Amoxicillin/clavulanic acid Normon 125 mg/31.25 mg/5 ml powder for oral suspension EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amoxicillin/Clavulanic acid Normon 125 mg/31.25 mg/5 ml powder for oral suspension EFG

amoxicillin/clavulanic acid

Read the entire leaflet carefully before starting to take this medicine, as 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 is usually prescribed for infants or children and should not be given to other people, even if they have the same symptoms as your child, as 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 administering Amoxicillin/Clavulanic acid Normon
3. How to administer Amoxicillin/Clavulanic acid Normon
4. Possible adverse 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 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 lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

Amoxicilina/Ácido clavulánico Normon 125 mg/31.25 mg/5 ml powder for oral suspension EFG is used in infants 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 starting Amoxicillin/Clavulanic Acid Normon

Do not administer Amoxicillin/Clavulanic Acid Normon to your child:

• If he or she is allergic to amoxicillin, clavulanic acid, penicillins, or any of the other ingredients of this medicine (see section 6).
• If he or she has ever had a severe allergic reaction to any other antibiotic. This could include rash or swelling of the face or throat.
• If he or she has ever had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.

? Do not give Amoxicillin/Clavulanic Acid Normon to your child if any of the above apply. Before starting treatment, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before giving this medicine to your child if:

• He or she has infectious mononucleosis.
• He or she is receiving treatment for liver or kidney problems.
• He or she does not urinate regularly.

If you are unsure whether any of the above conditions affect your child, inform your doctor or pharmacist before taking Amoxicillin/Clavulanic Acid Normon.

In some cases, your doctor may investigate the type of bacteria causing your child's infection. Depending on the results, your child may receive 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 side effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should watch for certain symptoms while your child is taking Amoxicillin/Clavulanic Acid Normon to reduce the risk of complications. See "Symptoms to watch for" in section 4.

Blood and urine tests

If your child is undergoing blood tests (such as studies of red blood cells or tests to check liver function) or urine tests (to monitor glucose levels), inform your doctor or nurse that your child is 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 your child is taking, has recently taken, or might need to take any other medicines.

If your child is taking allopurinol (used for gout) with Amoxicillin/Clavulanic Acid Normon, he or she may be more likely to develop a skin allergic reaction.

If your child is taking probenecid (used for gout), your doctor may adjust the 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 how methotrexate (a medicine used to treat cancer and severe psoriasis) works. 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 your daughter is taking this medicine and is pregnant or breastfeeding, thinks she might be pregnant, or plans to become pregnant, consult her doctor or pharmacist before using this medicine.

Consult your doctor or pharmacist before using any medicine.

Important information about some of the components of Amoxicillin/Clavulanic Acid Normon 125 mg/31.25 mg/5 ml powder for oral suspension EFG

Amoxicillin/Clavulanic Acid Normon contains sucrose

If your doctor has diagnosed your child with an intolerance to certain sugars, consult with him or her before taking this medicine.

Amoxicillin/Clavulanic Acid Normon contains sodium benzoate (E-211)

This medicine contains 0.4 mg of sodium benzoate (E-211) per ml. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

Amoxicillin/Clavulanic Acid Normon contains sodium

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

3. How to take Amoxicillin/Clavulanic Acid Normon

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

Adults and children weighing 40 kg or more

• Amoxicillin/Clavulanic Acid Normon is not usually recommended for adults and children weighing more than 40 kg. Seek advice from your doctor or pharmacist.

Children weighing less than 40 kg

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

• Your doctor will advise you on how much Amoxicillin/Clavulanic Acid Normon to give your infant or child.
• A plastic dosing spoon will be provided. You must use it to administer the correct dose to your infant or child.
• The usual dose is – 20 mg/5 mg up to 60 mg/15 mg per kilogram of body weight per day, given in three divided doses.

Patients with kidney or liver problems

• If your child has kidney problems, the dose may be reduced. Your doctor may choose a different formulation or another medicine.
• If your child has liver problems, blood tests will be performed more frequently to monitor liver function.

How to take Amoxicillin/Clavulanic Acid Normon

• Always shake the bottle well before each dose.
• Take at the beginning of a meal or shortly before eating.
• Space the doses evenly throughout the day, at least 4 hours apart. Do not take two doses within one hour.
• Do not give Amoxicillin/Clavulanic Acid Normon to your child for longer than 2 weeks. If your child continues to feel unwell, you should see your doctor again.

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

If you give your child 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.

Take the bottle with you to show the doctor.

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

If you forget to give Amoxicillin/Clavulanic Acid Normon

If you forget to give your child a dose, give it as soon as you remember. Do not give the next dose too soon; wait at least 4 hours before giving the next dose. Do not give your child a double dose to make up for a missed dose.

If your child stops taking Amoxicillin/Clavulanic Acid Normon

Continue giving your child this medicine for the full duration of treatment, even if they feel better. Your child needs to complete the full course to help fight the infection. If bacteria survive, the infection may return.

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

4. Possible adverse effects

Like all medicines, Amoxicillin/Clavulanic acid NORMON may produce adverse effects, although not everyone experiences them. The effects described below may occur with 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 a heart attack triggered by allergy (Kounis syndrome).

  • Contact your doctor immediately if your child experiences any of these symptoms. Stop administering 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 as soon as possible so they can advise you if your child has 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 happens, 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 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 develop into blisters resembling 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 urticaria (pustular exanthem).

• 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 your child has 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.

• Tooth staining (in children), which usually disappears with brushing.

• 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).

Adverse effects that may appear in blood or urine tests:

• Marked reduction 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 your child experiences any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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

Dry powder

Do not store above 25 °C. Keep in the original packaging to protect from light and moisture.

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

Liquid suspension

Store in the refrigerator (2 °C – 8 °C). Do not freeze.

Once reconstituted, the suspension must be used within 7 days.

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

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure how to dispose of unused medicines and their packaging, ask your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amoxicillin/Clavulanic Acid Normon 125 mg/31.25 mg/5 ml powder for oral suspension EFG

The active substances are amoxicillin and clavulanic acid. Each ml of reconstituted suspension contains 25 mg of amoxicillin (as amoxicillin trihydrate) and 6.25 mg of clavulanic acid (as potassium clavulanate). Each 5 ml of reconstituted suspension contains 125 mg of amoxicillin (as amoxicillin trihydrate) and 31.25 mg of clavulanic acid (as potassium clavulanate).

The other components (excipients) are: anhydrous citric acid (E-330), anhydrous sodium citrate (E-331), colloidal silica, microcrystalline cellulose (E-460i), sodium carboxymethylcellulose (E-466), xanthan gum (E-415), sodium benzoate (E-211), sucrose, orange flavour.

Appearance of the product and contents of the pack

Amoxicillin/Clavulanic Acid Normon 125 mg/31.25 mg powder for oral suspension is supplied in a bottle containing powder to prepare 120 ml of oral suspension and clinical packs containing 20 bottles of 120 ml. The bottles contain a white or slightly cream-coloured powder with a characteristic odour.

Marketing Authorisation Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

This leaflet was approved in April 2023.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es

Instructions for correct administration of the preparation

1. Invert the bottle to loosen powder adhering to the bottom. Fill with water up to the mark on the bottle located above the label and shake well before use. Invert and shake thoroughly. Shake before each use.
2. Use the spoon provided in the pack to administer the dose prescribed by the doctor.
3. After use, rinse the spoon. Store in the refrigerator and always shake well before use.