Leaflet: information for the user

Amoxicilina/Ácido clavulánico Normon 875 mg/125 mg powder for oral suspension in EFG sachets

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 has been prescribed for you and should not be given to others, even if they have the same symptoms of illness as you, 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 takeAmoxicilina/Ácido clavulánico Normon

3. How to takeAmoxicilina/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 the bacteria that cause infections. It contains two different medications called amoxicilina and ácido clavulánico. Amoxicilina belongs to a group of medications known as “penicilinas” that may sometimes lose its effectiveness (become inactive). The other component (ácido clavulánico) prevents this from happening.

Amoxicilina/Ácido clavulánico Normon is used in adults and children to treat the following infections:

•Middle ear infections and nasal sinus infections

•Respiratory tract infections

•Urinary tract infections

•Skin and soft tissue infections including dental infections

•Bone and joint infections.

Do not take Amoxicilina/Ácido clavulánico Normon:

•if you are allergic to amoxicilina, ácido clavulánico, penicilinas, or any of the other components of this medication (listed in section 6);

•if you have ever had a severe allergic reaction to any other antibiotic. This could include 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 Amoxicilina/Ácido clavulánico Normon if you include any of the above points.Before starting treatment with Amoxicilina/Ácido clavulánico Normon, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before taking this medication 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 symptoms affect you, inform your doctor or pharmacist before taking Amoxicilina/Ácido clavulánico Normon.

Your doctor may investigate the type of bacteria causing your infection. Depending on the results, they may prescribe a different presentation of Amoxicilina/Ácido clavulánico or another medication.

Be aware of the following symptoms

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

Blood and urine tests

If you are having blood tests (such as red blood cell studies or liver function studies) or urine tests (to control glucose levels), inform your doctor or nurse that you are taking Amoxicilina/Ácido clavulánico Normon. This is because Amoxicilina/Ácido clavulánico Normon may alter the results of these types of tests.

Other medications and Amoxicilina/Ácido clavulánico Normon

Inform your doctor or pharmacist if you are taking or have taken recently or may take any other medication.

If you are taking allopurinol (used for gout) with Amoxicilina/Ácido clavulánico Normon, you may be more likely to suffer an allergic reaction on the skin.

If you are 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 amoxicilina and is not recommended.

If you are taking anticoagulants (such as warfarin) with Amoxicilina/Ácido clavulánico Normon, you will need more blood tests.

Amoxicilina/Ácido clavulánico Normon may affect the action of methotrexate (a medication used to treat cancer and severe psoriasis). Penicillins may reduce the excretion of methotrexate and cause a potential increase in side effects.

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

Pregnancy and breastfeeding

If you are pregnant, or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Amoxicilina/Ácido clavulánico Normon may have side effects and symptoms that may make you unable to drive.

Do not drive or operate machinery unless you feel well.

Important information about one of the components of Amoxicilina/Ácido clavulánico Normon 875 mg/125 mg powder for oral suspension in EFG sachets

Amoxicilina/Ácido clavulánico Normon contains saccharose

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

Amoxicilina/Ácido clavulánico Normon contains sodium benzoate

This medication contains 8 mg of sodium benzoate in each sachet. 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 of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Adults and children weighing40 kg or more

•Recommended dose - 1 sachet administered twice a day

•Higher dose - 1 sachet administered three times a day

Children weighing less than40 kgof weight

Amoxicilina/Ácido clavulánico Normon875 mg/125 mg oral powder for suspension in EFG sachets, is not recommended.

Patients with kidney and liver problems

•If you have kidney problems, your dose may be changed. Your doctor may choose a different presentation or another medication.

•If you have liver problems, you will have more frequent blood tests to check how your liver is functioning.

How to take Amoxicilina/Ácido clavulánico Normon

•Just before taking Amoxicilina/Ácido clavulánico Normon, open the sachet and mix the contents in half a glass of water.

•Take it at the beginning of meals or a little before.

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

•Do not take this medication for more than 2 weeks. If you continue to feel unwell, consult your doctor.

If you take more Amoxicilina/Ácido clavulánico Normon than you should

If you take too much Amoxicilina/Ácido clavulánico Normon, you may experience symptoms such as stomach discomfort (nausea, vomiting, or diarrhea) or convulsions. Consult your doctor as soon as possible. Bring the packaging with you to show 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 forget to take Amoxicilina/Ácido clavulánico 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 the missed doses.

If you interrupt the treatment with Amoxicilina/Ácido clavulánico Normon

Continue taking this medication until you complete 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 get the infection again.

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

Like all medicines, Amoxicilina/Ácido clavulánico Normon can cause side effects, although not everyone will experience them. The side effects described below may occur when taking this medication.

Symptoms to be aware of

Allergic reactions:

• skin rash;

• inflammation 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, sometimes of the face or throat (angioedema), which causes difficulty breathing;
• collapse;
• chest pain in the context of allergic reactions, which can be a symptom of an allergic-induced heart attack (Kounis syndrome).
• • Contact your doctor immediatelyif you experience any of these symptoms.Stop taking 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

specific type of allergic reaction with the main symptom of repeated vomiting (1-4 hours

after taking the medication). 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 to1 in 10 patients

• thrush (Candida– fungal infection in the vagina, mouth, or mucous membranes);
• nausea, especially when taking high doses;
• if this occurs, take Amoxicilina/Ácido clavulánico Normon before meals.
• vomiting;
• diarrhea (in children).

Uncommon side effects

May affect1 in 100 patients

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

Uncommon side effects that may appear in 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 may form blisters that appear as small dianas (a dark spot in the center surrounded by a lighter area, with a dark ring around the edge –erythema multiforme).

• if you haveanyof these symptoms, consult your doctor urgently

Uncommon side effects that may appear in blood tests:

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

Unknown frequency

The frequency cannot be estimated from the available data.

• Allergic reactions (see above).
• Colitis (see above).
• Asymptomatic meningitis.
• Severe skin reactions:

• Generalized rash with blisters and skin peeling, 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 the body surface –toxic epidermal necrolysis).

• Red generalized rash with small pus-filled blisters (exfoliative dermatitis).

• Red exfoliative rash, with bumps under the skin and urticaria (pustular exanthem).
• Symptoms similar to the flu, with skin rash, fever, swollen lymph nodes, and abnormal blood test results (such as increased eosinophils (eosinophilia) and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).

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

• Liver inflammation (hepatitis);
• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver) that may turn the skin and white of the eyes yellow;
• kidney tubule inflammation;
• delayed blood clotting;
• hyperactivity;
• seizures (in patients taking high doses of Amoxicilina/Ácido clavulánico or with kidney problems);
• black tongue that appears hairy;
• stained teeth (in children), which usually disappears with brushing;
• rash with blisters arranged in a circle with a central crust or like a pearl necklace (IgA linear disease)
• meningitis caused by inflammation of the membranes surrounding the brain and spinal cord (asymptomatic meningitis).

Side effects that may appear in 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 damage.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the 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 medication.

Do not store above25ºC.

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

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.

Do not use Amoxicillin/Clavulanate Acid Normonif the packets are torn or damaged.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Amoxicilina/Ácido clavulánico Normon 875 mg/125 mg powder for oral suspension in EFG sachets

The active principles are amoxicilina and ácido clavulánico. Each sachet contains 875 mg of amoxicilina ( as amoxicilina trihydrate ) and 125 mg of ácido clavulánico ( as clavulanate potassium ).

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 content of the packaging

Amoxicilina/Ácido clavulánico Normon 875 mg/125 mg is presented in sachets containing powder for oral suspension. The sachets contain a white or slightly cream-colored powder with a characteristic odor.

Each package contains 20, 30 and 500 sachets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

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

Date of the last review of this leaflet: April 2023

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Instructions for reconstitution

Empty the contents of the sachet into a glass.

Add a small amount of water and mix well.

Take immediately.

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