Consumer medicine information

1. Why am I using APO-Cephalexin?

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

2. What should I know before I use APO-Cephalexin?

Do not use if you have ever had an allergic reaction to APO-Cephalexin 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 APO-Cephalexin? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APO-Cephalexin 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 APO-Cephalexin?

• Continue taking APO-Cephalexin 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 not clear completely or your symptoms may return.

5. What should I know while using APO-Cephalexin?

6. Are there any side effects?

Common side effects may include dizziness, tiredness, weakness or headache, mild diarrhoea or stomach upsets/pain, oral or vaginal thrush, itching in the genital or anal areas. Serious side effects include fever, itching or any type of skin rash, blistering or peeling, aching or swollen muscles or joints, severe vomiting, diarrhoea and/or stomach pain, skin or eyes yellowing, pale stools, dark urine, bleeding or bruising more easily than normal, feeling agitated, confused or seeing or hearing things, symptoms of an allergic reaction (eg. shortness of breath, difficulty breathing, swelling of face, lips, tongue, throat)
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.

1 Name of Medicine

Cefalexin monohydrate.

2 Qualitative and Quantitative Composition

Each capsule contains cefalexin monohydrate equivalent to 250 mg or 500 mg cefalexin anhydrous as the active ingredient.
Excipients with known effect. Contains sugars as lactose.
For the full list of excipients see Section 6.1 List of Excipients.

3 Pharmaceutical Form

250 mg capsules. Dark green and white, self-locked hard gelatin capsules of size 2, imprinted with RX656 in black ink, containing white to off-white granular powder/pellets.
500 mg capsules. Dark green and light green, self-locked hard gelatin capsules of size 0, imprinted with RX657 in black ink, containing white to off-white granular powder/pellets.

4 Clinical Particulars

4.9 Overdose

Symptoms. 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.
Treatment. 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

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

A semi-synthetic cephalosporin antibiotic for oral administration. The nucleus of cefalexin is related to that of other cephalosporin antibiotics. 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.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCEFAMO.gif Chemical Name: (6R,7R)-7-[[(R)-2-amino-2-phenylacetyl]amino]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate.
Molecular Formula: C₁₆H₁₇N₃₀O₄S.H₂O.
Molecular Weight: 365.41.
CAS number. 23325-78-2.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/APOCEPST.gif