Amoxicilina/acido clavulanico pensa pharma 875 mg/125 mg comprimidos recubiertos con pelicula efg

Leaflet: information for the patient

Amoxicillin/Clavulanic Acid pensa pharma 875 mg/125 mg

Film-coated tablets EFG

Read this leaflet carefully before you start taking this medicine, as 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. Do not give it to others even if they have the same symptoms 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 is Amoxicillin/Clavulanic Acid Pensa Pharma and what it is used for

2. What you need to know before starting to take Amoxicillin/Clavulanic Acid Pensa Pharma

3. How to take Amoxicillin/Clavulanic Acid Pensa Pharma

4. Possible side effects

5. Storage of Amoxicillin/Clavulanic Acid Pensa Pharma

6. Contents of the pack and additional information

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

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

Do not take Amoxicilina/Ácido clavulánico Pensa Pharma:

• Do not take Amoxicilina / Ácido clavulánico Pensa Pharma if you fall under any of the above points. Before starting treatment with Amoxicilina / Ácido clavulánico Pensa Pharma, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication if:

If you are unsure whether any of the above symptoms affect you, inform your doctor or pharmacist before taking Amoxicilina / Ácido clavulánico Pensa Pharma.

In some cases, 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 Pensa Pharma or another medication.

Symptoms to be aware of

Amoxicilina / ácido clavulánico may worsen existing conditions or cause severe side effects. These include allergic reactions, convulsions, and inflammation of the large intestine. Be aware of certain symptoms while taking amoxicilina / ácido clavulánico to reduce the risk of problems. See “Symptoms to be aware of” 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. This is because amoxicilina / ácido clavulánico may alter the results of these types of tests.

Use of Amoxicilina / Ácido clavulánico Pensa Pharma with other medications

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

If you are taking alopurinol (used to treat gout) with Amoxicilina / Ácido clavulánico, you may be more likely to experience a skin allergic reaction.

Probenecid (used to treat gout), concomitant use of probenecid may reduce the excretion of amoxicilina and is not recommended.

Metotrexato (a medication used to treat cancer and severe psoriasis), penicilinas may reduce the excretion of metotrexato and cause a potential increase in adverse effects.

If you are taking anticoagulants (such as warfarina) with Amoxicilina / Ácido clavulánico Pensa Pharma, more blood tests will be required.

Amoxicilina / ácido clavulánico 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, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Amoxicilina / Ácido clavulánico may cause side effects, and symptoms may make you unfit to drive. Do not drive or operate machinery unless you feel well.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubts, consult your doctor or pharmacist again.

Adults and children 40 kg or more

Children under 40 kg of weight

• It is preferable to treat children 6 years or less with oral suspension of amoxicillin/clavulanic acid or sachets.
• Ask your doctor or pharmacist for advice when administering amoxicillin/clavulanic acid to children weighing less than 40 kg. Tablets are not suitable for children weighing less than 25 kg.

Patients with kidney and liver problems

How to take Amoxicilina / Ácido clavulánico Pensa Pharma

If you take more Amoxicilina / Ácido clavulánico Pensa Pharma than you should

If you take too much Amoxicilina / Ácido clavulánico Pensa Pharma, 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 the 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 Pensa Pharma

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 Amoxicilina / Ácido clavulánico Pensa Pharma

Continue taking Amoxicilina / Ácido clavulánico Pensa Pharma 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 have the infection again.

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

Like all medicines, this medicine can 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

Allergic reactions:

• Contact your doctor immediatelyif you experience any of these symptoms.Stop taking Amoxicilina / Ácido clavulánico Pensa Pharma.

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.

• Contact your doctor as soon as possibleto advise you if you experience these symptoms.

Very common side effects

May affect more than 1 in 10 people

Common side effects

May affect up to 1 in 10 people

Uncommon side effects

May affect 1 in 100 people

Side effects that may appear in blood tests:

Rare side effects

May affect up to 1 in 1,000 people

• If you haveanyof these symptoms, consult a doctor urgently

Side effects that may appear in blood tests:

Unknown frequency

The frequency cannot be estimated from the available data.

• 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
  • inflammation of the kidney tubes
  • 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.

Side effects that may appear in blood or urine tests:

Drug-induced enterocolitis syndrome (DIES):

DIES has been reported mainly in children receiving 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.

• If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet,inform your doctor or pharmacist.

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 not mentioned in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and themedicines that you no longer need at the SIGREcollection point at the pharmacy. If in doubt, ask yourpharmacist how to dispose of the packaging and the medicines that you no longer need.By doing so, you will help protect the environment.

Composition of Amoxicillin / Clavulanic Acid Pensa Pharma

The active principles are amoxicillin and clavulanic acid. Each tablet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.

The other components are:

Appearance of the product and contents of the package

Amoxicillin / Clavulanic Acid Pensa Pharma 875 mg/125 mg Film-coated Tablets are white to off-white, oval-shaped, and scored tablets. They are available in packs of 20 and 30 tablets.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible manufacturer

PenCef Pharma GmbH

Breitenbachstrasse 13-14

13509 Berlin, Germany

Last review date of this leaflet:January 2023

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

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Advice and medical education

Antibiotics are used for the treatment of bacterial infections. They are not effective against viral infections.

Occasionally, a bacterial infection does not respond to antibiotic treatment. One of the most common reasons for this is that the bacteria causing the infection are resistant to the antibiotic being taken. This means that the bacteria can survive or grow despite the antibiotic.

Bacteria can become resistant to antibiotics for many reasons. Using antibiotics properly can reduce the likelihood of bacteria becoming resistant to them.

When your doctor prescribes an antibiotic, it is only for the course of your illness. Paying attention to the following advice will help prevent the emergence of resistant bacteria that may make the antibiotic ineffective.

If you still have antibiotics left over after completing treatment, hand in all unused medications to your pharmacy to ensure that the disposal requirements are met.