Gerard Laboratories

250 mg

Geramox 250 mg Capsules, hard.

500 mg

Geramox 500 mg Capsules, hard.

250 mg

Each capsule contains Amoxicillin Trihydrate equivalent to 250 mg amoxicillin (anhydrous).

500 mg

Each capsule contains Amoxicillin Trihydrate equivalent to 500 mg amoxicillin (anhydrous).

For a full list of excipients, see section 6.1.

Capsules, hard (capsule).

250 mg

Red cap with yellow body size 2 hard gelatin capsules marked “AX250” and “G” in black ink, containing a white to off white granular powder

500 mg

Red cap with a yellow body size OE hard gelatin capsules marked “AX500” and “G” in black ink, containing a white to off white granular powder.

In the treatment of infections due to organisms sensitive to Amoxicillin and in the oral prophylaxis of endocarditis related to dental procedures, and acute uncomplicated gonorrhoea.

Geramox Capsules are for oral use.

TREATMENT

Adults the elderly and children over 10 years of age

The usual total daily dosage is 750 mg in three divided doses.

In the treatment of uncomplicated gonorrhoea a single dose of 3 g may be used.

Children

6 -10 years

The usual total daily dosage is 375 - 750 mg in divided doses.

2 -5 years

375 mg daily in divided doses.

Under 2 years

100-300 mg daily in divided doses.

Dosage may be doubled in cases of severe infections.

PROPHYLAXIS

Adults and the elderly

A single dose of 3 g prior to the dental procedure.

Children

A single dose of 1 to 1.5 g prior to the procedure.

Note: In patients with renal insufficiency total daily dosage may need reduction if excretion of drug is delayed.

Use in patients with hypersensitivity to penicillins, including Ampicillin, or Cephalosporins.

Prolonged use of an anti-infective agent may result in super infection by organisms resistant to that anti-infective.

Patients with infectious mononucleosis frequently develop rashes with Ampicillin therapy. A similar tendency may be apparent with Amoxicillin.

Methotrexate excretion is reduced by penicillins. Patients should be monitored carefully for signs of methotrexate toxicity.

Probenecid decreases the renal excretion of penicillins. Plasma concentrations are enhanced if probenecid is given concomitantly.

Pencillins may decrease the efficacy of combined oral contraceptives. Patients should be warned of this.

The product should not be used during pregnancy unless considered essential by the physician. Amoxicillin is excreted in breast milk, presenting the risk of candidiasis and also of central nervous toxicity due to pre-maturity of the blood brain barrier. There is a theoretical possibility of later sensitisation.

None known.

Side effects as with other penicillins are uncommon and mainly of mild and transitory nature; Gastro-intestinal effects include diarrhoea, indigestion, nausea, epigastric discomfort and candida infection.

Urticarial and erythematous rashes have been reported. An urticarial rash suggests penicillin hypersensitivity, an erythematous rash may arise in patients receiving amoxicillin who have glandular fever or who have chronic lymphatic leukaemia. If a rash occurs treatment should be discontinued.

In common with other beta-lactam antibiotics, angioedema and anaphylaxis in hypersensitive patients have been reported.

Pseudomembranous colitis and interstitial nephritis have been reported rarely.

Gross overdose should not present problems if adequate fluid intake and urinary output are maintained; however crystalluria are a possibility. More specific measures may be necessary in patients with impaired renal function: the antibiotic is removed by haemodialysis.

Amoxicillin Trihydrate is a broad spectrum antibiotic.

Amoxicillin Trihydrate is well absorbed after oral administration; reaching peak levels 1-2 hours later, and excreted in the urine.

There are no preclinical safety data of relevance to the prescriber that are additional to those included in other sections of the SPC.

250 mg

Capsule contents

Talc

Magnesium stearate

Sodium starch glycolate Type A

Microcrystalline cellulose

500 mg

Capsule contents:

Talc

Magnesium stearate

Sodium starch glycolate Type A

Colloidal silicon dioxide.

250 mg & 500mg

Capsule shell

Gelatin

Erythrosine (E127)

Quinoline yellow (E104)

Titanium dioxide (E171)

Red iron oxide (E172).

Printing ink

Black iron oxide (E172)

Polydimethylsiloxane

Soya lecithin

Shellac

Not applicable.

4 years

Do not store above 25°C.

Polypropylene containers with polyethylene caps (and optional polypropylene ullage filler) containing 4, 15, 50, 100, 250, 500, or 1000 capsules (securitainers).

PVC/Aluminium foil blister packs containing 100, 250, 500, or 1000 capsules.

Not all pack sizes may be marketed.

No special requirements.

Generics [UK] Ltd

12 Station Close

Potters Bar

Hertfordshire

EN6 1TL

United Kingdom.

250 mg

PA 405/5/1

500 mg

PA 405/5/2

Date of first authorisation: 28 November 1984

Date of last renewal: 30 April 2008

May 2010