Augmentine 500 mg / 125 mg

30 tablets
Active ingredients: Amoxicillin / clavulanic acid

What is it and what is it used for?

For the treatment of bacterial infections caused by gram-negative and gram-positive amoxicillin-resistant pathogens, their resistance is due to b-lactamases, but they are susceptible to amoxicillin / clavulanic acid. Mixed infections with amoxicillin above-resistant and -sensitive pathogens can be treated with Augmentine alone.
If there exists reasonable suspicion that the aforementioned agents are a possible cause of a specific infection in question, the therapy with Augmentine tablets 500/125 mg can be started before the results of susceptibility testing.

Augmentine tablets 500/125 mg are suitable for the treatment of the following indications:
infections
• the upper and lower airways:
- Otitis media (middle ear inflammation)
- Sinusitis (nasal sinusitis)
- bronchitis (inflammation of the bronchial mucosa)
- pneumonia (pneumonia)
• the kidney and the urinary tract
• the skin and soft parts
Uncomplicated urogenital and rectal gonorrhea

Note:
Infections in the abdomen should first be treated intravenously.
Exciters spectrum of amoxicillin / clavulanic acid:
Gram-positive aerobes: Bacillus anthracis, Corynebacterium species, Enterococcus faecalis, Listeria monocytogenes1, Nocardia asteroides1, Staphylococcus aureus, coagulase-negative staphylococci (including Staphylococcus epidermidis), Streptococcus pneumoniae1, Streptococcus pyogenes1, Streptococcus species1, Streptococcus viridans1.
Gram-positive anaerobes: Clostridium species, Peptococcus species1, Peptostreptococcus species1.
Gram-negative aerobes: Bordetella pertussis1, Brucella species1, Escherichia coli, Gardnerella vaginalis1, Haemophilus influenzae, Helicobacter pylori1, Klebsiella species, Legionella species1, Moraxella catarrhalis, Neisseria gonorrhoeae, Neisseria meningitidis, Pasteurella multocida1, Proteus mirabilis, Proteus vulgaris, Salmonella species, Shigella species , Vibrio cholerae, Yersinia enterocolitica.
Gram-negative anaerobes: Bacteroides species (including Bacteroides fragilis), Fusobacterium species.
Resistant pathogens: methicillin resistant staphylococci, Citrobacter species, Enterobacter species, Serratia species, Providencia rettgeri, Morganella morganii, Providencia species, Pseudomonas aeruginosa, Mycoplasma species, Chlamydia species, Rikettsia species.

What should you watch out for before use?

Contraindications

• In which cases do you not take Augmentine tablets 500/125 mg?
You should not take Augmentine tablets 500/125 mg if you have already been allergic to certain beta-lactam antibiotics (eg penicillins, cephalosporins), as there is a risk of allergic (anaphylactic) shocks in these cases. Therefore, please inform your doctor about any previous antibiotic use.
If you are suffering from a severe hepatic impairment, or if you have had 500/125 mg of hepatic impairment or a gelatin before using Augmentine film tablets, you should not take this medicine.

Precautions for use and warnings

• What precautions must be taken?
For prolonged treatment, the renal, liver and blood levels should be monitored regularly. In patients with hepatic impairment, the liver values should be closely monitored regardless of the duration of the therapy. If the values deteriorate during treatment, a discontinuation of therapy should be considered.
If you are taking a bladder catheter, please tell your doctor, because a drug of this combination (amoxicillin) can form crystals at room temperature in high urine concentrations. Therefore, during the treatment with Augmentine film tablets, you should drink 500/125 mg sufficiently.
• What must be taken into account when taking part in road traffic, working with machines and working without a safe stop?
According to current experience, Augmentine film tablets 500/125 mg have no influence on the concentration and reactivity. In individual cases, side effects (see there) have been observed which make it impossible to perform the above-mentioned activities (eg anaphylactic shock, convulsions).

How is it used?

The following information applies to your doctor, unless your doctor has prescribed Augmentine film tablets 500/125 mg otherwise. Please observe the instructions for use, as Augmentine film tablets 500/125 mg otherwise can not work properly!

• How many Augmentine film tablets 500/125 mg and how often should you take Augmentine tablets 500/125 mg?
Dosing examples:
The details should be distributed as evenly as possible throughout the day; If possible, an intake at approximately 3-hour intervals should be recommended.
1) In the case of severe infections or an infection site, where the active substance of Augmentine is difficult to reach, an increase in dose to 3 times 2 film tablets daily is possible.
Elderly patients:
If you have no renal or hepatic impairment, take Augmentine tablets 500/125 mg as indicated above.
Patients with hepatic impairment:
If signs of liver damage are present, your doctor should check your liver function at regular intervals. If these values deteriorate under the administration of Augmentine film tablets 500/125 mg, a discontinuation of therapy should be considered (see also under "counter advertisements"). There is no specific dose recommendation for patients with hepatic impairment.
Patients with renal impairment and dialysis patients:
If you have kidney problems, please tell your doctor. He will then decide if you can take Augmentine tablets 500/125 mg.
If the renal function is impaired, the dose should be reduced according to the severity of the function disorder and adjusted to the body weight of the patient (see table).
Adults and adolescents with renal insufficiency:
Dosage for renal impairment with respect to a patient weighing 70 kg:
(Modified according to Höffler)
Conversion formula, based on the actual body weight (according to Höffler):
IS
YIST = Y70 x
70
YIST = calculated dose in patients with renal impairment
Y70 = dose for a patient weighing 70 kg (see table)
IST = patient weight in kg
Children with a kidney:
The following dosage recommendations are based on theoretical considerations and pharmacokinetic data. Dose-finding studies were not performed with these patients.
In children with renal impairment (from a GFR <30 ml / min), the maximum single dose is 15 mg amoxicillin + 3.75 mg clavulanic acid per kg body weight. The dose interval is 12 hours for one
GFR of 30 - 10 ml / min and 24 hours at a GFR of <10 ml / min.
Hemodialysis patients:
Adults and adolescents receive 500 mg amoxicillin + 125 mg clavulanic acid every 24 hours. In addition, they receive this dose during and at the end of hemodialysis. The following dosage recommendations for children are based on theoretical considerations and pharmacokinetic data. Dose-finding studies were not performed with these patients. Children then receive 15 mg of amoxicillin + 3.75 mg of clavulanic acid per kg of body weight every 24 hours. In addition, they receive the same dose during and at the end of hemodialysis.

• How and when should you take Augmentine film tablets 500/125 mg?
Please take the film tablets, without chewing, with liquid.
Augmentine film tablets 500/125 mg should be taken at the beginning of a meal. Thus taken, Augmentine film tablets 500/125 mg can work best and are at the same time the most tolerable. However, the drugs are also effective when taken before or after meals.
The details should be distributed as evenly as possible throughout the day; 3 times daily intake is recommended every 8 hours.
If you are taking a bladder catheter, please tell your doctor, as a drug of this combination (amoxicillin) can form crystals at high temperature in high urine concentrations. Therefore, during the treatment with Augmentine film tablets, you should drink 500/125 mg sufficiently.
In case of severe gastrointestinal disturbances with vomiting and / or diarrhea, you must inform your doctor. Ingestion is not appropriate, as sufficient absorption into the blood is not guaranteed.

• How long should you take Augmentine film tablets 500/125 mg?
Your doctor will decide about the duration of the application.
Please do not discontinue the treatment by yourself, even if you feel better. Normally the treatment with Augmentine film tablets 500/125 mg is continued after 3-4 days after improvement of the disease resp.
Do not take Augmentine tablets 500/125 mg for more than 14 days without an interim examination by your doctor. For prolonged treatment, kidney, liver and blood levels should be monitored regularly.
If you have received Augmentine film tablets 500/125 mg for the treatment of infections with specific pathogens (b-haemolysing streptococci), you must take Augmentine film tablets 500/125 mg for at least 10 days in order to achieve a sufficient treatment outcome. Otherwise there is a risk that late complications (eg rheumatic fever, glomerulonephritis) may occur.
Overdosing and other application errors

• What to do if Augmentine film tablets 500/125 mg are taken in too large quantities (intended or accidental overdose)?
Special measures for overdosing, except for withdrawal of the drug, are normally not required. The symptoms described in the "Side effects" section may occur. Very high doses can cause nausea, vomiting, abdominal pain and diarrhea. Please tell your doctor so that symptoms can be treated properly or, if necessary, the active substance can be removed from the body by hemodialysis.

• What should you watch out for if you have taken too little Augmentine tablets or missed a dose?
If you have forgotten to take Augmentine 500/500 mg tablets at the scheduled time, get it as soon as you can. The next dose should then be taken again at the scheduled time.

• What should you be aware of if you stop or stop the treatment prematurely?
Please do not discontinue the treatment with Augmentine film tablets 500/125 mg without consultation with your doctor. Your disease could be worsening.

What are possible side effects?

Interactions with other agents
Please tell your doctor in all cases if you are taking or have recently taken any other medicines besides Augmentine tablets 500/125 mg.

• What other substances or medicinal products affect the effect of Augmentine tablets 500/125 mg?
Specific other antibiotics (such as tetracyclines, macrolides, sulfonamides or chloramphenicol) may reduce the efficacy of Augmentine tablets 500/125 mg.
Samplesecid leads to an increase in the concentrations of the active substance amoxicillin in the blood and bile, since the excretion of amoxicillin is affected by the kidney. Therefore, Probenecid should not be used concomitantly with Augmentine tablets 500/125 mg.
Waterborne drugs (diuretics) accelerate the excretion of amoxicillin. This leads to a drop in the active substance concentration in the blood.

• What other substances or drugs can be affected by Augmentine film tablets 500/125 mg?
Under the therapy with amoxicillin, the safety of hormonal contraceptives ( "pill") can rarely be questioned. It is therefore recommended to use non-hormonal contraceptive measures.
Augmentine film tablets 500/125 mg can increase the intake of digoxin (the ingredient of various heart medications) into the body.
Augmentine film tablets 500/125 mg should not be used with disulfiram (alcohol cessation agent).

• What other interactions should be considered?
Cumarine can be used to increase the tendency to bleeding when concomitant medicinal products (coumarins) are co-administered.
The efficacy of Augmentine film tablets 500/125 mg and other medicinal products may be impaired by the incidence of diarrhea.
The concomitant use of allopurinol (a "gout solution") during the therapy with Augmentine film tablets 500/125 mg can promote the occurrence of allergic skin reactions.
Non-enzymatic methods for determining uric acid can give a false positive result. Likewise, the urobilinogen detection can be disturbed.
Please note that this information may also apply to recently used medicinal products.

Side effects

• What side effects may occur with the use of Augmentine film tablets 500/125 mg?
Hypersensitivity reactions:
Skin reactions that are characterized by skin rashes (exanthema) and itching may occur. The typical skin-like skin rash occurs 5 to 11 days after treatment. Also, hives with blistering and wheezing were occasionally observed. An immediate reaction to the skin in the form of a hackle suggests a genuine penicillin allergy and forces the therapy to terminate.
Rarely serious reactions to the skin have been associated with life-threatening general reactions such as Stevens-Johnson syndrome, erythema exsudativum multiforme, toxic epidermal necrolysis, bullous or exfoliative dermatitis (life-threatening diseases with blistering of the skin) and acute generalized pustulosis associated with exanthems Augmentine therapy.
If skin reactions occur, stop using Augmentine tablets 500/125 mg and tell your doctor.
Rarely severe allergic reactions, for example in the form of threatening (anaphylactic) shock, medication fever, multiplication of special blood corpuscles (eosinophilia), painful swelling of the skin and mucous membrane (quincke edema), internal laryngeal swelling with narrowing of the airways and dyspnea (laryngeal edema ), Serum disease, blood glut (hemolytic anemia), allergic vascular or renal disease (vasculitis or nephritis), as a result of sensitization to the 6-amino-penicillanic acid group. If you experience these symptoms, you need immediate medical attention.
In patients who are or have been infected with skin infections, hypersensitivity reactions (by antigen association between skin fungi and penicillin) can also be excluded.
Hypersensitivity reactions of all severity levels up to the allergic (anaphylactic) shock have also been observed after taking penicillins, although much less frequently than after injection (intravenous or intramuscular administration).
In addition, mucous membrane inflammations can occur, especially in the region of the mouth. Very rarely, a black hair loss can occur. Dry mouth and taste changes may occur.
Gastrointestinal tract:
Occasionally, amoxicillin / clavulanic acid may be associated with disorders of the stomach, nausea (more frequently at higher doses), vomiting, flatulence, soft stools or diarrhea (diarrhea), which are usually mild in nature and often subside during therapy . By taking amoxicillin / clavulanic acid at the beginning of meals, the tolerability can be improved.
Congenital inflammations (pseudomembranous or haemorrhagic colitis) have rarely been observed. If severe, persistent diarrhea occur during or during the first weeks after treatment, then a pseudomembranous colitis (in most cases caused by Clostridium difficile) is to be considered. This disease caused by an antibiotic treatment can be life-threatening (see "What counter-measures are to be taken with side effects?")
Rarely, an increased colonization of the intestine with yeast fungi was observed.
Kidney and urinary tract
Very rarely can a crystal formation of the active substance Amoxicillin (see precautions) in the urine come.
Liver:
Occasionally, a moderate increase in liver enzymes occurs without visible signs of disease. In rare cases an inflammation of the liver (hepatitis) and a (cholestatic) gland caused by congestion of the biliary fluid have been observed. These liver function disorders are more frequently observed with amoxicillin / clavulanic acid combinations than with amoxicillin alone. They manifest themselves with unusually severe itching, yellowing of the skin and eyeballs, darker urine, and lighter stools than usual. Hepatic impairment usually occurs during or shortly after therapy but in some cases only a few weeks after the end of therapy. They occur more frequently in men and elderly patients (65 years or older) and when treatment lasts longer than 14 days. They generally recede. However, they can be difficult (see countermeasures). Deaths were reported very rarely. These were almost always associated with severe basic illnesses or concomitant use of other drugs. In children these side effects were only very rarely observed.
Blood count:
Rare transient changes in blood count such as diminution of white blood cell count (leukopenia) or subgroup of white blood cells (neutropenia, agranulocytosis), or reduction or increase in blood platelet counts (thrombocytopenia). Rarely, transient changes in the blood count are observed, such as the reduction of all blood cell lines (pancytopenia), blood glut (anemia), prolongation of the coagulation time and the suppression of neoformation of blood cells in bone marrow (myelosuppression).
Disorders of the central nervous system:
In individual cases, hyperactivity, anxiety, insomnia, confusion, headache, aggression and seizures have been reported. Seizures may occur in patients with renal impairment or in patients receiving high doses.
Other side effects:
Any use of antibiotics can lead to the proliferation of pathogens which are insensitive to the drug used. Signs of possible secondary infection with such pathogens must be observed. Follow-up infections should be treated accordingly.

• What counter-measures should be taken with side effects?
The following extremely rare side effects (detailed explanations on these side effects see above) can be acute life-threatening under certain circumstances. Therefore, a doctor should immediately be informed if such an event occurs suddenly or develops unexpectedly.

• Pseudomembranous colitis:
Here, the doctor must consider terminating the therapy with Augmentine film tablets 500/125 mg depending on the indication and, if necessary, immediately initiate appropriate treatment (eg metronidazole or vancomycin orally). Medicines that inhibit intestinal movement (peristaltics) should not be taken.

• Serious acute hypersensitivity reactions (eg anaphylaxis):
The treatment with Augmentine film tablets 500/125 mg must be discontinued immediately and the usual emergency measures (eg antihistamines, corticosteroids, sympathomimetics and, if necessary, ventilation) must be initiated.

• Occurrence of epilepsy-like seizures:
The usual, appropriate emergency measures are indicated (eg to keep airways free, anticonvulsants such as diazepam or barbiturates).

• In the case of side effects affecting the liver:
If you notice any of the following signs, contact your doctor immediately: Unusual strong itching, yellowing of the skin and eyeballs, darker urine and brighter stool than usual.
If you miss any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Notes and information on the shelf life of the medicinal product
The expiry date of the medicinal product is printed on the carton. Do not use this medicine after this date!
• How to store Augmentine film tablets 500/125 mg?
Please keep your Augmentine film tablets 500/125 mg in the original packaging in a dry place not above 25 ° C.

Additional Information

Please read the following leaflet carefully because it contains important information about what you should consider when using this medicine. If you have any questions, please ask your doctor or pharmacist.
Usage information
Augmentine® film tablets 500/125 mg
Active ingredients: amoxicillin / clavulanic acid
No b-lactamase-forming agent has so far been known for these types of bacteria.

• In which cases is caution required when taking Augmentine film tablets 500/125 mg?
The following section describes when you should take Augmentine film tablets 500/125 mg only under certain conditions and with special caution. Please consult your doctor. This also applies if this information was previously used by you.
Please inform your doctor
- if you already have pronounced allergies or asthma, as allergic reactions are more likely.
- if you are suffering from Pfeifferschem glandular fever (mononucleosis infectiosa) or lymphatic leukemia, since inflammatory (erythematous) skin reactions occur more frequently in these cases.
- if you are suffering from a liver function disorder. In this case, your liver function values must be regularly checked during therapy (see section "Dosage instructions"). If the values deteriorate during therapy, the treatment may need to be stopped.
- if you have kidney problems. Your doctor will then decide how you should take Augmentine film tablets 500/125 mg (see also "Dosage Instructions").
- if you are suffering from a severe gastrointestinal disorder with vomiting and diarrhea, as Augmentine film tablets 500/125 mg may not be absorbed sufficiently in these cases.

• What should you watch during pregnancy and lactation?
There is limited information on the use of Augmentine during pregnancy. After application to pregnant women no adverse effects of amoxicillin / clavulanic acid on the fetus or neonate could be found. However, in a single study in women with premature ejaculation, it has been reported that the preventive treatment with Augmentine may cause an increased risk of tissue-damaging intestinal inflammation in the newborn. The use of Augmentine film tablets 500/125 mg should be carried out during pregnancy only after a strict risk / benefit assessment by the doctor.
Both active ingredients reach the embryo / fetus via the mother cake and are excreted into the mother's milk. It is possible to take Augmentine tablets 500/125 mg during breastfeeding, but in the case of the breast-fed infant, the mucous membranes may be affected by spasm and sprouts, which may require abatement. The possibility of sensitization is to be considered.

• What should be observed in children and elderly patients?
Older patients (65 years and older) should only be treated with caution and under control of liver function (see "Side effects").
For children <_ 20 kg body weight other dosage forms are available.
No special precautions are taken for children, unless there is a restriction of renal or hepatic function.

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