Augmentin 875 mg/125 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Augmentine 875mg/125mg film-coated tablets

amoxicillin/clavulanic acid

Read the entire leaflet carefully before you start taking this medicine, as 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 (or your child) only. Do not give it to other people, even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Augmentine is and what it is used for
2. What you need to know before taking Augmentine
3. How to take 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.

Augmentin is used in children and adults 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 starting Augmentine

Do not take Augmentine:

• if you are allergic to amoxicillin, clavulanic acid, penicillins, or any of the other ingredients of this medicine (listed in section 6)
• if you have ever had a severe allergic reaction (hypersensitivity) 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) while taking an antibiotic.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 conditions apply to 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, they may prescribe 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 be aware of certain symptoms while taking Augmentine to reduce the risk of complications. See “Symptoms to watch for” in section 4.

Blood and urine tests

If you are undergoing blood tests (such as studies of red blood cell status or liver function tests) or urine tests (to monitor 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.

Taking Augmentine with other medicines

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

If you are taking allopurinol (used for gout) with Augmentine, you may be more likely to develop a skin allergic reaction.

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

If anticoagulants (such as warfarin) are taken 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, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Talk to your doctor or pharmacist before using any medicine.

Driving and using machines

Augmentine may cause adverse effects, and symptoms may mean you should not drive.

Do not drive or operate machinery unless you feel well.

Augmentine contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; 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 in doubt, consult your doctor or pharmacist again.

Adults and children weighing 40kg or more

• Usual dose – 1 tablet taken twice daily.
• Higher dose – 1 tablet taken three times daily.

Children weighing less than 40kg

It is preferable to treat children aged 6 years or younger with Augmentine oral suspension or sachets.

Patients with kidney or liver problems

• If you have kidney problems, your dose may be adjusted. Your doctor may choose a different formulation or another medicine.
• If you have liver problems, you will have blood tests more frequently to monitor how your liver is functioning.

How to take Augmentine

• Take with meals.
• Swallow the tablets whole with a glass of water. The tablets can be broken along the score line to make them easier to swallow. Both halves of the tablet should be taken at the same time.
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within one hour.
• Do not take Augmentine for longer than 2 weeks. If you still feel unwell, consult your doctor.

If you take more Augmentine than you should

If you take too much Augmentine, symptoms such as stomach upset (nausea, vomiting, or diarrhoea) or seizures may occur. Contact your doctor as soon as possible. Take the container with you to show your doctor.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating 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 for the full duration of the prescribed treatment, even if you feel better. You need to complete the full course to cure the infection. If you do not, surviving bacteria may cause the infection to return.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The adverse 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 you experience any of these symptoms. Stop taking Augmentin.

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 recurrent 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 you have 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 Augmentin with food
• vomiting
• diarrhoea (in children)

Uncommon adverse effects

May affect up to 1 in 100 people

• skin rash, itching
• increased itchy rash (urticarial wheals )
• 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 develop into blisters resembling small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme )

• If you experience 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 (bullous exfoliative dermatitis )

• red rash with bumps under the skin and blisters (exanthematous pustulosis )

• 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 you have any of these symptoms.

• blistering rash arranged in circles with a central crust or resembling 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), which may cause the skin and whites of the eyes to turn yellow

• inflammation of the kidney ducts

• delayed blood clotting

• hyperactivity

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

• black, hairy-looking tongue

Adverse effects that may appear in blood or urine tests:

• marked decrease in the number of white blood cells
• low red blood cell count (haemolytic anaemia )
• crystals in the 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Augmentin Storage

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

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

Do not store above 25 °C.

Keep in the original packaging to protect from moisture.

Do not use if the tablets are cracked or damaged.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you are unsure how to dispose of unused medicines and packaging, please consult your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Augmentine

• The active substances are amoxicillin and clavulanic acid. Each tablet contains
  amoxicillin trihydrate equivalent to 875 mg of amoxicillin and potassium clavulanate equivalent to
  125 mg of clavulanic acid.

• The other components are: magnesium stearate, sodium carboxymethyl starch (Type A) (derived from potato starch), colloidal silica, microcrystalline cellulose. Coating: titanium dioxide (E171), hypromellose, macrogol (4000, 6000) and dimethicone.

Appearance of the product and contents of the pack

Capsule-shaped, white to off-white tablets, marked with “AC” and a score on one side.

Pack sizes of 2, 4, 10, 12, 14, 16, 20, 24, 30, 100 or 500 tablets.

Not all pack sizes may be marketed.

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

Austria – Augmentin
Belgium – Augmentin
Bulgaria – Augmentin
Cyprus – Augmentin
Czech Republic – Augmentin
Estonia – Augmentin
Germany – Augmentan
Greece – Augmentin
Hungary – Augmentin Duo
Ireland – Augmentin
Italy – Augmentin
Latvia – Augmentin
Lithuania – Augmentin
Luxembourg – Augmentin
Malta – Augmentin
Netherlands – Augmentin
Poland – Augmentin
Portugal – Augmentin Duo
Romania – Augmentin
Slovak Republic – Augmentin
Spain – Augmentine
United Kingdom – Augmentin

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

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