Cefuroxime Tablets USP 250mg Taj Pharma

Name of the medicinal product

Cefuroxime Tablets USP 250mg Taj Pharma
Cefuroxime Tablets USP 500mg Taj Pharma

Qualitative and quantitative composition

a) Cefuroxime Tablets USP 250mg Taj Pharma
Each film coated tablets contains:
Cefuroxime Axetil USP
Equivalent to Cefuroxime USP 250mg
Excipients: Q.S.

b) Cefuroxime Tablets USP 500mg Taj Pharma
Each film coated tablets contains:
Cefuroxime Axetil USP
Equivalent to Cefuroxime USP 500mg
Excipients: Q.S.

Excipients with known effect:

1 tablet contains 0.3mg aspartame

For the full list of excipients: see section 6.1.

Pharmaceutical form

Film-coated tablets
White to slightly yellowish, biconvex, oblong tablets scored on both sides.

The tablet can be divided into equal doses.

Clinical particulars

Therapeutic indications

Cefuroxime Taj Pharma axetil is indicated for the treatment of the infections listed below in adults and children from the age of 3 months (see sections 4.4 and 5.1).

Acute streptococcal tonsillitis and pharyngitis.
Acute bacterial sinusitis.
Acute otitis media.
Acute exacerbations of chronic bronchitis.
Cystitis
Uncomplicated skin and soft tissue infections.
Treatment of early Lyme disease.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Posology and method of administration

Posology

The usual course of therapy is seven days (may range from five to ten days).

Table 1. Adults and children (≥40 kg)

Indication	Dosage
Acute tonsillitis and pharyngitis, acute bacterial sinusitis	250mg twice daily
Acute otitis media	500mg twice daily
Acute exacerbations of chronic bronchitis	500mg twice daily
Cystitis	250mg twice daily
Pyelonephritis	250mg twice daily
Uncomplicated skin and soft tissue infections	250mg twice daily
Lyme disease	500mg twice daily for 14 days (range of 10 to 21 days)

Table 2. Children (<40 kg)

Indication	Dosage
Acute tonsillitis and pharyngitis, acute bacterial sinusitis	10mg/kg twice daily to a maximum of 125mg twice daily
Children aged two years or older with otitis media or, where appropriate, with more severe infections	15mg/kg twice daily to a maximum of 250mg twice daily
Cystitis	15mg/kg twice daily to a maximum of 250mg twice daily
Pyelonephritis	15mg/kg twice daily to a maximum of 250mg twice daily for 10 to 14 days
Uncomplicated skin and soft tissue infections	15mg/kg twice daily to a maximum of 250mg twice daily
Lyme disease	15mg/kg twice daily to a maximum of 250mg twice daily for 14 days (10 to 21 days)

There is no experience of using Cefuroxime Taj Pharma axetil in children under the age of 3 months.

Renal impairment

The safety and efficacy of Cefuroxime Taj Pharma axetil in patients with renal failure have not been established.

Cefuroxime Taj Pharma is primarily excreted by the kidneys. In patients with markedly impaired renal function it is recommended that the dosage of Cefuroxime Taj Pharma should be reduced to compensate for its slower excretion. Cefuroxime Taj Pharma is effectively removed by dialysis.

Table 3. Recommended doses for Cefuroxime Taj Pharma axetil in renal impairment

Creatinine clearance	T_1/2 (hrs)	Recommended dosage
≥30 mL/min/1.73 m²	1.4–2.4	no dose adjustment necessary (standard dose of 125mg to 500mg given twice daily)
10-29 mL/min/1.73 m²	4.6	standard individual dose given every 24 hours
<10 mL/min/1.73 m²	16.8	standard individual dose given every 48 hours
Patients on haemodialysis	2–4	a further standard individual dose should be given at the end of each dialysis

Hepatic impairment

There are no data available for patients with hepatic impairment. Since Cefuroxime Taj Pharma is primarily eliminated by the kidney, the presence of hepatic dysfunction is expected to have no effect on the pharmacokinetics of Cefuroxime Taj Pharma.

Method of administration

Oral use

Cefuroxime Taj Pharma axetil tablets should be taken after food for optimum absorption.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Patients with known hypersensitivity to cephalosporin antibiotics.

History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of betalactam antibacterial agent (penicillins, monobactams and carbapenems).

Special warnings and precautions for use

Hypersensitivity reactions

Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactam antibiotics because there is a risk of cross-sensitivity. As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported. In case of severe hypersensitivity reactions, treatment with Cefuroxime Taj Pharma must be discontinued immediately and adequate emergency measures must be initiated.

Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to Cefuroxime Taj Pharma, to other cephalosporins or to any other type of beta-lactam agent. Caution should be used if Cefuroxime Taj Pharma is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents.

Jarisch-Herxheimer reaction

The Jarisch-Herxheimer reaction has been seen following Cefuroxime Taj Pharma axetil treatment of Lyme disease. It results directly from the bactericidal activity of Cefuroxime Taj Pharma axetil on the causative bacteria of Lyme disease, the spirochaete Borrelia burgdorferi. Patients should be reassured that this is a common and usually self-limiting consequence of antibiotic treatment of Lyme disease (see section 4.8).

Overgrowth of non-susceptible microorganisms

As with other antibiotics, use of Cefuroxime Taj Pharma axetil may result in the overgrowth of Candida. Prolonged use may also result in the overgrowth of other non-susceptible microorganisms (e.g. enterococci and Clostridium difficile), which may require interruption of treatment (see section 4.8).

Antibacterial agent–associated pseudomembranous colitis have been reported with nearly all antibacterial agents, including Cefuroxime Taj Pharma and may range in severity from mild to life threatening. This diagnosis should be considered in patients with diarrhoea during or subsequent to the administration of Cefuroxime Taj Pharma (see section 4.8). Discontinuation of therapy with Cefuroxime Taj Pharma and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given (see section 4.8).

Interference with diagnostic tests

The development of a positive Coomb’s Test associated with the use of Cefuroxime Taj Pharma may interfere with cross matching of blood (see section 4.8).

As a false negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase methods are used to determine blood/plasma glucose levels in patients receiving Cefuroxime Taj Pharma axetil.

Important information about excipients

Special care should be taken with phenylketonuric patients because of the aspartame containing coating.

Cefuroxime Taj Pharma axetil 125mg coated tablets contain 0.2mg aspartame per tablet.

Cefuroxime Taj Pharma axetil 250mg coated tablets contain 0.3mg aspartame per tablet.

Interaction with other medicinal products and other forms of interaction

Drugs which reduce gastric acidity may result in a lower bioavailability of Cefuroxime Taj Pharma axetil compared with that of the fasting state and tend to cancel the effect of enhanced absorption after food.

Cefuroxime Taj Pharma is excreted by glomerular filtration and tubular secretion. Concomitant use of probenecid is not recommended. Concurrent administration of probenecid significantly increases the peak concentration, area under the serum concentration time curve and elimination half-life of Cefuroxime Taj Pharma.

Concomitant use with oral anticoagulants may give rise to increased INR.

Fertility, pregnancy and lactation

Pregnancy

There are limited data from the use of Cefuroxime Taj Pharma in pregnant women. Studies in animals have shown no harmful effects on pregnancy, embryonal or foetal development, parturition or postnatal development. Cefuroxime Taj Pharma axetil should be prescribed to pregnant women only if the benefit outweighs the risk.

Breastfeeding

Cefuroxime Taj Pharma is excreted in human milk in small quantities. Adverse effects at therapeutic doses are not expected, although a risk of diarrhoea and fungus infection of the mucous membranes cannot be excluded. Breastfeeding might have to be discontinued due to these effects. The possibility of sensitisation should be taken into account. Cefuroxime Taj Pharma should only be used during breastfeeding after benefit/risk assessment by the physician in charge.

Fertility

There are no data on the effects of Cefuroxime Taj Pharma axetil on fertility in humans. Reproductive studies in animals have shown no effects on fertility.

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, as this medicine may cause dizziness, patients should be warned to be cautious when driving or operating machinery.

Undesirable effects

The most common adverse reactions are Candida overgrowth, eosinophilia, headache, dizziness, gastrointestinal disturbances and transient rise in liver enzymes.

The frequency categories assigned to the adverse reactions below are estimates, as for most reactions suitable data (for example from placebo-controlled studies) for calculating incidence were not available. In addition the incidence of adverse reactions associated with Cefuroxime Taj Pharma axetil may vary according to the indication.

Data from large clinical studies were used to determine the frequency of very common to rare undesirable effects. The frequencies assigned to all other undesirable effects (i.e. those occurring at <1/10,000) were mainly determined using post-marketing data and refer to a reporting rate rather than true frequency. Placebo-controlled trial data were not available. Where incidences have been calculated from clinical trial data, these were based on drug-related (investigator assessed) data. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Treatment related adverse reactions, all grades, are listed below by MedDRA body system organ class, frequency and grade of severity. The following convention has been utilised for the classification of frequency: very common ≥ 1/10; common ≥ 1/100 to < 1/10, uncommon ≥ 1/1,000 to < 1/100; rare ≥ 1/10,000 to < 1/1,000; very rare < 1/10,000 and not known (cannot be estimated from the available data).

System organ class	Common	Uncommon	Not known
Infections and infestations	Candida overgrowth		Clostridium difficile overgrowth
Blood and lymphatic system disorders	eosinophilia	positive Coomb’s test, thrombocytopenia, leukopenia (sometimes profound)	haemolytic anaemia
Immune system disorders			drug fever, serum sickness, anaphylaxis, Jarisch-Herxheimer reaction
Nervous system disorders	headache, dizziness
Gastrointestinal disorders	diarrhoea, nausea, abdominal pain	vomiting	pseudomembranous colitis
Hepatobiliary disorders	transient increases of hepatic enzyme levels		jaundice (predominantly cholestatic), hepatitis
Skin and subcutaneous tissue disorders		skin rashes	urticaria, pruritus, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (exanthematic necrolysis) (see Immune system disorders), angioneurotic oedema
Description of selected adverse reactions Cephalosporins as a class tend to be absorbed onto the surface of red cells membranes and react with antibodies directed against the drug to produce a positive Coombs’ test (which can interfere with cross-matching of blood) and very rarely haemolytic anaemia. Transient rises in serum liver enzymes have been observed which are usually reversible.

Paediatric population

The safety profile for Cefuroxime Taj Pharma axetil in children is consistent with the profile in adults.

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 can lead to neurological sequelae including encephalopathy, convulsions and coma. Symptoms of overdose can occur if the dose is not reduced appropriately in patients with renal impairment (see sections 4.2 and 4.4).

Serum levels of Cefuroxime Taj Pharma can be reduced by haemodialysis and peritoneal dialysis.

Pharmacological properties
- Pharmacodynamic properties

Pharmacotherapeutic group: antibacterials for systemic use, second-generationce phalosporins,

Mechanism of action

Cefuroxime Taj Pharma axetil undergoes hydrolysis by esterase enzymes to the active antibiotic, Cefuroxime Taj Pharma.

Cefuroxime Taj Pharma inhibits bacterial cell wall synthesis following attachment to penicillin binding proteins (PBPs). This results in the interruption of cell wall (peptidoglycan) biosynthesis, which leads to bacterial cell lysis and death.

Mechanism of resistance

Bacterial resistance to Cefuroxime Taj Pharma may be due to one or more of the following mechanisms:

hydrolysis by beta-lactamases; including (but not limited to) by extended-spectrum beta-lactamases (ESBLs), and AmpC enzymes that may be induced or stably derepressed in certain aerobic Gram-negative bacteria species;
reduced affinity of penicillin-binding proteins for Cefuroxime Taj Pharma;
outer membrane impermeability, which restricts access of Cefuroxime Taj Pharma to penicillin binding proteins in Gram-negative bacteria;
bacterial efflux pumps.

Organisms that have acquired resistance to other injectable cephalosporins are expected to be resistant to Cefuroxime Taj Pharma.

Depending on the mechanism of resistance, organisms with acquired resistance to penicillins may demonstrate reduced susceptibility or resistance to Cefuroxime Taj Pharma.

Cefuroxime Taj Pharma axetil breakpoints

Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:

Microorganism	Breakpoints (mg/L)
	S	R
Enterobacteriaceae ^{1, 2}	≤8	>8
Staphylococcus spp.	Note³	Note³
Streptococcus A, B, C and G	Note⁴	Note⁴
Streptococcus pneumoniae	≤0.25	>0.5
Moraxella catarrhalis	≤0.125	>4
Haemophilus influenzae	≤0.125	>1
Non-species related breakpoints¹	IE⁵	IE⁵
¹The cephalosporin breakpoints for Enterobacteriaceae will detect all clinically important resistance mechanisms (including ESBL and plasmid mediated AmpC). Some strains that produce beta-lactamases are susceptible or intermediate to 3rd or 4th generation cephalosporins with these breakpoints and should be reported as found, i.e. the presence or absence of an ESBL does not in itself influence the categorization of susceptibility. In many areas, ESBL detection and characterization is recommended or mandatory for infection control purposes. ²Uncomplicated UTI (cystitis) only (see section 4.1). ³Susceptibility of staphylococci to cephalosporins is inferred from the methicillin susceptibility except for ceftazidme and cefixime and ceftibuten, which do not have breakpoints and should not be used for staphylococcal infections. ⁴The beta-lactam susceptibility of beta-haemolytic streptococci groups A, B, C and G is inferred from the penicillin susceptibility. ⁵insufficient evidence that the species in question is a good target for therapy with the drug. An MIC with a comment but without an accompanying S or R-categorization may be reported.

S=susceptible, R=resistant

Microbiological susceptibility

The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of Cefuroxime Taj Pharma axetil in at least some types of infections is questionable.

Cefuroxime Taj Pharma is usually active against the following microorganisms in vitro.

Commonly susceptible species

Gram-positive aerobes:

Staphylococcus aureus (methicillin-susceptible)*

Coagulase negative staphylococcus (methicillin susceptible)

Streptococcus pyogenes

Streptococcus agalactiae

Gram-negative aerobes:

Haemophilus influenzae

Haemophilus parainfluenzae

Moraxella catarrhalis

Spirochaetes:

Borrelia burgdorferi

Microorganisms for which acquired resistance may be a problem

Gram-positive aerobes:

Streptococcus pneumoniae

Gram-negative aerobes:

Citrobacter freundii

Enterobacter aerogenes

Enterobacter cloacae

Escherichia coli

Klebsiella pneumoniae

Proteus mirabilis

Proteus spp. (other than P. vulgaris)

Providencia spp.

Gram-positive anaerobes:

Peptostreptococcus spp.

Propionibacterium spp.

Gram-negative anaerobes:

Fusobacterium spp.

Bacteroides spp.

Inherently resistant microorganisms

Gram-positive aerobes:

Enterococcus faecalis

Enterococcus faecium

Gram-negative aerobes:

Acinetobacter spp.

Campylobacter spp.

Morganella morganii

Proteus vulgaris

Pseudomonas aeruginosa

Serratia marcescens

Gram-negative anaerobes:

Bacteroides fragilis

Others:

Chlamydia spp.

Mycoplasma spp.

Legionella spp.

* All methicillin-resistant S. aureus are resistant to Cefuroxime Taj Pharma.

Pharmacokinetic properties

Absorption

After oral administration Cefuroxime Taj Pharma axetil is absorbed from the gastrointestinal tract and rapidly hydrolysed in the intestinal mucosa and blood to release Cefuroxime Taj Pharma into the circulation. Optimum absorption occurs when it is administered shortly after a meal.

Following administration of Cefuroxime Taj Pharma axetil tablets peak serum levels (2.9 μg/mL for a 125mg dose, 4.4 μg/mL for a 250mg dose, 7.7 μg/mL for a 500mg dose and 13.6 μg/mL for a 1000mg dose) occur approximately 2.4 hours after dosing when taken with food. The pharmacokinetics of Cefuroxime Taj Pharma is linear over the oral dosage range of 125 to 1000mg. No accumulation of Cefuroxime Taj Pharma occurred following repeat oral doses of 250 to 500mg.

Distribution

Protein binding has been stated as 33 to 50% depending on the methodology used. Following a single dose of Cefuroxime Taj Pharma axetil 500mg tablet to 12 healthy volunteers, the apparent volume of distribution was 50 L (CV%=28%). Concentrations of Cefuroxime Taj Pharma in excess of the minimum inhibitory levels for common pathogens can be achieved in the tonsilla, sinus tissues, bronchial mucosa, bone, pleural fluid, joint fluid, synovial fluid, interstitial fluid, bile, sputum and aqueous humor. Cefuroxime Taj Pharma passes the blood-brain barrier when the meninges are inflamed.

Biotransformation

Cefuroxime Taj Pharma is not metabolised.

Elimination

The serum half-life is between 1 and 1.5 hours. Cefuroxime Taj Pharma is excreted by glomerular filtration and tubular secretion. The renal clearance is in the region of 125 to 148 mL/min/1.73 m².

Special patient populations

Gender

No differences in the pharmacokinetics of Cefuroxime Taj Pharma were observed between males and females.

Elderly

No special precaution is necessary in the elderly patients with normal renal function at dosages up to the normal maximum of 1 g per day. Elderly patients are more likely to have decreased renal function; therefore, the dose should be adjusted in accordance with the renal function in the elderly (see section 4.2).

Paediatrics population

In older infants (aged >3 months) and in children, the pharmacokinetics of Cefuroxime Taj Pharma are similar to that observed in adults.

There is no clinical trial data available on the use of Cefuroxime Taj Pharma axetil in children under the age of 3 months.

Renal impairment

The safety and efficacy of Cefuroxime Taj Pharma axetil in patients with renal failure have not been established.

Cefuroxime Taj Pharma is primarily excreted by the kidneys. Therefore, as with all such antibiotics, in patients with markedly impaired renal function (i.e. C1cr <30 mL/minute) it is recommended that the dosage of Cefuroxime Taj Pharma should be reduced to compensate for its slower excretion (see section 4.2). Cefuroxime Taj Pharma is effectively removed by dialysis.

Hepatic impairment

PK/PD relationship

For cephalosporins, the most important pharmacokinetic-pharmacodynamic index correlating with in vivo efficacy has been shown to be the percentage of the dosing interval (%T) that the unbound concentration remains above the minimum inhibitory concentration (MIC) of Cefuroxime Taj Pharma for individual target species (i.e. %T>MIC).

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development. No carcinogenicity studies have been performed; however, there is no evidence to suggest carcinogenic potential.

Gamma glutamyl transpeptidase activity in rat urine is inhibited by various cephalosporins, however the level of inhibition is less with Cefuroxime Taj Pharma. This may have significance in the interference in clinical laboratory tests in humans.

Pharmaceutical particulars

List of excipients

Core: sodium laurylsulfate, copovidone, croscarmellose sodium, magnesium stearate, colloidal anhydrous silica, granulated mannitol, microcrystalline cellulose, crospovidone, talc.

Coat: mannitol, soluble starch (potato), talc, titanium dioxide, aspartame

Incompatibilities

Not applicable

Shelf life

Al/Al strip:	36 months
Al/Al blister:	36 months

Special precautions for storage

Al/Al strip:	Store in the original packaging in order to protect from moisture
Al/Al blister:	Store in the original packaging in order to protect from moisture

This medicinal product does not require any special temperature storage conditions

Nature and contents of container

Al/Al strip packaging

Al/Al blister packaging

Pack sizes:

250mg: 8, 10, 12, 14, 15, 16, 20, 24 and 500 tablets

500mg: 8, 10, 12, 14, 15, 16, 20, 24 and 500 tablets

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

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

Package Leaflet: Information for the user

Cefuroxime Taj Pharma tablets USP 500mg Taj Pharma

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 or nurse.
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 or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

What Cefuroxime Taj Pharma is and what it is used for
What you need to know before you take Cefuroxime Taj Pharma
How to take Cefuroxime Taj Pharma
Possible side effects
How to store Cefuroxime Taj Pharma
Contents of the pack and other information

1.What Cefuroxime Taj Pharma is and what it is used for

Cefuroxime Taj Pharma is an antibiotic used in adults and children. It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Cefuroxime Taj Pharma is used to treat infections of:

the throat
sinus
middle ear
the lungs or chest
the urinary tract
the skin and soft tissues.

Cefuroxime Taj Pharma can also be used:

to treat Lyme disease (an infection spread by parasites called ticks).

Your doctor may test the type of bacteria causing your infection and monitor whether

the bacteria are sensitive to Cefuroxime Taj Pharma during your treatment.

What you need to know before you take Cefuroxime Taj Pharma

Do not take Cefuroxime Taj Pharma:

if you are allergic to Cefuroxime Taj Pharma axetil or any cephalosporin antibiotics or any of the other ingredients of Cefuroxime Taj Pharma (listed in section 6).
if you have ever had a severe allergic (hypersensitive) reaction to any other type of betalactam antibiotic (penicillins, monobactams and carbapenems).

If you think this applies to you, don’t take Cefuroxime Taj Pharma until you have checked with your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Cefuroxime Taj Pharma.

Children

Cefuroxime Taj Pharma is not recommended for children aged under 3 months, as the safety and effectiveness are not known in this age group.

You must look out for certain symptoms, such as allergic reactions, fungal infections

(such as candida) and severe diarrhoea (pseudomembranous colitis) while you are taking Cefuroxime Taj Pharma. This will reduce the risk of any problems. See ‘Conditions you need to look out for’ in Section 4.

If you need a blood test

Cefuroxime Taj Pharma can affect the results of a test for blood sugar levels, or a blood screen called the Coombs test. If you need a blood test:

Tell the person taking the sample that you are taking Cefuroxime Taj Pharma.

Other medicines and Cefuroxime Taj Pharma

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Medicines used to reduce the amount of acid in your stomach (e.g. antacids used to treat heartburn) can affect how Cefuroxime Taj Pharma works.

Probenecid

Oral anticoagulants

Tell your doctor or pharmacist if you are taking any medicine like this.

Contraceptive pills

Cefuroxime Taj Pharma may reduce the effectiveness of the contraceptive pill. If you are taking the contraceptive pill while you are being treated with Cefuroxime Taj Pharma you also need to use a barrier method of contraception (such as condoms). Ask your doctor for advice.

Pregnancy and breast-feeding and fertility

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

Cefuroxime Taj Pharma can make you dizzy and have other side effects that make you less alert.

Don’t drive or use machines if you do not feel well.

Important information about some of the ingredients of Cefuroxime Taj Pharma

Cefuroxime Taj Pharma tablets contain parabens which may cause allergic reactions (possibly delayed).
This medicine contains 0.00152mg sodium benzoate in each 125mg tablet
This medicine contains 0.00203mg sodium benzoate in each 250mg tablet
This medicine contains less than 1 mmol (23mg) sodium, that is to say essentially ‘sodium free’.

Check with your doctor that Cefuroxime Taj Pharma is suitable for you

How to take Cefuroxime Taj Pharma

Always take this medicine exactly as your doctor or pharmacist has told you to. Check with your doctor or pharmacist if you are not sure.

Take Cefuroxime Taj Pharma after food. This will help to make the treatment more effective.

Swallow Cefuroxime Taj Pharma tablets whole with some water.

Don’t chew, crush or split the tablets — this may make the treatment less effective.

The recommended dose

Adults

The recommended dose of Cefuroxime Taj Pharma is 250mg to 500mg twice daily depending on the severity and type of infection.

Children

The recommended dose of Cefuroxime Taj Pharma is 10mg/kg (to a maximum of 125mg) to 15mg/kg (to a maximum of 250mg) twice daily depending on:

the severity and type of infection Cefuroxime Taj Pharma is not recommended for children aged under 3 months, as the safety and effectiveness are not known in this age group.

Depending on the illness or how you or your child responds to treatment, the initial

dose may be changed or more than one course of treatment may be needed.

Patients with kidney problems

If you have a kidney problem, your doctor may change your dose.

Talk to your doctor if this applies to you.

If you take more Cefuroxime Taj Pharma than you should

If you take too much Cefuroxime Taj Pharma you may have neurological disorders, in particular you may be more likely to have fits (seizures).

Don’t delay. Contact your doctor or your nearest hospital emergency department immediately. If possible, show them the Cefuroxime Taj Pharma pack.

If you forget to take Cefuroxime Taj Pharma

Do not take a double dose to make up for a forgotten dose. Just take your next dose at the usual time.

If you stop taking Cefuroxime Taj Pharma

Don’t stop Cefuroxime Taj Pharma without advice

It is important that you take the full course of Cefuroxime Taj Pharma. Don’t stop unless your doctor advises you to – even if you are feeling better. If you don’t complete the full course of treatment, the infection may come back.

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

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Conditions you need to look out for

A small number of people taking Cefuroxime Taj Pharma get an allergic reaction or potentially serious skin reaction. Symptoms of these reactions include:

severe allergic reaction. Signs include raised and itchy rash, swelling, sometimes of the face or mouth causing difficulty in breathing.
skin rash, which may blister, and looks like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge).
a widespread rash with blisters and peeling skin. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis).

Other conditions you need to look out for while taking Cefuroxime Taj Pharma include:

fungal infections. Medicines like Cefuroxime Taj Pharma can cause an overgrowth of yeast (Candida) in the body which can lead to fungal infections (such as thrush). This side effect is more likely if you take Cefuroxime Taj Pharma for a long time.
severe diarrhoea (Pseudomembranous colitis). Medicines like Cefuroxime Taj Pharma can cause inflammation of the colon (large intestine), causing severe diarrhoea, usually with blood and mucus, stomach pain, fever.
Jarisch-Herxheimer reaction. Some patients may get a high temperature (fever), chills, headache, muscle pain and skin rash while being treated with Cefuroxime Taj Pharma for Lyme disease. This is known as the Jarisch-Herxheimer reaction.

Symptoms usually last a few hours or up to one day.

Contact a doctor or nurse immediately if you get any of these symptoms.

Common side effects

These may affect up to 1 in 10 people:

fungal infections (such as Candida)
headache
dizziness
diarrhoea
feeling sick
stomach pain.

Common side effects that may show up in blood tests:

an increase in a type of white blood cell (eosinophilia)
an increase in liver enzymes.

Uncommon side effects

These may affect up to 1 in 100 people:

being sick
skin rashes.

Uncommon side effects that may show up in blood tests:

a decrease in the number of blood platelets (cells that help blood to clot)
a decrease in the number of white blood cells
positive Coomb’s test.

Other side effects

Other side effects have occurred in a very small number of people, but their exact frequency is unknown:

severe diarrhoea (pseudomembranous colitis)
allergic reactions
skin reactions (including severe)
high temperature (fever)
yellowing of the whites of the eyes or skin
inflammation of the liver (hepatitis).
Side effects that may show up in blood tests:
red blood cells destroyed too quickly (haemolytic anaemia).

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.

How to store Cefuroxime Taj Pharma

Keep this medicine out of the sight and reach of children.

Store in the original pack at or below 30°C.

Do not use Cefuroxime Taj Pharma if the tablets are chipped or there are other visible signs of deterioration.

Do not use this medicine after the expiry date which is stated on the pack after EXP.

The expiry date refers to the last day of that month.

Don’t throw away any medicines via wastewater or household waste. Ask your

pharmacist how to throw away medicines you no longer use. These measures will

help to protect the environment.

Contents of the pack and other information

What Cefuroxime Taj Pharma contains

The active substance in each tablet is 125mg or 250mg Cefuroxime Taj Pharma (present as Cefuroxime Taj Pharma axetil).
The other ingredients are microcrystalline cellulose, croscarmellose sodium type A, sodium lauryl sulphate, hydrogenated vegetable oil, silica colloidal anhydrous, hypromellose, propylene glycol, methyl parahydroxybenzoate, propyl

parahydroxybenzoate and Opaspray white M-1- [containing titanium dioxide and sodium benzoate].

What Cefuroxime Taj Pharma looks like and contents of the pack

Cefuroxime Taj Pharma Tablets 250mg are white, film-coated, capsule-shaped tablets. They are packaged in aluminium foil blister packs, enclosed in a carton.
Each pack contains 6, 10, 12, 14, 16, 20, 24 and 50 tablets.

Cefuroxime Taj Pharma Tablets 500mg are white to off white, film-coated, capsule-shaped tablets.They are packaged in aluminium foil blister packs, enclosed in a carton.
Each pack contains 6, 10, 12, 14, 16, 20, 24 and 50 tablets.

Pack sizes:

250mg: 8, 10, 12, 14, 15, 16, 20, 24 and 500 tablets

500mg: 8, 10, 12, 14, 15, 16, 20, 24 and 500 tablets

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