Amoxicillin Git

Italy
Brand name Amoxicillin Git
Form tablets
Active substance / Dosage
AMOXICILLIN
Prescription type Prescription only
ATC code
J01CA04
Registration number 033290
Manufacturer S.F. GROUP S.R.L.

Amoxicillina GIT 1 g tablets
Amoxicillina GIT 5% powder for oral suspension
Generic medicine

COMPOSITION

Tablets
One tablet contains:
Active substance
Amoxicillin trihydrate g 1.148
(equivalent to anhydrous amoxicillin g 1)
Excipients:
microcrystalline cellulose – magnesium stearate – sodium carboxymethyl starch

Powder for oral suspension 5%
100 ml of suspension contain:
Active substance
Amoxicillin trihydrate g 5.74
(equivalent to anhydrous amoxicillin g 5)
Excipients:
precipitated silica (Aerosil) – sodium carboxymethylcellulose – sodium benzoate – tutti-frutti flavour –
sucrose

PHARMACEUTICAL FORM AND CONTENT
1 g tablets: Pack size: 12 tablets
5% oral suspension powder: 100 ml oral suspension bottle

THERAPEUTIC PHARMACOLOGICAL CATEGORY
Antibiotic

MARKETING AUTHORISATION HOLDER
S.F. GROUP S.R.L.
VIA TIBURTINA, 114

MANUFACTURER AND FINAL CONTROL

  • Biopharma S.r.l., Via delle Gerbere, 20/22 00040 Santa Palomba (Rome) (oral suspension)
  • Francia Farmaceutici S.r.l. – Industria Farmaco Biologica S.r.l., Via dei Pestagalli, 7 – 20138 Milan (tablets)
  • LA FA. RE. S.r.l., Via Sacerdote Benedetto Cozzolino, 77 – 80056 Ercolano (NA) (tablets)

THERAPEUTIC INDICATIONS
Infections caused by microorganisms sensitive to amoxicillin: acute and chronic respiratory tract infections, otorhinolaryngological and dental infections; genitourinary tract infections; enteric and biliary tract infections; dermatological infections and soft tissue infections; surgical infections.

CONTRAINDICATIONS

  • Hypersensitivity to the components or to chemically closely related substances. It is contraindicated in patients hypersensitive or allergic to penicillins and cephalosporins.
  • Infections caused by penicillinase-producing microorganisms.
  • Infectious mononucleosis (increased risk of skin reactions).

PRECAUTIONS FOR USE
Before starting therapy with amoxicillin, appropriate precautions should be taken to prevent adverse reactions, particularly obtaining a careful patient history regarding any previous hypersensitivity reactions to this or other drugs (especially other antibiotics). It should be noted that clinical and laboratory evidence demonstrates partial cross-allergenicity between different beta-lactam antibiotics.

INTERACTIONS
Cross-allergy with penicillin G and cephalosporins is possible. Concomitant administration of allopurinol increases the frequency of skin rashes. Concurrent use of oral contraceptives reduces their absorption. A synergistic therapeutic effect between semi-synthetic penicillins and aminoglycosides is known. Probenecid, when administered concomitantly, prolongs penicillin blood levels by renal competition. Acetylsalicylic acid, phenylbutazone, or other anti-inflammatory drugs at high doses, when administered concurrently, increase plasma levels and half-life of penicillins.

SPECIAL WARNINGS
In pregnant women and very young infants, the product should be administered only when clearly needed and under direct medical supervision.
During prolonged treatment with amoxicillin, periodic haematological, renal, and liver function tests should be performed, especially in patients with impaired hepatic or renal function.
Since a very high percentage of patients with infectious mononucleosis develop a skin rash after administration of amino-penicillins, amoxicillin should not be used in these patients.
Pseudomembranous colitis must be considered in the differential diagnosis of diarrhoea occurring during or shortly after antibiotic therapy. In particular, during prolonged treatment or at high doses, patients should be monitored for the emergence of infections caused by resistant organisms (e.g., oral or vaginal candidiasis).
Amoxicillin has not shown any interference with the ability to drive or operate machinery.

DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Unless otherwise prescribed by the physician, the recommended average doses are as follows:
1 g tablets – Adults: 1 tablet twice daily.
Oral suspension: 40–50 mg/kg/day, divided into 3 doses every 8 hours.
Approximately, when using the 5% suspension and the provided calibrated dosing spoon, the single doses according to the child's body weight are: up to 10 kg body weight: 2.5 ml every 8 hours; between 10 and 25 kg body weight: 5 ml every 8 hours; over 25 kg body weight: 10 ml every 8 hours.
The above doses may be increased at the physician’s discretion.
The duration of treatment should be determined according to the course of the infectious disease.

Instructions for preparing and storing the suspension
Add a small amount of water to the bottle, shake, then add more water until reaching the level indicated on the bottle, and shake again.
Shake the prepared suspension well before use.

OVERDOSAGE
No symptoms of overdose have been reported in humans so far.

UNDESIRABLE EFFECTS
Hypersensitivity reactions

  • Skin: Occasionally skin rash (urticarial or erythematous, maculopapular, morbilliform); rarely angioedema, exfoliative dermatitis, toxic epidermal necrolysis (Lyell’s syndrome), erythema multiforme; isolated cases of Stevens-Johnson syndrome.
  • Blood: Frequently eosinophilia; rarely haemolytic anaemia and positive direct Coombs test.
  • General: Rarely anaphylactic reactions with characteristic symptoms: severe and sudden hypotension, accelerated or slowed heartbeat, unusual fatigue or weakness, anxiety, restlessness, dizziness, loss of consciousness, breathing or swallowing difficulties, generalized pruritus especially on the soles of the feet and palms of the hands, urticaria with or without angioedema (swollen and itchy skin areas, most frequently located on extremities, external genitalia, and face, especially around eyes and lips), skin redness especially around the ears, cyanosis, profuse sweating, nausea, vomiting, cramp-like abdominal pain, diarrhoea; serum-sickness-like reactions (urticaria or skin rashes accompanied by arthritis, arthralgia, myalgia, and fever).

Blood
In addition to those listed under hypersensitivity reactions, rarely: anaemia, leucopenia, neutropenia, agranulocytosis, thrombocytopenia, thrombocytopenic purpura, abnormal platelet aggregation, prolonged bleeding time or activated partial thromboplastin time.

Gastrointestinal system
Occasionally: diarrhoea, vomiting, anorexia, epigastric pain, gastritis; rarely: glossitis, stomatitis, pseudomembranous colitis.

Kidney
Rarely acute interstitial nephritis.

Liver
Rarely moderate increase in serum transaminases, other signs of hepatic dysfunction (cholestatic, hepatocellular, mixed cholestatic-hepatocellular).

Nervous system
Rarely headache, dizziness.

General
Rarely superinfections due to resistant microorganisms.

Following the instructions contained in this leaflet reduces the risk of undesirable effects.
It is important to inform your doctor or pharmacist about the occurrence of any adverse effect, even if not described in this leaflet.

EXPIRY DATE AND STORAGE
EXPIRY DATE: see the expiry date indicated on the packaging
The shelf life refers to the product in undamaged original packaging, correctly stored.
Warning: do not use the medicine after the expiry date stated on the packaging.
KEEP THIS MEDICINE OUT OF THE REACH OF CHILDREN