Pyridoxine Tablets 40mg Taj Pharma 

  1. Name of the medicinal product

Pyridoxine Tablets 40mg
Pyridoxine Tablets 50mg

  1. Qualitative and quantitative composition

Pyridoxine Hydrochloride 40mg
Excipients                           qs

Pyridoxine Hydrochloride 50mg
Excipients                           qs

  1. Pharmaceutical form

Oral tablet

  1. Clinical particulars

4.1 Therapeutic indications

Pyridoxine Hydrochloride is used for isoniazid-induced peripheral neuritis, idiopathic sideroblastic anaemia and Vitamin B6 deficiency states.

4.2 Posology and method of administration

For isoniazid-induced peripheral neuritis

Adults:             Treatment – 50mg three times daily

Prophylaxis – Not suitable with this dosage form

Children:         This presentation is not recommended

For idiopathic sideroblastic anaemia

Adults: 100 to 400mg daily in divided doses

Children:         This presentation is not recommended

For deficiency states

Adults: 50 to 150mg daily in divided doses

Children:          This presentation is not recommended

Elderly: Dosage requirements appear to be similar to those for young adults

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special warnings and precautions for use

If symptoms persist or worsen, seek medical advice. Do not exceed the stated dose.

4.5 Interaction with other medicinal products and other forms of interaction

Many drugs may alter the metabolism or bioavailability of pyridoxine, including isoniazid, penicillamine and oral contraceptives, which may increase the requirements for pyridoxine. Pyridoxine hydrochloride may reduce the effect of levodopa, a drug used in the treatment of Parkinsons Disease unless a dopa decarboxylase inhibitor is also given.

4.6 Pregnancy and lactation

Data on exposed pregnancies indicate no adverse effects of pyridoxine in therapeutic doses on pregnancy or the health of the foetus or newborn child, or during lactation.

Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development.

Caution should be exercised when prescribing to pregnant women.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Long term administration of large doses of pyridoxine is associated with the development of severe peripheral neuritis.

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.

4.9 Overdose

  1. a) Symptoms – None reported
  2. b) Treatment – no treatment necessary.
  3. Pharmacological properties

5.1 Pharmacodynamic properties

Pyridoxine hydrochloride is Vitamin B6. It is converted to pyridoxal phosphate which is the co-enzyme for a variety of metabolic transformations. It is essential for human nutrition.

5.2 Pharmacokinetic properties

Pyridoxine hydrochloride is absorbed from the gastrointestinal tract and is converted to the active forms pyridoxal phosphate and pyridoxamine phosphate. It crosses the placental barrier and appears in breast milk. It is excreted in the urine as 4-pyridoxic acid.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the Summary of Product Characteristics.

  1. Pharmaceutical particulars

6.1 List of excipients

Calcium Hydrogen Phosphate BP

Starch Maize BP

Sodium Lauryl Sulphate BP

Magnesium Stearate BP

Purified Water BP (non-detectable in the final formulation)

6.2 Incompatibilities

None known

6.3 Shelf life

Two years

6.4 Special precautions for storage

Store below 25°C

Protect from light and moisture.

6.5 Nature and contents of container

Packs of 100 or 500 tablets contained in polypropylene securitainers or polyethylene containers.

Strip packs of opaque white or clear PVC film and 20μm aluminium foil of 10 or 14 tablets. Tablets will be packed in multiple strips of 10 tablets resulting in packs of 10, 20, 30, 40, 50, 60, 70, 80, 90 and 100 tablets, or tablets will be packed in multiple strips of 14 tablets resulting in packs of 14, 28, 56, 84 and 112 tablets.

6.6 Special precautions for disposal and other handling

Not applicable.

 

  1. 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

 

Pyridoxine Hydrochloride Tablets 40mg, 50mg Taj Pharma

 

PACKAGE LEAFLET INFORMATION FOR THE USER

 

Pyridoxine 40mg, 50mg Tablets Pyridoxine Hydrochloride

 

Read all of this leaflet carefully before you start using

  this medicine.

– Keep this leaflet. You may need to read it again.

  • If you have further questions, please ask your doctor or pharmacist.
  • This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as

 

The name of your medicine is Pyridoxine 50mg Tablets. In the rest of this leaflet it is called Pyridoxine Tablets.

 

In this leaflet:

  1. What Pyridoxine Tablets are and what they are used for
  2. Before you take Pyridoxine Tablets
  3. How to take Pyridoxine Tablets
  4. Possible side effects
  5. How to store Pyridoxine Tablets
  6. Further information

 

  1. What pyridoxine tablets are and what they are used for

The active ingredient in Pyridoxine Tablets is pyridoxine hydrochloride, which is Vitamin B6.

 

It is used to treat low levels of Vitamin B6 in the body and in the treatment of a condition called idiopathic sideroblastic anaemia where the red cells in the blood do not form properly.

 

Pyridoxine can also be used to treat damage to the nerves (peripheral neuritis) caused by isoniazid, a drug used to treat tuberculosis.

 

  1. Before you take pyridoxine tablets

Do not take Pyridoxine Tablets if:

  • you are allergic to pyridoxine hydrochloride or any of the other ingredients of Pyridoxine Tablets (see list under ‘What Pyridoxine Tablets contain’ in section 6)

 

If the above statement applies to you, you should not take Pyridoxine Tablets

 

Talk to your doctor before taking Pyridoxine Tablets if:

  • the patient is a Pyridoxine Tablets are not recommended for children.

 

Taking other medicines

Taking another medicine while you are taking Pyridoxine Tablets can affect how it or the other medicine works. Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those you may have bought yourself without a prescription.

 

Please check with your doctor if you are taking any of the

 

following (or any other medication):

  • levodopa, a drug used in the treatment of Parkinson’s disease
  • isoniazid, used to treat tuberculosis
  • oral contraceptives
  • penicillamine, used to treat arthritis and other

 

If you have any doubts about whether you should take this medicine then discuss matters with your doctor before taking it.

 

Pregnancy and breast-feeding

You should let your doctor know if you are pregnant or wish to become pregnant, or wish to breast-feed, whilst taking these tablets.

 

Driving and operating machines

Pyridoxine Tablets do not affect the ability to drive or operate machinery.

 

  1. How to take pyridoxine tablets

Your doctor will decide the dose which is best for you. Always follow your doctor’s instructions completely and also follow  any special instructions or warnings which appear on the label which the pharmacist has put on the package. Contact your doctor if your symptoms worsen or do not improve. If you do not understand, or are in any doubt, ask your doctor or pharmacist.

 

Unless instructed differently, take your tablets with a glass of water.

 

For the treatment of low levels of Vitamin B6 in the body

The usual dose in adults is 50 to 150mg daily in divided doses.

 

For the treatment of idiopathic sideroblastic anaemia

The usual adult dose is 100 to 400mg daily in divided doses.

 

For the treatment of nerve damage (peripheral neuritis) caused by isoniazid

The usual adult dose is 50mg three times a day.

 

Elderly

If you are elderly you will require similar doses to those given above.

 

Children

Pyridoxine Tablets are not recommended for use in children.

 

If you take more Pyridoxine Tablets than you should

If you accidentally take too many tablets contact your doctor or pharmacist or nearest hospital casualty department. Take this leaflet and any remaining tablets with you to show the doctor or pharmacist.

 

If you miss a dose of PyridoxineTablets

If you forget to take a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. Do not take a double dose to make up for a forgotten tablet.

 

Stopping Pyridoxine Tablets

You should continue to take Pyridoxine Tablets for as long as your doctor tells you to. Do not stop taking the medicine without talking to your doctor first.

  1. Possible side effects

Like many medicines Pyridoxine Tablets may cause side effects in some patients, although not everybody gets them.

 

If you take large doses of Pyridoxine Tablets for a long time you may develop problems with your nerves (peripheral neuritis). One of the symptoms of peripheral neuritis can be pins and needles.

 

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 national reporting systems listed below:

 

 

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

 

  1. How to store pyridoxine tablets

Keep out of the reach and sight of children.

 

Do not take this medicine if the expiry date on the label has passed. The expiry date refers to the last day of that month.

 

Pyridoxine Tablets should not be taken if they show signs of deterioration.

 

Store below 25°C.

 

Store in the original container or package in order to protect from light and moisture. Do not transfer the tablets to another container.

 

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.

 

  1. Further information

What Pyridoxine Tablets contain

The active ingredient in Pyridoxine Tablets is pyridoxine hydrochloride.

 

The other ingredients are calcium hydrogen phosphate, maize starch, sodium lauryl sulphate, magnesium stearate and purified water.

 

Contents of the pack

Pyridoxine Tablets are available in strip packs of 28 tablets.

 

7.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