This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use HYDROXOCOBALAMIN BASE 1 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Hydroxocobalamin Basi 1 mg/ml Solution for Injection

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet, you may need to read it again.
If you have any further questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

What is Hydroxocobalamin Basi and what is it used for
What you need to know before you use Hydroxocobalamin Basi
How to use Hydroxocobalamin Basi
Possible side effects
1. Storage of Hydroxocobalamin Basi

Contents of the Pack and Further Information

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

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

Hydroxocobalamin Basi is used to prevent and treat certain types of anemia, including Addison's pernicious anemia and other types of anemia resulting from a vitamin B12 deficiency.

2. What you need to know before you use Hydroxocobalamin Basi

Do not use Hydroxocobalamin Basi

if you are allergic to hydroxocobalamin or any of the other ingredients of this medicine (listed in section 6).

If any of the above applies to you, talk to your doctor, pharmacist, or nurse.

Warnings and Precautions

Talk to your doctor, pharmacist, or nurse before you start using Hydroxocobalamin Basi.

Talk to your doctor if:

you are pregnant, plan to become pregnant, or are breast-feeding;
you have megaloblastic anemia, a blood disorder characterized by the presence of abnormally large red blood cells.

Other Medicines and Hydroxocobalamin Basi

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor if you are taking any of the following medicines:

Antibiotics (for infection treatment) 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;
An antibiotic called chloramphenicol, as it may reduce the effect of Hydroxocobalamin Basi;
Oral contraceptives.

Pregnancy and Breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

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

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

Driving and Using Machines

It is unlikely that this medicine will affect your ability to drive or use machines. However, some people may feel dizzy or drowsy when receiving treatment with hydroxocobalamin. If this happens, do not drive or use machines.

Hydroxocobalamin Basi contains Sodium

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

3. How to use Hydroxocobalamin Basi

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, talk to your doctor or pharmacist again.

You will be given Hydroxocobalamin Basi by injection into a muscle. Your doctor will choose the right dose for you. This medicine may be given once or may be repeated every two days, weekly, or monthly, depending on how much your body needs.

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

Adults and Children

Treatment of anemia:

Without neurological symptoms (nervous system):

Initially 250 – 1,000 micrograms, every two days for 1 to 2 weeks, then 250 micrograms weekly until blood tests are normal.

Maintenance dose: 1,000 micrograms (1 ampoule) every 2 to 3 months.

With neurological symptoms:

1,000 micrograms (1 ampoule) every two days until improvement is seen.

Maintenance dose: 1,000 micrograms (1 ampoule) every 2 months.

Prevention of anemia:

1,000 micrograms (1 ampoule) every 2 to 3 months.

Instructions for Opening the Ampoule:

Hold the body of the ampoule between your thumb and index finger, with the point facing upwards;
Place the index finger of your other hand holding the top part of the ampoule. Place your thumb over the point;
With your index fingers close together, press the area of the point to open the ampoule.

Sequence of three steps showing a hand holding and manipulating an auto-injector with a protective cap

Medical Exams

While you are being treated with this medicine, your doctor will want you to have blood tests done periodically. This is to make sure the medicine is working correctly and that the dose you are receiving is right 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 unwell or experience side effects, you should talk to your doctor.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, stating the medicine and the amount ingested.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using Hydroxocobalamin Basi and tell your doctor immediately 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 whole body.

Other Side Effects

Frequency not known: cannot be estimated from the available data

Low potassium levels in the blood and irregular heartbeat during the initial stages of treatment;
Thrombocytosis (high 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;
Hives;

Feeling unwell or sick;
Being sick;
Diarrhea;
Urinating pink or red-colored urine;

Dizziness;
Headache;
Tremor;

Fever;
Chills;
Flushing;
Pain.

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Hydroxocobalamin Basi

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

Do not use this medicine after the expiry date which is stated on the packaging and on the ampoule label after EXP. The expiry date is the last day of the month stated.

Do not store above 25°C.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Hydroxocobalamin Basi

The active substance is hydroxocobalamin. Each 1 ml ampoule contains hydroxocobalamin chloride equivalent to 1,000 micrograms of hydroxocobalamin.
The other ingredients (excipients) are sodium chloride, glacial acetic acid, and water for injections.

Appearance and Pack Size of the Product

Hydroxocobalamin Basi is a clear red solution, free from visible particles, presented in glass ampoules. Pack size: 5 and 10 ampoules of 1 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

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

Email: [email protected]

Manufacturer

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 under the following names:

Portugal: Hidroxocobalamina Basi

Ireland: Hydroxocobalamin Basi 1000 microgram/ml solution for injection

Norway: Hydroxocobalamin Basi

Spain: Hidroxocobalamina Basi 1 mg/ml solution for injection

Date of the last revision of this leaflet: January 2023

Other Sources of Information

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

12+ years of clinical experience in university hospitals in Germany and Spain.
International education: Ukraine – Germany – Spain.
Member of the German Society of Surgeons (BDC).
Certified in radiological diagnostics and robotic surgery.
Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

HYDROXOCOBALAMIN BASE 1 mg/ml INJECTABLE SOLUTION

Jonathan Marshall Ben Ami

Andrei Popov

Jonathan Marshall Ben Ami

Andrei Popov