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AMOXICILLIN/BROMHEXINE ARDINE 500 mg/8 mg HARD CAPSULES

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About the medicine

How to use AMOXICILLIN/BROMHEXINE ARDINE 500 mg/8 mg HARD CAPSULES

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Amoxicillin/Bromhexine Ardine 500 mg/8 mg hard capsules

Amoxicillin/bromhexine

Read all of this 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.

  • 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 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

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

1. What Amoxicillin/Bromhexine Ardine is and what it is used for

Amoxicillin/Bromhexine Ardine contains the active substances amoxicillin and bromhexine.

Amoxicillin is an antibiotic belonging to a group of medicines called "penicillins".

Bromhexine is a drug that acts by decreasing the viscosity of bronchial mucus, facilitating expectoration. It completes the efficacy of amoxicillin by suppressing bronchial obstruction, improving respiratory function, and facilitating the diffusion of the antibiotic in sputum.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or common cold.

It is important to follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after finishing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

Amoxicillin/Bromhexine Ardine is indicated for the treatment of respiratory tract infections produced by bacteria and in which there is also abundant bronchial secretion, requiring the simultaneous use of a mucolytic agent (bromhexine):

  • Acute bacterial exacerbation of chronic bronchitis.
  • Community-acquired pneumonia.
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2. What you need to know before you take Amoxicillin/Bromhexine Ardine

Do not take Amoxicillin/Bromhexine Ardine

  • if you are allergic to amoxicillin, penicillins, bromhexine, or any of the other components of this medicine (listed in section 6)
  • if you have ever had an allergic reaction to any other antibiotic. This could include skin rash or swelling of the face or throat.
  • do not administer to children under 2 years of age.

Do not take Amoxicillin/Bromhexine Ardine if any of the above points apply to you. If you are not sure, consult your doctor or pharmacist before taking Amoxicillin/Bromhexine Ardine.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine if:

  • you have infectious mononucleosis (fever, sore throat, swollen glands, and extreme fatigue)
  • you have kidney problems
  • you do not urinate regularly.

There have been reports of severe skin reactions associated with the administration of bromhexine. If you develop a skin rash (including lesions of the mucous membranes, such as the mouth, throat, nose, eyes, and genitals), stop using Amoxicillin/Bromhexine Ardine and consult your doctor immediately.

If you are not sure if any of the above symptoms apply to you, inform your doctor or pharmacist before taking Amoxicillin/Bromhexine Ardine.

Blood and urine tests

If you are undergoing:

  • urine tests (glucose in urine) or blood tests for liver function
  • estriol tests (used during pregnancy to check if the baby is developing normally).

Tell your doctor or pharmacist that you are taking Amoxicillin/Bromhexine Ardine. This is because Amoxicillin/Bromhexine Ardine may alter the results of these types of tests.

This medicine should be used with caution in patients with kidney problems.

Taking Amoxicillin/Bromhexine Ardine with other medicines

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

  • If you are taking allopurinol (used for gout) with Amoxicillin/Bromhexine Ardine, you may be more likely to suffer a skin allergic reaction.
  • If you are taking probenecid (used to treat gout), your doctor may adjust the dose of Amoxicillin/Bromhexine Ardine. Concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
  • If you are taking anticoagulants (such as warfarin) with Amoxicillin/Bromhexine Ardine, more blood tests may be needed.
  • If you are taking other antibiotics (such as tetracycline), Amoxicillin/Bromhexine Ardine may be less effective.
  • If you are taking methotrexate (a medicine used to treat cancer and severe psoriasis), Amoxicillin/Bromhexine Ardine may increase the risk of side effects. Penicillins may reduce the excretion of methotrexate and cause a potential increase in side effects.

Pregnancy and breastfeeding

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

Driving and using machines

This medicine may have side effects, and the symptoms (such as allergic reactions, dizziness, and convulsions) may make you unfit to drive.

Do not drive or operate machinery unless you are feeling well.

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3. How to take Amoxicillin/Bromhexine Ardine

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with Amoxicillin/Bromhexine Ardine. Do not stop treatment before, even if you feel better, unless your doctor tells you to.

Amoxicillin/Bromhexine Ardine should be administered orally according to the instructions received from your doctor.

The posology will be as follows:

Children under 40 kg:

20 to 90 mg/kg/day in divided doses*. The standard dose will be:

Children from 10 to 20 kg in weight: 2.5 ml - 5 ml every 8 hours.

Children over 25 kg in weight: 5 ml - 10 ml every 8 hours.

Adults and children over 40 kg:

  • Acute bacterial exacerbation of chronic bronchitis: 500 mg every 8 hours, 750 mg to 1 g every 12 hours (10 ml every 8 hours and 15 to 20 ml every 12 hours). For severe infections, 750 mg to 1 g (15 to 20 ml) every 8 hours, for 10 days.
  • Community-acquired pneumonia: 500 mg to 1 g every 8 hours.

The indicated dose corresponds to the average recommended posology, however, in severe infections or those caused by less sensitive bacteria, the indicated doses may be increased according to medical criteria, depending on the severity of the infection.

If you take more Amoxicillin/Bromhexine Ardine than you should

If you have taken more Amoxicillin/Bromhexine Ardine than you should, the signs may be stomach upset (nausea, vomiting, or diarrhea) or crystals in the urine, which can be observed as cloudy urine or problems urinating.

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

If you forget to take Amoxicillin/Bromhexine Ardine

  • 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.

How long to take Amoxicillin/Bromhexine Ardine

  • Continue taking Amoxicillin/Bromhexine Ardine for the time your doctor has indicated, even if you feel better. You need to take all the doses to overcome the infection. If some bacteria survive, they can cause the infection to recur.
  • Once you finish treatment, if you continue to feel unwell, you should go back to see your doctor.

Thrush (a fungal infection of the moist parts of the body that can cause pain, itching, and white discharge) may appear if you take Amoxicillin/Bromhexine Ardine for a long time. If this happens, consult your doctor.

If you take Amoxicillin/Bromhexine Ardine for a long time, your doctor may perform additional tests to check that your kidneys, liver, and blood are working normally.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people):

  • Diarrhea and nausea.
  • Skin rash.

Uncommon side effects (may affect up to 1 in 100 people):

  • Vomiting.
  • Itching.

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

  • Hypersensitivity reactions
  • Exanthema, urticaria

Very rare side effects (may affect up to 1 in 10,000 people):

  • Fungal infections (mucocutaneous candidiasis).
  • Reversible decrease in the number of white blood cells.
  • Reversible decrease in the number of platelets (reversible thrombocytopenia), increased coagulation time, and prothrombin time.
  • Decrease in the number of red blood cells (hemolytic anemia).
  • Severe allergic reactions including angioedema, anaphylaxis (immediate hypersensitivity reaction), serum sickness (delayed allergic reaction), and hypersensitivity vasculitis.
  • Hyperkinesia (hyperactivity), dizziness, and convulsions.
  • Antibiotic-associated colitis.
  • Black hairy tongue.
  • Hepatitis and jaundice (yellowing of the skin and mucous membranes), moderate increase in liver enzymes.
  • Exfoliative and bullous dermatitis
  • Interstitial nephritis (inflammation of a part of the kidney), crystals in urine.

Side effects with unknown frequency (cannot be estimated from the available data)

  • Jarisch-Herxheimer reaction.
  • Anaphylactic reactions, such as anaphylactic shock, angioedema (rapidly progressing swelling of the skin, subcutaneous tissues, mucous membranes, or submucosal tissues), and pruritus.
  • Severe skin reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized 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)).
  • Chest pain in the context of allergic reactions, which can be a symptom of allergy-induced myocardial infarction (Kounis syndrome).
  • 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.
  • Crystals in the urine that cause acute kidney injury
  • Blistering rash arranged in a circle with a central crust or like a string of pearls (linear IgA disease)
  • Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicillin/Bromhexine Ardine

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

Do not store above 25°C. Store in the original packaging to protect from moisture.

Do not use Amoxicillin/Bromhexine Ardine after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amoxicillin/Bromhexine Ardine

  • The active substances are amoxicillin (trihydrate) and bromhexine (hydrochloride)
  • The other components are: magnesium stearate

Appearance of the product and packaging contents

Amoxicillin/Bromhexine Ardine 500 mg/8 mg hard capsules are presented in packs of 20 capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio Reig Jofre S.A.

Gran Capitán, 10

08970 Sant Joan Despí

Barcelona

Spain

Manufacturer

Laboratorio Reig Jofré, S.A.

C/ Jarama, s/n (Industrial Estate)

45007 Toledo

OTHER PRESENTATIONS

Amoxicillin/Bromhexine Ardine 250 mg/5 ml + 4 mg/5 ml powder for oral suspension.

Date of last revision of this leaflet: January 2023

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

Online doctors for AMOXICILLIN/BROMHEXINE ARDINE 500 mg/8 mg HARD CAPSULES

Discuss questions about AMOXICILLIN/BROMHEXINE ARDINE 500 mg/8 mg HARD CAPSULES, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (3)
Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns

Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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Doctor

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen 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.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • 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.

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Frequently Asked Questions

Is a prescription required for AMOXICILLIN/BROMHEXINE ARDINE 500 mg/8 mg HARD CAPSULES?
AMOXICILLIN/BROMHEXINE ARDINE 500 mg/8 mg HARD CAPSULES requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
Who manufactures AMOXICILLIN/BROMHEXINE ARDINE 500 mg/8 mg HARD CAPSULES?
AMOXICILLIN/BROMHEXINE ARDINE 500 mg/8 mg HARD CAPSULES is manufactured by Laboratorio Reig Jofre, S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of AMOXICILLIN/BROMHEXINE ARDINE 500 mg/8 mg HARD CAPSULES online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether AMOXICILLIN/BROMHEXINE ARDINE 500 mg/8 mg HARD CAPSULES is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to AMOXICILLIN/BROMHEXINE ARDINE 500 mg/8 mg HARD CAPSULES?
Other medicines with the same active substance () include Amoxicillin/Bromhexine Ardin 250mg/5ml + 4mg/5ml ORAL SUSPENSION POWDER. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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