Augmentin

Package leaflet: Information for the user

Augmentin, 500 mg + 125 mg, film-coated tablets
Amoxicillinum + Acidum clavulanicum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult 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 someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Augmentin is and what it is 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 Augmentin is and what it is used for

Augmentin is an antibiotic that kills bacteria causing infections.
Augmentin contains two different active substances: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called “penicillins”, whose action may sometimes be inhibited (inactivated). The second active component (clavulanic acid) counteracts this inactivation. Augmentin 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.

2. Important information before using Augmentin

When not to use Augmentin

• If the patient is allergic to amoxicillin, clavulanic acid, penicillin, or any of the other ingredients of this medicine (listed in section 6).
• If the patient has ever experienced severe allergic reactions to any other antibiotic. These may include skin rash or swelling of the face or throat.
• If the patient has ever had liver problems or jaundice (yellowing of the skin) related to taking an antibiotic.

➔ If any of the above circumstances apply to the patient, Augmentin must not be taken.
In case of doubt, consult the patient's doctor or pharmacist before starting Augmentin.

Warnings and precautions

Before starting Augmentin, consult the patient's doctor or pharmacist if the patient:

• has infectious mononucleosis,
• is being treated for liver or kidney disease,
• urinates irregularly.

If in doubt whether any of the above conditions apply to the patient, consult the doctor or pharmacist before starting Augmentin.

In some cases, the doctor may test which type of bacteria caused the patient's infection. Depending on the results, the patient may receive Augmentin at a different dose or a different medicine.

Conditions to be aware of

Taking Augmentin may worsen certain diseases or cause serious side effects, including allergic reactions, seizures, and inflammation of the large intestine. It is important to monitor whether the patient develops specific symptoms during treatment with Augmentin to reduce the risk of complications. See 'Conditions to be aware of' in section 4.

Blood and urine tests

If the patient is due to have blood tests (such as red blood cell counts or liver function tests) or urine tests (for glucose), inform the doctor or nurse that the patient is taking Augmentin. Augmentin may affect the results of these tests.

Augmentin and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

If the patient takes allopurinol (used for gout) at the same time as Augmentin, skin allergic reactions may be more likely.

If the patient is taking probenecid (used for gout), the doctor may decide to adjust the dose of Augmentin.

If the patient is taking anticoagulant medicines (such as warfarin) together with Augmentin, additional blood tests may be needed.

Augmentin may affect the action of methotrexate (a medicine used to treat cancer or rheumatic diseases).

Augmentin may affect the action of mycophenolate mofetil (a medicine used to prevent transplant rejection).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery

Augmentin may cause side effects that could impair the ability to drive.

Do not drive or operate machinery unless the patient feels well.

Augmentin contains sodium

• This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free."

3. How to take Augmentin

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If in doubt,
you should contact your doctor or pharmacist again.
Adults and children with body weight of 40 kg or more
The usual dose is:

• 1 tablet three times a day.

Children with body weight less than 40 kg
Children aged 6 years or younger should generally be treated with Augmentin in the form of an oral suspension.
You should consult your doctor or pharmacist before using Augmentin tablets in children with body weight below 40 kg. Augmentin tablets are not intended for use in children with body weight less than 25 kg.
Patients with kidney or liver disease

• If the patient has kidney problems, the dose of the medicine may need to be adjusted. Your doctor may prescribe a different dose of Augmentin or another medicine.
• If the patient has liver problems, blood tests may be performed more frequently to monitor liver function.

How to take Augmentin

• Take this medicine with food.
• Swallow the tablets whole with a glass of water. The tablets may be broken along the division line to make swallowing easier. Both parts of the tablet should be taken at the same time.
• Maintain regular intervals of at least 4 hours between doses taken during the day. Do not take 2 doses within 1 hour.
• Do not take Augmentin for longer than 2 weeks. If the patient still does not feel well, they should contact their doctor again.

Taking more Augmentin than prescribed
If the patient takes more Augmentin than prescribed, symptoms such as irritation of the stomach and intestines (nausea, vomiting or diarrhoea) or seizures may occur. Contact your doctor as soon as possible. Keep the cardboard packaging of the medicine to show it to the doctor.
Missing a dose of Augmentin
If the patient forgets to take a dose, they should take it as soon as they remember. Do not take the next dose too soon; wait approximately 4 hours before taking the next dose. Do not take a double dose to make up for a missed dose.
Stopping treatment with Augmentin
You should continue taking Augmentin for the full duration of treatment, even if you start to feel better. All doses are necessary to eliminate the infection. If some bacteria survive, they may cause the infection to return.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Below is a list of possible adverse effects associated with this medicine.
Symptoms that require attention
Allergic reactions:

• Skin rash
• Vasculitis, which may appear as red or purple raised spots on the skin, but may also affect other organs
• Fever, joint pain, swelling of glands in the neck, armpits or groin
• Swelling, sometimes affecting the face or throat (angioedema), causing difficulty in breathing
• Fainting
• Chest pain related to an allergic reaction, which may indicate an allergy leading to heart attack (Kounis syndrome)

➔ If any of these symptoms occur, seek immediate medical advice
and discontinue Augmentin treatment immediately.
Inflammation of the large intestine
Inflammation of the large intestine causing watery diarrhoea, usually with blood and mucus, abdominal
pain and (or) fever.
Drug-induced enterocolitis syndrome (DIES)
Drug-induced enterocolitis syndrome has occurred mainly in children receiving amoxicillin
with clavulanic acid. This is a type of allergic reaction, the main symptom of which is recurrent vomiting
(1 to 4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhoea,
and low blood pressure.
Acute pancreatitis
If the patient experiences severe and persistent pain in the stomach area, this may be a sign of acute
pancreatitis.
➔ If any of these symptoms occur, contact your doctor as soon as possible
for medical advice.
Very common adverse effects
May occur in more than 1 in 10 patients

• Diarrhoea (in adults)

Common adverse effects
May occur in less than 1 in 10 patients

• Fungal infections (candidiasis – yeast infections of the vagina, mouth or skin folds)
• Nausea, particularly when high doses are used ➔ if this occurs, take Augmentin with food
• Vomiting
• Diarrhoea (in children)

Uncommon adverse effects
May occur in no more than 1 in 100 patients

• Skin rash, itching
• Raised, itchy rash (urticaria)
• Indigestion
• Dizziness
• Headache

Uncommon adverse effects that may be revealed by blood tests:

• Increased activity of certain substances (enzymes) produced in the liver

Rare adverse effects
May occur in no more than 1 in 1,000 patients

• Skin rash, which may include blisters and appear as target-like lesions (dark spot in the centre, surrounded by a lighter ring and a dark ring at the edge – erythema multiforme). ➔ If the patient notices any of these symptoms, they should contact a doctor urgently.

Rare adverse effects that may appear in blood test results:

• Low number of platelets (cells involved in blood clotting)
• Low number of white blood cells

Adverse effects with unknown frequency
Frequency cannot be estimated from the available data.

• Allergic reactions (see above)
• Inflammation of the large intestine (see above)
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• Severe skin reactions:
  • Widespread skin rash with blisters and skin peeling, particularly around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome), and a more severe form causing extensive skin detachment (over 30% of body surface area – toxic epidermal necrolysis)
  • Widespread red rash with small pustules (bullous exfoliative dermatitis)
  • Red, scaly rash with subcutaneous nodules and blisters (acute generalised exanthematous pustulosis)
  • Flu-like symptoms with 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 typically observed on both buttocks, inner upper thighs, underarms and neck (symmetrical, photo-exposed and flexural eruption induced by drugs (SDRIFE)).

➔ If the patient experiences any of these symptoms, seek immediate medical advice.

• Blistering rash arranged in a ring-like pattern with scabs in the centre or resembling a string of pearls (linear IgA dermatosis)
• Hepatitis (liver inflammation)
• Jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may cause yellowing of the skin and whites of the eyes
• Inflammation of the kidney tubules
• Prolonged blood clotting time
• Psychomotor hyperactivity
• Seizures (in patients receiving high doses of Augmentin or with kidney disease)
• Black hairy tongue (a black, hairy appearance of the tongue)

Adverse effects that may appear in blood or urine test results:

• Marked decrease in white blood cell count
• Low number of red blood cells (haemolytic anaemia)
• Crystals in urine leading to acute kidney injury

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Augmentin

Keep this 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 stated month. The code 'Lot' on the packaging
indicates the batch number.
Do not store above 25°C.
The shelf-life of the medicine after first opening of the aluminium sachets: 30 days.
Store in the original packaging to protect from moisture.
Do not use if the tablets are broken or otherwise damaged.
Medicines must 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 coated tablet contains 500 mg of amoxicillin as amoxicillin trihydrate and 125 mg of clavulanic acid as potassium clavulanate.
• Other ingredients are: tablet core – magnesium stearate, sodium carboxymethyl starch (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 coated tablets, 500 mg + 125 mg, are white or off-white, oval-shaped tablets with an imprint “AC” and a break line on one side.
They are packed in:

• blisters in a cardboard box. Each pack contains 4, 10, 12, 14, 16, 20, 24, 30, 100 or 500 tablets.
• blisters in sachets within a cardboard box. The sachet contains a desiccant. The desiccant should remain in the sachet. Do not swallow it. Each pack contains 14, 20 or 21 tablets.

Not all pack types and sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24,
D24 YK11, Ireland
Manufacturer: Glaxo Wellcome Production, Z.I. de la Peyenniere, 53100 Mayenne cedex, France
For further information about this medicinal product, please contact the Marketing Authorisation Holder's representative:
GSK Services Sp. z o.o., ul. Rzymowskiego 53, 02-697 Warsaw, Poland, tel. (22) 576-90-00
This medicinal product is authorised in the European Economic Area countries under the following names:
Austria – Augmentin
Belgium – Augmentin
Bulgaria – Augmentin
Cyprus – Augmentin
Czech Republic – Augmentin
Estonia – Augmentin
Germany – Augmentan
Greece – Augmentin
Hungary – Augmentin Duo
Ireland – Augmentin
Latvia – Augmentin
Lithuania – Augmentin
Luxembourg – Augmentin
Malta – Augmentin
Netherlands – Augmentin
Norway – Augmentin
Poland – Augmentin
Portugal – Augmentin
Romania – Augmentin
Slovakia – Augmentin
Slovenia – Augmentin
Spain – Augmentine, Clavumox
United Kingdom – Augmentin
(logo of the Marketing Authorisation Holder)
Medical education
Antibiotics are used to treat bacterial infections. They are ineffective in treating viral infections.
Sometimes bacterial infections do not respond to antibiotic treatment.
One of the most common reasons for this is that bacteria are resistant to the antibiotic used.
This means that bacteria can survive or multiply despite antibiotic treatment.
Bacteria may become resistant to antibiotics for various reasons. Careful use of antibiotics
can help reduce the risk of development of antibiotic-resistant bacteria.
The antibiotic prescribed by your doctor is intended solely for the treatment of your current condition.
Paying attention to the following advice will help prevent the development of resistant bacteria, which could hinder the effectiveness of antibiotics.

1. It is very important to take the antibiotic at the correct dose, at the right time, and for the full duration prescribed. Please read the instructions provided in the package leaflet and, if any of them are unclear, ask your doctor or pharmacist for clarification.
2. You should not take an antibiotic unless it has been specifically prescribed for you. You should take it only to treat the infection for which it was prescribed.
3. You should not take an antibiotic prescribed for someone else, even if they had a similar infection.
4. Do not give antibiotics prescribed for you to other people.
5. If you have any leftover antibiotic after completing the treatment as directed by your doctor, return it to a pharmacy that accepts such returns, so it can be properly disposed of.