovite B12may cause adverse effects, although not everyone will experience them.

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

- Blood and lymphatic system disorders: polycythemia vera. At the beginning of treatment, cases of peripheral vascular thrombosis have been described.

- Immunological system disorders:anaphylactic shock and death.

- Metabolism and nutrition disorders:hypokalemia.

- Eye disorders: optic nerve atrophy.

- Cardiac disorders:at the beginning of treatment, cases ofcongestive heart failure

have been reported.

- Respiratory, thoracic, and mediastinal disorders: at the beginning of treatment, cases of pulmonary edema have been reported.

- Gastrointestinal disorders: mild transient diarrhea.

- Skin and subcutaneous tissue disorders: pruritus, transient rash, urticaria.

- General disorders and administration site conditions: pain at the injection site, feeling of inflammation throughout the body.

Reporting of Adverse Effects:

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

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use Optovite B12after 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 medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Optovite B121.000 micrograms

The active principle is cianocobalamina. Each ampoule contains 1.000 micrograms of cianocobalamina.

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

Appearance of the product and contents of the packaging

Red, transparent injectable solution, presented in packaging containing 5 ampoules of 2 ml each.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

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

Date of the last review of this leaflet:December 2004

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

Information for healthcare professionals

The intramuscular injection will be performed in a wide muscle mass.

The intravenous administration is exceptional, and will be performed by diluting small amounts of cianocobalamina in a parenteral administration solution. The administration of large amounts of cianocobalamina would result in a nearly total loss through urine.