Amoxicillin/clavulanic acid Tarbis Farma 875 mg/125 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Amoxicillin/Clavulanic acid Tarbis Farma 875 mg/125 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Amoxicillin/Clavulanic acid Tarbis Farma is and what it is used for
2. What you need to know before taking Amoxicillin/Clavulanic acid Tarbis Farma
3. How to take Amoxicillin/Clavulanic acid Tarbis Farma
4. Possible adverse effects
5. How to store Amoxicillin/Clavulanic acid Tarbis Farma
6. Contents of the pack and other information

1. What Amoxicillin/Clavulanic Acid Tarbis Farma is and what it is used for

Amoxicillin/Clavulanic Acid Tarbis Farma is an antibiotic that kills bacteria causing infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins," which sometimes may lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

Amoxicillin/Clavulanic acid Tarbis Farma is 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.

2. What you need to know before starting to take Amoxicillin/Clavulanic Acid Tarbis Farma

Do not take Amoxicillin/Clavulanic Acid Tarbis Farma:

• if you are allergic to amoxicillin, clavulanic acid, penicillins, or to any of the other ingredients of this medicine (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) while taking an antibiotic.

• Do not take amoxicillin/clavulanic acid if any of the above apply to you. Before starting treatment with amoxicillin/clavulanic acid, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine 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 conditions apply to 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 medicine.

Symptoms to watch for

Amoxicillin/clavulanic acid may worsen certain existing conditions or cause serious adverse effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should be aware of certain symptoms while taking amoxicillin/clavulanic acid to reduce the risk of complications. See "Symptoms to watch for" in section 4.

Blood and urine tests

If you are undergoing blood tests (such as red blood cell assessments or liver function tests) or urine tests (to monitor glucose levels), inform your doctor or nurse that you are taking this medicine. This is because amoxicillin/clavulanic acid may alter the results of these types of tests.

Use of amoxicillin/clavulanic acid with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 experience a skin allergic reaction.

If you are taking probenecid (used to treat gout), concomitant use with probenecid may reduce the excretion of amoxicillin and is not recommended.

If anticoagulants (such as warfarin) are taken with amoxicillin/clavulanic acid, more blood tests will be needed.

If you are taking methotrexate (a medicine used to treat cancer and severe psoriasis), penicillins may reduce methotrexate excretion and potentially increase adverse effects.

Amoxicillin/clavulanic acid may affect how mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs) works.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Talk to your doctor or pharmacist before using any medicine.

Driving and using machines

Amoxicillin/clavulanic acid may cause adverse effects, and the symptoms may mean you should not drive. Do not drive or operate machinery unless you feel well.

3. How to take Amoxicillin/Clavulanic Acid Tarbis Farma

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults and children weighing 40 kg or more

• Usual dose: 1 tablet twice daily
• Higher dose: 1 tablet three times daily

Children weighing less than 40 kg

• It is preferable to treat children aged 6 years or younger with amoxicillin/clavulanic acid oral suspension or sachets.

Patients with kidney or liver problems

• If you have kidney problems, your dose may be adjusted. Your doctor may choose a different formulation or another medicine.
• If you have liver problems, you will have blood tests more frequently to monitor liver function.

How to take Amoxicillin/Clavulanic Acid Tarbis Farma

• Take with food
• Swallow the tablets whole with a glass of water. The score line is intended only for splitting the tablet if you have difficulty swallowing it whole. You must take both halves of the tablet at the same time.
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
• Do not take amoxicillin/clavulanic acid for longer than 2 weeks. If you still feel unwell, consult your doctor.

If you take more amoxicillin/clavulanic acid than you should

If you take too much amoxicillin/clavulanic acid, symptoms such as stomach discomfort (nausea, vomiting, or diarrhea) or seizures may occur. Contact your doctor as soon as possible. Take the packaging with you to show your doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine 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 a missed dose.

If you stop taking amoxicillin/clavulanic acid

Continue taking amoxicillin/clavulanic acid for the full duration of treatment, even if you start to feel better. You need to complete the full course to cure the infection. If you do not, surviving bacteria may cause the infection to return.

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

4. Possible adverse effects

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

Symptoms to watch out for

Allergic reactions:

• skin rash

• inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may affect other parts of the body

• fever, joint pain, swollen glands in the neck, armpits, or groin

• swelling, sometimes of the face or throat (angioedema), causing difficulty breathing

• collapse

• Contact your doctor immediately if you experience any of these symptoms. Stop taking amoxicillin/clavulanic acid.

Inflammation of the large intestine

Inflammation of the large intestine, causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.

• Contact your doctor as soon as possible for advice if you have these symptoms.

Very common adverse effects (may affect more than 1 in 10 patients)

• diarrhoea (in adults)

Common adverse effects (may affect up to 1 in 10 patients)

• thrush (Candida – fungal infection in the vagina, mouth, or mucous membranes)

• nausea, especially when high doses are taken

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

• vomiting

• diarrhoea (in children)

Uncommon adverse effects (may affect 1 in 100 patients)

• skin rash, itching
• increased itchy rash (urticarial wheals)
• indigestion
• dizziness
• headache

Uncommon side effects that may appear in blood tests:

• increased levels of certain substances (enzymes) produced by the liver

Rare adverse effects (may affect up to 1 in 1,000 patients)

• skin rash that may form blisters resembling small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme)

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

Rare adverse effects that may appear in blood tests:

• low count of cells involved in blood clotting
• low white blood cell count

Frequency not known

Frequency cannot be estimated from the available data

• allergic reactions (see above)

• inflammation of the large intestine (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 a heart attack triggered by allergy (Kounis syndrome)

• Drug-induced enterocolitis syndrome (DIES): DIES has been reported mainly in children receiving amoxicillin. It is a type of allergic reaction with the main symptom being repeated vomiting (1–4 hours after taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure

• crystals in the urine causing acute kidney injury

• blistering rash arranged in circles with central crusts or resembling a string of pearls (linear IgA disease)

• acute inflammation of the pancreas (acute pancreatitis). If you have severe and persistent pain in the stomach area, this could be a sign of acute pancreatitis

• severe skin reactions:

  • widespread blistering rash with peeling skin, 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 body surface – toxic epidermal necrolysis)
  • widespread red rash with small pus-filled blisters (exfoliative bullous dermatitis)
  • red rash with lumps under the skin and blisters (exanthematous pustulosis)
  • flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (such as increased white blood cells (eosinophilia) 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), which may cause the skin and whites of the eyes to turn yellow

• inflammation of the kidney tubules

• delayed blood clotting

• hyperactivity

• seizures (in patients taking high doses of this medicine or who have kidney problems)

• black, hairy-looking tongue

Adverse effects that may appear in blood or urine tests:

• significant reduction in white blood cell count
• low red blood cell count (haemolytic anaemia)
• crystals in the urine

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicillin/Clavulanic Acid Tarbis Farma

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

Do not store above 25°C. Store in the original packaging to protect from moisture.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials should be returned to the SIGRE collection point at your pharmacy. If you are unsure, please consult your pharmacist on how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Package contents and additional information

Composition of Amoxicillin/Clavulanic Acid Tarbis Farma

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

Core: Microcrystalline cellulose, crospovidone, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.

Coating: Butyl methacrylate copolymer, titanium dioxide, talc, macrogol 6000.

Appearance of the product and contents of the container

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

Blister packs containing 20 and 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 the most recent review of this package leaflet: January 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/