Leaflet: Information for the User

Amoxicillin/Clavulanic AcidTarbis Farma875 mg/125 mg Film-Coated Tablets EFG

Read this leaflet carefully before you start to take 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. Do not give it to others, even if they have the same symptoms, 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.

Amoxicilina/Ácido clavulánico Tarbis Farma 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 inactive). The other component (ácido clavulánico) prevents this from happening.

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

• Middle ear and nasal sinus infections
• Respiratory tract infections
• Urinary tract infections
• Skin and soft tissue infections, including dental infections
• Bone and joint infections

Do not take Amoxicilina/Ácido clavulánicoTarbis Farma:

• if you are allergic 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 if you fall under any of the above points. Before starting treatment with amoxicilina/ácido clavulánico,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 takingthis medication.

In some cases, your doctor may investigate the type of bacteria causing your infection.

Depending on the results, you may be prescribed a different presentation of amoxicilina/ácido clavulánico or another medication.

Symptoms to be aware of

Amoxicilina/ácido clavulánico 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 amoxicilina/ácido clavulánico to reduce the risk of problems. See “Symptoms to be aware of” insection 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 this medication. This is because amoxicilina/ácido clavulánico may alter the results of these types of tests.

Use of amoxicilina/ácido clavulánico with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take other medications, including those obtained without a prescription and herbal medications.

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

If you are taking probenecid (used to treat gout), concurrent use of probenecid may reduce amoxicilina excretion and is not recommended.

If you are taking anticoagulants (such as warfarin) with amoxicilina/ácido clavulánico, more blood tests will be required.

If you are taking methotrexate (a medication used to treat cancer and severe psoriasis), penicillins may reduce methotrexate excretion and cause a potential increase in side effects.

Amoxicilina/ácido clavulánico may affect how micophenolate mofetil (a medication used to prevent organ transplant rejection) works.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking 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 indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults and children 40 kg or more

• Usual dose: 1 tablet twice a day
• Higher dose: 1 tablet 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 the sachets.

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 Amoxicillin/Clavulanic acidTarbis Farma

• Take with meals
• Swallow the tablets whole with a glass of water The groove is only for breaking the tablet if you find it difficult to swallow it whole. You must take both halves of the tablet at the same time.
• Space the doses throughout the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
• Do not take Amoxicillin/Clavulanic acid for more than 2 weeks. If you continue to feel unwell, consult your doctor.

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. 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 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 the missed doses.

If you interrupt the treatment with amoxicillin/clavulanic acid

Continue taking amoxicillin/clavulanic acid 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 questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The side effects listed below may occur with this medicine.

Be aware of these symptoms

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 amoxicillin/clavulanic acid.

Colitis:

Colitis, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

• Contact your doctor as soon as possibleso that they can advise you, if you have 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)

• thrush (Candida– fungal infection of the vagina, mouth, or mucous membranes)
• nausea, especially when taking high doses

• if this happens, take amoxicillin/clavulanic acid with meals

• vomiting
• diarrhea (in children).

Uncommon side effects(may affect 1 in 100 patients)

• skin rash, itching
• increased pruritic rash (urticarial)
• indigestion
• dizziness
• headache.

Less common 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 resemble small darts (eritema multiforme)

• If you experience any of these symptoms, consult your doctor urgently

Less common 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).
• Chest pain in the context of allergic reactions, which may be a symptom of allergic-induced heart attack (Kounis syndrome).
• Drug-induced enterocolitis syndrome (DIES): DIES has been reported mainly 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.
• Crystals in the urine that cause acute kidney damage.
• Rash with blisters arranged in a circle with a central crust or like a pearl necklace (IgA linear disease).
• Acute pancreatitis. If you have severe and persistent pain in the abdominal area, this could be a sign of acute pancreatitis.
• 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)
  • generalized red rash with bumps under the skin and blisters (pustular exanthem).
  • flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (such as increased eosinophils and elevated liver enzymes)(drug reaction with eosinophilia and systemic symptoms (DRESS)).

• 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 the white of the eyes yellow
• inflammation of the kidney tubules
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses of this medication or with kidney problems)

black tongue that appears hairy

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.

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 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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Amoxicilina/Ácido clavulániTarbis Farma

• The active principles are amoxicilina and clavulanic acid.
• Each film-coated tablet contains amoxicilina trihydrate equivalent to 875 mg of amoxicilina and potassium clavulanate equivalent to 125 mg of clavulanic acid.
• The other components are:

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 contents of the packaging

White or off-white, oval, scored film-coated tablets.

Blister packs containing 20 and 30 film-coated tablets.

Holder of the marketing authorization and responsible manufacturer

Holder

Tarbis Farma S.L.

Av. Carlos III 94

08028 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 /