Amoxicillin Capsules

Generic

Prescription-only medicine (antibiotic)

Oral beta-lactam antibiotic capsules (penicillin class)

Amoxicillin 500 mg Capsules are licensed prescription Only medicines in the UK, with individual products authorised by the Medicines and Healthcare products Regulatory Agency (MHRA).
Manufactured in accordance with Good Manufacturing Practice (GMP) and distributed under appropriate wholesale and pharmacy standards.
Product characteristics, indications, dosing and safety information are defined in the MHRA Approved Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) for each licensed brand.

Amoxicillin 500 mg Capsules are licensed prescription Only medicines in the UK, with individual products authorised by the Medicines and Healthcare products Regulatory Agency (MHRA).
Manufactured in accordance with Good Manufacturing Practice (GMP) and distributed under appropriate wholesale and pharmacy standards.
Product characteristics, indications, dosing and safety information are defined in the MHRA Approved Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) for each licensed brand.

Oral beta-lactam antibiotic capsules (penicillin class)

Description

Amoxicillin 500mg Capsules x15 is a UK prescription-only oral antibiotic from the penicillin group, supplied as a pack of fifteen hard capsules each containing 500 mg of amoxicillin (as amoxicillin trihydrate). Amoxicillin works by inhibiting bacterial cell wall synthesis, causing susceptible bacteria to rupture and die, which helps the body’s immune system clear the infection. It is commonly prescribed for a wide range of bacterial infections including chest infections (such as pneumonia and bronchitis), ear, nose and throat infections, urinary tract infections, skin and soft tissue infections, and dental infections such as dental abscesses. In combination with other medicines (for example clarithromycin and a proton pump inhibitor), it may also be used to eradicate Helicobacter pylori in patients with stomach or duodenal ulcers. Treatment, dose and duration are determined by a prescriber based on the type and severity of infection and individual patient factors, and it is important that patients complete the full prescribed course to reduce the risk of treatment failure and antibiotic resistance.

Bnefits

Broadly active against many common Gram-positive and some Gram-negative bacteria when sensitive, providing versatile coverage for a range of community-acquired infections
First-line treatment option in UK and international guidelines for conditions such as otitis media, sinusitis, some chest infections and dental abscesses when appropriate
Oral capsule formulation allows convenient dosing for ambulatory patients
Beta-lactam mechanism (cell wall inhibition) is well understood with extensive clinical experience and safety data
Can be used in combination regimens (for example with clarithromycin and a proton pump inhibitor) to eradicate Helicobacter pylori infection in suitable patients
Availability as generic capsules from multiple licensed manufacturers helps maintain affordability and access within healthcare systems

Indications

Acute bacterial sinusitis (where bacterial infection is suspected or confirmed)
Acute otitis media (middle ear infection)
Acute streptococcal tonsillitis and pharyngitis
Acute exacerbations of chronic bronchitis and community-acquired pneumonia (where pathogens are susceptible)
Urinary tract infections (such as cystitis and pyelonephritis) caused by susceptible organisms
Skin and soft tissue infections, including cellulitis and wound infections, where appropriate
Dental abscess and other dental infections, usually in conjunction with dental procedures
Part of combination therapy for the eradication of Helicobacter pylori associated with peptic ulcer disease (with other prescribed medicines)
Other infections caused by amoxicillin-sensitive organisms as specified in the relevant Summary of Product Characteristics and local/national guidelines

Composition

Each hard capsule contains 500 mg amoxicillin as amoxicillin trihydrate (active ingredient).
Capsule shell and excipients vary by manufacturer and may include ingredients such as magnesium stearate, microcrystalline cellulose, sodium starch glycolate, colloidal anhydrous silica, gelatin, colouring agents and printing inks as listed in the specific brand’s Summary of Product Characteristics.
Lactose, dyes or other excipients of known effect may be present in some brands; patients with known excipient intolerances should check the specific package leaflet.

Formulation

Pharmaceutical form: hard capsules for oral administration.
Typical appearance (generic UK products): size 0 or similar hard capsules containing white to off-white powder; capsule colours and imprint vary by manufacturer (for example red/buff capsules printed with identifying code).
Class: beta-lactam antibiotic (aminopenicillin).

Packaging

Pack size: 15 × 500 mg hard capsules.
Supplied in blister strips or bottles (packaging type varies by manufacturer), within an outer carton including patient information leaflet.
Product supplied as a prescription-only medicine; brands may vary depending on stock and supplier at the time of dispensing.

Usage

Use only as prescribed by a suitably qualified healthcare professional after clinical assessment.
Capsules are usually swallowed whole with water and may be taken with or without food; taking with food can help reduce stomach upset for some patients.
The usual adult dose for many infections is within the range of 250 mg to 500 mg three times a day; however, the exact dose, frequency and duration are determined by the prescriber according to infection type, severity, kidney function and other patient factors.
For some indications (such as more severe infections, specific urinary tract infections or Helicobacter pylori eradication), higher doses or different regimens may be used as outlined in official product information and clinical guidelines.
Patients should complete the full prescribed course even if symptoms improve before finishing, unless a prescriber advises stopping early, to help prevent relapse and reduce the development of antibiotic resistance.
If a dose is forgotten, it should generally be taken as soon as remembered unless it is nearly time for the next dose; doses should not be doubled to make up for a missed dose, and patients should follow the advice on the patient information leaflet or from their prescriber.
Patients should read the patient information leaflet that accompanies the medicine and seek medical or pharmaceutical advice if they are unsure how to take the capsules or have concerns about side effects.

Contraindications

Known hypersensitivity to amoxicillin, any other penicillin or any of the excipients in the specific capsule formulation.
History of a severe immediate hypersensitivity reaction (for example anaphylaxis) to another beta-lactam antibiotic such as a cephalosporin, carbapenem or monobactam.
Caution or alternative antibiotics are required in patients with a history of allergic reactions, particularly drug-induced rashes or asthma associated with penicillin.
Not suitable for treating infections known or suspected to be caused by organisms resistant to amoxicillin; prescribers should take local resistance patterns and microbiology results into account.
Use in patients with significant renal impairment may require dose adjustment and close medical supervision.
Any additional contraindications or cautions listed in the specific licensed product’s Summary of Product Characteristics or as advised by the prescriber.

Adverse Effects

Common gastrointestinal side effects such as nausea, vomiting, diarrhoea and mild abdominal discomfort.
Possible mild skin rashes, particularly in individuals with glandular fever (infectious mononucleosis) or certain viral infections when exposed to amoxicillin.
Overgrowth of non-susceptible organisms such as Candida (for example oral or vaginal thrush) with prolonged use.
Less common but more serious reactions including severe allergic reactions (anaphylaxis), angioedema, serum sickness-like reactions, Stevens–Johnson syndrome, toxic epidermal necrolysis or other serious skin reactions; these require urgent medical attention.
Liver function disturbances, cholestatic jaundice or hepatitis, usually reversible after stopping treatment but requiring medical evaluation.
Changes in blood counts (for example anaemia, thrombocytopenia, leucopenia) have been reported rarely and are generally reversible.
Clostridioides difficile-associated diarrhoea/colitis can occur with almost any antibiotic; persistent or severe diarrhoea should be evaluated promptly.
Patients should read the patient information leaflet for a full list of possible side effects and seek medical advice if they experience severe, unusual or worrying symptoms.

Storage Conditions

Store below 25°C (or as indicated on the specific product packaging).
Keep the capsules in the original package to protect them from moisture and light.
Do not use after the expiry date stated on the carton and blister/bottle.
Keep out of the sight and reach of children.
Return unused or expired medicines to a pharmacy for safe disposal; do not dispose of via household waste or wastewater.

Duration

Treatment duration depends on the type and severity of infection and is determined by the prescriber. Many common infections are treated for 5\u20137 days, while certain conditions (such as more severe infections or Helicobacter pylori eradication) may require longer or specific regimens according to clinical guidelines.

Onset

Symptomatic improvement in bacterial infections commonly begins within a few days of starting appropriate therapy; however, patients should continue taking the medicine for the full prescribed course even if they feel better sooner.