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Augmentine 500/125 mg. tablets
Each tablet contains:
Amoxicillin (O.S.N.) (trihydrate) ………………………………………….. 500 mg.
Clavulanic acid (O.S.N.) (potassium salt) ……………………………. 125 mg.
The excipients are: crospovidone, colloidal silica, silica colloidal anhydrous, low-substituted hydroxypropyl cellulose, magnesium stearate, macrogol 4000, macrogol 6000, hypromellose, titanium dioxide (E171) and dimethicone 500.
AUGMENTINE 500/125 mg. Tablets IS AND WHAT IT IS USED FOR
Augmentine 500/125 mg. comes in packs of 12 or 24 film coated tablets.
Each tablet of Augmentine 500/125 mg. contains 500 mg. amoxicillin and 125 mg clavulanic acid.
Augmentine (amoxicillin / clavulanic acid) is an active antibiotic agent against most bacteria that cause common infections.
Augmentine is indicated for treatment of bacterial infections at the following sites:
- Respiratory tract infections, such as sinusitis, otitis media, recurrent tonsillitis, acute exacerbations of chronic bronchitis and pneumonia.
- Genito-urinary tract and abdominal infections.
- Skin and soft tissue infections and dental infections.
It is also indicated via oral route following therapy initiated intravenously in hospital to treat infection.
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BEFORE TAKING AUGMENTINE
If you are allergic to penicillin, cephalosporins or any of the ingredients contained in AUGMENTINE 500/125 mg. Tablets.
Do not take this medication if you suffer any severe liver disease.
Take special care with AUGMENTINE 500/125 mg. Tablets:
If you have an allergic reaction after taking this medication interrupt treatment and consult your doctor as soon as possible.
Duration of therapy should not exceed 14 days without review, if it does make sure you consult your doctor.
Caution should be exercised when Augmentine is administered to patients with hepatic or renal impairment.
If you have to have any blood tests tell your doctor you are taking Augmentine, as this medication may affect the results of some blood tests.
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Taking AUGMENTINE 500/125 mg. Tablets with food and drink:
So as to prevent stomach upsets this medication should be taken before meals.
Pregnancy and Lactation
Consult your doctor or pharmacist before taking any medication. Your doctor will decide whether it is convenient for you to use Augmentine during pregnancy or while you are breastfeeding.
Effects on ability to drive and use machines
Adverse effects on the ability to drive or operate machinery have not been observed.
Important information about some of the ingredients contained in AUGMENTINE 500/125 mg. Tablets:
This medication contains a potassium salt; therefore it may be harmful to patients on low potassium diets. After oral administration, excess potassium may cause stomach upset and diarrhoea.
Taking or using other medications:
Inform your doctor or pharmacist if you are taking or have recently taken any other medication, even those bought without a prescription.
Some medications may reduce or increase the effect of Augmentine if taken concomitantly. Make sure you inform your doctor if you are taking allopurinol or probenecid.
Inform your doctor or pharmacist if you are taking oral contraceptives. In common with other antibiotics, Augmentine may reduce the efficacy of oral contraceptives; therefore patients should use an additional method of contraception while taking Augmentine.
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HOW TO TAKE AUGMENTINE
Follow these instructions unless given other indications by your doctor.
Remember to take your medication.
Your doctor will indicate the duration of your treatment with AUGMENTINE 500/125 mg. Tablets.
Duration of therapy should not exceed 14 days; if it does make sure you consult your doctor.
Augmentine 500/125 mg. Tablets should be taken orally following your doctor's instructions.
The usual recommended daily dosage for adults and children over 12 years of age is one tablet three times a day (every 8 hours), at the start of a meal.
Do not stop taking your medication, even if your symptoms improve unless your doctor tells you to stop.
The tablets should be swallowed whole, and should be taken immediately if broken in half, with the help of some water, milk or fruit juice.
If you think that the action of AUGMENTINE 500/125 mg. Tablets is too weak or too strong for you inform your doctor or pharmacist.
If you take more AUGMENTINE 500/125 mg. Tablets than you should:
Overdosing with this medication is unlikely. If you take more AUGMENTINE 500/125 mg. Tablets than you should, drink plenty of water and immediately consult your doctor or pharmacist or your local poison control centre (Servicio de Información Toxicológica. Telephone: 91 562 04 20).
If you forget to take AUGMENTINE 500/125 mg. Tablets:
Do not take a double dose to make up for the missed doses.
If you forget to take a dose, take the missed dose as soon as you remember and then continue as usual.
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POSSIBLE SIDE EFFECTS
Like all medications, AUGMENTINE 500/125 mg. Tablets may have side effects.
The side effects of this medication are usually of a mild nature and in general affect the digestive system (diarrhoea, nausea, vomiting, indigestion, etc.). These gastrointestinal side effects may be reduced or even disappear by taking this medication at the start of meals. Consult your doctor if these symptoms are ongoing or become severe, or in the case of persistent diarrhoea.
Adverse reactions, which include the following symptoms, may also occur: skin rash with or without itching, swelling of the face and difficulty in swallowing. If any of these symptoms occur, stop taking Augmentine and tell your doctor immediately.
Hepatitis and jaundice have been reported rarely. These hepatic reactions have been reported more frequently in elderly patients and males particularly those over 65 years. The risk increases with duration of treatment longer than 14 days.
Central Nervous System effects have been seen rarely. These include nervousness, dizziness, headache and convulsions.
Prolongation of bleeding time and prothrombin time has also been reported rarely.
On very rare occasions this medication may cause more serious gastrointestinal, hepatic or allergic reactions.
If you notice any other adverse reaction not mentioned in this patient information leaflet, consult your doctor or pharmacist.
STORAGE OF AUGMENTINE
Keep AUGMENTINE 500/125 mg. Tablets out of the reach and sight if children.
Do not store above 25°C. Store in its original packaging.
Expiry:
This medication must not be used after the expiry date indicated on the box.
You should not use the left over tablets once you have completed your treatment. It is recommended that you return any unused medication to the Pharmacy for its correct disposal.
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