Amoxicillin 500mg capsules

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:
Amoxicillin trihydrate
Available from:
Brown & Burk UK Ltd
ATC code:
J01CA04
INN (International Name):
Amoxicillin trihydrate
Dosage:
500mg
Pharmaceutical form:
Capsule
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 05010103; GTIN: 5060124640822
Authorization number:
PL 25298/0089

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Package Leaflet (PIL)

Package leaflet: Information for the user

Amoxicillin 250mg & 500 mg Capsules

(Amoxicillin)

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 sign of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. See section 4.

What is in this leaflet

What Amoxicillin capsules is and what it is used for

What you need to know before you take Amoxicillin capsules

How to take Amoxicillin capsules

Possible side effects

How to store Amoxicillin capsules

Contents of the pack and other information.

1.

What Amoxicillin capsules is and what it is used for

What Amoxicillin Capsule is

Amoxicillin 250 mg and 500 mg Capsules is an antibiotic. The active ingredient is amoxicillin. This

belongs to a group of medicines called ‘penicillins’.

What Amoxicillin Capsule is used for

Amoxicillin Capsule is used to treat infections caused by bacteria in different parts of the body.

Amoxicillin Capsule may also be used in combination with other medicines to treat stomach ulcers.

2.

What

you need to know before you take Amoxicillin capsules

Do not take Amoxicillin capsule:

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 Capsules if any of the above apply. If you are not sure, talk to your doctor or

pharmacist before taking Amoxicillin Capsules.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Amoxicillin Capsule 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 Capsules.

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 Amoxicillin Capsule. This is because Amoxicillin

Capsule can affect the results of these tests.

Other medicines and Amoxicillin Capsules

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 Capsules, 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 Capsules.

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 Capsules may be less effective.

If you are taking methotrexate (used for the treatment of cancer and severe psoriasis) Amoxicillin

Capsules may cause an increase in side effects.

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 Capsules 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.

3.

How to take Amoxicillin Capsules

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 Capsules 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 Capsules 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 Capsules than you should

If you have taken too much Amoxicillin Capsules, 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 urinating. Talk

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

If you forget to take Amoxicillin Capsules

If you forget to take a dose , take it as soon as you remember.

Do not 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 Capsules for?

Keep taking Amoxicillin Capsules 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 Capsules is used for a long time. If this occurs tell your doctor.

If you take Amoxicillin Capsules 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 medicine, 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 Capsules 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 Capsules, 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 genitals. 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 reaction which occur during treatment with Amoxicillin Capsules 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. They are mainly associated with people having treatment over

a long period, males and the elderly. You must tell 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 medicines or for up to several weeks after.

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

Sometimes you may get less severe skin reactions such as:

a middle itchy rash (round, pink-red patches), ‘hive-like’ swollen areas on forearms, legs, palms,

hands or feet. This is uncommon (may affect up to 1 in 100 people).

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

The other possible side effects are:

Common

(may affect up to 1 in 10 people)

skin rash

feeling sick (nausea)

diarrhoea.

Uncommon

(may affect up to 1 in 100 people)

being sick (vomiting).

Very rare

(may affect 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 chances 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

low number of white blood cells

low number of cells involved in blood clotting

the blood may take longer to clot than it normally would. You may notice this if you have a

nosebleed or cut yourself.

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. You can also report side effects directly via Yellow Card Scheme, Website:

www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the

safety of this medicine.

5.

How to store Amoxicillin Capsules

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

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

refers to the last day of that month.

Store in the original pack below 30°C.

Do not use this medicine if you notice visible signs of deterioration.

Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw

away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Amoxicillin Capsules contains

The active substance is each capsule is 250 mg or 500 mg Amoxicillin (as trihydrate).

The other ingredients are Croscarmellose Sodium, Magnesium stearate, Sunset yellow E110,

Carmosine E122, Brilliant blue E133, Quinoline Yellow E 104, Titanium dioxide E171, Methyl

parahydroxybenzoate E218, Propyl parahydroxybenzoate E216, Gelatin (TSE Free) and Sodium

lauryl sulphate .

What Amoxicillin Capsules looks like and contents of the pack

Red / Buff coloured capsules printed with ‘AMOXY 250’ in black ink.

Red / Buff coloured capsules printed with ‘AMOXY 500’ in black ink.

Amoxicillin 250mg and 500mg are supplied in pack sizes of 21, 100 & 500. Not all packs sizes may be

marketed.

Marketing Authorization Holder and Manufacturer

BROWN & BURK UK LIMITED,

5 Marryat Close, Hounslow West,

Middlesex, TW4 5DQ, United Kingdom

This leaflet was last revised in January 2020

General advice regarding the use of antibiotics

Antibiotics are used to treat infections caused by bacteria. They have no effect against infections caused

by viruses.

Sometimes an infection caused by bacteria does not respond to a course of an antibiotic. One of the

commonest reasons for this to occur is because the bacteria causing the infection are resistant to the

antibiotic that is being taken. This means that they can survive and even multiply despite the antibiotic.

Bacteria can become resistant to antibiotics for many reasons. Using antibiotics carefully can help to

reduce the chance of bacteria becoming resistant to them.

When your doctor prescribes a course of an antibiotic it is intended to treat only your current illness.

Paying attention to the following advice will help prevent the emergence of resistant bacteria that could

stop the antibiotic working.

It is very important that you take the antibiotic at the right dose, at the right times and for the right

number of days. Read the instructions on the label and if you do not understand anything ask your

doctor or pharmacist to explain.

You should not take an antibiotic unless it has been prescribed specifically for you and you should

use it only to treat the infection for which it was prescribed.

You should not take antibiotics that have been prescribed for other people even if they had an

infection that was similar to yours.

You should not give antibiotics that were prescribed for you to other people.

If you have any antibiotic left over when you have taken the course as directed by your doctor you

should take the remainder to a pharmacy for appropriate disposal.

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Object 1

Amoxicillin 500 mg Capsules

Summary of Product Characteristics Updated 29-Aug-2019 | Brown & Burk UK Ltd

1. Name of the medicinal product

2. Qualitative and quantitative composition

3. Pharmaceutical form

4. Clinical particulars

4.1 Therapeutic indications

4.2 Posology and method of administration

4.3 Contraindications

4.4 Special warnings and precautions for use

4.5 Interaction with other medicinal products and other forms of interaction

4.6 Fertility, pregnancy and lactation

4.7 Effects on ability to drive and use machines

4.8 Undesirable effects

4.9 Overdose

5. Pharmacological properties

5.1 Pharmacodynamic properties

5.2 Pharmacokinetic properties

5.3 Preclinical safety data

6. Pharmaceutical particulars

6.1 List of excipients

6.2 Incompatibilities

6.3 Shelf life

6.4 Special precautions for storage

6.5 Nature and contents of container

6.6 Special precautions for disposal and other handling

7. Marketing authorisation holder

8. Marketing authorisation number(s)

9. Date of first authorisation/renewal of the authorisation

10. Date of revision of the text

1. Name of the medicinal product

Amoxicillin 500 mg Capsules

2. Qualitative and quantitative composition

Each Filled capsule contains Amoxicillin Trihydrate BP/EP equivalent to Amoxicillin 500 mg.

For a full list of excipients, see section 6.1.

3. Pharmaceutical form

Capsules:

Amoxicillin 500 mg Capsules : Red / Buff Coloured size '0' Capsules containg white to off white powder

printed with 'AMOXY 500 ' in black ink.

4. Clinical particulars

4.1 Therapeutic indications

Amoxicillin is indicated for the treatment of the following infections in adults and children (see section

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

Indication*

Dose*

Acute bacterial sinusitis

250 mg to 500 mg every 8 hours or 750 mg to 1 g every

12 hours

For severe infections 750 mg to 1 g every 8 hours

Acute cystitis may be treated with 3 g twice daily for one

Asymptomatic bacteriuria in pregnancy

Acute pyelonephritis

Dental abscess with spreading cellulitis

Acute cystitis

Acute otitis media

500 mg every 8 hours, 750 mg to 1 g every 12 hours

For severe infections 750 mg to 1 g every 8 hours for 10

days

Acute streptococcal tonsillitis and pharyngitis

Acute exacerbations of chronic bronchitis

Community acquired pneumonia

500 mg to 1 g every 8 hours

Typhoid and paratyphoid fever

500 mg to 2 g every 8 hours

Prosthetic joint infections

500 mg to 1 g every 8 hours

Prophylaxis of endocarditis

2 g orally, single dose 30 to 60 minutes before procedure

Helicobacter pylori eradication

750 mg to 1 g twice daily in combination with a proton

pump inhibitor (e.g. omeprazole, lansoprazole) and

another antibiotic (e.g. clarithromycin, metronidazole)

for 7 days

Lyme disease (see section 4.4)

Early stage: 500 mg to 1 g every 8 hours up to a

maximum of 4 g/day in divided doses for 14 days (10 to

21 days)

Late stage (systemic involvement): 500 mg to 2 g every 8

hours up to a maximum of 6 g/day in divided doses for

10 to 30 days

*Consideration should be given to the official treatment guidelines for each indication

Children <40 kg

Children may be treated with Amoxicillin capsules.

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

Recommended doses:

Indication

Dose

Acute bacterial sinusitis

20 to 90 mg/kg/day in divided doses*

Acute otitis media

Community acquired pneumonia

Acute cystitis

Acute pyelonephritis

Dental abscess with spreading cellulitis

Acute streptococcal tonsillitis and pharyngitis

40 to 90 mg/kg/day in divided doses*

Typhoid and paratyphoid fever

100 mg/kg/day in three divided doses

Prophylaxis of endocarditis

50 mg/kg orally, single dose 30 to 60 minutes before

procedure

Lyme disease (see section 4.4)

Early stage: 25 to 50 mg/kg/day in three divided

doses for 10 to 21 days

Late stage (systemic involvement): 100 mg/kg/day in

three divided doses for 10 to 30 days

+ Consideration should be given to the official treatment guidelines for each indication.

*Twice daily dosing regimens should only be considered when the dose is in the upper range.

Elderly

No dose adjustment is considered necessary.

Renal impairment

GFR (ml/min)

Adults and children ≥ 40 kg

Children < 40 kg

greater than 30

no adjustment necessary

no adjustment necessary

10 to 30

maximum 500 mg twice daily

15 mg/kg given twice daily

(maximum 500 mg twice daily)

less than 10

maximum 500 mg/day

15 mg/kg given as a single daily

dose (maximum 500 mg)

In the majority of cases, parenteral therapy is preferred.

In patients receiving haemodialysis

Amoxicillin may be removed from the circulation by haemodialysis.

Haemodialysis

Adults and children over 40 kg 500 mg every 24 h.

Prior to haemodialysis one additional dose of 500 mg should be

administered. In order to restore circulating drug levels, another dose of

500 mg should be administered after haemodialysis.

Children under 40 kg

15 mg/kg/day given as a single daily dose (maximum 500 mg).

Prior to haemodialysis one additional dose of 15 mg/kg should be

administered. In order to restore circulating drug levels, another dose of 15

mg/kg should be administered after 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:

Amoxicillin capsules is for oral use.

Absorption of amoxicillin is unimpaired by food.

Therapy can be started parenterally according to the dosing recommendations of the intravenous

formulation and continued with an oral preparation.

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 agents (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 penicillin 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 dose should be adjusted according to the degree of impairment (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 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 sections

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 minimize 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 agents

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.

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.

Breast-feeding

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 (≥1/1000 to <1/100)

rare (≥1/10,000 to <1/1000)

very rare (<1/10,000)

Not known (cannot be estimated from the available data)

Infections and infestations

Very rare: Mucocutaneous candidiasis

Blood and lymphatic system disorders

Very rare: Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible

thrombocytopenia and haemolytic anaemia.

Prolongation of bleeding time and prothrombin time (see section 4.4)

Immune system disorders

Very rare: Severe allergic reactions, including angioneurotic oedema, anaphylaxis , serum sickness and

hypersensitivity vasculitis (see Section 4.4 ).

Not Known: Jarisch-Herxheimer reaction (see section 4.4).

Nervous system disorders

Very rare: Hyperkinesia, dizziness and convulsions (see section 4.4).

Gastrointestinal disorders

Clinical Trial Data

* Common: Diarrhoea and nausea.

* Uncommon: Vomiting.

Post-marketing Data

Very rare: Antibiotic associated colitis (including pseudomembraneous colitis and haemorrhagic colitis

see section 4.4).

Black hairy tongue

Hepatobiliary disorders

Very rare: Hepatitis and cholestatic jaundice. A moderate rise in AST and/or ALT.

Skin and subcutaneous tissue disorders

Clinical Trial Data

*Common: Skin rash

*Uncommon: Urticaria and pruritus

Post-marketing Data

Very rare: Skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal

necrolysis, bullous and exfoliative dermatitis, acute generalised exanthematous pustulosis (AGEP) (See

section 4.4) and drug reaction with eosinophilia and systemic symptoms (DRESS).

Renal and urinary tract disorders

Very rare: Interstitial nephritis,Crystalluria (see Section 4.4 and 4.9 Overdose)

*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. Healthcare professionals are

asked to report any suspected adverse reactions via Yellow Card Scheme Website:

www.mhra.gov.uk/yellowcard.

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; ATC Code J01CA04

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/pharmacodynamics 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.

Organism

MIC breakpoint (mg/L)

Susceptible ≤

Resistant >

Enterobacteriaceae

Staphylococcus spp.

Note

Note

Read the complete document

UKPAR Amoxicillin 250mg & 500mg capsules, hard

PL 20117/0214-5

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AMOXICILLIN 250MG CAPSULES, HARD

AMOXICILLIN 500MG CAPSULES, HARD

UKPAR

TABLE OF CONTENTS

Lay Summary

Page 2

Scientific discussion

Page 3

Steps taken for assessment

Page 12

Steps taken after authorisation – summary

Page 13

Summary of Product Characteristics

Product Information Leaflet

Labelling

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AMOXICILLIN 250MG CAPSULES, HARD

AMOXICILLIN 500MG CAPSULES, HARD

LAY SUMMARY

On 10 August 2012, the MHRA granted Morningside Healthcare Limited Marketing

Authorisations (licences) for the medicinal products Amoxicillin 250mg and 500mg

Capsules, Hard (PL 20117/0214-5). These are prescription-only medicines (POM)

used to treat a wide range of bacterial infections, which may include those affecting

the:

Chest (bronchitis or pneumonia)

Tonsils (tonsillitis)

Pharynx (pharyngitis)

Ears (otitis media)

Sinuses (sinusitis)

Kidneys, bladder or the urethra (cystitis, urethritis, pyelonephritis)

Abdomen (gastro-intestinal infections)

Heart (endocarditis)

Amoxicillin 250mg and 500mg Capsules, Hard contains the active substance

amoxicillin (as amoxicillin trihydrate), which is one of a group of medicines called

“penicillins”. These medicines are also known as “antibiotics” and they work by

killing the bacteria that cause infections.

No new or unexpected safety concerns arose from these applications and it was,

therefore, judged that the benefits of taking Amoxicillin 250mg and 500mg Capsules,

Hard outweigh the risks, hence Marketing Authorisations have been granted.

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AMOXICILLIN 250MG CAPSULES, HARD

AMOXICILLIN 500MG CAPSULES, HARD

SCIENTIFIC DISCUSSION

TABLE OF CONTENTS

Introduction

Page 4

Pharmaceutical assessment

Page 5

Preclinical assessment

Page 7

Clinical assessment (including statistical assessment)

Page 8

Overall conclusions and risk benefit assessment

Page 11

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INTRODUCTION

Based on the review of the data on quality, safety and efficacy, the UK granted

marketing authorisations for the medicinal products Amoxicillin 250mg and 500mg

Capsules, Hard (PL 20117/0214-5) on 10 August 2012 to Morningside Healthcare

Limited.

These are applications for two strengths of Amoxicillin Capsules, Hard, submitted as

abridged simple applications according to Article 10c of Directive 2001/83/EC, cross-

referring to Amoxicillin 250 and 500mg Capsules (PL 20117/0030-1), which were

originally granted licences to Morningside Healthcare Limited in March 2008.

The products contain the active ingredient amoxicillin, an aminopenicillin that is used

principally for the treatment of infections caused by susceptible gram-negative

bacteria (e.g.,

Haemophilus influenzae

Escherichia coli

Proteus mirabilis

Salmonella

). Amoxicillin is also used for the treatment of infections caused by

susceptible gram-positive bacteria (e.g.,

Streptococcus pneumoniae

, enterococci,

nonpenicillinase-producing staphylococci,

Listeria

). However, like other

aminopenicillins, amoxicillin generally should not be used for the treatment of

streptococcal or staphylococcal infections (when a natural penicillin would be

effective).

Amoxicillin is indicated for the treatment of the following bacterial infections when

caused by amoxicillin-sensitive gram-positive and gram-negative pathogens:

Infections of the upper respiratory tract, including infections of the ears,

nose and throat: Acute otitis media, acute sinusitis and bacterial

pharyngitis.

Infections of the lower respiratory tract: Acute exacerbation of chronic

bronchitis, community-acquired pneumonia.

Infections of the kidneys and the genito-urinary tract: Cystitis,

pyelonephritis.

Infections of the gastrointestinal tract: It may be necessary to use

combination therapy when treating infections caused by anaerobic

organisms.

Endocarditis: Amoxicillin may be used for the prevention of bacteraemia,

associated with procedures such as dental extraction, in patients at risk of

developing bacterial endocarditis. Amoxicillin may also be used for the

treatment of endocarditis as an extension of parenteral therapy.

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PHARMACEUTICAL ASSESSMENT

LICENCE NO:

PL 20117/0214-5

PROPRIETARY NAME:

Amoxicillin 250mg and 500mg Capsules, Hard

ACTIVE(S):

Amoxicillin trihydrate

COMPANY NAME:

Morningside Healthcare Limited

E.C. ARTICLE:

Article 10c (formerly Article 10.1(a)(i)) of Directive 2001/83/EC

LEGAL STATUS:

1.

INTRODUCTION

These are simple, piggyback applications for Amoxicillin 250mg and 500mg

Capsules, Hard submitted under Article 10c (formerly Article 10.1(a)(i)) of Directive

2001/83/EC. The proposed MA holder is Morningside Healthcare Limited, 115

Narborough Road, Leicester, LE3 0PA, United Kingdom.

The applications cross-refer to Amoxicillin 250 and 500mg Capsules (PL

20117/0030-1), which were originally granted licences to Morningside Healthcare

Limited in March 2008.

The current applications are considered valid.

2.

MARKETING AUTHORISATION APPLICATION FORM

2.1 NAME(S)

The proposed names of the products are Amoxicillin 250mg Capsules, Hard, and

Amoxicllin 500mg Capsules, Hard. The products have been named in line with

current requirements.

2.2 Strength, pharmaceutical form, route of administration, container and pack

sizes

Each filled capsule contains 250mg or 500mg amoxicillin. They are to be packed in

aluminium/polyvinylchloride blister packs in pack sizes of 21 capsules. Not all pack

sizes may be marketed, but the marketing authorisation holder has committed to

submitting all labelling mock-ups to the licensing authorities for approval before

marketing any pack size of the product.

The proposed shelf-life (36 months) and storage conditions (Store below 30

C) are

consistent with the details registered for the cross-reference products.

2.3 Legal status

On approval, the products will be available as prescription-only medicines (POM).

2.4 Marketing authorisation holder/Contact Persons/Company

Morningside Healthcare Limited, 115 Narborough Road, Leicester, LE3 0PA, United

Kingdom.

The QP responsible for pharmacovigilance is stated and his CV is included.

2.5

Manufacturers

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The proposed manufacturing sites are consistent with those registered for the

cross-reference product and evidence of Good Manufacturing Practice (GMP)

compliance has been provided.

2.6 Qualitative and quantitative composition

The proposed composition is consistent with the details registered for the cross-

reference product.

2.7 Manufacturing process

The proposed manufacturing process is consistent with the details registered for the

cross-reference products and the maximum batch sizes are stated.

2.8 Finished product/shelf-life specification

The proposed finished product specifications are in line with the details registered for

the cross-reference product.

2.9 Drug substance specification

The proposed drug substance specification is consistent with the details registered for

the cross-reference products.

2.10 TSE Compliance

With the exception of gelatin, no materials of animal or human origin are included in

these products. Suitable certificates have been provided to show that the gelatin is

sourced under conditions in line with current regulations concerning the minimising

of BSE/TSE. This is consistent with the cross-reference products.

3.

EXPERT REPORTS

The applicant has included detailed expert reports in Module 2 of the applications.

Signed declarations and copies of the experts’ CVs are enclosed in Module 1.4 for the

quality, non-clinical and clinical experts. All are considered to have sufficient

experience for their responsibilities.

4.

PRODUCT NAME & APPEARANCE

See 2.1 for details of the proposed product names. The appearance of the products is

identical to the cross-reference products.

5.

SUMMARY OF PRODUCT CHARACTERISTICS (SmPC)

The proposed SmPCs are consistent with the details registered for the cross-reference

products.

6.

PATIENT INFORMATION LEAFLET/CARTON

The patient information leaflet has been prepared in-line with the details registered for

the cross-reference products.

Carton and blister

The proposed artwork is comparable to the artwork registered for the cross-reference

products and complies with statutory requirements. In-line with current legislation,

the applicant has also included the name of the product in Braille on the outer

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packaging and has included sufficient space for a standard UK pharmacy dispensing

label.

7.

CONCLUSIONS

The data submitted with the applications are acceptable. From a quality perspective,

Marketing Authorisations should be granted.

NON-CLINICAL ASSESSMENT

No new non-clinical data have been supplied with these applications and none are

required for applications of this type.

CLINICAL ASSESSMENT

No new clinical data have been supplied with these applications and none are required

for applications of this type.

OVERALL CONCLUSION AND RISK BENEFIT ASSESSMENT

QUALITY

The important quality characteristics of Amoxicillin 250mg and 500mg Capsules

Hard are well-defined and controlled. The specifications and batch analytical results

indicate consistency from batch to batch. There are no outstanding quality issues that

would have a negative impact on the benefit/risk balance.

NON-CLINICAL

No new non-clinical data were submitted and none are required for applications of

this type.

CLINICAL PHARMACOLOGY/EFFICACY

No new clinical pharmacology/efficacy data have been submitted with these

applications and none are required.

SAFETY

No new safety data have been submitted with these applications and none are

required.

No new or unexpected safety concerns arise from these applications.

The SPC, PIL and labelling are satisfactory.

RISK-BENEFIT ASSESSMENT

The quality of the product is acceptable and no new preclinical or clinical safety

concerns have been identified. Extensive clinical experience with amoxicillin is

considered to have demonstrated the therapeutic value of the compound. The risk

benefit is, therefore, considered to be positive.

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AMOXICILLIN 250MG CAPSULES, HARD

AMOXICILLIN 500MG CAPSULES, HARD

STEPS TAKEN FOR ASSESMENT

The MHRA received the marketing authorisation applications on 14 September

2011

Following standard checks and communication with the applicant the MHRA

considered the applications valid on 12 October 2011

Following assessment of the applications the MHRA requested further

information relating to the dossiers on 9 December 2011 and 6 March 2012.

The applicant responded to the MHRA’s requests, providing further information

on 13 January 2012 and 8 June 2012.

The applications were determined on 10 August 2012

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AMOXICILLIN 250MG CAPSULES, HARD

AMOXICILLIN 500MG CAPSULES, HARD

STEPS TAKEN AFTER AUTHORISATION - SUMMARY

Date

submitted

Application

type

Scope

Outcome

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Summary of Product Characteristics and Patient Information Leaflet

The current approved UK versions of the Summaries of Product Characteristics

(SmPCs) and Patient Information Leaflets (PILs) for these products is available on the

MHRA website.

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Labelling

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