Augmentin 100 mg/ml + 12.5 mg/ml powder for oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Augmentine 100mg/ml + 12.5mg/ml powder for oral suspension

amoxicillin/clavulanic acid

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

Contents of the leaflet

1. What Augmentine is and what it is used for
2. What you need to know before administering Augmentine
3. How to administer Augmentine
4. Possible side effects
5. How to store Augmentine
6. 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 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 influenza or the common cold. It is important to follow your doctor's instructions regarding dosage, administration, and duration of treatment. Do not store or reuse this medication. If you have leftover antibiotics after completing the treatment, return them to the pharmacy for proper disposal. Medicines should not be disposed of via wastewater or household waste.

Augmentin 100 mg/ml + 12.5 mg/ml powder for oral suspension 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 administering Augmentine

Do not give Augmentine to your child

• if they are allergic to amoxicillin, clavulanic acid, or any of the other components 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) while taking an antibiotic.

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before administering 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 conditions affect your child, inform your doctor or pharmacist before they take Augmentine.

In some cases, your doctor may investigate the type of bacteria causing your child's infection. Depending on the results, your child may be given 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 watch for certain symptoms while your child is taking Augmentine to reduce the risk of complications. See “Symptoms to watch for” in section 4.

Blood and urine tests

If your child is having blood tests (such as red blood cell studies or liver function tests) or urine tests (to monitor glucose levels), inform your doctor or nurse that they are taking Augmentine. This is because Augmentine may 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 need to use any other medicines.

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

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

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

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

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

Pregnancy, breastfeeding, and fertility

If your daughter is taking 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 cause adverse effects, and the symptoms may mean that driving or operating machinery should be avoided.

Do not drive or operate machinery unless you feel well.

Augmentine contains 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 if you have 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 you that your child has an intolerance to certain sugars, consult with them before taking this medicine.

• This medicine contains less than 23 mg of sodium (1 mmol) per ml; therefore, it is essentially “sodium-free”.

3. How to take Augmentine

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

Adults and children weighing 40 kg or more

• Augmentine is not normally recommended for adults and children weighing 40 kg or more. Please seek advice from your doctor or pharmacist.

Children weighing less than 40 kg

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

• The recommended dose is 40 mg/5 mg up to 80 mg/10 mg per kilogram of body weight per day, administered in three divided doses.
• Your doctor will advise you on how much Augmentine to give your child.
• A plastic spoon or oral dosing syringe will be provided. You must use it to administer the correct dose to your child. Instructions for using the dosing syringe are provided at the end of this leaflet.

Patients with kidney or liver problems

• If your child has kidney problems, the dose may be reduced. Your doctor may choose a different formulation or another medicine.
• If your child has liver problems, blood tests will be performed more frequently to monitor liver function.

How to take Augmentine

• Always shake the bottle well before each dose.
• Take with meals.
• Space doses evenly throughout the day, at least 4 hours apart. Do not take two doses within one hour.
• Do not give Augmentine to your child for longer than two weeks. If your child still feels unwell, you should see the doctor again.

If you give more Augmentine than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

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 give a double dose to make up for forgotten doses.

If your child stops taking Augmentine

Continue giving your child Augmentine for the full duration of the treatment, even if they feel better. Your child needs to complete the full course to help fight the infection. If any bacteria survive, the infection may return.

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

4. Possible adverse effects

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

Symptoms to watch for

Allergic reactions:

• skin rash

• inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may 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), causing difficulty breathing

• collapse

• chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (Kounis syndrome).

• Contact your doctor immediately if your child experiences any of these symptoms. Stop giving Augmentine.

Inflammation of the large intestine

Inflammation of the large intestine, causing watery diarrhoea 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 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, diarrhoea, 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 as soon as possible for advice if your child has these symptoms.

Very common adverse effects

May affect more than 1 in 10 people

• diarrhoea (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 Augmentine with food

• vomiting

• diarrhoea (in children)

Uncommon adverse effects

May affect up to 1 in 100 people

• skin rash, itching
• increased itchy rash (urticarial weals)
• 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

• skin rash, which may blister and look like small targets (dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme)

• If you have any of these symptoms, consult a 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.

• allergic reactions (see above)

• inflammation of the large intestine (see above)

• inflammation of the membranes surrounding the brain and spinal cord (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 skin peeling (more than 30% of body surface – toxic epidermal necrolysis)

• widespread rash with small pus-filled blisters (exfoliative bullous dermatitis)

• red rash with bumps under the skin and hives (pustular exanthem)

• 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 typically seen on both sides of the buttocks, upper inner thighs, armpits, and neck (Symmetrical Drug-Related Intertriginous and Flexural Erythema (SDRIFE))

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

• blistering rash arranged in circles with a central crust or resembling a string of beads (linear IgA disease)

• inflammation of the liver (hepatitis)

• 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 yellow

• inflammation of the kidney tubules

• delayed blood clotting

• hyperactivity

• seizures (in patients taking high doses of Augmentine or with kidney problems)

• black, hairy-looking tongue

• stained teeth (in children), which usually disappear with brushing

Adverse effects that may appear in blood or urine tests:

• significant reduction in white blood cell count
• low red blood cell count (haemolytic anaemia)
• crystals in urine causing acute kidney injury

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Augmentin

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

Dry powder

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

Do not use this medicine after the expiry date (EXP) stated on the carton. The expiry date refers to the last day of the month indicated.

Liquid suspension

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

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

Medicines must not be disposed of via wastewater or household waste. Return empty containers and any unused medicines to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Augmentine 100 mg/ml + 12.5 mg/ml powder for oral suspension

• The active substances 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 flavouring (contains maltodextrin).
• See section 2 for further important information about aspartame (E951), sodium benzoate (E211), maltodextrine and sodium in Augmentine.

Nature of the product and contents of the container

Augmentine 100 mg/ml + 12.5 mg/ml powder for oral suspension is a white powder presented in transparent glass bottles of 45, 107 or 147 ml. After reconstitution, the bottle may contain 30 ml, 40 ml, 60 ml or 120 ml of a white liquid mixture called suspension.

Only certain pack sizes may be marketed.

The 40 ml pack includes a dosing syringe and the 120 ml pack includes a spoon to assist administration of the product.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicine is authorised in the Member States of the European Economic Area under the following names:

France – Augmentin

Germany – Augmentan

Netherlands – Augmentin

Spain – Augmentine

Date of the most recent review of this leaflet: May 2024.

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

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Instructions for reconstitution

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

1. Shake the bottle to loosen any adhering powder.

1. Remove the bottle cap.

1. Remove the aluminium seal.

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

Concentration	Volume of water to add for reconstitution (ml)	Final volume of reconstituted suspension (ml)
100 mg/ml + 12.5 mg/ml	26	30
34	40
52	60
103	120

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

Instructions for use of the oral dosing syringe (40 ml size)

An oral dosing syringe is provided for administering Augmentine

The syringe is intended solely for use with Augmentine and must not be used to administer other medications, as the markings on the syringe are specific to this product. The syringe is supplied with an adapter that allows it to be attached to the bottle.

The dose is indicated on the oral dosing syringe in millilitres (ml). You must give your child the dose recommended by your doctor.

Check that the syringe and adapter are clean before use; rinse with clean water if necessary.

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

2. 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).

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

4. Invert the bottle, holding the syringe, and withdraw the dose prescribed by your doctor.

5. Place the bottle upright and remove the syringe.

6. To administer the dose, carefully place the tip of the syringe into the child's mouth and slowly push the plunger of the syringe (repeat steps 3, 4, 5, and 6 if more than one syringeful is required to administer the full dose).

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

8. Replace the cap on the bottle.

9. Store in a refrigerator and always shake well before use.

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