AUGMENTINE 500 mg/125 mg FILM-COATED TABLETS

2. What you need to know before you take Augmentine

Do not take Augmentine:

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

Do not take Augmentine if you are included in 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 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 formulation of Augmentine or another medication.

Symptoms to be aware of

Augmentine can worsen certain existing conditions or cause serious side effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should 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 status or liver function tests) or urine tests (to check glucose levels), inform your doctor or nurse that you are taking Augmentine. This is because Augmentine can alter the results of these types of tests.

Using Augmentine with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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 dose of Augmentine.

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

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

Augmentine may affect how mycophenolate mofetil (a medicine 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Augmentine may cause side effects that can affect your ability to drive or operate machinery.

Do not drive or operate machinery unless you are feeling well.

Augmentine contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Augmentine

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

Adults and children over 40 kg

The recommended dose is:

• 1 tablet three times a day.

Children under 40 kg

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

Ask your doctor or pharmacist for advice when administering Augmentine tablets to children who weigh less than 40 kg. The tablets are not suitable for children who weigh 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 formulation or another medicine.
• If you have liver problems, you will have more frequent blood tests to check how your liver is working.

How to take Augmentine

• Take with meals.
• Swallow the tablets whole with a glass of water.
• The tablet can be broken along the break line to make it easier to swallow. You should take both parts of the tablet at the same time.
• Space out the doses during 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 are still feeling 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 upset (nausea, vomiting, or diarrhea) or seizures. Consult your doctor as soon as possible. Take the pack 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, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget 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 make up for forgotten doses.

If you stop taking Augmentine

Continue taking Augmentine until you finish the treatment, even if you feel better. You need to take the full treatment to cure the infection. If you do not, the bacteria that survive may cause you to become infected again.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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 immediately if you experience any of these symptoms.Stop taking 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 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 medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

Acute pancreatitis (inflammation of the pancreas)

If you have severe and persistent stomach pain, this could be a sign of acute pancreatitis.

• Contact your doctor immediately if 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 to 1 in 10 people

• thrush (Candida - fungal infection in 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 pruritic 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 your doctor urgently if you have 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)
• inflammation of the large intestine (see above)
• inflammation of the membranes that surround 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 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 blisters (pustular exanthematous eruption)
• flu-like symptoms with skin rash, fever, gland inflammation, 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 immediately if you have any of these symptoms.

• rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease)
• liver inflammation (hepatitis)
• jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver) that can make the skin and the whites of the eyes turn yellow
• inflammation of the kidney ducts
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses of Augmentine or with kidney problems)
• black hairy tongue.

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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: 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.

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

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

Do not use if the tablets are broken or damaged.

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 in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Augmentine 500 mg/125 mg film-coated tablets

• The active substances 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 ingredients 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 packaging contents

Oval-shaped tablets, white to off-white in color, with "AC" engraved on one side. Packs containing 30 film-coated tablets.

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 Peyennière

53100 Mayenne (France)

This medicine is authorized in the Member States of the European Economic Area under 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

Slovak Republic - Augmentin

Slovenia - Augmentin

United Kingdom - Augmentin

Date of the last revision of this leaflet:May 2024.

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