Leaflet: information for the user

Augmentine 875mg/125mg 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you (or your child) only, and should not be given 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.

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

Augmentine is used in children and adults 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 (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) 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.

Your doctor may investigate the type of bacteria causing your infection. Depending on the results, your doctor may prescribe a different presentation of Augmentine or another medication.

Be aware of the following symptoms

Augmentine may worsen 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“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 taking Augmentine. This is because Augmentine may alter the results of these types of tests.

Use of Augmentine with other medications

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 experience 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 required.

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

Augmentine may affect how micophenolate 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.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Do not drive or operate machinery unless you feel well.

Augmentine contains sodium

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

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

Adults and children 40 kg or more

•Usual dose – 1 tablet administered twice a day.

•Higher dose – 1 tablet administered 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.

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. The tablets can be broken through the notch to make it easier to swallow. You should take both halves of the tablet at the same time.

•Space the doses throughout the day, at least 4 hours apart. Do not take 2 doses in one 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 seizures. Consult your doctor as soon as possible. Bring the packaging with you to show the doctor.

You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication 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 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 have 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. The side effects listed below may occur with this medicine.

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
• collapseor
• 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 as soon as possible for advice, if you experience 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
• • if this happens, take Augmentine with meals
• vomiting
• diarrhea (in children)

Uncommon side effects

May affect 1 in 100 people

• skin rash, itching
• increased pruritic rash (urticarial)
• 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 10,000 people

• skin rash, which may form blisters that appear as small dianas (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 a doctor urgently.

Rare 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 with pus (exfoliative bullous dermatitis)
• red rash, with lumps under the skin and blisters (pustular exanthema)
• 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, in the neck (symmetrical flexural and intertriginous drug-related exanthema (SDRIFE)).

• Contact a doctor immediately if you experience any of these symptoms.
• rash with blisters arranged in a circle with a central crust or as a pearl necklace (IgA linear disease)
• inflammation of the liver (hepatitis)
• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver) that can 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 trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofAugmentine

• The active principles 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 carboxymethylcellulose (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 package

Tablets in capsule shape, white to off-white in color, bearing the imprint “AC” and a notch on one side.

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

Not all package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Responsible for manufacturing:

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:

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

Slovakia – Augmentin

Spain – Augmentine

United Kingdom – Augmentin

Last review date of this leaflet:May 2024.

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