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, 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. 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 others, 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, pharmacist or nurse. 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 inhibited (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 experienced severe allergic reactions to any other antibiotic. These may include skin rash or swelling of the face or throat.

• If the patient has ever had liver problems or jaundice (yellowing of the skin) associated with the use of an antibiotic.

  • If any of the above situations apply to the patient, Augmentin must not be taken. 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,
• Has irregular urination.

If in doubt whether any of the above 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. Be alert 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 might take in the future.

• If the patient is taking allopurinol (used for gout), skin allergic reactions may be more likely when taken together with 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 transplant rejection).

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects 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 adverse effects and symptoms that could impair the ability to drive or operate machinery.
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 your 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 generally be treated with Augmentin oral suspension.
Consult your doctor or pharmacist before administering Augmentin tablets to 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 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. The tablets may be broken along the score 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 prescribed
If a patient takes more Augmentin than prescribed, 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 it to the doctor.
If a dose of Augmentin is missed
If a 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 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The adverse reactions that may occur with the use of this medicine are listed below.

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

  • If any of these symptoms occur, seek medical advice immediately. Stop taking Augmentin.

Inflammation of the large intestine (colitis)
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 adverse reactions
May affect more than 1 in 10 people

• diarrhoea (in adults)

Common adverse reactions
May affect less than 1 in 10 people

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

Uncommon adverse reactions
May affect no more than 1 in 100 people

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

Uncommon adverse reactions that may be revealed in blood tests:

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

Rare adverse reactions
May affect no more than 1 in 1,000 people

• 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 around the edge – erythema multiforme)
  • if the patient notices any of these symptoms, contact a doctor urgently.

Rare adverse reactions that may appear in blood test results:

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

Adverse reactions with unknown frequency
Frequency cannot be estimated from the available data.

• Allergic reactions (see above)
• Inflammation of the large intestine (colitis) (see above)
• Inflammation of the protective membranes surrounding the brain (aseptic meningitis)
• Severe skin reactions:
  • widespread skin rash, with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genital organs (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 nodules under the skin 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)
  • If any of these symptoms occur, contact a doctor immediately.
• Liver inflammation (hepatitis)
• Jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may cause 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

Adverse reactions that may appear in blood or urine tests:

• severe decrease in white blood cell count
• low number of red blood cells (haemolytic anaemia)
• crystals in urine

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions 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.
Store below 25°C in the original packaging to protect from moisture.
Tablets in blisters contained in sachets should be used within 30 days of opening the sachet.
Do not use if the tablets are broken or otherwise damaged.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such 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.
• Other ingredients are: tablet core – magnesium stearate, sodium carboxymethyl starch (type A), colloidal anhydrous silica, microcrystalline cellulose; tablet coating – titanium dioxide (E 171), hypromellose (5 cps, 15 cps), macrogol (4000, 6000), dimethicone 500.

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

• blisters in a cardboard box. Each package contains 14 tablets.
• blisters in sachets within a cardboard box. The sachets contain a desiccant. The desiccant must be left in the sachet. Do not swallow it. Each package contains 14 tablets.

For more detailed information, please contact the responsible entity or parallel importer.
Responsible entity in Romania, 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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Permit number in Romania, country of export: 8164/2015/01
8164/2015/02
8164/2015/03
8164/2015/08
Parallel import permit number: 785/12
This medicinal product is authorised for marketing in the European Economic Area member states 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

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 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 prescribed number of days. Please read the instructions in the package leaflet and, if any are unclear, ask your doctor or pharmacist for clarification.
2. The patient should not take an antibiotic unless it has been specifically prescribed for them. It should be taken only to treat the infection for which it was prescribed.
3. The patient 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 treatment as directed by your doctor, return it to a pharmacy for proper disposal.