AUGMENTINE 500 mg/125 mg ORAL SUSPENSION POWDER IN SACHETS

Introduction

Package Leaflet: Information for the User

Augmentine 500 mg/125 mg Powder for Oral Suspension in Sachets

amoxicillin/clavulanic acid

Read all of this leaflet carefully before you start 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 only, do not pass it on to others, it may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist, this includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Augmentine and what is it used for
2. What you need to know before you take Augmentine
3. How to take Augmentine
4. Possible side effects
5. Storing Augmentine
6. Contents of the pack and further information

1. What is Augmentine and what is it used for

Augmentine is an antibiotic that eliminates the bacteria that cause 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 lose their effectiveness (become 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 the flu or the common cold. It is important to follow the dosage instructions, the number of doses, and the duration of treatment indicated by your doctor. Do not save or reuse this medicine. If you have any leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

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 take Augmentine

Do not take Augmentine

• if you are allergic to amoxicillin, clavulanic acid, 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. This could include a skin rash or swelling of the face or throat
• if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

• Do not take Augmentine if you are included in any of the above points. Before starting treatment with Augmentine, if you are not sure, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Augmentine if:

• you have infectious mononucleosis
• you are receiving treatment for liver or kidney problems
• you do not urinate regularly.

If you are not sure if any of the above symptoms affect you, inform your doctor or pharmacist before taking Augmentine.

In some cases, your doctor may investigate the type of bacteria that is causing your infection.

Depending on the results, you may be prescribed a different presentation of Augmentine or another medicine.

Symptoms to be aware of

Augmentine can worsen certain existing conditions or cause serious side effects.

These include allergic reactions, convulsions, and inflammation of the large intestine. You should be aware of certain symptoms while taking Augmentine to reduce the risk of problems. See “Symptoms to be aware of”in section 4.

Blood and urine tests

If you are having blood tests (such as red blood cell status or liver function tests) or urine tests (to check 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 take any other medicines.

If you are taking allopurinol (used for gout) with Augmentine, you may be more likely to suffer a skin allergic reaction.

If you are taking probenecid (used for gout), your doctor may adjust the dose of Augmentine.

If you are taking anticoagulants (such as warfarin) 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Augmentine may have side effects, and the symptoms can make you unfit to drive.

Do not drive or operate machinery unless you feel well.

Augmentinecontains aspartame, maltodextrin, and sodium

• This medicine contains 15 mg of aspartame in each sachet. Aspartame is a source of phenylalanine that may be harmful to patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
• This medicine contains maltodextrin (glucose). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.
• This medicine contains less than 23 mg of sodium (1 mmol) per sachet; it is essentially “sodium-free”.

3. How to take Augmentine

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults and children over 40 kg

The recommended dose is:

• 1 sachet administered three times a day

Children under 40 kg

Augmentine 500 mg/125 mg powder for oral suspension in sachets is not recommended.

Patients with kidney and liver problems

• If you have kidney problems, your dose may be changed. Your doctor may choose a different presentation or another medicine.
• If you have liver problems, you will have more frequent blood tests to check how your liver is working.

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 start of meals or a while before.
• Space out the doses during the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
• Do not take Augmentine for more than 2 weeks. If you are still feeling 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 diarrhea) or convulsions may appear. Consult your doctor as soon as possible. Bring the package with you to show the doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 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 forgotten doses.

If you stop taking Augmentine

Continue taking Augmentine until you finish the treatment, even if you feel better. You need to take the complete treatment to cure the infection. If you do not, the surviving bacteria may cause you to have the infection again.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects described below may occur when taking this medicine.

Symptoms to be aware of

Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis) that can appear as red or purple spots on the skin but can affect other parts of the body
• fever, joint pain, swollen glands in the neck, armpits, or groin
• swelling, sometimes of the face or throat (angioedema), which can cause difficulty breathing
• collapse
• chest pain in the context of allergic reactions, which can be a symptom of an allergic myocardial infarction (Kounis syndrome).

• Contact your doctor immediatelyif you experience any of these symptoms. Stop taking Augmentine.

Inflammation of the large intestine

Inflammation of the large intestine, which causes watery diarrhea, 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 certain type of allergic reaction with the main symptom of repeated vomiting (1-4 hours after administering the medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

Acute pancreatitis

If you have severe and persistent stomach pain, this could be a sign of acute pancreatitis.

• Contact your doctor immediatelyif you experience any of these symptoms.

Very common side effects

May affect more than 1 in 10 people

• diarrhea (in adults).

Common side 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 Augmentine before meals

• vomiting
• diarrhea (in children).

Uncommon side effects

May affect up to 1 in 100 people

• skin rash, itching
• increased pruritic rash (urticarial rash)
• indigestion
• dizziness
• headache.

Uncommon side effects that may appear in blood tests:

• increase in some substances (enzymes) produced by the liver.

Rare side effects

May affect up to 1 in 1,000 people

• skin rash, which can form blisters that look like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme).

• Consult your doctor urgentlyif you have anyof these symptoms.

Rare side effects that may appear in blood tests:

• low count of cells involved in blood clotting
• low count of white blood cells.

Frequency not known

Frequency cannot be estimated from the available data.

• allergic reactions (see above)
• 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 peeling of the skin (more than 30% of the body surface – toxic epidermal necrolysis)

• widespread rash with small blisters containing pus (bullous exfoliative dermatitis)
• red rash with bumps under the skin and blisters (pustular exanthematous eruption)
• flu-like symptoms with skin rash, fever, gland inflammation, and abnormal blood test results (such as increased white blood cells (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• red rash usually observed on both sides of the buttocks, on the upper inner thighs, in the armpits, on the neck (Symmetrical Drug-Related Intertriginous and Flexural Exanthema (SDRIFE)).

• Contact a doctor immediatelyif you have anyof these symptoms.

• blistering rash arranged in a circle with a central crust or like a string of pearls (linear IgA disease)
• inflammation of the liver (hepatitis)
• jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver) that can make the skin and the whites of the eyes turn yellow
• inflammation of the kidney ducts
• delayed blood clotting
• hyperactivity
• convulsions (in patients taking high doses of Augmentine or with kidney problems)
• black hairy tongue
• stained teeth (in children), which usually disappears with brushing.

Side effects that may appear in blood or urine tests:

• significant reduction in the number of white blood cells
• low count of red blood cells (hemolytic anemia)
• crystals in the urine that cause acute kidney injury.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Vigilance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Augmentine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date that appears on the packaging after EXP. 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 sachets are broken or damaged.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Augmentine 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 ingredients (excipients) are: magnesium stearate, crospovidone, hydrated colloidal silica, aspartame (E951), peach-lemon-strawberry flavoring (contains maltodextrin and sodium).
• See section 2 for more important information about some of the ingredients of Augmentine.

Appearance of the product and packaging contents

Augmentine 500 mg/125 mg powder for oral suspension in sachets contains a white powder for oral suspension.

The sachets come in a box. Each pack contains 16 or 30 sachets.

Only some 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

[email protected]

Manufacturer:

Glaxo Wellcome Production

Z.I. de la Peyennière

53100 Mayenne

France

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium – Augmentin

Luxembourg – Augmentin

Spain – Augmentine

Date of the last revision of this leaflet:May 2024.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

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Instructions for reconstitution

Pour the contents of the sachet into half a glass of water, shake until a suspension is obtained, and take immediately.