Augmentin 500 mg/125 mg powder for oral suspension in sachets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Augmentine 500 mg/125 mg powder for oral suspension in sachets
amoxicillin/clavulanic acid
Read this entire leaflet carefully before you start taking this medicine, as 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. Do not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are 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 side effects
- How to store Augmentine
- Contents of the pack and other information
1. What Augmentine is and what it is used for
Augmentine 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, frequency, and duration of treatment. Do not store 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 via wastewater or household waste.
Augmentine 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. What you need to know before you start taking Augmentine
Do not take Augmentine
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if you are allergic to amoxicillin, clavulanic acid, penicillins, or any of the other ingredients of this medicine (listed in section 6)
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if you have ever had a severe allergic reaction to any other antibiotic. This could include a skin rash or swelling of the face or throat
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if you have ever had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.
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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:
- you have infectious mononucleosis
- you are receiving treatment for liver or kidney problems
- 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, you may be prescribed 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 tests to assess red blood cells or liver function) or urine tests (to monitor glucose levels), inform your doctor or nurse that you are taking Augmentine. This is because Augmentine can alter the results of these types of tests.
Other medicines and Augmentine
Tell 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 works (a medicine used to prevent organ rejection in transplant patients).
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 aspartame, maltodextrin, and sodium
- This medicine contains 15 mg of aspartame per sachet. Aspartame is a source of phenylalanine, which may be harmful to patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.
- This medicine contains maltodextrin (glucose). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.
- This medicine contains less than 23 mg of sodium (1 mmol) per sachet; this 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 sachet taken three times a day
Children weighing less than 40 kg
Augmentine 500 mg/125 mg powder for oral suspension in sachets is not recommended.
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
- Just before taking Augmentine, open the sachet and mix the contents in half a glass of water.
- Take it at the beginning of meals or shortly before.
- Space the 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 upset (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, indicating 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. The adverse effects described below may occur when taking this medicine.
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 in the context of allergic reactions, which may be a symptom of an allergic-triggered heart attack (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 diarrhea, usually with blood and mucus, stomach pain and/or fever.
Drug-induced enterocolitis syndrome (DIES)
DIES has mainly been reported 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, diarrhea, 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
- diarrhea (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 before meals
- vomiting
- diarrhea (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
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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 have 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 the 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 surrounding the brain and spinal cord (aseptic meningitis)
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severe skin reactions:
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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)
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widespread rash with small pus-filled blisters (exfoliative bullous dermatitis)
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red rash with bumps under the skin and blisters (pustular exanthema)
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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))
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red rash typically seen on both buttocks, inner upper thighs, armpits, and 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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blistering rash arranged in circles 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 yellowish
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inflammation of kidney tubules
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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 who have kidney problems)
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black, hairy-looking tongue
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stained teeth (in children), which usually disappear with brushing.
Adverse effects that may appear in blood or urine tests:
- significant reduction in the number of white blood cells
- low red blood cell count (hemolytic anemia)
- 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 may 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 sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 25 ºC.
Keep in the original packaging to protect from moisture.
Do not use if the sachets are torn or damaged.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of packaging and unused medicines at a SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Augmentin 500 mg/125 mg powder for oral suspension in sachets
- The active substances are amoxicillin and clavulanic acid. Each sachet contains amoxicillin trihydrate equivalent to 500 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.
- The other components (excipients) are: magnesium stearate, crospovidone, colloidal hydrated silica, aspartame (E951), peach-lemon-strawberry flavouring (containing maltodextrin and sodium).
- See section 2 for more information on important details about some of the components of Augmentin.
Nature of the product and pack contents
Augmentin 500 mg/125 mg powder for oral suspension in sachets contains a white to off-white powder for oral suspension.
The sachets come in a box. Each pack contains 16 or 30 sachets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 authorized in the Member States of the European Economic Area under the following names:
Belgium – Augmentin
Luxembourg – Augmentin
Spain – Augmentine
Date of the most recent revision 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 Medical Devices (AEMPS): http://www.aemps.gob.es
Instructions for reconstitution
Empty the contents of the sachet into half a glass of water, shake until a suspension is formed, and take immediately.