AUGMENTINE 875 mg/125 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Augmentine 875mg/125mg film-coated tablets

amoxicillin/clavulanic acid

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Augmentine and what is it used for
2. What you need to know before you take Augmentine
3. How to take Augmentine
4. Possible side effects
5. Storage of Augmentine
6. Contents of the pack and other information

1. What is Augmentine and what is it used for

Augmentine is an antibiotic that eliminates the bacteria that cause infections. It contains two different drugs called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins" that can sometimes lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

Augmentine 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 you take Augmentine

Do not take Augmentine:

• if you are allergic to amoxicillin, clavulanic acid, 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 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 studies) 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

Tell 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 the way 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.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Augmentine may have side effects, and the symptoms can make you unfit to drive.

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

Augmentine contains sodium

This medicine contains less than 23 mg of sodium (1mmol) 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 40kg

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

Children under 40kg in weight

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

Patients with kidney and liver problems

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

How to take Augmentine

• Take with food.
• Swallow the tablets whole with a glass of water. The tablets can be broken along the score line to make them easier to swallow. You should take both halves of the tablet at the same time.
• Space the doses out 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.

You can also contact the Toxicology Information Service on +34 91 562 04 20, quoting the medicine and the amount taken.

If you forget to take Augmentine

If you miss 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

Keep taking Augmentine until you finish the treatment, even if you feel better. You need to complete the full treatment to cure the infection. If you do not, the bacteria that survive may cause you to become ill 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. The side effects listed below can occur with this medicine.

Symptoms to be aware of

Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis) which 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 takingAugmentine.

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 as soon as possible for advice if you have 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 (hives)
• indigestion
• dizziness
• headache.

Uncommon side effects that may appear in your 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).

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

Rare side effects that may appear in your 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)
• 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 psoriasis)
• flu-like symptoms with a 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 usually observed on both sides of the buttocks, on the upper inner thighs, in the armpits, or 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)
• inflammation of the liver (hepatitis)
• jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver) that can make the skin and whites of the eyes turn yellow
• inflammation of the kidney tubes
• 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 your blood or urine tests:

• significant decrease 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 via 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. Storage of Augmentine

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

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

Do not store above 25°C.

Store in the original package 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 pack and any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of the pack and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition ofAugmentine

• The active ingredients 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 ingredients are: magnesium stearate, sodium carboxymethylcellulose (Type A) (derived from potato starch), colloidal silicon dioxide, microcrystalline cellulose. Coating: titanium dioxide (E171), hypromellose, macrogol (4000, 6000), and dimethicone.

Appearance of the product and pack contents

Tablets are capsule-shaped, white to off-white in color, and marked with "AC" and a score line on one side.

Packs 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 medicine 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 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