Patient Information Leaflet

Amoxicilina/ácido clavulánico SUN 500 mg/125 mg Film-Coated Tablets EFG

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you (or your child) only. Do not give it to others even if they have similar symptoms, 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.

Contentsof the leaflet:

1.What isAmoxicilina/ácido clavulánico Sunand what is it used for

2.What you need to know before starting to takeAmoxicilina/ácido clavulánico Sun

1. How to takeAmoxicilina/ácido clavulánico Sun

4.Possible side effects

1. Storage ofAmoxicilina/ácido clavulánico Sun

6. Contents of the pack and additional information

Amoxicilina/ácido clavulánico Sun is an antibiotic and works by destroying the bacteria that cause infections. It contains two different medicines called amoxicilina and ácido clavulánico. Amoxicilina belongs to a group of medicines called "penicilinas" that sometimes cannot act (become inactive). The other active component (ácido clavulánico) prevents this from happening.

Amoxicilina/ácido clavulánico Sun film-coated tabletsare 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 takeAmoxicilina/ácido clavulánico Sun:If you are allergic (hypersensitive) to amoxicilina, to acid clavulánico, to penicilina or any of the other components ofAmoxicilina/ácido clavulánico Sun(listed in section 6).

• If you have ever had an allergic (hypersensitive) reaction to any other antibiotic. This may 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 takeAmoxicilina/ácido clavulánico Sunif any of the above circumstances apply to you. If you are unsure, consult your doctor or pharmacist before takingAmoxicilina/ácido clavulánico Sun.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine if:

• You have glandular fever.
• You are being treated for liver or kidney problems.
• You are not urinating normally.

If you are unsure whether any of the above may apply to you, speak with your doctor or pharmacist before takingAmoxicilina/ácido clavulánico Sun.

In some cases, your doctor may investigate the type of bacteria causing your infection. Depending on the results, you may receive a different concentration of amoxicilina/clavulánic acid tablets or a different medicine.

Conditions that require special attention

Amoxicilina/ácido clavulánico Sunmay make some existing conditions worse or cause serious side effects. These include allergic reactions, convulsions (fits) and inflammation of the large intestine. You should watch for certain symptoms while takingAmoxicilina/ácido clavulánico Sunto reduce the risk of any problems. SeeSection 4.

Blood and urine tests

If you are having blood tests (such as tests to see the state of your red blood cells or liver function tests) or urine tests (to determine your glucose levels), inform your doctor or nurse that you are takingAmoxicilina/ácido clavulánico Sunas it may affect the results of these types of tests.

Use ofAmoxicilina/ácido clavulánico Sunwith other medicines

Inform your doctor or pharmacist if you are taking/using or have taken recently or may have to use any other medicine. This includes medicines that can be bought without a prescription.

If you are taking allopurinol (used for gout) with Amoxicilina/ácido clavulánico Sun, you may be more likely to have an allergic skin reaction.

Probenecid (used to treat gout), concomitant use of probenecid may reduce the excretion of amoxicilina and is not recommended.

If you are taking medicines to prevent blood clotting (such as warfarin) with amoxicilina/clavulánic acid, additional blood tests may be necessary.

Methotrexate (a medicine used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate and cause a potential increase in side effects.

Amoxicilina/clavulánic acid may affect the way mycophenolate mofetil (a medicine used to prevent organ rejection in transplant patients) works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Consult your doctor or pharmacist before taking any medicine.

Driving and operating machinery

Amoxicilina/ácido clavulánico Sunmay cause side effects and symptoms that may make you unfit to drive. Do not drive or operate machinery unless you feel well.

Amoxicilina/ácido clavulánico Sun contains sodium

This medicine contains less than 1 mmol ofsodium (23 mg) pertablet; this 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 who weigh40 kg or more

The recommended dose is

• 1 tablet three times a day

Children who weigh less than40 kg

Children 6 years old or less should preferably be treated with amoxicillin/clavulanate oral suspension or capsules.

Consult your doctor or pharmacist before administeringamoxicillin/clavulanatetablets to children who weigh less than40 kg. Tablets are not suitable for children weighing less than 25 kg.

Patients with renal and hepatic problems

• If you have kidney problems, the dose may be adjusted. Your doctor may choose a different concentration or medication.
• If you have liver problems, you may need to have blood tests more frequently to check how your liver is functioning.

How to take Amoxicilina/ácido clavulánico Sun

• Swallow the tablets whole with a glass of water with food.
• Take the doses evenly spaced throughout the day, with a minimum interval of 4hours. Do not take 2 doses in 1 hour.
• Do not take amoxicilina/ácido clavulánico for more than two weeks. If you continue to feel unwell, you must see your doctor again.

If you take more Amoxicilina/ácido clavulánico Sun than you should

If you take too muchamoxicilina/ácido clavulánico, you may experience stomach problems (nausea, vomiting, or diarrhea) or seizures. Talk to your doctor as soon as possible. Bring the medication box to show it to your 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 Amoxicilina/ácido clavulánico Sun

If you forgot to take a dose,take it as soon as you remember. Do not take the next dose too soon, but wait 4 hours before taking it. Do not take a double dose to make up for the missed dose.

If you interrupt the treatment with Amoxicilina/ácido clavulánico Sun

Continue takingamoxicilina/ácido clavulánicountil you finish the treatment, even if you feel better. You need all the doses to fight the infection. If some bacteria survive, they may make the infection come back.

If you have any other questions 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 following side effects may occur with this medicine.

Be aware of the following symptoms

• Angioedema, which is swelling, sometimes of the face or throat, that causes difficulty breathing
• Angioedema can cause swelling, sometimes of the face or throat, that causes difficulty breathing
• Angioedema can cause swelling, sometimes of the face or throat, that causes difficulty breathing
• Angioedema can cause swelling, sometimes of the face or throat, that 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)

Contact your doctor immediately if you experience any of these symptoms.Stop taking Amoxicilina/ácido clavulánico SUN.

Intestinal inflammation

Intestinal inflammation, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

Acute pancreatitis

If you have intense and persistent pain in the abdominal area, this could be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES):

DIES has been reported mainly in children taking amoxicillin. It is a certain type of allergic reaction with the main symptom of repeated vomiting (1-4 hours after taking the medication). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

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

Moderately common (may affect more than 1 in 10 people)

• Diarhea (in adults).

Common (may affect up to 1 in 10 people)

• Candidiasis (vaginal, oral, or skin infections caused by fungi).
• Nausea, especially when taking high doses.

→ If affected, take amoxicilina/ácido clavulánico SUNcoated tablets with meals.

• Vomiting.
• Diarhea (in children)

Rare (may affect up to 1 in 100 people)

• Skin rash, itching.
• Raised skin rash withitching (hives).
• Indigestion.
• Dizziness.
• Headache.

Side effects that may appear in your blood tests:

• Elevation of certain substances (enzymes) produced by the liver.

Rare (may affect up to 1 in 1,000 people)

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

Side effects that may appear in your blood tests:

• Low levels of cells that participate in blood clotting.
• Low levels of white blood cells.

Unknown frequency (frequency cannot be estimated from available data)

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

• inflammation of the liver (hepatitis)
• ictericia, caused by an increase in bilirubin in the blood (a substance produced by the liver) that can turn the skin and the white of the eyes yellow
• inflammation of the kidney tubules.
• retardation of blood clotting
• hyperactivity.
• convulsions (in patients taking high doses of Augmentine or with renal problems)
• black tongue with a hairy appearance.
• overgrowth of non-susceptible organisms

Side effects that may appear in your blood or urine tests:

• Intense reduction in the number of white blood cells.
• Low levels of red blood cells (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, pharmacist, or nurse, 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: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging. The expiration date refers to the last day of the month.

Store in the original packaging to protect it from light.

Do not store at a temperature above25°C.

The tablets must be used within 30 days after opening the bag.

If your doctor tells you to stop taking the coated tablets, return them to the pharmacist.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you do not need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you do not need. In this way, you will help protect the environment.

Composition of Amoxicilina/acid clavulanic SUN

The active principles are amoxicilina and acid clavulanic.

Each film-coated tablet contains 500 mg of amoxicilina (as amoxicilina trihydrate) and 125 mg of acid clavulanic (as clavulanate potassium).

The other components are microcrystalline cellulose, sodium carboxymethyl starch, anhydrous colloidal silica, povidone, Eudragit E100, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400, talc.

Amoxicilina / acid clavulanic SUN 500 mg/125 mg film-coated tablets are white to off-white, oval, marked with RX713 on one side and flat on the other side.

Appearance of the product and contents of the pack

Packs with 10, 12, 14, 15, 16, 20, 21, 24, 30, 40 or 50 film-coated tablets in PVC/PVdC/Alu blisters in a bag (polyester film/aluminium foil/polyethylene film) with a sachet containing 1 g of desiccant.

Do not ingest the desiccant sachet contained in the bag.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sun Pharmaceutical Industries Europe B.V,

Polarisavenue 87,

2132JH Hoofddorp,

Netherlands

Responsible for manufacturing

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Or

Alkaloida Chemical Company Zrt

Kabay János u.294440

Tiszavasv

Hungary

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona.

Spain

Phone: +34 93 342 78 90

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names

UK (Northern Ireland)Co-amoxiclav 500/125mg Tablets

DEAMOXICLAV BASICS 500 mg/125 mg Filmtabletten

ESAmoxicilina/Acido clavulánico SUN 500/125 mg film-coated tablets EFG

Date of the last revision of this leaflet:April 2023

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

Advice/medical education

Antibiotics are used for the treatment of bacterial infections. They are not effective against viral infections.

Occasionally, a bacterial infection does not respond to antibiotic treatment. One of the most common reasons for this is that the bacteria causing the infection are resistant to the antibiotic being taken. This means that the bacteria can survive or grow despite the antibiotic.

Bacteria can become resistant to antibiotics for many reasons. Using antibiotics appropriately can reduce the likelihood of bacteria becoming resistant to them.

When your doctor prescribes an antibiotic, it is only for the course of your illness.

Paying attention to the following advice will help prevent the appearance of resistant bacteria that may make the antibiotic ineffective.

1. It is very important to take the antibiotic in the correct dose, at the indicated hours, and for the correct number of days. Read the label instructions and if you do not understand anything, ask your doctor or pharmacist.

2. Do not take an antibiotic unless you have been prescribed it specifically for you and use it only for the infection for which you have been prescribed it.

3. Do not take antibiotics that have been prescribed for other people, even if they have the same or a similar infection to yours.

4. Do not give antibiotics that have been prescribed for you to other people.

5. If you still have antibiotics left over after completing treatment, hand over all unused medicines to your pharmacy to ensure that the disposal requirements are met