Leaflet: information for the user

Augmentine 500 mg/125 mg film-coated tablets

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 or pharmacist.
• This medicine has been prescribedonlyfor you, and you must not give it to others even if they have the same symptomsas 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.

1. What isAugmentineand what it is used for

2. What you need to know before starting to takeAugmentine

3. How to takeAugmentine

4. Possible side effects

5. Storage ofAugmentine

6. Contents of the pack and additional information

Augmentine is an antibiotic that eliminates the 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.

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 the dose, administration interval, and treatment duration indicated by your doctor. Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it 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 infections and sinus infections

•respiratory tract infections

•urinary tract infections

•skin and soft tissue infections, including dental infections

•bone and joint infections.

Do not take Augmentin:

• if you are allergic to amoxicillin, clavulanic acid, penicillins, or any of the other components of this medication (see 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 Augmentinif you include any of the above points. Before starting treatment withAugmentin, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist beforestarting totake Augmentin if:

• you have infectious mononucleosis

• you are receiving treatment for liver or kidney problems

• you do not urinate regularly.

If you are unsure if any of the above symptoms affect you, inform your doctor or

pharmacist before takingAugmentin.

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 ofAugmentinor another medication.

Be aware of the following symptoms

Augmentinmay worsen existing conditions or cause severe adverse effectsincluding allergic reactions, convulsions, and inflammation of the large intestine. Be aware of certain symptoms while takingAugmentinto reduce the risk of problems. See“Be aware of the following symptoms”in section 4.

Blood and urine tests

If you are having blood tests (such as red blood cell studies or liver function studies) or urine tests (to control glucose levels), inform your doctor or nurse that you are takingAugmentin. This is becauseAugmentinmay alter the results of these types of tests.

Use ofAugmentinwith other medications

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

If you are taking allopurinol (used for gout) withAugmentin, you may be more likely to suffer a skin allergy reaction.

If you are taking probenecid (used for gout), your doctor may adjust the dose of Augmentin.

If you are taking anticoagulants (such as warfarin) withAugmentinyou will need more blood tests.

Augmentinmay affect the way methotrexate (a medication used to treat cancer or rheumatic diseases) works.

Augmentinmay affect how mycophenolate mofetil (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

Augmentinmay cause adverse effects and symptoms may make you unable to drive.

Do not drive or operate machinery unless you feel well.

Augmentin contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions of 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 three times a day.

Children under 40 kg of weight

It is preferable to treat children 6 years or less with the oral suspension of Augmentine or the sachets.

Ask your doctor or pharmacist for advice when administering Augmentine tablets to children weighing less than 40 kg.The tablets are not suitable for children weighing less than 25 kg.

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 functioning.

How to take Augmentine

• Take with meals.
• Swallow the tablets whole with a glass of water.
• You can break the tablet along the break line to make it easier to swallow. You must take the two parts of the tablet at the same time.
• Space the doses throughout the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
• Do not take Augmentine for more than 2 weeks. If you continue to feel unwell, consult your doctor.

If you take more Augmentine than you should

If you take too much Augmentine, you may experience symptoms such as stomach discomfort (nausea, vomiting, or diarrhea) or convulsions. 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Augmentine

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 compensate for the missed doses.

If you interrupt the treatment with Augmentine

Continue taking Augmentine until you complete the treatment, even if you feel better. You need to take the complete 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 doubts 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.

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 can be a symptom of an allergic-induced heart attack (Kounis syndrome).

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 immediatelyif you experience any of these symptoms.

Very common side effects

May affect more than 1 in 10 people

• diarrhea (in adults).

Common side effects

May affect up to1 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 meals
• vomiting
• diarrhea (in children).

Uncommon side effects

May affect up to1 in 100 people

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

Uncommon side effects that may appear in blood tests:

Rare side effects

May affect up to1 in 10,000 people

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

• If you experience any of these symptoms, consult your doctor urgently.

Uncommon 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 the 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 containing pus (exfoliative bullous dermatitis)
• red rash, with bumps under the skin and blisters (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, on the upper inner thighs, in the armpits, neck (symmetrical flexural intertriginous drug reaction (SDRIFE)).

• Contact your doctor immediately if you experience any of these symptoms.

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

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 (EXP) that appears on the packaging. 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 tablets are broken or damaged.

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

Composition ofAugmentine500 mg/125 mg film-coated tablets

• The active ingredients are amoxicillin and clavulanic acid. Each tablet contains amoxicillin trihydrate equivalent to 500 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.
• The other components are: Core - magnesium stearate, sodium carboxymethylcellulose (type A) (derived from potato starch), anhydrous colloidal silica, microcrystalline cellulose. Coating - titanium dioxide (E171), hypromellose, macrogol (4000, 6000) and dimethicone.

Appearance of the product and contents of the pack

Oval-shaped white to off-white tablets bearing the imprint “AC” on one face. Packs containing 30 film-coated tablets.

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 Peyennière

53100 Mayenne (France)

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

Germany - Augmentan

Austria - Augmentin

Belgium - Augmentin

Bulgaria - Augmentin

Cyprus - Augmentin

Czech Republic - Augmentin

Spain - Augmentine

Estonia - Augmentin

Greece - Augmentin

Hungary - Augmentin Duo

Ireland - Augmentin

Latvia - Augmentin

Lithuania - Augmentin

Luxembourg - Augmentin

Malta - Augmentin

Norway - Augmentin

Netherlands - Augmentin

Poland - Augmentin

Portugal - Augmentin

Romania - Augmentin

Slovakia - Augmentin

Slovenia - Augmentin

United Kingdom - Augmentin

Last review date of this leaflet:May 2024.

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