


Ask a doctor about a prescription for AMOXICILLIN/CLAVULANIC ACID TARBIS FARMA 500 mg/125 mg FILM-COATED TABLETS
Package Leaflet: Information for the Patient
Amoxicillin/Clavulanic Acid Tarbis Farma 500 mg/125 mg Film-Coated Tablets EFG
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Contents of the Package Leaflet
Amoxicillin/Clavulanic Acid Tarbis Farma is an antibiotic that eliminates the bacteria that cause infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins" which can sometimes lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.
Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold. It is essential to follow the dosage instructions, administration intervals, and treatment duration indicated by your doctor. Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medications down the drain or in the trash. |
Amoxicillin/Clavulanic Acid Tarbis Farma is used in adults and children to treat the following infections:
Do not take amoxicillin/clavulanic acid:
Do not take amoxicillin/clavulanic acid if you are included in any of the above points.Before starting treatment with amoxicillin/clavulanic acid, if you are unsure, consult your doctor or pharmacist.
Warnings and Precautions
Tell your doctor or pharmacist before taking this medicine if:
If you are unsure whether any of the above symptoms affect you, inform your doctor or pharmacist before taking this medicine.
In some cases, your doctor may investigate the type of bacteria causing your infection.
Depending on the results, you may be prescribed a different formulation of amoxicillin/clavulanic acid or another medication.
Symptoms to be Aware of
Amoxicillin/Clavulanic Acid Tarbis Farma can worsen certain existing conditions or cause serious side effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should be aware of certain symptoms while taking this medication 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 status or liver function studies) or urine tests (to check glucose levels), inform your doctor or nurse that you are taking this medicine. This is because this medicine can alter the results of these types of tests.
Using Amoxicillin/Clavulanic Acid with Other Medicines
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription and herbal medicines.
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 probenecid (used to treat gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
If you are taking anticoagulants (such as warfarin) with amoxicillin/clavulanic acid, more frequent blood tests will be needed.
If you are taking methotrexate (a medicine used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate and cause a potential increase in side effects.
This medicine may affect the action of mycophenolate mofetil (a medicine used to prevent organ rejection after transplantation).
Pregnancy, Breastfeeding, and Fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and Using Machines
Amoxicillin/Clavulanic Acid Tarbis Farma can have side effects and the symptoms may make you unfit to drive.
Do not drive or operate machinery unless you are feeling well.
Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.
Adults and Children Over 40 kg
The usual dose is:
Children Under 40 kg
It is preferable to treat children under 6 years with the oral suspension of amoxicillin/clavulanic acid or sachets.
Ask your doctor or pharmacist for advice when administering amoxicillin/clavulanic acid tablets to children who weigh less than 40 kg. The tablets are not suitable for children who weigh less than 25 kg.
Patients with Kidney and Liver Problems
How to Take Amoxicillin/Clavulanic Acid Tarbis Farma
If You Take More Amoxicillin/Clavulanic Acid Than You Should
If you take too much amoxicillin/clavulanic acid, you may experience symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures. Consult your doctor as soon as possible. Take the package with you to show the doctor.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.
If You Forget to Take Amoxicillin/Clavulanic Acid
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 forgotten doses.
If You Stop Taking Amoxicillin/Clavulanic Acid
Continue taking amoxicillin/clavulanic acid until you finish the treatment, even if you feel better. You need to take the full treatment to cure the infection. If you do not, the bacteria that survive may cause you to become infected again.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Symptoms to be Aware of
Allergic Reactions:
Contact your doctor immediatelyif you experience any of these symptoms. Stop taking this medicine.
Inflammation of the Large Intestine
Inflammation of the large intestine, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.
Contact your doctor immediatelyif 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 to 1 in 10 patients)
Uncommon Side Effects(may affect up to 1 in 100 patients)
Uncommon Side Effects that may Appear in Your Blood Tests:
Rare Side Effects(may affect up to 1 in 1,000 patients)
If you experience any of these symptoms, consult a doctor urgently.
Rare Side Effects that may Appear in Your Blood Tests:
Frequency Not Known
Frequency cannot be estimated from the available data.
(more than 30% of the body surface - toxic epidermal necrolysis)
Contact your doctor immediately if you experience any of these symptoms.
Side effects that may appear in your blood or urine tests:
Reporting of Side Effects
If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Keep in the original packaging to protect from moisture.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.
Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.
Composition of Amoxicillin/Clavulanic Acid Tarbis Farma
Core: microcrystalline cellulose, crospovidone, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.
Coating: basic butyl methacrylate copolymer, titanium dioxide, talc, macrogol 6000.
Appearance of the Product and Package Contents
White or almost white, oval, film-coated tablets with a score line.
Amoxicillin/Clavulanic Acid Tarbis Farma is available in blister packs containing 30 film-coated tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Tarbis Farma S.L.
Av. Carlos III 94
08028 Barcelona - Spain
Manufacturer:
PenCef Pharma GmbH
Breitenbachstrasse 13-14
13509 Berlin - Germany
Date of Last Revision of this Leaflet: January 2023
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/.
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