Augmentin

Leaflet accompanying the packaging: information for the user

Augmentin, 500 mg + 125 mg, film-coated tablets

Amoxicillin + Clavulanic acid

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you (or your child). Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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 (neutralized) by bacteria. The other 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 taking Augmentin

When not to take 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 a severe allergic reaction to any other antibiotic.
• If the patient has ever had liver or kidney problems, or jaundice (yellowing of the skin) caused by taking an antibiotic.

➔

If any of these conditions apply to the patient, they should not take Augmentin.

Augmentin.If in doubt, the patient should consult their doctor or pharmacist before taking Augmentin.

Warnings and precautions

Before taking Augmentin, the patient should consult their doctor or pharmacist if they:

• have infectious mononucleosis
• are being treated for liver or kidney disease
• have irregular urine output.

If in doubt whether any of these conditions apply to the patient, they should consult their doctor or pharmacist before taking Augmentin.
In some cases, the doctor may need to test the type of bacteria causing the patient's infection.
Depending on the results, the patient may be given Augmentin in a different dose or a different medicine.

Conditions to watch out for

Taking Augmentin can worsen the course of certain diseases or cause severe side effects, including allergic reactions, seizures, and colitis. The patient should be aware of certain symptoms to minimize the risk of any problems. See ‘Conditions to watch out for’ in section 4.

Blood and urine tests

If the patient is going to have blood tests (such as red blood cell count or liver function tests) or urine tests (for glucose), they should tell their doctor or nurse that they are taking Augmentin. Augmentin may affect the results of these tests.

Augmentin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, or have recently taken, and about any medicines they plan to take.
If the patient is taking allopurinol (for gout), they may be more likely to experience skin allergic reactions.
If the patient is taking probenecid (for gout), their doctor may decide to adjust the dose of Augmentin.
If the patient is taking blood-thinning medicines (such as warfarin), they 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should ask their doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Augmentin may cause side effects that can affect the patient's ability to drive or use machines.
The patient should not drive or use machines unless they feel well.

Augmentin contains sodium

• This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially ‘sodium-free’.

3. How to take Augmentin

This medicine should always be taken exactly as advised by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist again.

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 old should preferably be treated with Augmentin oral suspension.
The patient should consult their doctor or pharmacist before giving Augmentin tablets to children under 40 kg. Augmentin tablets are not suitable for children under 25 kg.

Patients with kidney and liver disease

• If the patient has kidney disease, the dose of Augmentin may need to be adjusted. The doctor may choose a different dose of Augmentin or a different medicine.
• If the patient has liver disease, they may need to have more frequent blood tests to check how their liver is working.

How to take Augmentin

• The medicine should be taken with food.
• The tablets should be swallowed whole with a glass of water. The tablets can be broken in half to make them easier to swallow. The patient should take both halves of the tablet at the same time.
• The patient should keep at least 4-hour intervals between doses taken in a 24-hour period. They should not take 2 doses in 1 hour.
• The patient should not take Augmentin for more than 2 weeks. If they still do not feel better, they should consult their doctor again.

Taking more than the recommended dose of Augmentin

If the patient takes more Augmentin than they should, they may experience symptoms such as stomach and intestinal upset (nausea, vomiting, or diarrhea) or seizures. They should contact their doctor as soon as possible. They should take the carton and tablet packaging with them to show the doctor.

Missing a dose of Augmentin

If the patient forgets to take a dose, they should take it as soon as they remember. They should not take the next dose too early; they should wait about 4 hours before taking the next dose. They should not take a double dose to make up for a missed dose.

Stopping treatment with Augmentin

The patient should continue to take Augmentin until they finish the course, even if they feel better. All doses of the medicine are needed to fight the infection. If some bacteria survive, they can cause the infection to come back.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Augmentin can cause side effects, although not everybody gets them.
The following are side effects of Augmentin that may occur:

Conditions to watch out 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 the patient experiences any of these symptoms, they should contact their doctor immediately.
They 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)

DIES has mainly occurred in children taking amoxicillin with clavulanic acid. It is a type of allergic reaction, the main symptom of which is repeated vomiting (1 to 4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

Acute pancreatitis

If the patient has severe and persistent stomach pain, it may be a sign of acute pancreatitis.
➔
If the patient experiences any of these symptoms, they should contact their doctor as soon as possible
for 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, the patient should take Augmentin with food
• vomiting
• diarrhea (in children).

Uncommon side effects

May affect up to 1 in 100 people

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

Uncommon side effects that may be seen 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, which may blister and look like small targets (central dark spot surrounded by a paler area, with a dark ring on the edge - erythema multiforme). ➔ If the patient notices any of these symptoms, they should contact their doctor urgently.

Rare side effects that may be seen in blood tests:

• low number of blood cells involved in clotting
• low number of white blood cells.

Side effects with unknown frequency

Frequency cannot be estimated from the available data.

• Allergic reactions (see above)
• Colitis (see above)
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• Severe skin reactions:
• -widespread skin rash, with blisters and peeling, 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 bumps (pustular exanthem)
• -red, scaly rash with thickening of the skin and bumps, 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, flexural, and papular eruption caused by a drug (SDRIFE)).

➔

If the patient experiences any of these symptoms, they should contact their doctor immediately.

• Blisters arranged in a ring shape with crusts in the center or like a string of pearls (linear IgA dermatosis)
• Hepatitis
• Jaundice, caused by increased bilirubin levels in the blood, which can cause yellowing of the skin and eyes.
• Inflammation of the renal tubules
• 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 seen in blood or urine tests:

• marked decrease in the number of white blood cells
• low number of red blood cells (hemolytic anemia)
• crystals in the urine, leading to acute kidney damage.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health,
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 authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Augmentin

The medicine should be stored 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 month stated. The abbreviation ‘Lot’ on the packaging means batch number.
Do not store above 25°C.
The shelf life of the medicine after opening 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. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Augmentin contains

• The active substances of Augmentin are amoxicillin and clavulanic acid. Each film-coated tablet contains 500 mg of amoxicillin as amoxicillin trihydrate and 125 mg of 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 dimeticone (silicone oil).

What Augmentin looks like and contents of the pack

Augmentin 500 mg + 125 mg film-coated tablets are white or almost white, oval-shaped, and scored on one side with “AC”.
They are packaged in:

• blister packs in a cardboard box. Each pack contains 4, 10, 12, 14, 16, 20, 24, 30, 100, or 500 tablets.
• blister packs in sachets in a cardboard box. The sachet contains a desiccant. The desiccant should be left in the sachet. It should not be swallowed. Each pack contains 14, 20, or 21 tablets.

Not all pack sizes and types may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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
To obtain more detailed information on this medicine, the patient should contact the representative of the marketing authorization holder:
GSK Services Sp. z o.o., ul. Rzymowskiego 53, 02-697 Warsaw, tel. (22) 576-90-00

This medicinal product is authorized in the Member States of the European Economic Area 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

Date of last revision of the leaflet:

(logo of the marketing authorization holder)

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.
This means that the bacteria can survive or multiply despite the use of the antibiotic.
Bacteria can become resistant to antibiotics for many reasons. The careful use of antibiotics can help reduce the likelihood of bacteria becoming resistant.
The antibiotic prescribed by the doctor is intended only to treat the current illness. Paying attention to the following advice will help prevent the development of resistant bacteria, which could make the antibiotic ineffective.

• 1. It is very important to take the antibiotic in the right dose, at the right time, and for the right number of days. The patient should read the instructions in the information about the medicine and, if they do not understand any of them, ask their doctor or pharmacist to explain.
• 2. The patient should not take an antibiotic unless it has been prescribed specifically for them. They should only take it to treat the infection for which it was prescribed.
• 3. The patient should not take an antibiotic that was prescribed for someone else, even if they had a similar infection.
• 4. The patient should not give their antibiotics to others.
• 5. If the patient has any leftover antibiotic after completing the treatment as advised by their doctor, they should return it to the pharmacy, which will dispose of it properly.