1. NAME OF THE MEDICINAL PRODUCT

Amoxicillin Capsules USP 250mg Taj Pharma
Amoxicillin Capsules USP 500mg Taj Pharma

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

a) Each capsule contains:
Amoxicillin trihydrate
Equivalent to amoxicillin        250mg
Excipients                                q.s

b) Each capsule contains:
Amoxicillin trihydrate
Equivalent to amoxicillin        500mg
Excipients                                  q.s

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Capsule.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Treatment of infection:

Amoxillin capsules is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1):

• Acute bacterial sinusitis
• Acute Otitis media
• Acute streptococcal tonsillitis and pharyngitis
• Acute exacerbations of chronic bronchitis
• Community acquired pneumonia
• Acute cystitis
• Asymptomatic Bacteriuria in pregnancy
• Acute pyelonephritis
• Typhoid and paratyphoid fever
• Dental abscess with spreading cellulitis
• Prosthetic joint infections
• Helicobacter pylori eradication
• Lyme disease

Amoxicillin is also indicated for the prophylaxis of endocarditis

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

4.2 Posology and method of administration

Posology

The dose of Amoxicillin that is selected to treat an individual infection should take into account:

• The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4)
• The severity and the site of the infection
• The age, weight and renal function of the patient; as shown below

The duration of therapy should be determined by the type of infection and the response of the patient, and should generally be as short as possible. Some infections require longer periods of treatment (see section 4.4 regarding prolonged therapy).

Adults and children ≥40 kg

Children <40 kg

Children weighing 40 kg or more should be prescribed the adult dosage.

Recommended doses:

Elderly

No dose adjustment is considered necessary.

Renal impairment

In patients receiving haemodialysis

Amoxicillin may be removed from the circulation by haemodialysis.

In patients receiving peritoneal dialysis

Amoxicillin maximum 500 mg/day.

Hepatic impairment

Dose with caution and monitor hepatic function at regular intervals (see sections 4.4 and 4.8).

Method of administration

Oral:

Amoxicillin is for oral use.

Absorption of Amoxicillin is unimpaired by food.

Swallow with water without opening capsule.

4.3 Contraindications

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

History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam).

4.4 Special warnings and precautions for use

Hypersensitivity reactions

Before initiating therapy with amoxicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam agencts (see sections 4.3 and 4.8).

Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions) have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of hypersensitivity and in atopic individuals. If an allergic reaction occurs, amoxicillin therapy must be discontinued and appropriate alternative therapy instituted.

Non-susceptible microorganisms

Amoxicillin is not suitable for the treatment of some types of infection unless the pathogen is already documented and known to be susceptible or there is a very high likelihood that the pathogen would be suitable for treatment with amoxicillin (see section 5.1). This particularly applies when considering the treatment of patients with urinary tract infections and severe infections of the ear, nose and throat.

Convulsions

Convulsions may occur in patients with impaired renal function or in those receiving high doses or in patients with predisposing factors (e.g. history of seizures, treated epilepsy or meningeal disorders (see section 4.8).

Renal impairment

In patients with renal impairment, the rate of excretion of amoxicillin will be reduced depending on the degree of impairment and it may be necessary to reduce the total daily unit amoxicillin dosage accordingly (see section 4.2).

Skin reactions

The occurrence at the treatment initiation of a feverish generalised erythema associated with pustula may be a symptom of acute generalised exanthemous pustulosis (AEGP, see section 4.8). This reaction requires amoxicillin discontinuation and contra-indicates any subsequent administration.

Amoxicillin should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.

Jarisch-Herxheimer reaction

The Jarisch-Herxheimer reaction has been seen following amoxicillin treatment of Lyme disease (see section 4.8). It results directly from the bactericidal activity of amoxicillin 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.

Overgrowth of non-susceptible microorganisms

Prolonged use may also occasionally result in overgrowth of non-susceptible organisms. Antibiotic-associated colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life threatening (see section 4.8). Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during, or subsequent to, the administration of any antibiotics. Should antibiotic-associated colitis occur, amoxicillin should immediately be discontinued, a physician consulted and an appropriate therapy initiated. Anti-peristaltic medicinal products are contra-indicated in this situation.

Prolonged therapy

Periodic assessment of organ system functions; including renal, hepatic and haematopoietic function is advisable during prolonged therapy. Elevated liver enzymes and changes in blood counts have been reported (see section 4.8).

Anticoagulants

Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin. Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation (see section 4.5 and 4.8).

Crystalluria:

In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria. In patients with bladder catheters, a regular check of patency should be maintained (see section 4.8 and 4.9).

Interference with diagnostic tests

Elevated serum and urinary levels of amoxicillin are likely to affect certain laboratory tests. Due to the high urinary concentrations of amoxicillin, false positive readings are common with chemical methods.

It is recommended that when testing for the presence of glucose in urine during amoxicillin treatment, enzymatic glucose oxidase methods should be used.

The presence of amoxicillin may distort assay results for oestriol in pregnant women.

Important information about excipients

The capsules contain sunset yellow, E110 which can cause allergic-type reactions including asthma.

4.5 Interaction with other medicinal products and other forms of interaction

Probenecid:

Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use of probenecid may result in increased and prolonged blood levels of amoxicillin.

Allopurinol:

Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.

Tetracyclines :

Tetracyclines and other bacteriostatic drugs may interfere with the bactericidal effects of amoxicillin.

Oral anticoagulants:

Oral anticoagulants and penicillin antibiotics have been widely used in practice without reports of interaction. However, in the literature there are cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin. Moreover, adjustments in the dose of oral anticoagulants may be necessary (see sections 4.4 and 4.8).

Methotrexate

Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.

4.6 Fertility, pregnancy and lactation

Pregnancy:

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Limited data on the use of amoxicillin during pregnancy in humans do not indicate an increased risk of congenital malformations. Amoxicillin may be used in pregnancy when the potential benefits outweigh the potential risks associated with treatment.

Breastfeeding

Amoxicillin is excreted into breast milk in small quantities with the possible risk of sensitisation. Consequently, diarrhoea and fungus infection of the mucous membranes are possible in the breast-fed infant, so that breast-feeding might have to be discontinued. Amoxicillin should only be used during breast-feeding after benefit/risk assessment by the physician in charge.

Fertility:

There are no data on the effects of amoxicillin on fertility in humans. Reproductive studies in animals have shown no effects on fertility.

4.7 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, undesirable effects may occur (e.g. allergic reactions, dizziness, convulsions), which may influence the ability to drive and use machines (see section 4.8).

4.8 Undesirable effects

The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and skin rash.

The ADRs derived from clinical studies and post-marketing surveillance with amoxicillin, presented by MedDRA System Organ Class are listed below.

The following terminologies have been used in order to classify the occurrence of undesirable effects.

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)

Not known (cannot be estimated from the available data)

*The incidence of these AEs was derived from clinical studies involving a total of approximately 6,000 adult and paediatric patients taking amoxicillin.

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

Symptoms and signs of overdose:

Gastrointestinal symptoms (such as nausea, vomiting and diarrhoea) and disturbance of the fluid and electrolyte balances may be evident. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed. Convulsions may occur in patients with impaired renal function or in those receiving high doses (see sections 4.4 and 4.8).

Treatment of intoxication:

Gastrointestinal symptoms may be treated symptomatically, with attention to the water/electrolyte balance.

Amoxicillin may be removed from the circulation by haemodialysis.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: penicillins with extended spectrum.

Mechanism of action

Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PBPs) in the biosynthetic pathway of bacterial peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually followed by cell lysis and death.

Amoxicillin is susceptible to degradation by beta-lactamases produced by resistant bacteria and therefore the spectrum of activity of amoxicillin alone does not include organisms which produce these enzymes.

Pharmacokinetic/pharmacodynamic relationship

The time above the minimum inhibitory concentration (T>MIC) is considered to be the major determinant of efficacy for amoxicillin.

Mechanisms of resistance

The main mechanisms of resistance to amoxicillin are:

• Inactivation by bacterial beta-lactamases.
• Alteration of PBPs, which reduce the affinity of the antibacterial agent for the target.

Impermeability of bacteria or efflux pump mechanisms may cause or contribute to bacterial resistance, particularly in Gram-negative bacteria.

Breakpoints

MIC breakpoints for amoxicillin are those of the European Committee on Antimicrobial Susceptibility Testing (EUCAST) version 5.0.

The prevalence of 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 the agent in at least some types of infections is questionable.

5.2 Pharmacokinetic properties

Oral

Absorption

Amoxicillin fully dissociates in aqueous solution at physiological pH. It is rapidly and well absorbed by the oral route of administration. Following oral administration, amoxicillin is approximately 70% bioavailable. The time to peak plasma concentration (T_max) is approximately one hour.

The pharmacokinetic results for a study, in which an amoxicillin dose of 250 mg three times daily was administered in the fasting state to groups of healthy volunteers are presented below.

In the range 250 to 3000 mg the bioavailability is linear in proportion to dose (measured as C_max and AUC). The absorption is not influenced by simultaneous food intake.

Haemodialysis can be used for elimination of amoxicillin.

Distribution

About 18% of total plasma amoxicillin is bound to protein and the apparent volume of distribution is around 0.3 to 0.4 l/kg.

Following intravenous administration, amoxicillin has been found in gall bladder, abdominal tissue, skin, fat, muscle tissues, synovial and peritoneal fluids, bile and pus. Amoxicillin does not adequately distribute into the cerebrospinal fluid.

From animal studies there is no evidence for significant tissue retention of drug-derived material. Amoxicillin, like most penicillins, can be detected in breast milk (see section 4.6).

Amoxicillin has been shown to cross the placental barrier (see section 4.6).

Biotransformation

Amoxicillin is partly excreted in the urine as the inactive penicilloic acid in quantities equivalent to up to 10 to 25% of the initial dose.

Elimination

The major route of elimination for amoxicillin is via the kidney.

Amoxicillin has a mean elimination half-life of approximately one hour and a mean total clearance of approximately 25 l/hour in healthy subjects. Approximately 60 to 70% of the amoxicillin is excreted unchanged in urine during the first 6 hours after administration of a single 250 mg or 500 mg dose of amoxicillin. Various studies have found the urinary excretion to be 50-85% for amoxicillin over a 24 hour period.

Concomitant use of probenecid delays amoxicillin excretion (see section 4.5).

Age

The elimination half-life of amoxicillin is similar for children aged around 3 months to 2 years and older children and adults. For very young children (including preterm newborns) in the first week of life the interval of administration should not exceed twice daily administration due to immaturity of the renal pathway of elimination. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Gender

Following oral administration of amoxicillin/ to healthy males and female subjects, gender has no significant impact on the pharmacokinetics of amoxicillin.

Renal impairment

The total serum clearance of amoxicillin decreases proportionately with decreasing renal function (see sections 4.2 and 4.4).

Hepatic impairment

Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals.

5.3 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.

Carcinogenicity studies have not been conducted with amoxicillin.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Each gelatin capsule contains: Gelatin (capsule body and cap), Magnesium stearate & Colloidal anhydrous silica.

Capsule colours: Carmoisine, Quinoline yellow, Yellow Iron Oxide & Titanium Dioxide.

Printing ink: Shellac, Dehydrated Alcohol, Isopropyl Alcohol, Butyl Alcohol, Propylene Glycol, Black Iron Oxide & Purified water.

6.2 Incompatibilities

Not applicable

6.3 Shelf life

36 months.

6.4 Special precautions for storage

Do not store above 25°C. Store in the original package.

6.5 Nature and contents of container

Amoxicillin capsules come in blister/bottle packs of 10, 14, 20, 30, 40, 50, 60, 90, 100 and 500 capsules.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special instructions for use/handling.

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

Amoxicillin Capsules USP 250mg/500mg
(Amoxicillin)

Package Leaflet: Information for The User

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 (or for your child) 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Amoxicillin.

What is in this leaflet:

1. What Amoxicillin is and what it is used for
   2. What you need to know before you take Amoxicillin
   3. How to take Amoxicillin
   4. Possible side effects
   5. How to store Amoxicillin
   6. Contents of the pack and other information
2. What Amoxicillin is and what it is used for

What Amoxicillin is

Amoxicillin is an antibiotic. The active ingredient is amoxicillin. This belongs to a group of medicines called ‘penicillins’.

What Amoxicillin is used for

Amoxicillin is used to treat infections caused by bacteria in different parts of the body. Amoxicillin may also be used in combination with other medicines to treat stomach ulcers.

2. What you need to know before you take Amoxicillin

Do not take Amoxicillin:

• if you are allergic to amoxicillin, penicillin or any of the other ingredients of this medicine (listed in section 6).
• if you have ever had an allergic reaction to any antibiotic. This can include a skin rash or swelling of the face or throat.

Do not take Amoxicillin if any of the above apply. If you are not sure, talk to your doctor or pharmacist before taking Amoxicillin.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Amoxicillin if you:

• have glandular fever (fever, sore throat, swollen glands and extreme tiredness)
• have kidney problems
• are not urinating regularly

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Amoxicillin.

Blood and urine tests

If you are having:

• Urine tests (glucose) or blood tests for liver function
• Oestriol tests (used during pregnancy to check the baby is developing normally)

Tell your doctor or pharmacist that you are taking Amoxil. This is because Amoxil can affect the results of these tests.

Other medicines and Amoxicillin

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

• If you are taking allopurinol (used for gout) with Amoxicillin, it may be more likely that you will have an allergic skin reaction.
• If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of Amoxicillin.
• If you are taking medicines to help stop blood clots (such as warfarin), you may need extra blood tests.
• If you are taking other antibiotics (such as tetracycline) Amoxicillin may be less effective.
• If you are taking methotrexate (used for the treatment of cancer and severe psoriasis) Amoxicillin may cause an increase in side effects.

Taking Amoxicillin capsules with food and drink

Amoxicillin capsules do not have known interactions with food or drink.

Pregnancy and breast-feeding

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

Amoxicillin can have side effects and the symptoms (such as allergic reactions, dizziness and convulsions) may make you unfit to drive.

Do not drive or operate machinery unless you are feeling well.

Important information about some of the ingredients of Amoxicillin Capsules

Amoxicillin 250mg capsules contain Carmoisine (E122) which may cause allergic reactions.

Amoxicillin 500mg capsules contain Carmoisine (E122) which may cause allergic reactions.

3. HOW TO TAKE AMOXICILLIN

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

• Swallow with water without opening capsule.
• Space the doses evenly during the day, at least 4 hours apart

The recommended dose is:

Children weighing less than 40 kg

All doses are worked out depending on the child’s body weight in kilograms.

• Your doctor will advise you how much Amoxicillin you should give to your baby or child.
• The usual dose is 40 mg to 90 mg for each kilogram of body weight a day, given in two or three divided doses.
• The maximum recommended dose is 100 mg for each kilogram of body weight a day.

Adults, elderly patients and children weighing 40 kg or more

The usual dose of Amoxicillin is 250 mg to 500 mg three times a day or 750 mg to 1 g every 12 hours, depending on the severity and type of infection.

• Severe infections:750 mg to 1 g three times a day.
• Urinary tract infection:3 g twice daily for one day.
• Lyme disease (an infection spread by parasites called ticks):Isolated erythema migrans (early stage – red or pink circular rash): 4 g a day, Systemic manifestations (late stage – for more serious symptoms or when the disease spreads around your body): up to 6 g a day.
• Stomach ulcers:one 750 mg or one 1 g dose twice a day for 7 days with other antibiotics and medicines to treat stomach ulcers.
• To prevent heart infection during surgery:the dose will vary according to the type of surgery. Other medicines may also be given at the same time. Your doctor, pharmacist or nurse can give you more details.
• The maximum recommended dose is 6 g per day.

Kidney problems

If you have kidney problems the dose might be lower than the usual dose.

If you take more Amoxicillin than you should

If you have taken too much Amoxicillin, signs might be an upset stomach (feeling sick, being sick or diarrhoea) or crystals in the urine, which may be seen as cloudy urine, or problems passing urine.

Talk to your doctor as soon as possible. Take the medicine to show the doctor.

If you forget to take Amoxicillin

• If you forget to take a dose don’t worry, take it as soon as you remember.
• Don’t take the next dose too soon, wait about 4 hours before taking the next dose.
• Do not take a double dose to make up for a forgotten dose.

How long should you take Amoxicillin for?

• Keep taking Amoxil for as long as your doctor has told you to, even if you feel better. You need every dose to help fight the infection. If some bacteria survive they can cause the infection to come back.
• Once you finish treatment, if you still feel unwell you should go back to see the doctor.

Thrush (a yeast infection of moist areas of the body which can cause soreness, itching and white discharge) may develop if Amoxicillin is used for a long time. If this occurs, tell your doctor.

If you take Amoxicillin for a long time, your doctor may perform additional tests to check your kidneys, liver and blood are working normally.

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

4. POSSIBLE SIDE EFFECTS

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

Stop taking Amoxicillin and see a doctor straight away, if you notice any of the following serious side effects – you may need urgent medical treatment:

The following are very rare (may affect up to 1 in 10,000 people)

• Allergic reactions, the signs may include: skin itching or rash, swelling of the face, lips, tongue, body or breathing difficulties. These can be serious and occasionally deaths have occurred
• Rash or pinpoint flat red round spots under the skin surface or bruising of the skin. This is due to inflammation of blood vessel walls due to an allergic reaction. It can be associated with joint pain (arthritis) and kidney problems
• A delayed allergic reaction can occur usually 7 to 12 days after having Amoxicillin, some signs include: rashes, fever, joint pains and enlargement of the lymph nodes especially under the arms
• A skin reaction known as ‘erythema multiforme’ where you may develop: itchy reddish purple patches on the skin especially on the palms of the hands or soles of the feet, ‘hive-like’ raised swollen areas on the skin, tender areas on the surfaces of the mouth, eyes and private parts. You may have a fever and be very tired
• Other severe skin reactions can include: changes in skin colour, bumps under the skin, blistering, pustules, peeling, redness, pain, itching, scaling. These may be associated with fever, headaches and body aches
• Flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).
• High temperature (fever), chills, a sore throat or other signs of an infection, or if you bruise easily. These may be signs of a problem with your blood cells
• The Jarisch-Herxheimer reactionwhich occurs during treatment with Amoxicillin for Lyme disease and causes fever, chills, headache, muscle pain and skin rash.
• Inflammation of the large bowel (colon) with diarrhoea sometimes containing blood, pain and fever
• Serious liver side effects may occur which are often reversible. Hepatitis and cholestatic jaundice, They are mainly associated with people having treatment over a long period, males and the elderly. You must tell your doctor urgently if you get:
  • severe diarrhoea with bleeding
  • blisters, redness or bruising of the skin
  • darker urine or paler stools
  • yellowing of the skin or the whites of the eyes (jaundice). See also anaemia below which might result in jaundice.

These can happen when having the medicine or for up to several weeks after.

If any of the above happen stop taking the medicine and see your doctor straight away.

Sometimes you may get less severe skin reactions such as:

• a mildly itchy rash (round, pink-red patches), ‘hive-like’ swollen areas on forearms, legs, palms, hands or feet. This is uncommon (affects less than 1 in 100 people).

If you have any of these talk to your doctor as Amoxicillin will need to be stopped.

The following side effects have been reported at the approximate frequencies shown:

Common (may affect up to 1 in 10 people):

• Diarrhoea
• Skin rash
• Feeling sick (nausea)

Uncommon (may affect up to 1 in 100 people):

• Being sick (vomiting)

Very Rare (may affects up to 1 in 10,000 people):

• Thrush (a yeast infection of the vagina, mouth or skin folds), you can get treatment for thrush from your doctor or pharmacist
• Kidney problems
• Fits (convulsions), seen in patients on high doses or with kidney problems
• Dizziness
• Hyperactivity
• Crystals in the urine, which may be seen as cloudy urine, or difficulty or discomfort in passing urine. Make sure you drink plenty of fluids to reduce the chance of these symptoms
• The tongue may change to yellow, brown or black and it may have a hairy appearance
• An excessive breakdown of red blood cells causing a form of anaemia. Signs include: tiredness, headaches, shortness of breath, dizziness, looking pale and yellowing of the skin and the whites of the eyes
• The blood may take longer to clot than it normally would. You may notice this if you have a nosebleed or cut yourself.
• Low number of white blood cells
• Low number of cells involved with blood clotting

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.

5. HOW TO STORE AMOXICILLIN

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

The capsules must be kept in their original package and stored in a dry place below 25°C. Do not use Amoxicillin after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month.

Do not use this medicine if there are visible signs of deterioration.

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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Amoxicillin contains:

The active ingredient is Amoxicillin (as amoxicillin trihydrate).

a) Each capsule contains:
Amoxicillin trihydrate
Equivalent to amoxicillin        250mg
Excipients                                q.s

b) Each capsule contains:
Amoxicillin trihydrate
Equivalent to amoxicillin        500mg
Excipients                                  q.s

Each gelatin capsule contains: Gelatin (capsule body and cap), Magnesium stearate & Colloidal anhydrous silica.

Capsule colours: Carmoisine, Quinoline yellow, Yellow Iron Oxide & Titanium Dioxide.

Printing ink: Shellac, Dehydrated Alcohol, Isopropyl Alcohol, Butyl Alcohol, Propylene Glycol, Black Iron Oxide & Purified water.

What Amoxicillin looks like and contents of the pack:

Amoxicillin capsules come in blister/bottle packs of 10, 14, 20, 30, 40, 50, 60, 90, 100 and 500 capsules.

Not all pack sizes may be marketed.

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