Package Leaflet: Information for the User

Augmentine 100mg/ml + 12,5mg/ml powder for oral suspension

amoxicillin/clavulanic acid

Read this 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, consult your doctor, pharmacist or nurse.
• This medicine is usually prescribed for children, and should not be given to other people even if they have the same symptoms as your child, as it may harm them.
• If your childexperiences any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet.See section 4.

1. What is Augmentine and what it is used for

2. What you need to know before taking Augmentine

3. How to take Augmentine

4. Possible side effects

5. Storage of Augmentine

6. Contents of the pack and additional information

Augmentine is an antibiotic that eliminates bacteria that cause infections. It contains two different medications called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medications known as "penicillins" that can sometimes lose their effectiveness (become inactive). The other component (clavulanic acid) prevents this from happening.

Augmentine100mg/ml + 12.5mg/ml oral powder for suspensionis 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

Do not administer Augmentin to your child

•if he is allergic to amoxicillin, clavulanic acid, or any of the other components of this medication (see section 6)

•if he has ever had a severe allergic reaction to any other antibiotic. This could include skin rash or swelling of the face or throat

•if he has ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

?Do not give Augmentin to your child if any of the above points apply. Before starting treatment with Augmentin, if you are unsure, speak with your doctor or pharmacist.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before administering Augmentin to your child if:

•he has infectious mononucleosis

•he is receiving treatment for liver or kidney problems

•he does not urinate regularly.

If you are unsure whether any of the above symptoms affect your child, inform your doctor or pharmacist before taking Augmentin.

In some cases, your doctor may investigate the type of bacteria causing your child's infection. Depending on the results, your child may receive a different presentation of Augmentin or another medication.

Be aware of these symptoms

Augmentin may worsen existing conditions or cause severe side effects. These include allergic reactions, convulsions, and inflammation of the large intestine. Be aware of certain symptoms while your child is taking Augmentin to reduce the risk of problems. See“Be aware of these symptoms”in section 4.

Blood and urine tests

If your child is undergoing blood tests (such as red blood cell studies or liver function tests)or urine tests (to control glucose levels), inform your doctor or nurse that your child is taking Augmentin. This is because Augmentin may alter the results of these types of tests.

Other medications and Augmentin

Inform your doctor or pharmacist if your child is using, has used recently, or may need to use any other medication.

If your child is taking allopurinol (used for gout) with Augmentin, it may be more likely to have a skin allergic reaction.

If your child is taking probenecid (used for gout), your doctor may adjust the Augmentin dose.

If anticoagulants (such as warfarin) are taken with Augmentin, more blood tests will be required.

Augmentin may affect the way methotrexate (a medication for cancer or rheumatic diseases) works.

Augmentin may affect how micophenolate mofetil (a medication used to prevent organ rejection in transplant patients) works.

Pregnancy, breastfeeding, and fertility

If your daughter is to take this medication and is pregnant or breastfeeding, or thinks she may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Augmentin may cause side effects and symptoms that may make you unable to drive.

Do not drive or operate machinery unless you feel well.

Augmentincontains aspartame, sodium benzoate, maltodextrin, and sodium

• This medication contains 3.2mg of aspartame per ml. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.
• This medication contains1.7mg of sodium benzoate per ml.Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).

• Augmentin contains maltodextrin (glucose).If your doctor has indicated that your child has an intolerance to certain sugars, consult with them before taking this medication.
• This medication contains less than 23mg of sodium (1 mmol) per ml; this is essentially “sodium-free”.

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

Adults and children weighing40kg or more

•Not normally recommended for adults and children weighing40kg or more. Consult your doctor or pharmacist.

Children weighing less than 40kg

All doses are expressed in relation to the child's body weight in kilograms.

•The recommended dose is 40mg/5mg to 80mg/10mg per kilogram of body weight and day, administered in three divided doses.

•Your doctor will advise how much Augmentine to give to your child.

•You will be provided with a plastic spoon or dosing syringe. You must use it to give the correct dose to your child. The instructions for using the dosing syringe are provided at the end of this leaflet.

Patients with kidney and liver problems

• If your child has kidney problems, the dose may be reduced. Your doctor may choose a different presentation or another medication.

•If your child has liver problems, blood tests will be performed more frequently to check how their liver is functioning.

How to administer Augmentine

• Always shake the bottle well before each dose.

• Administer with meals.

•Space the doses throughout the day, at least 4 hours apart. Do not take 2 doses in 1 hour.

•Do not administer Augmentine to your child for more than two weeks. If your child continues to feel unwell, they should return to see the doctor.

If you administer more Augmentinethan you should

If you administer too much Augmentine to your child, symptoms such as stomach discomfort (nausea, vomiting, diarrhea, or convulsions) may appear.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to administer Augmentine

If you forget to administer a dose, give it to your child as soon as you remember. Do not give your child the next dose too soon, wait at least 4 hours before giving the next dose. Do not take a double dose to compensate for the missed doses.

If your child interrupts the treatment with Augmentine

Continue administering Augmentine to your child until the treatment is completed, even if they are feeling better. Your child needs to take the complete treatment to help them fight the infection. If bacteria survive, they will get the infection again.

If you have any other doubts about the use of this medication, consult your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The side effects listed below may occur with this medicine.

Symptoms to be aware of

Allergic reactions:

• skin rash

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

• Contact your doctor immediatelyif your child experiences any of these symptoms.Stop administering Augmentine.

Colitis

Colitis, 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 medication). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

Acute pancreatitis

If you have intense and continuous pain in the stomach area, this could be a sign of acute pancreatitis.

• Contact your doctor as soon as possibleto advise you if your child has these symptoms.

Very common side effects

May affect more than1 in 10 people

• diarrhea (in adults).

Common side effects

May affectup to 1 in 10 people

• thrush (Candida– fungal infection in the vagina, mouth, or mucous membranes)
• nausea, especially when taking high doses

• take Augmentine with meals if this occurs

• vomiting
• diarrhea (in children).

Uncommon side effects

May affect up to1 in 100 people

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

Side effects that may appear in blood tests:

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

Rare side effects

May affect up to1 in 10,000 people

• skin eruption, which may form blisters that appear as small darts (central dark spot surrounded by a lighter area, with a dark ring around the edge -erythema multiforme).

• Seek medical attention immediately if you experience any of these symptoms.

Side effects that may appear in blood tests:

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

Unknown frequency

The frequency cannot be estimated from available data.

• allergic reactions (see above)
• colitis (see above)
• inflammation of the membranes surrounding the brain and spinal cord(aseptic meningitis)
• severe skin reactions:

• widespread rash with blisters and skin peeling, 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 area -toxic epidermal necrolysis)
• widespread rash with small blisters containing pus (exfoliative bullous dermatitis)
• red rash with bumps under the skin and urticaria (pustular exanthem)
• flu-like symptoms with skin rash, fever, swollen lymph nodes, and abnormal blood test results (such as increased eosinophils (eosinophilia) and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS))
• red rash observed on both sides of the buttocks, upper inner thighs, armpits, neck (symmetrical flexural intertriginous exanthem related to drugs (SDRIFE)).

• Contact a doctor immediately if your child experiences any of these symptoms.

• rash with blisters arranged in a circle with a central crust or as a pearl necklace (linear IgA disease)
• inflammation of the liver (hepatitis)
• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver) that may turn the skin and white of the eyes yellow
• inflammation of the kidney tubules
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses of Augmentine or with kidney problems)
• black tongue that appears hairy
• 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 red blood cell count (hemolytic anemia)
• crystals in the urine that cause acute kidney injury.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use, http://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Dry powder

Do not store at a temperature above 25 °C. Store in the original packaging to protect it from moisture.

Do not use this medication after the expiration date (EXP) that appears on the packaging. The expiration date is the last day of the month indicated.

Liquid suspension

Store in the refrigerator (between 2 °C and 8 °C). Do not freeze.

Once reconstituted, the suspension must be used within the first 7 days.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medications. By doing so, you will help to protect the environment.

Composition of Augmentin100mg/ml + 12,5mg/ml powder for oral suspension

• The active ingredients are amoxicillin and clavulanic acid. Each ml of suspension contains amoxicillin trihydrate equivalent to100mg of amoxicillin and potassium clavulanate equivalent to12,5mgofclavulanic acid.
• The other components (excipients) are magnesium stearate, aspartame (E951), crospovidone, xanthan gum, hydrated colloidal silica, anhydrous colloidal silica, sodium benzoate (E211), sodium caramel, strawberry flavoring (contains maltodextrin).
• See section 2 for more important information about aspartame (E951), sodium benzoate (E211), maltodextrin, and sodium in Augmentin.

Appearance of the product and contents of the container

Augmentin 100mg/ml + 12,5mg/ml powder for oral suspension is a white powder that

is presented in transparent glass bottles of 45, 107 or 147ml. Once reconstituted, the bottle may contain 30ml, 40ml, 60ml or 120ml of a white liquid mixture called suspension.

Only some sizes of packaging may be commercially available.

The 40ml containers include a dosing syringe and the 120ml container a spoon, to facilitate the administration of the product.

Marketing authorization holder and manufacturer responsible

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 responsible::

Glaxo Wellcome Production

Z.I. de la Peyenniere

53101 Mayenne

Cedex - France

This medicinal product is authorized in the member states of the European Economic Area with the following names:

France – Augmentin

Germany - Augmentan

Netherlands – Augmentin

Spain- Augmentine

Latest revision date of thisleaflet:May 2024.

The detailed information of this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

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Instructions for reconstitution

Remove the cap from the bottle. Check that the aluminum closure is intact before using the product. Replace the cap on the bottle.

1. Shake the bottle to release the powder adhering to it.

1. Remove the cap from the bottle.

1. Remove the aluminum closure.

1. Add the volume of water (as shown in the table below).Replace the cap on the bottle, invert and shake well again.

Alternatively, shake the bottle to release the powder adhering to it, then fill with water up to just below the notch located above the label on the bottle (format 30, 60, 120ml) or just below the arrow mark on the label (format 40ml).Replace the cap on the bottle, invert and shake well. Then, fill with water exactly up to the notch or the arrow mark. Replace the cap on the bottle, invert and shake well again.

Instructions for use of the syringe (format 40ml)

A syringe is provided for administering Augmentin

The syringe is only for use with Augmentin and should not be used to administer other medications, as the markings on the syringe are specific to this product. The syringe is provided with an adapter that allows it to be attached to the bottle.

The dose is indicated on the oral dosing syringe in milliliters (ml). You should give your child the recommended dose as instructed by your doctor.

Check the cleanliness of the syringe and the adapter before use; rinse with clean water if necessary.

1. Shake the bottle with the reconstituted suspension well before each dose.

.

1. Remove the adapter from the syringe. Grasp the bottle firmly and insert the adapter into the neck of the bottle (the adapter should stay in place).

1. Insert the syringe into the adapter, ensuring it is securely attached.

1. Invert the bottle while holding the syringe and remove the required dose as instructed by your doctor.

1. Place the bottle upright and remove the syringe.

1. To administer the dose, carefully place the tip of the syringe in the mouth and slowly push the plunger of the syringe (repeat steps 3, 4, 5, and 6 if more than one syringe is required to administer the dose).

1. Rinse the syringe thoroughly with clean water. Allow the syringe to dry completely before reusing it.

1. Replace the cap on the bottle.

1. Store in the refrigerator and always shake before use.

Once reconstituted, the suspension should be used within 7 days.