1. Name of the medicinal product

Trimethoprim Tablets USP 100mg Taj Pharma
Trimethoprim Tablets USP 200mg Taj Pharma

2. Qualitative and quantitative composition

a) Trimethoprim Tablets USP 100mg Taj Pharma
Each tablet contains:
Trimethoprim USP 100mg
Excipients: Q.S.

b) Trimethoprim Tablets USP 200mg Taj Pharma
Each tablet contains:
Trimethoprim USP 100mg
Excipients: Q.S.

For full list of excipients see section-6

3. Pharmaceutical form

Uncoated tablet

  1. Clinical particulars

Therapeutic indications

Treatment of susceptible infections (caused by Trimethoprim Taj Pharma sensitive organisms including urinary and respiratory tract infections. Prophylaxis of recurrent urinary tract infections.

Posology and method of administration

Acute infections:

Treatment should continue for a period of between 3 days (eg, uncomplicated bacterial cystitis in women) to 2 weeks depending on the nature and severity of the infection. The first dose may be doubled.

Adults: 200mg twice daily

Paediatric population:

Children over 12 years: Same as adult dose

Children 6 – 12 years: 100mg twice daily

Children under 6 years: This dosage form is not suitable for use in children younger than 6 years.

Elderly: Dosage is dependent on renal function. See special dosage schedule below.

Advised dosage schedule where there is reduced kidney function:

eGFR (ml/min)Dosage advised
Over 30Normal
15 – 30Normal for 3 days then half dose
Under 15Half the normal dose

Monitoring of renal function and serum electrolytes should be considered particularly with longer term use, in patients with impaired renal function.

Trimethoprim Taj Pharma should only be initiated and used in dialysis patients under close supervision from specialists in both infectious disease and renal medicine. Trimethoprim Taj Pharma is removed by dialysis.

Monitoring Trimethoprim Taj Pharma plasma concentration may be considered with long term therapy but the value of this in individual cases should first be discussed with specialists in infectious disease and renal medicine.

Long-term treatment and prevention therapy:
Adults: 100mg at night
Paediatric Population:

Children over 12 years: Same as adult dose

Children 6-12 years: 50mg at night. Where a single daily dose is required, dosage at bedtime may maximise urinary concentrations. The approximate dosage in children is 2mg Trimethoprim Taj Pharma per kg body weight per day.

Elderly: Dose depends on renal function. Refer to special dosage schedule above.

Method of administration

For oral administration.

Contraindications

Severe hepatic insufficiency.Megaloblastic anaemia and other blood dyscrasias. Trimethoprim Taj Pharma should not be administered to premature infants or children under 4 months of age. Trimethoprim Taj Pharma should not be administered to pregnant women.

Hypersensitivity to Trimethoprim Taj Pharma or any other constituents of the medication (listed in section 6.1).

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

Special warnings and precautions for use

Trimethoprim Taj Pharma should not be administered to pregnant women, premature infants or infants during the first few weeks of life.

Patients with marked impairment of renal function: Care should be taken to avoid accumulation and resulting adverse haematological effect.

Monitoring of renal function and serum electrolytes should be considered particularly with longer term use.

Trimethoprim Taj Pharma should only be initiated and used in dialysis patients under close supervision from specialists in both infectious disease and renal medicine.

Trimethoprim Taj Pharma may cause depression of haemopoiesis. Regular haematological tests should be undertaken in patients receiving long term treatment and those predisposed to folate deficiency, (e.g. the elderly), to check for possible pancytopaenia. Although an effect on folate metabolism is possible, interference with haematopoiesis rarely occurs at the recommended dose. If any such change is seen, folinic acid should reverse the effect. Elderly people may be more susceptible and a lower dose may be advisable. If there is evidence of folic acid deficiency, calcium folinate should be administered and response checked by haematologic monitoring. It may be necessary to discontinue Trimethoprim Taj Pharma. Particular care should be exercised in the haematological monitoring of children on long term therapy.

Close monitoring of serum electrolytes is advised in patients at risk forhyperkalaemia (see section 4.8). Elevations in serum potassium have been observed in some patients treated with Trimethoprim Taj Pharma. Patients at risk for the development of hyperkalaemia include those with renal insufficiency, poorly controlled diabetes mellitus, or those using concomitant potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, renin angiotensin system inhibitors (eg: ACE inhibitors or renin angiotensin receptor blockers), or those patients taking other drugs associated with increases in serum potassium (e.g. heparin). If concomitant use of the above-mentioned agents is deemed appropriate, monitoring of serum potassium is recommended (see section 4.5).

Monitoring of blood glucose is advised if co-administered with repaglinide (see section 4.5).

Caution should be used in patients with acute porphyria

Interaction with other medicinal products and other forms of interaction

Folate antagonists and anticonvulsants: Trimethoprim Taj Pharma may induce folate deficiency in patients predisposed to folate deficiency such as those receiving concomitant folate antagonists or anticonvulsants.

Bone marrow depressants: Trimethoprim Taj Pharma may increase the risk for bone marrow aplasia. Cytotoxic agents such as azathioprine, mercaptopurine and methotrexate increase the risk of haematologic toxicity when given with Trimethoprim Taj Pharma.

Special care is necessary in patients receiving pyrimethamine in addition to Trimethoprim Taj Pharma.

Phenytoin and Digoxin: Careful monitoring of patients treated with digoxin or phenytoin is advised as Trimethoprim Taj Pharma may increase plasma concentration of these agents by increasing their elimination half life.

Rifampicin may decrease Trimethoprim Taj Pharma concentrations.

Diuretics: In elderly patients taking diuretics, particularly thiazides, there is an increased incidence of thrombocytopaenia with purpura.

Concomitant use of drugs that may increase serum potassium levels may lead to a significant increase in serum potassium. Potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, renin-angiotensin system inhibitors (eg: ACE inhibitors or renin angiotensin receptor blockers) and other potassium increasing substances (eg: heparin). Monitoring of potassium should be undertaken as appropriate (see section 4.4).

Cyclosporin: Increased risk of nephrotoxicity.

Procainamide: Trimethoprim Taj Pharma increases plasma concentrations of procainamide.

Dapsone: Plasma concentrations of Trimethoprim Taj Pharma and dapsone may increase when taken together.

Repaglinide: Trimethoprim Taj Pharma may enhance the hypoglycaemic effects of repaglinide.

Anticoagulants: Trimethoprim Taj Pharma may potentate the anticoagulant effect of warfarin and other coumarins.

Antibacterials: Plasma concentration of Trimethoprim Taj Pharma is possibly reduced by rifampicin. Plasma concentration of both drugs may increase when Trimethoprim Taj Pharma is given with dapsone.

Antimalarials: Increased antifolate effect when Trimethoprim Taj Pharma is given with pyrimethamine.

Pregnancy and breast-feeding

Pregnancy

Trimethoprim Taj Pharma is contraindicated in pregnant women, premature infants or infants during the first few weeks of life.

Breast-Feeding

Although Trimethoprim Taj Pharma is excreted in breast milk, it is not necessarily contraindicated for short-term therapy during lactation. This should be kept in mind when considering administration to breast- feeding women.

Effects on ability to drive and use machines

None that are known.

Undesirable effects

The following list of undesirable effects have been reported by health care professionals. Sometimes it may be difficult to distinguish reactions caused by the condition being treated from adverse drug reactions, which means that not all the listed reactions were caused by drug administration.

The most frequent adverse effects at usual doses are pruritus and skin rash (in about 3 to 7% of patients) and mild, gastrointestinal disturbances including nausea, vomiting and glossitis. These effects are generally mild and quickly reversible on withdrawal of the drug.

Infections and Infestations

Common: Monilial overgrowth

Blood and lymphatic system disorders

Very rare: Leucopenia, neutropenia, thrombocytopenia, pancytopaenia, bone marrow depression, agranulocytosis, aplastic anaemia, haemolytic anaemia, eosinophilia, purpura, haemolysis,

Unknown: Megaloblastic anaemia, methaemoglobinaemia, hyperkalaemia (particularly in the elderly and in HIV patients), methaemoglobinaemia. Trimethoprim Taj Pharma therapy may affect haematopoiesis.

Fatalities have been reported (especially in the elderly, or those with impairment of renal or hepatic function in whom careful monitoring is advised- refer to Section 4.3 Contraindications), however the majority of haematological changes are mild and reversible when treatment is stopped.

Immune system disorders

Very rare: Hypersensitivity, anaphylaxis, anaphylactoid reaction, drug fever, allergic vasculitis resembling Henoch-Schoenlein purpura, periarteritis nodosa, systemic lupus erythematosus.

Metabolism and nutrition disorders

Very common: Hyperkalaemia

Very rare: Hypoglycaemia, hyponatraemia, anorexia

Close supervision is recommended when Trimethoprim Taj Pharma is used in elderly patients or in patients taking high doses as these patients may be more susceptible to hyperkalaemia and hyponatraemia

Psychiatric disorders

Very rare: Depression, hallucinations, confusional states, agitation, anxiety, abnormal behavior, insomnia and nightmares.

Nervous system disorders

Common: Headache

Very rare: Dyskinesias, aseptic meningitis, tremor, ataxia, dizziness, lethargy, syncope, paraesthesiae, convulsions, peripheral neuritis, vertigo, tinnitus.

Aseptic meningitis was rapidly reversible on withdrawal of the drug, but recurred in a number of cases on re-exposure to either co-trimoxazole or to Trimethoprim Taj Pharma alone.

Eye disorders

Very rare: uveitis

Respiratory, thoracic and mediastinal disorders

Very rare: Cough, shortness of breath, wheeze, epistaxis

Gastrointestinal disorders

Common: Nausea, diarrhoea, vomiting.

Very rare: Constipation, glossitis, stomatitis, pseudomembranous colitis, pancreatitis.

Unknown: Sore mouth

Hepatobiliary disorders

Very rare: Disturbance in liver enzymes, elevation of serum transaminases, elevation of bilirubin levels, cholestatic jaundice, hepatic necrosis. Cholestatic jaundice and hepatic necrosis may be fatal.

Skin and subcutaneous tissue disorders

Common: Skin rashes, urticaria

Very rare: Photosensitivity, exfoliative dermatitis, fixed drug eruption, erythema multiforme, erythema nodusum, Stevens-Johnson Syndrome, toxic epidermal necrolysis, bullous dermatitis, purpura, angioedema

Unknown: Pruritis, Lyell’s syndrome (toxic epidermal necrolysis) carries a high mortality.

Musculoskeletal and connective tissue disorders

Very rare: Arthralgia and myalgia a

Renal and urinary disorders

Very rare: Impaired renal function (sometimes reported as renal failure), haematuria,

Unknown: Raised serum creatinine and blood urea nitrogen levels. It is not known however, whether this represents inhibition of creatinine tubular secretion or genuine renal dysfunction.

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

Treat symptomatically, gastric lavage and forced diuresis can be used.

Depression of haematopoiesis by Trimethoprim Taj Pharma can be counteracted by intramuscular injections of calcium folinate.

  1. Pharmacological properties

Pharmacodynamic properties

Pharmacotherapeutic group: Systemic antibacterial.

Mechanisms of action

Trimethoprim Taj Pharma is a dihydrofolate reductase inhibitor which affects the nucleoprotein metabolism of micro- organisms by interference in the folic-folinic acid systems, inhibiting the conversion of bacterial dihydrofolic acid to tetrahydrofolic acid, required for the synthesis of some amino acids. Its effects are considerably greater on the cells of micro-organisms than on the mammalian cells. Trimethoprim Taj Pharma may be bactericidal or bacteriostatic depending on growth conditions.

In vitro Trimethoprim Taj Pharma has effects on most Gram-positive and Gram-negative aerobic organisms, including enterobacteria such as E Coli, Proteus, Klebsiella pneumoniae, Streptococcus faecalis, Streptococcus pneumoniae, Haemophilus influenzae and Staphylococcus aureus.

It has no effect on Mycobacterium tuberculosis, Neisseria gonorrhoeae, Nocardia species, Pseudomonas aeruginosa, Treponema pallidum, Brucella abortis or anaerobic bacteria.

Mechanism(s) of resistance

Resistance to Trimethoprim Taj Pharma may be due to several mechanisms. Clinical resistance is often due to plasmid mediated dihydrofolate reductases that are resistant to Trimethoprim Taj Pharma: such genes may become incorporated into the chromosome via transposons. Resistance may also be due to overproduction of dihydrofolate reductase, changes in cell permeability, or bacterial mutants which are intrinsically resistant to Trimethoprim Taj Pharma because they depend on exogenous thymidine and thymine for growth. Emergence of resistance to Trimethoprim Taj Pharma does not appear to be any higher in areas where it is used alone than in areas where Trimethoprim Taj Pharma is used in combination with sulphonamides. Nonetheless, Trimethoprim Taj Pharma resistance has been reported in many species, and very high frequencies of resistance have been seen in some developing countries, particularly among Enterobacteriaceae.

EUCAST clinical MIC breakpoints to separate susceptible (S) pathogens from resistant (R) pathogens are:

EUCAST Species-related breakpoints (Susceptible •
EnterobacteriacStaphylococEnterococc
2/>42/>40.032/>1 *

*The activity of Trimethoprim Taj Pharma is uncertain against enterococci. Hence the wild type population is categorized asintermediate.

Pharmacokinetic properties

Trimethoprim Taj Pharma is rapidly and almost completely absorbed from the gastrointestinal track and peak concentration in the circulation occur about 1-4 hours after an oral dose. Peak plasma concentrations of about 1µg/ml have been reported after a single dose of 100mg. Approximately 40-70% is bound to plasma proteins. Tissue concentrations are reported to be higher than serum concentrations with particularly high concentrations occurring in the kidneys and lungs but concentrations in the cerebrospinal fluid are about one half of those in the blood. About 40 to 60% of a dose is excreted in the urine within 24 hours (mainly as unchanged drug) together with metabolites; hence, patients with impairment of renal function such as the elderly may require a reduction in dosage due to accumulation. Urinary concentrations are generally well above the MIC of common pathogens for more than 24 hours after the last dose. The half-life is approximately 8-10 hours. It appears in breast milk.

Preclinical safety data

Not relevant

6. Pharmaceutical particulars

List of excipients

Lactose monohydrate

Povidone K30, Crospovidone, Sodium starch glycolate (Type A), Magnesium stearate

Purified water

6.2. Incompatibilities

None reported

Shelf life

36 months

Special precautions for storage

Store below 25°C in a dry place. Protect from light.

Nature and contents of container

15/18/20/21/28/30/100/500 100 or 500 tablets. Also available in a PVC blister with aluminium lidding foil containing 28 tablets.

Not all pack size may be marketed

Special precautions for disposal and other handling

No special instructions

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

Trimethoprim Tablets USP 100mg Taj Pharma

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

(Trimethoprim Taj Pharma Tablets)

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 or pharmacist.
  • 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. This includes any side effects not listed in this leaflet, see section 4.

 WHAT IS IN THIS LEAFLET

  1. What Trimethoprim Taj Pharma Tablets are and what they are used for
  2. What you need to know before you take Trimethoprim Taj Pharma Tablets
  3. How to take Trimethoprim Taj Pharma Tablets
  4. Possible side effects
  5. How to store Trimethoprim Taj Pharma Tablets
  6. Contents of the pack and other information

1. WHAT TRIMETHOPRIM TABLETS ARE AND WHAT THEY ARE USED FOR

Trimethoprim Taj Pharma Tablets belong to a group of medicines known as antibacterials. They are used to kill a wide range of bacteria that cause infections in your body, primarily urinary and respiratory tract infections.

This medicine can also be used for prevention of recurrent urinary tract infections.

  1. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRIMETHOPRIM TABLETS

DO NOT take Trimethoprim Taj Pharma Tablets if you:

  • are allergic (hypersensitive) to trimethoprim or to any of the other ingredients (see section 6, Contents of the pack and other  information)
  • are pregnant
  • suffer from severe liver problems
  • suffer from any blood disorders such as anaemia

Trimethoprim Taj Pharma should not be administered to premature babies or infants under 4 months of age.

The tablet form is NOT recommended for use in children under 6 years

  • The oral liquid form should be used.

Warnings and precautions

Talk to your doctor or pharmacist before taking Trimethoprim Taj Pharma Tablets if you:

  • are pregnant
  • suffer from kidney problems/kidney disease or are having dialysis treatment.
  • have a deficiency (are low) in folic acid (may cause anaemia)
  • are at greater risk of high levels of potassium in your blood (hyperkalaemia), e.g. the elderly or those on higher doses
  • are also taking repaglinide (medicine for treating diabetes)
  • suffer from porphyria (a disorder that causes skin sensitivity to light, pain attacks and muscle weakness)
  • Trimethoprim Taj Pharma should not be given to premature babies or babies during the first few weeks of life.

You should let your doctor know and ask his/her advice if you suffer from or have ever had any of the above.

Trimethoprim Taj Pharma can increase potassium blood levels. Patients at risk of increased potassium blood levels include those with kidney problems, poorly controlled diabetes, or those on certain medicines or potassium supplements. The symptoms of severe hyperkalaemia might include muscle cramps, irregular heart rhythm, diarrhoea, nausea, dizziness or headache. Your doctor may perform blood tests to monitor your potassium blood levels.

Your doctor may wish to do regular blood tests if you need long-term treatment or are prone to anaemia.

Children

This dosage form is not suitable for use in children younger than 6 years.

Other medicines and Trimethoprim Taj Pharma

Please inform your doctor or pharmacist if you are taking, or have recently taken any other medicines, even those not prescribed. Your medicine may interfere with other medicines that you are taking.

Take care with the following medicines:

  • repaglinide, used to treat diabetes
  • procainamide, to treat abnormal heart rhythm
  • digoxin, to treat certain heart conditions
  • potassium supplements
  • medicines known as ACE inhibitors and angiotensin II antagonists (used to treat high blood pressure and certain heart conditions).
  • heparin (used to treat and prevent blood clots)
  • diuretics (water tablets such as furosemide, eplerenone, spironolactone, amiloride or triamterene)
  • rifampicin (antibiotic), used to treat TB
  • anticoagulants (to prevent clots from forming in the blood e.g. warfarin)
  • phenytoin, to treat epilepsy
  • pyrimethamine and dapsone, used to treat malaria
  • immunosuppressant drugs – used in cancer treatment (e.g.
  • methotrexate) or to treat organ rejection after transplant (e.g. azathioprine or ciclosporin)
  • bone marrow depressants
  • spironolactone

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or a planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Trimethoprim Taj Pharma should not be used in pregnancy. DO NOT take Trimethoprim Taj Pharma Tablets if you are pregnant. If you are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

There is no evidence to suggest that Trimethoprim Taj Pharma Tablets affect the ability to drive or operate machinery. Important information about some of the ingredients of Trimethoprim Taj Pharma Tablets

These tablets contain a sugar called lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

  1. HOW TO TAKE TRIMETHOPRIM TABLETS

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. They can be swallowed with a glass of water, but not chewed, at the same time each day.

Dosage

Adults and children over 12 years

Severe or sudden infections: usually your doctor will prescribe 200mg taken twice daily.

Long term treatment and prevention therapy: 100mg at night

Elderly

Dosage is dependent on kidney function.

Elderly patients with kidney problems will usually be prescribed a reduced dose.

Children aged 6 – 12 years

Severe or sudden infections: 100mg twice daily

Long term treatment and prevention therapy: 50mg at night. The usual dose is around 2mg/kg body weight of the child per day.

Children under 6

This tablet form of Trimethoprim Taj Pharma is not recommended for use in children under 6 years.

Your doctor has carefully chosen the correct dosage for you, taking into account the severity of your condition, your age and any other particular reasons special to you. Instructions on how many tablets to take and when to take them will be printed on the dispensing label on the pack.

Never change the dose of your medicine without talking to your doctor first.

If you take more of your medicine than you should

If you (your child or someone else) take too many tablets, tell a doctor or pharmacist or go to the nearest hospital casualty department straight away. Remember to take this leaflet and the tablet packaging with you.

If you forget to take your medicine

If you do forget to take a dose of your medicine at the correct time, take it as soon as you remember, then take the next dose at the right time. DO NOT take a double dose.

If you stop taking your medicine

Keep taking this medicine until your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking this medicine, your condition may re-occur or get worse. If you experience symptoms on stopping treatment, contact your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Trimethoprim Taj Pharma Tablets can cause side effects, although not everybody gets them.

Rare serious allergic reactions have occurred known as anaphylactic or anaphylactoid reactions.

STOP taking Trimethoprim Taj Pharma Tablets and contact your doctor or go to your nearest hospital casualty department IMMEDIATELY if you notice any of the following symptoms:

  • difficulty breathing
  • swelling of the face, lips, tongue and throat
  • chest pain
  • shock, fainting or collapse
  • blistering/peeling of the skin
  • pancreatitis (signs may include a sudden, severe upper abdominal pain)
  • skin eruptions/lesions
  • deep swelling of the skin (angioedema)
  • jaundice (yellowing of the skin or whites of the eyes)
  • elevation of serum transaminases (an indication of liver damage)
  • elevation of bilirubin levels

Tell your doctor or pharmacist if you notice any of the following side effects:

Very Common (may affect more than 1 in 10 people)

  • hyperkalaemia (particularly in the elderly and in HIV patients) which
  • is high levels of potassium in the blood (may result in abnormal heart rhythm)

Common (may affect up to 1 in 10 people)

  • headache
  • skin rashes
  • hives
  • thrush
  • nausea, diarrhoea, vomiting

Very rare (may affect up to 1 in 10,000 people)

  • constipation, severe watery/bloody diarrhoea
  • cough
  • agitation
  • abnormal behaviour
  • aseptic meningitis can occur in some patients. This may show as a combination of symptoms such as headache, fever, stiff neck,  tiredness, feeling ill and your eyes become very sensitive to bright light
  • kidney problems (signs may include painful urination or blood in the urine)
  • dizziness, tiredness
  • convulsions
  • involuntary movements
  • pins and needles, shakiness, tremors
  • ringing in the ears, vertigo
  • eye redness and pain
  • increased sensitivity of the skin to the sun
  • low blood sugar
  • low levels of sodium in the blood (may cause nausea, tiredness, muscle cramping)
  • anorexia
  • depression, anxiety, sleeping difficulties and nightmares
  • confusion, hallucinations
  • joint and muscle ache
  • shortness of breath, wheezing, nosebleeds
  • lupus erythematosus (an auto-immune disorder)
  • purple discolorations of the skin
  • hypersensitivity, anaphylaxis, anaphylactoid reaction drug fever, allergic vasculitis
  • reduction in numbers of blood cells
  • sore tongue and mouth
  • anaemia
  • sore throat

Unknown (frequency cannot be estimated)

  • pruritus (itching)
  • elevation of serum creatinine and blood urea nitrogen levels

If any side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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.

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

  1. HOW TO STORE TRIMETHOPRIM TABLETS

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not use Trimethoprim Taj Pharma Tablets after the ‘expiry date’ printed on the pack. The expiry date refers to the last day of that month.

Store your tablets below 25ºC (room temperature) in a dry place and protect from light. Keep it in the pack in which it was given to you. Do not transfer your tablets to another container. Return any leftover tablets to your pharmacist, unless your doctor tells you to keep them.

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. CONTENTS OF THE PACK AND OTHER INFORMATION

What Trimethoprim Taj Pharma Tablets contain

Trimethoprim Taj Pharma Tablets are available in two strengths, 100mg and 200mg. The active ingredient is trimethoprim, which is an antibiotic. Other ingredients are lactose monohydrate, povidone K30, crospovidone, sodium starch glycolate Type A and magnesium stearate.

What Trimethoprim Taj Pharma Tablets look like and contents of the pack

Trimethoprim Taj Pharma 100mg tablets are available in pack sizes of 28, 100 and 500.

Not all pack size 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