Consumer medicine information

Cefaclor GH

Cefaclor

BRAND INFORMATION

Brand name

Cefaclor GH

Active ingredient

Cefaclor

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Cefaclor GH.

What is in this leaflet

This leaflet answers some common questions about Cefaclor GH. It does not contain all the available information.

It does not take the place of talking to your doctor and pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Cefaclor GH against the benefits it is expected to have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Cefaclor GH is used for

Cefaclor GH tablets contain cefaclor monohydrate as the active ingredient.

Cefaclor GH is an antibiotic used to treat infections in different parts of the body caused by bacteria, including infections of the:

  • ears, nose, throat and tonsils (upper respiratory tract);
  • chest and lungs (lower respiratory tract);
  • bladder and kidneys (lower urinary tract);
  • skin.

Cefaclor GH will not work against infections caused by viruses such as colds or the flu.

Cefaclor GH belongs to a group of antibiotics called cephalosporins, which are closely related to penicillins.

Cefaclor GH works by killing the bacteria causing your infection or by stopping its growth.

Your doctor may have prescribed Cefaclor GH for another reason. Ask your doctor if you have any questions about why Cefaclor GH has been prescribed for you.

This medicine is available only with a doctor’s prescription.

There is no evidence that Cefaclor GH is addictive.

There is not enough information to recommend the use of this medicine for children under the age of 12 years.

Before you take Cefaclor GH

When you must not take it

Do not take Cefaclor GH tablets if:

  • You have an allergy to Cefaclor GH, cefaclor, other cephalosporins or any of the ingredients listed at the end of this leaflet.
    Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
  • You have had a serious allergic reaction to penicillins.
  • The packaging is torn or shows signs of tampering.
  • The expiry date on the pack has passed.
    If you take this medicine after the expiry date has passed, it may not work as well (or it may make you feel sick).

Do not give Cefaclor GH to a child under the age of 12 years. The safety and efficacy of this product in children has not been established.

If you are not sure whether you should start using Cefaclor GH, talk to your doctor.

Before you start to take it

You must tell your doctor:

  1. If you have any type of allergic reaction to cephalosporin medicines, penicillin medicines or any other antibiotic medicines.
You may have an increased chance of being allergic to Cefaclor GH if you are allergic to cephalosporins or penicillins.
  1. If you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.
  2. If you have or have ever had any other health problems/medical conditions, including:
  • kidney disease;
  • severe bowel conditions/disease;
  • liver disease.
  1. If you are pregnant or intend to become pregnant.
Your doctor will discuss the risks and benefits of using Cefaclor GH during pregnancy.
  1. If you are breastfeeding or plan to breastfeed.
Your doctor will discuss the risks and benefits of using Cefaclor GH when breastfeeding.

If you have not told your doctor about any of the above, tell them before you start taking Cefaclor GH.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Cefaclor GH. These include:

  • Antacids:
    If you need to take an antacid, do not take it within 1 hour of taking Cefaclor GH.
  • Probenecid (eg. Pro-Cid).

These medicines may be affected by Cefaclor GH, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking Cefaclor GH.

How to take Cefaclor GH

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.

How much to take

Your doctor will decide what dose and how long you will receive Cefaclor GH. This depends on your infection and other factors, such as your weight.

How to take it

Swallow the prescribed dose of Cefaclor GH tablets whole with a full glass of water. Do not cut, crush or chew the tablets.

Keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days.

If you do not complete the full course of treatment prescribed by your doctor, the infection may not clear completely or your symptoms may return.

When to take it

Take Cefaclor GH at about the same time each day with food. This will have the best effect. It will also help you to remember when to take the tablets

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember and then go back to taking it as you would normally.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

Do not take a double dose to make up for the dose that you missed.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too much Cefaclor GH. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep telephone numbers of these places/services handy.

If you take too many Cefaclor GH tablets, you may have:

  • sick;
  • vomiting;
  • upset stomach;
  • diarrhoea.

While you are taking Cefaclor GH

Things you must do

If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.

If you get severe diarrhoea tell your doctor, pharmacist or nurse immediately. Do this even if it occurs several weeks after Cefaclor GH has been stopped.

Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any diarrhoea medicine without first checking with your doctor.

If you get a sore white mouth or tongue while taking or soon after stopping Cefaclor GH, tell your doctor. Also tell your doctor if you get vaginal itching or discharge.

This may mean you have a fungal infection called thrush. Sometimes the use of Cefaclor GH allows fungi to grow and the above symptoms to occur. Cefaclor GH does not work against fungi.

If you become pregnant while you are taking Cefaclor GH, tell your doctor.

If you are about to start taking any new medicine, tell your doctor and pharmacist that you are taking Cefaclor GH.

If you have to have any blood or urine tests, tell your doctor you are taking Cefaclor GH tablets. Cefaclor GH may affect the results of some blood and urine tests.

Tell all the doctors, surgeons or dentists and pharmacists who are treating you that you are receiving Cefaclor GH if you are about to undergo surgery or an operation.

It may affect other medicines used during surgery.

Keep all of your doctor’s appointments so that your progress can be checked. Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

If you are diabetic, check with your doctor or pharmacist before using urine sugar tests. Cefaclor GH may cause false test results with some urine sugar tests.

Things you must not do

Do not give Cefaclor GH to anyone else, even if they have the same condition as you.

Do not use Cefaclor GH to treat any other complaints unless your doctor tells you to.

Do not stop taking your medicine or change the dosage without checking with your doctor.

Things to be careful of

Be careful driving or operating machinery until you know how Cefaclor GH affects you.

Cefaclor GH generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, Cefaclor GH may cause dizziness or tiredness in some people.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Cefaclor GH.

Like other medicines, Cefaclor GH can cause some side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.

Ask your doctor or pharmacist to answer any questions you may have.

While you are taking it

Tell your doctor if you notice any of the following and they worry you:

  • oral thrush – white, furry, sore tongue and mouth;
  • vaginal thrush – sore and itchy vagina and/or discharge;
  • itchy rash;
  • diarrhoea.

The above list includes the more common side effects of your medicine. They are usually mild and short-lived.

Tell your doctor as soon as possible if you notice any of the following and they worry you:

  • nausea;
  • vomiting;
  • drowsiness;
  • headache;
  • hyperactivity, nervousness, insomnia, confusion, dizziness, hallucinations;
  • severe muscle stiffness;
  • swelling of the joints with or without fever;
  • pain in the joints with or without fever;
  • itching or swelling of the skin;
  • yellowing of the skin or eyes;
  • frequent infections such as fever, severe chills, sore throat or mouth ulcers;
  • bleeding or bruising more easily than normal;
  • difficulty in swallowing or breathing.

The above list includes serious side effects which may require medical attention. Serious side effects are rare.

Tell your doctor immediately if you notice any of the following, particularly if they occur several weeks after stopping treatment with Cefaclor GH:

  • severe abdominal cramps or stomach cramps;
  • watery and severe diarrhoea which may also be bloody;
  • fever, in combination with one or both of the above.

Do not take any diarrhoea medicine without first checking with your doctor. You may have a serious condition affecting your bowel, requiring urgent medical attention.

Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital, if you notice any of the following:

  • sudden signs of allergy such as rash, itching or hives on the skin with swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing.

These is a very serious side effect of Cefaclor GH. If you have them, you may have had a serious allergic reaction to Cefaclor GH. You may need urgent medical attention or hospitalisation. This side effect is very rare.

Tell your doctor if you notice anything else that is making you feel unwell.

Other side effects not listed above may also occur in some people. These include:

  • swelling of the liver;
  • inflammation of the kidney.

Some of these side effects can only be found when your doctor does tests from time to time to check your progress.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After taking Cefaclor GH

Storage

Keep it in a cool, dry place where the temperature stays below 25°C.

Do not store it or any other medicine in the bathroom or near a sink.

Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one and a half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking Cefaclor GH or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets that are left over.

Product description

What it looks like

Cefaclor GH 375 mg modified release tablets are capsule-shaped, biconvex, unscored, blue film-coated tablets imprinted with “Cefaclor CD 375 mg” in black ink. Cefaclor GH tablets are available in a pack of 10 tablets.

Ingredients

Active ingredient

Each tablet contains 375 mg cefaclor (as monohydrate.

Other ingredients

  • hypromellose;
  • hyprolose;
  • lactose monohydrate;
  • magnesium stearate;
  • purified talc;
  • colloidal anhydrous silica;
  • OPADRY complete film coating system 02B50703 BLUE (PI 12176);
  • WB monogramming ink NS-78-17821 BLACK (PI 12156).

Cefaclor GH does not contain gluten, sucrose, tartrazine or any other azo dyes.

Australian Registration Numbers

Cefaclor GH 375 mg:
AUST R 182048

Distributor

Generic Health Pty Ltd
Suite 2, Level 2
19-23 Prospect Street
Box Hill, VIC, 3128
Australia

Email: [email protected]
Telephone: +61 3 9809 7900
Website: www.generichealth.com.au

This leaflet was prepared in February 2020.

Published by MIMS May 2020

BRAND INFORMATION

Brand name

Cefaclor GH

Active ingredient

Cefaclor

Schedule

S4

 

Notes

Distributed by Generic Health Pty Ltd.

1 Name of Medicine

Cefaclor monohydrate.

6.7 Physicochemical Properties

Cefaclor monohydrate is a white to off-white crystalline powder, slightly soluble in water, but is insoluble in alcohol and chloroform.

Chemical structure.


Chemical Name: 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate.
Molecular formula: C15H14ClN3O4S.H2O.
Molecular weight: 385.8.

CAS number.

70356-03-5.

2 Qualitative and Quantitative Composition

Each tablet contains 375 mg cefaclor as (monohydrate).

List of excipients with known effects.

Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Cefaclor GH 375 mg modified release tablets are capsule-shaped, biconvex, unscored, blue film-coated tablets imprinted with "Cefaclor CD 375 mg" in black ink.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Microbiology.

In vitro tests demonstrate that the bactericidal action of the cephalosporins results from inhibition of cell wall synthesis. Cefaclor is stable in the presence of bacterial β-lactamases; consequently, β-lactamase producing organisms resistant to penicillins and some cephalosporins may be susceptible to cefaclor. Cefaclor may have useful activity against the following organisms in vitro and in clinical infections.

Gram positive organisms.

Staphylococcus aureus, Staphylococcus saprophyticus, Streptococcus pneumoniae and Streptococcus pyogenes (group A Streptococci). Note that cefaclor is not active against methicillin resistant Staphylococci.

Gram negative organisms.

Haemophilus influenzae, Moraxella (Branhamella) catarrhalis, Escherichia coli. Klebsiella pneumoniae and Proteus mirabilis.

Note.

The pseudomonas sp. Acinetobacter calcoaceticus, Enterococci, Enterobacter sp., indole positive Proteus, and Serratia sp. are resistant to cefaclor.

Susceptibility testing.

Dilution or diffusion techniques - either quantitative (MIC) or breakpoint, should be used following a regularly updated, recognised and standardised method (e.g. NCCLS). Standardised susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures.
A report of "Susceptible" indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of "Intermediate" indicates that the result should be considered equivocal, and if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone, which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of "Resistant" indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Note.

The prevalence of resistance may vary geographically for selected species and local information on resistance is desirable, particularly when treating severe infections.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Cefaclor GH is well absorbed after oral administration, with peak plasma levels being reached in about 2 hours. Following a single dose of Cefaclor GH Cmax is approximately 3.8 microgram/mL and AUC is 11.5 microgram.h/mL. When taken with food the time to reach maximum plasma levels is increased to about 3 hours and Cmax increases by 20%. The effects of food on Cmax and Tmax are also seen with other modified release preparations of cefaclor.
The plasma half-life in healthy subjects is approximately 50 minutes.
Other studies with sustained release preparations of cefaclor have shown that concomitant administration of cimetidine does not affect the rate or extent of absorption. Administration of magnesium or aluminium hydroxide containing antacids one hour after sustained release preparations of cefaclor had no effect on the rate of absorption, but resulted in a 17% decrease in the extent of absorption. The effect of antacids taken at other times is uncertain.
In elderly subjects (> 65 years) with normal serum creatinine values, a higher peak plasma concentration and area under the curve (AUC) are effects resulting from mildly diminished renal function and are not expected to have clinical significance. Therefore, dosage changes are not necessary in elderly subjects with normal renal function. There is no evidence of metabolism of cefaclor in humans.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

Studies in animals have not been performed to evaluate the carcinogenic or mutagenic potential for cefaclor modified release.

4 Clinical Particulars

4.1 Therapeutic Indications

For the treatment of the following infections caused by susceptible organisms in adults and children 12 years and older.
Lower respiratory infections, including community acquired pneumonia of mild to moderate severity (excluding atypical pneumonia), acute bronchitis and exacerbation of chronic bronchitis.
Upper respiratory infections, including pharyngitis, tonsillitis and acute bacterial sinusitis.
Symptomatic lower urinary tract infections, including cystitis.
Skin and skin structure infections.

Note.

1. Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor modified release is generally effective in the eradication of streptococci from oropharynx; however, substantial data establishing the efficacy of cefaclor modified release in the subsequent prevention of rheumatic fever are not available.
2. Bacteriologic studies to determine the causative organism and its susceptibility to cefaclor should be performed. Therapy may be started while awaiting the results of these studies. Once these results become available, antimicrobial therapy should be adjusted accordingly.

4.3 Contraindications

Known allergy to cephalosporins or previous experience of a major allergy to penicillin (see Section 4.4 Special Warnings and Precautions for Use).
The safety and efficacy of this product have not been established in children.

4.4 Special Warnings and Precautions for Use

Penicillin sensitive patients.

Cephalosporin antibiotics should be administered cautiously in this patient group. There is clinical and laboratory evidence of partial cross allergenicity of the penicillins and the cephalosporins and there are instances in which patients have had reactions, including anaphylaxis, to both drug classes. Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid) reactions have been reported in patients on penicillin/cephalosporin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins/cephalosporins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin/cephalosporin hypersensitivity who have experienced severe reactions when treated with a penicillin/cephalosporin.

Severe allergic reaction to penicillin or cephalosporin class of drugs.

Past history of a severe allergic reaction to drug from the penicillin or cephalosporin group of drugs is a contraindication to the use of cefaclor modified release. Before initiating therapy with any cephalosporin careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If an allergic reaction occurs, cefaclor modified release should be discontinued and the appropriate therapy instituted. Serious anaphylactoid reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management, including intubation, should also be administered as indicated.
Broad spectrum antibiotics should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Colitis.

Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including cefaclor. A toxin produced by Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patient who develop diarrhoea or colitis in association with antibiotic use (this may occur up to several weeks after cessation of antibiotic therapy), mild cases usually respond to drug discontinuation alone. However, in moderate to severe cases appropriate therapy such as oral antibacterial agents effective against Cl. difficile should be considered.
Fluids, electrolytes and protein replacement therapy should be provided when indicated.
Drugs which delay peristalsis, e.g. opiates and diphenoxylate with atropine (Lomotil), may prolong and/or worsen the condition and should not be used.

Adequate treatment period.

As with antibiotic therapy in general, administration of cefaclor modified release should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or after evidence of bacterial eradication has been obtained. A minimum of 10 days of treatment is recommended in infections caused by group A β-haemolytic Streptococci in order to guard against the risk of rheumatic fever or glomerulonephritis.

Prolonged use of cefaclor modified release.

This may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.

Use in hepatic impairment.

Cefaclor modified release should be used with caution in patients with hepatic disease, as documented clinical experience in this group of patients is lacking.

Use in renal impairment.

Cefaclor modified release should be administered with caution in the presence of markedly impaired renal function. Since the half-life of cefaclor in anuria is 2.3 to 2.8 hours, dosage adjustments for patients with moderate or severe renal impairment are usually not required. Clinical experience with cefaclor under such conditions is limited; therefore, careful clinical observation and laboratory studies should be made.

Use in the elderly.

No data available.

Paediatric use.

Safety and effectiveness of this product has not been studied in children. Serum sickness-like reactions including arthritis and arthralgia have been reported more frequently in children than in adults with the use of cefaclor.

Effects on laboratory tests.

Administration of cefaclor modified release may result in a false positive reaction for glucose in the urine. This phenomenon has been seen in patients taking cephalosporin antibiotics when the test is performed using Benedict's and Fehling's solution and also with Clinitest tablets but not with Tes-Tape (Glucose Enzymatic Test Strip, USP).
Positive direct Coombs' tests have been reported during treatment with cefaclor. In haematological studies or in transfusion cross matching procedures when antiglobulin tests are performed on the minor side or in Coombs' testing of newborn infants whose mothers have received cephalosporin antibiotics before parturition, it should be recognised that a positive Coombs' test may be due to the drug.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The extent of absorption of cefaclor is diminished if magnesium or aluminium hydroxide containing antacids are taken within 1 hour of administration; cimetidine did not alter either the rate or the extent of absorption of cefaclor. As with other β-lactam antibiotics, the renal excretion of cefaclor (and presumably cefaclor modified release) is inhibited by probenecid. No other significant drug interactions were noted during clinical trials.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Reproduction studies have revealed no evidence of impaired fertility.
(Category B1)
The oral administration of high dose cefaclor (500 mg/kg) in pregnant rats and mice has resulted in a slight increase of minor skeletal malformation. Safety of this product for use during pregnancy has not been established. Cefaclor should not be used in women of childbearing potential unless, in the judgement of the treating clinician, its use is considered essential to the welfare of the patient and the expected benefits outweigh potential risks.

Labour and delivery.

Cefaclor modified release has not been studied for use during labour and delivery. Treatment should be given only if clearly needed.
No studies have been done with cefaclor modified release. Small amounts of cefaclor have been detected in breast milk following administration of single 500 mg doses of cefaclor. Average levels were 0.18, 0.20, 0.21 and 0.16 microgram/mL at 2, 3, 4 and 5 hours respectively. Trace amounts were detected at 1 hour. The effect on breastfed infants is not known. Caution should be exercised when cefaclor modified release is administered to a breastfeeding woman.

4.8 Adverse Effects (Undesirable Effects)

Clinical trials.

The majority of adverse reactions observed in clinical trials of cefaclor modified release were mild and transient. Drug related adverse reactions requiring discontinuation of therapy occurred in 1.7% of patients. The following adverse reactions have been reported following use of cefaclor modified release in clinical trials. Incidence rates were less than 1% except where otherwise noted.

Gastrointestinal.

Diarrhoea (3.4%), nausea (2.5%), vomiting and dyspepsia.

Hypersensitivity.

Rash, urticaria or pruritus occurred in approximately 1.7% of patients. One serum sickness-like reaction (0.03%) was reported among the 3,272 patients treated with cefaclor modified release during the controlled clinical trials.

Haematological and lymphatic systems.

Eosinophilia.

Genitourinary.

Vaginal moniliasis (2.5%) and vaginitis (1.7%).

Acute bacterial sinusitis.

Adverse events reported during a clinical trial of cefaclor modified release (750 mg b.i.d.) vs cefaclor capsules (500 mg t.i.d.) in patients with acute bacterial sinusitis are shown in Table 1. All adverse events occurring at an incidence of 2% or greater are included:
The following adverse effects have been reported in patients treated with cefaclor modified release; the causal relationship is uncertain; incidence rates were less than 1% except where otherwise noted.

Central nervous system.

Headache (3.2%), dizziness and somnolence.

Hepatic.

Transient elevations in AST, ALT and alkaline phosphatase.

Renal.

Transient increases in serum urea or creatinine.

Laboratory tests.

Transient thrombocytopenia, leucopoenia, lymphocytosis, neutropenia and abnormal urinalysis.
In addition, the following adverse reactions and altered laboratory tests have been reported in patients treated with the regular (not sustained release) cefaclor preparations.
Cases of serum sickness-like reactions have been reported with the use of cefaclor. These have been reported more frequently in children than in adults, with an overall occurrence ranging from 0.5% (1 in 200) in one trial, to 0.024% (2 in 8346) in overall clinical trials (with an incidence in children in clinical trials of 0.055%). The worldwide reporting rate for serum sickness-like reactions in adults is very rare (< 0.01%). Serum sickness-like reactions are characterised by findings of erythema multiforme, rashes and other skin manifestations accompanied by arthritis/arthralgia, with or without fever, and differ from classic serum sickness in that there is infrequently associated lymphadenopathy and proteinuria, no circulating immune complexes and no evidence to date of sequelae of the reaction. While further investigation is ongoing, serum sickness-like reactions appear to be due to hypersensitivity and more often occur during or following a second (or subsequent) course of therapy with cefaclor. Such reactions have been reported more frequently in children than in adults. Signs and symptoms usually occur a few days after initiation of therapy and subside within a few days after cessation of therapy; occasionally these reactions have resulted in hospitalisation, usually of short duration (median hospitalisation: 2 to 3 days, based on postmarketing surveillance studies). In those requiring hospitalisation, the symptoms have ranged from mild to severe at the time of admission with more of the severe reactions occurring in children. Antihistamines and glucocorticoids appear to enhance resolution of the signs and symptoms. No serious sequelae have been reported. More severe hypersensitivity reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported rarely. Anaphylaxis may be more common in patients with a history of penicillin allergy. The worldwide reporting rate for anaphylaxis in the total population is very rare (< 0.01%).
Positive direct Coombs' test and genital pruritus have been reported. Symptoms of pseudomembranous colitis may appear either during or after antibiotics treatment.
The following reactions have been reported rarely in patients treated with cefaclor; reversible interstitial nephritis; hepatic dysfunction, including hepatitis and cholestatic jaundice; increased prothrombin time in patients receiving cefaclor and warfarin concomitantly. Reversible hyperactivity, nervousness, insomnia, confusion, hallucinations, hypertonia, haemolytic anaemia, agranulocytosis, aplastic anaemia, fever and angioedema.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

Administer orally.
Cefaclor GH can be taken with or without food, however absorption is enhanced when cefaclor is administered with food (see Section 5.2 Pharmacokinetic Properties).
The tablets should not be cut, crushed or chewed.

Adults.

The usual adult dosage is 375 mg twice daily.
For pneumonia, and acute bacterial sinusitis the recommended dosage is 750 mg twice daily. For acute bacterial sinusitis Cefaclor GH should be taken for 10 days.
For infections involving S. pyogenes (group A Streptococci), a therapeutic dosage of Cefaclor GH should be administered for at least ten days.

Renal impairment.

For patients with markedly impaired renal function see Section 4.4 Special Warnings and Precautions for Use.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.9 Overdose

Signs and symptoms.

The toxic symptoms following an overdose of cefaclor modified release may include nausea, vomiting, epigastric distress and diarrhoea. The severity of the epigastric distress and the diarrhoea are dose related. If other symptoms are present, it is probable that they are secondary to an underlying disease state, an allergic reaction, or the effects of other intoxication.

Treatment.

In managing overdose, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in the patient.
Protect the patient's airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or charcoal.
Forced diuresis, peritoneal dialysis, haemodialysis or charcoal haemoperfusion have not been established as beneficial for an overdose of cefaclor.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Cefaclor GH tablets contain the following inactive ingredients: hypromellose, hyprolose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, purified talc, Opadry complete film coating system 02B50703 Blue (PI 12176) and Opacode WB monogramming ink NS-78-17821 Black (PI 12156).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Protect from moisture and light.

6.5 Nature and Contents of Container

Available in PVC/PVDC/Al blister packs of 10 tablets.

Australian registration numbers.

Cefaclor GH 375 mg: AUST R 182048.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

Summary Table of Changes