Amoxicillin Normon 250 mg/5 ml powder for oral suspension EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amoxicilina Normon 250 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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you (or your child) only, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Amoxicilina Normon is and what it is used for
2. What you need to know before taking Amoxicilina Normon
3. How to take Amoxicilina Normon
4. Possible side effects
5. How to store Amoxicilina Normon

Contents of the pack and other information

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

What Amoxicilina Normon is

Amoxicilina Normon is an antibiotic. The active substance is amoxicillin. This medicine belongs to a group of medicines known as "penicillins".

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

Do not keep or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

What Amoxicilina Normon is used for

Amoxicilina Normon is used to treat bacterial infections affecting various parts of the body. Amoxicilina Normon may also be used in combination with other medicines to treat stomach ulcers.

2. What you need to know before taking Amoxicilina Normon

Do not take Amoxicilina 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 skin rash or swelling of the face or throat.

Do not take Amoxicilina Normon if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Amoxicilina Normon.

Warnings and precautions

Talk to your doctor or pharmacist before taking Amoxicilina 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 unsure whether any of the above conditions apply to you, inform your doctor or pharmacist before taking Amoxicilina Normon.

Blood and urine tests

If you are undergoing:

• urine tests (urine glucose) or blood tests for liver function
• tests for estriol (used during pregnancy to check whether the baby is developing normally),

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

Taking Amoxicilina Normon with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

• If you are taking allopurinol (used for gout) with Amoxicilina Normon, you may be more likely to experience a skin allergic reaction.
• 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 may reduce the excretion of amoxicillin and is not recommended.
• If you are taking anticoagulants (such as warfarin) with Amoxicilina Normon, additional blood tests may be required.
• 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 (a medicine used to treat cancer and severe psoriasis): penicillins may reduce methotrexate excretion and potentially increase adverse effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Amoxicilina Normon may cause adverse effects, and symptoms (such as allergic reactions, dizziness, and seizures) may mean you should not drive.

Do not drive or operate machinery unless you feel well.

Amoxicilina Normon contains sucrose, glucose, methyl parahydroxybenzoate (E-218), and propyl parahydroxybenzoate (E-216)

• This medicine contains sucrose and glucose. If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

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

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

3. How to take Amoxicilina Normon

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

Take the medicine once reconstituted. Reconstitution must be carried out as follows:

• Invert and shake the bottle to loosen the powder adhering to the bottom.
• Fill the bottle with water up to the arrow on the label of the bottle.
• Invert and shake well, then refill with water up to the mark. Invert and shake again.
• Shake well before taking each dose.
• Space the doses evenly throughout the day, at least 4 hours apart.

The usual dose is:

Children weighing less than 40 kg

All doses are based on the child's body weight in kilograms.

• Your doctor will tell you how much Amoxicilina Normon to give 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 weighing 40 kg or more

This suspension is normally not recommended for adults and children weighing more than 40 kg. Please seek advice from your doctor or pharmacist.

Renal 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, symptoms may include stomach discomfort (nausea, vomiting, or diarrhea) or crystals in the urine, which may appear as cloudy urine or difficulty urinating. Contact your doctor as soon as possible. Take the medicine with you to show it. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget 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 make up for forgotten doses.

How long to take Amoxicilina Normon

• Continue taking Amoxicilina Normon for the length of time prescribed by your doctor, even if you feel better. You need to take all doses to completely eliminate the infection. If some bacteria survive, the infection may return.
• After completing the treatment, if you still feel unwell, you should see your doctor again.

Candidiasis (a fungal infection in moist areas of the body that may cause pain, itching, and white discharge) may occur if Amoxicilina Normon is taken for a prolonged period. If this happens, consult your doctor.

If you take Amoxicilina Normon for a prolonged period, your doctor may perform additional blood tests to check that your kidneys, liver, and blood are functioning normally.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Stop taking Amoxicilina Normon and see a doctor immediately if you experience any of the following serious adverse effects – you may need urgent medical treatment:

The following adverse effects are very rare (may affect up to 1 in 10,000 people):

• allergic reactions, signs may include: skin itching or rash, swelling of the face, lips, tongue, body, or difficulty breathing. These can be severe and, in some cases, have resulted in death
• skin rash or flat red spots the size of pinpricks under the skin surface or bruising on the skin. This is due to inflammation of the blood vessel walls caused by 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 Normon; some signs include: rashes, fever, joint pain, and swollen lymph nodes, especially under the arms
• a skin reaction called "erythema multiforme," in which you may develop: itchy purple or reddish spots on the skin, especially on the palms of the hands or soles of the feet, swollen raised areas on the skin, soft tissue lesions in the mouth, eyes, and genitals. You may also have fever and feel very tired
• other serious skin reactions may include: 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, swollen glands, 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, which occurs during treatment with Amoxicilina Normon 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 adverse effects in the liver may occur. These are mainly associated with prolonged treatment, male gender, and advanced age. You should contact 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 whites of the eyes (jaundice). See also anemia below, which can lead to jaundice.

These may occur during treatment or up to several weeks after.

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

Sometimes you may experience less severe skin reactions such as:

• a moderate itchy rash (round, pink-red spots), swollen areas resembling blisters on forearms, legs, palms, hands, or feet. This is uncommon (may affect up to 1 in 100 people).

If you have any of these, speak with your doctor, as you will need to discontinue treatment with Amoxicilina Normon.

Other possible adverse 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)

• candidiasis (fungal infection in the vagina, mouth, or skin folds); treatment is available from your doctor or pharmacist for candidiasis
• kidney problems
• seizures (convulsions), observed in patients receiving high doses or with kidney problems
• dizziness
• hyperactivity
• crystals in the urine causing acute kidney injury, 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
• changes in tooth discoloration, 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 leading to a type of anemia. Signs include: fatigue, headache, difficulty breathing, dizziness, paleness, and yellowing of the skin and whites of the eyes
• low number of white blood cells
• low number of platelets (cells involved in blood clotting)
• blood may take longer than normal to clot. This may be noticed as nosebleeds or prolonged bleeding from cuts.

Frequency not known

• chest pain in the context of allergic reactions, which may be a symptom of allergy-triggered heart attack (Kounis syndrome)
• drug-induced enterocolitis syndrome (DIES): DIES has been reported mainly in children receiving amoxicillin. It is a type of allergic reaction with the main symptom being 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 causing acute kidney injury.
• blistering rash arranged in circles with central crusts or resembling a "string of pearls" (linear IgA disease)
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicillin Normon

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

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 any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amoxicilina Normon

• The active substance is amoxicillin. Each 5 ml of suspension contains 250 mg of amoxicillin.
• The other components are: sucrose, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), anhydrous sodium citrate, orange flavour (containing glucose in maltodextrin derived from maize and other excipients), and colloidal silica (Aerosil 200).

Appearance of the product and contents of the pack

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

Only certain pack 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 most recent revision of this leaflet: May 2025.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products: 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 appropriately can reduce the likelihood of bacteria becoming resistant.

When your doctor prescribes an antibiotic, it is intended solely for the treatment of your current illness. Following these recommendations will help prevent the development of resistant bacteria, which could make antibiotics ineffective:

1. It is very important to take the antibiotic at the correct dose, at the prescribed times, and for the full duration of treatment. Read the instructions in the leaflet carefully, and if you do not understand something, ask your doctor or pharmacist.
2. Do not take an antibiotic unless it has been specifically prescribed for you, and use it only for the infection for which it was prescribed.
3. Do not take antibiotics that have been prescribed for other people, even if they had an infection similar to yours.
4. Do not give antibiotics prescribed for you to other people.
5. If you have any antibiotic left after completing your treatment, return all unused medicine to your pharmacy to ensure proper disposal.

Reconstitution instructions

Check that the cap is intact before use.

Invert and shake the bottle to loosen any powder adhering to the bottom.

Fill the bottle with water up to the arrow indicated on the label.

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

Shake well before taking each dose.