Amoxicillin/clavulanic acid Sun 875 mg/125 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amoxicillin/Clavulanic acid SUN 875 mg/125 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• 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) and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Amoxicillin/Clavulanic acid SUN is and what it is used for
2. What you need to know before taking Amoxicillin/Clavulanic acid SUN
3. How to take Amoxicillin/Clavulanic acid SUN
4. Possible side effects
5. How to store Amoxicillin/Clavulanic acid SUN
6. Contents of the pack and other information

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

Amoxicilina/ácido clavulánico is an antibiotic that kills bacteria causing infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as “penicillins” which can sometimes become ineffective (inactivated). The other 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 that you follow your doctor's instructions regarding dosage, dosing intervals, and duration of treatment.

Do not keep or reuse this medicine. If you have leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via the sink or with household waste.

Amoxicilina/ácido clavulánico 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 taking Amoxicillin/Clavulanic Acid Sun Do not take Amoxicillin/Clavulanic Acid Sun:

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins, or any of the other ingredients of this medicine (see 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 neck
• 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 apply to you. Before starting treatment with amoxicillin/clavulanic acid, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Tell your doctor or pharmacist before taking Amoxicillin/Clavulanic Acid Sun 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 Amoxicillin/Clavulanic Acid Sun.

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 amoxicillin/clavulanic acid or another medicine.

Symptoms to watch for

Amoxicillin/Clavulanic Acid Sun 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 amoxicillin/clavulanic acid to reduce the risk of complications. See “Symptoms to watch for” in section 4.

Blood and urine tests

If you are having 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 Amoxicillin/Clavulanic Acid Sun. This is because amoxicillin/clavulanic acid may alter the results of these types of tests.

Using Amoxicillin/Clavulanic Acid Sun with other medicines

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

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

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

If anticoagulants (such as warfarin) are taken with Amoxicillin/Clavulanic Acid Sun, more blood tests will be needed.

Methotrexate (a medicine used to treat cancer and severe psoriasis): penicillins can reduce methotrexate excretion and potentially increase adverse effects.

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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Amoxicillin/Clavulanic Acid Sun may cause adverse effects, and symptoms may make it unsafe 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; that is, essentially "sodium-free".

3. How to take Amoxicillin/Clavulanic Acid SUN

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

Adults and children weighing 40 kg or more

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

Children weighing less than 40 kg

It is preferable to treat children aged 6 years or younger with amoxicillin/clavulanic acid oral suspension or sachets.

Seek advice from your doctor or pharmacist before administering Amoxicillin/Clavulanic Acid SUN to children weighing less than 40 kg. Tablets are not suitable for children weighing less than 25 kg.

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 liver function.

How to take Amoxicillin/Clavulanic Acid SUN

• Swallow the tablets whole with a glass of water, taken with meals.
• The tablets can be divided along the score line to make swallowing easier. You must take both halves of the tablet at the same time.
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take two doses within one hour.
• Do not take amoxicillin/clavulanic acid for longer than 2 weeks. If you still feel unwell, consult your doctor.

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

If you take too much amoxicillin/clavulanic acid, symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures may occur. Contact your doctor as soon as possible. Take the packaging with you to show your doctor.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Amoxicillin/Clavulanic Acid SUN

If you forget 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 a missed dose.

If you stop taking Amoxicillin/Clavulanic Acid SUN

Continue taking amoxicillin/clavulanic acid for the full duration of 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, amoxicillin/clavulanic acid may cause adverse effects, although not everyone experiences them.

The side effects listed below may occur with this medicine.

Side effects you should be aware of

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 mouth (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

Amoxicillin/Clavulanic Acid 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 mainly been reported 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 as soon as possible for advice if you have these symptoms.

Very common adverse effects

(may affect more than 1 in 10 patients)

???diarrhea (in adults)

Common adverse effects

(may affect up to 1 in 10 patients)

???thrush (Candida – fungal infection in the vagina, mouth or mucous membranes)
???nausea, especially when taking high doses

→ if this happens, take Amoxicillin/Clavulanic Acid Sun before meals
???vomiting
???diarrhea (in children)

Uncommon adverse effects

(may affect up to 1 in 100 patients)

???skin rash, itching
???worsening of itchy rash (urticarial wheals)
???indigestion
???dizziness
???headache

Uncommon adverse effects that may appear in your blood tests:

Increase in certain substances (enzymes) produced by the liver, indicating liver damage.

Rare adverse effects

(may affect up to 1 in 1,000 patients)

??skin rash, which may blister and resemble 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 a doctor urgently

Rare adverse 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 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 peeling of the skin (more than 30% of body surface – toxic epidermal necrolysis)
? widespread rash with small pus-filled blisters (exfoliative bullous dermatitis)
? red rash with bumps under the skin and blisters (pustular exanthema)
? 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 appearing on both buttocks, inner thighs, armpits and neck (symmetrical intertriginous and flexural exanthema induced by drugs [SDRIFE])
? blistering rash arranged in circles with central crusts or resembling a string of pearls (linear IgA disease)

Contact a doctor immediately if you have any of these side effects.

???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 Amoxicillin/Clavulanic Acid Sun or who have kidney problems)
???black, hairy-looking tongue
???tooth discoloration (in children), which usually resolves with brushing

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

???significant decrease in white blood cell count
???low red blood cell count (hemolytic anemia)
??crystals in the urine

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: 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

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date 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 light.

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

6. Contents of the pack and other information

Composition of Amoxicillin/Clavulanic Acid Sun

The active substances are amoxicillin and clavulanic acid. One film-coated tablet contains 875 mg of amoxicillin trihydrate and 125 mg of clavulanic acid.

The other components (excipients) are:

Tablet core:

Microcrystalline cellulose, sodium starch glycolate from potato, colloidal anhydrous silica, povidone, Eudragit E100, magnesium stearate.

Film coating:

Hypromellose, titanium dioxide (E171), macrogol 400, talc.

Appearance of the product and contents of the pack

Amoxicillin/Clavulanic Acid Sun are capsule-shaped, white to off-white film-coated tablets, marked “RX509” on one side and with a score line on the other side.

The score line is intended only for ease of swallowing and breaking the tablet, but not for dividing it into equal doses.

Amoxicillin/Clavulanic Acid Sun is available in packs of 8, 10, 12, 14, 16, 20, 21, 24, 28, 30, 60 and 100 film-coated tablets. The blisters are packed in a bag which also contains a desiccant.

Do not ingest the desiccant!

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.,
Polarisavenue 87
2132 JH 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. 29, Tiszavasvári, 4440
Hungary

Terapia SA
Str. Fabricii nr. 124,
Cluj Napoca,
400 632, Romania

or

Ecopharm EOOD
29 Atanas Dukov Str., fl. 3,
1407 Sofia, Bulgaria

Local representative

Sun Pharma Laboratorios, S.L.
Rambla de Catalunya, 53-55
08007 Barcelona, Spain
Tel.: +34 342 78 90

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

DE – AMOXICLAV BASICS 875 mg/125 mg Filmtabletten
BG - ?????????? 875 mg/125 mg ????????? ????????
ES – Amoxicillin/Clavulanic Acid SUN 875 mg/125 mg film-coated tablets EFG
IT – Amoxicillin and Clavulanic Acid SUN 875 mg + 125 mg film-coated tablets
PL – Ramoclav
RO – Enhancin 875mg/125mg film-coated tablets

Date of the most recent review of this leaflet: January 2026

Medical advice/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.

When your doctor prescribes an antibiotic, it is intended solely for your current illness. Following the advice below will help you prevent the development of resistant bacteria, which could make antibiotics ineffective.

1. It is very important to take the antibiotic at the correct dose, at the prescribed times, and for the full duration of treatment. Read the instructions on the packaging carefully, and if you do not understand something, ask your doctor or pharmacist.
2. You should not take an antibiotic unless it has been specifically prescribed for you, and you should use it only for the infection for which it was prescribed.
3. Do not take antibiotics prescribed for other people, even if they have the same or a similar infection to yours.
4. Do not give your antibiotics 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.

Detailed information on this medicinal product is available on the website of the Spanish Medicines Agency: http://www.aemps.gob.es