Amoxicilina/acido clavulanico pensa pharma 875 mg/125 mg comprimidos recubiertos con pelicula efg
Introduction
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
1. What is Amoxicilina/Ácido Clavulánico Pensa Pharma and what is it used for
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.
Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or a cold.
It is essential to follow the instructions regarding the dose, administration interval, and treatment duration indicated by your doctor.
Do not store or reuse this medication. If you have leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of the medication through the drain or in the trash.
Amoxicilina / Ácido clavulánico Pensa Pharma is used in children and adults to treat the following infections:
- Middle ear infections and sinus infections
- Respiratory tract infections
- Urinary tract infections
- Skin and soft tissue infections, including dental infections
- Bone and joint infections.
2. What you need to know before starting to take Amoxicillin/Clavulanic Acid Pensa Pharma
Do not take Amoxicilina/Ácido clavulánico Pensa Pharma:
- if you are allergic (hypersensitive) 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 (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 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:
- 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 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.
3. How to take Amoxicillin/Clavulanic Acid Pensa Pharma
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
- Usual dose: 1 tablet administered twice a day
- Higher dose: 1 tablet administered three times a day
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
- 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 take Amoxicilina / Ácido clavulánico Pensa Pharma
- Swallow the tablets whole with a glass of water at the beginning of meals or a little before. The groove is only for breaking the tablet if it is difficult to swallow it whole.
- Space the doses throughout the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
- Do not take Amoxicilina / Ácido clavulánico Pensa Pharma for more than 2 weeks. If you continue to feel unwell, consult your doctor.
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.
4. Possible Adverse Effects
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.
- 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
- diarrhea (in adults).
Common side effects
May affect up to 1 in 10 people
- thrush (Candida– fungal infection of the vagina, mouth, or mucous membranes)
- nausea, especially when taking high doses. If you experience this, take Amoxicilina / Ácido clavulánico before meals
- vomiting
- diarrhea (in children).
Uncommon side effects
May affect 1 in 100 people
- skin rash, itching
- increased pruritic rash (urticarial)
- indigestion
- dizziness
- headache.
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 people
- skin rash, which may form blisters that appear as small dianas (central dark spot surrounded by a lighter area, with a dark ring around the edge –erythema multiforme)
- If you haveanyof these symptoms, consult a doctor urgently
Side effects that may appear in blood tests:
- low count of cells involved in blood clotting
- low count of white blood cells
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 red rash with small blisters with pus (exfoliative dermatitis bullous)
- red exfoliative rash, with bumps under the skin and blisters (exanthematous pustulosis).
- flu-like symptoms with skin rash, fever, swollen lymph nodes, and abnormal blood test results (such as increased leukocytes (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
- 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:
- significant reduction in the number of white blood cells
- low count of red blood cells (hemolytic anemia)
- crystals in the urine that cause acute kidney damage.
- chest pain in the context of allergic reactions, which may be a symptom of allergic-induced heart attack (Kounis syndrome).
- skin rash with blisters arranged in a circle with a central crust or as a pearl necklace (IgA linear disease).
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.
5. Conservation of Amoxicilina/Clavulanic Acid Pensa Pharma
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.
6. Contents of the packaging and additional information
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:
- Tablet core:microcrystalline cellulose (E460), crospovidone type A (E1202), croscarmellose sodium, anhydrous colloidal silica (E551), magnesium stearate (E470b).
- Coating:basic butyl methacrylate copolymer, titanium dioxide (E171), talc (E553b), macrogol 6000.
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.
- It is very important to take the antibiotic in the correct dose, at the indicated hours, and for the correct number of days. Read the label instructions and if you do not understand something, ask your doctor or pharmacist.
- You should not take an antibiotic unless you have been prescribed it specifically for you and you should use it only for the infection for which you have been prescribed it.
- You should not take antibiotics that have been prescribed for other people, even if they have the same or a similar infection to yours.
- You should not give antibiotics that have been prescribed for you to other people.
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.
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