Label:Information for the User

Amoxicilina Ardine 500 mg Powder for Oral Suspension in EFG Blister Packs

amoxicilina

Read this label carefully before starting to take this medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• 1. If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribedonlyto you (or your child), and you must not give it to other people even if they havethe same symptomsas you,as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

What is Amoxicilina Ardine

Amoxicilina Ardine is an antibiotic. The active ingredient is amoxicilina. This medication belongs to a group of medications known as “penicilins”.

What is Amoxicilina Ardine 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 medications to treat stomach ulcers.

Do not take Amoxicilina Ardine

• if you are allergic to amoxicillin, penicillins, or any of the other components of this medication (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 take Amoxicilina Ardine if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking Amoxicilina Ardine.

Warnings and precautions

Consult your doctor or pharmacist before taking Amoxicilina Ardine if:

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

If you are unsure whether any of the above situations apply to you, inform your doctor or pharmacist before taking Amoxicilina 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)

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

Use of Amoxicilina Ardine with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

• If you are taking allopurinol (used for gout) with Amoxicilina Ardine, you may be more likely to have a skin rash.
• If you are taking probenecid (used to treat gout), your doctor may adjust the dose of Amoxicilina Ardine. The concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
• If you are taking anticoagulants (such as warfarin) with Amoxicilina Ardine, more blood tests may be necessary.
• If you are taking other antibiotics (such as tetracycline), Amoxicilina Ardine may be less effective.
• If you are taking methotrexate (a medication used to treat cancer and severe psoriasis), Amoxicilina Ardine may increase the risk of side effects. Penicillins may reduce the excretion of methotrexate and increase the risk of side effects.

Pregnancy and breastfeeding

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

Driving and operating machinery

Amoxicilina Ardine may cause side effects and symptoms (such as allergic reactions, dizziness, and seizures) that may make it unsafe to drive.

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

Amoxicilina Ardine contains glucose, sucrose, and sodium

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

Patients with diabetes mellitus should note thatthis medication contains 3.1 g of sucrose per tablet.

Patients on low-sodium diets should note that this medication contains 8.23 mg (0.36 mmol) of sodium per tablet.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• Empty the contents of the packet into 10 to 20 ml of water. Shake until a suspension forms. Take immediately.
• Space the doses uniformly throughout the day, at least separated by 4 hours.

The usual dose is:

Children under 40 kg of weight

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

• Your doctor will tell you how much Amoxicilina Ardine to administer to your baby or child.
• The usual dose is 40 mg to 90 mg per kilogram of body weight per day, administered 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 40 kg of weight 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 infections:3 g twice a day, for one day.
• Lyme disease (a disease caused by some parasites called ticks):erythema migrans isolated (early stage – circular pink or red rash): 4 g per day; systemic manifestations (late stage – with more severe symptoms or when the disease spreads throughout the body): up to 6 g per day.
• Stomach ulcers:one dose of 750 mg or one dose of 1 g, twice a day, for 7 days with other antibiotics and medications to treat stomach ulcers.
• To prevent heart infection during surgery:The dose will vary depending on the type of surgery. Other medications may be administered at the same time. Your doctor, pharmacist, or nurse can provide more details.
• The maximum recommended dose is 6 g per day.

Renal problems

If you have renal 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, the signs may be stomach discomfort (nausea, vomiting, or diarrhea) or crystals in the urine, which may be observed as cloudy urine or difficulty urinating. Talk to your doctor as soon as possible.

Also, you can call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot 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 compensate for the missed doses.

How long should you take Amoxicilina Ardine

• Continue taking Amoxicilina Ardine for the time your doctor has told you, even if you feel better. You need to take all the doses to overcome the infection. If some bacteria survive, they may cause the infection to recur.
• Once you have finished the treatment, if you continue to feel unwell, you should go back to see your doctor.

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

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

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

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

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

The following side effects are very rare (can affect up to 1 in 10,000 people)

• Allergic reactions, symptoms may include: skin itching or rash, facial swelling, lip, tongue, body, or difficulty breathing. These can be severe and, in some cases, have been fatal
• Rash on the skin or flat red spots like the tip of a pin under the skin's surface or bruises on the skin. This is due to the inflammation of the blood vessel walls due to an allergic reaction. It may be associated with joint pain (arthritis) and kidney problems
• You may experience a delayed allergic reaction up to 7 to 12 days after taking Amoxicilina Ardine, some symptoms include: rashes, fever, joint pain, and lymph node enlargement, especially under the arms
• A skin reaction called 'erythema multiforme' in which you may develop: purple or reddish rashes with itching on the skin, especially on the palms of the hands or soles of the feet, swollen areas on the skin, soft tissues on the surface of the mouth, eyes, and genitals. You may have a fever and feel very tired
• Other severe skin reactions may include: skin color change, lumps under the skin, blisters, pustules with pus, peeling, redness, pain, itching. These may be associated with fever, headache, and body aches
• Flu-like symptoms with skin rash, fever, gland inflammation, and abnormal blood test results (such as increased eosinophils and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS))
• Fever, chills, sore throat, or other signs of infection, or appearance of bruises easily. These may be signs of a problem with your blood cells
• Reaction ofJarisch-Herxheimerthat occurs during treatment with Amoxicilina Ardine for Lyme disease and causesfever, chills, headache, muscle pain, and skin rash
• Inflammation of the large intestine (colon) with diarrhea (sometimes with blood), pain, and fever
• You may experience severe side effects in the liver. These are mainly associated with prolonged treatments, men, and advanced age. Inform your doctor immediately if you have:
• • Severe diarrhea with bleeding
  • Blisters, redness, or bruises on the skin
  • Dark urine or pale stools
  • Skin and white of the eyes yellowish in color (jaundice). See anemia below, which may cause jaundice.
• Chest pain in the context of allergic reactions, which may be a symptom of an allergy-induced 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 of repeated vomiting (1-4 hours after taking the medication). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.
• Crystals in the urine that cause acute kidney damage
• Rash with blisters arranged in a circle with a central crust or like a pearl necklace (IgA linear disease)
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)

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

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

At times, you may experience milder skin reactions such as:

• A moderate rash with itching (round, pink-red rashes), swollen areas with blister-like appearance on forearms, legs, palms, hands, or feet. This is rare (can affect up to 1 in 100 people).

If you experience any of them, talk to your doctor as you will need to interrupt your treatment with Amoxicilina Ardine.

Other possible side effects are:

Frequent(can affect up to 1 in 10 people)

• Skin rash
• Nausea
• Diarrhea.

Rare(can affect up to 1 in 100 people)

• Vomiting.

Very rare(can 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 kidney problems
• Dizziness
• Hyperactivity
• Crystals in the urine, which may appear as cloudy urine or difficulty or discomfort urinating. Make sure to drink plenty of liquid to reduce the likelihood of these symptoms
• Alteration in tooth color, which usually disappears with brushing (this has been reported in children)
• The tongue may change color to yellow, brown, or black and may have a hairy appearance
• Excessive breaking of red blood cells that causes a type of anemia. Symptoms include: fatigue, headache, difficulty breathing, dizziness, paleness, and yellowish skin and eye color
• Low white blood cell count
• Low count of cells involved in blood clotting
• Blood may take longer than usual to clot. You may notice this if you bleed from the nose or cut yourself.

Reporting of side effects

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

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

Do not use this medication after the expiration datethat appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture

Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointof your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Amoxicilina Ardine

• The active ingredient in each sachet is 500 mg of amoxicilina.
• The other components are:

Anhydrous trisodium citrate (sodium)

Anhydrous colloidal silica

Titanium dioxide (E171)

Raspberry flavor (contains glucose and cornstarch)

Sodium lauryl sulfate (sodium)

Magnesium stearate

Sucrose

Appearance of the product and contents of the package

Amoxicilina Ardine 500 mg powder for oral suspension in sachet contains a white powder in single-dose sachets. These sachets are packaged in a blister pack. It is available in packs of 20 and 30 sachets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Reig Jofre, S.A. Laboratory

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Responsible for manufacturing

Reig Jofre, S.A. Laboratory

Jarama, 111

45007 Toledo

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 of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/