Package Insert: Information for the User

Amoxicilina Ardine 250 mg/5 ml Powder for Oral Suspension EFG

amoxicilina

Read this package insert carefully before starting to take this medication, becauseit contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you (or your child), and you should not give it to others even if they have the same symptoms as 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 package insert. See section 4.

What is Amoxicilina Ardine

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

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, penicillin, 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 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 having:

• urine tests (glucose in urine) or blood tests for liver function
• blood tests for estriol (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 othermedication.

• If you are taking allopurinol (used for gout) with amoxicilina ardine, you may be more likely to suffer 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 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 medication used to treat cancer and severe psoriasis), amoxicilina ardine may cause an increase in 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, or think you may be pregnant, or plan to become 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, saccharose, and sodium

This medication contains glucose and saccharose. 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 that this medication contains 1.6 g of saccharose per 5 ml (320 mg per ml).

It may cause tooth decay.

Patients with low-sodium diets should note that this medication contains 16.43 mg (0.71 mmol) of sodium per 5 ml of reconstituted suspension.

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

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

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

This suspension is not usually recommended for adults and children weighing more than 40 kg. Ask your doctor or pharmacist for advice.

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 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. Bring the medication to show them. You can also call the Toxicology 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 make up 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 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 medication, ask your doctor or pharmacist.

Like all medicines, this medicinecan 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 needurgent medical treatment:

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

• allergic reactions, symptoms may include: itching or rash, swelling of the face, lips, tongue, body, or difficulty breathing. These can be severe and, in some cases, have been fatal
• skin rash or flat, round, red spots like the tip of a pin under the skin's surface or bruises on the skin. This is due to inflammation of the blood vessel walls due to an allergic reaction. It may be associated with joint pain (arthritis) and kidney problems
• a delayed allergic reaction may occur 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,boils with pus, peeling, redness, pain, and 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 the appearance of bruises easily. These may be signs of a problem with your blood cells
• Jarisch-Herxheimer reaction that occursduring treatment with Amoxicilina Ardine for Lyme diseaseand 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
  • yellowing of the skin and the white of the eyes (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 several weeks after.

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

Sometimes you may experience milder skin reactions such as:

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

Discuss this with 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 fluids to reduce the likelihood of these symptoms
• change 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 appear hairy
• excessive breaking of red blood cells, which causes a type of anemia. Symptoms include: fatigue, headache, difficulty breathing, dizziness, paleness, and yellowing of the skin and the white of the eyes
• 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 not listed 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 date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Dry Powder

Store in the original packaging to protect it from moisture.

Liquid Suspension

Once the suspension is reconstituted, it must be used within the following 14 days in the refrigerator.

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

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at your local pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Amoxicilina Ardine

• The active ingredient is amoxicilina. In each 5 ml of suspension, the content of amoxicilina is 250 mg.
• The other components are:Anhydrous citric acid (E330), Trisodium citrate dihydrate (E331) (sodium), Sodium benzoate (E211), Microcrystalline cellulose (E460)/Sodium carboxymethyl cellulose (E466), Strawberry flavor (contains glucose and cornstarch), Aerosil, Magnesium stearate, Sodium lauryl sulfate (sodium) and Sucrose.

Appearance of the product and contents of the package

Amoxicilina Ardine 250 mg/5 ml oral powder for suspension is a white powder in glass bottles of type II, topaz color with a nominal volume of 114 ml (for 40 ml presentations) or 158 ml (for 120 ml presentations). These bottles are packaged in a case with a graduated dosing syringefor a medium dose of 30 mg/kg of weight and day, with the equivalence in weight of the child and milliliters per dose.

Holder of the marketing authorizationand responsible for manufacturing:

Holder of the marketing authorization:

Reig Jofré, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Responsible for manufacturing:

Reig Jofré, S.A.

Jarama, 111 (Industrial Polygon)

45007 (Toledo)

Date of the last review of this leaflet: January 2023.

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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Instructions for reconstitution

Check that the stopper is intact before use.

Invert and shake the bottle to release the powder adhering to the bottom.

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

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

Shake well before taking each dose.