Package Insert: Information for the User

Amoxicilina/Ácido clavulánico SUN 875 mg/125 mg Film-Coated Tablets EFG

Read this package insert carefully before starting to take the medication.

- Keep this package insert, as you may need to read it again.

- If you have any doubts, consult your doctor or pharmacist.

- This medication has been prescribed to you (or your child) 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

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

3. How to takeAmoxicilina/Ácido clavulánico Sun

4. Possible adverse effects

5. Storage ofAmoxicilina/Ácido clavulánico Sun

6. Contents of the package and additional information

Amoxicilina/ácido clavulánicois an antibiotic that eliminates the bacteria that cause infections. It contains two different medications called amoxicilina and ácido clavulánico. Amoxicilina belongs to a group of medications known as “penicilinas” that sometimes may lose its effectiveness (become inactivated). The other component (ácido clavulánico) prevents this from happening.

Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or a cold.

It is essential to follow the instructions regarding the dose, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of the medication through the drain or in the trash.

Amoxicilina/ácido clavulánicois 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.

• If you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins, or any of the other components of this medication (see 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 neck

• If you have ever had liver problems or jaundice (yellow discoloration of the skin) when taking an antibiotic.

Do not take Amoxicilina/Ácido clavulánico Sun if you fall under any of the above points. Before starting treatment with amoxicillin/clavulanic acid, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Inform your doctor or pharmacist before taking this medication 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 amoxicillin/clavulanic acid.

In some cases, your doctor may investigate the type of bacteria causing your infection.

Depending on the results, your doctor may prescribe a different presentation of amoxicillin/clavulanic acid or another medication.

Symptoms to be aware of

Amoxicillin/clavulanic acid may worsen existing conditions or cause serious side effects. These include allergic reactions, seizures, and inflammation of the large intestine. Be aware of certain symptoms while taking amoxicillin/clavulanic acid 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 studies or liver function studies) or urine tests (to control glucose levels), inform your doctor or nurse that you are taking amoxicillin/clavulanic acid. This is because amoxicillin/clavulanic acid may alter the results of these types of tests.

Use of Amoxicilina/Ácido clavulánico Sun with other medications

Inform your doctor or pharmacist if you are taking/using, have taken/recently used, or may need to use any other medication.

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

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

If you are taking anticoagulants (such as warfarin) with amoxicillin/clavulanic acid, more blood tests will be needed.

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

Amoxicillin/clavulanic acid may affect how micophenolate mofetil (a medication used to prevent organ rejection in transplant patients) works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Amoxicillin/clavulanic acid may cause side effects, and symptoms may make you unable to drive. Do not drive or operate machinery unless you feel well.

Amoxicilina/Ácido clavulánico Sun contains sodium

This medication contains less than 1 mmol of sodium (23 mg) 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 twice a day

• Higher dose – 1 tablet 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 amoxicillin/clavulanic acid or the sachets.

Ask your doctor or pharmacist for advice when administering Amoxicillin/Clavulanic Acid Sun to children weighing less than 40 kg.

The tablets are not suitable for children weighing less than 25 kg.

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 working.

How to take Amoxicillin/Clavulanic Acid Sun

• Swallow the tablets whole with a glass of water with meals.

• The tablets can be split along the notch to make them easier to swallow. You should take both halves of the tablet at the same time.

• Space out your doses during the day, at least 4 hours apart. Do not take two doses in one hour.

• Do not take amoxicillin/clavulanic acid for more than 2 weeks. If you continue to feel unwell, consult your doctor.

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

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

You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

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, wait at least 4 hours before taking the next dose.

Do not take a double dose to make up for the missed dose.

If you stop taking Amoxicillin/Clavulanic Acid Sun

Continue taking amoxicillin/clavulanic acid until you complete the treatment, even if you feel better. You need to take the full treatment to cure the infection. If you do not, the surviving bacteria may cause the infection to return.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, amoxicillin/clavulanic acid can cause side effects, although not everyone will experience them.

The side effects listed below may occur with this medicine.

Be aware of these symptoms

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 mouth (angioedema), which can cause 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

Amoxicillin/Clavulanic Acid Sun.

Colitis

Colitis, 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 stomach area, this could be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES):

DIES has been mainly reported 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 medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

Contact your doctor as soon as possibleto advise you, if you have these symptoms.

Very common side effects

(may affect more than 1 in 10 patients)

???diarrhea (in adults).

Common side effects

(may affect up to 1 in 10 patients)

???mouth ulcers (candida– fungal infection in the vagina, mouth, or mucous membranes)

???nausea, especially when taking high doses

→if this happens, takeamoxicillin/clavulanic acidbefore meals

???vomiting

???diarrhea (in children).

Uncommon side effects

(may affect 1 in 100 patients)

???skin rash, itching

???increased pruritic rash (urticarial rash)

???indigestion

???dizziness

???headache.

Side effects that may appear in your blood tests:

Increase in some substances (enzymes) produced by the liver as indicators of liver damage.

Rare side effects

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

??skin rash, which may form blisters that look like small darts (central dark spot surrounded by a lighter area, with a dark ring around the edge –erythema multiforme)

if you have any of these symptoms, consult a doctor urgently

Side effects that may appear in your blood tests:

??low count of cells involved in blood clotting

??low count of white blood cells

Unknown frequency (frequency cannot be estimated from available data.)

???Allergic reactions (see above)

???Colitis (see above)

????inflammation of the protective membrane surrounding the brain(aseptic meningitis)

???severe skin reactions:

?generalized rashwith blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and in its most severe form, causing widespread skin peeling (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 white blood cells (eosinophilia) and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).

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) that can turn the skin and white of the eyes yellow

???inflammation of the bile ducts

???delayed blood clotting

???hyperactivity

???seizures (in patients taking high doses ofamoxicillin/clavulanic acidor those with kidney problems)

???black tongue that looks hairy

???stained teeth (in children),which usually disappears with brushing.

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

???significantly reduced number of white blood cells

???low count of red blood cells (hemolytic anemia)

??crystals in the urine.

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 Vigilance of Medicines for Human Use:https://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 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 light.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Amoxicillin/Clavulanic Acid Sun

The active ingredients are amoxicillin and clavulanic acid. A film-coated tablet contains 1.004,3 mg of amoxicillin trihydrate equivalent to 875 mg of amoxicillin and 148.9 mg of potassium clavulanate equivalent to 125 mg of clavulanic acid.

The other components (excipients) are: microcrystalline cellulose, potato starch glycolate sodium, anhydrous colloidal silica, povidone, eudragit 100, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400, and talc.

Appearance of the product and contents of the package

Amoxicillin/Clavulanic Acid Sunare capsule-shaped tablets, white to off-white in color, with "RX509" engraved on one face and a notch on the other face.

Packages of 8, 10, 12, 14, 16, 20, 21, 24, 28, 30, 60, and 100 tablets in packages ofPVC/PVdC/Alu inside a (Poliester/aluminum/polyester/Polyethylene) overwrap, which contains a desiccant bag.

Do not ingest the desiccant bag contained in the inner bag.

Not all package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder:

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Responsible manufacturer:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87,

2132 JH, Hoofddorp

Netherlands

or

Alkaloida Chemical Company Zrt.

Kabay János u.29., Tiszavasvári, 4440

Hungaryor

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 medicine is authorized in the member states of the European Economic Area with 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

Last review date of this leaflet: May 2023

Medical advice/education

Antibiotics are used to treat 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 properly 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 emergence of resistant bacteria that may make the antibiotic ineffective.

1. It is very important to take the antibiotic at the correct dose, at the indicated hours, and for the correct number of days. Read the label instructions and if you do not understand something, 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 it has been prescribed.

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 medications to your pharmacy to ensure that the disposal requirements are met.

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines: http://www.aemps.gob.es