Hydroxocobalamin Basi 1 mg/ml solution for injection

Package leaflet: Information for the user

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

Contents of this leaflet

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

2. What you need to know before using Hydroxocobalamin Basi

3. How to use Hydroxocobalamin Basi

4. Possible side effects

   1. How to store Hydroxocobalamin Basi

5. Contents of the pack and other information

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

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

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

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

Do not use Hydroxocobalamin Basi

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

If this applies to you, consult your doctor, pharmacist, or nurse.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Hydroxocobalamin Basi.

Consult your doctor if:

• you are pregnant, planning to become pregnant, or breastfeeding;
• you have megaloblastic anemia, a blood disorder characterized by the presence of abnormally large blood cells.

Other medicines and Hydroxocobalamin Basi

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

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

• 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 measuring vitamin B12 levels in blood or urine;
• An antibiotic called chloramphenicol, which may reduce the effect of Hydroxocobalamin Basi;
• Oral contraceptives.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist 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 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 operate machinery. However, some people may feel dizzy or drowsy when receiving hydroxocobalamin treatment. If this occurs, do not drive or operate machinery.

Hydroxocobalamin Basi contains sodium

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

3. How to use Hidroxocobalamina Basi

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Hidroxocobalamina Basi will be administered to you by means of an intramuscular injection. Your doctor will choose the appropriate dose for you. This medicine may be given only once or repeated every two days, weekly, or monthly, depending on your body's needs.

Recommended doses in severe cases, administered by deep intramuscular injection, are as follows:

Adults and Children

• Treatment of anemia:

• Without neurological involvement (nervous system):

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

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

• With neurological involvement:

1,000 micrograms (1 vial) every two days while improvement is observed.

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

• Prevention of anemia:

1,000 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 scored mark facing upwards;
2. Place the index finger of your other hand on the top of the vial. Place your thumb over the scored mark;
3. With your index fingers close together, press on the area of the scored mark to open the vial.

Medical examinations

While you are receiving treatment with this medicine, your doctor will want you to have periodic blood tests. This is to ensure that the medicine is working properly and that the dose you are receiving is appropriate for you.

If you use more Hidroxocobalamina Basi than you should

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

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop using Hydroxocobalamin 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 spreads over the entire body.

Other adverse effects

Frequency not known: cannot be estimated from available data

• Low blood potassium levels and irregular heartbeat during the initial stages of treatment;

• Thrombocytosis (elevated number of platelets in blood);

• Rash;

• Blisters;

• Pain at injection site;

• Hardening of the skin at injection site;

• Necrosis (destruction of the skin) around the injection site;

• Muscle cramps;

• Feeling unwell or ill;

• Malaise;

• Diarrhea;

• Pink or red-colored urine;

• Dizziness;

• Headache;

• Tremor;

• Fever;

• Chills;

• Hot flushes;

• Pain.

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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 stated on the container and on the ampoule label after EXP. The expiry date refers to the last day of the month indicated.

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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Hidroxocobalamina Basi

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

Appearance of the product and contents of the pack

Hidroxocobalamina Basi is a clear red solution, free from visible particles, supplied in glass ampoules. Pack sizes: 5 and 10 ampoules of 1 ml.

Only some 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

E-mail: [email protected]

Manufacturer

Laboratórios Basi - Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 and 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 medicinal product is authorised in the European Economic Area countries 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 latest revision of this leaflet: January 2023

Other sources of information

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