Background pattern
Amoxicilina/acido clavulanico stada 500 mg/125 mg comprimidos recubiertos con pelicula efg

Amoxicilina/acido clavulanico stada 500 mg/125 mg comprimidos recubiertos con pelicula efg

About the medicine

How to use Amoxicilina/acido clavulanico stada 500 mg/125 mg comprimidos recubiertos con pelicula efg

Introduction

Patient Information Leaflet

Amoxicilina/Ácido clavulánico Stada 500 mg/125 mg Film-Coated Tablets EFG

Read this leaflet carefully before you start taking this medicine because 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Amoxicilina/Ácido clavulánico Stada and what is it used for

2.What you need to know before you start taking Amoxicilina/Ácido clavulánico Stada

3.How to take Amoxicilina/Ácido clavulánico Stada

4.Possible side effects

5.Storage of Amoxicilina/Ácido clavulánico Stada

6.Contents of the pack and additional information

1. What is Amoxicilina/Ácido clavulánico Stada and what is it used for

Amoxicilina/Ácido clavulánico Stada is 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 antibiotics after completing treatment, return them to the pharmacy for proper disposal. Do not dispose of medications through the drain or in the trash.

Amoxicilina/ácido clavulánico is used in adults and children 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

2. What you need to know before starting to take Amoxicilina/Clavulanic Acid Stada

Do not take Amoxicilina/Ácido clavulánico Stada:

if you are allergic to amoxicilina, ácido clavulánico, penicilins, or any of the other components of this medication (listed in 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 (yellowing of the skin) when taking an antibiotic.

Do not takeAmoxicilina/Ácido clavulánico Stadaif you fall under any of the above points.Before starting treatment with amoxicilina/ácido clavulánico, 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 this medication.

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 amoxicilina/ácido clavulánico or another medication.

Symptoms to be aware of

Amoxicilina/ácido clavulánico may worsen existing conditions or cause serious side effects. These include allergic reactions, convulsions, and inflammation of the large intestine. Be aware of certain symptoms while taking this medication 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 this medication. This is becausethis medicationmay alter the results of these types of tests.

Use ofAmoxicilina/Ácido clavulánico Stadawith other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those acquired without a prescription and herbal medications.

If you are taking allopurinol (used for gout) with amoxicilina/ácido clavulánico, you may be more likely to suffer a skin allergic reaction.

If you are taking probenecid (used for gout), your doctor may adjust the dose of amoxicilina/ácido clavulánico.

If you are taking anticoagulants (such as warfarin) with amoxicilina/ácido clavulánico, more blood tests will be required.

This medication may affect the action of methotrexate (a medication used to treat cancer or rheumatic diseases).

This medicationmay affect the action of micofenolato de mofetilo (a medication used to prevent organ transplant rejection).

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

Amoxicilina/ácido clavulánico may cause side effects and symptoms that may make you unfit to drive.

Do not drive or operate machinery unless you feel well.

Amoxicilina/Ácido clavulánico Stada contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

3. How to take Amoxicilina/Clavulanic Acid Stada

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

The recommended dose is:

1 tablet three times a day.

Children under 40 kg

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

Ask your doctor or pharmacist for advice when administering amoxicillin/clavulanic acid tablets to children weighing less than 40 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 Amoxicilina/Ácido clavulánico Stada

Swallow the tablets whole with a glass of water at the beginning of meals or a little before.

Space the doses throughout the day, at least 4 hours apart. Do not take 2 doses in 1 hour.

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

If you take moreAmoxicilina/Ácido clavulánico Stadathan you should

If you take too much amoxicillin/clavulanic acid, you may experience symptoms such as stomach discomfort (nausea, vomiting, or diarrhea) or seizures.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Amoxicilina/Ácido clavulánico Stada

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.

If you stop taking Amoxicilina/Ácido clavulánico Stada

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Symptoms to be aware of

Allergic reactions:

  • skin rash
  • inflammation of blood vessels (vasculitis) that may appear as red or purple spots on the skin, but canaffect other parts of the body
  • fever, joint pain, lymphadenopathy, axillary or inguinal lymphadenopathy
  • swelling, sometimes of the face or mouth (angioedema), whichcauses difficulty breathing
  • collapse
  • chest pain in the context of allergic reactions, which may be a symptom of allergic-induced myocardial infarction (Kounis syndrome).

?Contact your doctorimmediatelyif you experience any ofthese symptoms.Stop taking this medicine.

Colitis

Colitis, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

Acute pancreatitis

If you have had severe and persistent pain in the abdominal area, it may be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES)

DIES has been reported mainly in children taking amoxicillin. It isa 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 doctoras soon as possibleto advise you, 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 acidbefore meals

  • vomiting
  • diarrhea (in children).

Rare side effectsfrequent(may affect 1 in 100 people)

  • skin rash, itching
  • increased pruritic rash (urticariah)
  • indigestion
  • dizziness
  • headache.

Side effects that may appear in your blood tests:

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

Rare side effects(may affect up to 1 in 1,000 people)

  • skin rash, which may form blisters that appear as small dianas (central dark spot surrounded by a lighter area, with a dark ring around the edge –erythema multiforme)

?If you have any of these symptoms, see a doctor urgently.

Side effectsthat may appear in your blood tests:

  • low count of cells involved in blood clotting
  • low white blood cell count

Other side effects

Other side effects that have occurred in a very small number of patients and whose exact frequency isnot known (cannot be estimated from available data):

  • Allergic reactions (see above)
  • Colitis (see above)
  • Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
  • Rash with blisters arranged in a circle with a central crust or as a string of pearls (IgA linear disease)
  • 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 with pus (exfoliative bullous dermatitis)
  • red exfoliative rash, with bumps under the skin and urticaria (exanthematous pustulosis).
    • flu-like symptoms with skin rash, fever, lymphadenopathy, and abnormal blood test results (such as eosinophilia and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).

?Contact your 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 may make the skin
  • and white of the eyes turn yellow
  • inflammation of the renal tubules
  • delayed blood clotting
  • hyperactivity
  • seizures (in patients taking high doses of amoxicillin/clavulanic acid or with renal problems)
  • black tongue that appears hairy
  • stained teeth (in children), which usually disappears with brushing.

Effects that may appear in your blood or urine tests:

  • significant reduction in the number of white blood cells
  • low red blood cell count (hemolytic anemia)
  • crystals in the urine that cause acute kidney injury.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist,even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance 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.

5. Conservation of Amoxicilina/Clavulanic Acid Stada

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

Do not use this medication after the expiration datethat appears on the packaging and in the blister pack. 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 and moisture.

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 pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will be helping to protect the environment.

6. Contents of the packaging and additional information

Composition ofAmoxicilina/Ácido clavulánico Stada

  • The active principles are: amoxicilina and ácido clavulánico. Each tablet contains 500 mg of amoxicilina and 125 mg of ácido clavulánico.
  • The other components are:

Nucleus of the tablet

Colloidal anhydrous silica, magnesium stearate, carboxymethylcellulose sodium (type A) (from potato), microcrystalline cellulose

Coating of the tablet

Triethyl citrate, hypromellose, talc, ethylcellulose, cetyl alcohol, sodium lauryl sulfate, titanium dioxide (E171).

Appearance of the product and contents of the packaging

Amoxicilina/Ácido clavulánico Stada are film-coated, oblong, white or slightly yellowish tablets (10 mm x 21 mm), marked on one side (GG N6).

Amoxicilina/Ácido clavulánico Stada is presented in Al/Al blisters containing 10, 12, 20, 21, 24 or 30 film-coated tablets.

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing:

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Sandoz Gesellschaft m.b.H.

Biochemiestrasse 10

A-6250 Kundl

Austria

or

Clonmel Healthcare Ltd.

Waterford Road, Clonmel, Co. Tipperary

Ireland

Last review date of this leaflet: January 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

About the medicine

How much does Amoxicilina/acido clavulanico stada 500 mg/125 mg comprimidos recubiertos con pelicula efg cost in Spain in 2025?

The average price of Amoxicilina/acido clavulanico stada 500 mg/125 mg comprimidos recubiertos con pelicula efg in June, 2025 is around 5.84 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.

Talk to a doctor online

Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.

5.01 review
Doctor

Anna Moret

Dermatology18 years of experience

Dr. Anna Moret is a board-certified dermatologist and dermatovenereologist. She specialises in adult and pediatric dermatology, venereology, aesthetic skin care, and general medicine. Her consultations are evidence-based and tailored to each patient’s dermatological needs.

Dr. Moret provides expert evaluation and treatment for: • Skin conditions such as eczema, acne, rosacea, dermatitis, and psoriasis • Hair and scalp issues including hair loss, dandruff, and seborrheic dermatitis • Pediatric skin problems — from newborns to adolescents • Sexually transmitted infections (STIs) and dermatovenereology • Aesthetic concerns: skin ageing, non-invasive cosmetic treatments • Skin allergies and hypersensitivity reactions • Mole checks, lesion evaluation, and skin cancer screening • Skincare advice and personalised cosmeceutical routines

Combining dermatology with general medical knowledge, Dr. Moret offers comprehensive care that addresses both skin health and underlying conditions. She also holds certification from the Canadian Board of Aesthetic Medicine, ensuring an internationally aligned approach to aesthetic dermatology.

CameraBook a video appointment
5.06 reviews
Doctor

Alina Tsurkan

Family medicine12 years of experience

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including: • Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs • ENT conditions: sinusitis, tonsillitis, otitis (ear infections), sore throat, allergic rhinitis • Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation • Digestive issues: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), constipation, bloating, nausea • Urinary and reproductive health: urinary tract infections (UTIs), cystitis, prevention of recurrent infections • Chronic diseases: hypertension, diabetes, thyroid disorders, elevated cholesterol, weight management • Neurological complaints: headaches, migraines, sleep disturbances, fatigue, general weakness • Women’s health: menstrual irregularities, perimenopausal symptoms, preventive screening • Children’s health: fever, infections, digestive issues, follow-ups, vaccination guidance

She also provides: • IMT medical certificates for driving licence exchange in Portugal • Personalised preventive care and wellness consultations • Interpretation of test results and medical reports • Follow-up care and medication review • Support in managing multiple coexisting conditions • Remote prescription management and medical documentation

Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

CameraBook a video appointment
5.04 reviews
Doctor

Andrei Popov

General medicine6 years of experience

Dr. Andrei Popov is a licensed pain management specialist and general practitioner based in Spain. He provides expert online care for adults dealing with both chronic and acute pain, as well as a wide range of everyday health concerns.

He specialises in diagnosing and treating pain conditions that affect quality of life, including: • Chronic pain lasting more than 3 months • Migraines and recurring headaches • Neck, back, lower back, and joint pain • Post-traumatic pain following injury or surgery • Nerve-related pain, fibromyalgia, and neuralgia In addition to pain management, Dr. Popov helps patients with: • Respiratory infections (colds, bronchitis, pneumonia) • High blood pressure and metabolic conditions such as diabetes • Preventive care and routine health check-ups

Online consultations last up to 30 minutes and include a detailed symptom review, personalised treatment planning, and medical follow-up when needed.

Dr. Popov’s approach is rooted in evidence-based medicine, combined with individualised care tailored to each patient’s history, lifestyle, and clinical needs.

CameraBook a video appointment
5.05 reviews
Doctor

Yevgen Yakovenko

General surgery11 years of experience

Dr. Yevhenii Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise: • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan. • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions. • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies. • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries. • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required. • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up. • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data. • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications: • 12+ years of clinical experience in university hospitals in Germany and Spain • International education: Ukraine – Germany – Spain • Member of the German Society of Surgeons (BDC) • Certified in radiological diagnostics and robotic surgery • Active participant in international medical conferences and research

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

CameraBook a video appointment
See all doctors

Stay informed and save on care

Get health tips, platform updates, and exclusive promos for subscribers.

Follow us on social media
FacebookInstagramTikTok