Package Leaflet: Information for the User

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

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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 may sometimes lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or a cold. It is essential to follow the instructions regarding dosage, administration, and treatment duration as indicated by your doctor. Do not store or reuse this medication. If you have leftover antibiotics after completing treatment, return them to the pharmacy for proper disposal. Do not dispose of medications through the drain or in the trash.

Augmentine is used in adults and children to treat the following infections:

• middle ear and nasal sinus infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections, including dental infections
• bone and joint infections.

Do not take Augmentine

• If you are allergic to amoxicillin, clavulanic acid, penicillins, or any of the other components of this medication (listed in section 6)
• If you have ever had a severe allergic reaction to any other antibiotic. This could include 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 fall under any of the above points. Before starting treatment with Augmentine, if you are unsure, 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 unsure whether 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 causing your infection.

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

Symptoms to be aware of

Augmentine 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 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 studies or liver function tests) or urine tests (to control glucose levels), inform your doctor or nurse that you are taking Augmentine. This is because Augmentine may alter the results of these types of tests.

Other medications and Augmentine

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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 Augmentine dose.

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

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

Augmentine may affect how micofenolato de mofetilo (a medication 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 medication.

Driving and operating machinery

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

Do not drive or operate machinery unless you feel well.

Augmentinecontains aspartame, maltodextrin, and sodium

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

Adults and children 40 kg or more

The recommended dose is:

• 1 tablet administered three times a day

Children under 40 kg of weight

Augmentin 500 mg/125 mg oral powder for 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 medication.
• If you have liver problems, you will have more frequent blood tests to check how your liver is working.

How to Take Augmentin

• Just before taking Augmentin, open the sachet and mix the contents in half a glass of water.
• Take it at the beginning of meals or a little earlier.
• Space out the doses during the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
• Do not take Augmentin for more than 2 weeks. If you continue to feel unwell, consult your doctor.

If you take more Augmentin than you should

If you take too much Augmentin, you may experience symptoms such as stomach discomfort (nausea, vomiting, or diarrhea) or seizures. Consult your doctor as soon as possible. Bring the packaging 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 medication and the amount ingested.

If you forget to take Augmentin

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 the missed doses.

If you interrupt the treatment with Augmentin

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

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

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

Be aware of these symptoms

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 you experience any of these symptoms.Stop taking 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 taking 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 persistent pain in the stomach area, this could be a sign of acute pancreatitis.

• Contact your doctor immediately if you experience any of thesesymptoms.

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)
• 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 to 1 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).

• If you haveanyof these symptoms, consult your doctor urgently.

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:

-generalized 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)

-generalized rash with small blisters with pus (exfoliative bullous dermatitis)

-red rash, with bumps under the skin and blisters (pustular exanthem)

- symptoms similar to the flu 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, on the upper inner thighs, in the armpits, neck (pharmaceutical-related intertriginous and flexural symmetric exanthem (SDRIFE)).

• Contact a doctor immediately if you have any of these symptoms.

• blistering rash arranged in a circle with a central crust or as a string of pearls (IgA linear 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
• convulsions (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 damage.

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 the Spanish System for the Pharmacovigilance of Medicines for Human Use: 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.

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

Do not store at a temperature above 25°C.

Store in the original packaging to protect it from moisture.

Do not use if the packets are torn or damaged.

Medications should not be disposed of through drains or trash. Deposit the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Augmentine 500 mg/125 mg powder for oral suspension in sachets

• The active principles 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 components (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 components of Augmentine.

Appearance of the product and content of the container

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

The sachets come inside a box. Each container contains 16 or 30 sachets.

Only some container sizes may be marketed.

Marketing authorization holder and responsible 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]

Responsible 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 with the following names:

Belgium – Augmentin

Luxembourg – Augmentin

Spain – Augmentine

Last review date of this leaflet: May 2024.

The detailed and updated information about this medicine 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

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