Patient Leaflet Updated 15-Jun-2022 | Flynn Pharma Ltd
Cefalexin 125 mg/5 ml & 250mg/5ml Granules for Oral Suspension
Package leaflet: Information for the user
Cefalexin 125 mg/5 ml Granules for Oral Suspension
Cefalexin 250 mg/5 ml Granules for Oral Suspension
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Cefalexin is and what it is used for
2. What you need to know before you take Cefalexin
3. How to take Cefalexin
4. Possible side effects
5. How to store Cefalexin
6. Contents of the pack and other information
1 What Cefalexin is and what it is used for
Cefalexin contains the active ingredient cefalexin monohydrate, which is an antibiotic.
Cefalexin is used to treat the following infections caused by bacteria that can be killed by cefalexin:
2 What you need to know before you take Cefalexin
Do not take Cefalexin:
Warnings and precautions
Talk to your doctor or pharmacist before taking Cefalexin if you:
Tell your doctor if you are having blood or urine tests. Cefalexin may interfere with these tests.
Acute generalised exanthematous pustulosis (AGEP) has been reported with the use of cefalexin. AGEP appears at the initiation of treatment as a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The most common location: mainly localized on the skin folds, trunk, and upper extremities. The highest risk for occurrence of this serious skin reaction is within the first week of treatment. If you develop a serious rash or another of these skin symptoms, stop taking cefalexin and contact your doctor or seek medical attention immediately.
Other medicines and Cefalexin
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 of the following, as they may interact with your Cefalexin:
It may still be all right for you to be given Cefalexin 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
Cefalexin should not affect your ability to drive or use machines.
Important information about the ingredients of Cefalexin
Cefalexin contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Also contains Allura Red (E129) which may cause allergic reactions.
This medicine contains less than 1 mmol sodium (23 mg) per 5 ml, that is to say essentially ‘sodium free’.
3 How to take Cefalexin
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your pharmacist should make up the suspension before you are given it.
The bottle is turned upside down and tapped to loosen the powder. Then a total of 60 ml water in two portions is added, shaking after each addition until all the powder is in suspension.
The suspension should be shaken well before use.
Adults and the elderly
The usual total daily dose is 1-4 g orally, in divided doses.
Use in children
The usual total daily dose for children is 25-50 mg/kg (body weight) in divided doses.
For most infections the following schedule is suggested:
Children under 5 years: 125 mg every 8 hours.
Children 5 years and over: 250 mg every 8 hours.
In severe infections, the dose may be doubled. In the treatment of middle ear infections, a total daily dose of 75 to 100 mg/kg in 4 doses is required.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, 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:
The following side effects have been reported
Reporting of side effects
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 the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5 How to store Cefalexin
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 bottle or carton after EXP. The expiry date refers to the last day of that month.
Do not store granules above 25°C.
After reconstitution, the suspension should be stored in a cool place (6°C-15°C) or in a refrigerator (2°C-8°C) and to be used within 10 days.
Discard unused portion 10 days after dispensing.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6 Contents of the pack and other information
What Cefalexin contains
The active substance is cefalexin monohydrate.
The other ingredients are:
Sucrose, imitation guarana flavour, allura red AC (E129), sodium lauryl sulphate, methylcellulose 15, dimeticone, xanthan gum and pregelatinised starch.
What Cefalexin looks like and contents of the pack
White granules which when reconstituted with water give a red suspension.
Available in 100 ml plastic bottles with screw caps.
Marketing Authorisation Holder
This leaflet was last revised in May 2022
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