Leaflet: information for the user

Amoxicilina Normon 500 mg powder for oral suspension in EFG sachets

Amoxicilina

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you (or your child) only, and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

What is Amoxicilina Normon

Amoxicilina Normon is an antibiotic. The active ingredient is amoxicilina. This belongs to a group of medicines called “penicillins”.

What is Amoxicilina Normon used for

Amoxicilina Normon is used to treat infections caused by bacteria in different parts of the body. Amoxicilina Normon may also be used in combination with other medications to treat stomach ulcers.

Do not take Amoxicilina Normon:

• 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 Normon if any of the above points apply to you. If you are unsure, consult your doctor or pharmacist before taking Amoxicilina Normon.

Warnings and precautions

Consult your doctor or pharmacist before taking Amoxicilina Normon 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 Normon.

Blood and urine tests

If you are having:

• urine tests (glucose in urine) or blood tests for liver function
• estriol analysis (used during pregnancy to check if the baby is developing normally).

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

Use of Amoxicilina Normon 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 Normon, you may be more likely to experience a skin rash.
• If you are taking probenecid (used for gout), your doctor may need to adjust the dose of Amoxicilina Normon. Probenecid (used to treat gout), concomitant use with probenecid may reduce the excretion of amoxicillin and is not recommended
• If you are taking anticoagulants (such as warfarin) with Amoxicilina Normon, more blood tests may be necessary.
• If you are taking other antibiotics (such as tetracycline) Amoxicilina Normon may be less effective.
• If you are taking methotrexate (used to treat cancer and severe psoriasis) Amoxicilina Normon may cause an increase in adverse effects. Methotrexate (medication used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate and cause a potential increase in adverse 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 Normon may cause adverse effects, and symptoms (such as allergic reactions, dizziness, and seizures) may make it unsafe to drive.

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

Amoxicilina Normon containssucrose, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), and sodium.

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

It may harm your teeth.

• It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).
• This medication contains less than 23 mg of sodium (1 mmol); this is, essentially “sodium-free”.

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 Normon 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 Normon 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 (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.

Kidney problems

If you have kidney problems, the dose may be lower than the usual dose.

If you take more Amoxicilina Normonthan you should

If you have taken more Amoxicilina Normon than you should, the signs may be stomach upset (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 Normon

• 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 Normon

• Continue taking Amoxicilina Normon 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 Normon for a prolonged period. If this happens, consult your doctor.

If you take Amoxicilina Normon 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 Normon 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: itching of the skin or rash, swelling of the face, lips, tongue, body, or difficulty breathing. These can be severe and, in some cases, have been fatal
• Rash on the skin 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 walls of blood vessels 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 Normon, some symptoms include: rashes, fever, joint pain, and enlargement of lymph nodes, 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 fever and be very tired
• Other severe skin reactions may be: changes in skin color, lumps under the skin, blisters, pustules, peeling, redness, pain, itching, exfoliation. They may be accompanied by fever, headache, and body aches
• Symptoms of a flu-like illness with skin rash, fever, inflammation of glands, 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 occurs during treatment with Amoxicilina Normon for Lyme disease and causes fever, chills, headache, and 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 can cause jaundice.

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.

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

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

Inform your doctor if you experience any of them, as you will need to interrupt your treatment with Amoxicilina Normon.

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 (vaginal, oral, or skin fungal infection), 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
• Hypersensitivity
• Crystals in the urine that cause acute kidney damage, which may appear as cloudy urine or difficulty or discomfort urinating. Make sure to drink plenty of fluids to reduce the risk of these symptoms
• Your tongue may change color to yellow, brown, or black and may appear hairy
• Excessive breakdown of red blood cells, which 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.

Unknown frequency

• Chest pain in the context of allergic reactions, which may be a symptom of allergic-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)

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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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.

Store at room temperature.

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 pointat 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 Normon

• The active ingredient is amoxicilina. Each sachet contains 500 mg of amoxicilina.
• The other components are:colloidal silica, orange essence, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), saccharose and anhydrous sodium citrate (sodium).

Appearance of the product and contents of the package

Amoxicilina Normon 500 mg powder for oral suspension in sachets contains a white or almost cream-colored powder in aluminum sachets. These sachets are conditioned in a case. It is available in packs of 20 and 30 sachets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last review of this leaflet: April 2023

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Deviceshttp://www.aemps.gob.es

General advice regarding the use of antibiotics

Antibiotics are used for the treatment of bacterial infections. They are not effective against viral infections.

At times, 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 likelihood of bacteria becoming resistant to them.

When your doctor prescribes an antibiotic, it is only for treating your current illness. Paying attention to the following advice will help prevent the emergence of resistant bacteria that may make the antibiotic ineffective:

1. It is very important that you take the antibiotic in the correct dose, at the indicated hours, and for the correct number of days. Read the instructions on the leaflet and, if you do not understand something, ask your doctor or pharmacist.
2. You should not take an antibiotic unless you have been prescribed it specifically for you and you should use it only for the infection for which you have been prescribed it.
3. You should not take antibiotics that have been prescribed for other people even if they had a similar infection to yours.
4. You should not give antibiotics that have been prescribed for you to other people.

If you still have antibiotic left after completing treatment, hand in all unused medicines to your pharmacy to ensure that the disposal requirements are met.