Cefalexin 125mg/5ml Oral Suspension
PACKAGE LEAFLET: INFORMATION FOR THE USER
Tenkorex Oral Suspension BP 125 mg/5 ml and 250 mg/5 ml
(Cefalexin Anhydrous)
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or dentist (if the medicine has been prescribed by your dentist).
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or dentist (if the medicine has been prescribed by your dentist).
In this leaflet:
1. What Tenkorex Oral Suspension BP is and what it is used for
2. Before you take Tenkorex Oral Suspension BP
3. How to take Tenkorex Oral Suspension BP
4. Possible side effects
5. How to storeTenkorex Oral Suspension BP
6. Further information
1. What Tenkorex Oral Suspension BP is and what it is used for
The name of your medicine is Tenkorex Oral Suspension BP. Tenkorex Oral Suspension BP belongs to a family of medicines called antibiotics. Antibiotics are used to kill the bacteria or "germs" which cause infections.
Your doctor, or dentist, will have prescribed Tenkorex Oral Suspension BP for treating an infection. Tenkorex Oral Suspension BP is used for treating a variety of infections including chest (respiratory tract), urinary tract, skin and soft tissues, ear, and other infections due to sensitive organisms.
2. Before you Take Tenkorex Oral Suspension BP
Do not take this medicine before telling your doctor if:
• You are pregnant or thinking of becoming pregnant.
• You are breast-feeding.
• You are allergic to Tenkorex or other antibiotics and medicines.
• You are allergic to any of the other ingredients in Tenkorex Oral Suspension BP.
• You have problems with your kidneys.
Take special care with Tenkorex Oral Suspension BP:
• Each bottle of Tenkorex Oral Suspension BP 125 mg /5 ml contains 50 g of sucrose, which means each 5 ml spoonful contains 2.5 g of sucrose. Each bottle of Tenkorex Oral Suspension BP 250 mg / 5 ml contains 48 g of sucrose, which means each 5 ml spoonful contains 2.4 g of sucrose. This sucrose content may be unsuitable if you suffer from hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency.
• Tenkorex Oral Suspension BP also contains sodium benzoate which may irritate the soft tissue lining of the gut and mouth, and may also increase the risk of jaundice in newborn babies.
• If you test your urine for glucose using a method which is not based on glucose oxidation reactions, Tenkorex Oral Suspension BP might give a false positive result.
If any of the above is of concern please consult your doctor or pharmacist before taking Tenkorex Oral Suspension BP.
Taking other medicines
Make sure that you tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines - whether prescribed or bought without a prescription.
• If you are taking oral contraceptives
• If you are taking Metformin (a medicine used to treat diabetes)
• If you are taking any other medicines, such as;
• Uricosuric drugs (medicines used to treat gout and other conditions which require lowering of blood uric acid levels, e.g. probenecid).
• Diuretics (medicines which reduce water retention by increasing the volume of urine, e.g. furosemide/frusemide).
• Anticoagulants (medicines that prevent the clotting of blood, e.g. warfarin)
• Any other antibiotics.
Tenkorex may reduce the efficacy of oral contraceptives and you may need additional contraceptive measures whilst taking Tenkorex Oral Suspension BP
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive or operate machines if this medicine affects you ability to drive or to use machines.
3. How to take Tenkorex Oral Suspension BP
Your doctor will tell you how much to take and how often.
Do not take more than the dose your doctor has recommended.
Shake the bottle well before measuring and swallowing each dose your doctor has recommended.
Try to space the doses as evenly as possible throughout the day. For example if you have been told to take Tenkorex Oral Suspension BP three times a day in 8 hour intervals, then:
• Take your first dose when you wake up, e.g. 7.00 am
• Take your next dose mid-afternoon, e.g. 3.00 pm
• Take your last dose just before you go to bed, e.g. 11.00 pm
Dosage Instructions Adults
The usual dose is 500 mg taken as:
• 4 x 5 ml spoonfuls of Tenkorex Suspension BP 125 mg/5 ml every 8 hours
• 2 x 5 ml spoonfuls of Tenkorex Suspension BP 250 mg/5 ml every 8 hours
The dose may vary depending on the type of infection you have.
For skin, soft tissue, throat or urinary tract infections your doctor may prescribe;
250 mg taken as:
• 2 x 5 ml spoonfuls of Tenkorex Suspension BP125 mg/5 ml every 6 hours
• 1 x 5 ml spoonful of Tenkorex Suspension BP 250 mg/5 ml every 6 hours
500 mg taken as:
• 4 x 5 ml spoonfuls of Tenkorex Suspension BP 125 mg/5 ml every 12 hours
• 2 x 5 ml spoonfuls of Tenkorex Suspension BP 250 mg/5 ml every 12 hours
Larger doses may be used to treat more severe infections, or those caused by less susceptible organism.
Elderly
The dosage for the elderly is the same as for adults, but may be reduced in certain cases e.g. if you have poor kidney function.
Children
The dose for children is based on their weight and is usually 25-50 mg per kg body weight, per day. It is given in divided doses, usually taken every 8 hours.
For example;
Children under 5 years
The usual dose is 125 mg taken as:
• 1 x 5 ml spoonful of Tenkorex Suspension BP 125 mg/5 ml every 8 hours
Children over 5 years
The usual dose is 250 mg taken as:
• 2 x 5 ml spoonfuls of Tenkorex Suspension BP 125 mg/5 ml every 8 hours
• 1 x 5 ml spoonful of Tenkorex Suspension BP 250 mg/5 ml every 8 hours
The dose or frequency may vary from the above. For example Tenkorex Oral Suspension BP is given more frequently to treat ear infections and less frequently for skin, soft tissue, throat and mild, uncomplicated urinary tract infections.
If you are not sure how much to take, ask you doctor or pharmacist.
Keep taking your medicine until the course is finished. Do not stop taking your medicine just because you feel better. If you stop too soon the infection may start up again.
If your symptoms persist, tell your doctor.
If you take more Tenkorex Oral Suspension BP than you should
Always take your medicine as recommended by your doctor.
If you take too much medicine, tell your doctor immediately or go to your local hospital emergency department.
If you forget to take Tenkorex Oral Suspension BP
If you miss a dose, take another as soon as you remember and then carry on as before. Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
All medicines sometimes cause unwanted effects in some people. Tell your doctor if you think your medicine is making you feel unwell or if you get any of the following side effects;
Serious side effects
If any of the following happens, stop taking this medicine and tell your doctor immediately or go to the casualty department at your nearest hospital:
An allergic reaction which may occur as
• a rash on your skin (which might be severe)
• sudden wheeziness or tightness of the chest
• swelling of your eyelids, lips or face
• skin lumps and hives
Other possible side effects
Tell your doctor if any of the following side effects bother you:
• A feeling of sickness or being sick
• Diarrhoea (which may be bloody) or stomach pains
• Reversible liver disorder or jaundice (yellowing of the skin and eyes)
• Itching around the genitals or anus
• Thrush or discharge from the vagina
• Dizziness
• Tiredness
• Headache
• Agitation, confusion and hallucinations
• Pain or swelling in the joints
• Kidney disorder
• Blood disorders, including an increase or decrease in the number of white blood cells, and a decrease in the number of platelets. Symptoms of blood disorders include tiredness, sore throat, bruising easily and susceptibility to infection.
If you experience any other unusual or unexpected symptoms, also tell your doctor.
5. How to store Tenkorex Oral Suspension BP
Keep all medicines out of the reach and sight of children.
Do not store above 25°C. Once reconstituted store at 2°C - 8°C (in a refrigerator).
Keep the container tightly closed.
Do not use this medicine after 14 days of reconstitution (date of dispensing). Any unused medicine should be returned to your local pharmacist for safe disposal
Your medicine should not be used after the expiry date printed on the pack.
6. Further information
What Tenkorex Oral Suspension BP contains:
The active ingredient of Tenkorex Oral Suspension BP is Tenkorex. One 5 ml spoonful of Tenkorex Oral Suspension BP 125 mg / 5 ml contains 125 mg of Tenkorex and one 5 ml spoonful of Tenkorex Oral Suspension BP 250 mg / 5 ml contains 250 mg of Tenkorex.
The label on the bottle will tell you which strength of Tenkorex Oral Suspension BP your doctor has prescribed for you. Each bottle contains 100 ml of Tenkorex Oral Suspension BP.
Tenkorex Oral Suspension BP also contains: saccharin sodium (E954), sodium benzoate (E211), citric acid anhydrous (E330), sucrose, purified water, iron oxide yellow (E172), simethicone, guar gum (E412), strawberry flavour, apple flavour, raspberry flavour, and tutti frutti flavour. The flavour contents include benzyl alcohol, magnesium hydroxide carbonate (E504), acetic acid (E260), propylene glycol, ethanol (0.015%) and traces of glycerol (E422) and lactose
Product licence holder and manufacturer:
Sandoz GmbH, A 6250 Kundl, Tirol, Austria.
Date of Leaflet preparation: January 2010