Prospecto: information for the user

Hidroxocobalamina Basi 1 mg/ml injectable solution

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

1.What is Hidroxocobalamina Basi and for what it is used

2.What you need to know before starting to use Hidroxocobalamina Basi

3.How to use Hidroxocobalamina Basi

4.Possible adverse effects

1. Storage of Hidroxocobalamina Basi

6.Contents of the package and additional information

Hydroxocobalamin Base is a form of Vitamin B12, an essential vitamin that is necessary for the production of red blood cells.

Hydroxocobalamin Base is used to prevent and treat certain types of anemia, including Addisonian pernicious anemia and other types of anemia resulting from a deficiency of Vitamin B12.

No use Hidroxocobalamina Basi

-if you are allergic to hydroxocobalamin or any of the other components of this medication (listed in section 6).

Consult your doctor, pharmacist, or nurse if this occurs.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Hydroxocobalamina Basi.

Consult your doctor if:

-you are pregnant, intend to become pregnant, or are breastfeeding;

-you have megaloblastic anemia. A hematological disorder characterized by the presence of abnormally large blood cells.

Other medications and Hydroxocobalamina Basi

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Particularly, inform your doctor if you are taking any of the following medications:

-Antibiotics (for the treatment of infections) or antimetabolites (medicines that stop cell division, such as mercaptopurine for leukemia), as these treatments may interfere with tests to measure vitamin B12 levels in blood or urine;

-A antibiotic called chloramphenicol, as it may reduce the effect of Hydroxocobalamina Basi;

-Oral contraceptives.

Pregnancy and lactation

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

Hydroxocobalamina Basi should not be used during pregnancy to treat a type of anemia called megaloblastic anemia, unless you also have a vitamin B12 deficiency.

Hydroxocobalamina Basi passes into breast milk, but it is unlikely to harm your baby.

Driving and operating machinery

It is unlikely that this medication will affect your ability to drive or operate machinery. However, some people may feel dizzy or drowsy when receiving treatment with hydroxocobalamin. In this case, do not drive or operate machinery.

Hydroxocobalamina Basi contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

You will be administered Hydroxocobalamin Basi through an injection into a muscle. Your doctor will choose the appropriate dose for you. This medication may be administered once or may be repeated every two days, weekly, or monthly, depending on how much your body needs.

The recommended doses in severe situations, by deep injection into a muscle, are as follows:

Adults and Children

• Treatment of anemia:

• Without neurological impairment (nervous system):

Initially 250 – 1000 micrograms, every two days for 1 to 2 weeks, then 250micrograms weekly until blood tests are normal.

Maintenance dose: 1000 micrograms (1 vial) every 2 to 3 months.

• With neurological impairment:

1000 micrograms (1 vial) every two days while improvement is noted.

Maintenance dose: 1000 micrograms (1 vial) every 2 months.

• Prevention of anemia:

1000 micrograms (1 vial) every 2 to 3 months.

Instructions for opening the vial:

1. Hold the body of the vial between your thumb and index finger, with the point upwards;

2. Place the index finger of the other hand holding the top of the vial. Place your thumb on the point;

3. With your index fingers close together, press the area of the point to open the vial.

Medical Exams

While you are being treated with this medication, your doctor will want you to have blood tests periodically. This is to ensure that the medication is working correctly and that the dose you are receiving is the appropriate one for you.

If you use more Hydroxocobalamin Basi than you should

If you think you have used too much Hydroxocobalamin Basi, it is unlikely that you will need special treatment. However, if you feel any discomfort or adverse effects, you should inform your doctor.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Stop using Hidroxocobalamina Basi and immediately inform your doctor if you experience any of the following symptoms:

• Difficulty breathing;
• Swelling of the eyelids, face, or lips;
• Rash or itching, especially if it covers the entire body.

Other Adverse Effects

Unknown Frequency: cannot be estimated from available data

• Low levels of potassium in the blood and irregular heartbeat during the initial stages of treatment;
• Thrombocytosis (elevated platelet count in the blood);

• Rash;
• Blisters;
• Pain at the injection site;
• Hardening of the skin at the injection site;
• Necrosis (skin destruction) around the injection site;
• Wheals;

• Feeling unwell or sick;
• Feeling indisposed;
• Diarrhea;
• Pink or red-colored urine;

• Dizziness;
• Headache;
• Tremor;

• Fever;
• Chills;
• Hot flashes;
• Pain.

Reporting 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 for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and on the ampule label after EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

The product should not be used if it is not a red transparent solution or if it contains visible particles.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the medications you no longer need. By doing so, you will help protect the environment.

Composition of Hydroxocobalamine Base

• The active ingredient is hydroxocobalamine. Each ampoule of 1 ml contains chloride of hydroxocobalamine equivalent to 1,000 micrograms of hydroxocobalamine.
• The other components (excipients) are sodium chloride, glacial acetic acid, and water for injectable preparations.

Appearance of the product and contents of the container

Hydroxocobalamine Base is a transparent, red-colored solution, free of visible particles, presented in glass ampoules. Container size: 5 and 10 ampoules of 1 ml.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization

Laboratórios Basi - Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lote 15

3450-232 Mortágua, Portugal

Tel.: +351 231 920 250

Fax: +351 231 921 055

E mail:[email protected]

Responsible for manufacturing

Laboratórios Basi - Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira Lotes 8, 15 e 16

3450-232 Mortágua

Portugal

Local representative

Laphysan SAU,

Calle Anabel Segura 11,

Complejo Empresarial Albatros, Edificio A, Planta 4, puerta D

28108 Alcobendas (Madrid)

This medicine is authorized in the member states of the European Economic Area with the following names:

Portugal: Hydroxocobalamine Base
Ireland: Hydroxocobalamin Basi 1000 microgram/ml solution for injection

Norway: Hydroxocobalamin Basi

Spain: Hydroxocobalamine Basi 1 mg/ml injectable solution

Last review date of this leaflet: January 2023

Other sources of information

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/