Augmentin

Package leaflet: Information for the user

Augmentin, 875 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. 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 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. What you need to know 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 blocked (inactivated). The second active ingredient (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 had severe allergic reactions to any other antibiotic. These may include skin rash or swelling of the face or throat.
• If the patient has ever experienced liver problems or jaundice (yellowing of the skin) associated with taking an antibiotic.

If any of the above situations apply, the patient should not take Augmentin.
In case of doubt, consult the doctor or pharmacist before starting Augmentin.

Warnings and precautions

Before starting Augmentin, discuss this with the doctor or pharmacist if the patient:

• Has infectious mononucleosis.
• Is being treated for liver or kidney disease.
• Has irregular urination.

If in doubt whether any of the above conditions apply, consult the doctor or pharmacist before starting Augmentin.
In some cases, the doctor may investigate which type of bacteria caused the 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 colitis. It is important to monitor for 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 count 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 is taking allopurinol (used for gout), there may be a higher chance of developing skin allergic reactions while taking Augmentin.
• 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 organ transplant rejection).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks she might 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 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, i.e. it is considered "sodium-free".

3. How to take Augmentin

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Adults and children weighing 40 kg or more

• Usual dose – 1 tablet twice daily.
• Higher dose – 1 tablet three times daily.

Children weighing less than 40 kg
Children aged 6 years or younger should preferably be treated with Augmentin in the form of an
oral suspension. Consult your doctor or pharmacist before using Augmentin tablets in children weighing less than 40 kg. Augmentin tablets are not intended for use in children weighing 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. The doctor may prescribe a different dose of Augmentin or an alternative 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 score line to aid swallowing. Both parts of the tablet should be taken at the same time.
• Maintain regular intervals of at least 4 hours between doses 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 better, contact the doctor again.

Taking more Augmentin than recommended
If a patient takes more Augmentin than recommended, symptoms such as stomach and intestinal irritation (nausea, vomiting, or diarrhoea) or seizures may occur. Contact your doctor as soon as possible. Keep the cardboard packaging of the medicine to show to the doctor.
Missing a dose of Augmentin
If a patient forgets to take a dose, take it as soon as remembered. 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 Augmentin treatment
Continue taking Augmentin for the full duration of treatment, even if the patient feels 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 doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The side effects listed below may occur with the use of this
medicine.
Symptoms to be aware of
Allergic reactions:

• skin rash
• vasculitis, which may appear as red or purple raised spots on the skin, but may 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 be a sign of an allergy leading to heart attack (Kounis syndrome).

If any of these symptoms occur, seek immediate medical advice
and discontinue use of Augmentin.
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 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 has severe and persistent pain in the stomach area, this may be a sign of acute pancreatitis.
If any of these symptoms occur, seek immediate medical advice
from your doctor.
Very common side effects
May affect more than 1 in 10 people

• diarrhoea (in adults).

Common side effects
May affect up to 1 in 10 people

• fungal infections (candidiasis - yeast infections of the vagina, mouth or skin folds)
• nausea, especially when taking high doses; if this occurs, take Augmentin with food
• vomiting
• diarrhoea (in children).

Uncommon side effects
May affect up to 1 in 100 people

• skin rash, itching
• raised, itchy rash (urticaria)
• indigestion
• dizziness
• headache.

Uncommon side effects that may be revealed in blood tests:

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

Rare side effects
May affect up to 1 in 1,000 people

• skin rash, possibly with blisters and appearing as target-like lesions (a dark spot in the centre surrounded by a lighter ring and a dark ring around the edge - erythema multiforme); if the patient notices any of these symptoms, they should contact a doctor urgently.

Rare side effects that may appear in blood test results:

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

Side 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 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 (over 30% of body surface area - toxic epidermal necrolysis)
  • widespread red rash with small pus-filled blisters (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)
  • symmetrical, flexural and intertriginous eruption typically seen on both sides of the buttocks, inner thighs, underarms and neck (symmetrical drug-related intertriginous and flexural exanthema (SDRIFE)).

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

• Blistering rash arranged in a ring-like pattern with crusts in the central area or resembling a string of pearls (linear IgA dermatosis).
• Inflammation of the liver.
• Jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may result in yellowing of the skin and whites of the eyes.
• Inflammation of the kidney tubules.
• Prolonged blood clotting time.
• Hyperactivity.
• Seizures (in people receiving high doses of Augmentin or with kidney disease).
• Black, hairy-looking tongue.

Side effects that may appear in blood or urine tests:

• severe decrease in the number of white blood cells
• low number of red blood cells (haemolytic anaemia)
• crystals in the urine leading to acute kidney injury.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side 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
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Augmentin

Keep this medicine out of 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.
Do not store above 25°C.
The shelf life of the medicine after first opening 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 in use. Following this advice helps 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 875 mg of amoxicillin as amoxicillin trihydrate and 125 mg of clavulanic acid as potassium clavulanate.
• The other ingredients are: tablet core – magnesium stearate, sodium carboxymethyl starch (type A), colloidal anhydrous silica, microcrystalline cellulose; tablet coating – titanium dioxide (E171), hypromellose, polyethylene glycol (4000, 6000), and dimethicone (silicone oil).

What Augmentin looks like and contents of the pack
Augmentin 875 mg + 125 mg film-coated tablets are white or off-white, capsule-shaped tablets,
with the imprint “AC” and a break line on one side.
They are packed in:

• blisters in a cardboard box. Each pack contains 2, 4, 10, 12, 14, 16, 20, 24, 30, 100 or 500 tablets.
• blisters in sachets within a cardboard box. The sachet contains a desiccant to absorb moisture. The desiccant must be left in the sachet. Do not swallow it. Each pack contains 14 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 local representative of the Marketing Authorisation Holder:
GSK Services Sp. z o.o., ul. Rzymowskiego 53, 02-697 Warszawa
tel. (22) 576-90-00

This medicinal product is authorised for sale 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
Italy – Augmentin
Latvia – Augmentin
Lithuania – Augmentin
Luxembourg – Augmentin
Malta – Augmentin
Netherlands – Augmentin
Poland – Augmentin
Portugal – Augmentin Duo
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 prescribed antibiotic.
This means that bacteria can survive or multiply despite the use of the antibiotic.
Bacteria may become resistant to antibiotics for various reasons. Careful use of antibiotics
can help reduce the risk of developing bacterial resistance.
The antibiotic prescribed by your doctor is intended solely for the treatment of your current illness.
Following the advice below will help prevent the development of resistant bacteria that 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 prescribed duration. Read the instructions in the package leaflet carefully, and if any of them are unclear, ask your doctor or pharmacist for clarification.
2. Do 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. Do not take an antibiotic prescribed for someone else, even if their symptoms were similar.
4. Do not give your prescribed antibiotics to other people.
5. If any antibiotic remains after completing the prescribed course of treatment, return it to a pharmacy for proper disposal.