Amoxicillin/Bromhexine Ardin 250mg/5ml + 4mg/5ml ORAL SUSPENSION POWDER

Introduction

Package Leaflet: Information for the User

Amoxicillin/Bromhexine Ardine 250 mg/5 ml + 4 mg/5 ml Powder for Oral Suspension

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 that belongs 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 effectiveness 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 the common cold.

It is essential that you follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. 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 into the trash.

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

• Acute bacterial exacerbation of chronic bronchitis.

• Community-acquired pneumonia.

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 a 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 having:

• 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 necessary.
• If you are taking other antibiotics (such as tetracycline), Amoxicillin/Bromhexine Ardine may be less effective.
• If you are taking methotrexate (a medicine for treating cancer and severe psoriasis), Amoxicillin/Bromhexine Ardine may increase the adverse effects. Penicillins may reduce the excretion of methotrexate and cause a potential increase in adverse effects.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

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 adverse effects and symptoms (such as allergic reactions, dizziness, and convulsions) that may make you unfit to drive.

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

Important information about some of the ingredients of Amoxicillin/Bromhexine Ardine

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking the medicine.

Patients with diabetes mellitus should note that this medicine contains approximately 0.66 g/ml of sucrose.

3. How to take Amoxicillin/Bromhexine Ardine

Follow the instructions for administration of Amoxicillin/Bromhexine Ardine indicated by your doctor or pharmacist. In case of 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 dosage 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 dosage, 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.

Instructions for the correct administration of the preparation

Invert the bottle to release the powder stuck to the bottom. Add a little water and shake. Fill with water up to the line marked with the arrow. Shake before using.

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 the 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 functioning 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 skin and mucous membranes), moderate increase in liver enzymes.
• Exfoliative and bullous dermatitis
• Interstitial nephritis (inflammation of a kidney area), crystals in urine.

Side effects with unknown frequency (cannot be estimated from 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, gland inflammation, and abnormal blood test results (such as increased leukocytes (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 side effects 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.

Once reconstituted, do not store the oral suspension at more than 25°C; the validity period in these conditions is 14 days.

Do not use Amoxicillin/Bromhexine Ardine after the expiry date stated on the packaging. The expiry 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 medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. 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: sucrose, sodium benzoate, disodium edetate dihydrate, anhydrous sodium citrate, strawberry flavor, peach flavor.

Appearance of the product and contents of the pack

Amoxicillin/Bromhexine Ardine is presented in packs to prepare 120 ml of suspension.

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 (Polígono Industrial)

45007 Toledo

OTHER PRESENTATIONS

Amoxicillin/Bromhexine Ardine 500 mg/8 mg hard capsules.

Date of the 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