Amoxicillin/clavulanic acid Sun 500 mg/125 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Amoxicillin/Clavulanic Acid SUN 500 mg/125 mg Film-coated Tablets EFG

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you (or your child) only, and you should not give it to other people, even if they have the same symptoms as you, because it could 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.

Contents of the leaflet:

1. What Amoxicillin/Clavulanic Acid Sun is and what it is used for

2. What you need to know before starting to take Amoxicillin/Clavulanic Acid Sun

1. How to take Amoxicillin/Clavulanic Acid Sun

4. Possible adverse effects

1. Storage of Amoxicillin/Clavulanic acid Sun

2. Contents of the pack and additional information

1. What Amoxicilina/ácido clavulánico Sun is and what it is used for

Amoxicilina/ácido clavulánico Sun is an antibiotic that works by destroying the bacteria causing infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins," which sometimes become ineffective (inactive). The other active component (clavulanic acid) prevents this from happening.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important to follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not keep or reuse this medicine. If you have any leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of down the sink or in household waste.

Amoxicillin/clavulanic acid Sun film-coated tablets are used in adults and children 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 Amoxicillin/Clavulanic Acid Sun

Do not take Amoxicillin/Clavulanic Acid Sun: If you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin, or any of the other ingredients of Amoxicillin/Clavulanic Acid Sun (listed in section 6).

• If you have ever had an allergic reaction (hypersensitivity) 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) while taking an antibiotic.

Do not take Amoxicillin/Clavulanic Acid Sun if any of the above circumstances apply to you. If you are unsure, consult your doctor or pharmacist before taking Amoxicillin/Clavulanic Acid Sun.

Warnings and precautions

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

• You have swollen lymph nodes.
• You are being treated for liver or kidney problems.
• You are not urinating normally.

If you are unsure whether any of the above apply to you, speak with your doctor or pharmacist before taking Amoxicillin/Clavulanic Acid Sun.

In some cases, your doctor may investigate the type of bacteria causing your infection. Depending on the results, you might receive a different strength of amoxicillin/clavulanic acid tablets or a different medicine.

Conditions requiring special attention

Amoxicillin/Clavulanic Acid Sun may worsen existing conditions or cause serious adverse effects. These include allergic reactions, seizures (fits), and inflammation of the large intestine. You should monitor for certain symptoms while taking Amoxicillin/Clavulanic Acid Sun to reduce the risk of any problems. “Side effects to be aware of” See Section 4.

Blood and urine tests

If you are having blood tests (such as tests to check red blood cell status or liver function tests) or urine tests (to measure glucose), inform your doctor or nurse that you are taking Amoxicillin/Clavulanic Acid Sun, as Amoxicillin/Clavulanic Acid Sun may affect the results of these types of tests.

Use of Amoxicillin/Clavulanic Acid Sun with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines available without a prescription.

If you are taking allopurinol (used for gout) with Amoxicillin/Clavulanic Acid Sun, you may be more likely to develop an allergic skin reaction.

If you are taking probenecid (used to treat gout), your doctor may decide to adjust the dose of Amoxicillin/Clavulanic Acid.

If medicines used to prevent blood clots (such as warfarin) are taken with Amoxicillin/Clavulanic Acid Sun, additional blood tests may be required.

Amoxicillin/Clavulanic Acid Sun may affect the effectiveness of methotrexate (a medicine used to treat cancer or rheumatic diseases).

Amoxicillin/Clavulanic Acid may affect how mycophenolate mofetil (a medicine used to prevent organ rejection in transplant patients) works.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before taking any medicine.

Driving and use of machines

Amoxicillin/clavulanic acid Sun may have adverse effects and symptoms that could impair your ability to drive. Do not drive or operate machinery unless you feel well.

Amoxicillin/clavulanic acid Sun contains sodium

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

3. How to take Amoxicillin/Clavulanic acid SUN film-coated tablets

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults and children weighing 40 kg or more

The recommended dose is

• 1 tablet three times a day

Children weighing less than 40 kg

Children aged 6 years or younger should preferably be treated with amoxicillin/clavulanic acid oral suspension or sachets.

Consult your doctor or pharmacist before administering amoxicillin/clavulanic acid tablets to children weighing less than 40 kg. The tablets are not suitable for children weighing less than 25 kg.

Patients with renal or hepatic impairment

• If you have kidney problems, your dose may need to be adjusted. Your doctor may choose a different strength or a different medicine.
• If you have liver problems, you may have blood tests more frequently to monitor how well your liver is working.

How to take Amoxicillin/Clavulanic acid SUN

• Swallow the film-coated tablets whole with a glass of water and with food.
• Space your doses evenly throughout the day, with a minimum interval of 4 hours. Do not take 2 doses within 1 hour.
• Do not take amoxicillin/clavulanic acid for longer than two weeks. If you still feel unwell, you should see your doctor again.

If you take more Amoxicillin/Clavulanic acid SUN than you should

If you take too much amoxicillin/clavulanic acid, you may experience stomach problems (nausea, vomiting, or diarrhea) or have seizures. Speak to your doctor as soon as possible. Take the medicine pack with you to show your doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Amoxicillin/Clavulanic acid SUN

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

If you stop treatment with Amoxicillin/Clavulanic acid SUN

Keep taking amoxicillin/clavulanic acid until the course is finished, even if you feel better. You need all the doses to fight the infection. If some bacteria survive, they 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 experiences them. The following side effects may occur with this medicine.

Side effects you should be aware of

Allergic reactions:

• Inflammation of blood vessels (vasculitis), which may appear as raised red or purple spots on the skin, but may affect other parts of the body.
• Fever, joint pain, swelling of the lymph nodes in the neck, armpit, 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 Amoxicilina/ácido clavulánico SUN.

Inflammation of the large intestine

Inflammation of the large intestine, causing watery diarrhea, usually with blood and mucus, stomach pain and/or fever.

Drug-induced enterocolitis syndrome (DIES):

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

Acute inflammation of the pancreas (acute pancreatitis). If you have severe and persistent abdominal pain, this could be a sign of acute pancreatitis.

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

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

• Diarrhea (in adults).

Common (may affect up to 1 in 10 people)

• Candidiasis (yeast infection of the vagina, mouth, or skin folds).
• Feeling sick (nausea), especially when taking high doses.

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

• Vomiting.
• Diarrhea (in children).

Uncommon (may affect up to 1 in 100 people)

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

Uncommon adverse effects that may appear in your blood tests:

• Increase in certain substances (enzymes) produced by the liver.

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

• Skin rash, which may form 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 side effects, consult your doctor urgently.

Rare adverse effects that may appear in your blood tests:

• Low number of cells involved in blood clotting.
• Low number of white blood cells.

Frequency unknown (frequency cannot be estimated from available data)

• Allergic reactions (see above)
• Inflammation of the large intestine (see above)
• Inflammation of the protective membrane surrounding the brain (aseptic meningitis)
• Serious 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 detachment (more than 30% of body surface area – toxic epidermal necrolysis)
  • Widespread rash with small pus-filled blisters (exfoliative bullous 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))
  • Rash with blistering arranged in a circular pattern with a central crust or resembling a "pearl necklace" (linear IgA disease)

Contact a doctor immediately if you have any of these symptoms.

• 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 tubules
• Delayed blood clotting
• Hyperactivity
• Seizures (in patients taking high doses of Augmentin or who have kidney problems)
• Black hairy tongue
• Overgrowth of non-susceptible organisms

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

• Severe reduction in the number of white blood cells.
• Low number of red blood cells (hemolytic anemia).
• Crystals in the urine causing acute kidney injury.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicillin/Clavulanic Acid SUN coated tablets

Keep out of sight and reach of children.

Do not use this medicine after the expiry date shown on the packaging. The expiry date refers to the last day of the month.

Store in the original packaging to protect from light.

Do not store above 25 °C.

The tablets should be used within 30 days after opening the pouch.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Amoxicillin/clavulanic acid SUN

The active substances are amoxicillin and clavulanic acid.

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

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

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

Presentation of the product and contents of the pack

Amoxicillin/clavulanic acid Sun is available in blisters containing packs of 10, 12, 14, 15, 16, 20, 21, 24, 30, 40 or 50 film-coated tablets in PVC/PVdC/Alu blisters in a pouch (polyester film/aluminium foil/polyester film/polyethylene) with a sachet containing 1 g of desiccant.

The blister is packaged in a pouch (polyester film/aluminium foil/polyester film/polyethylene) which also contains a desiccant.

Do not ingest the desiccant sachet contained inside the pouch.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.,
Polarisavenue 87,
2132JH Hoofddorp,
The Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Or

Alkaloida Chemical Company Zrt
Kabay János u. 294440
Tiszavasvári
Hungary

Local representative

Sun Pharma Laboratorios, S.L.
Rambla de Catalunya 53-55
08007 Barcelona, Spain
Tel.: +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) under the following names:

UK (Northern Ireland): Co-amoxiclav 500/125mg Tablets
DE: AMOXICLAV BASICS 500 mg/125 mg Filmtabletten
ES: Amoxicilina/Ácido clavulánico SUN 500/125 mg comprimidos recubiertos con película EFG

Date of the most recent review of this leaflet: December 2025

Detailed and up-to-date 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 to treat bacterial infections. They are not effective against viral infections.

Sometimes 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 intended solely for the treatment of your current illness.

Following the advice below will help you prevent the development of resistant bacteria, which could render antibiotics ineffective.

1. It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the full prescribed duration. Ask your doctor or pharmacist if you are unsure.
2. You should not take an antibiotic unless it has been specifically prescribed for you, and you should use it only for the infection it was prescribed for.
3. You should not take antibiotics prescribed for other people, even if they have the same or a similar infection to yours.
4. You should not give antibiotics prescribed for you to other people.
5. If you have any antibiotic left after completing your treatment, return all unused medicines to your pharmacy to ensure proper disposal in accordance with applicable regulations.