Cobalin-H Injection

Patient Leaflet Updated 28-Oct-2024 | ADVANZ Pharma

Cobalin-H Injection

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

COBALIN-H® 1000 microgram/ml INJECTION

(hydroxocobalamin)

Read all of this leaflet carefully before you start taking 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.

The name of your medicine is Cobalin-H 1000 microgram/ml Injection, it will be referred to as Cobalin-H Injection throughout the PIL for ease hereafter.

What is in this leaflet:

1. What Cobalin-H Injection is and what it is used for
2. What you need to know before Cobalin-H Injection is given
3. How Cobalin-H Injection is given
4. Possible side effects
5. How to store Cobalin-H Injection
6. Contents of the pack and other information

1. WHAT COBALIN-H INJECTION IS AND WHAT IT IS USED FOR

This medicine contains hydroxocobalamin which is a form of Vitamin B12. Vitamin B12 contains cobalt. Hydroxocobalamin is given for:

  • Addisonian pernicious anaemia (caused when absorption of Vitamin B12 from the stomach is reduced).
  • Tobacco amblyopia (poor sight caused by toxins such as tobacco).
  • Leber’s atrophy (degeneration of the optic nerve resulting in loss of central vision).
  • Treatment/prevention of other macrocytic anaemias due to deficiency in vitamin B12.

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.

This injection is usually given to you by your doctor or someone else trained to give it to you.

2. WHAT YOU NEED TO KNOW BEFORE COBALIN-H INJECTION IS GIVEN
Do not use Cobalin-H Injection:
  • If you are allergic to active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions:

Talk to your doctor, pharmacist or nurse before you are given Cobalin-H Injection

  • If you are aware of abnormal heart beats, tell your doctor or nurse.
  • If, after several weeks’ treatment, you do not feel any improvement, discuss this with your doctor or nurse.
  • If you have a known cobalt allergy.

Other medicines and Cobalin-H Injection

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

Cobalin-H Injection can interfere with the action of some other drugs and some drugs can have an effect on Cobalin-H Injection. The following drugs can cause some problems when taken together with Cobalin-H Injection:

  • chloramphenicol (an antibiotic) can reduce the effects of Cobalin-H Injection.
  • oral contraceptives may reduce the blood levels of Cobalin-H Injection.

The following medicines do not alter the effectiveness of Cobalin-H Injection but make it more difficult to measure the amount of Vitamin B12 in the body:

  • antibiotics.
  • antimetabolites (used to treat tumours and blood disorders).

Pregnancy, breast feeding and fertility

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

Cobalin-H 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.

Cobalin-H Injection passes into the breast milk but is unlikely affect your baby.

Fertility

No data available

Driving and using machines

Your medicine is unlikely to affect your ability to drive or to operate machinery. However, some people may feel dizzy or drowsy when given Cobalin-H Injection. If this happens to you, do not drive or operate machinery.

Cobalin-H Injection contains sodium

Cobalin-H Injection contains less than 1mmol sodium (23 mg) per 1ml that is to say essentially ‘sodium-free’.

3. HOW COBALIN-H INJECTION IS GIVEN

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Cobalin-H Injection 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 microgram and 1000 microgram 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 Cobalin-H Injection will be reduced to 1mg every 2-3 months or as required.

If you use more Cobalin-H Injection than you should:

Being given more than the intended dose of hydroxocobalamin 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.

If you forget to take Cobalin-H injection:

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.

4. POSSIBLE SIDE EFFECTS

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.
  • swelling of the lips and face, difficulty in breathing, skin rash and redness (these may be symptoms of a serious allergic reaction)
  • irregular heartbeat (caused by low levels of potassium in the blood) during early stages of treatment.

Rare: may affect up to 1 in 1,000 people

  • Acniform and bullous eruptions (acne-like and blistery skin eruptions)

Not known: frequency cannot be estimated from the available data

  • Headache, dizziness
  • Nausea (feeling sick), vomiting, diarrhoea
  • Malaise (feeling unwell)
  • Rash, itching
  • Injection site reactions including injection site pain, injection site erythema, injection site pruritus, injection site induration, and injection site swelling (Reactions at the site of the injection)
  • Exanthema (a widespread skin rash)
  • Chromaturia (unusual coloured urine)
  • Fever
  • Hot flushes (a feeling of intense heat with sweating and rapid heartbeat)
  • Chills (feeling of coldness accompanied by shivering)
  • Paraesthesia (feeling of pins and needles)
  • Tremor (tremble or shakes)
  • Hypokalaemia (decreased potassium levels in the blood)
  • Reactive thrombocytosis (body produces too many platelets)

Reporting of side effects

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 at: www.mhra.gov.uk/yellowcard 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.

5. HOW TO STORE COBALIN-H INJECTION

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

Store below 25ºC and protect from light.

The product should not be used if it is not a clear red liquid or if it contains visible particles. Do not use this medicine after the expiry date which is stated on the ampoule and carton after “EXP”. The expiry date refers to the last day of that month.

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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Cobalin-H Injection contains

The active substance is: hydroxocobalamin 1000 microgram/ml.

The other ingredients are: sodium dihydrogen orthophosphate, sodium chloride and Water for Injections with sodium hydroxide and/or hydrochloric acid as pH adjusters.

The product is suitable for vegetarians and vegans.

What Cobalin-H Injection looks like and contents of the pack

The product is a clear red liquid, supplied in 5 clear glass vials. Each vial contains 1000 micrograms hydroxocobalamin.

Marketing Authorisation Holder
Amdipharm UK Limited
Dashwood House
69 Old Broad Street
London
EC2M 1QS
United Kingdom

(send all enquiries to this address).

Manufacturer
Mercury Pharmaceuticals Limited
Dashwood House
69 Old Broad Street
London
EC2M 1QS
United Kingdom

®Cobalin-H injection is a registered trade mark

PL 20072/0217

This leaflet was last revised in May 2024.

Company Contact Details
ADVANZ Pharma
Address

Dashwood House, 69 Old Broad Street, London, EC2M 1QS, UK

Medical Information Direct Line

+44 (0)208 588 9131

WWW

www.advanzpharma.com

Telephone

+44 (0)208 588 9131

Medical Information e-mail
Customer Care direct line

+44 (0)208 588 9273