Amoxicillin Ardiné 1000 mg powder for oral suspension in sachets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amoxicilina Ardine 1000 mg powder for oral suspension in sachets EFG

amoxicillin

Read all of 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.

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

Contents of the leaflet

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 adverse 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 called "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 the instructions regarding dose, dosing interval, and duration of treatment as given by your doctor.

Do not keep or reuse this medicine. If you have leftover antibiotic after completing 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 Amoxicilina Ardine

Do not take Amoxicilina Ardine

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

Warnings and precautions

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

• you have infectious mononucleosis (fever, sore throat, swollen glands, and extreme tiredness)
• 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 Amoxicilina 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 Amoxicilina Ardine. This is because Amoxicilina Ardine may alter the results of these types of tests.

Use of Amoxicilina Ardine with other medicines

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 Amoxicilina 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 Amoxicilina Ardine. Concomitant use of probenecid may reduce the excretion of Amoxicilina and is not recommended.
• If you are taking anticoagulants (such as warfarin) with Amoxicilina Ardine, additional blood tests may be required.
• If you are taking other antibiotics (such as tetracycline), Amoxicilina Ardine may be less effective.
• If you are taking methotrexate (a medicine used to treat cancer and severe psoriasis), Amoxicilina Ardine may cause an increase in adverse effects. Penicillins may reduce the excretion of methotrexate and cause a potentially increased risk of 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

Amoxicilina 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.

Amoxicilina Ardine contains glucose, sucrose, and sodium

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

Patients with diabetes mellitus should be aware that this medicine contains 3.1 g of sucrose per sachet.

Patients on low-sodium diets should be aware that this medicine contains 8.23 mg (0.36 mmol) of sodium per sachet.

3. How to take Amoxicilina Ardine

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

• Empty the contents of the sachet into 10 to 20 ml of water. Shake until a suspension is formed. Take immediately.
• Space your doses evenly throughout the day, with doses 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

The usual dose of Amoxicilina Ardine is 250 mg to 500 mg three times a day or 750 mg to 1 g every 12 hours, depending on the severity and type of infection.

• Severe infections: 750 mg to 1 g, three times a day.
• Urinary tract infection: 3 g twice a day for one day.
• Lyme disease (an infection caused by parasites called ticks): isolated erythema migrans (early stage – circular pink or red rash): 4 g per day; systemic manifestations (late stage – more severe symptoms or when the disease spreads throughout the body): up to 6 g per day.
• Stomach ulcers: a dose of 750 mg or 1 g, twice a day for 7 days, together with other antibiotics and medicines for treating stomach ulcers.
• To prevent heart infection during surgery: the dose will vary depending on the type of surgery. Other medicines may be given at the same time. Your doctor, pharmacist, or nurse can provide further details.
• The maximum recommended dose is 6 g per day.

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 Ardine than you should, symptoms may include stomach discomfort (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. Take the medicine with you so you can show it.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of 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 you should take Amoxicilina Ardine

• Continue taking Amoxicilina Ardine for as long as your doctor has told you, 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.
• If you still feel unwell after finishing the treatment, you should see your doctor again.

You may develop candidiasis (a fungal infection affecting moist areas of the body that can cause pain, itching, and white discharge) if you take Amoxicilina Ardine for a prolonged period. If this occurs, consult your doctor.

If you take Amoxicilina Ardine for a long time, 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 led to death
• skin rash or flat, round red spots like pinpricks 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 swollen lymph nodes, especially under the arms
• a skin reaction called ‘erythema multiforme’ in which you may develop: itchy purple or reddish spots 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 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 diarrhea (sometimes bloody), 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 diarrhea 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 a heart attack triggered by allergy (Kounis syndrome).
• Drug-induced enterocolitis syndrome (DIES): DIES has been reported mainly in children receiving amoxicillin. 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.
• 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 with a blister-like appearance on the 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 your treatment with Amoxicilina Ardine.

Other possible adverse effects are:

Common (may affect up to 1 in 10 people)

• skin rash
• nausea
• diarrhea.

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
• epileptic 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 you drink plenty of fluids to reduce the likelihood of these symptoms
• changes in tooth coloration, which usually disappears with brushing (this has been reported in children)
• the tongue may turn yellow, brown, or black and may appear hairy
• excessive breakdown of red blood cells causing a type of anaemia. Signs include: fatigue, 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. You may notice this 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 Medicinal Products: 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.

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located 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. Package contents and additional information

Composition of Amoxicilina Ardine

• The active substance in each sachet is 1000 mg of amoxicillin.
• The other components are:

Anhydrous trisodium citrate (sodium)

Anhydrous colloidal silica

Titanium dioxide (E-171)

Raspberry flavour (contains glucose and maize starch)

Sodium lauryl sulfate (sodium)

Talc (E553b)

Sucrose

Appearance of the product and contents of the pack

Amoxicilina Ardine 1000 mg powder for oral suspension in sachet contains a white-coloured powder in single-dose sachets. These sachets are packed in a carton. It is available in packs of 20 and 30 sachets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Manufacturer

Laboratorio Reig Jofre, S.A.

Jarama, 111

45007 Toledo

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

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