Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
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.
Talk to your doctor or pharmacist before taking Amoxicillin Capsule if you: have glandular fever (fever, sore throat, swollen glands and extreme tiredness)
Package Leaflet (PIL) Package leaflet: Information for the user
Amoxicillin 250mg & 500 mg Capsules
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
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.
Conditions you need to look out for Amoxicillin Capsules can make some existing conditions worse, or cause serious side effects, such as severe allergic reactions, serious skin reactions, chest pain, repetitive vomiting within 1 to 4 hours of Amoxicillin Capsules administration or severe diarrhoea (pseudomembranous colitis). You must look out for certain symptoms while you are receiving Amoxicillin Capsules to help reduce the risk of any problems (see section 4). 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 to treat gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended. 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 to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate causing a potential 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. Important information about excipients • This medicine contains less than 1 mmol sodium (23 mg) per ml that is to say essentially 'sodium-free'.
If you cannot swallow the capsules, tell your doctor and he or she may prescribe another presentation that is more appropriate for you. Capsules are not suitable for patients who cannot swallow capsules due to the risk of choking. Other presentations are available, depending on the dosage, including oral formulations that can be used especially in patients who cannot swallow capsules. 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: 750 mg or 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.
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 chest pain which can be a sign of a potentially serious allergic reaction called Kounis syndrome repetitive vomiting (1 to 4 hours after Amoxicillin Capsules administration), stomach pain, abnormal drowsiness, diarrhoea and low blood pressure which can be a sign of a serious allergic reaction called drug induced enterocolitis syndrome 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)). a red rash commonly seen on both sides of buttocks, upper inner thighs, armpits, neck (Symmetrical Drug-Related Intertriginous and Flexural Exanthema (SDRIFE)) 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 mildly 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 urine, leading to acute renal injury 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. Rash with blisters arranged in a circle with central crusting or like a string of pearls (linear IgA disease) Inflammation of the membranes that surround the brain and spinal cord (aseptic meningitis) 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.
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.
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 blister pack and plastic container. Pack sizes: Blister: 15, 21 capsules (for 500 mg & 250 mg) Plastic container: 100 & 500 capsules. 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 10/2025
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.
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. 1. 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. 2. 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. 3. You should not take antibiotics that have been prescribed for other people even if they had an infection that was similar to yours. 4. You should not give antibiotics that were prescribed for you to other people. 5. 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.
Amoxicillin 500 mg Capsules comes as capsule containing 500mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Amoxicillin 500 mg Capsules is amoxicillin trihydrate.
Medicines with the same active substance, strength and form include: Amoxicillin 500 mg Capsules, Amoxicillin 500mg Capsules. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Amoxicillin 500 mg Capsules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
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 (AECB)/ acute exacerbation of chronic obstructive pulmonary disease (AECOPD)
• 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.
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 day
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.
Capsules are not suitable for the treatment of patients who cannot swallow capsules due to the risk of going down the wrong way.
Other presentations are available, depending on the dosage, including oral presentations that can be used especially in patients who cannot swallow capsules.
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).
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 receiving beta-lactam antibiotics (sec section 4.3). Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction (see section 4.8). Presenting symptoms of such reactions can include chest pain occurring in association with an allergic reaction to amoxicillin (see section 4.8). 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.
Drug-induced enterocolitis syndrome (DIES) has been reported mainly in children receiving amoxicillin (see section 4.8). DIES is an allergic reaction with the leading symptom of protracted vomiting (1-4 hours after drug administration) in the absence of allergic skin or respiratory symptoms. Further symptoms could comprise abdominal pain, lethargy, diarrhoea, hypotension or leucocytosis with neutrophilia. There have been severe cases including progression to shock.
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 (including acute renal injury) 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 sections 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.
Important information about excipients
• This medicine contains less than 1 mmol sodium (23 mg) per ml that is to say essentially 'sodium-free'.
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.
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.
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).
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, aseptic meningitis, convulsions (see section 4.4).
Cardiac disorders
Very rare
Kounis syndrome (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), drug-induced enterocolitis syndrome (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), drug reaction with eosinophilia and systemic symptoms (DRESS), symmetrical drug-related intertriginous and flexural exanthema (SDRIFE) (baboon syndrome) (see also Immune system disorders), linear IgA disease.
Renal and urinary disorders
Very rare:
Interstitial nephritis
Crystalluria (see sections 4.4 and 4.9)
* 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.
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).
Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see section 4.4).
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.
Ask anything about Amoxicillin 500 mg Capsules. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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