Leaflet: information for the user

Amoxicilina/Ácido clavulánico Normon125 mg/31,25 mg/5 ml powder for oral suspension 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, consult your doctor or pharmacist.

-This medicine is normally prescribed for 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isAmoxicilina/Ácido clavulánico Normonand what it is used for

2. What you need to know before starting to administerAmoxicilina/Ácido clavulánico Normon

3. How to administerAmoxicilina/Ácido clavulánico Normon

4. Possible side effects

5. Storage ofAmoxicilina/Ácido clavulánico Normon

6. Contents of the pack and additional information

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

Amoxicilina/Ácido clavulánico Normon125 mg/31,25 mg/5 mloral powder for suspension EFGis 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

Do not administerAmoxicilina/Ácido clavulánico Normonto your child:

•If he is allergic to amoxicillin, clavulanic acid, penicillins, or any of the other components of this medication (see section 6).

•If he has ever had a severe allergic reaction to any other antibiotic. This could include skin rash or swelling of the face or throat.

•If he has ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

?Do not giveAmoxicilina/Ácido clavulánico Normonto your child if any of the above points apply.. Before starting treatment if you are unsure, consult with your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before administering this medication to your child if:

•He has infectious mononucleosis.

•He is receiving treatment for liver or kidney problems.

•He does not urinate regularly.

If you are unsure whether any of the above symptoms affect your child, inform your doctor or pharmacist before takingAmoxicilina/Ácido clavulánico 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 presentation of amoxicillin/clavulanic acid or another medication.

Be aware of the following symptoms

Amoxicilina/Ácido clavulánico Normon may worsen existing conditions or cause serious side effects. These include allergic reactions, convulsions, and inflammation of the large intestine. Be aware of the following symptoms while your child is taking Amoxicilina/Ácido clavulánico Normon, to reduce the risk of problems. See “Be aware of the following symptoms” in thesection 4.

Blood and urine tests

If your child is having blood tests (such as studies of red blood cell status or studies to check liver function)or urine tests(to control glucose levels),inform your doctor or nurse that your child is takingAmoxicilina/Ácido clavulánico Normon. This is becauseAmoxicilina/Ácido clavulánico Normonmay alter the results of these types of tests.

Other medications andAmoxicilina/Ácido clavulánicoNormon

Inform your doctor or pharmacist if your child is using or has used recently or may need to use other medications.

If your child is taking allopurinol (used for gout) with Amoxicilina/Ácido clavulánico Normon, it may be more likely that he will have an allergic reaction to the skin.

If your child is taking probenecid (used for gout), your doctor may adjust the dose of Amoxicilina/Ácido clavulánico Normon.The concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.

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

Amoxicilina/Ácido clavulánico Normon may affect the way methotrexate (a medication for cancer and severe psoriasis) works.

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

Pregnancy, breastfeeding, and fertility

If your daughter is going to take this medication and is pregnant or breastfeeding,or if you think you might be pregnant, consult your doctor or pharmacist before using this medication.

Consultyour doctor or pharmacist before usingany medication.

Important information about some of the components of Amoxicilina/Ácido clavulánico Normon125 mg/31,25 mg/5 ml oral suspension EFG

Amoxicilina/Ácido clavulánico Normon contains saccharose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Amoxicilina/Ácido clavulánico Normon contains sodium benzoate (E-211)

This medication 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 old).

Amoxicilina/Ácido clavulánico Normon contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per dose; 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 weighing40 kg or more

•It is not usually recommended for adults and children weighing more than40 kg. Consult your doctor or pharmacist.

Children weighing less than40 kg

All doses are expressed in relation to the child's body weight in kilograms.

•Your doctor will advise you how muchAmoxicilina/Ácido clavulánico Normonto give to the infant or child.

•A plastic dosing spoon will be provided. You must use it to give the correct dose to the infant or child.

•The usual dose is – 20 mg/5 mg to 60 mg/15 mgper kilogram of body weight and 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 presentation or another medication.

•If your child has liver problems, blood tests will be performed more frequently to check how their liver is functioning.

How to administerAmoxicilina/Ácido clavulánico Normon

•Always shake the bottle well before each dose

•Administer at the beginning of meals or a little before

•Space doses throughout the day, at least 4 hours apart. Do not take 2 doses in 1 hour.

•Do not administer Amoxicilina/Ácido clavulánico Normon to your child for more than 2 weeks. If your child continues to feel unwell, they should see their doctor again.

If you administer moreAmoxicilina/Ácido clavulánico Normonthan you should

If you administer too muchAmoxicilina/Ácido clavulánico Normonto your child, symptoms such as stomach upset (nausea, vomiting, or diarrhea) or convulsions may appear. Consult your doctor as soon as possible.

Take the bottle to show it to your doctor.

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

If you forgot to administerAmoxicilina/Ácido clavulánico Normon

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

If your child stops takingAmoxicilina/Ácido clavulánico Normon

Continue administering this medication to your child until the treatment is completed, even if they are feeling better. Your child needs to take the complete treatment to help them fight the infection. If bacteria survive, they will get the infection again.

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

Like all medicines, Amoxicilina/Ácido clavulánico NORMON may cause side effects, although not everyone will experience them. The side effects described below may appear with this medicine.

Symptoms to be aware of

Allergic reactions:

• Skin rash.

• Swelling 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 of the face or throat (angioedema), which causes difficulty breathing.
• Loss of consciousness.
• Chest pain in the context of allergic reactions, which may be a symptom of an allergic-induced heart attack (Kounis syndrome).
• • Contact your doctor immediately if your child experiences any of these symptoms.Stop administering 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 amoxicilina. 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 possible for 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 infection in the vagina, mouth, or mucous membranes).
• Nausea, especially when taking high doses.
• If this happens, take Amoxicilina/Ácido clavulánico Normon before meals.
• Vomiting.
• Diarhea (in children).

Uncommon side effects:

May affect up to 1 in 100 patients.

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

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 may form blisters that look like small darts (erythema multiforme).

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

Side effects that may appear in blood 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 your child experiences any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance 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.

Dry Powder

Do not store at a temperature above 25 °C . Store in the original packaging to protect it from light and humidity.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration 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 medication out of the sight and reach of children.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medicines. By doing so, you will help protect the environment.

Composition of Amoxicilina/Ácido clavulánico Normon 125 mg/31,25 mg/5 ml powder for oral suspension EFG

The active principles are amoxicilina and ácido clavulánico. Each ml of reconstituted suspension contains 25 mg of amoxicilina (as amoxicilina trihidrato) and 6.25 mg of ácido clavulánico (as clavulanato potásico) . Each 5 ml of reconstituted suspension contains 125 mg of amoxicilina (as amoxicilina trihidrato) and 31.25 mg of ácido clavulánico (as clavulanato potásico).

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, orange essence.

Appearance of the product and contents of the packaging

Amoxicilina/Ácido clavulánico 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 packaging containing 20 bottles of 120 ml . The bottles contain a white or slightly cream-colored powder with a characteristic odor.

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 in April 2023.

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

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Instructions for correct administration of the preparation

1. Invert the bottle to release the powder adhering to the bottom. Complete with water up to the notch on the bottle located above the label and shake before using. Invert and shake well. Shake before using.
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 shake always before using.