Augmentin

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Augmentin, 875 mg + 125 mg (1 g), film-coated tablets
Amoxicillinum + Acidum clavulanicum
Please read 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, 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 other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, inform 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 with bactericidal activity against bacteria causing infections.
Augmentin contains two different active substances: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called "penicillins", the action of which 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 infections and sinusitis
• 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 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 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 conditions apply, the patient should not take Augmentin.
If in doubt, consult the doctor or pharmacist before starting Augmentin.
Warnings and precautions
Before starting Augmentin, discuss with the doctor or pharmacist if the patient:

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

If in doubt whether the above conditions apply, consult the doctor or pharmacist before starting Augmentin.
In some cases, the doctor may test which type of bacteria caused the infection.
Depending on the results, the patient may receive Augmentin at a different dose or another medicine.
Conditions to be aware of
Taking Augmentin may worsen certain diseases or cause serious adverse effects, including allergic reactions, seizures, and colitis. It is important to monitor whether the patient experiences specific symptoms while taking 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 with other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
If allopurinol (used in gout) is taken at the same time as Augmentin, skin allergic reactions may be more likely.
If probenecid (used in gout) is taken with Augmentin, the doctor may decide to adjust the dose of Augmentin.
If anticoagulant medicines (such as warfarin) are taken at the same time as Augmentin, additional blood tests may be necessary.
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 using machines
Augmentin may cause adverse effects and symptoms that may 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. the medicine is considered "sodium-free".

3. How to use Augmentin

This medicine should always be taken exactly as your doctor or pharmacist has advised. If you are unsure,
you should 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 usually be treated with Augmentin in the form of an oral suspension.
You should 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 problems

• 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 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. Tablets may be broken along the break 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 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, they should contact their doctor again.

Taking more Augmentin than recommended
If the 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 quickly as possible. Keep the cardboard packaging of the medicine to show it to the doctor.
If you forget to take 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 Augmentin treatment
Continue taking Augmentin for the full duration of treatment, even if the patient starts 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Below is a list of side effects that 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 also affect other organs
• fever, joint pain, swelling of glands in the neck, under the arm or in the groin
• swelling, sometimes affecting the face or throat (angioedema), causing difficulty in breathing
• fainting.

If any of these symptoms occur, seek immediate medical attention
and stop taking Augmentin.
Inflammation of the large intestine
Inflammation of the large intestine causing watery diarrhoea, usually with blood and mucus, abdominal
pain and (or) fever.
If any of these symptoms occur, contact your doctor as soon as possible
for advice.
Very common side effects
May occur in more than 1 in 10 patients:

• diarrhoea (in adults).

Common side effects
May occur in less than 1 in 10 patients:

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

Uncommon side effects
May occur in no more than 1 in 100 patients:

• 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 occur in no more than 1 in 1,000 patients:

• skin rash, possibly with blisters and appearing 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 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 protective membranes surrounding the brain (aseptic meningitis).
• Severe skin reactions:
• widespread skin rash, within which blisters and skin peeling may occur, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing extensive skin peeling (more than 30% of body surface – toxic epidermal necrolysis)
• widespread red rash with small pus-filled blisters (bullous exfoliative dermatitis)
• red scaly rash with subcutaneous nodules 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 any of these symptoms occur, seek immediate medical attention.

• Inflammation of the liver.
• Jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may lead to yellowing of the skin and whites of the eyes.
• Inflammation of the kidney tubules.
• Prolonged blood clotting time.
• Restlessness.
• Seizures (in patients 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.

Reporting of side effects
If any side effects occur, including any not listed
in this leaflet, inform your doctor or pharmacist. Side effects can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921301, fax: +48 22 4921309,
website: https://smz.ezdrowie.gov.pl.
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.
The expiry date refers to the last day of the stated month.
Tablets in blisters contained in sachets should be used within 30 days of opening the sachet.
Store below 25°C. Keep 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. These measures 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 875 mg amoxicillin as amoxicillin trihydrate and 125 mg 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 (E 171), hypromellose (2506/5, 2506/15), polyethylene glycol (4000, 6000), dimethicone.

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 an embossing “AC” and a break line on one side. They are packed in Al/PVC/PVDC foil blisters in an aluminum pouch containing a desiccant. The desiccant must remain in the pouch. Do not swallow it.

Each pack contains 14 tablets.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation 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 in:
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 authorisation number in the Czech Republic, the country of export: 15/644/96-C
Parallel import authorisation number: 94/15
This medicinal product is authorised for marketing in the Member States of the European Economic Area under the following trade 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

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 may help reduce the development of bacterial resistance.
The antibiotic prescribed by your doctor is intended solely for the treatment of your current illness. 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 correct time, and for the correct number of days. Please read the instructions in the package leaflet carefully, and if any are unclear, ask your doctor or pharmacist for clarification.
2. Patients should not take an antibiotic unless it has been prescribed specifically for them. It should be taken only to treat the infection for which it was prescribed.
3. Patients should not take an antibiotic prescribed for another person, even if that person had a similar infection.
4. Do not give antibiotics prescribed for you to other people.
5. If any antibiotic remains after completing the prescribed course of treatment, return it to a pharmacy for proper disposal.