AUGMENTINE 100mg/ml + 12.5 mg/ml ORAL SUSPENSION POWDER

2. What you need to know before you give Augmentine

Do not give Augmentine to your child

• if they are allergic to amoxicillin, clavulanic acid, or any of the other ingredients of this medicine (see section 6)
• if they 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 they have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not give Augmentine to your child if any of the above applies. Before starting treatment with Augmentine, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before giving Augmentine to your child if:

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

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

In some cases, your doctor may investigate the type of bacteria that causes your child's infection. Depending on the results, your child may receive a different formulation of Augmentine or another medicine.

Symptoms to be aware of

Augmentine can worsen certain existing conditions or cause severe side effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should be aware of certain symptoms while your child is taking Augmentine to reduce the risk of problems. See "Symptoms to be aware of"in section 4.

Blood and urine tests

If your child is having blood tests (such as red blood cell analysis or liver function tests) or urine tests (to check glucose levels), inform your doctor or nurse that they 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 your child is using, has recently used, or might use any other medicines.

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

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

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

Augmentine may affect the way methotrexate (a medicine used to treat cancer or rheumatic diseases) works.

Augmentine may affect the way mycophenolate mofetil (a medicine used to prevent organ rejection in transplant patients) works.

Pregnancy, breastfeeding, and fertility

If your daughter is going to take this medicine and is pregnant or breastfeeding, thinks she may be pregnant, or plans to become pregnant, consult her doctor or pharmacist before using this medicine.

Driving and using machines

Augmentine may have side effects, and the symptoms may make your child unfit to drive.

Do not drive or operate machinery unless your child feels well.

Augmentinecontains aspartame, sodium benzoate, maltodextrin, and sodium

• This medicine contains 3.2 mg of aspartame per ml. Aspartame is a source of phenylalanine, which may be harmful in people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
• This medicine contains 1.7 mg 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 of age).

• Augmentine contains maltodextrin (glucose). If your doctor has told your child that they have an intolerance to some sugars, consult them before taking this medicine.
• This medicine contains less than 23 mg of sodium (1 mmol) per ml; this is essentially "sodium-free".

3. How to give Augmentine

Follow the administration instructions for this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Adults and children over40kgin weight

• It is not usually recommended for adults and children who weigh 40 kg or more. Ask your doctor or pharmacist for advice.

Children under40kg

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

• The recommended dose is 40mg/5mg to 80mg/10mg per kilogram of body weight per day, given in three divided doses.
• Your doctor will advise you on how much Augmentine to give your child.
• You will be provided with a plastic spoon or dosing syringe. You must use it to give your child the correct dose. 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, they may need a lower dose. Your doctor may choose a different formulation of Augmentine or another medicine.
• If your child has liver problems, they will have more frequent blood tests to check how their liver is working.

How to give Augmentine

• Always shake the bottle well before each dose.
• Give with meals.
• Space out the doses during the day, at least 4 hours apart. Do not give 2 doses in 1 hour.
• Do not give Augmentine to your child for more than 2 weeks. If your child is still unwell, they should see a doctor again.

If you give more Augmentine than you should

If you give your child too much Augmentine, they may experience symptoms such as stomach upset (nausea, vomiting, diarrhea, or seizures).

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 taken.

If you forget to give Augmentine

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

If your child stops taking Augmentine

Keep giving your child Augmentine until the treatment is finished, even if they feel better. Your child needs to take the full treatment to help combat the infection. If bacteria survive, the infection will return.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects listed below can occur with 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 allergy-induced heart attack (Kounis syndrome).

• Contact your doctor immediatelyif your child experiences any of these symptoms. Stop giving 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 taking amoxicillin/clavulanic acid. It is a certain type of allergic reaction with the main symptom of repeated vomiting (1-4 hours after taking the medicine). Other symptoms may include stomach pain, lethargy, diarrhea, and low blood pressure.

Acute pancreatitis

If your child has severe and persistent stomach pain, this could be a sign of acute pancreatitis.

• Contact your doctor as soon as possiblefor advice if your child has 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 of the vagina, mouth, or mucous membranes)
• nausea, especially when taking high doses

• vomiting
• diarrhea (in children).

Uncommon side effects

May affect up to 1 in 100 people

• skin rash, itching
• increased itching rash (urticaria)
• 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 a doctor urgentlyif your child has any of 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)
aseptic meningitis)
• 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 hives (pustular exanthematous)
• 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))
• red rash usually observed on both sides of the buttocks, on the upper inner thighs, in the armpits, and on the neck (Symmetrical Drug-Related Intertriginous and Flexural Exanthema (SDRIFE)).

• Contact a doctor immediatelyif your child has any of these symptoms.

• skin rash with blisters arranged in a circle with a central crust or like a necklace (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 whites of the eyes turn yellow
• delayed blood clotting
• hyperactivity
• seizures (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 decrease in the number of white blood cells
• low red blood cell count (hemolytic anemia)
• crystals in the urine that can cause acute kidney injury.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use, http://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.

Dry powder

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

Do not use this medicine after the expiration date (CAD) 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 7 days.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition of Augmentine100mg/ml + 12.5mg/ml powder for oral suspension

• The active ingredients are amoxicillin and clavulanic acid. Each ml of suspension contains amoxicillin trihydrate equivalent to 100 mg of amoxicillin and potassium clavulanate equivalent to 12.5 mg of clavulanic acid.
• The other components (excipients) are magnesium stearate, aspartame (E951), crospovidone, xanthan gum, hydrated colloidal silica, anhydrous colloidal silica, sodium benzoate (E211), sodium carmellose, strawberry flavoring (contains maltodextrin).
• See section 2 for more important information about aspartame (E951), sodium benzoate (E211), maltodextrin, and sodium in Augmentine.

Appearance of the Product and Container Content

Augmentine 100 mg/ml + 12.5 mg/ml powder for oral suspension is a white powder

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

Only some package sizes may be marketed.

The 40 ml packages include a dosing syringe, and the 120 ml package includes a spoon, to facilitate administration of the product.

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 Peyenniere

53101 Mayenne

Cedex - France

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

France – Augmentin

Germany - Augmentan

Netherlands – Augmentin

Spain - Augmentine

Date of the Last Revision of thisleaflet:May 2024.

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

---------------------------------------------------------------------------------------------------------------

Reconstitution Instructions

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

1. Shake the bottle to loosen the attached powder.

1. Remove the cap from the bottle.

1. Remove the aluminum seal.

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

Instructions for Using the Syringe (40ml format)

A syringe is provided to administer Augmentine

The syringe is only for use with Augmentine and should not be used to administer other medications, as the marks 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 prescribed by their doctor.

Check the cleanliness of the syringe and 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. Hold the bottle firmly and insert the adapter into the neck of the bottle (the adapter should remain in place).

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

1. Invert the bottle, holding the syringe, and withdraw the required dose as indicated by your doctor.

1. Put 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 syringe plunger (repeat steps 3, 4, 5, and 6 if more than one syringe is required to administer the dose).

1. Rinse the syringe well 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.