Active ingredients: Cefalexina (Cefalexin monohydrate)
KEFORAL 250 mg / 5 ml, Granules for oral suspension
Keforal package inserts are available for pack sizes:- KEFORAL 250 mg / 5 ml, Granules for oral suspension
- KEFORAL 500 mg Film-coated tablets, KEFORAL 1 g Film-coated tablets
Why is Keforal used? What is it for?
Keforal is an antibiotic and works by killing the bacteria that cause infections. It contains the active substance cefalexin monohydrate, which belongs to a group of medicines called 'cephalosporins'.
Keforal is used in children to treat the following infections: - respiratory tract infections; - sinusitis;
- skin and soft tissue infections;
- bone and joint infections;
- dental infections;
- otitis media;
- urinary tract infections.
Before and during therapy, your doctor may prescribe tests to check the effectiveness of the antibiotic (bacteriological cultures, sensitivity tests) and, if necessary, check the function of your kidneys.
Contraindications When Keforal should not be used
If you are allergic to cefalexin, other cephalosporins or any of the other ingredients of this medicine (listed in section 6);
Precautions for use What you need to know before taking Keforal
Before taking Keforal, talk to your doctor or pharmacist, especially if you have had a severe allergic reaction to any other antibiotic (for example a penicillin) as you may also be allergic to Keforal.
Tell your doctor if diarrhea occurs during treatment with Keforal.
Keforal can affect the results of tests for the presence of sugar in the urine and a blood test known as a Coombs test. If you are having these tests, tell the person taking the sample that you are taking this medicine.
Before taking KEFORAL tell your doctor if:
- suffer from kidney failure. In this case, your doctor will ask you to perform some tests before taking the medicine and during therapy;
- suffer from gastrointestinal diseases;
Interactions Which drugs or foods can modify the effect of Keforal
There are no known interactions with other drugs. However, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Warnings It is important to know that:
Pregnancy and breastfeeding
During pregnancy and breastfeeding, your doctor will prescribe this medicine only if clearly needed and only after evaluating the benefit of treatment with Keforal for the mother compared to the risk for the baby.
Driving and using machines
Keforal does not normally affect the ability to drive and use machines.
KEFORAL contains sucrose
If your doctor has diagnosed your child or you as having an "intolerance to some sugars, contact your doctor before taking this medicine.
Dose, Method and Time of Administration How to use Keforal: Posology
Always take this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
The recommended dose is 25-100 mg / kg per day, depending on the severity of the infection, in divided doses. Your doctor will tell you the exact dose to take and the frequency of administration.
Below is a table referring to the maximum dose of 100 mg / kg
For the 25 mg / kg dose, use a quarter of the quantities shown in the table.
For the 50 mg / kg dose, use half of the quantities shown in the table.
Instructions for preparing the oral suspension
- shake the bottle well to disperse the powder
- add water up to the level indicated by the arrow on the label
- close the bottle and shake well (with the addition of water the product turns red)
- the volume will decrease below the level indicated by the arrow, then add water again, up to the level indicated by the arrow and shake well until a uniform suspension is obtained
- use the syringe or measuring cup for administration
- shake well before each administration.
Overdose What to do if you have taken too much Keforal
If you take more KEFORAL than you should
If you accidentally take more Keforal than prescribed, contact your doctor immediately or go to the nearest hospital emergency room. If you take too much of the medicine, symptoms may include nausea, vomiting, epigastric discomfort (stomach upset). ), diarrhea and blood in the urine (haematuria).
If you forget to take KEFORAL
Take the missed dose as soon as you remember, unless it is almost time for your next dose. In this case, continue taking Keforal at the usual time and at the dose determined by your doctor. Do not double the next dose to make up for a forgotten one.
If you stop taking KEFORAL
Continue to take Keforal for as long as your doctor tells you, even if you feel better. The duration of treatment must be respected to fight the infection. If some bacteria survive, they can cause the infection to return.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist
Side Effects What are the side effects of Keforal
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Gastro-intestinal effects
- nausea
- He retched
- digestive disorders (dyspepsia)
- abdominal pain
- infrequent cases of diarrhea (in rare cases so severe as to require discontinuation of therapy).
Allergic reactions
- rash
- urticaria
- swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing and breathing (angioedema)
and rarely
- a particular rash that may appear as blisters and appear as small targets (central dark spot surrounded by a "paler area, with a dark ring around the edge - erythema multiforme);
- widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and
- a more severe form causing extensive peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis).
Anaphylaxis has also been reported.
Other manifestations
- anal and genital itching
- genital infection (moniliasis)
- vaginitis and vaginal discharge
- dizziness
- tiredness
- headache
- visible effects in blood tests: increase or decrease in the number of white blood cells, slight increase in some proteins (enzymes) produced by the liver.
Rarely, following administration with medicines belonging to the beta-lactam class of antibiotics (such as Keforal), the following have been reported:
- transient hepatitis
- yellowing of the skin and whites of the eyes (jaundice)
- kidney inflammation (reversible interstitial nephritis)
- haemolytic anemia.
Compliance with the instructions contained in this leaflet reduces the risk of undesirable effects.
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 national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
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 carton after EXP. The expiry date refers to the last day of that month.
Once reconstituted, the oral suspension must be stored in the refrigerator (between +2 and + 8 ° C) and used within 14 days.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
What KEFORAL contains
- The active ingredient is cefalexin (as cefalexin monohydrate). 5 ml of suspension contain 250 mg of cefalexin.
- The other ingredients are sodium lauryl sulfate, Allura red AC E129, methylcellulose 15, dimethicone 350, xanthan gum, pregelatinised starch, Guarana 51880TP flavor imitation, sucrose.
Description of what KEFORAL looks like and contents of the pack
Before reconstitution Keforal is a white powder; after reconstitution it appears as a red colored suspension.
Keforal is available in 100ml polyethylene bottles.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
