Read this leaflet carefully before you start taking this medicine.  (DOWNLOAD)

• Keep this leaflet. You may need to read it again before, during or after use of this medicine. – If you have any further questions, ask your health care provider. 
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm  them, even if their symptoms are the same as yours. 
• If any of the side effects become serious, or if you notice any side effects not listed in  this leaflet, please inform your health care provider. 

In this leaflet: 

1. What Vitamin B complex injection is and what it is used for 
2. What you need to know before you are given Vitamin B complex injection  3. How to take Vitamin B complex injection  
3. Possible side effects 
4. How to store Vitamin B complex injection 
5. Contents of the pack and other information 

 

1. WHAT VITAMIN B COMPLEX INJECTION IS AND WHAT IT IS USED FOR Vitamin B complex is a vitamin preparation, containing vitamin B1 (thiamine), vitamin  B2, Nicotinamide and Sodium D-panthothenate. Vitamin B complex is used to treat  diseases of the nervous system, associated with proven deficiency of B vitamins  which cannot be corrected by diet.  

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN VITAMIN B COMPLEX  INJECTION 

Do not use Vitamin B complex:  

• If you are allergic to thiamine hydrochloride (vitamin B1), pyridoxine hydrochloride  (vitamin B6), cyanocobalamin (vitamin B12) or any of the other ingredients of this  medicine.  
• If you suffer from serious heart conduction disorders (i.e., the electrical impulses that  coordinate your heartbeats don’t work properly) 
• If you suffer from acute congestive heart failure 
• If you are pregnant or breast-feed your baby 
• In children under 12 years due to the presence of benzyl alcohol and the high dose of  vitamins 

Warnings and precautions 

Talk to your doctor or pharmacist before using Vitamin B complex.  

Vitamin B complex must be injected into the muscles only.  

It must not be injected into the vein.  

In case Vitamin B complex is by mistake injected into your vein, your doctor will  monitor your state closely. 

Vitamin B1 20mg, Vitamin B2 1.37mg, Nicotinamide 100mg, Sodium D-panthothenate 10mg 

If used for longer than 6 months, this medicine can cause damage to your nerves  (neuropathies). The symptoms are tingling, numbness or burning sensation in the feet  or hands. Talk to your doctor if you have any of these symptoms. No special  precautions are required in the elderly. 

Taking other medicines with Vitamin B complex injection  

Tell your doctor or pharmacist if you are taking, have recently taken or might take any  other medicines. It is especially important to tell if you are taking any of the following  medicines: 

• medicines for tuberculosis (cycloserine, isoniazid); 
• penicillamine (for rheumatoid arthritis);  
• adrenaline (used to treat life threatening allergic reaction or to restart your heart if it  has stopped) noradrenaline (used to increase blood pressure to normal levels);  • antibiotics belonging to a group of sulfonamides, e.g., sulfasalazine, sulfamethoxazole;  • levodopa (for Parkinson’s disease); other vitamins; 
• sulfite-containing medicines. Ask your doctor or pharmacist if you are not sure if any of  your medicines contain sulfite 

Pregnancy 

If you are pregnant or think you may be pregnant or are planning to have a baby, ask  your doctor or pharmacist for advice before taking this medicine. Due to the amounts of  the active ingredients, treatment during your pregnancy is only useful if vitamin B1 and  B6 deficiency has been confirmed. Vitamin B complex should not be used during  pregnancy unless your doctor considers it as clearly necessary. 

Breast-feeding 

If you are breast-feeding, ask your doctor or pharmacist for advice before taking this  medicine. Due to the amounts of the active ingredients, treatment while breast-feeding is  only useful if vitamin B1 and B6 deficiency has been confirmed. Vitamin B complex should  not be used while breast-feeding unless your doctor considers it as clearly necessary. 

Driving and using machines 

Vitamin B complex has no or negligible influence on the ability to drive and use  machines. 

Vitamin B complex contains benzyl alcohol, sodium and potassium. Benzyl alcohol may  rarely cause allergy-like (anaphylactoid) reactions. This medicinal product contains less  than 1 mmol sodium (23 mg) per dose (2 mL) i.e. essentially “sodium free”. This  medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially  “potassium-free 

3. HOW TO TAKE VITAMIN B COMPLEX  

Always use this medicine exactly as your doctor has told you. Check with your doctor if  you are not sure. The recommended dose is: 

Vitamin B1 20mg, Vitamin B2 1.37mg, Nicotinamide 100mg, Sodium D-panthothenate 10mg 

• In cases of severe and acute pain, the recommended dose is one injection (2 ml) a day.  • After the pain is relieved or in case of less severe disease, the recommended dose is  one injection (2 ml) 2 to 3 times a week.  

Method of administration  

Vitamin B complex solution for injection is injected deep into your muscle. It should not  be given by any other route! (see also “Warnings and precautions”)  

Duration of treatment  

Your doctor will decide how long you will need the treatment and will assess your  condition every week. As soon as possible, your doctor will advise you to start using  oral vitamin B preparation. 

If you think you have been given too much 

If you are accidentally given too much of Vitamin B complex and you feel unwell,  immediately contact a doctor. 

If you missed a dose  

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 product, ask your doctor or nurse. 

4. POSSIBLE SIDE EFFECTS  

Like all medicines, this medicine can cause side effects, although not everybody gets  them. If you experienced any of the following side effects, stop treatment with Vitamin B  complex and contact your doctor. You may need urgent medical treatment.  

Rare side effects (may affect up to 1 in 1,000 people):  

• Severe allergy-like (anaphylactoid) reactions may occur due to benzyl alcohol content.  

Side effects of unknown frequency (frequency cannot be estimated from the  available data):  

• Allergic reactions, e.g., skin rash, shortness of breath, shock, swelling of the hands, feet,  or ankles, the face, lips, tongue and /or throat with difficulty in swallowing or breathing  (angioedema) 
• Skin reactions, including itching and hives 
• Acne  
• Dizziness 
• Drowsiness  
• Slow heart rate (bradycardia), fast heart rate (tachycardia), irregular heart rate  (arrhythmia) 
• Vomiting 

Vitamin B1 20mg, Vitamin B2 1.37mg, Nicotinamide 100mg, Sodium D-panthothenate 10mg 

• Sweating  
• Cramps  
• Burning at the injection site 

If this medicine is by mistake injected into your vein or too large dose in injected, the  following side effects may occur: dizziness, vomiting, slow or irregular heart rate,  drowsiness, cramps. 

5. HOW TO STORE VITAMIN B COMPLEX INJECTION  

• Keep all medicines out of the reach of children. 
• Store between 2oC – 8oC
• Do not use this medicine after the expiry date ‘Exp. Date’ which is stated on the label and  carton. The expiry date refers to the last day of that month. 

6. FURTHER INFORMATION 

What Vitamin B complex contains 

The active substances are Vitamin B1 20mg, Vitamin B2 1.37mg, Nicotinamide 100mg,  Sodium D-panthothenate 10mg 

What Vitamin B Complex Injection looks like and contents of the pack Vitamin B complex is solution available as 10 x 1mL ampoules, placed in carton with insert