AMOXICILLIN CLAVULANATE SUN 500 mg/125 mg FILM-COATED TABLETS

Amoxicillin/Clavulanic Acid Sun film-coated tabletsare 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 taking Amoxicillin/Clavulanic Acid Sun

Do not takeAmoxicillin/Clavulanic Acid Sun:If you are allergic (hypersensitive) toamoxicillin, clavulanic acid, penicillin, or any of the other components ofAmoxicillin/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) when taking an antibiotic.

Do not takeAmoxicillin/Clavulanic Acid Sunif 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 medication 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 applies to you, talk to 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 may receive a different concentration of amoxicillin/clavulanic acid tablets or a different medication.

Conditions that require special attention

Amoxicillin/Clavulanic Acid Sun may worsen existing problems or cause severe side effects, including allergic reactions, seizures (fits), and inflammation of the large intestine. You should monitor certain symptoms while taking Amoxicillin/Clavulanic Acid Sun to reduce the risk of any problems. See Section 4.

Blood and urine tests

If you are having blood tests (such as tests to check the condition of red blood cells or liver function tests) or urine tests (to check for 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 tests.

Using Amoxicillin/Clavulanic Acid Sun with other medications

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medications, including those that can be bought without a prescription.

If you are taking allopurinol (used for gout) with Amoxicillin/Clavulanic Acid 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 amoxicillin and is not recommended.

If you are taking medications to prevent blood clots (such as warfarin) with amoxicillin/clavulanic acid Sun, additional blood tests may be necessary.

Methotrexate (a medication 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 medication used to prevent organ rejection in transplant patients) works.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before taking any medication.

Driving and using machines

Amoxicillin/Clavulanic Acid Sun may have side effects, and the symptoms may make you unfit to drive. Do not drive or use machines unless you feel well.

Amoxicillin/Clavulanic Acid Sun contains sodium

This medication 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 the instructions for administration of this medication indicated by your doctor or pharmacist exactly. In case of doubt, consult your doctor or pharmacist again.

Adults and children weighing40 kgor more

The recommended dose is

• 1 tablet three times a day

Children weighing less than40 kg

Children 6 years or younger should be treated preferably 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 kidney and liver 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 working.

How to take Amoxicillin/Clavulanic Acid Sun

• Swallow the tablets whole with a glass of water with food.
• Space the doses evenly during the day, with a minimum interval of 4 hours. Do not take 2 doses in 1 hour.
• Do not take amoxicillin/clavulanic acid for more than two weeks. If you are still feeling 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 have stomach problems (nausea, vomiting, or diarrhea) or have seizures. Talk to your doctor as soon as possible. Bring the medicine box to show the doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication 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, but wait about 4 hours before taking it. Do not take a double dose to make up for the forgotten dose.

If you stop taking Amoxicillin/Clavulanic Acid Sun

Keep taking amoxicillin/clavulanic acid until you finish the treatment, 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 other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them. The following side effects may occur with this medication.

Symptoms to be aware ofAllergic reactions:

• Inflammation of blood vessels (vasculitis) that can be visible as raised red or purple spots on the skin but can 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), 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 immediatelyif 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 inflammation of the pancreas (acute pancreatitis)

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 medication). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

Contact your doctor immediatelyif 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 (vaginal, mouth, or skin fold infection caused by yeast).
• Feeling sick (nausea), especially when taking high doses

→ If affected, take amoxicillin/clavulanic acid SUN film-coated tablets with meals.

• Vomiting.
• Diarrhea (in children)

Uncommon (may affect up to 1 in 100 people)

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

Uncommon side effects that may appear in your blood tests:

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

Rare (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).

Rare side effects that may appear in your blood tests:

• Low number of blood cells involved in blood clotting.
• Low number 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:
• • Widespread rash with 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)
  • Widespread rash with small blisters containing pus (bullous exfoliative dermatitis)
  • Red rash with bumps under the skin and blisters (pustular exanthematous)
  • Flu-like symptoms with skin rash, fever, glandular inflammation, 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 blisters arranged in a circle with a central crust or like a necklace (linear IgA disease).

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

• Inflammation of the liver (hepatitis)
• Jaundice, caused by an increase in 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 tubules.
• Delayed blood clotting
• Hyperactivity.
• Seizures (in patients taking high doses of Augmentin or with kidney problems)
• Black hairy tongue.
• Overgrowth of non-susceptible organisms

Side 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 that cause acute kidney injury.

Reporting of side effects:

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. You can also report them 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 medication.

5. Storage of Amoxicillin/Clavulanic Acid SUN film-coated tablets

Keep out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging. The expiration 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 of opening the bag.

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

Medications should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. 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.

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

The other ingredients are microcrystalline cellulose, sodium starch glycolate, anhydrous colloidal 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, marked with RX713 on one side and flat on the other side.

Product Appearance and Container Content

Packages 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/aluminum foil/polyester film/polyethylene) with a sachet containing 1 g of desiccant.

Do not ingest the desiccant sachet inside the bag.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 4400

Tiszavasvári

Hungary

Local Representative

Sun Pharma Laboratories, 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 Amoxicillin/Clavulanic Acid SUN 500/125 mg film-coated tablets EFG

Date of the last revision of this leaflet:April 2023

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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 tips will help you 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.
5. If you still have antibiotic left after completing the treatment, return all unused medication to your pharmacy to ensure that disposal requirements are met.