AMOXICILLIN/CLAVULANIC ACID NORMON 500 mg / 125 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Amoxicillin/Clavulanic Acid Normon 500 mg/125 mg Film-Coated Tablets EFG

amoxicillin/clavulanic acid

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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What Amoxicillin/Clavulanic Acid Normon is and what it is used for
2. What you need to know before you take Amoxicillin/Clavulanic Acid Normon
3. How to take Amoxicillin/Clavulanic Acid Normon
4. Possible side effects
5. Storage of Amoxicillin/Clavulanic Acid Normon
6. Contents of the pack and other information

1. What Amoxicillin/Clavulanic Acid Normon is and what it is used for

Amoxicillin/Clavulanic Acid Normon is an antibiotic that eliminates the bacteria that cause infections. It contains two different drugs called amoxicillin and clavulanic acid. Amoxicillin belongs to the group of medicines known as "penicillins" that can sometimes lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold. It is essential that you follow the instructions regarding dosage, 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 throw medicines down the drain or into the trash.

Amoxicillin/Clavulanic Acid 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.

2. What you need to know before you take Amoxicillin/Clavulanic Acid Normon

Do not take Amoxicillin/Clavulanic Acid Normon:

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, to penicillins, or to any of the other components of this medicine (see section 6)
• if you have ever had a severe allergic reaction to any other antibiotic. This could include a 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 Amoxicillin/Clavulanic Acid Normon if you are included in any of the above points.Before starting treatment with Amoxicillin/Clavulanic Acid Normon, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

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

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

If you are unsure if any of the above symptoms affect you, inform your doctor or pharmacist before taking Amoxicillin/Clavulanic Acid 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 formulation of Amoxicillin/Clavulanic Acid or another medicine.

Symptoms to be aware of

Amoxicillin/Clavulanic Acid Normon can worsen certain existing conditions or cause severe side effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should be aware of certain symptoms while taking Amoxicillin/Clavulanic Acid 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 status or liver function studies) or urine tests (to check glucose levels), inform your doctor or nurse that you are taking Amoxicillin/Clavulanic Acid Normon. This is because Amoxicillin/Clavulanic Acid Normon can alter the results of these types of tests.

Other medicines and Amoxicillin/Clavulanic Acid Normon

Tell your doctor or pharmacist if you are taking or have recently taken or may need to take any other medicines.

If you are taking allopurinol (used for gout) with Amoxicillin/Clavulanic Acid 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/Clavulanic Acid Normon. Concomitant use of probenecid can reduce the excretion of amoxicillin and is not recommended.

If you are taking anticoagulants (such as warfarin) with Amoxicillin/Clavulanic Acid Normon, more blood tests will be needed.

Amoxicillin/Clavulanic Acid Normon can affect the action of methotrexate (a medicine used to treat cancer and severe psoriasis). Penicillins can reduce the excretion of methotrexate and cause a potential increase in side effects.

Amoxicillin/Clavulanic Acid Normon can affect how mycophenolate mofetil (a medicine used to prevent organ rejection in transplant patients) works.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Amoxicillin/Clavulanic Acid Normon can have side effects and the symptoms can make you unfit to drive.

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

Amoxicillin/Clavulanic Acid Normon contains sodium

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

3. How to take Amoxicillin/Clavulanic Acid Normon

Follow the instructions for administration of Amoxicillin/Clavulanic Acid Normon exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults and children over 40 kg

The recommended dose is:

• 1 tablet administered three times a day

Children under 40 kg

It is preferable to treat children under 6 years old with the oral suspension of Amoxicillin/Clavulanic Acid Normon or sachets.

Ask your doctor or pharmacist for advice when administering Amoxicillin/Clavulanic Acid Normon tablets to children who weigh less than 40 kg. The tablets are not suitable for children who weigh 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 formulation or another medicine.
• If you have liver problems, you will have more frequent blood tests to check how your liver is working.

How to take Amoxicillin/Clavulanic Acid Normon

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

If you take more Amoxicillin/Clavulanic Acid Normon than you should

If you take too much Amoxicillin/Clavulanic Acid Normon, symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures may occur. Consult your doctor as soon as possible. Take the package with you to show the doctor.

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

If you forget to take Amoxicillin/Clavulanic Acid 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.

If you stop taking Amoxicillin/Clavulanic Acid Normon

Continue taking Amoxicillin/Clavulanic Acid Normon until you finish 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 have the infection again.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 can appear as red or purple spots on the skin but can affect other parts of the body,
• fever, joint pain, swollen glands in the neck, armpits, or groin,
• swelling, sometimes of the face or throat (angioedema), which can cause difficulty breathing,
• collapse,
• chest pain in the context of allergic reactions, which can be a symptom of allergy-induced heart attack (Kounis syndrome).

• Contact your doctor immediatelyif you experience any of these symptoms. Stop taking Amoxicillin/Clavulanic Acid Normon.

Inflammation of the large intestine

Inflammation of the large intestine, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

Acute pancreatitis

If you have severe and persistent stomach pain, this could be a sign of acute pancreatitis.

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.

• 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 in the vagina, mouth, or mucous membranes),
• nausea, especially when taking high doses,

• vomiting,
• diarrhea (in children).

Uncommon side effects

May affect up to 1 in 100 patients

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

Uncommon side effects that may appear in your 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 can form blisters that look like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme)

• Consult a doctor urgentlyif you have any of these symptoms

Rare side effects that may appear in your blood tests:

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

Frequency not known

Frequency cannot be estimated from the available data.

• allergic reactions (see above)
aseptic meningitis)
• severe skin reactions:
• • widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and in its most severe form, causing widespread peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis)
  • generalized red rash with small blisters containing pus (exfoliative dermatitis)
  • red exfoliative rash, with bumps under the skin and blisters (pustular exanthematous)
  • 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)).

• Contact a doctor immediatelyif you have any of these symptoms.

• inflammation of the liver (hepatitis)
• jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver) that can make the skin and the whites of the eyes turn yellow
• inflammation of the kidney ducts
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses of amoxicillin/clavulanic acid or with kidney problems)
• black hairy tongue
• rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease)
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

Side effects that may appear in your 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 injury.

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicillin/Clavulanic Acid Normon

Do not store above 25°C.

Keep in the original packaging to protect from light and moisture.

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

Do not use this medicine after the expiry date (EXP) that appears on the packaging. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amoxicillin/Clavulanic Acid Normon 500 mg/125 mg Film-Coated Tablets EFG

The active ingredients are amoxicillin and clavulanic acid. Each tablet contains 500 mg of amoxicillin (as amoxicillin trihydrate) and 125 mg of clavulanic acid (as potassium clavulanate).

The other ingredients (excipients) are: crospovidone, potato 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 packaging contents

Amoxicillin/Clavulanic Acid Normon 500 mg/125 mg is presented in the form of film-coated tablets. The tablets are white or slightly yellow, elongated, biconvex, and scored.

Each pack contains 30 and 500 film-coated tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

This leaflet was approved inApril 2023.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es