Augmentin

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Augmentin, 875 mg + 125 mg (1 g), coated tablets

Amoxicillin + Clavulanic acid

You should carefully read the contents of the leaflet before using 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 further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for you (or your child). 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, you should 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 packaging 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:

• 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 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 kidney problems, or jaundice (yellowing of the skin) caused by taking an antibiotic.

If any of these conditions apply to you, you should not take Augmentin.

If you are unsure, you should consult your doctor or pharmacist before taking Augmentin.

Warnings and precautions

Before taking Augmentin, you should discuss it with your doctor or pharmacist if you:

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

If you are unsure whether any of these conditions apply to you, you should consult your doctor or pharmacist before taking Augmentin.
In some cases, your doctor may need to test the type of bacteria causing your infection.
Depending on the results, you may be given Augmentin in a different dose or a different medicine.

Conditions to be aware of

Taking Augmentin can worsen the course of some diseases or cause severe side effects, including allergic reactions, seizures, and colitis. You 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 you are going to have blood tests (such as red blood cell count or liver function tests) or urine tests (for glucose), you should tell your doctor or nurse that you are taking Augmentin. Augmentin may affect the results of these tests.

Augmentin and other medicines

You should 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 (used for gout) at the same time as Augmentin, you may be more likely to experience skin allergic reactions.
If you are taking probenecid (used for gout), your doctor may decide to adjust the dose of Augmentin.
If you are taking blood-thinning medicines (such as warfarin) at the same time as Augmentin, you may need to have additional 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should 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.
You should 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 means it is essentially "sodium-free".

3. How to take Augmentin

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should ask your 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 in the form of oral suspension. You should consult your doctor or pharmacist before giving Augmentin tablets to children with a body weight below 40 kg. Augmentin tablets are not intended for use in children with a body weight of less than 25 kg.

Patients with kidney and liver diseases

• If you have kidney disease, the dose of Augmentin may need to be changed. Your doctor may choose a different dose of Augmentin or a different medicine.
• 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

• 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 along the break line to make them easier to swallow. Both halves of the tablet should be taken at the same time.
• You should keep equal intervals of at least 4 hours between doses taken during the day. You should not take 2 doses within 1 hour of each other.
• You should not take Augmentin for more than 2 weeks. If you still do not feel better, you should contact your doctor again.

Taking a higher dose of Augmentin than recommended

If you take more Augmentin than you should, you may experience symptoms such as stomach and intestinal upset (nausea, vomiting, or diarrhea) or seizures. You should contact your doctor as soon as possible. You should take the carton of the medicine with you to show the doctor.

Missing a dose of Augmentin

If you forget to take a dose, you should take it as soon as you remember. You should not take the next dose too soon, you should wait about 4 hours before taking the next dose. You should not take a double dose to make up for a missed dose.

Stopping treatment with Augmentin

You should continue to take Augmentin until you finish the treatment, even if you feel better. All doses of the medicine are needed to fight the infection. If some bacteria survive, they can cause a relapse of the infection.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

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

Conditions to be aware of

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, swelling of the lymph nodes in the neck, armpit, or groin
• swelling, sometimes involving the face or throat (angioedema), which can cause difficulty breathing
• fainting.

If you experience any of these symptoms, you should 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.
If you experience any of these symptoms, you should contact your doctor as soon as possible for advice.

Very common side effects

These may occur in more than 1 in 10 people:

• diarrhea (in adults).

Common side effects

These may occur in less than 1 in 10 people:

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

Uncommon side effects

These may occur in less than 1 in 100 people:

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

Uncommon side effects that may appear in blood test results:

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

Rare side effects

These may occur in less than 1 in 1000 people:

• skin rash, which can appear with blisters and look like small targets (dark spot in the center, surrounded by a lighter ring with a dark ring on the edge - erythema multiforme) if you notice any of these symptoms, you should contact your doctor urgently.

Rare side effects that may appear in blood test results:

• low number of blood cells involved in blood 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).
• Meningitis (aseptic meningitis).
• Severe skin reactions:
• widespread skin rash, which can appear 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 peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis)
• widespread red rash on the skin, which can appear 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 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).

If you experience any of these symptoms, you should contact your doctor immediately.

• Hepatitis.
• Jaundice, caused by increased bilirubin levels in the blood, which can cause yellowing of the skin and eyes.
• Tubulointerstitial nephritis.
• Prolonged bleeding time.
• Hyperactivity.
• Seizures (in people taking high doses of Augmentin or with kidney disease).
• Black hairy tongue.

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

• markedly decreased white blood cell count
• low red blood cell count (hemolytic anemia)
• crystals in the urine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring, 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.
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 the sight and reach of children.
You 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.
Tablets in blisters packed in aluminum sachets should be used within 30 days of opening the sachet.
Store in a temperature below 25°C. 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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 carboxymethylcellulose (type A), colloidal anhydrous silica, microcrystalline cellulose; tablet coating- titanium dioxide (E 171), hypromellose (2506/5, 2506/15), macrogol (4000, 6000), dimeticone.
• dimeticone.

What Augmentin looks like and contents of the pack

Augmentin 875 mg + 125 mg coated tablets are white or almost white, capsule-shaped with "AC" engraved and a break line on one side.
They are packed in blisters of aluminum/PVC/PVDC in an aluminum sachet containing a desiccant, in a cardboard box. The desiccant should be left in the sachet. Do not swallow it.
Each pack contains 14 tablets.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

Prodlekpol Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in the Czech Republic, the country of export:15/644/96-C
Parallel import authorization number:94/15

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: 10.05.2022

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 being taken.
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 likelihood of bacteria becoming resistant.
The antibiotic prescribed by your 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 correct dose, at the correct time, and for the correct number of days. You should read the instructions in the patient information leaflet and if you do not understand any of them, you should ask your doctor or pharmacist to explain.
• 2. You should not take an antibiotic that has not been prescribed for you. You should only take it to treat the infection for which it was prescribed.
• 3. You should not take an antibiotic that was prescribed for someone else, even if they had a similar infection.
• 4. You should not give antibiotics prescribed for you to other people.
• 5. If you have any leftover antibiotic after completing the treatment as advised by your doctor, you should return it to the pharmacy for proper disposal.

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