Augmentin Es

Leaflet attached to the packaging: information for the user

Augmentin ES, (600 mg + 42.9 mg)/5 ml, powder for oral suspension

Amoxicillin + Clavulanic acid

Read the leaflet carefully before starting to use the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine is usually prescribed for infants or children. Do not give it to others. The medicine may harm another person, even if their symptoms are the same as your child's.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Augmentin ES and what is it used for
• 2. Important information before using Augmentin ES
• 3. How to use Augmentin ES
• 4. Possible side effects
• 5. How to store Augmentin ES
• 6. Contents of the packaging and other information

1. What is Augmentin ES and what is it used for

Augmentin ES is an antibiotic that works by killing bacteria that cause infections.
Augmentin ES contains two different medicines: amoxicillin and clavulanic acid. Amoxicillin belongs
to a group of medicines called "penicillins", which are sometimes inactivated (neutralized). The second active ingredient (clavulanic acid) counteracts this inactivation.
Augmentin ES is used in infants and children to treat the following infections:

• middle ear infections
• lung infections.

2. Important information before using Augmentin ES

When not to give Augmentin ES to a child

• 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 can include skin rash or swelling of the face or throat.
• If the patient has ever had liver function disorders or jaundice (yellowing of the skin) associated with the use of an antibiotic.

If the above circumstances apply to the patient, they should not take Augmentin ES

Augmentin ES.If in doubt before starting to use Augmentin ES, consult a doctor or pharmacist.

Warnings and precautions

Before starting to give Augmentin ES to a child, consult a doctor or pharmacist if the patient:

• has infectious mononucleosis
• is being treated for liver or kidney disease
• has irregular urination.

If in doubt whether the above circumstances apply to the patient, consult a doctor or pharmacist before starting to give Augmentin ES.
In some cases, the doctor may test what type of bacteria caused the patient's infection.
Depending on the results, the patient may receive Augmentin ES in a different dose or a different medicine.

Conditions to watch out for

Using Augmentin ES may worsen the course of some diseases or cause severe side effects, including allergic reactions, seizures, and colitis. Pay attention to whether the patient experiences certain symptoms during the use of Augmentin ES to reduce the risk of any problems. See ' Conditions to watch out for
for' in section 4.

Blood and urine tests

If the patient is to have blood tests (such as red blood cell tests or liver function tests) or urine tests (for glucose), inform the doctor or nurse that the patient is taking Augmentin ES. Augmentin ES may affect the results of these tests.

Augmentin ES and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
If the patient is taking allopurinol (used for gout) at the same time as Augmentin ES, they may be more likely to experience skin allergic reactions.
If the patient is taking probenecid (used for gout), the doctor may decide to adjust the dose of Augmentin ES.
If the patient is taking blood-thinning medicines (such as warfarin) at the same time as Augmentin ES, additional blood tests may be necessary.
Augmentin ES may affect the action of methotrexate (a medicine used to treat cancer or rheumatic diseases).
Augmentin ES may affect the action of mycophenolate mofetil (a medicine used to prevent transplant rejection).

Pregnancy and breastfeeding

Inform the doctor or pharmacist if the patient is pregnant or breastfeeding.
Before taking any medicine, consult a doctor or pharmacist.

Important information about some ingredients of Augmentin ES

• This medicine contains 2.72 mg of aspartame in each milliliter. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.
• Augmentin ES contains maltodextrin (glucose). If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.
• This medicine contains less than 1 mmol (23 mg) of sodium per ml, which means the medicine is considered "sodium-free".

3. How to use Augmentin ES

This medicine should always be used as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Adults and children weighing 40 kg or more

• This suspension is not usually recommended for use in adults and children weighing 40 kg or more. Consult a doctor or pharmacist for advice.

Children weighing less than 40 kg

All doses are determined based on the child's weight in kilograms.

• The doctor will advise what dose of Augmentin ES to give to the child.
• A plastic measuring spoon is included with the medicine packaging. Use it to give the child the correct dose.
• The usual dose is (90 mg + 6.4 mg) per kilogram of body weight per day, given in two divided doses. Augmentin ES is not recommended for use in children under 3 months of age.

Patients with kidney and liver disease

• If the patient has kidney disease, the dose of the medicine may be changed. The doctor may choose a different dose of Augmentin ES or a different medicine.
• If the patient has liver disease, they may need to have blood tests more often to check how their liver is working.

How to give Augmentin ES

• Always shake the bottle well before giving each dose.
• Give the medicine with food.
• Keep equal intervals of at least 4 hours between doses given during the day. Do not give 2 doses within 1 hour.
• Do not give Augmentin ES to a child for more than 2 weeks. If the patient still does not feel well, consult a doctor again.

Using more than the recommended dose of Augmentin ES

If the patient has taken more than the recommended dose of Augmentin ES, they may experience symptoms such as stomach and intestinal irritation (nausea, vomiting, or diarrhea) or seizures. Consult a doctor as soon as possible. Bring the medicine packaging with you to show the doctor.

Missing a dose of Augmentin ES

If a dose of Augmentin ES is missed, give it as soon as remembered. Do not give the next dose too soon, wait about 4 hours before giving the next dose. Do not give a double dose to make up for a missed dose.

Stopping the use of Augmentin ES

Continue to give Augmentin ES until the end of the treatment, even if the patient feels better. All doses of the medicine are needed to fight the infection. If some bacteria survive, they may cause the infection to recur.
If you have any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Augmentin ES can cause side effects, although not everybody gets them.
The following are side effects of Augmentin ES that may occur.

Conditions to watch out for

Allergic reactions:

• skin rash
• vasculitis, which can appear as red or purple, raised spots on the skin, but can also affect other organs
• fever, joint pain, swelling of the lymph nodes in the neck, armpit, or groin
• swelling, sometimes involving the face or throat (angioedema), causing difficulty breathing
• fainting
• chest pain associated with an allergic reaction, which can be a sign of an allergy leading to a heart attack (Kounis syndrome).

If any of these symptoms occur, consult a doctor immediately.
Stop using Augmentin ES.

Colitis

Colitis, causing watery diarrhea, usually with blood and mucus, abdominal pain, and (or) fever.
Drug-induced enterocolitis syndrome (DIES)
Drug-induced enterocolitis occurred mainly in children receiving amoxicillin with clavulanic acid. It is a type of allergic reaction, the leading symptom of which is repeated vomiting (1 to 4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

Acute pancreatitis

If the patient has severe and persistent abdominal pain, it may be a sign of acute pancreatitis.
If any of these symptoms occur, consult a doctor immediately
for advice.

Very common side effects

May occur in more than 1 in 10 patients

• diarrhea (in adults).

Common side effects

May occur in up to 1 in 10 patients

• thrush (candidiasis - fungal infections of the vagina, mouth, or skin folds)
• nausea, especially when taking large doses; if they occur, give Augmentin ES with food
• vomiting
• diarrhea (in children).

Uncommon side effects

May occur in up to 1 in 100 patients

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

Uncommon side effects that may appear in blood or urine tests:

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

Rare side effects

May occur in up to 1 in 1,000 patients

• skin rash, which can occur with blisters and look like small targets (a dark spot in the center surrounded by a lighter border with a dark ring around the edge - erythema multiforme). If the patient notices any of these symptoms, they should consult a doctor urgently.

Rare side effects that may appear in blood or urine tests:

• low number of platelets in the blood
• low number of white blood cells.

Side effects with unknown frequency

Frequency cannot be estimated from the available data.

• Allergic reactions (see above).
• Colitis (see above).
• Meningitis (aseptic meningitis).
• Severe skin reactions:
• -widespread skin rash, which can occur with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing widespread skin peeling (more than 30% of the body surface - toxic epidermal necrolysis)
• -widespread red skin rash, which can occur with small pus-filled blisters (bullous exfoliative dermatitis)
• -red, scaly rash with thickening under the skin and blisters (acute generalized exanthematous pustulosis)
• -flu-like symptoms with a 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)
• -red rash usually observed on both buttocks, upper inner thighs, under the arms, and on the neck (symmetrical, flexural, and papular drug rash (SDRIFE)).

If the patient experiences any of these symptoms, they should consult a doctor immediately.

• Blistering rash arranged in a ring shape with crusts in the center or like a string of pearls (linear IgA dermatosis).
• Hepatitis .
• Jaundice, caused by an increase in bilirubin (a substance produced in the liver) in the blood, which can cause yellowing of the skin and eyes.
• Tubulointerstitial nephritis.
• Prolonged blood clotting time.
• Hyperactivity.
• Seizures (in people taking high doses of Augmentin ES or with kidney disease).
• Black hairy tongue, which looks like it is hairy.
• Tooth discoloration (in children), which can usually be removed by brushing.

Side effects that may appear in blood or urine tests:

• markedly decreased number of white blood cells
• low number of red blood cells (hemolytic anemia)
• crystals in the urine leading to acute kidney damage.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, tell a doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Augmentin ES

Keep the medicine out of sight and reach of children.
Dry powder
Store in the original packaging to protect from moisture.
Do not store above 25°C.
Do not use Augmentin ES after the expiry date stated on the packaging after:
EXP. The expiry date stated is the last day of the stated month. The abbreviation 'Lot' on the packaging means batch number.
Prepared suspension (medicine after adding water)
Store the prepared suspension in the refrigerator (at a temperature between 2°C and 8°C), do not freeze.
Shelf life of the suspension - 10 days.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed, as this will help protect the environment.

6. Contents of the packaging and other information

What Augmentin ES contains

• The active substances are amoxicillin and clavulanic acid. Each milliliter of the prepared oral suspension contains amoxicillin trihydrate equivalent to 120 mg of amoxicillin and potassium clavulanate equivalent to 8.58 mg of clavulanic acid.
• The other ingredients are: aspartame (E951), xanthan gum, silicon dioxide, colloidal anhydrous silica, sodium carboxymethylcellulose, and strawberry flavor (containing maltodextrin).
• Further information about aspartame (E951) and maltodextrin - see section 2.

What Augmentin ES looks like and what the packaging contains

Augmentin ES, (600 mg + 42.9 mg)/5 ml, powder for oral suspension, is a white powder supplied in a glass bottle. A plastic measuring spoon is included with the packaging.
After adding water, the bottle contains 50 ml, 75 ml, 100 ml, or 150 ml of a white liquid mixture called a suspension.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder Manufacturer

GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland
Glaxo Wellcome Production
ZI de la Peyenniere
53100 Mayenne
France
To obtain more detailed information about this medicine, contact the representative of the marketing authorization holder:
GSK Services Sp. z o.o.
tel. (22) 576-90-00

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

Bulgaria – Augmentin ES
Cyprus – Augmentin ES
Poland – Augmentin ES
Portugal – Augmentin ES
Romania – Augmentin ES
Slovakia – Augmentin ES

Date of last revision of the leaflet: January 2025

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 phenomenon is that bacteria are resistant to the administered antibiotic.
This means that bacteria can survive or multiply despite the use of an antibiotic.
Bacteria can become resistant to antibiotics for many reasons. Careful use of antibiotics can help reduce the possibility of bacteria developing resistance.
An antibiotic prescribed by a doctor is intended only to treat the current illness. Paying attention to the following tips will help prevent the development of resistant bacteria, which could reduce the effectiveness of the antibiotic.

• 1. It is very important to take the antibiotic in the correct dose, at the right time, and for the right number of days. Read the instructions in the patient information leaflet and if any of them are unclear, ask a doctor or pharmacist to explain.

• 2. The patient should not take an antibiotic if it was not prescribed specifically for them. They should only take it to treat the infection for which the antibiotic was prescribed.
• 3. The patient should not take an antibiotic prescribed for another person, even if they had a similar infection.
• 4. Do not give antibiotics prescribed for one patient to other people.
• 5. If there are any leftover antibiotics after completing the treatment as directed by the doctor, return them to the pharmacy, which will accept them for proper disposal.

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Instructions for preparing the medicine for use

Open the cap. Before use, check if the protective foil on the bottle has been damaged. Close the cap.

• 1. Shake the medicine bottle to loosen the powder.

• 2. Open the cap.

• 3. Tear off the protective foil.

• 4. To prepare the suspension, use boiled water cooled to room temperature. Add water (the volume is indicated below). Close the cap, turn the bottle upside down, and shake well.

Alternative method of preparing the suspension: fill the bottle with water to a level just below the mark on the label. Close the cap, turn the bottle upside down, and shake carefully, then fill with water exactly to the mark on the label. Close the cap, turn the bottle upside down, and shake carefully again.