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. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

fever, chills, fatigue and viral symptoms
cough, sore throat, nasal congestion, breathing discomfort
bronchitis and mild asthma flare-ups
nausea, diarrhoea, abdominal pain, digestive infections
rashes, allergic reactions, redness, insect bites
muscle or joint pain, mild injuries, sprains
headache, dizziness, migraine symptoms
stress-related symptoms, sleep disturbances
questions about test results and treatment plans
management of chronic conditions in stable phases

Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

Advanced Trauma Life Support (ATLS)
Basic and Advanced Cardiac Life Support (BLS/ACLS)
Pediatric Advanced Life Support (PALS)
Prehospital Trauma Life Support (PHTLS)
eFAST and critical care transthoracic echocardiography
aviation medicine

He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.

HYDROXOCOBALAMIN BASE 1 mg/ml INJECTABLE SOLUTION

Tarek Agami

Nuno Tavares Lopes

Tarek Agami

Nuno Tavares Lopes