Package Leaflet: Information for the User

Amoxicilina Normon 750 mg Tablets EFG

Amoxicilina

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you (or your child) only. Do not pass it on to others even if their symptoms are the same. 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 can also be used in combination with other medicines to treat stomach ulcers.

Do not take Amoxicilina Normon:

• 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 Normon if any of the above applies 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 tests (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 have a skin allergic reaction.
• If you are taking probenecid (used for gout), your doctor may 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 increase the risk of side effects. Methotrexate (used to treat cancer and severe psoriasis), 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, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Amoxicilina Normon 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 Normon contains sodium.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

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

• Swallow the tablets with water. The tablets can be dissolved in water and ingested immediately. The groove is only for fractioning and facilitating swallowing, but not for dividing into equal doses.
• 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 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 Normon than you should

If you have taken more Amoxicilina Normon 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 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: 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 dots 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 Normon, 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 fever and feel 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 pain.
• Symptoms similar to the flu 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 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 liver side effects. 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 (jaundice). See anemia below, which may cause jaundice.

These may occur during treatment or several weeks after.

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

Sometimes 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).

If you have any of them, talk to your doctor 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 get 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
• 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 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 leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: http://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.

Store below 30°C.

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 packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need.This will help protect the environment.

Composition of Amoxicilina Normon

• The active ingredient is amoxicilina. Each tablet contains 750 mg of amoxicilina
• The other components are: sodium saccharin, crospovidone, orange essence, and magnesium stearate.

Appearance of the product and contents of the package:

Amoxicilina Normon 750 mg tablets EFG are white or slightly cream-colored, elongated, biconvex, and scored tablets. The score is only for breaking and facilitating swallowing, but not for dividing into equal doses.

They are packaged in a blister pack in a box. It is available in packaging of 20 and 30 tablets.

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 on this medication is available on the website of the Spanish Agency for 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 appropriately 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 leaflet instructions and, if you do not understand something, ask your doctor or pharmacist.
2. You should not take an antibiotic unless it has been prescribed specifically for you and you should use it only for the infection for which it has been prescribed.
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.
5. If you still have antibiotics left over after completing treatment, hand over all unused medications to your pharmacy to ensure that the disposal requirements are met.