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The product code(s) for this leaflet is: PL 12762/0008.
Hydroxocobalamin 1mg/ml Solution for Injection
Hydroxocobalamin 1mg/ml Solution for Injection
hydroxocobalamin acetate
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.
The name of your medicine is Hydroxocobalamin 1mg/ml Solution for Injection. It will be referred to as Hydroxocobalamin Injection for ease of use hereafter.
1. What Hydroxocobalamin Injection is and what it is used for
2. What you need to know before you are given Hydroxocobalamin injection
3. How Hydroxocobalamin injection is given to you
4. Possible side effects
5. How to store Hydroxocobalamin injection
6. Contents of the pack and other information
This medicine contains Hydroxocobalamin which is a form of Vitamin B12. Vitamin B12 contains cobalt. Hydroxocobalamin is given for:
Vitamin B12 is needed for physical growth and development and for the formation of red blood cells in the bone marrow. It is also required for absorption of folic acid and carbohydrates from food and for keeping the nerve (neurological) system healthy.
The body only requires a small amount of the vitamin daily so a deficiency may take months or even years to develop. Eventually, the formation of abnormally large red blood cells (macrocytes) with reduced ability to carry oxygen from enlarged cells (megaloblasts) in the bone marrow, gives rise to anaemia. Symptoms of Vitamin B12 deficiency anaemia include sore mouth and tongue, numbness and tingling in the arms and legs, memory loss and depression.
Tell your doctor, pharmacist or nurse before you are given Hydroxocobalamin injection:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Hydroxocobalamin injection can interfere with the action of some other drugs and some drugs can have an effect on Hydroxocobalamin injection. The following drugs can cause some problems when taken together with Hydroxocobalamin Injection:
The following medicines do not alter the effectiveness of Hydroxocobalamin Injection but make it more difficult to measure the amount of Vitamin B12 in the body:
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 taking this medicine.
Pregnancy
Hydroxocobalamin injection should not be used for the treatment of megaloblastic anaemia of pregnancy.
Breast feeding
If you are breast feeding you should tell your doctor before you are given this medicine.
Hydroxocobalamin injection passes into the breast milk but is unlikely affect your baby.
Fertility
No data available
Your medicine is unlikely to affect your ability to drive or to operate machinery. However, some people may feel dizzy or drowsy when given Hydroxocobalamin injection. If this happens to you, do not drive or operate machinery.
Hydroxocobalamin injection contains less than 1mmol (23mg) of sodium per 2ml , that is to say essentially ‘sodium-free’.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Hydroxocobalamin will be given to you by injection into a muscle. The dose depends on your individual needs and responses to treatment. Your blood levels of Vitamin B12 and folic acid are likely to be monitored both before and during treatment. If you have doubts about the treatment or want more information about your medicine or the monitoring procedure, do ask the doctor or nurse.
The recommended dose is
Adults and Children
Initial dose: This varies between 250 mcg and 1mg given daily or on alternative days. The actual dosage depends on your specific illness and your response to treatment.
Maintenance dose: Your doctor will check your condition regularly. When he/she feels that your health has improved sufficiently, your dose of Hydroxocobalamin Injection will be reduced to 1mg every 2-3 months or as required.
Being given more than the intended dose of hydroxocobalamin injection is unlikely to cause a problem requiring treatment.
Tell the doctor if you are experiencing any side effects or think you may be reacting badly so that he/she can give appropriate treatment.
If you have already left the medical premises, contact your nearest hospital, doctor or nurse.
It is unlikely that you will miss a dose as your doctor or nurse will be giving it to you. However, it is important not to have a double dose if you have missed one. Ask your doctor or nurse when you should have the next dose.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines this medicine, can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of the following symptoms after you have been given the injection. Although they are very rare, these symptoms can be serious.
Rare: may affect up to 1 in 1,000 people
Not known: frequency cannot be estimated from the available data
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
By reporting side effects you can help provide more information on the safety of this medicine.
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 label and carton after “EXP”. The expiry date refers to the last day of that month.
Do not store above 25°C. Keep the ampoule in the outer carton in order to protect from light.
If only part used, discard the remaining solution.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is Hydroxocobalamin.
The other ingredients are sodium chloride, glacial acetic acid in water for injections.
Hydroxocobalamin injection is a sterile solution for injection.
Each glass ampoule contains 1ml of solution, which contains the active ingredient hydroxocobalamin acetate (equivalent to hydroxocobalamin 1mg in 1ml sterile solution). Each carton contains five 1ml ampoules.
This leaflet was last revised in January 2024.