Vitamin B Compound Strong Tablets Taj Pharma

  1. Name of the medicinal product

Vitamin B Compound Strong Tablets Taj Pharma

  1. Qualitative and quantitative composition

Each film coated tablet contains:
Nicotinamide 20mg
Pyridoxine Hydrochloride 2mg
Riboflavine 2mg
Thiamine Mononitrate 4.85mg
Also contains lactose.

For a full list of excipients, see section 6.1

  1. Pharmaceutical form
    Film-coated tablet.
  1. Clinical particulars
    • Therapeutic indications

1) For the treatment of clinical and sub-clinical vitamin B deficiency states (manifestations of which include glossitis, stomatitis, cheilosis, the heart manifestations of beriberi, the skin manifestations of pellagra, corneal vascularisation and polyneuritis).

  • Posology and method of administration

Adults (including elderly) and children over 3 years: One to two tablets three times daily.
Children under 3 years: Not recommended.
For oral administration.

  • Contraindications
    Known hypersensitivity to any of the active constituents.
  • Special warnings and precautions for use

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

  • Interaction with other medicinal products and other forms of interaction

Pyridoxine may increase the peripheral metabolism of levodopa, reducing therapeutic efficacy of the latter drug. Therefore, patients with Parkinson’s disease who are receiving treatment with plain levodopa should not take vitamin B6 in doses which greatly exceed the daily requirement. This does not apply when levodopa is combined with a peripheral decarboxylase inhibitor.

  • Pregnancy and lactation

The usual precautions should be observed when administering drugs during pregnancy, especially in the first trimester.

In high doses, pyridoxine may interfere with prolactin release and should only be used with caution in nursing mothers.

  • Effects on ability to drive and use machines

None known.

  • Undesirable effects

Toxic effects are unlikely since any excess vitamin B is excreted.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Overdose
Excess vitamin B is readily excreted, therefore no serious problems are anticipated for the administration of vitamin B in this form.

  1. Pharmacological properties
    • Pharmacodynamic properties

Nicotinamide is a vitamin
Pyridoxine hydrochloride is a vitamin (B6)
Riboflavine is a vitamin (B2)
Thiamine mononitrate is a vitamin (B1)
The vitamin B-complex comprises a group of water-soluble factors more or less closely associated in their natural occurrence. It is known that nearly every vitamin of the B-complex forms part of a co-enzyme essential for the metabolism of protein, carbohydrate or fatty acid.

  • Pharmacokinetic properties

Nicotinamide is readily absorbed from the GI tract following oral administration and is widely distributed in the body tissues. Small amounts of nicotinamide are excreted unchanged in urine following therapeutic doses, however, the amount excreted unchanged is increased with larger doses.

Pyridoxine is absorbed from the GI tract and is converted to the active form pyridoxal phosphate. It is excreted in the urine as 4-pyridoxic acid.
Riboflavine is absorbed from the GI tract and in the circulation is bound to plasma proteins. Although widely distributed, little is stored in the body, and amounts in excess of requirements are excreted in the urine.
Thiamine is absorbed from the GI tract and is widely distributed to most body tissues. It is not stored to any appreciable extent in the body and amounts in excess of requirements are excreted in the urine as unchanged thiamine or metabolites.

  • Preclinical safety data

Not applicable.

  1. Pharmaceutical particulars
    • List of excipients

Tablet core contains:
Lactose monohydrate, Magnesium stearate, Maize starch, Pregelatinised maize starch, Stearic acid
Film-coat contains:
Hypromellose, Hydroxypropyl Cellulose, Medium Chain Triglycerides, Macrogol 3350, Titanium Dioxide , Iron oxide Red, Iron oxide Black

  • Incompatibilities

None known.

  • Shelf life

Shelf-life
Two years from the date of manufacture.
Shelf-life after dilution/reconstitution
Not applicable.
Shelf-life after first opening
Not applicable.

  • Special precautions for storage

Store below 25°C in a dry place.

  • Nature and contents of container

The product may also be supplied in blister packs in cartons:
Pack sizes: 28, 30, 56, 60, 84, 90, 100, 112, 120, 168, 180, 250, 500,
Maximum size of bulk packs: 500.

  • Special precautions for disposal and other handling

Not applicable.
Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Vitamin B Compound Strong Tablets Taj Pharma

Package Leaflet Information
Read all of this leaflet carefully before you start taking this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine is for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • The full name of this medicine is Vitamin B Compound Strong Filmcoated Tablets but within this leaflet it will be referred to as Vitamin B Compound Strong Tablets.
  1. What Vitamin B Compound Strong Tablets are and what they are used for
  2. Before you take
  3. How to take
  4. Possible side effects
  5. How to store
  6. Further information

1. What Vitamin B Compound Strong Tablets are and what they are used for
Vitamin B Compound Strong Tablets may be used to treat:

  • Vitamin B deficiency. The effects of a vitamin B deficiency can include: swelling of the tongue, mouth or lips, swelling of nerves which can cause pain, tenderness or loss of function and the growth of new blood vessels in the eye which can affect vision.
  • the effects on the heart which occur in beri beri (a condition caused by vitamin B1 (thiamine) deficiency).
  • the effects on the skin which occur in pellagra (a condition caused by nicotinamide deficiency).heart which occur in beri beri (a condition caused by vitamin B1 (thiamine) deficiency).
  • the effects on the skin which occur in pellagra (a condition caused by nicotinamide deficiency).
  1. Before you take

Do not take Vitamin B Compound Strong Tablets and tell your doctor if you:

  • are allergic (hypersensitive) to nicotinamide, pyridoxine hydrochloride, riboflavine, thiamine mononitrate or any other ingredients in Vitamin B Compound Strong Tablets (see section 6).

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, especially levodopa (for Parkinson’s disease) or medicines obtained without a prescription.

Pregnancy and breast-feeding
If you are pregnant particularly in the first three months, planning to become pregnant or are breast-feeding, speak to your doctor or pharmacist before taking this medicine.
Important information on some ingredients in Vitamin B Compound
Strong Tablets

  • If you have been told you have a intolerance to some sugars, contact your doctor before taking this medicine, as it contains lactose.
  1. How to take
    Always take Vitamin B Compound Strong Tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
    Swallow the tablets whole.

Doses:

Adults (including elderly) and children over

3 years
1-2 tablets to be taken three times a day.

Children under 3 years
Not recommended.
If you take more than you should
If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately.
If you forget to take the Tablets
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

  1. Possible side effects
    Vitamin B Compound Strong Tablets are unlikely to cause side-effects as any excess vitamin B is excreted from the body.

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.
By reporting side effects you can help provide more information on the safety of this medicine.

  1. How to store

Keep out of the sight and reach of children. Store below 25°C in a dry place.
Do not use Vitamin B Compound Strong Tablets after the expiry date stated on the label/carton/bottle.
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Manufactured in India by:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

 

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