AMOXICILLIN ARDINE 1000 mg ORAL SUSPENSION POWDER IN SACHETS

2. What you need to know before taking Amoxicilina Ardine

Do not take Amoxicilina Ardine

• if you are allergic to amoxicillin, penicillin, 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 take Amoxicilina Ardine if any of the above points apply 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 glands, 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 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)

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.

Using Amoxicilina Ardine with other medicines

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

• 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 the 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, 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 medicine used to treat cancer and severe psoriasis), Amoxicilina 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

Amoxicilina Ardine 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 feel well.

Amoxicilina 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 with them before taking this medicine.

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

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

3. How to take Amoxicilina Ardine

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

• Empty the contents of the sachet into 10-20 ml of water. Shake until a suspension forms. Take immediately.
• Space out the doses evenly throughout the day, at least 4 hours apart.

The usual dose is:

Children under 40 kg in weight

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

• Your doctor will indicate how much Amoxicilina Ardine to administer to your baby or child.
• The usual dose is 40-90 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 over 40 kg in weight

The usual dose of Amoxicilina Ardine is 250-500 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 - with 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 a dose of 1 g, twice a day, for 7 days with other antibiotics and medicines to treat stomach ulcers.
• To prevent heart infection during surgery:the dose will vary depending on the type of surgery. Other medicines 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.

Kidney 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, the signs may be stomach upset (nausea, vomiting, or diarrhea) or crystals in the urine, which can be seen as cloudy urine or difficulty urinating. Talk to your doctor as soon as possible. Bring the medicine with you to show them.

You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

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 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.

You may experience 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

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

• allergic reactions, the signs can include: itching of the skin or rash, swelling of the face, lips, tongue, body, or difficulty breathing. These can be serious and, in some cases, have been fatal.
• skin rash or flat red spots under the skin surface or bruising of the skin. This is due to inflammation of the blood vessel walls due to an allergic reaction. It can be associated with joint pain (arthritis) and kidney problems.
• a delayed allergic reaction may appear 7-12 days after taking Amoxicilina Ardine, some signs include: rashes, fever, joint pain, and swelling of the lymph nodes, especially under the arms.
• a skin reaction called 'erythema multiforme' in which you may develop: purple or reddish patches 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, or genitals. You may have a fever and feel very tired.
• other serious skin reactions may include: change in skin color, lumps under the skin, blisters, pimples with pus, peeling, redness, pain, itching. These can be associated with fever, headache, and body pain.
• flu-like symptoms with skin rash, fever, gland inflammation, 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 can be signs of a problem with your blood cells.
• Jarisch-Herxheimer reaction that occurs during treatment with Amoxicilina Ardine for Lyme disease and causes fever, chills, headache, muscle pain, and skin rash.
• inflammation of the large intestine (colon) with diarrhea (sometimes with blood), pain, and fever.
• serious liver effects may occur. These are mainly associated with prolonged treatments, males, and the elderly. You should inform your doctor immediately if you have:
• • severe diarrhea with bleeding.
  • blisters, redness, or bruising of the skin.
  • dark urine or pale stools.
  • yellowing of the skin and the whites of the eyes (jaundice). See also anemia below, which can lead to jaundice.
• Chest pain in the context of allergic reactions, which can be a symptom of 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 medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.
• Crystals in the urine that cause acute kidney injury.
• A skin rash with blisters 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).

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

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

Sometimes you may experience less severe skin reactions such as:

• a moderate rash with itching (round, pink-red patches), 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 experience any of these, talk to your doctor, as you will need to interrupt your treatment with Amoxicilina Ardine.

Other possible side 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 get treatment for candidiasis from your doctor or pharmacist.
• kidney problems.
• seizures (convulsions), observed in patients treated with high doses or with kidney problems.
• dizziness.
• hyperactivity.
• crystals in the urine, which can appear as cloudy urine or difficulty or discomfort when urinating. Make sure to drink plenty of fluids to reduce the possibility of these symptoms.
• discoloration of the teeth, 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.
• a excessive breakdown of red blood cells that causes a type of anemia. The signs include: fatigue, headache, difficulty breathing, dizziness, paleness, and yellowing of the skin and the whites of the eyes.
• low white blood cell count.
• low number of cells involved in blood clotting.
• the blood may take longer than usual to clot. You may notice this if you have a nosebleed or cut yourself.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicilina Ardine

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

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

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

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

6. Container Content and Additional Information

Composition of Amoxicilina Ardine

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

Anhydrous trisodium citrate (sodium)

Anhydrous colloidal silica

Titanium dioxide (E-171)

Raspberry flavor (contains glucose and corn starch)

Sodium lauryl sulfate (sodium)

Talc (E553b)

Sucrose

Appearance of the Product and Container Content

Amoxicilina Ardine 1000 mg powder for oral suspension in sachet contains a white-colored powder in monodose sachets. These sachets are packaged in a box. 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 Last Revision of this Leaflet: January 2023.

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