Amoxicillin/clavulanic acid Normon 500 mg/125 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amoxicillin/Clavulanic acid Normon 500 mg/125 mg film-coated tablets EFG

amoxicillin/clavulanic acid

Read the entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Amoxicillin/Clavulanic acid Normon is and what it is used for
2. What you need to know before taking Amoxicillin/Clavulanic acid Normon
3. How to take Amoxicillin/Clavulanic acid Normon
4. Possible side effects
5. How to store 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 kills bacteria causing infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins", which can sometimes become ineffective (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 influenza or the common cold. It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment. Do not store or reuse this medicine. If you have leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via the drain or in household waste.

Amoxicillin/Clavulanic Acid Normon is used in adults and children to treat the following infections:

• Middle ear and 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 taking Amoxicillin/Clavulanic Acid Normon

Do not take Amoxicillin/Clavulanic Acid Normon:

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins, or any of the other ingredients of this medicine (see section 6)

• if you have ever had a serious 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) while taking an antibiotic.

• Do not take Amoxicillin/Clavulanic Acid Normon if any of the above apply to you. 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 taking 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 whether any of the above conditions apply to 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, they may prescribe a different formulation of Amoxicillin/Clavulanic Acid or another medicine.

Symptoms to watch for

Amoxicillin/Clavulanic Acid Normon may worsen certain existing conditions or cause serious adverse 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 complications. See "Symptoms to watch for" in section 4.

Blood and urine tests

If you are undergoing blood tests (such as studies of red blood cell status or liver function tests) or urine tests (to monitor glucose levels), inform your doctor or nurse that you are taking Amoxicillin/Clavulanic Acid Normon. This is because Amoxicillin/Clavulanic Acid Normon may alter the results of these types of tests.

Other medicines and Amoxicillin/Clavulanic Acid Normon

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 Amoxicillin/Clavulanic Acid Normon, you may be more likely to develop a skin allergic reaction.

If you are taking probenecid (used for gout), your doctor may adjust your dose of Amoxicillin/Clavulanic Acid Normon. Concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.

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

Amoxicillin/Clavulanic Acid Normon may affect the action of methotrexate (a medicine used to treat cancer and severe psoriasis). Penicillins may reduce methotrexate excretion and potentially increase adverse effects.

Amoxicillin/Clavulanic Acid Normon may 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 are planning to become pregnant, consult your doctor or pharmacist before using any medicine.

Driving and using machines

Amoxicillin/Clavulanic Acid Normon may cause adverse effects, and symptoms may mean you should not drive.

Do not drive or operate machinery unless you feel well.

Amoxicillin/Clavulanic Acid Normon contains sodium

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

3. How to take Amoxicillin/Clavulanic Acid Normon

Follow exactly the instructions for use of Amoxicillin/Clavulanic Acid Normon provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults and children weighing 40 kg or more

The recommended dose is:

• 1 tablet taken three times a day

Children weighing less than 40 kg

It is preferable to treat children aged 6 years or younger with Amoxicillin/Clavulanic Acid Normon oral suspension or sachets.

Seek advice from your doctor or pharmacist when administering Amoxicillin/Clavulanic Acid Normon tablets to children weighing less than 40 kg. The tablets are not suitable for children weighing less than 25 kg.

Patients with kidney or liver problems

• If you have kidney problems, your dose may be adjusted. Your doctor may choose a different formulation or another medicine.
• If you have liver problems, you will have blood tests more frequently to monitor liver function.

How to take Amoxicillin/Clavulanic Acid Normon

• Take with meals
• Swallow the tablets whole with a glass of water at the beginning of a meal or shortly before.
• The tablet may be divided along the break line to make swallowing easier. You must take both parts of the tablet at the same time.
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
• Do not take this medicine for longer than 2 weeks. If you still feel 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. Contact your doctor as soon as possible. Bring the packaging with you to show your doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 a missed dose.

If you stop taking Amoxicillin/Clavulanic Acid Normon

Continue taking Amoxicillin/Clavulanic Acid Normon until the treatment is complete, even if you feel better. You need to complete the full course of treatment to cure the infection. If you do not, surviving bacteria may cause the infection to return.

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

4. Possible adverse effects

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

Symptoms to watch for

Allergic reactions:

• skin rash,

• inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may 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), causing difficulty breathing,

• collapse,

• chest pain in the context of allergic reactions, which may be a symptom of heart attack triggered by allergy (Kounis syndrome).

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

Inflammation of the large intestine

Inflammation of the large intestine, causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.

Acute inflammation of the pancreas (acute pancreatitis)

If you have severe and persistent pain in the stomach area, 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 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, diarrhoea, and low blood pressure.

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

Very common adverse effects

May affect more than 1 in 10 patients

• diarrhoea (in adults).

Common adverse effects

May affect up to 1 in 10 patients

• thrush (Candida – fungal infection in the vagina, mouth, or mucous membranes),

• nausea, especially when high doses are taken,

• if this occurs, take Amoxicillin/Clavulanic Acid Normon before meals

• vomiting,

• diarrhoea (in children).

Uncommon adverse effects

May affect up to 1 in 100 patients

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

Uncommon adverse effects that may appear in your blood tests:

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

Rare adverse effects

May affect up to 1 in 1,000 patients

• skin rash, which may blister and resemble small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme)

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

Rare adverse effects that may appear in blood tests:

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

Frequency not known

Frequency cannot be estimated from the available data.

• allergic reactions (see above)

• inflammation of the large intestine (see above)

• inflammation of the protective membrane surrounding the brain (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 skin peeling (more than 30% of body surface – toxic epidermal necrolysis)
  • widespread red rash with small pus-filled blisters (exfoliative bullous dermatitis)
  • exfoliative red rash with lumps under the skin and blisters (exanthematous pustulosis)
  • 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)).

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

• inflammation of the liver (hepatitis)

• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver), which may cause the skin and whites of the eyes to turn yellow

• inflammation of the kidney tubules

• delayed blood clotting

• hyperactivity

• seizures (in patients taking high doses of amoxicillin/clavulanic acid or who have kidney problems)

• black, hairy-looking tongue

• blistering rash arranged in a ring with a central crust or resembling a string of pearls (linear IgA disease)

• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

Adverse effects that may appear in your blood or urine tests:

• significant decrease in the number of white blood cells
• low red blood cell count (haemolytic anaemia)
• crystals in the urine causing acute kidney injury.

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, 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: www.notificaRAM.es.

By reporting adverse 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 sight and reach of children.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers 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 substances 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 components (excipients) are: crospovidone, sodium starch glycolate from potato, colloidal anhydrous silica, microcrystalline cellulose (E-460i), magnesium stearate (E-470b), hypromellose, macrogol 6000, titanium dioxide (E-171) and talc (E-553b).

Appearance of the medicine and contents of the pack

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

Each pack contains 20, 30 or 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 last approved in April 2023.

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