Package Leaflet: Information for the User

Amoxicilina/Ácido clavulánico Normon 500 mg/125 mg Film-Coated Tablets EFG

amoxicilina/ácido clavulánico

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 only. Do not give it to others, even if they have the same symptoms of illness 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.

Amoxicilina/Ácido clavulánico Normon is an antibiotic that eliminates the bacteria that cause infections. It contains two different medications called amoxicilina and ácido clavulánico. Amoxicilina belongs to a group of medications known as “penicilinas” which can sometimes lose its effectiveness (become inactive). The other component (ácido clavulánico) prevents this from happening.

Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or a cold. It is essential to follow the instructions regarding the dose, administration interval, and treatment duration indicated by your doctor.Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of the medication through the drain or in the trash.

Amoxicilina/Ácido clavulánico Normon is used in adults and children to treat the following infections:

• Middle ear and nasal sinus infections
• Respiratory tract infections
• Urinary tract infections
• Skin and soft tissue infections including dental infections
• Bone and joint infections

Do not take Amoxicilina/Ácido clavulánico Normon:

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins, or any of the other components of this medication (see section 6)
• if you have ever had a severe allergic reaction to any other antibiotic. This could include skin rash or swelling of the face or throat
• if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

• Do not take Amoxicilina/Ácido clavulánico Normon if you are included in any of the above points.Before starting treatment with Amoxicilina/Ácido clavulánico Normon, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication if:

• you have infectious mononucleosis
• you are receiving treatment for liver or kidney problems
• you do not urinate regularly.

If you are unsure whether any of the above symptoms affect you, inform your doctor or pharmacist before taking Amoxicilina/Ácido clavulánico Normon.

In some cases, your doctor may investigate the type of bacteria causing your infection. Depending on the results, you may be prescribed a different presentation of Amoxicilina/Ácido clavulánico or another medication.

Symptoms to be aware of

Amoxicilina/Ácido clavulánico Normon may worsen existing conditions or cause severe side effects. These include allergic reactions, convulsions, and inflammation of the large intestine. Be aware of certain symptoms while taking Amoxicilina/Ácido clavulánico Normon to reduce the risk of problems. See “Symptoms to be aware of” in section 4.

Blood and urine tests

If you are having blood tests (such as red blood cell studies or liver function studies) or urine tests (to control glucose levels), inform your doctor or nurse that you are taking Amoxicilina/Ácido clavulánico Normon. This is because Amoxicilina/Ácido clavulánico Normon may alter the results of these types of tests.

Other medications and Amoxicilina/Ácido clavulánico Normon

Inform your doctor or pharmacist if you are taking or have taken recently or may take any other medication.

If you are taking allopurinol (used for gout) with Amoxicilina/Ácido clavulánico 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 Amoxicilina/Ácido clavulánico Normon. Concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.

If you are taking anticoagulants (such as warfarin) with Amoxicilina/Ácido clavulánico Normon, more blood tests will be required.

Amoxicilina/Ácido clavulánico Normon may affect the action of methotrexate (a medication used to treat cancer and severe psoriasis).The penicillins may reduce the excretion of methotrexate and cause a potential increase in side effects.

Amoxicilina/Ácido clavulánico Normon may affect how micophenolate mofetil (a medication used to prevent organ rejection in transplant patients) works.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Amoxicilina/Ácido clavulánico Normon may cause side effects and symptoms that may make you unable to drive.

Do not drive or operate machinery unless you feel well.

Amoxicilina/Ácido clavulánico Normon contains sodium

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

Follow exactly the administration instructions for Amoxicilina/Ácido clavulánico Normon as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

Adults and children 40 kg or more

The recommended dose is:

• 1 tablet administered three times a day

Children under 40 kg of weight

It is preferable to treat children 6 years or less with the oral suspension of Amoxicilina/Ácido clavulánico Normon or the sachets.

Ask your doctor or pharmacist for advice when administering Amoxicilina/Ácido clavulánico Normon tablets to children weighing less than 40 kg. Tablets are not suitable for children weighing less than 25 kg.

Patients with kidney and liver problems

• If you have kidney problems, your dose may be changed. Your doctor may choose a different presentation or another medication.
• If you have liver problems, you will have more frequent blood tests to check how your liver is functioning.

How to take Amoxicilina/Ácido clavulánico Normon

• Take with meals
• Swallow the tablets whole with a glass of water at the beginning of meals or a little before.
• You can break the tablet along the break line to make it easier to swallow. You must take both parts of the tablet at the same time.
• Space out your doses during the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
• Do not take this medication for more than 2 weeks. If you continue to feel unwell, consult your doctor.

If you take more Amoxicilina/Ácido clavulánico Normon than you should

If you take too much Amoxicilina/Ácido clavulánico Normon, you may experience symptoms such as stomach discomfort (nausea, vomiting, or diarrhea) or seizures. Consult your doctor as soon as possible. Bring the packaging with you to show your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Amoxicilina/Ácido clavulánico 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 the missed doses.

If you interrupt the treatment with Amoxicilina/Ácido clavulánico Normon

Continue taking Amoxicilina/Ácido clavulánico Normon until you complete the treatment, even if you feel better. You need to take the complete treatment to cure the infection. If you do not, the surviving bacteria may cause you to get the infection again.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The side effects described below may occur when taking this medicine.

Symptoms to be aware of

Allergic reactions:

• skin rash,
• inflammation of blood vessels (vasculitis) that may appear as red or purple spots on the skin, but can affect other parts of the body,
• fever, joint pain, swollen lymph nodes in the neck, armpits, or groin,
• swelling, sometimes of the face or throat (angioedema), which causes difficulty breathing,
• collapse,
• chest pain in the context of allergic reactions, which can be a symptom of an allergic-induced heart attack (Kounis syndrome).

• Contact your doctor immediatelyif you experience any of these symptoms.Stop taking Amoxicilina/Ácido clavulánico Normon.

Colitis:

Colitis, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

Acute pancreatitis:

If you have intense and persistent pain in the stomach area, this could be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES):

DIES has been mainly reported in children taking 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.

• Contact your doctor immediately, if you experience any of these symptoms.

Very common side effects

May affect more than 1 in 10 patients

• diarrhea (in adults).

Common side effects

May affect up to 1 in 10 patients

• thrush (Candida– fungal infection of the vagina, mouth, or mucous membranes),
• nausea, especially when taking high doses ,

• if you experience this, take Amoxicilina/Ácido clavulánico Normon before meals

• vomiting,
• diarrhea (in children).

Uncommon side effects

May affect 1 in 100 patients

• skin rash, itching,
• increased pruritic rash (urticarial rash),
• indigestion,
• dizziness,
• headache.

Side effects that may appear in blood tests:

• increase in some substances (enzymes) produced by the liver.

Rare side effects

May affect up to 1 in 1,000 patients

• skin rash, which may form blisters that appear as small dots (multiforme rash)

• If you experience any of these symptoms, consult a doctor urgently

Side effects that may appear in blood tests:

• low count of cells involved in blood clotting
• low white blood cell count

Unknown frequency

The frequency cannot be estimated from the available data.

• allergic reactions (see above)
• colitis (see above)
• inflammation of the protective membrane surrounding the brain (aseptic meningitis)
• severe skin reactions:
• • generalized rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and in its most severe form, causing widespread skin peeling (more than 30% of the body surface -toxic epidermal necrolysis)
  • generalized red rash with small pus-filled blisters (exfoliative dermatitis)
  • red exfoliative rash, with lumps under the skin and blisters (pustular exanthema)
  • flu-like symptoms with skin rash, fever, swollen lymph nodes, and abnormal blood test results (such as increased eosinophils (eosinophilia) and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).

• Contact a doctor immediately if you experience any of these symptoms.

• inflammation of the liver (hepatitis)
• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver) that may turn the skin and white of the eyes yellow
• inflammation of the kidney tubules
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses of amoxicillin/Ácido clavulánico or with kidney problems)
• black tongue that appears hairy
• 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).

Side effects that may appear in blood or urine tests:

• significant reduction in the number of white blood cells
• low red blood cell count (hemolytic anemia)
• crystals in the urine that cause acute kidney damage.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, 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 the Vigilance of Medicines for Human Use: www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Do not store above 25°C.

Store in the original packaging to protect it from light and humidity.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date (CAD) that appears on the packaging. The expiration date is the last day of the month indicated.

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 pointat the 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/Ácido clavulánico Normon 500 mg/125 mg film-coated tablets EFG

The active principles are amoxicilina and ácido clavulánico. Each tablet contains 500 mg of amoxicilina (as amoxicilina trihydrate) and 125 mg of ácido clavulánico (as clavulanate potassium).

The other components (excipients) are: crospovidone, sodium starch glycolate, colloidal silica, microcrystalline cellulose (E-460i), magnesium stearate (E-470b), hypromellose, macrogol 6000, titanium dioxide (E-171) and talc (E-553b).

Appearance of the product and content of the packaging

Amoxicilina/Ácido clavulánico Normon 500 mg/125 mg is presented in the form of film-coated tablets. The tablets are white or slightly yellowish, elongated, biconvex, and scored.

Each package contains 30 and 500 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

This leaflet has been approved inApril 2023.

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es