AMOXICILLIN/CLAVULANIC ACID SUN 875 mg/125 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Amoxicillin/Clavulanic Acid SUN 875 mg/125 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you (or your child) only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What Amoxicillin/Clavulanic Acid Sun is and what it is used for
2. What you need to know before you take Amoxicillin/Clavulanic Acid Sun
3. How to take Amoxicillin/Clavulanic Acid Sun
4. Possible side effects

5 Storage of Amoxicillin/Clavulanic Acid Sun

1. Contents of the pack and further information

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

Amoxicillin/clavulanic acid is an antibiotic that eliminates the bacteria that cause infections. It contains two different drugs called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins" which can sometimes lose their effectiveness (become 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 the flu or the common cold.

It is essential to follow the dosage instructions, administration intervals, and treatment duration indicated by your doctor.

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

Amoxicillin/clavulanic acid 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 you take Amoxicillin/Clavulanic Acid Sun Do not take Amoxicillin/Clavulanic Acid Sun:

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, to penicillins, or to 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) when taking an antibiotic.

Do not take Amoxicillin/Clavulanic Acid Sun if you are included in any of the above points. If you are not sure, consult your doctor or pharmacist before starting treatment with amoxicillin/clavulanic acid.

Warnings and precautions

Tell your doctor or pharmacist before taking this medicine if:

• you have infectious mononucleosis
• you are receiving treatment for liver or kidney problems
• you do not urinate regularly.

If you are not sure if 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, you may be prescribed a different formulation of amoxicillin/clavulanic acid or another medication.

Symptoms to be aware of

Amoxicillin/clavulanic acid can worsen certain existing conditions or cause serious side effects. These include allergic reactions, convulsions, and inflammation of the large intestine. You should 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 status or liver function studies) or urine tests (to check glucose levels), inform your doctor or nurse that you are taking amoxicillin/clavulanic acid. This is because amoxicillin/clavulanic acid can 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, have recently taken, or might take any other medicines.

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

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

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

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.

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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Amoxicillin/clavulanic acid may have side effects that can affect your ability to drive or use machines. Do not drive or operate machinery unless you are feeling 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

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Adults and children over 40 kg

• Usual dose – 1 tablet twice a day
• Higher dose – 1 tablet three times a day

Children under 40 kg

It is preferable to treat children under 6 years with the oral suspension of amoxicillin/clavulanic acid or sachets.

Ask your doctor or pharmacist for advice when administering Amoxicillin/Clavulanic Acid Sun to children who weigh less than 40 kg. Tablets are not suitable for children who weigh 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 formulation or another medicine.

How to take Amoxicillin/Clavulanic Acid Sun

• Swallow the tablets whole with a glass of water with meals.
• The tablets can be broken along the score line to make them easier to swallow. You should take both halves of the tablet at the same time.
• Space out the 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 are still feeling 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. Take the package with you to show the doctor.

You can also contact the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine 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 a forgotten dose.

If you stop taking Amoxicillin/Clavulanic Acid Sun

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, amoxicillin/clavulanic acid can cause side effects, although not everybody gets them.

The following side effects may occur with this medicine.

Symptoms to be aware of

Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis) which can appear as red or purple spots on the skin, but can 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), which can cause difficulty breathing
• collapse.
• Chest pain in the context of allergic reactions, which can be a symptom of allergy-induced heart attack (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, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

Acute pancreatitis (inflammation of the pancreas)

If you have severe and persistent stomach pain, this could be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES):

DIES has been reported mainly in children receiving 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 possiblefor advice if you have 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 of the vagina, mouth, or mucous membranes)

???nausea, especially when taking high doses

→ if this happens, take amoxicillin/clavulanic acid before meals

???vomiting

???diarrhea (in children).

Uncommon side effects

(may affect up to 1 in 100 people)

???skin rash, itching

???increased pruritic rash (urticarial rash)

???indigestion

???dizziness

???headache.

Uncommon side effects that may appear in your blood tests:

Increased levels of certain substances (enzymes) produced by the liver, indicating liver damage.

Rare side effects

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

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

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

Rare side effects that may appear in your blood tests:

??low count of blood cells involved in blood clotting

??low count of white blood cells

Frequency not known (frequency cannot be estimated from the available data.)

???Allergic reactions (see above)

???Inflammation of the large intestine (see above)

????Inflammation of the protective membrane surrounding the brain (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 containing pus (bullous exfoliative dermatitis)

? red rash with bumps under the skin and blisters (pustular exanthematous eruption).

? 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)).

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 make the skin and the whites of the eyes turn yellow

???inflammation of the kidney ducts

???delayed blood clotting

???hyperactivity

???convulsions (in patients taking high doses of amoxicillin/clavulanic acid SUN or with kidney problems)

???black hairy tongue

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

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

???significant decrease in the 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month stated.

Do not store above 25°C.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy for proper disposal. If you have any doubts, ask your pharmacist how to dispose of the containers and unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Composition of Amoxicillin/Clavulanic Acid Sun

The active ingredients are amoxicillin and clavulanic acid. One 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, anhydrous colloidal silica, povidone, eudragit 100, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400, and talc.

Appearance of the Product and Container Content

Amoxicillin/Clavulanic Acid Sun are capsule-shaped tablets, white to off-white in color, with "RX509" engraved on one side and a score line on the other side.

Packaging of 8, 10, 12, 14, 16, 20, 21, 24, 28, 30, 60, and 100 tablets in PVC/PVdC/Alu blisters, inside a pouch (Polyester/aluminum/polyester/polyethylene), which contains a desiccant bag.

Do not ingest the desiccant bag contained inside the pouch.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder:

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Manufacturer:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87,

2132 JH, Hoofddorp

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 Laboratories, 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 Last Revision of this Leaflet: May 2023

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 properly can reduce the chances 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 can make the antibiotic ineffective.

2. You should not take an antibiotic unless it has been specifically prescribed for you, and you should only use it for the infection for which it was prescribed.
3. You should not take antibiotics that have been prescribed for other people, even if they have the same or a similar infection to yours.
4. You should not give antibiotics that have been prescribed for you to other people.

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