Amoxicillin/Clavulanic Acid Normon 125 mg/31.25 mg/5 ml ORAL SUSPENSION POWDER

Introduction

Package Leaflet: Information for the User

Amoxicillin/Clavulanic Acid Normon125 mg/31.25 mg/5 ml Powder for Oral Suspension 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 is usually prescribed to infants or children and should not be given to others, even if they have the same symptoms as your child, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Amoxicillin/Clavulanic Acid Normon and what is it used for
2. What you need to know before you start taking Amoxicillin/Clavulanic Acid Normon
3. How to take Amoxicillin/Clavulanic Acid Normon
4. Possible side effects
5. Storage of Amoxicillin/Clavulanic Acid Normon
6. Package Contents and Additional Information

1. What is Amoxicillin/Clavulanic Acid Normon and what is it 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 a group of medicines known as "penicillins" that can sometimes lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

Amoxicillin/Clavulanic Acid 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 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 start taking Amoxicillin/Clavulanic Acid Normon

Do not giveAmoxicillin/Clavulanic Acid Normonto your child:

• If they are allergic to amoxicillin, clavulanic acid, or any of the other components of this medicine (see section 6).
• If they 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 they have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not giveAmoxicillin/Clavulanic Acid Normonto your child if any of the above applies. If you are unsure, consult your doctor or pharmacist before starting treatment.

Warnings and Precautions

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

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

If you are unsure whether any of the above symptoms 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 that causes your child's infection. Depending on the results, your child may receive 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 serious side effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should be aware of certain symptoms while your child is 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 your child is having blood tests (such as studies of red blood cell status or tests to check liver function) or urine tests (to check glucose levels), inform your doctor or nurse that they are taking Amoxicillin/Clavulanic Acid Normon. This is because Amoxicillin/Clavulanic Acid Normon can alter the results of these types of tests.

Other Medicines andAmoxicillin/Clavulanic Acid Normon

Tell your doctor or pharmacist if your child is using or has recently used or might use other medicines.

If your child is taking allopurinol (used for gout) with Amoxicillin/Clavulanic Acid Normon, they may be more likely to have 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 can 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 way metotrexato (a medicine for treating cancer and severe psoriasis) works. Penicillins can reduce the excretion of metotrexato and cause a potential increase in side 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 going to take this medicine and is pregnant or breastfeeding, thinks she may 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 Components of Amoxicillin/Clavulanic Acid Normon125 mg/31.25 mg/5 ml Powder for Oral Suspension EFG

Amoxicillin/Clavulanic Acid Normon contains Sucrose

If your doctor has told you that your child has an intolerance to certain sugars, consult with them 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 can 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; this is essentially "sodium-free".

3. How to Take Amoxicillin/Clavulanic Acid Normon

Follow the instructions for taking Amoxicillin/Clavulanic Acid Normon exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

Adults and Children over40 kg

• This medicine is not usually recommended for adults and children weighing over 40 kg. Ask your doctor or pharmacist for advice.

Children under40 kg

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

• Your doctor will advise you how much Amoxicillin/Clavulanic Acid Normon to give to your infant or child.
• You will be provided with a plastic measuring spoon. You should use it to give the correct dose to your infant or child.
• The usual dose is 20 mg/5 mg to 60 mg/15 mg per kilogram of body weight per day, administered in three divided doses.

Patients with Kidney and 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, they will have more frequent blood tests to check how their liver is working.

How to TakeAmoxicillin/Clavulanic Acid Normon

• Always shake the bottle well before each dose
• Administer at the start of meals or a while before
• Space out the doses during the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
• Do not give Amoxicillin/Clavulanic Acid Normon to your child for more than 2 weeks. If your child is still feeling unwell, they should see a doctor again.

If You Give Your Child MoreAmoxicillin/Clavulanic Acid NormonThan They Should

If you give your child too much Amoxicillin/Clavulanic Acid Normon, they may experience symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures. Consult your doctor as soon as possible.

Take the bottle 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 taken.

If You Forget to GiveAmoxicillin/Clavulanic Acid Normon

If you forget to give your child a dose, give it to them 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 missed doses.

If Your Child Stops TakingAmoxicillin/Clavulanic Acid Normon

Continue giving your child this medicine until the treatment is finished, even if they feel better. Your child needs to take the complete treatment to help combat the infection. If bacteria survive, the infection will return.

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

4. Possible Side Effects

Like all medicines, Amoxicillin/Clavulanic Acid Normon can cause side effects, although not everyone gets them. The effects described below can occur with 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 an allergy-induced heart attack (Kounis syndrome).
• • Contact your doctor immediatelyif your child experiences any of these symptoms. Stop givingAmoxicillin/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 Inflammation of the Pancreas (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 as soon as possiblefor advice if your child has 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.
• • If this happens, take Amoxicillin/Clavulanic Acid Normon before meals.
• Vomiting.
• Diarrhea (in children).

Uncommon Side Effects

May affect up to 1 in 100 patients

• Skin rash, itching.
• Increased itchy rash (urticarial rash).
• Indigestion.
• Dizziness.
• Headache.

Uncommon side effects that may appear in blood tests:

• Increased levels of certain substances (enzymes) produced by the liver.

Rare Side Effects

May affect up to 1 in 1,000 patients

• Skin rash that 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)

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

Rare side effects that may appear in 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).
• Inflammation of the large intestine (see above).
• Inflammation of the membrane that surrounds the brain and spinal cord (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 dermatitisbullous).

• Red exfoliative rash with bumps under the skin and hives (pustular exanthematous).
• Symptoms like the flu 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 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.
• Stained teeth (in children), which usually disappears with brushing.
• Rash with blisters arranged in a circle with a central crust or like a necklace (linear IgA disease).
• Inflammation of the membranes that surround 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 count of red blood cells (hemolytic anemia).
• Crystals in the urine that cause acute kidney injury.

Reporting of Side Effects:

If your child experiences any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: 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

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 packaging after EXP. The expiry date is 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 the first 7 days.

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

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition of Amoxicillin/Clavulanic Acid Normon125 mg/31.25 mg/5 ml powder for oral suspension EFG

The active ingredients 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) and sodium carboxymethylcellulose (E-466), xanthan gum (E-415), sodium benzoate (E-211), sucrose, and orange essence.

Appearance of the Product and Container Content

Amoxicillin/Clavulanic Acid Normon 125 mg/31.25 mg powder for oral suspension is presented 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 creamy powder with a characteristic odor.

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 medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

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Instructions for Correct Administration of the Preparation

1. Invert the bottle to loosen the powder stuck to the bottom. Fill with water up to the notch on the bottle located above the label and shake before use. Invert and shake well. Shake before use.
2. Use the spoon included in the packaging to administer the dose indicated by the doctor.
3. After use, rinse the spoon. Store in the refrigerator and always shake before use.