Ciprofloxacin 250mg Tablet POM x10

Generic

Pharmaceutical Product

Oral fluoroquinolone antibiotic tablet

UK MHRA Licensed prescription Only medicinal product containing ciprofloxacin (ATC code J01MA02).
Manufactured by UK or EU Approved manufacturers under Good Manufacturing Practice (GMP) standards.
Subject to MHRA pharmacovigilance requirements, including Yellow Card adverse event reporting.
Pack supplied by Williams Medical Supplies complies with UK medicines distribution regulations for POM products.

UK MHRA Licensed prescription Only medicinal product containing ciprofloxacin (ATC code J01MA02).
Manufactured by UK or EU Approved manufacturers under Good Manufacturing Practice (GMP) standards.
Subject to MHRA pharmacovigilance requirements, including Yellow Card adverse event reporting.
Pack supplied by Williams Medical Supplies complies with UK medicines distribution regulations for POM products.

Oral fluoroquinolone antibiotic tablet

Description

Ciprofloxacin 250mg Tablet POM x10 is a UK prescription-only (POM) oral antibiotic product containing the fluoroquinolone ciprofloxacin, supplied in a pack of 10 tablets. It is used for the treatment of a range of susceptible bacterial infections in adults (and in certain indications in children and adolescents) when use of a fluoroquinolone is considered appropriate according to official guidance and the Summary of Product Characteristics for the specific generic brand dispensed.

Bnefits

Broad-spectrum antibacterial activity against many Gram-negative and some Gram-positive organisms, including common urinary tract and respiratory pathogens.
Indicated (brand-dependent) for infections such as certain lower respiratory tract infections, complicated and uncomplicated urinary tract infections, acute pyelonephritis, chronic bacterial prostatitis, some gastrointestinal and intra-abdominal infections, skin and soft-tissue infections, bone and joint infections, and certain genital tract infections when other first-line agents are unsuitable.
Available as an oral tablet, allowing step-down therapy from intravenous treatment and facilitating outpatient management where clinically appropriate.
250mg strength allows dose flexibility, including lower-dose regimens or renal dose adjustments where required.
Extensive clinical experience and established dosing guidance in national and international treatment guidelines for specific indications.

Indications

The exact licensed indications may vary between manufacturers; in UK SmPCs for ciprofloxacin 250mg film-coated tablets they commonly include treatment of the following infections in adults (where use of a fluoroquinolone is considered appropriate and taking account of local resistance patterns and guidelines):
• Lower respiratory tract infections due to Gram-negative bacteria (e.g. exacerbations of chronic obstructive pulmonary disease, broncho-pulmonary infections in cystic fibrosis or bronchiectasis, pneumonia).
• Chronic suppurative otitis media and acute exacerbation of chronic sinusitis (especially where Gram-negative bacteria are suspected).
• Uncomplicated acute cystitis (usually when other recommended agents are inappropriate).
• Complicated urinary tract infections and acute pyelonephritis.
• Chronic bacterial prostatitis.
• Gastrointestinal and intra-abdominal infections caused by susceptible organisms.
• Infections of the skin and soft tissues caused by Gram-negative bacteria.
• Bone and joint infections.
• Genital tract infections including certain forms of gonococcal infections and epididymo-orchitis due to Gram-negative bacteria.
• Certain systemic infections such as bacteraemia associated with the above infections.
In children and adolescents, ciprofloxacin use is generally restricted to specific severe infections (e.g. bronchopulmonary infections in cystic fibrosis, complicated urinary tract infections and pyelonephritis, post-exposure prophylaxis and treatment of inhalational anthrax) under specialist supervision in line with the SmPC and national guidelines.

Composition

Active ingredient: Ciprofloxacin (as ciprofloxacin hydrochloride) 250 mg per tablet.
Excipients: The exact excipient profile varies by manufacturer (e.g. may include microcrystalline cellulose, maize starch, pregelatinised starch, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide, macrogol, etc.). For the specific product supplied, the full qualitative and quantitative excipient list is provided in the individual manufacturer’s Summary of Product Characteristics and Package Leaflet.

Formulation

Pharmaceutical form: Film-coated tablet for oral administration.
Strength: 250 mg ciprofloxacin (as ciprofloxacin hydrochloride) per tablet.
Appearance: Typically white to off-white or slightly yellowish, round or oblong film-coated tablets (exact shape and markings vary by manufacturer).

Packaging

Pack size: 10 tablets (POM) as listed by Williams Medical Supplies.
Tablets are usually supplied in PVC/Aluminium blister strips within an outer carton (specific materials and configuration may vary by generic brand).
Outer packaging is labelled with product name, strength, legal classification (POM), batch number, expiry date, storage instructions, and manufacturer’s details.

Usage

For oral use only.
Dose, frequency and duration of therapy must be determined by a prescriber based on the type and severity of infection, susceptibility of the pathogen, renal function, and relevant clinical guidelines.
Tablets are usually taken twice daily (every 12 hours), with typical adult doses ranging from 250 mg to 750 mg twice daily depending on indication and severity.
Swallow tablets whole with a sufficient amount of fluid; they may be taken with or without food, but administration at approximately the same times each day is recommended.
Avoid taking ciprofloxacin at the same time as dairy products (such as milk or yoghurt) or mineral-fortified drinks (e.g. calcium-fortified juice) alone, or products containing significant amounts of calcium, iron, magnesium, aluminium or other polyvalent cations (such as certain antacids, sucralfate, or phosphate binders), because these can reduce absorption. Where such products are needed, they should usually be taken at least 2 hours before or 4 hours after ciprofloxacin (consult the specific SmPC).
Patients should remain well hydrated during treatment.
The full prescribed course should be completed even if symptoms improve earlier, unless the prescriber advises otherwise.
Tablets should not be split or crushed unless the specific brand information and prescriber allow this.
Always follow the directions given by the prescribing doctor and the instructions in the patient information leaflet for the specific brand supplied.

Contraindications

Hypersensitivity to ciprofloxacin, other quinolones/fluoroquinolones, or any excipient in the specific formulation.
History of serious adverse reaction (e.g. tendon disorders such as tendinitis or tendon rupture) associated with fluoroquinolone or quinolone use.
Ciprofloxacin should generally not be used concomitantly with tizanidine due to the risk of clinically significant interactions (marked hypotension and sedation).
Use in children and adolescents is limited to specific severe infections under specialist guidance; routine use for common infections in this age group is contraindicated in many SmPCs due to risk of musculoskeletal adverse effects.
Caution or avoidance is advised in patients with a history of tendon disorders related to quinolone use, in known QT-interval prolongation or risk factors for torsades de pointes, in glucose-6-phosphate dehydrogenase (G6PD) deficiency, in epilepsy or other conditions that predispose to seizures, and in severe renal or hepatic impairment unless benefits outweigh risks and appropriate dosage adjustments and monitoring are in place.

Adverse Effects

Very common and common adverse effects reported in SmPCs include: nausea, diarrhoea, vomiting, abdominal pain, dyspepsia, and transient increases in liver enzymes.
Central nervous system effects: headache, dizziness, sleep disturbances (including insomnia), nervousness; less commonly confusion, tremor, seizures, psychotic reactions and depression have been reported. In rare cases, these can persist after stopping treatment.
Musculoskeletal effects: arthralgia, myalgia, and tendon disorders including tendinitis and tendon rupture (particularly of the Achilles tendon), sometimes bilateral and potentially occurring within 48 hours of starting treatment; risk is increased in older patients, those on corticosteroids and in transplant recipients.
Cardiac effects: QT interval prolongation and very rare cases of torsades de pointes, especially in patients with risk factors or when combined with other QT-prolonging medicines.
Hypersensitivity and immune reactions: rash, pruritus, urticaria, photosensitivity reactions; more serious reactions including anaphylaxis, angioedema, drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens–Johnson syndrome and toxic epidermal necrolysis have been reported.
Gastrointestinal effects: antibiotic-associated colitis / Clostridioides difficile-associated diarrhoea, which may be life-threatening; treatment should be stopped if severe, persistent diarrhoea occurs and appropriate management instituted.
Hepatic effects: elevations of liver enzymes and bilirubin; rare cases of hepatitis, cholestatic jaundice, and hepatic failure, including fatal cases, have been reported.
Metabolic and endocrine effects: dysglycaemia (including hypoglycaemia and hyperglycaemia), particularly in diabetic patients treated with insulin or oral hypoglycaemics.
Renal effects: transient increases in serum creatinine and urea; rare reports of interstitial nephritis and renal impairment.
Other: visual disturbances, taste disturbances, peripheral neuropathy (which may be irreversible), blood dyscrasias (e.g. leukopenia, eosinophilia, thrombocytopenia), and exacerbation of myasthenia gravis.
Patients should read the patient information leaflet for the specific generic brand supplied and report any unexpected or severe side effects to their prescriber and via the Yellow Card Scheme (in the UK).

Storage Conditions

Do not store above 25°C (typical requirement in UK SmPCs for ciprofloxacin tablets; check the specific brand packaging for exact limits).
Store in the original package to protect from moisture and light.
Keep the blister strips or container tightly closed when not in use.
Keep out of the sight and reach of children.
Do not use after the expiry date stated on the carton and blister.
Unused tablets or expired medicine should be disposed of in accordance with local requirements; do not dispose of via wastewater or household waste.

Duration

The duration of therapy depends on the type and severity of infection and clinical response. According to UK SmPCs, treatment commonly ranges from 5\u201321 days (or longer in severe or complicated infections such as osteomyelitis), and should follow official guidelines and prescriber instruction.

Onset

Bactericidal activity begins shortly after adequate plasma concentrations are reached; clinical improvement is usually observed within a few days of starting therapy, although this varies with infection type and severity. Treatment should be continued for the full prescribed course even if symptoms improve early.