AMOXICILLIN NORMON 250 mg/5 ml ORAL SUSPENSION POWDER

2. What you need to know before you take Amoxicillin Normon

Do not take Amoxicillin Normon:

• 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 Amoxicillin Normon if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking Amoxicillin Normon.

Warnings and precautions

Consult your doctor or pharmacist before taking Amoxicillin Normon 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 Amoxicillin 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).

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

Using Amoxicillin Normon 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 Amoxicillin Normon, you may be more likely to suffer a skin allergic reaction.
• If you are taking probenecid (used for gout), your doctor may adjust the dose of Amoxicillin Normon. Probenecid (used to treat gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
• If you are taking anticoagulants (such as warfarin) with Amoxicillin Normon, more blood tests may be needed.
• If you are taking other antibiotics (such as tetracycline), Amoxicillin Normon may be less effective.
• If you are taking methotrexate (used for cancer treatment and severe psoriasis), Amoxicillin Normon may increase the risk of side effects. Methotrexate (medication 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Amoxicillin Normon may cause side effects and symptoms (such as allergic reactions, dizziness, and convulsions) that may make you unfit to drive.

Do not drive or operate machinery unless you feel well.

Amoxicillin Normon containssucrose, glucose,methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216)

• This medicine contains sucrose and glucose. If your doctor has told you that you have an intolerance to some sugars, consult before taking this medicine.

Patients with diabetes mellitus should note that this medicine contains 2.15 g of sucrose and 1.12 mg of glucose per dose.

• It may cause tooth decay. It may cause allergic reactions (possibly delayed) because it contains propyl parahydroxybenzoate (E-216) and methyl parahydroxybenzoate (E-218).

3. How to take Amoxicillin Normon

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

Take the medicine once reconstituted. Reconstitution should be done as follows:

• Invert and shake the bottle to loosen the powder stuck to the bottom.
• Fill the bottle with water just up to the arrow on the label.
• Invert and shake well, then fill with water up to the mark. Invert and shake again.
• Shake well before taking 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 Amoxicillin Normon 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 Amoxicillin Normon than you should

If you have taken more Amoxicillin Normon 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. Take 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 Amoxicillin 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 make up for forgotten doses.

How long to take Amoxicillin Normon

• Continue taking Amoxicillin 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 come back.
• Once you finish the treatment, if you still feel unwell, you should go back to see your doctor.

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

If you take Amoxicillin Normon for a long time, your doctor may perform additional tests to check that your kidneys, liver, and blood are working 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 Amoxicillin Normon and see a doctor immediately if you get 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, flat, red patches under the skin 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 Amoxicillin Normon, 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 with a raised appearance 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 be: changes in skin color, lumps under the skin, blisters, pustules, peeling, redness, pain, itching, exfoliation. These may be accompanied by 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 Amoxicillin 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
• 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 lead to jaundice.

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.

Sometimes you may get less serious skin reactions such as:

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

If you get any of these, talk to your doctor as you will need to stop your treatment with Amoxicillin Normon.

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 (yeast 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 that cause acute kidney injury, 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
• 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.

Frequency not known

• 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.
• blistering skin rash arranged in a circle with a central crust or like a string of pearls (linear IgA disease)
• inflammation of the membranes that surround the brain and spinal cord (aseptic meningitis)

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 through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Amoxicillin Normon

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 at room temperature.

Reconstituted suspension:

Do not store above 25°C or in the refrigerator (between 2°C and 8°C). Use within 14 days.

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. 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 Contents and Additional Information

Composition of Amoxicilina Normon

• The active ingredient is amoxicillin. In each 5 ml of suspension, the amoxicillin content is 250 mg.
• The other components are: sucrose, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), anhydrous sodium citrate, orange flavor (contains glucose in maltodextrin from corn and other excipients) and colloidal silicon dioxide (Aerosil 200).

Appearance of the Product and Container Contents

Amoxicilina Normon 250 mg/5 ml oral powder for suspension EFG is a white powder with yellowish granules in amber glass bottles with a nominal volume of 108 ml and 180 ml (for 40 ml and 120 ml presentations). The bottles are packaged in a cardboard box with a 2.5 ml and 5 ml dosing spoon.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the Last Revision of this Leaflet: May 2025.

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

General Advice on 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 advice will help you prevent the appearance of resistant bacteria that can make the antibiotic not work:

1. It is very important that you take the antibiotic in the correct dose, at the indicated times, and for the correct number of days. Read the instructions in the leaflet and, if you do not understand something, ask your doctor or pharmacist.
2. 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.
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 antibiotic left after completing the treatment, return all unused medication to your pharmacy to ensure that disposal requirements are met.

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 arrow on the label.

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

Shake well before taking each dose.