Amoxicillin/clavulanic acid Aurovitas 875 mg/125 mg powder for oral suspension in sachets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Amoxicillin/Clavulanic Acid Aurovitas 875 mg/125 mg powder for oral suspension in sachets EFG

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• 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 only, 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 adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Amoxicillin/Clavulanic Acid Aurovitas is an antibiotic that kills bacteria causing infections. It contains two different active substances 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 influenza or the common cold.

It is important that you follow your doctor's instructions regarding dosage, dosing intervals, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Amoxicillin/Clavulanic Acid is 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 starting to take Amoxicillin/Clavulanic Acid Aurovitas

Do not take Amoxicillin/Clavulanic Acid Aurovitas

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

→Do not take amoxicillin/clavulanic acid if any of the above apply to you.

Before starting treatment with amoxicillin/clavulanic acid, consult your doctor or pharmacist if you are unsure.

Warnings and precautions

Talk to your doctor or pharmacist before taking amoxicillin/clavulanic acid 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 apply to 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 medicine.

Symptoms to watch for

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 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 undergoing blood tests (such as red blood cell assessments or liver function tests) or urine tests (to monitor 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 tests.

Other medicines and Amoxicillin/Clavulanic Acid Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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, more blood tests will be required.

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, 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 may make it unsafe for you to drive. Do not drive or operate machinery unless you feel well.

Amoxicillin/Clavulanic Acid Aurovitas contains aspartame and maltodextrin

This medicine contains 22.5 mg of aspartame (E951) per sachet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

This medicine contains maltodextrin (glucose). If your doctor has diagnosed you with an intolerance to certain sugars, consult him or her before taking this medicine.

3. How to take Amoxicillin/Clavulanic Acid Aurovitas

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Adults and children weighing 40 kg or more

• Usual dose: one sachet twice daily.
• Higher dose: one sachet three times daily.

Children weighing less than 40 kg

Seek advice from your doctor or pharmacist when administering amoxicillin/clavulanic acid 875 mg/125 mg oral suspension in sachets to children weighing less than 40 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 Aurovitas

• Just before taking amoxicillin/clavulanic acid, open the sachet and mix its contents in half a glass of water.
• Take it at the beginning of meals or shortly before meals.
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 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 Aurovitas 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 and bring the packaging with you to show the doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Amoxicillin/Clavulanic Acid Aurovitas

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 forgotten doses.

If you stop treatment with Amoxicillin/Clavulanic Acid Aurovitas

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, this medicine can cause adverse effects, although not everyone will experience them. The following adverse effects may occur with this medicine.

Symptoms to 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 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 your doctor immediately if you experience any of these symptoms. Stop taking amoxicillin/clavulanic acid.

Inflammation of the large intestine

Inflammation of the large intestine, causing 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 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/clavulanic acid. 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.

→ Contact your doctor as soon as possible for advice if you experience 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).
• Discomfort (nausea), especially when taking high doses.

→ if this happens, take amoxicillin/clavulanic acid with food:

• Vomiting.
• Diarrhea (in children).

Uncommon adverse effects (may affect up to 1 in 100 patients):

• Skin rash, itching.
• Increased itchy rash (urticarial wheals).
• Indigestion.
• Dizziness.
• Headache.

Uncommon adverse effects that may appear in blood tests:

• 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 form blisters resembling small targets (a dark central 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 adverse effects that may appear in blood tests:

• Low count of cells involved in blood clotting (thrombocytopenia);
• Low white blood cell count (leukopenia).

Other adverse effects

• Allergic reactions (see above).

• Inflammation of the large intestine (see above).

• Inflammation of the protective membranes covering the brain and spinal cord (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 skin peeling (more than 30% of body surface – toxic epidermal necrolysis),

• generalized red rash with small pus-filled blisters (bullous exfoliative dermatitis),

• exfoliative red 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, inner upper thighs, armpits, and neck (Symmetrical Drug-Related Intertriginous and Flexural Exanthema (SDRIFE)),

• 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 have any of the following symptoms:

• rash with blistering arranged in a ring-shaped pattern with a central crust or resembling a "string of pearls" (linear IgA disease);
• 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 or who have kidney problems);
• black, hairy-looking tongue;
• stained teeth (in children), which usually disappear with brushing.

Adverse effects that may appear in blood or urine tests:

• significant reduction in white blood cell count;
• low red blood cell count (hemolytic anemia);
• crystals in the urine causing acute kidney injury.

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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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

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

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

Store below 30°C.

Keep in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. 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 Amoxicilina/Ácido clavulánico Aurovitas

• The active substances are amoxicillin and clavulanic acid.

Each sachet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.

• The other components (excipients) are: Crospovidone (Type-A), magnesium stearate, silicon dioxide and aspartame (E 951).

Composition of strawberry guarana flavour: corn maltodextrin, propylene glycol (E1520), flavouring substances, triethyl citrate (E1505), flavouring preparations.

Composition of lemon flavour: natural flavouring substances, flavouring preparations, flavouring substances, corn maltodextrin, alpha-tocopherol (E307).

Composition of peach flavour: corn maltodextrin, glyceryl triacetate (E1518), flavouring substances, flavouring preparations, natural flavouring substances.

• See section 2 for further important information on some of the components of this medicine.

Nature of the product and contents of the pack

Powder for oral suspension in sachets.

White to pale yellow powder.

Amoxicilina/Ácido clavulánico Aurovitas 875 mg/125 mg powder for oral suspension is available in sachets.

Pack sizes: 8, 12, 20 or 30 sachets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

Or

Generis Farmacêutica, S.A.

Rua João Deus, 19

2700-487 Amadora, Lisboa

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier,

Lyon, Rhone 69007,

France

This medicine is authorised in the European Economic Area member states under the following names:

Spain: Amoxicilina/Ácido clavulánico Aurovitas 875 mg/125 mg powder for oral suspension in sachets EFG

France: AMOXICILLIN/CLAVULANIC ACID ARROW LAB 1 g/125 mg, powder for oral suspension in single-dose sachets (amoxicillin/clavulanic acid ratio: 8/1)

Italy: Amoxicillina/Acido clavulanico Aurobindo Pharma Italia

Malta: Amoxicillin/clavulanic acid Aurobindo 875 mg/125 mg powder for oral suspension in sachet

Date of latest review of this leaflet: December 2025

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

Medical advice/education Antibiotics are used to treat infections caused by bacteria. They have no effect against infections caused by viruses. Sometimes, a bacterial infection does not respond to a course of an antibiotic. One of the most common reasons for this is that the bacteria causing the infection are resistant to the antibiotic being taken. This means they can survive and even multiply despite the antibiotic. Bacteria can become resistant to antibiotics for many reasons. Careful use of antibiotics can help reduce the likelihood of bacteria becoming resistant to them. When your doctor prescribes you a course of an antibiotic, it is intended only to treat your current illness. Following the advice below will help prevent the development of resistant bacteria that could stop antibiotics from working. It is very important to take the antibiotic at the correct dose, at the right times, and for the correct number of days. Read the instructions on the label, and if you do not understand anything, ask your doctor or pharmacist to explain it. You should not take an antibiotic unless it has been specifically prescribed for you, and you should use it only to treat the infection for which it was prescribed. You should not take antibiotics that were prescribed for other people, even if they had an infection similar to yours. You should not give antibiotics prescribed for you to other people. If you have any antibiotic left over after completing the treatment as directed by your doctor, you should return the remainder to a pharmacy for proper disposal.

Reconstitution instructions

Pour the contents of the sachet into half a glass of water, shake until a suspension is obtained, and take immediately.