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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amoxicillin/Clavulanic acid Aurovitas Pharma 500mg/125mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given 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 effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Amoxicillin/Clavulanic Acid 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 sometimes may lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

Amoxicillin/clavulanic acid is used in adults and children to treat the following infections:

• Infections of the middle ear and sinuses,
• 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 Aurovitas Pharma

Do not take Amoxicillin/Clavulanic Acid Aurovitas Pharma

• If you are allergic to amoxicillin, clavulanic acid, penicillins, or any of the other ingredients of this medicine (listed in section 6).
• If you have had a severe allergic (hypersensitivity) reaction to any other antibiotic. This may include a mild skin rash or swelling of the face and throat.
• If you have had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.

Do not take Amoxicillin/Clavulanic Acid Aurovitas Pharma if any of the above apply to you.

If you are unsure, consult your doctor or pharmacist before taking amoxicillin/clavulanic acid.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Amoxicillin/Clavulanic Acid Aurovitas Pharma if you:

• Have glandular fever or swollen glands (lymph nodes),
• Are being treated for kidney or liver problems,
• Do not urinate regularly.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking this medicine.

In some cases, your doctor may investigate the type of bacteria causing the infection. Depending on the results, a different strength of Amoxicillin/Clavulanic Acid or another medicine may be prescribed.

Conditions that need to be monitored

Amoxicillin/clavulanic acid may worsen certain pre-existing conditions or cause serious adverse effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should be alert to certain symptoms while taking amoxicillin/clavulanic acid to reduce the risk of complications. See “Conditions that need to be monitored” in section 4.

Blood and urine tests

Inform your doctor or nurse that you are taking amoxicillin/clavulanic acid if you need to have blood tests (such as red blood cell counts or liver function tests) or urine tests (for glucose). This is because amoxicillin/clavulanic acid may affect the results of these tests.

Other medicines and Amoxicillin/Clavulanic Acid Aurovitas Pharma

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

If you are taking allopurinol (for gout) together with amoxicillin/clavulanic acid, there may be an increased risk of developing 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 a medicine to prevent blood clots (such as warfarin) together with amoxicillin/clavulanic acid, additional blood tests may be required.

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

Amoxicillin/clavulanic acid may affect how mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs) works.

Pregnancy, breastfeeding, and fertility

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.

Driving and using machines

Amoxicillin/clavulanic acid may cause adverse effects and symptoms that impair your ability to drive.

Do not drive or operate machinery unless you feel well.

Amoxicillin/Clavulanic Acid Aurovitas Pharma contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

3. How to take Amoxicillin/Clavulanic Acid Aurovitas Pharma

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 one tablet three times a day.

Children weighing less than 40 kg:

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

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

Patients with liver or kidney problems:

• The dose may be adjusted in case of kidney problems. Your doctor may prescribe a different strength or a different medicine.
• In case of liver problems, more frequent blood tests may be performed to check that the liver is functioning properly.

How to take Amoxicillin/Clavulanic Acid Aurovitas Pharma:

• Take with food.
• Swallow the tablets whole with a glass of water.
• The tablets may be broken along the score line (notch) to make them easier to swallow. You must take both parts of the tablet at the same time.
• Space doses evenly throughout the day, leaving at least 4 hours between each dose. Do not take 2 doses within one hour.
• Do not take amoxicillin/clavulanic acid for longer than two weeks. Consult your doctor if you still feel unwell.

If you take more Amoxicillin/Clavulanic Acid Aurovitas Pharma than you should

If you have taken more Amoxicillin/Clavulanic Acid Aurovitas Pharma than you should have, you may experience stomach discomfort (feeling unwell or diarrhoea) or seizures. Contact your doctor, pharmacist, or the Toxicology Information Service immediately, telephone 91 562 04 20. Do not forget to bring the medicine container or bottle.

If you forget to take Amoxicillin/Clavulanic Acid Aurovitas Pharma

If you forget to take a dose, take it as soon as you remember. Do not take the next dose too soon. Wait approximately 4 hours before taking the next dose.

Do not take a double dose to make up for forgotten doses.

If you stop treatment with Amoxicillin/Clavulanic Acid Aurovitas Pharma

You must continue taking amoxicillin/clavulanic acid for the full duration of the treatment, even if you feel better. Each dose is necessary to help eliminate the infection. If any bacteria survive, the infection may 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 will experience them. The following adverse effects may occur with this medicine.

Symptoms you should be aware of:

Allergic reactions:

• skin rash,

• inflammation of the veins (vasculitis), which may appear as 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, armpits, 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 an allergic-triggered heart attack (Kounis syndrome).

• Contact a doctor immediately if you experience any of these symptoms. Discontinue treatment with amoxicillin/clavulanic acid.

Inflammation of the large intestine:

Inflammation of the large intestine may cause watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.

Acute inflammation of the pancreas (acute pancreatitis):

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

Drug-induced enterocolitis syndrome (DIES):

DIES has been reported mainly in children receiving amoxicillin/clavulanate. 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, diarrhoea, and low blood pressure.

• Contact a doctor immediately if you experience any of these symptoms.

Very common adverse effects:

May affect more than 1 in 10 patients

• diarrhoea (in adults).

Common adverse effects:

May affect up to 1 in 10 patients

• candidiasis (thrush – a fungal infection in the vagina, mouth, or skin folds),

• feeling unwell (nausea), especially when taking high doses,

• If affected, take amoxicillin/clavulanic acid with food

• vomiting,

• diarrhoea (in children).

Uncommon adverse effects:

May affect up to 1 in 100 patients

• skin rash, itching,
• raised itchy rash (hives or urticaria),
• indigestion,
• dizziness,
• headache.

Uncommon blood test abnormalities:

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

Rare adverse effects:

May affect up to 1 in 1,000 patients

• skin rash that may develop into blisters and resembles small targets (dark central spots surrounded by a paler area with a dark ring around the edge – erythema multiforme).

• Seek urgent medical advice if you experience any of these symptoms.

Rare blood test abnormalities:

• low number of cells responsible for blood clotting (platelets),
• low number of white blood cells.

Frequency not known:

Cannot be estimated from the available data.

• allergic reactions (see above),

• inflammation of the large intestine (see above),

• crystals in the urine causing acute kidney injury,

• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis),

• inflammation of the bile duct (cholangitis),

• severe skin reactions:

  • widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (stevens-Johnson syndrome) and a more severe form causing extensive skin peeling (more than 30% of the body surface – toxic epidermal necrolysis),
  • widespread red rash with small blisters containing pus (exfoliative bullous dermatitis),
  • red scaly 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)),
  • red rash typically seen on both sides of the buttocks, upper inner thighs, armpits, and neck (symmetrical intertriginous and flexural drug eruption (SDRIFE)).

• blistering rash arranged in circles with central crusts or resembling a string of pearls (linear IgA disease).

• Contact a doctor immediately if you experience any of these symptoms:

• inflammation of the liver (hepatitis),

• jaundice, caused by increased bilirubin levels in the blood (a substance produced by the liver), which may cause yellowing of the skin and whites of the eyes,

• inflammation of the kidney tubules,

• slower blood clotting,

• hyperactivity,

• seizures (in people taking high doses of amoxicillin/clavulanic acid or with kidney problems),

• black, hairy-looking tongue.

Adverse effects that may appear in blood tests:

• severe reduction in the number of white blood cells in the blood,
• low number of red blood cells in the blood (haemolytic anaemia).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via 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 Aurovitas Pharma

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton, blister, and label of the bottle after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from light and moisture.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy’s SIGRE point. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amoxicillin/Clavulanic Acid Aurovitas Pharma

The active substances in Amoxicillin/Clavulanic Acid Aurovitas Pharma are amoxicillin trihydrate and potassium clavulanate.

One film-coated tablet contains 500 mg of amoxicillin and 125 mg of clavulanic acid.

The other components are:

Core

Microcrystalline cellulose (E460), colloidal anhydrous silica, magnesium stearate (E470b), sodium carboxymethylstarch (type A) (derived from potato starch).

Coating

Hypromellose (E464), macrogol 400, titanium dioxide (E171).

Appearance of the product and contents of the pack

Film-coated tablets.

Amoxicillin/Clavulanic Acid Aurovitas Pharma 500 mg/125 mg film-coated tablets EFG are film-coated, oval, white tablets, marked with the letter “A” on one side and the number “64” on the other.

Amoxicillin/Clavulanic Acid Aurovitas Pharma tablets are available in aluminum/aluminum blisters (polyamide/aluminum/PVC-aluminum foil) containing 4, 5, 6, 7, 8, 10, 12, 14, 15, 16, 20, 21, 24, 25, 30, 35, 40, 50, 100 and 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorized in EEA Member States under the following names:

Germany Amoxi-Clavulan Aurobindo 500 mg/125 mg Filmtabletten

Austria Amoxicillin/Clavulansäure A-med 500 mg/125 mg Filmtabletten

Denmark Amoxicillin/Clavulansyre Aurobindo

Spain Amoxicillin/Clavulanic Acid Aurovitas Pharma 500 mg/125 mg film-coated tablets EFG

Netherlands Amoxicilline/Clavulaanzuur Aurobindo 500 mg/125 mg, filmomhulde tabletten

Romania AMOXIPLUS 500mg / 125mg, comprimate filmate

Sweden Amoxicillin/Clavulanic acid Aurobindo 500 mg/125 mg filmdragerade tabletter

Date of the most recent review of this leaflet: 12/2025

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