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

Prospect: information for the user

Amoxicilina/Ácido clavulánico Tevagen500mg/125mg powder for oral suspension in EFG sachets

Read this prospect carefully before starting to take the medicine.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, 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, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to takeAmoxicilina/Ácido clavulánico Tevagen

3.How to takeAmoxicilina/Ácido clavulánico Tevagen

4.Possible adverse effects

1. Storage ofAmoxicilina/Ácido clavulánico Tevagen

6.Contents of the pack and additional information

Amoxicilina/Ácido clavulánico Tevagenis an antibiotic that eliminates the 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 Tevagenis used in adults 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

Do not takeAmoxicillin/Clavulanic AcidTevagen:

• if you are allergic (hypersensitive) 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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Amoxicillin/Clavulanic Acid Tevagen

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

If you are unsure if any of the above symptoms affect you, inform your doctor or pharmacist before taking this medication

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

Be aware of these symptoms

Amoxicillin/Clavulanic Acid may worsen existing conditions or cause serious side effects

These include allergic reactions, convulsions, and inflammation of the large intestine. Be aware of certain symptoms while taking this medication to reduce the risk of problems. See “Be aware of these 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 Amoxicillin/Clavulanic Acid

This is because Amoxicillin/Clavulanic Acid may alter the results of these types of tests

Taking Amoxicillin/Clavulanic Acid Tevagen with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription

• If you are taking allopurinol (used for gout) with Amoxicillin/Clavulanic Acid, you may be more likely to suffer a skin allergic reaction

• If you are taking anticoagulants (such as warfarin) with Amoxicillin/Clavulanic Acid, you will need more blood tests

• Methodrexate (a medication used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate and cause a potential increase in side effects

• Probenecid (used to treat gout), concurrent use with probenecid may reduce the excretion of amoxicillin and is not recommended

• Amoxicillin/Clavulanic Acid may affect how micofenolato de mofetilo (a medication used to prevent organ rejection in transplant patients) works

Pregnancy, breastfeeding, and fertility

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

Amoxicillin/Clavulanic Acid Tevagen may cause side effects and symptoms that may make you unable to drive

Do not drive or operate machinery unless you feel well

Amoxicillin/Clavulanic Acid Tevagen contains saccharose, glucose, and sodium

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

This medication contains less than 1 mmol of sodium (23 mg); it 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 40 kg or more

The recommended dose is:

• 1 sachet administered three times a day

Children under 40 kg

Amoxicillin/Clavulanate 500 mg/125 mg sachets are 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 Amoxicillin/Clavulanate Tevagen

•Just before takingAmoxicillin/Clavulanate Tevagen, open 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 takeAmoxicillin/Clavulanate Tevagenfor more than 2 weeks. If you continue to feel unwell, consult your doctor.

If you take more Amoxicillin/Clavulanate Tevagen than you should

If you take too muchAmoxicillin/Clavulanate Tevagen, you may experience symptoms such as stomach discomfort (nausea, vomiting, or diarrhea) or convulsions.

In case of overdose or accidental ingestion, also consult the Toxicological Information Service, phone (91) 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take Amoxicillin/Clavulanate Tevagen

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.

If you interrupt the treatment with Amoxicillin/Clavulanate Tevagen

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 the infection to return.

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

Like all medicines, this medicinecan cause side effects, although not everyone will experience them. The side effects described below may occur when taking this medicine.

Symptoms to be aware of

Reactionsto allergens:

• 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 glands in the neck, armpits, or groin
• swelling, sometimes of the face or mouth (angioedema), which causes difficulty breathing
• collapse.
• chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by an allergy (Kounis syndrome).

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 medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

• Contact your doctor as soon as possibleso they can advise you if you experience 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

• mouth ulcers (candida– fungal infection in the vagina, mouth, or mucous membranes)
• nausea, especially when taking high doses
• • if this happens, takeAmoxicilina/ Ácido clavulánico Tevagenbefore meals
• vomiting
• diarrhea (in children).

Uncommon side effects

May affect1 in 100 patients

• skin rash, itching
• increased pruritic rash (urticarial)
• 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 look like small darts (eritema multiforme)

• if you haveanyof these symptoms, consult your doctor urgently

Rare 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 membranes surrounding the brain and spinal cord (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)
• generalized rash with small blisters containing pus (exfoliative bullous dermatitis)
• red rash, with bumps under the skin and urticaria (pustular exanthema).
• flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (such as elevated eosinophils and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).
• skin rash with blisters arranged in a circle with a central crust or as a string of pearls (IgA linear disease).

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

• inflammation of the liver (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
• inflammation of the kidney tubules
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses of Amoxicilina/Ácido clavulánico or with kidney problems)
• black tongue that looks hairy
• stained teeth (in children), which usually disappears with brushing.

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,which may 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 leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use Website: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Do not store at a temperature above25ºC.

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

Do not useAmoxicilina/Clavulanic Acid Tevagenafter the expiration date that appears on the packaging and over after CAD. The expiration date is the last day of the month indicated.

Do not useAmoxicilina/Clavulanic Acid Tevagenif the blisters are broken 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 of Amoxicillin/Clavulanic Acid Tevagen 500mg/125mg powder fororal suspension in sachets

• The active principles are amoxicillin and clavulanic acid. Each sachet contains: 500 mg of amoxicillin (as amoxicillin trihydrate) and 125 mg of clavulanic acid (as potassium clavulanate)
• The other components are: silicon dioxide gel (E551), trisodium citrate (E331), sucrose, raspberry aroma (contains glucose) and fruit aroma (contains glucose).

Appearance of the product and contents of the package

White powder.

30 sachet packs

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Teva Pharma S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor

Alcobendas, 28108 Madrid

Responsible manufacturer:

Laboratorios Reig Jofré S.A.

C/Jarama 111, Industrial Estate

45007 Toledo

This leaflet was approved in March 2023

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

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Instructions for reconstitution

Empty the contents of the sachet into 10-20 ml of water, shake until a suspension is obtained, and take immediately.