Augmentin

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Augmentin, 875 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) only. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 prevented from working (inactivated). The second active ingredient (clavulanic acid) prevents 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. These can include skin rash or swelling of the face or throat.
• •If the patient has ever had liver 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 discuss it with 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 test the type of bacteria that caused the patient's infection.
Depending on the results, the patient may be given Augmentin in a different dose or a different medicine.

Conditions to be aware of

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 be aware of 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 the medicines they are taking now or have recently taken, as well as any medicines they plan to take.
If the patient is taking allopurinol (used for gout) at the same time as Augmentin, they may be more likely to get a skin rash.
If the patient is taking probenecid (used for gout), their doctor may decide to adjust the dose of Augmentin.
If the patient is taking blood-thinning medicines (such as warfarin) at the same time as Augmentin, they may need to have extra blood tests.
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, 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 ask their doctor or pharmacist.

Adults and children with a body weight of 40 kg or more

• •The usual dose is 1 tablet twice a day.
• •A higher 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 intended for use in children under 25 kg.

Patients with kidney and liver disease

• •If the patient has kidney disease, the dose of Augmentin may need to be changed. 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 a gap of at least 4 hours 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 contact their doctor again.

Taking a higher dose of Augmentin than recommended

If the patient takes more Augmentin than they should, they may experience symptoms such as stomach and gut upset (nausea, vomiting, or diarrhea) or seizures. They should contact their doctor as soon as possible. They should take the carton of Augmentin 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 deal with the infection. If some bacteria survive, they can cause the infection to come back.
If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Augmentin can cause side effects, although not everybody gets them.
The following side effects may occur when taking this medicine.

Conditions to be aware of

Allergic reactions:

• •skin rash
• •inflammation of blood vessels, 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.
• If the patient experiences any of these symptoms, they should contact their doctor immediately.

The patient should stop taking Augmentin.

Colitis

Colitis, which can cause watery diarrhea, usually with blood and mucus, stomach pain, and (or) fever.

• If the patient experiences any of these symptoms, they should contact their doctor as soon as possible for advice.

Very common side effects

These may occur in more than 1 in 10 patients

• •diarrhea (in adults).

Common side effects

These may occur in less than 1 in 10 patients

• •thrush (candida 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

These may occur in less than 1 in 100 patients

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

Uncommon side effects that may show up in blood tests:

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

Rare side effects

These may occur in less than 1 in 1,000 patients

• •skin rash, which can blister and look like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge - erythema multiforme)
• if the patient notices any of these symptoms, they should contact their doctor urgently.

Rare side effects that may show up in blood tests:

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

Side effects with unknown frequency

The frequency cannot be estimated from the available data.

• •Allergic reactions (see above)
• •Colitis (see above)
• •Inflammation of the membranes surrounding the brain (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 elevated white blood cell count (eosinophilia) and elevated liver enzymes); drug reaction with eosinophilia and systemic symptoms (DRESS).

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

• •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
• •Inflammation of the kidney 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 show up in blood or urine tests:

• •significantly decreased number of white blood cells
• •low number of red blood cells (hemolytic anemia)
• •crystals in the urine.

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health, via the online reporting system at https://smz.ezdrowie.gov.pl. By reporting side effects, the patient can help provide more information on the safety of this medicine.

5. How to store Augmentin

The medicine should be kept out of the sight and reach of children.
The patient should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
The medicine should be stored in a temperature below 25°C, in the original packaging to protect it from moisture.
Tablets in blisters packed in sachets should be used within 30 days of opening the sachet.
The patient should not use the medicine 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 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 carboxymethylcellulose (type A), colloidal anhydrous silica, microcrystalline cellulose; tablet coating- titanium dioxide (E 171), hypromellose (5cps, 15cps), macrogol (4000, 6000), dimethicone 500.

What Augmentin looks like and contents of the pack

Augmentin 875 mg + 125 mg film-coated tablets are white or almost white, capsule-shaped with "AC" engraved and a break line on one side.
They are packed in:

• •blisters in a cardboard box. Each pack contains 14 tablets.
• •blisters in sachets in a cardboard box. The sachets contain a desiccant. The desiccant should be left in the sachet. It should not be swallowed. Each pack contains 14 tablets.

For more detailed information, the patient should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

GlaxoSmithKline (Ireland) Limited
12 Riverwalk
Citywest Business Campus Dublin 24
Ireland

Manufacturer:

Glaxo Wellcome Production
Z.I. de la Peyenniere
53100 Mayenne cedex, France

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Romania, the country of export:
8164/2015/01
8164/2015/02
8164/2015/03
8164/2015/08

Parallel import authorization number: 785/12

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
Finland - Augmentin
Germany - Augmentan
Greece - Augmentin
Hungary - Augmentin Duo
Iceland - Augmentin
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
Date of leaflet approval: 28.10.2022

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 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. Careful use of antibiotics can help reduce the risk 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 stop the antibiotic from working.

• 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 ask their doctor or pharmacist to explain anything they do not understand.
• 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 have a similar infection.
• 4. The patient should not give their antibiotic to anyone else.
• 5. If there are any leftover antibiotics after the patient has finished their course of treatment, they should return them to the pharmacy for proper disposal.

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