Augmentin is an antibiotic drug produced and marketed by the pharmaceutical company GlaxoSmithKline based on Amoxicillin + Clavulanic acid. Clavulin, based on Clavulanic acid, is from the Fournier Pharma company, while Neoduplamox, also based on Amoxicillin + Clavulanic acid and by Procter & Gamble.
The Augmentin User Information Leaflet by GlaxoSmithKline (GSK). The specialty
Augmentin 875 mg / 125 mg film-coated tablets Amoxicillin / Clavulanic acid.
Read all of this leaflet carefully before taking this medicine as it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you personally (or for your child). Never pass it on to others. In fact, for others this medicine may be dangerous, even if their symptoms are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. What is in this leaflet:
1. What Augmentin is and what it is used for;
2. What you need to know before you take Augmentin;
3. How to take Augmentin;
4. Possible side effects;
5. How to store Augmentin;
6. Contents of the pack and other important information.
What Augmentin is and what it is used for
Augmentin is an antibiotic that 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’, whose activity can sometimes be blocked (i.e. made inactive). The other active component (clavulanic acid) prevents this from happening. Augmentin is used in adults and children to treat the following infections
Ear and sinus infections;
respiratory tract infections;
urinary tract infections;
skin and soft tissue infections, including dental infections;
bone and joint infections. What you need to know before you take Augmentin
Do not take Augmentin:
if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of Augmentin;
if you have ever had a severe allergic (hypersensitivity) reaction to any other antibiotic. This can include 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 Augmentin if any of these apply to you. If you are unsure, talk to your doctor or pharmacist before taking Augmentin.
Take special care with Augmentin and talk to your doctor or pharmacist before taking this medicine if you:
have infectious mononucleosis;
have been being treated for liver or kidney problems;
does not urinate regularly.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Augmentin.
In some cases, your doctor may do an investigation to assess the type of bacterium that caused your infection. Based on the results, he / she may prescribe a different strength of Augmentin or a different medicine. Conditions you need to look out for
Augmentin can make some existing conditions worse or cause serious side effects. These can include allergic reactions, seizures and inflammation of the intestines. You must look out for some symptoms while taking Augmentin, in order to reduce any risk. Blood and urine tests
If you are having blood tests (such as red blood cell tests or liver function tests) or urine tests (for glucose), tell the doctor or nurse that you are taking. Augmentin. This is because Augmentin can influence the results of this type of test. Other medicines and Augmentin
Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines. If you are taking allopurinol (used for gout) with Augmentin, it is very likely that you may have an allergic skin reaction.
If you are taking probenecid (used for gout), your doctor may decide to change your dose of Augmentin.
If you are taking medicines (such as warfarin) that help prevent blood clots from forming together with Augmentin, then you may need to have additional blood tests. Augmentin can affect the way methotrexate (a medicine used to treat cancer or rheumatic diseases) works.
Augmentin can affect how mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs) works. Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines
Augmentin can have side effects and the symptoms may make you unsuitable for driving. Don’t drive vehicles or use machines unless you feel better. How to take Augmentin
Always take Augmentin exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.Adults and children weighing 40 kg or more:
Usual dose – 1 tablet twice a day
Higher dose – 1 tablet three times a day Children weighing less than 40 kg
Children up to 6 years of age should preferably be treated with Augmentin oral suspension or sachets. Ask your doctor or pharmacist for advice on administering Augmentin tablets to children weighing less than 40 kg. The tablets are not suitable for children weighing less than 25 kg. Patients with kidney or liver
problems If you have kidney problems the dose may be changed. Your doctor may choose a different strength or a different medicine.
If you have liver problems you may have more frequent blood tests to check how your liver is working. How to swallow Augmentin
Swallow the tablet whole with a glass of water at the start of a meal or just before. The tablets can be divided along the score line to make it easier to take. Both pieces of the tablet should be taken at the same time.
Space the doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
Do not take Augmentin for more than 2 weeks. If you still feel unwell you should go back to the doctor. If you take more Augmentin than you should (overdose)
If you take too much Augmentin, the signs may include upset stomach (nausea, vomiting or diarrhea) or convulsions. Talk to your doctor as soon as possible. Bring the medicine pack or bottle to show to the doctor. If you forget to take Augmentin
If you forget to take a dose, take it as soon as you remember. You should not take your next dose too soon, but you should wait about 4 hours. Do not take a double dose to make up for a forgotten dose. If you stop taking Augmentin
Continue to take Augmentin until the treatment is finished, even if you feel better. You need every dose 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. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Conditions you need to look out for: Allergic reactions
Skin rashes;
inflammation of the blood vessels (vasculitis) which may be visible as red or purple spots on the skin, but which can also 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 your doctor immediately if you get any of these symptoms. Stop taking Augmentin. Inflammation of the intestine
Inflammation of the intestine, causing watery diarrhea usually with blood and mucus, stomach pain and / or fever.
If you get these symptoms, contact your doctor as soon as possible for advice. Very common side effects These
may affect more than 1 in 10 people.
Diarrhea (in adults). Common side effects
They may affect up to 1 in 10 people.
Thrush (candida – a yeast infection of the vagina, mouth, or skin folds);
nausea, especially when taking high doses: if you suffer from this, take Augmentin before meals;
He retched;
diarrhea (in children). Uncommon side effects These
may affect up to 1 in 100 people.
Skin rashes, itching;
raised, itchy rash (hives);
bad digestion;
dizziness
headache.
Uncommon side effects that may show up in blood tests: increase in some proteins (enzymes) produced by the liver. Rare side effects
They may affect up to 1 in 1,000 people.
Skin rashes, which may appear as blisters and look like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme).
If you notice any of these symptoms contact your doctor urgently. Rare side effects may show up in blood tests
Low number of cells involved in blood clotting;
low white blood cell count Other side effects
Other side effects occur in a very limited number of people, but their exact frequency is not known.
Allergic reactions (see above);
Intestinal inflammation (see above);
Inflammation of the protective membrane surrounding the brain (aseptic meningitis)
Severe skin reactions:
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);
widespread red rash with small pus-containing blisters (bullous exfoliative dermatitis);
rash, red, crusted and swollen under the skin and blisters (pustular rash).
If you get any of these symptoms, contact your doctor immediately.
Inflammation of the liver (hepatitis);
jaundice, caused by increases in the blood of bilirubin (a substance produced in the liver) which can make the skin and whites of the eyes appear yellow;
inflammation of the tubules of the kidneys;
blood takes longer to clot;
hyperactivity;
seizures (in people taking high doses of Augmentin or who have kidney problems);
black tongue that appears covered in hair;
stains on the teeth (in children), usually removed by brushing. Side effects that may show up in blood or urine tests
Severe reduction in the number of white blood cells;
low number of red blood cells (haemolytic anemia);
crystals in the urine.
If you get side effects, if any of the side effects get serious or bothersome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 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 through the website of the Italian Medicines Agency (AIFA): http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of this medicine. How to store Augmentin
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 package. The expiry date refers to the last day of the month.
Do not store above 25 ° C.
The tablets stored in a sachet with desiccant must be used within 30 days of opening.
Store in the original container to protect from moisture.
Do not use the tablets if they are chipped or damaged.
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. Contents of the pack and other information
What Augmentin contains: 875mg / 125mg film-coated tablets.
The active ingredients are amoxicillin and clavulanic acid.
Each tablet contains: amoxicillin trihydrate corresponding to 875 mg of amoxicillin and potassium clavulanate corresponding to 125 mg of clavulanic acid.
The other ingredients are: tablet core – colloidal silica, magnesium stearate, potato starch sodium, microcrystalline cellulose. Tablet coating – hypromellose 5 cps, hypromellose 15 cps, titanium dioxide, macrogol 4000, macrogol 6000, dimethicone. What Augmentin looks like and contents of the pack
Augmentin 875 mg / 125 mg – film-coated tablets – white to off-white, capsule-shaped, debossed with AC on both sides and with a score line on one side.
They are packaged in blister packs, contained in a cardboard box. Each pack contains 2, 4, 10, 12, 14, 16, 20, 24, 30, 100 or 500 tablets.
Blisters with desiccant bag, contained in a cardboard box. Each pack contains 14 tablets. Not all pack sizes may be marketed. Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder in Spain: GlaxoSmithKline, SA – PTM – C / Severo Ochoa, 2 – 28760 Tres Cantos (Madrid).
Parallel Import Authorization Holder in Italy: BB Farma srl ​​- Viale Europa, 160 – 21017 Samarate (VA). Manufacturer
SmithKline Beecham Pharmaceuticals – Clarendon Road – BN 14 8QH Worthing – West Sussex – United Kingdom. Glaxo Wellcome Production – ZI de la Peyenniere -53100 Mayenne (France)
Repackaged by (see letter next to the lot):
(A) – Falorni srl – Via Provinciale Lucchese -Loc. Masotti 51030 Serravalle Pistoiese (PT)
(B) – Fiege Logistics Italia SpA – Via Amendola, 1 20090 Caleppio di Settala (MI)
(C) – SCF snc – Via F. Barbarossa, 7 – 26824 Cavenago d’Adda (LO)
This medicinal product is authorized in the Member States of the EEA under the following names: 875 mg / 125 mg film-coated tablets.
Austria – Augmentin
Belgium – Augmentin
Bulgaria – Augmentin
Cyprus – Augmentin
Czech Republic – Augmentin
Estonia – Augmentin
Finland – Augmentin
Germany – Augmentan
Greece – Augmentin
Hungary – Augmentin Duo
Iceland – Augmentin
Ireland – Augmentin
Italy – Augmentin-Clavulin
Latvia – Augmentin
Lithuania – Augmentin
Luxembourg – Augmentin
Malta – Augmentin
Netherlands – Augmentin
Poland – Augmentin
Portugal – Augmentin Duo
Romania – Augmentin
Slovak Republic – Augmentin
Spain – Augmentine, Clavumox
United Kingdom – Augmentin
This leaflet was last updated on: 07/2014
All third party trademarks and trade names belong to their respective owners. Behavioral hygiene and bacterial resistance
Antibiotics are used for the treatment of bacterial infections. They are not effective for viral infections. Sometimes an infection caused by bacteria does not respond to antibiotic therapy. The most common reason this happens is that the bacteria causing the infection are resistant to the antibiotic being used. This means that the bacteria survive and multiply despite the antibiotic. Bacteria become resistant to antibiotics for several reasons. Using antibiotics appropriately can reduce the onset of resistance to bacteria.
When your doctor prescribes antibiotic therapy, this is only indicated for the current illness. Pay attention to the following tips, in order to avoid the emergence of bacterial resistance that causes blockage of antibiotic activity.
1. It is very important that you take the antibiotic in the right dose, at the right times and for the right number of days. Read the instructions in the package leaflet and, if you do not understand anything, ask your doctor or pharmacist for an explanation.
2. Do not take antibiotics unless they have been specifically prescribed for you and only use them for the infection for which they were prescribed.
3. Do not use antibiotics that other people have been prescribed, even if you have an infection similar to theirs.
4. Do not give to others the antibiotics that have been specifically prescribed for you.
5. If you have any antibiotic left over at the end of your treatment, return it to your pharmacist so that it can be disposed of properly. Equivalent drugs
There are many Augoxin-equivalent drugs based on Amoxicillin + Clavulanic Acid. These are: Abba, Abioclav, Acadimox, Aklav, Amoxicillin + Clavulanic Acid, Amoxicillin + Clavulanic Acid ABC, Amoxicillin + Clavulanic Acid Almus, Amoxicillin + Clavulanic Acid Alter, Amoxicillin + Clavulanic Acid, Amisto Clavulanic Aristo + Aurobindo Italy, Amoxicillin + Clavulanic Acid Biopharma, Amoxicillin + Clavulanic Acid Bluefish, Amoxicillin + Clavulanic Acid DOC Generici, Amoxicillin + Clavulanic Acid Germed Pharma, Amoxicillin + Clavulanic Acid Hexal, Amoxicill Cl, Amoxicill + + Clavulanic Acid Pensa, Amoxicillin + Clavulanic Acid Ranbaxy,

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