AMOXICILLIN ARDINE 125 mg/5 ml ORAL SUSPENSION POWDER

Introduction

Package Leaflet: Information for the User

Amoxicilina Ardine 125 mg/5 ml Powder for Oral Suspension EFG

amoxicillin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.Keep this leaflet. You may need to read it again..

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

What is Amoxicilina Ardine

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 the flu or the common cold.

It is important that you follow the instructions regarding dosage, administration interval, and treatment duration as indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

What is Amoxicilina Ardine used for

Amoxicilina Ardine is used to treat infections caused by bacteria in different parts of the body. Amoxicilina Ardine can also be used in combination with other medicines to treat stomach ulcers.

2. What you need to know before you 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 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 not sure, 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 not sure if 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).

Tell 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

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

• If you are taking allopurinol (used for gout) with Amoxicilina Ardine, you may be more likely to suffer an allergic skin 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 amoxicillin and is not recommended.
• If you are taking anticoagulants (such as warfarin) with Amoxicilina Ardine, more blood tests may be needed.
• 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Amoxicilina Ardine may cause side effects such as allergic reactions, dizziness, and convulsions, which may affect your ability to drive or operate machinery.

Do not drive or operate machinery unless you are feeling 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 some sugars, consult with them before taking this medicine.

Patients with diabetes mellitus should note that this medicine contains 1.25 g of sucrose per 5 ml of suspension (250 mg per ml).

It may cause tooth decay.

Patients on low-sodium diets should note that this medicine contains 8.42 mg (0.36 mmol) of sodium per 5 ml of reconstituted suspension.

3. How to take Amoxicilina Ardine

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

• Shake the bottle well before each dose.
• 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 tell you how much Amoxicilina Ardine to give to 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 over 40 kg in weight

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

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 than you should, the signs may include stomach upset (nausea, vomiting, or diarrhea) or crystals in the urine, which may appear as cloudy urine or difficulty urinating. Talk to your doctor as soon as possible. Take the medicine with you to show them. You can also call the Toxicology Information Service, telephone 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 duration indicated by your doctor, 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 treatment, if you continue to feel unwell, you should go back to see your doctor.

Thrush (a fungal infection of the moist parts of the body that can cause pain, itching, and white discharge) may occur if you take Amoxicilina Ardine for a long time. If this happens, consult your doctor.

If you take Amoxicilina Ardine for a long time, your doctor may perform additional 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody 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 may 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 round 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 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 swelling of the lymph nodes especially under the arms
• a skin reaction called 'erythema multiforme' in which you may develop: purple or reddish spots 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 be 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 may 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 may 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 tell 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 cause jaundice.
• Chest pain in the context of allergic reactions, which may be a symptom of allergy-induced myocardial infarction (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 eruption 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 occur, stop taking the medicine and see a doctor immediately.

You may also experience less serious 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 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)

• thrush (fungal infection in the vagina, mouth, or skin folds), you can get treatment for thrush 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 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
• 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: tiredness, 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 normal to clot. You may notice this if you have a nosebleed or cut yourself.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Monitoring System: 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 expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

Dry powder

Store in the original package to protect from moisture.

Liquid suspension

125 mg/5 ml: Once the suspension is reconstituted, it must be used within 7 days in the refrigerator.

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

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Composition of Amoxicilina Ardine

The active ingredient is amoxicillin. In each 5 ml of suspension, the amoxicillin content is 125 mg.

The other components are: Anhydrous citric acid (E330), Sodium citrate dihydrate (E331) (sodium), Sodium benzoate (E211), Microcrystalline cellulose (E460)/sodium carboxymethyl cellulose (E466), Raspberry flavor (contains glucose and corn starch), Aerosil, Magnesium stearate, Sodium lauryl sulfate (sodium), and Sucrose.

Appearance of the Product and Container Content

Amoxicilina Ardine 125 mg/5 ml powder for oral suspension is a white powder in type II amber glass bottles with a nominal volume of 158 ml (for 120 ml presentations). These bottles are packaged in a box with a double dosing spoon.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Laboratorio Reig Jofré, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Manufacturer:

Laboratorio Reig Jofré, S.A.

Jarama, 111 (Industrial Estate)

45007 (Toledo)

Date of the Last Revision of this Prospectus: 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/

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 antibiotic.

Bacteria can become resistant to antibiotics for many reasons. Using antibiotics properly can reduce the chances of bacteria becoming resistant to them.

When your doctor prescribes an antibiotic, it is only to treat your current illness. Paying attention to the following tips will help you prevent the appearance of resistant bacteria that can make the antibiotic not work:

1. You should not take an antibiotic unless it has been specifically prescribed for you, and you should only use it for the infection for which it was prescribed.
2. You should not take antibiotics that have been prescribed for other people, even if they had a similar infection to yours.
3. You should not give antibiotics that have been prescribed for you to other people.
4. If you still have antibiotic left after completing the treatment, return all unused medication to your pharmacy to ensure that disposal requirements are met.

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Reconstitution Instructions

Check that the cap is intact before use.

Invert and shake the bottle to loosen the powder stuck to the bottom.

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

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

Shake well before taking each dose.