Amoxicillin Ardiné 250 mg/5 ml powder for oral suspension EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Amoxicilina Ardine 250 mg/5 ml powder for oral suspension EFG

amoxicillin

Read the entire 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 (or your child) 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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Amoxicilina Ardine is and what it is used for

What Amoxicilina Ardine is

Amoxicilina Ardine is an antibiotic. The active substance is amoxicillin. This medicine belongs to a group of medicines known as "penicillins".

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

It is important that you follow your doctor's instructions regarding dosage, dosing interval, 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.

What Amoxicilina Ardine is used for

Amoxicilina Ardine is used to treat bacterial infections in different parts of the body. Amoxicilina Ardine may also be used in combination with other medicines to treat stomach ulcers.

2. What you need to know before starting to take Amoxicillin Ardine

Do not take Amoxicillin Ardine:

• if you are allergic to amoxicillin, penicillin, or to any of the other ingredients 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 take Amoxicillin Ardine if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Amoxicillin Ardine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Amoxicillin Ardine if:

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

If you are unsure whether any of the above conditions apply to you, inform your doctor or pharmacist before taking Amoxicillin Ardine.

Blood and urine tests

If you are undergoing:

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

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

Use of Amoxicillin Ardine with other medicines

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 (used for gout) with Amoxicillin Ardine, you may be more likely to experience a skin allergic reaction.
• If you are taking probenecid (used to treat gout), your doctor may adjust your dose of Amoxicillin 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 Ardine, additional blood tests may be required.
• If you are taking other antibiotics (such as tetracycline), Amoxicillin Ardine may be less effective.
• If you are taking methotrexate (a medicine used to treat cancer and severe psoriasis), Amoxicillin Ardine may cause an increase in adverse effects. Penicillins may reduce methotrexate excretion and potentially increase adverse effects.

Pregnancy and breastfeeding

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 Ardine may cause adverse effects, and symptoms (such as allergic reactions, dizziness, and seizures) may mean you should not drive.

Do not drive or operate machinery unless you feel well.

Amoxicillin Ardine contains glucose, sucrose, and sodium

This medicine contains glucose and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

Patients with diabetes mellitus should be aware that this medicine contains 1.6 g of sucrose per 5 ml (320 mg per ml).

It may cause tooth decay.

Patients on low-sodium diets should be aware that this medicine contains 16.43 mg (0.71 mmol) of sodium per 5 ml of reconstituted suspension.

3. How to take Amoxicilina Ardine

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

• Shake the bottle well before each dose.
• Space your doses evenly throughout the day, at least 4 hours apart.

The usual dose is:

Children weighing less than 40 kg

All doses are based on the child's body weight in kilograms.

• Your doctor will tell you how much Amoxicilina Ardine to give your baby or child.
• The usual dose is 40 mg to 90 mg per kilogram of body weight per day, given in two or three divided doses.
• The maximum recommended dose is 100 mg per kilogram of body weight per day.

Adults, elderly patients, and children weighing 40 kg or more

This suspension is generally not recommended for adults and children weighing more than 40 kg. Please seek advice from your doctor or pharmacist.

Renal problems

If you have kidney problems, the dose may be lower than the usual dose.

If you take more Amoxicilina Ardine than you should

If you have taken more Amoxicilina than you should, symptoms may include stomach upset (nausea, vomiting, or diarrhea) or crystals in the urine, which may appear as cloudy urine or difficulty urinating. Contact your doctor as soon as possible. Bring the medicine with you to show it to the doctor. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Amoxicilina 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 Amoxicilina Ardine

• Continue taking Amoxicilina Ardine for the length of time prescribed by your doctor, even if you feel better. You need to take all the doses to completely eliminate the infection. If some bacteria survive, the infection may return.
• After completing the treatment, if you still feel unwell, you should see your doctor again.

Prolonged use of Amoxicilina Ardine may lead to candidiasis (a fungal infection in moist areas of the body that may cause pain, itching, and white discharge). If this occurs, consult your doctor.

If you take Amoxicilina Ardine for a prolonged period, your doctor may perform additional blood tests to check that your kidneys, liver, and blood are functioning normally.

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.

Stop taking Amoxicilina Ardine and see a doctor immediately if you experience any of the following serious adverse effects – you may need urgent medical treatment:

The following adverse effects are very rare (may affect up to 1 in 10,000 people):

• allergic reactions, signs may include: skin itching or rash, swelling of the face, lips, tongue, body, or difficulty breathing. These may be severe and, in some cases, have resulted in death
• skin rash or flat, round red spots like the tip of a pin under the skin surface or bruising on the skin. This is due to inflammation of the walls of blood vessels caused by an allergic reaction. It may be associated with joint pain (arthritis) and kidney problems
• a delayed allergic reaction may occur 7 to 12 days after taking Amoxicilina Ardine, some signs include: rashes, fever, joint pain, and enlargement of lymph nodes, especially under the arms
• a skin reaction called 'erythema multiforme' in which you may develop: itchy purple or reddish hives on the skin, especially on the palms of the hands or soles of the feet, raised swollen areas on the skin, soft tissue lesions on the surface of the mouth, eyes, and genitals. You may also have fever and feel very tired
• other serious skin reactions may include: change in skin color, lumps under the skin, blisters, pus-filled pimples, peeling, redness, pain, itching. These may be associated with fever, headache, and body pain
• 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))
• fever, chills, sore throat, or other signs of infection, or easy bruising. These may be signs of a problem with your blood cells
• Jarisch-Herxheimer reaction occurring during treatment with Amoxicilina Ardine for Lyme disease, causing fever, chills, headache, muscle pain, and skin rash
• inflammation of the large intestine (colon) with diarrhoea (sometimes with blood), pain, and fever
• serious adverse effects in the liver may occur. These are mainly associated with prolonged treatment, male sex, and advanced age. You should inform your doctor immediately if you have:
  • severe diarrhoea with bleeding
  • blisters, redness, or bruising on the skin
  • dark urine or pale stools
  • yellowing of the skin and whites of the eyes (jaundice). See also anaemia below, which may lead to jaundice.
• chest pain in the context of allergic reactions, which may be a symptom of an allergic-triggered heart attack (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 being repeated vomiting (1-4 hours after taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.
• crystals in the urine causing acute kidney injury.
• blistering rash arranged in circles with central crusts or resembling a string of pearls (linear IgA disease)
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)

These may occur during treatment or up to several weeks afterwards.

If any of the above symptoms appear, stop taking the medicine and see your doctor immediately.

Sometimes you may experience less severe skin reactions such as:

• a moderate rash with itching (round, pink-red spots), swollen areas resembling blisters on forearms, legs, palms, hands, or feet. This is uncommon (may affect up to 1 in 100 people).

If you have any of these, speak to your doctor as you will need to stop treatment with Amoxicilina Ardine.

Other possible adverse effects are:

Common (may affect up to 1 in 10 people)

• skin rash
• nausea
• diarrhoea.

Uncommon (may affect up to 1 in 100 people)

• vomiting.

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

• candidiasis (fungal infection in the vagina, mouth, or skin folds); you can obtain treatment from your doctor or pharmacist for candidiasis
• kidney problems
• seizures (convulsions), observed in patients treated with high doses or with kidney problems
• dizziness
• hyperactivity
• crystals in the urine, which may appear as cloudy urine or difficulty or discomfort when urinating. Make sure to drink plenty of fluids to reduce the likelihood of these symptoms
• change in tooth coloration, which usually disappears with brushing (this has been reported in children)
• the tongue may change color to yellow, brown, or black and may appear hairy
• excessive breakdown of red blood cells causing a type of anaemia. Signs include: tiredness, headache, difficulty breathing, dizziness, paleness, and yellowing of the skin and whites of the eyes
• low number of white blood cells
• low number of cells involved in blood clotting
• blood may take longer than normal to clot. This may be noticed if you have nosebleeds or cuts that bleed excessively.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, 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 Ardine

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

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

Dry powder

Store in the original packaging to protect it from moisture.

Liquid suspension

Once reconstituted, the suspension must be used within 14 days when stored in the refrigerator.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your usual pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amoxicilina Ardine

• The active substance is amoxicillin. Each 5 ml of suspension contains 250 mg of amoxicillin.
• The other components are: Anhydrous citric acid (E330), trisodium citrate dihydrate (E331) (sodium), sodium benzoate (E211), microcrystalline cellulose (E460)/sodium carboxymethylcellulose (E466), raspberry flavour (contains glucose and maize starch), Aerosil, magnesium stearate, sodium lauryl sulfate (sodium), and sucrose.

Appearance of the product and contents of the pack

Amoxicilina Ardine 250 mg/5 ml powder for oral suspension is a white powder contained in type II amber glass bottles with a nominal volume of 114 ml (for the 40 ml presentations) or 158 ml (for the 120 ml presentations). These bottles are packaged in a carton box with a graduated oral dosing syringe for a standard dose of 30 mg/kg per day, showing the child's weight and the corresponding volume in millilitres per dose.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

Laboratorio Reig Jofré, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Manufacturer:

Laboratorio Reig Jofré, S.A.

Jarama, 111 (Polígono Industrial)

45007 (Toledo)

Date of the most recent revision of this leaflet: January 2023.

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

General advice regarding the use of antibiotics

Antibiotics are used to treat bacterial infections. They are not effective against viral infections.

Sometimes a bacterial infection does not respond to antibiotic treatment. One of the most common reasons for this is that the bacteria causing the infection are resistant to the antibiotic being taken. This means that the bacteria can survive or grow despite the presence of the antibiotic.

Bacteria can become resistant to antibiotics for many reasons. Using antibiotics appropriately can reduce the likelihood of bacteria developing resistance.

When your doctor prescribes an antibiotic, it is intended solely for the treatment of your current illness. Following the advice below will help you prevent the emergence of resistant bacteria, which could render antibiotics ineffective:

1. It is very important to take the antibiotic at the correct dose, at the recommended times, and for the full prescribed duration. Read the instructions in the leaflet carefully, and if you do not understand something, ask your doctor or pharmacist.
2. You should not take an antibiotic unless it has been specifically prescribed for you, and you should use it only for the infection for which it was prescribed.
3. You should not take antibiotics that have been prescribed for other people, even if their infection seemed similar to yours.
4. You should not give antibiotics prescribed for you to other people.
5. If you have leftover antibiotics after completing your treatment, return all unused medicines to your pharmacy to ensure they are properly disposed of.

Reconstitution instructions

Check that the cap is intact before use.

Invert and shake the bottle to loosen any powder adhering to the bottom.

Fill the bottle with water up to the mark indicated by an arrow on the label of the bottle.

Invert and shake well, then refill with water up to the mark. Invert and shake again.

Shake well before taking each dose.