SUMMARY CMI

Cefalexin Sandoz^®

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 Cefalexin Sandoz?

Cefalexin Sandoz contains the active ingredient cefalexin monohydrate. Cefalexin Sandoz is used to treat infections caused by bacteria in different parts of the body, including infections of the respiratory tract (throat, tonsils, chest and lungs), nose (sinusitis), ears (otitis media), skin and soft tissue, kidneys and bladder (genitourinary tract).

For more information, see Section 1. Why am I using Cefalexin Sandoz? in the full CMI.

2. What should I know before I use Cefalexin Sandoz?

Do not use if you have ever had an allergic reaction to cefalexin monohydrate, penicillin, other cephalosporins 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 Cefalexin Sandoz? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Cefalexin Sandoz 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 Cefalexin Sandoz?

• Follow all directions given to you by your doctor or pharmacist.
• You doctor will tell you how much and how often you should take Cefalexin Sandoz.

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

5. What should I know while using Cefalexin Sandoz?

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

6. Are there any 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

Cefalexin Sandoz^®

Active ingredient(s): cefalexin monohydrate

Consumer Medicine Information (CMI)

This leaflet provides important information about using Cefalexin Sandoz. 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 Cefalexin Sandoz.

Where to find information in this leaflet:

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

1. Why am I using Cefalexin Sandoz?

Cefalexin Sandoz contains the active ingredient cefalexin monohydrate. This medicine belongs to a group of medicines called cephalosporins. These antibiotics work by killing the bacteria that are causing your infection.

Cefalexin Sandoz is used to treat infections caused by bacteria in different parts of the body, including infections of the:

• respiratory tract (throat, tonsils, chest and lungs)
• nose (sinusitis)
• ears (otitis media)
• skin and soft tissue
• kidneys and bladder (genitourinary tract).

Ask your doctor or pharmacist if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

There is no evidence that it is addictive.

2. What should I know before I use Cefalexin Sandoz?

Warnings

Do not use Cefalexin Sandoz if:

• you are allergic to cefalexin monohydrate, penicillin, 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.
• the expiry date (EXP) on the pack has passed.
• the packaging is torn or shows signs of tampering.

Do not take Cefalexin Sandoz suspension if it has been in your refrigerator for longer than two weeks.

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 any other medical conditions including:
  - liver disease
  - kidney disease
  - bowel disease.

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

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

Talk to your doctor if you are pregnant or intend to become pregnant or are breastfeeding.

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 may interfere with Cefalexin Sandoz and affect how it works.

These include:

• probenecid (e.g. Pro-Cid), a medicine commonly used to treat gout
• metformin, a medicine used in the treatment of diabetes.

These medicines may be affected by Cefalexin Sandoz or may affect how well it works. You may need different amounts of your medicines or you may need to take different medicines.

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

4. How do I use Cefalexin Sandoz?

Follow all directions given to you by your doctor or pharmacist carefully.

These directions may differ from the information contained in this leaflet.

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

Your Pharmacist will make up the suspension in the bottle, before giving it to you.

FOR PHARMACIST ONLY - Instructions for reconstitution:

Cefalexin Sandoz 125 mg/5mL oral suspension: Invert bottle and tap to loosen granules. Add 64 mL of water to granules in the bottle. Close and shake well at once.

Cefalexin Sandoz 250 mg/5mL oral suspension: Invert bottle and tap to loosen granules. Add 63 mL of water to granules in the bottle. Close and shake well at once.

How much to take

Cefalexin Sandoz is available as 500 mg capsules as well as 125 mg/5 mL and 250 mg/5 mL suspensions.

Adults

The usual adult dose is 500 mg every 6 hours. Your doctor may recommend a different dose depending on your condition.

Children

Your child's doctor will tell you how much Cefalexin Sandoz your child should take. This will depend on your child's age, weight, and the type of infection.

How to take Cefalexin Sandoz

Capsule

• Swallow Cefalexin Sandoz capsules with a glass of water.

Suspension

• Always shake the bottle before measuring the correct volume to give to your child.

When to take Cefalexin Sandoz

• Take each dose of Cefalexin Sandoz at about the same time each day.
• Taking each dose of Cefalexin Sandoz at the same time each day will have the best effect. It will also help you to remember when to take the medicine.
• It does not matter if you take Cefalexin Sandoz before or after food.

How to long to take Cefalexin Sandoz

• Continue taking Cefalexin Sandoz until you finish the pack or until your doctor recommends.

If you forget to use Cefalexin Sandoz

Cefalexin Sandoz should be used regularly at the same time each day. If you miss your dose at the usual time, take it as soon as you remember, and then go back to taking your medicine as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose 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 use too much Cefalexin Sandoz

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

Symptoms of an overdose may include feeling sick in the stomach, diarrhoea, blood in the urine, unusually increased reflexes, convulsions or hallucinations.

You should immediately:

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

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

5. What should I know while using Cefalexin Sandoz?

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 are treating you that you are taking Cefalexin Sandoz, especially if you are about to be started on any new medicines.
• Tell your doctor if you become pregnant while taking this medicine.
• If you are about to have any blood tests, tell your doctor that you are taking Cefalexin Sandoz.
  It may interfere with the results of some tests.
• If you are diabetic, check with your doctor or pharmacist before using urine sugar tests.
  Cefalexin Sandoz may affect the results of some of these 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.

Things you should not do

• Do not stop using this medicine suddenly or change the dosage without first checking with your doctor.
  If you stop taking it, your condition may worsen.
• Do not take Cefalexin Sandoz 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.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Cefalexin Sandoz affects you.

It may cause dizziness in some people.

Children should be careful when riding bicycles or climbing trees.

Looking after your medicine

Cefalexin Sandoz capsules

• Keep the capsules in the blister pack until it is time to take them.
• If you take your capsules out of the blister pack, they will not keep as well.
• Keep your capsules in a cool dry place where the temperature stays below 25°C.

Cefalexin Sandoz suspension

• Keep your suspension refrigerated (do not freeze). If you take the suspension out of the refrigerator, it will not keep well.
• Keep the bottle tightly closed.
• Do not use any suspension that is left in the bottle after 14 days.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it.

When to discard your medicine

If your doctor tells you to stop taking Cefalexin Sandoz, or the capsules have passed their expiry date or more than 14 days have passed since the suspension was mixed, ask your pharmacist what to do with any medicine that is left over.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

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

Common side effects

Serious side effects

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

• severe stomach cramps or pain
• severe, watery or bloody diarrhoea
• fever, in combination with one 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 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 Cefalexin Sandoz contains

Cefalexin Sandoz capsules:

Cefalexin Sandoz capsules does not contain lactose, sucrose, gluten, tartrazine or azo dyes.

Cefalexin Sandoz suspension:

Do not take this medicine if you are allergic to any of these ingredients.

What Cefalexin Sandoz looks like

Cefalexin Sandoz capsules:

Cefalexin Sandoz 500 mg capsules are opaque white in colour. Each pack contains 20 capsules (AUST R 78980).

Cefalexin Sandoz suspension:

Your pharmacist will make up the medicine in the bottle before dispensing it to you. Cefalexin Sandoz suspensions are orange-yellow in colour with a fruity flavour. Each bottle contains 100 mL.

It is available in two different strengths:

• 125 mg/5 mL (AUST R 78981)
• 250 mg/5 mL (AUST R 78982)

Who distributes Cefalexin Sandoz

Sandoz Pty Ltd
100 Pacific Highway
North Sydney, NSW 2060
Australia
Tel 1800 726 369

This leaflet was prepared in July 2024.

^® Registered Trade Mark. The trade marks mentioned in this material are the property of their respective owners.

Published by MIMS September 2024

1 Name of Medicine

Cefalexin monohydrate.

2 Qualitative and Quantitative Composition

Cefalexin Sandoz capsules contains cefalexin (as monohydrate) equivalent to 500 mg of cefalexin anhydrous.
Cefalexin Sandoz Powder for Oral Suspension contains cefalexin (as monohydrate) equivalent to 125 mg/5 mL or 250 mg/5 mL of cefalexin anhydrous.

Excipients with known effect.

Cefalexin Sandoz Powder for Oral Suspension.

3 Pharmaceutical Form

Capsules.

Powder for oral suspension.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of the following infections when caused by susceptible strains of the designated micro-organisms.

Respiratory tract infections.

Bacterial sinusitis.

Otitis media.

Skin and skin structure infections.

Genitourinary tract infections, including acute prostatitis.

Note.

4.2 Dose and Method of Administration

Dosage.

Adults.

Children.

Method of administration.

Dosage adjustment.

Renal impairment.

4.3 Contraindications

Known allergy to the cephalosporin group of antibiotics or previous experience of a major allergy to penicillin (see Section 4.4 Special Warnings and Precautions for Use).
Cefalexin Sandoz is not indicated in the management of bacterial infections of the brain or spinal column.

4.4 Special Warnings and Precautions for Use

Before instituting therapy with cefalexin, every attempt should be made to determine if the patient has had previous hypersensitivity reactions to the cephalosporins, penicillins, or other drugs. This product should be given cautiously to penicillin sensitive patients.
There is some clinical and laboratory evidence of partial cross allergenicity of the penicillins and the cephalosporins. Patients have been reported to have had severe reactions (including anaphylaxis) to both drugs.
If an allergic reaction to cefalexin occurs, the drug should be discontinued and the patient treated with the usual agents (e.g. adrenaline or other pressor amines, antihistamines or corticosteroids).
Pseudomembranous colitis has been reported with virtually all broad-spectrum antibiotics (including macrolides, semisynthetic penicillins, and cephalosporins); therefore, it is important to consider its diagnosis in patients who develop diarrhoea in association with the use of antibiotics. Mild cases of pseudomembranous colitis usually respond to drug discontinuance alone. In moderate to severe cases, appropriate measures should be taken. Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including cefalexin. 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 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 with a suitable oral antibacterial agent effective against Cl. difficile should be considered. Fluids, electrolytes and protein replacement therapy should be provided when indicated.
Drugs that delay peristalsis e.g. opiates and diphenoxylate with atropine (e.g. Lomotil), may prolong and/or worsen the condition and should not be used.
Broad-spectrum antibiotics should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. As with other broad-spectrum antibiotics, colitis, including rare instances of pseudomembranous colitis, has been reported in conjunction with therapy with cefalexin.
Patients should be followed carefully so that any side effects or unusual manifestations of drug idiosyncrasy may be detected.
Prolonged use of cefalexin 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.
Indicated surgical procedures should be performed in conjunction with antibiotic therapy.

Severe cutaneous adverse reactions.

Neurotoxicity.

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-lactams, the renal excretion of cefalexin is inhibited by probenecid.
In healthy subjects given single 500 mg doses of cefalexin and metformin, plasma metformin C_max and AUC increased by an average 34% and 24%, respectively, and metformin renal clearance decreased by an average of 14%. The interaction of cefalexin and metformin following multiple dose administration has not been studied. Administration of a cephalosporin to a metformin-treated patient may result in increased metformin exposure. A potential interaction between cefalexin and metformin may result in accumulation of metformin.

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)

Adverse drug reactions reported with cefalexin are very rare (< 0.01%) and are listed below:

Blood and lymphatic system disorders.

Gastrointestinal disorders.

General disorders and administration site conditions.

Hepatobiliary disorders.

Immune system disorders.

Infections and infestations.

Musculoskeletal and connective tissue disorders.

Nervous system disorders.

Psychiatric disorders.

Renal and urinary disorders.

Reproductive and breast disorders.

Skin and subcutaneous tissue disorders.

Reporting suspected adverse effects.

4.9 Overdose

There is no definite experience of poisoning or severe overdosage with cefalexin. However, clinical features of overdosage may be similar to those seen with other cephalosporins and penicillins, i.e. convulsions, hallucinations, hyperreflexia, electrolyte imbalance, gastrointestinal disturbances and haematuria.
In the event of severe overdosage, general supportive care is recommended including close clinical and laboratory monitoring of haematological, renal, hepatic functions and coagulation status until the patient is stable.
Forced diuresis, peritoneal dialysis, haemodialysis or charcoal haemoperfusion have not been established as beneficial for an overdose of cefalexin.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

A semisynthetic cephalosporin antibiotic for oral administration. The nucleus of cefalexin is related to that of other cephalosporin antibiotics.

Mechanism of action.

Note.

Note.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Capsule 500 mg.

Suspension.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
For information on interactions with other medicines and other forms of interactions, see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

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

Capsule 500 mg.

Powder for oral suspension.

6.5 Nature and Contents of Container

Capsules.

Powder for oral suspension.

6.6 Special Precautions for Disposal

Other handling.

Reconstitution of Cefalexin Sandoz granules for oral suspension 125 mg/5 mL.

Reconstitution of Cefalexin Sandoz granules for oral suspension 250 mg/5 mL.

6.7 Physicochemical Properties

The compound is a zwitterion; i.e. the molecule contains both a basic and an acidic group. The isoelectric point of cefalexin in water is approximately 4.5 to 5. The crystalline form of cefalexin, which is available, is a monohydrate. It is a white or almost white crystalline solid having a bitter taste. Solubility in water is about 1% at room temperature. It is practically insoluble in alcohol and in ether. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cefalexin has a d-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes