Augmentin
How to use Augmentin
Leaflet accompanying the packaging: information for the user
Augmentin, 250 mg + 125 mg, film-coated tablets
Amoxicillin + Clavulanic acid
Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
- 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 (or your child) only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Table of contents of the leaflet
- 1. What is Augmentin and what is it used for
- 2. Important information before taking Augmentin
- 3. How to take Augmentin
- 4. Possible side effects
- 5. How to store Augmentin
- 6. Contents of the pack and other information
1. What is Augmentin and what is it used for
Augmentin is an antibiotic that works by killing bacteria that cause infections.
Augmentin contains two different medicines: amoxicillin and clavulanic acid. Amoxicillin belongs
to a group of medicines called “penicillins”, which are sometimes inactivated (inhibited) by
bacteria. The other active ingredient (clavulanic acid) stops this inactivation.
Augmentin is used in adults and children to treat the following infections:
- sinusitis
- urinary tract infections
- skin infections
- dental infections.
2. Important information before taking Augmentin
When not to take Augmentin
- If you are allergic to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of this medicine (listed in section 6).
- If you have ever had a severe allergic reaction to any other antibiotic.
- If you have ever had liver or jaundice (yellowing of the skin) problems caused by taking an antibiotic.
If any of the above apply to you, do not take Augmentin
Augmentin.If you are unsure, consult your doctor or pharmacist before taking Augmentin.
Warnings and precautions
Before taking Augmentin, consult your doctor or pharmacist if you:
- have infectious mononucleosis
- are being treated for liver or kidney disease
- have irregular urine output.
If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking Augmentin.
In some cases, your doctor may test the type of bacteria causing your infection.
Depending on the results, you may be given Augmentin at a different dose or a different medicine.
Conditions to watch for
Taking Augmentin may worsen certain conditions or cause severe side effects, including allergic reactions, seizures, and colitis. You should be aware of certain symptoms during Augmentin treatment to minimize the risk of any problems. See ‘Conditions to watch for
’in section 4.
Blood and urine tests
If you are going to have blood tests (such as red blood cell count or liver function tests) or urine tests (for glucose), tell your doctor or nurse that you are taking Augmentin. Augmentin may affect the results of these tests.
Augmentin and other medicines
Tell your doctor or pharmacist about all the medicines you are taking now or have recently taken, as well as any medicines you plan to take.
If you are taking allopurinol (for gout), you may be more likely to experience skin allergic reactions.
If you are taking probenecid (for gout), your doctor may decide to adjust your Augmentin dose.
If you are taking blood thinners (such as warfarin) at the same time as Augmentin, you may need to have extra blood tests.
Augmentin may affect the action of methotrexate (a medicine used to treat cancer or rheumatoid arthritis).
Augmentin may affect the action of mycophenolate mofetil (a medicine used to prevent transplant rejection).
Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Augmentin may cause side effects that can affect your ability to drive or use machines.
Do not drive or use machines unless you feel well.
Augmentin contains sodium
- This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.
3. How to take Augmentin
Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Adults and children with a body weight of 40 kg or more
The usual dose is:
- 1 tablet three times a day.
Children with a body weight of less than 40 kg
Children under 6 years should be treated with Augmentin oral suspension.
Augmentin tablets are not recommended.
Patients with kidney and liver disease
- If you have kidney disease, your doctor may need to adjust your dose.
- If you have liver disease, you may need to have more frequent blood tests to check how your liver is working.
How to take Augmentin
- Take the medicine with food.
- Swallow the tablets whole with a glass of water.
- Keep at least 4-hour intervals between doses taken during the day. Do not take 2 doses within 1 hour of each other.
- Do not take Augmentin for more than 2 weeks. If you still do not feel better, consult your doctor.
Taking more than the recommended dose of Augmentin
If you take more Augmentin than you should, you may experience symptoms such as stomach and intestine upset (nausea, vomiting, or diarrhea) or seizures. Contact your doctor as soon as possible. Bring the carton and blister pack with you to show the doctor.
Missing a dose of Augmentin
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too soon, wait about 4 hours before taking the next dose. Do not take a double dose to make up for a forgotten dose.
Stopping treatment with Augmentin
Keep taking Augmentin until you finish the treatment, even if you feel better. All doses are needed to kill the bacteria causing the infection. If some bacteria survive, they may cause the infection to come back.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Augmentin can cause side effects, although not everybody gets them.
The following are some of the side effects that may occur.
Conditions to watch for
Allergic reactions:
- skin rash
- vasculitis, which can appear as red or purple, raised spots on the skin, but can also affect other organs
- fever, joint pain, swollen lymph nodes in the neck, armpit, or groin
- swelling, sometimes including the face or throat (angioedema), which can cause difficulty breathing
- fainting
- chest pain associated with an allergic reaction, which can be a sign of an allergy leading to a heart attack (Kounis syndrome).
If you experience any of these symptoms, contact your doctor immediately. You should stop taking Augmentin.
Colitis
Colitis, which can cause watery diarrhea, usually with blood and mucus, abdominal pain, and (or) fever.
Drug-induced enterocolitis syndrome (DIES)
Drug-induced enterocolitis syndrome occurred mainly in children taking amoxicillin with clavulanic acid. It is a type of allergic reaction, with recurring vomiting (1 to 4 hours after taking the medicine) as the leading symptom. Further symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.
Acute pancreatitis
If you have severe and persistent stomach pain, it may be a sign of acute pancreatitis.
If you experience any of these symptoms, contact your doctor immediatelyfor advice .
Very common side effects
May affect more than 1 in 10 people
- diarrhea (in adults).
Common side effects
May affect up to 1 in 10 people
- thrush (candidiasis - fungal infections of the vagina, mouth, or skin folds)
- nausea, especially when taking high doses; if this happens, take Augmentin with food
- vomiting
- diarrhea (in children).
Uncommon side effects
May affect up to 1 in 100 people
- skin rash, itching
- raised, itchy, red rash (hives)
- indigestion
- dizziness
- headache.
Uncommon side effects that may be detected in blood tests:
- increased levels of certain substances (enzymes) produced in the liver.
Rare side effects
May affect up to 1 in 1,000 people
- skin rash, which may blister and look like small targets (dark spot in the center, surrounded by a lighter ring with a dark ring on the edge - erythema multiforme)
- low levels of blood cells involved in clotting
- low levels of white blood cells.
Side effects with unknown frequency
Frequency cannot be estimated from the available data.
- Allergic reactions (see above)
- Colitis (see above)
- Aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord)
- Severe skin reactions:
- widespread skin rash, with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing widespread skin peeling (more than 30% of the body surface - toxic epidermal necrolysis)
- widespread red skin rash, with small pus-filled blisters (bullous exfoliative dermatitis)
- red, scaly rash with thickening of the skin and blisters (acute generalized exanthematous pustulosis)
- flu-like symptoms with a rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and increased liver enzyme activity); drug reaction with eosinophilia and systemic symptoms (DRESS)
- red rash, usually observed on both sides of the buttocks, upper inner thighs, under the arms, and on the neck (symmetrical, vesicular, and flexural drug eruption (SDRIFE)). If you experience any of these symptoms, contact your doctor immediately.
- Blisters on the skin, arranged in a ring shape with crusts in the center or like a string of pearls (linear IgA dermatosis).
- Hepatitis.
- Jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which can cause yellowing of the skin and eyes.
- Tubulointerstitial nephritis.
- Prolonged blood clotting time.
- Restlessness.
- Seizures (in people taking high doses of Augmentin or with kidney disease).
- Black hairy tongue.
Side effects that may be detected in blood or urine tests:
- marked decrease in white blood cell count
- low red blood cell count (hemolytic anemia)
- crystals in the urine, leading to acute kidney damage.
Reporting side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych,
Al. Jerozolimskie 181C, 02-222 Warsaw
phone: +48 22 49 21 301
fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Augmentin
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
The batch number (Lot) is stated on the packaging.
Do not store above 25°C.
The shelf life after first opening of the aluminum sachets is 30 days.
Store in the original packaging to protect from moisture.
Do not use if the tablets are broken or damaged in any way.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the pack and other information
What Augmentin contains
- The active substances are amoxicillin and clavulanic acid. Each film-coated tablet contains 250 mg amoxicillin as amoxicillin trihydrate and 125 mg clavulanic acid as potassium clavulanate.
- The other ingredients are: tablet core- magnesium stearate, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, microcrystalline cellulose; tablet coating- titanium dioxide (E171), hypromellose, macrogol (4000, 6000), and dimethicone (silicone oil).
What Augmentin looks like and contents of the pack
Augmentin 250 mg + 125 mg film-coated tablets are white or almost white, oval-shaped, and engraved with “Augmentin” on one side.
Packaged in blisters in a carton. The sachet contains a desiccant. Do not eat the desiccant. Each pack contains 21 tablets.
Marketing authorization holder and manufacturer
Marketing authorization holder Manufacturer
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Glaxo Wellcome Production,
Zone Industrielle de la Peyenniere,
Citywest Business Campus
Dublin 24
D24 YK11
Ireland
53100 Mayenne,
France
To obtain more detailed information on this medicine, contact the marketing authorization holder’s representative:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
phone: (22) 576-90-00
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Bulgaria – Augmentin
Hungary – Augmentin Duo
Ireland – Augmentin
Malta – Augmentin
Poland – Augmentin
Slovakia – Augmentin
United Kingdom – Augmentin
Date of last revision of the leaflet: January 2025
Medical education
Antibiotics are used to treat bacterial infections. They are ineffective against viral infections.
Sometimes, bacterial infections do not respond to antibiotic treatment.
One of the most common reasons for this is that the bacteria are resistant to the antibiotic being taken.
This means that the bacteria can survive or multiply despite the use of antibiotics.
Bacteria can become resistant to antibiotics for many reasons. Careful use of antibiotics can help reduce the risk of bacteria becoming resistant.
The antibiotic prescribed by your doctor is intended only to treat your current illness. Paying attention to the following advice will help prevent the development of resistant bacteria that may stop the antibiotic from working.
- 1. It is very important to take the antibiotic at the right dose, at the right time, and for the right number of days. Read the instructions in the patient information leaflet and ask your doctor or pharmacist to explain anything you do not understand.
- 2. You should not take an antibiotic unless it has been prescribed specifically for you. You should only take it to treat the infection for which it was prescribed.
- 3. You should not take an antibiotic that has been prescribed for someone else, even if they have a similar infection.
- 4. Do not give your antibiotic to anyone else.
- 5. If you have any leftover antibiotic after completing your treatment as directed by your doctor, return it to the pharmacy, which will dispose of it properly. This will help protect the environment.
- Country of registration
- Active substance
- Prescription requiredYes
- ImporterGlaxo Wellcome Production
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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