- Name of the medicinal product
Thiamine Hydrochloride Tablets USP 50mg Taj Pharma
Thiamine Hydrochloride Tablets USP 100mg Taj Pharma
Thiamine Hydrochloride Tablets USP 300mg Taj Pharma
- Qualitative and quantitative composition
a) Thiamine Hydrochloride Tablets USP 50mg Taj Pharma
Each uncoated tablet contains:
Thiamine hydrochloride USP 50mg
Excipients: Q.S.
b) Thiamine Hydrochloride Tablets USP 100mg Taj Pharma
Each uncoated tablet contains:
Thiamine hydrochloride USP 100mg
Excipients: Q.S.
c) Thiamine Hydrochloride Tablets USP 300mg Taj Pharma
Each uncoated tablet contains:
Thiamine hydrochloride USP 300mg
Excipients: Q.S.
This product contains lactose – see section 4.4. For a full list of excipients, see section 6.1.
- Pharmaceutical form
Uncoated Tablet
White uncoated tablets,
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
- Clinical particulars
- Therapeutic indications
Treatment of Thiamine deficiency
- Posology and method of administration
Adults, the Elderly and Children over three years:
Mild chronic deficiency: 50mg daily
Severe deficiency: 100mg three times daily.
Not recommended for children under three years.
Route of administration: oral
- Contraindications
Hypersensitivity to Thiamine Hydrochloride Taj Pharma or to any of the excipients listed in section 6.1
- Special warnings and precautions for use
This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicinal product also contains sucrose. Patients with rare hereditary problems of fructose intolerance, malabsorption or sucrose-isomaltase insufficiency should not take this medicine
- Interaction with other medicinal products and other forms of interaction
The Thiamine antagonists thiosemicarbazone and 5-fluorouracil can neutralise the effect of Thiamine. Patients using any of these treatments may need their Thiamine dose adjusted.
Thiamine could give false positive results for urobilinogen determination by the Ehrlich’s reaction. High doses of Thiamine may interfere with spectrophotometric assays of theophylline plasma concentration.
- Pregnancy and lactation
This product is not intended for use in pregnant or lactating women.
- Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed. However, patients should be cautioned to see how they react before driving or operating machinery.
- Undesirable effects
Gastrointestinal disorders:
Mild gastrointestinal events such as nausea, vomiting, diarrhoea, and abdominal pain have been reported. Frequency not known (cannot be estimated from data).
Immune system disorders:
Hypersensitivity reactions have been reported (mainly after parenteral administration). Allergic and anaphylactic reactions, with symptoms of pruritus, urticaria, itching, hives, angioedema, abdominal pain, respiratory distress, tachycardia, palpitations, and shock have been reported in single cases. Frequency not known (cannot be estimated from data).
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
Overdose has not been reported.
- Pharmacological properties
- Pharmacodynamic properties
Pharmacotheraputic Group: Vitamin B1, Plain
Thiamine is an essential co-enzyme for carbohydrate metabolism.
- Pharmacokinetic properties
Thiamine is well absorbed from the gastrointestinal tract following oral administration, although the absorption of large doses is limited. It is widely distributed to most body tissues and appears in breast milk. Within the cell, Thiamine is mostly present as the diphosphate. Thiamine is not stored to any appreciable extent in the body; amounts in excess of the body’s requirements are excreted in the urine as unchanged Thiamine or metabolites.
- Preclinical safety data
No relevant data
- Pharmaceutical particulars
- List of excipients
Lactose monohydrate
Maize starch
Sucrose
Sodium starch glycolate
Talc
Magnesium stearate
- Incompatibilities
None known
- Shelf life
36 months.
- Special precautions for storage
Do not store above 25°C; store in the original package.
- Nature and contents of container
Pack Size:
Each container contains of 50, 60, 80, 100, 120, 240, 360 and 500 tablets in a polypropylene bottle with a polyethylene cap.
- Special precautions for disposal and other handling
None
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
Thiamine Hydrochloride Tablets USP 100mg Taj Pharma
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve.
- If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section
WHAT IS IN THIS LEAFLET
- What Thiamine Hydrochloride Taj Pharma Tablets are and what they are used for
- What you need to know before you take Thiamine Hydrochloride Taj Pharma Tablets
- How to take Thiamine Hydrochloride Taj Pharma Tablets
- Possible side effects
- How to store Thiamine Hydrochloride Taj Pharma Tablets
- Contents of the pack and other information
1. WHAT THIAMINE HYDROCHLORIDE TABLETS ARE AND WHAT THEY ARE USED FOR
Thiamine Hydrochloride Taj Pharma Tablets are vitamin tablets which contain Thiamine (vitamin B1).
They are used to treat Thiamine deficiency (when your body does not have enough of the vitamin).
Even though Thiamine is found naturally in many foods (especially in yeast, wholegrain cereals, meats and beans), sometimes your body requires a supplement. This may be because your diet does not contain enough Thiamine or you may not be absorbing it from your diet effectively. You may also have a special need for extra Thiamine, especially if you are excreting it quickly from your body (e.g. in your urine). By taking Thiamine Hydrochloride Taj Pharma Tablets, you can make sure you have sufficient Thiamine in your diet
- WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIAMINE HYDROCHLORIDE TABLETS
DO NOT take Thiamine Hydrochloride Taj Pharma
Tablets if you are:
- Allergic (hypersensitive) to Thiamine or any of the other ingredients in this medicine (see section 6, Contents of the pack and other information)
- Under 12 years of age
Other medicines and Thiamine Hydrochloride Taj Pharma Tablets:
Tell your doctor or pharmacist if you are taking any other medicines, including those obtained without a prescription, such as vitamins or herbal preparations which you have bought yourself.
Certain medicines can reduce the effect of your Thiamine tablets.
Tell your doctor if you are taking the following medicine because he/she may need to adjust your Thiamine dose:
- fluorouracil (used to treat certain cancers and viral infections)
Pregnancy, breast-feeding and fertility
Do not take Thiamine Hydrochloride Taj Pharma Tablets 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.
Driving and using machines
This medicine is not known to affect the ability to drive or use machines. However, if you feel you may be affected, do not drive or use machines and speak to your doctor.
Having blood tests or other medical tests
High concentrations of Thiamine in the blood can affect certain medical tests. If you are having a blood test, scan or any other medical test, tell your doctor that you are taking Thiamine tablets.
Thiamine Hydrochloride Taj Pharma Tablets contains lactose
These tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
- HOW TO TAKE THIAMINE HYDROCHLORIDE TABLETS
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults and children over 12 years of age
The tablets should be swallowed with water. Do not chew the tablets.
50mg:
Mild deficiency: 1-2 tablets once a day
Severe deficiency: 2 tablets 2-3 times a day
100mg/300mg:
Mild deficiency: 1 tablet once a day
Severe deficiency: 1 tablet 2-3 times a day
The tablets can be taken as long as symptoms persist or a dietary supplement is required, follow the recommendation of your doctor or pharmacist.
If your condition does not improve, tell your doctor.
Children under 12 years of age:
Not recommended
If you take more Thiamine Hydrochloride Taj Pharma Tablets than you should
This is unlikely to be harmful, but if you have taken too many tablets tell your doctor or pharmacist immediately or contact your nearest emergency department.
If you forget to take Thiamine Hydrochloride Taj Pharma Tablets
Take your dose as soon as you remember, then carry on taking your tablets as usual.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist
- POSSIBLE SIDE EFFECTS
Like all medicines Thiamine Hydrochloride Taj Pharma Tablets can cause side effects, although not everybody gets them. Side effects are unlikely at the recommended doses.
Very few people may experience an allergic reaction after taking this medicine, symptoms of this could be:
- Rash or skin irritation
- Swelling of face, lips, throat or tongue
- Stomach pain
- Difficulty in breathing or swallowing
- Rapid pulse
- Heart pain
Some people may experience a mild stomach upset after taking this medicine, symptoms of this could be:
- Nausea
- Vomiting
- Stomach pain
- Diarrhoea
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
- HOW TO STORE THIAMINE HYDROCHLORIDE TABLETS
Keep this medicine out of the sight and reach of children.
Store below 25ºC. This product should be stored in its original pack.
Do not use Thiamine Hydrochloride Taj Pharma Tablets after the expiry date which is stated on the carton and container pot. The expiry date refers to the last day of that month.
After first opening of the pot, Thiamine Hydrochloride Taj Pharma Tablets should be used within 100 days.
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.
- CONTENTS OF THE PACK AND OTHER INFORMATION
What Thiamine Hydrochloride Taj Pharma Tablets contain
The active substance is Thiamine hydrochloride (50mg, 100mg and 300mg per tablet).
The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, stearic acid and magnesium stearate.
What Thiamine Hydrochloride Taj Pharma Tablets look like and contents of the pack
Thiamine Hydrochloride Tablets USP 50mg/100mg/300mg are white or almost white biconvex round,
Pack Size:
Each container contains of 50, 60, 80, 100, 120, 240, 360 and 500 tablets in a polypropylene bottle with a polyethylene cap.
Not all pack sizes may be marketed
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
