CEFACLOR

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
CEFACLOR
Available from:
Chanelle Medical
ATC code:
J01DC04
INN (International Name):
CEFACLOR
Dosage:
250 Milligram
Pharmaceutical form:
Capsules Hard
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
cefaclor
Authorization status:
Not Marketed
Authorization number:
PA0688/013/001
Authorization date:
2007-04-13

ID: PL 116/117 M IE

Version: 05

Review date: 18/01/2017

Prepared by:

Approved by:

Page 1 of 3

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cefaclor 250 mg Capsules

Cefaclor 500 mg Capsules

Cefaclor

Read all of this leaflet carefully before you start taking this medicine because it contains important

information for you

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if

their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not

listed in this leaflet. See section 4.

What is in this leaflet:

What Cefaclor Capsules are and what they are used for

What you need to know before you take Cefaclor Capsules

How to take Cefaclor Capsules

Possible side effects

How to store Cefaclor Capsules

Contents of the pack and other information

Cefaclor capsules contain the active ingredient cefaclor, which is an antibiotic.

Cefaclor capsules are used to treat the following infections caused by bacteria that can be killed by cefaclor:

Bronchitis

Infection of lung tissue (pneumonia)

Bladder (cystitis) and kidney infections

Throat infections including tonsillitis and pharyngitis

Middle ear infections (otitis media)

Skin and soft tissue (e.g. muscle) infections

Infection of the sinuses (sinusitis)

Do not take Cefaclor Capsules if:

you are allergic (hypersensitive) to cefaclor, any cephalosporin (other similar antibiotics) or any of

the other ingredients of Cefaclor capsules (these are listed in Section 6 of this leaflet).

An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat

or tongue.

Warnings and Precautions

Talk to your doctor before taking Cefaclor capsules if you

have had an allergic reaction to penicillins or other drugs in the past

have a history of gastrointestinal disease, especially inflammation of the colon (colitis)

have severe kidney problems

1.

What Cefaclor Capsules are and what they are used for

2.

What you need to know before you take Cefaclor Capsules

ID: PL 116/117 M IE

Version: 05

Review date: 18/01/2017

Prepared by:

Approved by:

Page 2 of 3

Tell your doctor if you are having blood or urine tests. Cefaclor capsules may interfere with these tests.

Other medicines and Cefaclor capsules

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines, including medicines obtained without a prescription. This is especially important for the

following, as they may interact with your Cefaclor capsules:

warfarin (a blood thinner)

probenecid (a treatment for gout)

It may still be all right for you to be given Cefaclor capsules and your doctor will be able to decide what is

suitable for you

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your

doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Cefaclor capsules should not affect your ability to drive or use machines.

Always take Cefaclor Capsules exactly as your doctor has told you. Check with your doctor or pharmacist if

you are not sure.

Dosage

Adults and the elderly

:

The usual dose is 250 mg three times a day. Your doctor will tell you if you need to take a higher dose.

Patients undergoing regular dialysis:

The usual dose is 250 mg to 1 g prior to dialysis. A dose of 250 mg to

500 mg every 6 to 8 hours is recommended between periods of dialysis.

Use in children:

Cefaclor capsules are not recommended for children.

If you take more Cefaclor Capsules than you should

Go to the nearest accident and emergency department or tell your doctor straight away.

If you forget to take Cefaclor Capsules

If you miss a dose, take one as soon as you can. If you have missed several doses, tell your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

3.

How to take Cefaclor Capsules

4.

Possible side effects

ID: PL 116/117 M IE

Version: 05

Review date: 18/01/2017

Prepared by:

Approved by:

Page 3 of 3

Like all medicines, this medicine can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although serious allergic reactions are very rare.

Tell your

doctor immediately if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids,

face, lips or limbs, rash or itching (especially affecting your whole body).

Serious side effects

The following side effects are serious. You should stop taking this medicine and contact your doctor

immediately if you experience them:

serious peeling or blistering of the skin

severe diarrhea, possibly with blood or mucus.

The following side effects have been reported

diarrhea

feeling sick (nausea)

vomiting

measle-like rash, (alone)

itching

red wheals on the skin (urticarial) (alone)

rash with wide spread joint pain and / or stiffness, swollen lymph glands, fever and, possibly, cloudy

urine

swollen arms or legs

breathlessness

changes in blood counts, which may show up as bruising or a very tired feeling. You will need a

blood test to confirm this.

damage to your liver or kidneys which can only be detected by a blood and / or urine test

jaundice (yellow skin and eyes)

weakness

pins and needles in the hands or feet

fainting

abnormally excitable behavior

agitation

nervousness

sleeplessness

confusion

tight muscles

dizziness

seeing or hearing things (hallucinations)

itching of the vagina caused by thrush (candidiasis).

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed

in this leaflet. You can also report side effects directly via: HPRA Pharmacovigilance, Earlsfort Terrace,

IRL- Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, www.hpra.ie; E-mail: medsafety@hpra.ie. By

reporting side effects you can help provide more information on the safety of this medicine.

4.

Possible side effects

ID: PL 116/117 M IE

Version: 05

Review date: 18/01/2017

Prepared by:

Approved by:

Page 4 of 3

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and the carton. The expiry date

refers to the last day of that month.

This medicinal product does not require any special storage conditions

Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the

environment.

What Cefaclor Capsules contain

The active substance is cefaclor (as cefaclor monohydrate). Each 250 mg capsule contains 250 mg of

cefaclor (as cefaclor monohydrate). Each 500 mg capsule contains 500 mg of cefaclor (as cefaclor

monohydrate). The other ingredients are sodium starch glycollate (type A), silica colloidal anhydrous and

magnesium stearate. The capsule shell is made of gelatin. The colouring agents used are indigo carmine

(E132), titanium dioxide (E171) and iron oxide (E172).

What Cefaclor Capsules look like and contents of the pack

Cefaclor 250 mg Capsules are blue and green. Cefaclor 500 mg Capsules are grey and green. They come in

packs of 8, 10, 16, 20, 24, 30, 32, 40, 48, 50, 56, 60, 64, 70, 72, 80, 88, 90, 96 or 100. Not all pack sizes may

be marketed.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder and manufacturer is Chanelle Medical, Loughrea, Co. Galway, Ireland.

This leaflet was last revised in

01/2017

5.

How to store Cefaclor Capsules

6.

Contents of the pack and other information

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Cefaclor 250mg Capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains 250 mg of cefaclor (as monohydrate).

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Capsule, hard

Cefaclor 250 mg capsules are blue and green.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Cefaclor is indicated for the treatment of the following infections due to susceptible microorganisms:

Rispiratory tract infections, including pneumonia, bronchitis, exacerbations of chronic bronchitis, pharyngitis, and

tonsillitis, and as part of the management of sinusitis.

Otitis media.

Skin and soft tissue infections.

Urinary tract infections, including pyelonephritis and cystitis.

Cefaclor has been found to be effective in both acute and chronic urinary tract infections.

Cefaclor is generally effective in the eradication of streptococci from the nasopharynx, however, data establishing

efficacy in the subsequent prevention of either rheumatic fever or bacterial endocarditis are not available.

4.2 Posology and method of administration

Posology

Adults (including the elderly):

The usual adult dosage is 250 mg every eight hours. A dosage of 250mg, administered 3 times daily for 10 days, is

recommended for sinusitis. For more severe infections or those caused by less susceptible organisms, doses may be

doubled. Doses of 4 g per day have been administered safely to normal subjects for 28 days, but the total daily dosage

should not exceed this amount.

Children:

The usual recommended daily dose for children is 20 mg/kg/day, in divided doses, every eight hours, as indicated. For

bronchitis and pneumonia, the dosage is 20 mg/kg/day in divided doses, administered 3 times daily. For otitis media

and pharyngitis, the total daily dosage may be divided and administered every 12 hours. Safety and efficacy have not

been established for use in infants aged less than one month.

In more serious infections, otitis media and infections caused by less susceptible organisms, 40 mg/kg/day, in divided

doses is recommended, up to a daily maximum of 1 g.

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In the treatment of beta-haemolytic streptococcal infections, therapy should be continued for at least 10 days.

Patients with impaired renal function:

Cefaclor may be administered in the presence of impaired renal function. Under such conditions, dosage is unchanged.

Cefaclor should be administered with caution in the presence of markedly impaired renal function. Since the half-life of

cefaclor in anuric patients is 2.3 to 2.8 hours (compared to 0.6 to 0.9 hours in normal subjects), dosage adjustments for

patients with moderate or severe renal impairment are not usually required. Clinical experiences with cefaclor under

such conditions is limited; therefore, careful clinical observation and laboratory studies should be made.

Patients undergoing haemodialysis:

Haemodialysis shortens serum half-life by 25 -30%. In patients undergoing regular haemodialysis, a loading dose of

250 mg – 1 g, administered prior to dialysis, and a therapeutic dose of 250 mg – 500 mg every six to eight hours

maintained during interdialytic periods is recommended.

Method of administration

Cefaclor is administered orally.

4.3 Contraindications

Hypersensitivity to cephalosporins.

4.4 Special warnings and precautions for use

Warnings

Before instituting therapy with cefaclor, every effort should be made to determine whether the patient has had previous

hypersensitivity reactions to cefaclor, cephalosporins, penicillins or other drugs. Cefaclor should be given cautiously to

penicillin-sensitive patients because cross-hypersensitivity, including anaphylaxis, among beta-lactam antibiotics has

been clearly documented.

If an allergic reaction to cefaclor occurs, the drug should be discontinued and the patient treated with the appropriate

agents.

Pseudomembranous colitis has been reported with virtually all broad-spectrum antibiotics, including macrolides, semi-

synthetic penicillins and cephalosporins. It is important, therefore, to consider its diagnosis in patients who develop

diarrhoea in association with the use of antibiotics. Such colitis may range in severity from mild to life-threatening.

Mild cases usually respond to drug discontinuance alone. In moderate to severe cases, appropriate measures should be

taken.

Precautions

Broad-spectrum antibiotics should be prescribed with caution in individuals with a history of gastro-intestinal disease,

particularly colitis.

Prolonged use of cefaclor may result in the overgrowth of non-susceptible organisms. If superinfection occurs during

therapy, appropriate measures should be taken.

Positive direct Coombs’ tests have been reported during treatment with the cephalosporin antibiotics. In haematological

studies or in transfusion cross-matching procedures, when anti-globulin tests are performed on the minor side, or in

Coombs’ testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be

recognised that a positive Coombs’ test may be due to the drug.

A false-positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with copper

sulphate test tablets.

Cross-resistance may exist between penicillins and cephalosporins.

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4.5 Interaction with other medicinal products and other forms of interaction

There have been rare reports of increased prothrombin time,

with or without

clinical

bleeding,

in patients receiving

cefaclor and warfarin concomitantly. It is recommended that in such patients, regular monitoring of prothrombin time

should be considered, with adjustment of dosage if necessary.

The renal excretion of cefaclor is inhibited by probenecid.

4.6 Fertility, pregnancy and lactation

Pregnancy:

Cefaclor should not be administered during pregnancy unless considered essential by the physician. Animal studies

have shown no evidence of impaired fertility or teratogenicity. However there are no adequate or well controlled

studies in pregnant women.

Breast-feeding:

Small amounts of cefaclor have been detected in breast milk following administration of single 500 mg doses.

Average levels of about 0.2 micrograms/ml or less were detected up to 5 hours later. Trace amounts were detected at

one hour. As the effect on nursing infants is not known, caution should be exercised when cefaclor is administered to a

nursing woman.

4.7 Effects on ability to drive and use machines

Cefaclor has no known influence on the ability to drive and use machines.

4.8 Undesirable effects

Gastro-intestinal:

The most frequent side-effect has been diarrhoea. It is rarely severe enough to warrant cessation of therapy. Colitis,

including rare instances of pseudomembranous colitis, has been reported. Nausea and vomiting have also occurred.

Hypersensitivity:

Allergic reactions, such as morbilliform eruptions, pruritus and urticaria, have been observed. These reactions usually

subside upon discontinuation of therapy. Serum sickness-like reactions (erythema multiforme minor, rashes or other

skin manifestations accompanied by arthritis/arthralgia, with or without fever) have been reported. Lymphadenopathy

and proteinuria are infrequent; there are no circulating immune complexes and no evidence of sequelae. Occasionally,

solitary symptoms may occur, but do not represent a serum sickness-like reaction. Serum sickness-like reactions are

apparently due to hypersensitivity and have usually occurred 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 usually subside within a few days of cessation of

therapy. Antihistamines and corticosteroids appear to enhance resolution of the syndrome. No serious sequelae have

been reported.

There are rare reports of erythema multiforme major (Stevens-Johnson syndrome), toxic epidermal necrolysis and

anaphylaxis. Anaphylaxis may be more common in patients with a history of penicillin allergy. Anaphylactoid events

may present as solitary symptoms, including angioedema, asthenia, oedema (including face and limbs), dyspnoea,

paraesthesias, syncope, or vasodilatation.

Rarely, hypersensitivity symptoms may persist for several months.

Haematological:

Eosinophilia, positive Coombs'

tests and, rarely, thrombocytopenia. Transient lymphocytosis, leucopenia and, rarely,

haemolytic anaemia, aplastic anaemia, agranulocytosis and reversible neutropenia of possible clinical significance. See

’Drug Interactions’.

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Hepatic:

Transient hepatitis and cholestatic jaundice have been reported rarely, slight elevations in AST, ALT or alkaline

phosphatase values.

Renal:

Reversible interstitial nephritis has occurred rarely, also slight elevations in blood urea or serum creatinine or abnormal

urinalysis.

Central nervous system:

Reversible hyperactivity, agitation, nervousness, insomnia, confusion, hypertonia, dizziness, hallucinations and

somnolence have been reported rarely.

Miscellaneous:

Genital pruritus, vaginitis and vaginal moniliasis.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorization 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 via: HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2. Tel: +353 1 6764971;

Fax: +353 1 6762517; Website: www.hpra.ie; email: medsafety@hpra.ie

4.9 Overdose

Symptoms of nausea, vomiting, epigastric distress and diarrhoea would be anticipated.

Treatment: Unless 5 times the normal total daily dose has been ingested, gastro-intestinal decontamination will not be

necessary. General management may consist of supportive therapy.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: second-generation cephalosporins, ATC code: J01DC04

Cefaclor is a semi-synthetic cephalosporin antibiotic. The bacterial action of the cephalosporins results from their

inhibition of cell-wall synthesis.

Cefaclor is active against the following organisms in vitro: Alpha- and beta-haemolytic streptococci; Staphylococci,

including coagulase positive, coagulase-negative and penicillinase-producing strains; Streptococcus pyogenes; Str.

Pneumoniae penicillin- sensitive strains; Branhamella catarrhalis; Escherichia coli; Proteus mirabilis; Klebsiella

spp; Haemophilus influenzae, including beta-lactamase-producing strains.

Cefaclor has no activity against Pseudomonas spp. or Acinetobacter spp. Methicillin- resistant staphylococci and most

strains of enterococci (eg, Str. faecalis) and penicillin-resistant Str. Pneumoniae are resistant to cefaclor. Cefaclor is

not active against most strains of Enterobacter spp, Serratia spp, Morganella morganii, Proteus vulgaris and

Providencia rettgeri. The rare beta-lactamase-negative, ampicillin- resistant H. influenzae should be considered

resistant to cefaclor.

5.2 Pharmacokinetic properties

Cefaclor is well absorbed after oral administration in fasting subjects. Total absorption is unchanged in the presence of

food; however, peak plasma levels are reduced by about half and the peak is delayed. Following administration of 250

mg, 500 mg and 1 g to fasting subjects, average peak plasma concentration of 7, 13 and 23 mg/l, respectively were

obtained within 30 to 60 minutes. The serum half-life in normal subjects is 0.6 to 0.9 hour. Probenecid significantly

prolongs the half-life.

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In patients with reduced renal function, the serum half-life of cefaclor is slightly prolonged. In those with complete

absence of renal function, the plasma half-life of the intact molecule is 2.3 to 2.8 hours. Haemodialysis shortens the

half-life by 25 – 30 %. Cefaclor is about 50 % bound to plasma proteins. The drug is rapidly excreted by the kidneys;

up to 85 % appears unchanged in the urine within 8 hours, the greater part within 2 hours. During this 8 hour period,

peak urine concentrations following 250 mg, 500 mg and 1g doses were about 600, 900 and 1900 mg/l, respectively.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber in addition to that summarised in other sections of the

Summary of Product Characteristics.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium Starch Glycollate (Type A)

Silica, Colloidal Anhydrous

Magnesium Stearate

Capsule Shell

Indigo carmine (FD & C Blue 2) (E132)

Titanium Dioxide (E171)

Black Iron Oxide (E172)

Yellow Iron Oxide (E172)

Gelatin

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Blister strips composed of PVC/PVdC and Aluminium foil.

Cartons of 8, 10, 16, 20, 24, 30, 32, 40, 48, 50, 56, 60, 64, 70, 72, 80, 88, 90, 96 or 100; not all pack sizes may be

marketed.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Chanelle Medical

Loughrea

Co. Galway

Ireland

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8 MARKETING AUTHORISATION NUMBER

PA0688/013/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation 13

April 2007

Date of last renewal 13

April 2012

10 DATE OF REVISION OF THE TEXT

March 2017

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6

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