Augmentine 500 mg/125 mg film-coated tablets
Spain
Table of Contents
Package Leaflet: Information for the User
Introduction
Package Leaflet: Information for the User
Augmentine 500 mg/125 mg Film-coated Tablets
amoxicillin/clavulanic acid
Read the entire leaflet carefully before you start 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 only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Augmentine is and what it is used for
- What you need to know before taking Augmentine
- How to take Augmentine
- Possible adverse effects
- How to store Augmentine
- 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. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins," which can sometimes become ineffective (inactivated). The other component (clavulanic acid) prevents this from happening.
Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold. It is important that you follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment. Do not keep or reuse this medicine. If you have any antibiotic left after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines down the drain or with household waste.
Augmentin is used in adults and children to treat the following infections:
- middle ear and paranasal sinus infections
- respiratory tract infections
- urinary tract infections
- skin and soft tissue infections, including dental infections
- bone and joint infections.
2. What you need to know before taking Augmentine
Do not take Augmentine:
- if you are allergic to amoxicillin, clavulanic acid, penicillins, or any of the other ingredients of this medicine (see section 6)
- if you have ever had a severe allergic reaction to any other antibiotic. This could include skin rash or swelling of the face or throat
- if you have ever had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.
?Do not take Augmentine if any of the above apply to you. Before starting treatment with Augmentine, if you are unsure, consult your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Augmentine if:
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you have infectious mononucleosis
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you are receiving treatment for liver or kidney problems
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you do not urinate regularly.
If you are unsure whether any of the above conditions apply to you, inform your doctor or
pharmacist before taking Augmentine.
In some cases, your doctor may investigate the type of bacteria causing your infection.
Depending on the results, they may prescribe a different formulation of Augmentine or another medicine.
Symptoms to watch for
Augmentine may worsen certain existing conditions or cause serious adverse effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should be aware of certain symptoms while taking Augmentine to reduce the risk of complications. See “Symptoms to watch for” in section 4.
Blood and urine tests
If you are having blood tests (such as studies of red blood cell status or liver function tests) or urine tests (to monitor glucose levels), inform your doctor or nurse that you are taking Augmentine. This is because Augmentine may alter the results of these types of tests.
Taking Augmentine with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
If you are taking allopurinol (used for gout) with Augmentine, you may be more likely to develop a skin allergic reaction.
If you are taking probenecid (used for gout), your doctor may adjust your dose of Augmentine.
If anticoagulants (such as warfarin) are taken with Augmentine, more blood tests will be needed.
Augmentine may affect the action of methotrexate (a medicine used to treat cancer or rheumatic diseases).
Augmentine may affect how mycophenolate mofetil (a medicine used to prevent organ rejection in transplant patients) works.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Augmentine may cause adverse effects, and the symptoms may mean you should not drive.
Do not drive or operate machinery unless you feel well.
Augmentine contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially “sodium-free”.
3. How to take Augmentine
Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.
Adults and children weighing 40 kg or more
The recommended dose is:
- 1 tablet three times a day.
Children weighing less than 40 kg
It is preferable to treat children aged 6 years or younger with Augmentine oral suspension or sachets.
Seek advice from your doctor or pharmacist before administering Augmentine tablets to children weighing less than 40 kg. The tablets are not suitable for children weighing less than 25 kg.
Patients with kidney or liver problems
- If you have kidney problems, your dose may be adjusted. Your doctor may choose a different formulation or another medicine.
- If you have liver problems, you will have blood tests more frequently to monitor liver function.
How to take Augmentine
- Take with food.
- Swallow the tablets whole with a glass of water.
- The tablet may be divided along the break line to make swallowing easier. You must take both parts of the tablet at the same time.
- Space your doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
- Do not take Augmentine for longer than 2 weeks. If you still feel unwell, consult your doctor.
If you take more Augmentine than you should
If you take too much Augmentine, symptoms such as stomach discomfort (nausea, vomiting, or diarrhoea) or seizures may occur. Contact your doctor as soon as possible. Take the packaging with you to show your doctor.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the medicine and the amount ingested.
If you forget to take Augmentine
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too soon; wait at least 4 hours before taking the next dose. Do not take a double dose to make up for a missed dose.
If you stop taking Augmentine
Continue taking Augmentine for the full duration of treatment, even if you feel better. You need to complete the full course to cure the infection. If you do not, surviving bacteria may cause the infection to return.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Symptoms to watch for
Allergic reactions:
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skin rash
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inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may affect other parts of the body
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fever, joint pain, swollen glands in the neck, armpits or groin
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swelling, sometimes of the face or throat (angioedema), causing difficulty breathing
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collapse
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chest pain during allergic reactions, which may be a symptom of heart attack triggered by allergy (Kounis syndrome).
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Contact your doctor immediately if you experience any of these symptoms. Stop taking Augmentin.
Inflammation of the large intestine
Inflammation of the large intestine, causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.
Drug-induced enterocolitis syndrome (DIES)
DIES has been reported mainly in children receiving amoxicillin/clavulanic acid. It is a type of allergic reaction with the main symptom being repeated vomiting (1–4 hours after taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.
Acute inflammation of the pancreas (acute pancreatitis)
If you have severe and persistent pain in the stomach area, this could be a sign of acute pancreatitis.
- Contact your doctor immediately if you experience any of these symptoms.
Very common adverse effects
May affect more than 1 in 10 people
- diarrhoea (in adults)
Common adverse effects
May affect up to 1 in 10 people
- thrush (Candida – fungal infection in the vagina, mouth or mucous membranes)
- nausea, especially when taking high doses
- if this happens, take Augmentin with food
- vomiting
- diarrhoea (in children)
Uncommon adverse effects
May affect up to 1 in 100 people
- skin rash, itching
- increased itchy rash (urticarial wheals)
- indigestion
- dizziness
- headache
Uncommon adverse effects that may appear in blood tests:
- increase in certain substances (enzymes) produced by the liver
Rare adverse effects
May affect up to 1 in 1,000 people
-
skin rash, which may blister and resemble small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme).
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If you experience any of these symptoms, consult your doctor urgently.
Rare adverse effects that may appear in blood tests:
- low count of cells involved in blood clotting
- low white blood cell count
Frequency not known
Frequency cannot be estimated from available data.
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allergic reactions (see above)
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inflammation of the large intestine (see above)
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inflammation of the membranes covering the brain and spinal cord (aseptic meningitis)
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severe skin reactions:
- widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and in its most severe form, causing widespread skin peeling (more than 30% of body surface – toxic epidermal necrolysis)
- widespread rash with small pus-filled blisters (exfoliative bullous dermatitis)
- red rash with bumps under the skin and blisters (exanthematous pustulosis)
- flu-like symptoms with skin rash, fever, swollen glands and abnormal blood test results (such as increased white blood cells (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
- rash typically seen on both sides of the buttocks, upper inner thighs, armpits, neck (Symmetrical Drug-related Intertriginous and Flexural Exanthema (SDRIFE))
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Contact a doctor immediately if you have any of these symptoms.
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rash with blisters arranged in a circle with a central crust or resembling a string of pearls (linear IgA disease)
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inflammation of the liver (hepatitis)
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jaundice, caused by increased bilirubin in the blood (a substance produced by the liver), which may cause the skin and whites of the eyes to turn yellow
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inflammation of the kidney ducts
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delayed blood clotting
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hyperactivity
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seizures (in patients taking high doses of Augmentin or with kidney problems)
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black, hairy-looking tongue
Adverse effects that may appear in blood or urine tests:
- significant reduction in the number of white blood cells
- low red blood cell count (haemolytic anaemia)
- crystals in the urine causing acute kidney injury
Reporting of adverse effects:
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Augmentine
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date is the last day of the month indicated.
Do not store above 25 °C. Keep in the original packaging to protect from moisture.
Do not use if the tablets are broken or damaged.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point 
at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Augmentine 500 mg/125 mg film-coated tablets
- The active substances are amoxicillin and clavulanic acid. Each tablet contains amoxicillin trihydrate equivalent to 500 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.
- The other components are: Core - magnesium stearate, sodium carboxymethyl starch (type A) (derived from potato starch), colloidal anhydrous silica, microcrystalline cellulose. Coating - titanium dioxide (E171), hypromellose, polyethylene glycol (4000, 6000) and dimethicone.
Appearance of the product and contents of the pack
Oval-shaped, white to off-white film-coated tablets, engraved with "AC" on one side. Packs containing 30 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline, S.A.
P.T.M. C/ Severo Ochoa, 2
28760 Tres Cantos (Madrid)
Tel: +34 900 202 700
Manufacturer:
Glaxo Wellcome Production
Z.I. de la Peyennière
53100 Mayenne (France)
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany - Augmentan
Austria - Augmentin
Belgium - Augmentin
Bulgaria - Augmentin
Cyprus - Augmentin
Czech Republic - Augmentin
Spain - Augmentine
Estonia - Augmentin
Greece - Augmentin
Hungary - Augmentin Duo
Ireland - Augmentin
Latvia - Augmentin
Lithuania - Augmentin
Luxembourg - Augmentin
Malta - Augmentin
Norway - Augmentin
Netherlands - Augmentin
Poland - Augmentin
Portugal - Augmentin
Romania - Augmentin
Slovak Republic - Augmentin
Slovenia - Augmentin
United Kingdom - Augmentin
Date of the most recent review of this leaflet: May 2024.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es