Amoxicilina/acido clavulanico normon 500 mg/125 mg polvo para suspension oral en sobres efg

Leaflet: information for the user

Amoxicilina/Ácido clavulánico Normon500 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 only and should not be given to others, even if they have the same symptoms of illness, 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.

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

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

3. How toadministerAmoxicilina/Ácido clavulánico Normon

4. Possible side effects

5. Storage ofAmoxicilina/Ácido clavulánico Normon

6. Contents of the pack and additional information

Amoxicilina/Ácido clavulánico Normonis 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 sometimes may lose its effectiveness (become inactive). The other component (ácido clavulánico) prevents this from happening.

Amoxicilina/Ácido clavulánico Normonis 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 takeAmoxicilina/Ácido clavulánico Normon:

•if you are allergic to amoxicillin, clavulanic acid, penicillins, or any of the other components of this medication (listed in section 6);

•if you have ever had a severe allergic reaction (hypersensitivity) 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 takeAmoxicilina/Ácido clavulánico Normonif you fall under any of the above points. Before starting treatment withAmoxicilina/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 takingAmoxicilina/Ácido clavulánico Normon.

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

Be aware of the following symptoms

Amoxicilina/Ácido clavulánico Normon may worsen certain 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 takingAmoxicilina/Ácido clavulánico Normon. This is becauseAmoxicilina/Ácido clavulánico Normonmay alter the results of these types of tests.

Other medications andAmoxicilina/Ácido clavulánico Normon

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

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

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

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

Amoxicilina/Ácido clavulánico Normonmay 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 Normonmay 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 any medication.

Driving and operating machinery

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

Do not drive or operate machinery unless you feel well.

Important information about some of the components ofAmoxicilina/Ácido clavulánico Normon500 mg/125 mg powder for oral suspension in EFG sachets

Amoxicilina/Ácido clavulánico Normon contains sucrose

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 again.

Adults and children weighing40 kg or more

The recommended dose is:

•1 dose administered three times a day.

Children under40 kgin weight

Amoxicilina/Ácido clavulánico Normon 500 mg/125 mg oral powder for suspension EFG 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 working.

How to takeAmoxicilina/Ácido clavulánico Normon

•Just before takingAmoxicilina/ Ácido clavulánico Normonopen the sachet and mix the contents in half a glass of water.

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

•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 moreAmoxicilina/Ácido clavulánico Normonthan you should

If you take too muchAmoxicilina/Ácido clavulánico Normon, you may experience symptoms such as stomach discomfort (nausea, vomiting, or diarrhea) or seizures. Consult your doctor as soon as possible. Bring the packaging with you to show 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 takeAmoxicilina/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 withAmoxicilina/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 Normoncan 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 of the face or throat (angioedema), which can cause difficulty breathing;
• collapse,
• chest painin 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 takingAmoxicilina/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 amoxicillin. It is a certain 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, takeAmoxicilina/Ácido clavulánicoNormonbefore 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 dots (central dark spot 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).
• inflammation of the protective membrane surrounding the brain (aseptic 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 rash with small blisters containing pus (exfoliative dermatitis).

• red exfoliative rash, with lumps under the skin and urticaria (pustular exanthema).
• flu-like symptoms 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 your doctor immediately if you experience any of these symptoms.

• liver inflammation (hepatitis).
• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver) that can turn the skin and white of the eyes yellow.
• kidney tubule inflammation.
• delayed blood clotting.
• hyperactivity.
• seizures (in patients taking high doses ofAmoxicilina/Ácido clavulánicoor those 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 as a pearl necklace(IgA linear disease)
• inflammationof the membranes surrounding 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 red blood cell count (hemolytic anemia).
• crystals in the urine that cause acute kidney damage.

Reporting 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 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 medication.

Do not store at a temperature above25ºC.

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

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not useAmoxicillin/Clavulanic Acid Normonif the packets are torn or damaged.

Medicines 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 ofAmoxicilina/Ácido clavulánico Normon500 mg/125 mg powder for oral suspension in EFG sachets

The active principles are amoxicilina and ácido clavulánico. Each sachet contains 500 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 contents of the packaging

Amoxicilina/Ácido clavulánico Normon 500 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 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 medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es