SUMMARY CMI

CECLOR^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using CECLOR?

CECLOR contains the active ingredient cefaclor. CECLOR is used to treat infections caused by bacteria in different parts of the body. For more information, see Section 1. Why am I using CECLOR? in the full CMI.

2. What should I know before I use CECLOR?

Do not use if you have ever had an allergic reaction to CECLOR or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use CECLOR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with CECLOR and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use CECLOR?

• Your doctor will tell you how much CECLOR you need to take.
• This will depend on the type of infection you have.

More instructions can be found in Section 4. How do I use CECLOR? in the full CMI.

5. What should I know while using CECLOR?

For more information, see Section 5. What should I know while using CECLOR? in the full CMI.

6. Are there any side effects?

Tell your doctor or pharmacist if you notice any of the following and they worry you: diarrhoea; itchy rash; oral thrush - white, furry, sore tongue or mouth; vaginal thrush - sore and itchy vagina and/or abnormal discharge. Tell your doctor as soon as possible if you notice any of the following: 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.

This is not a complete list of all possible side effects. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

CECLOR^®

Active ingredient(s): cefaclor (as monohydrate)

Consumer Medicine Information (CMI)

This leaflet provides important information about using CECLOR. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using CECLOR.

Where to find information in this leaflet:

1. Why am I using CECLOR?
2. What should I know before I use CECLOR?
3. What if I am taking other medicines?
4. How do I use CECLOR?
5. What should I know while using CECLOR?
6. Are there any side effects?
7. Product details

1. Why am I using CECLOR?

CECLOR contains the active ingredient cefaclor monohydrate. CECLOR belongs to a group of antibiotics called cephalosporins. These antibiotics works by killing the bacteria that are causing your infection.

CECLOR is used to treat infections caused by bacteria in different parts of the body. This includes infections of the:

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

Ask your doctor if you have any questions about why CECLOR has been prescribed for you.

Your doctor may have prescribed it for another reason.

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

This medicine is not addictive.

2. What should I know before I use CECLOR?

Warnings

Do not use CECLOR if:

• you are allergic to any medicine containing cefaclor monohydrate, 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
  Always check the ingredients to make sure you can use this medicine.

Do not take CECLOR if you have had a serious allergic reaction to penicillin.

Do not give this medicine to a child under the age of one month.

Safety and effectiveness in children younger than one month have not been established.

Do not take this medicine after the expiry date printed on the carton and bottle label or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Check with your doctor if you:

• are allergic to any other medicines or any foods, preservatives or dyes.
• have or have had any of the following medical conditions:
  - kidney disease
  - severe bowel conditions
  - liver disease

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

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.

Your doctor can discuss with you the risks and benefits involved.

3. What if I am taking other medicines?

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

Some medicines and CECLOR may interfere with each other. These include:

• probenecid (e.g. Pro-Cid), a medicine used to treat gout and to promote the excretion of uric acid

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking CECLOR.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect CECLOR.

4. How do I use CECLOR?

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 carton or bottle, ask your doctor or pharmacist for help.

How much to take

• Your doctor will tell you how much CECLOR you need to take.
• This will depend on the type of infection you have.
• Follow the instructions provided when CECLOR was prescribed, including the number of days it should be taken.

How to take it

• Shake the bottle well and accurately measure the dose with a medicine measure.
• Shaking the bottle and using a medicine measure will make sure that you get the correct dose. You can buy a medicine measure from your pharmacist.
• It does not matter if you take this medicine with or without food.

How long to take it

Continue taking your medicine for as long as your doctor tells you.

It is important to complete the full course prescribed by your doctor, even if you begin to feel better after a few days. If you do not, the bacteria causing your infection may continue to grow and multiply so that your infection may not clear completely or your symptoms may return.

If you forget to take CECLOR

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 your medicine as you would normally.

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

If you are not sure what to do, ask your doctor or pharmacist.

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

If you take too much CECLOR

If you think that you have used too much CECLOR, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (Australia telephone 13 11 26) for advice, or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

Symptoms of an overdose may include feeling sick, vomiting, upset stomach or diarrhoea.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using CECLOR?

Things you should do

• Tell your doctor if the symptoms of your infection do not improve within a few days, or if they become worse.
• Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.
• If you become pregnant while taking this medicine, tell your doctor immediately.
• If you are about to have any blood tests, tell your doctor that you are taking this medicine.
  It may interfere with the results of some tests.
• 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.
  CECLOR may cause false test results with some urine sugar tests.

Things you should not do

• Do not take CECLOR to treat any other complaints unless your doctor tells you to.
• Do not give your medicine to anyone else, even if they have the same condition as you.
• Do not stop taking your medicine or lower the dosage without checking with your doctor.

Driving or using machines

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

This medicine may cause dizziness or drowsiness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Children should be careful when riding bicycles or climbing trees.

Looking after your medicine

Keep CECLOR suspension in your refrigerator at 2°C to 8°C where young children cannot reach it. Do not freeze.

Keep the bottle tightly closed.

The suspension should be shaken well before use and discarded after 14 days.

Getting rid of any unwanted medicine

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

6. Are there any side effects?

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

This medicine helps most people with infection, but it may have unwanted side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

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

Less serious side effects

Serious side effects

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.

More serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What CECLOR contains

What CECLOR looks like

CECLOR 125 mg / 5 mL: A pink free-flowing dry powder. After constitution a red coloured suspension with a characteristic strawberry odour. (AUST R 347594)

Available in bottle of 100 mL.

CECLOR 250 mg / 5 mL: A pink free-flowing dry powder. After constitution a red coloured suspension with a characteristic strawberry odour. (AUST R 347593)

Available in bottle of 75 mL.

Who distributes CECLOR

Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

This leaflet was prepared in January 2024.

CECLOR® is a Viatris company trade mark

CECLOR_cmi\Jan24/00

Published by MIMS March 2024

1 Name of Medicine

Cefaclor (as monohydrate).

2 Qualitative and Quantitative Composition

Each 5 mL of Ceclor powder for oral liquid upon reconstitution contains 125 mg or 250 mg of cefaclor (as monohydrate) as the active ingredient.

Excipients of known effect.

3 Pharmaceutical Form

Ceclor 125 mg/5 mL and 250 mg/5 mL powder for oral liquids are pink free-flowing dry powders. After constitution, a red coloured suspension with a characteristic strawberry odour is formed.

4 Clinical Particulars

4.1 Therapeutic Indications

Ceclor is indicated for the treatment of the following types of infections caused by or likely to be caused by susceptible organisms:
Lower respiratory infections, including pneumonia, bronchitis and exacerbations of chronic bronchitis.
Upper respiratory infections, including pharyngitis, tonsillitis and otitis media.
Skin and skin structure infections.
Urinary tract infections, including pyelonephritis and cystitis.

Note.

4.2 Dose and Method of Administration

Ceclor is administered orally.

Directions for reconstitution of Ceclor.

125 mg/5 mL.

250 mg/5 mL.

Adults.

Children.

4.3 Contraindications

Ceclor is contraindicated in patients with known allergy to the cephalosporin group of antibiotics or who have previously experienced a major allergy to penicillin (see Section 4.4 Special Warnings and Precautions for Use).
Ceclor is also contraindicated in infants under the age of one month as safety and efficacy of this product has not been established in prematures and infants under one month of age.

4.4 Special Warnings and Precautions for Use

In penicillin-sensitive patients, cephalosporin antibiotics should be administered cautiously. 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.
Past history of a severe allergic reaction to penicillin/ cephalosporin is a contraindication to the use of Ceclor. 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, Ceclor should be discontinued and the appropriate therapy instituted. Serious anaphylactoid reactions require immediate emergency treatment with adrenaline (epinephrine). 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.
Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including cefaclor. A toxin produced with 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 patients 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 with a suitable oral antibacterial agent effective against C. difficile should be considered. Fluids, electrolytes and protein replacement 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.
As with antibiotic therapy in general, administration of Ceclor 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 ten days of treatment is recommended in infections caused by group A beta-haemolytic streptococci in order to guard against the risk of rheumatic fever or glomerulonephritis.
Prolonged use of Ceclor may result in the overgrowth of non-susceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.

Neurotoxicity.

Severe cutaneous adverse reactions.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

As with other β-lactam antibiotics, the renal excretion of Ceclor is inhibited by probenecid.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

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.

4.8 Adverse Effects (Undesirable Effects)

Gastrointestinal.

Hepatic.

Hypersensitivity.

Blood.

Kidney.

Superinfection.

Central nervous system.

Other.

Severe and other subcutaneous tissue disorders.

Post-marketing experience.

Nervous system disorders.

Reporting suspected adverse effects.

4.9 Overdose

Signs and symptoms.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Note.

Note.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Metabolism.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

The powder for oral liquid also contains the following inactive ingredients: Dimeticone 350, erythrosine, methylcellulose, sodium lauryl sulfate, Strawberry Flavour 52312 AP0551 (ARTG PI No.: 274), sucrose, pregelatinised starch, xanthan gum.

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

Dry powder: store below 25°C.
Reconstituted suspension: store at 2°C to 8°C (Refrigerate. Do not freeze). Use within 14 days and discard remaining portion thereafter.

6.5 Nature and Contents of Container

Container type: bottle (HDPE).
Pack sizes: 75 mL (250 mg/5 mL), 100 mL (125 mg/5 mL).
Some strengths, pack sizes and/or pack types may not be marketed.

Australian register of therapeutic goods (ARTG).

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes