Klavox is a generic form for the Brand ” AUGMENTIN ” , produced by ” SPIMACO – Saudi Pharmaceutical Industries & Medical Appliances Corporation “ a local Saudi Pharmaceutical company. It is available in KSA , Arabian Gulf countries and North Africa countries . in EGYPT the price of 14 ( 1 gram tablet ) is 75 L.E. , 70 ml ( 228mg/5ml suspension ) is 39.75 L.E. , 70 ml ( 457 mg / 5 ml suspension ) is 48 L.E.
Forms
· Film-Coated Tablets 1 g .
· 228mg/5ml Powder for oral suspension .
· 457mg/5ml Powder for oral suspension.
Composition
Amoxicillin and Clavulanic acid
General instruction
· Read all of this leaflet carefully before you start giving your child this medicine.
· Keep this leaflet. You may need to read it again.
· If you have any further questions, ask your doctor or pharmacist.
· This medicine is usually prescribed for a baby or child. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child’s.
· If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
WHAT KLAVOX IS AND WHAT IT IS USED FOR
Klavox is an antibiotic and works by killing bacteria that cause infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called “penicillins” that can sometimes be stopped from working (made inactive). The other active component (clavulanic acid) stops this from happening.
Klavox is used in adults and children to treat the following infections
· Middle ear and sinus infections
· Respiratory tract infections
· Urinary tract infections
· Skin and soft tissue infections including dental infections
· Bone and joint infections.
BEFORE YOU TAKE KLAVOX
Do not take Klavox
If you are allergic (hypersensitive) to amoxicillin, clavulanic acid or any of the other ingredients of Klavox .
If you have ever had an allergic (hypersensitive) reaction to any other antibiotic. This can include a skin rash or swelling of the face or neck.
If you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic
Do not take Klavox if any of the above applies to you
If you are not sure, talk to your doctor or pharmacist before giving Klavox.
Take special care with Klavox
Check with your doctor or pharmacist before taking this medicine if you:
have glandular fever
are being treated for liver or kidney problems
are not passing water regularly.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Klavox.
In some cases, your doctor may investigate the type of bacteria that causing your infection. Depending on the results, you may be given a diferent strength of Klavox or a different medicine.
Conditions you need to look out for
Klavox can make some existing conditions worse, or cause serious side effects . These include allergic reactions, convulsions (fits) and inflammation of the large intestine. You must look out for certain symptoms while you are taking Klavox, to reduce the risk of any problems. See ‘Conditions you need to look out for’ in Section 4.
Blood or urine tests
If you are having blood tests (such as red blood cell status tests or liver function tests) or urine tests (to check the sugar level), let the doctor or nurse know that you are taking Klavox. This is because Klavox can affect the results of these types of tests.
Using other medicines
Please tell your doctor or pharmacist if you are taking or has recently taken any otner medicines. This includes medicines that can be bought without a prescription and herbal medicines.
· If you are taking allopurinol (used for gout) with Klavox. it may be more likely, that they will have an allergic skin reaction.
· If you are taking probenecid (used for gout), your doctor may decide to adjust the dose of Klavox.
· If medicines to help stop blood clots (such as warfarin) are taken with Klavox then extra blood tests may be needed.
· Klavox can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.
· Klavox may affect how mciophenolate mofetil (a medicine used to prevent body’s rejection for transplanted organs) works.
Pregnancy and breast-feeding
If your patient who is about to take this medicine is pregnant or breast-feeding, please tell your doctor or pharmacist.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Klavox may causes side. effects which may affect your ability to drive. Do not drive or use machines if you are not well.
Important information about some of the ingredients of Klavox
Klavox contains aspartame (NF) which is a source of phenylalanine. This may be harmful for children born with a condition called ‘phenylketonuria’.
HOW TO TAKE KLAVOX
Always take Klavox exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Adults and children weighing 40 kg or over
Usual doses: one tablet (1g) twice daily.
High dose: one tablet (1g) three times daily.
Suspension is not usually recommended for adults and children weighing 40
kg and over. Ask your doctor or pharmacist for advice.
Children weighing less than 40 kg
All doses are worked out depending on the child’s bodyweight in kilograms.
Your doctor will advise you how much Klavox you should give to your baby or child.
You may be provided with a plastic measuring spoon or measuring cup. You should use this to give the correct dose to your baby or child.
Usual dose: 25 mg/3.6 mg to 45 mg/6.4 mg for each kilogram of body weight a day, given in two divided doses.
High dose: up to 70mg/10mg for each kilogram of body weight a day given in two divided doses.
Patients with kidney and liver problems
If you or your child has kidney problems the dose might be lowered. A different strength or a different medicine may be chosen by your doctor.
If you or your child has liver problems they may have more frequent blood tests to see how their liver is working.
How to take Klavox
Tablets
The whole tablet should be swallowed with a cup of water before or in the start of a meal.
Space the doses evenly during the day, at least 4 hours apart.
Do not take 2 doses in 1 hour .
Do not take Klavox for more than 2 weeks . If you still feel unwell you should go back to see the doctor.
Suspension
Always shake the bottle well before each dose
Give at the start of a meal or slightly before.
Space the doses evenly during the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
Do not take Klavox for more than 2 weeks. If you still feel unwell you should go back to see the doctor.
If you take more Klavox than you should
If you take too much Klavox, signs might include an upset stomach (feeling sick, being sick or diarrhoea) or convulsions.
Talk to your doctor as soon as possible. Take the medicine to show the doctor.
If you forget to take Klavox
If you forget to take a dose, take it as soon as you remember. You should not take the next dose too soon, but wait about 4 hours before taking the next dose.
If you stop taking Klavox
Keep taking Klavox until the treatment is finished, even if you feel better.
You need every dose to help fight the infection. If some bacteria survive they can cause the infection to come back.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, Klavox can cause side effects, although not everybody gets them. The side effects below may happen with this medicine.
Conditions you need to look out for Allergic reactions
· Skin rash
· Inflammation of blood vessels (vasculitis) which may be visible as red or purple raised spots on the skin, but can affect other parts of the body
· Fever, joint pain, swollen glands in the neck, armpit or groin
· Swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing.
· Collapse.
Contact a doctor immediately if you or your child gets any of these symptoms. Stop taking or giving Klavox.
Inflammation of large intestine
Inflammation of the large intestine, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever.
Contact your doctor as soon as possible for advice if you or your child gets these symptoms.
Very common side effects
These may affect more than 1 in 10 people
Diarrhoea (in adults).
Common side effects
These may affect up to 1 in 10 people
Thrush (candida – a yeast infection of the vagina, mouth or skin folds).
Feeling sick (nausea), especially when taking high doses – If affected take Klavox before food
Vomiting
Diarrhoea (in children).
Uncommon side effects
These may affect up to 1 in 100 people
Skin rash, itching
Raised itchy rash (hives(
Indigestion
Dizziness
Headache.
Uncommon side effects that may show up in blood tests:
•Increase in some substances (enzymes) produced by the liver.
Rare side effects
These may affect up to 1 in 1000 people
Skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge – erythema multiforme).
If you notice any of these symptoms contact a doctor urgently. Rare side effects that may show up in blood tests:
Low number of cells involved in blood clotting.
Low number of white blood cells.
Other side effects
Allergic reactions
Inflammation of the large intestine
Inflammation of the protective membrane surrounding the brain (Aseptic meningitis).
Serious skin reactions
a widespread rash with blisters and peeling skin particularty around the mouth, nose, eyes and genitals (Stevens-Johnsion syndrome ) , and a more severe form, causing extensive peeling of the skin ( more tha 30 % of the body surface – toxic epidermal necrolysis ) .
widespread red skin rash with small pus – containing blisters ( bullous exfoliative dermatitis ) .
a red , scaly rash with bumps under the skin and blisters ( exanthemous pustulosis) .
Contact a doctor immediately if you or your child gets any of these symptoms.
Inflammation of the liver (hepatitis)
Jaundice, caused by increases in the blood of bilirubin (a substance produced in the liver) which may make your child’s skin and whites of the eyes appear yellow.
Inflammation of tubes in the kidney .
Blood take longer to clot .
Hypersensitivity .
Convulsions (in people taking high doses of klavox or who have kidney problems ).
Black tongue which looks hairy.
Stained teeth ( in children ) , usually removed by brushing .
Side effects that may show up in blood or urine tests:
Low numbers of red blood cells ( haemolytic anaemia ).
Sever reduction in the number of white blood cells .
Crystals in urine.
If you or your child gets side effects. Tell your doctor or pharmacist if any of the side effects become severe or troublesome, or if you notice any side effects not listed in this article.
HOW TO STORE KLAVOX
Keep out of the reach and sight of children .
Do not use Klavox after the expiry date stated on the carton . The expiry date refers to the last day of that month .
The expiry date which is stated on the bottle label is for the pharmacist’s use.
Suspension should be used within 7 days after reconstitution.
Store below 25°C
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
FURTHER INFORMATION
What Klavox contains
Klavox 1 g tablet
each Klavox 1 g tablet contains 875 mg amoxicillin and 125 mg clavulanic acid.
Klavox 228mg/5ml Powder for oral suspension
When reconstituted each 5 ml contains 200 mg amoxicillin and 28.5 mg clavulanic acid.
Klavox 457mg/5ml Powder for oral suspension
When reconstituted each 5 ml contains 400 mg amoxicillin and 57 mg clavulanic acid.
The amoxicillin is present as amoxicillin trihydrate and the clavulanic acid is present as potassium clavulanate.
Excipients
Tablets
Magnesium Stearate, Colloidal Silicon Dioxide, Sodium Starch Glycolate, and Avicel PH 112.
Coating Material
Opadry OY-S-7300 and Silicon Oil.
Suspension
The other ingredients are Xantham Gum, Hydroxypropyl Methyl cellulose, Aspartame NF, Colloidal Silicon Dioxide, Succinic Acid, Silicon Dioxide NF 18 Silica Gel, Raspberry Dry Flavour NN07943, Orange Dry Flavour 61027 1 E, Orange Dry Flavour 9/027108, Orange Dry Flavour 653970, Golden Syrup Dry Flavour 52.927.
What Klavox looks like and contents of the pack
Klavox 1g tablet is a white to off-white oblong shaped film-coated tablet with breakline on one side and other side with numbers “167“. .Each pack of Klavox 1 g tablets contains 14 tablets.
Klavox 457mg/5ml white Powder for oral suspension: 70 ml/pack.
Klavox 228mg/5ml white Powder for oral suspension: 70 ml/pack
Clear bottle with tamper evident ring cap.
To report any side effects
National pharmacovigilance center ( NPC):
· FAX : 00966112057662 .
· TOLL – FREE : 8002490000.
· E.MAIL : npc.drug@sfda.gov.sa.
Marketer and manufacturer
Marketing authorization holder and manufacturer SPIMACO .
Al-Qassim Pharmaceutical Plant .
Saudi Pharmaceutical Industries & Medical Appliances Corporation .
Saudi Arabia.