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

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Read the entire leaflet carefully before you start taking this medicine.

• 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 (or your child), and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Amoxicillin/Clavulanic Acid Tarbis is and what it is used for
2. Before you take Amoxicillin/Clavulanic Acid Tarbis
3. How to take Amoxicillin/Clavulanic Acid Tarbis
4. Possible side effects
5. How to store Amoxicillin/Clavulanic Acid Tarbis
6. Further information

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

Amoxicillin/Clavulanic Acid Tarbis 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 can sometimes lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

Amoxicillin/Clavulanic Acid Tarbis is used in children and adults 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. Before taking Amoxicillin/Clavulanic Acid Tarbis

Do not take Amoxicillin/Clavulanic Acid Tarbis:

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins, or any of the other ingredients of Amoxicillin/Clavulanic Acid Tarbis (see 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 neck
• if you have ever had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.

Do not take Amoxicillin/Clavulanic Acid Tarbis if any of the above apply to you. Before starting treatment with Amoxicillin/Clavulanic Acid Tarbis, if you are unsure, consult your doctor or pharmacist.

Take special care with Amoxicillin/Clavulanic Acid Tarbis

Inform 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 Amoxicillin/Clavulanic Acid Tarbis.

In some cases, your doctor may investigate the type of bacteria causing your infection. Depending on the results, they may prescribe a different formulation of Amoxicillin/Clavulanic Acid or another medicine.

Symptoms to watch for

Amoxicillin/Clavulanic Acid Tarbis 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 Tarbis to reduce the risk of problems. See "Symptoms to watch for" in section 4.

Blood and urine tests

If you are undergoing blood tests (such as studies of red blood cell status or liver function tests) or urine tests (to monitor glucose levels), inform your doctor or nurse that you are taking Amoxicillin/Clavulanic Acid Tarbis. This is because Amoxicillin/Clavulanic Acid Tarbis may alter the results of these types of tests.

Use of other medicines

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

If you are taking allopurinol (used for gout) with Amoxicillin/Clavulanic Acid Tarbis, you may be more likely to develop 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 Tarbis, 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.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are breastfeeding, speak with your doctor or pharmacist.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Amoxicillin/Clavulanic Acid Tarbis 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

Follow exactly the instructions given by your doctor for taking Amoxicillin/Clavulanic Acid Tarbis. If you have any doubts, consult your doctor or pharmacist.

Adults and children weighing 40 kg or more

• Usual dose – 1 tablet twice a day
• Higher dose – 1 tablet three times a day

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.

Seek advice from your doctor or pharmacist when administering Amoxicillin/Clavulanic Acid Tarbis to children weighing less than 40 kg.

Patients with kidney or liver problems

• If you have kidney problems, your dose may need to 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

• Swallow the tablets whole with a glass of water at the beginning of a meal or shortly before.
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take two doses within one hour.
• Do not take Amoxicillin/Clavulanic Acid Tarbis for longer than 2 weeks. If you still feel unwell, consult your doctor.

If you take more Amoxicillin/Clavulanic Acid Tarbis than you should

If you take too much Amoxicillin/Clavulanic Acid Tarbis, symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures may occur. Contact your doctor as soon as possible and bring the pack with you to show the doctor.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Amoxicillin/Clavulanic Acid Tarbis

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 stop taking Amoxicillin/Clavulanic Acid Tarbis

Continue taking Amoxicillin/Clavulanic Acid Tarbis for the full duration of the treatment, even if you start to feel better. You must 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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Amoxicillin/Clavulanic acid Tarbis can cause adverse effects, although not everyone experiences them.

Symptoms to watch 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 mouth (angioedema), causing difficulty breathing
• collapse.

? Contact your doctor immediately if you experience any of these symptoms. Stop taking Amoxicillin/Clavulanic acid Tarbis.

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

• mouth, vaginal or mucosal fungal infections (candidiasis)
• nausea, especially when taking high doses

→ if this happens, take Amoxicillin/Clavulanic acid Tarbis before meals

• vomiting
• diarrhoea (in children)

Uncommon adverse effects

May affect up to 1 in 100 patients

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

Uncommon adverse 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, which may blister and resemble 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 a doctor urgently

Rare adverse effects that may appear in blood tests:

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

Not known (cannot be estimated from available data)

• Chest pain in the context of allergic reactions, which may be a symptom of an allergy-triggered heart attack (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 urine causing acute kidney injury.
• Blistering rash arranged in circles with central crusts or resembling a string of pearls (linear IgA disease).
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

Other adverse effects

Other adverse effects that have occurred in a very small number of patients and whose frequency is unknown:

• Allergic reactions (see above)
• Inflammation of the large intestine (see above)
• Serious skin reactions:
  • widespread 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 body surface – toxic epidermal necrolysis)
  • widespread rash with small pus-filled blisters (exfoliative bullous dermatitis)
  • red rash with bumps 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 have any of these symptoms.

• liver inflammation (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 ducts
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses of Amoxicillin/Clavulanic acid or who have kidney problems)
• black, hairy-looking tongue
• stained teeth (in children), which usually disappear with brushing

Adverse effects that may appear in blood or urine tests:

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

If you experience adverse effects

? If you consider any of the adverse effects you experience to be severe or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Amoxicillin/Clavulanic Acid Tarbis

No special storage conditions are required.

Keep in the original packaging to protect from light and moisture.

Keep out of the reach and sight of children.

Do not use Amoxicillin/Clavulanic Acid Tarbis after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Information provided

Composition of Amoxicillin/Clavulanic Acid Tarbis 875 mg/125 mg film-coated tablets

The active substances are amoxicillin and clavulanic acid. Each tablet contains: Amoxicillin (as amoxicillin trihydrate) 875 mg and Clavulanic acid (as potassium clavulanate) 125 mg.

The other components (excipients) are: magnesium stearate, colloidal silicon dioxide, sodium starch glycolate from potato, microcrystalline cellulose. Coating: titanium dioxide, hypromellose, macrogol 4000, macrogol 6000, dimethicone, purified water.

Appearance of the product and contents of the package

Oval, white or almost white film-coated tablets.

Pack sizes: 20, 30 and 500 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028-Barcelona

Manufacturer:

Laboratorio Reig Jofré, S.A

C/ Jarama 111

45007 Toledo

This leaflet was approved in January 2023

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

Medical advice/education

Antibiotics are used to treat bacterial infections. They are not effective against viral infections.

Sometimes a bacterial infection does not respond to antibiotic treatment. One of the most common reasons this occurs is because 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 appropriately can reduce the likelihood of bacteria becoming resistant to them.

When your doctor prescribes an antibiotic, it is intended solely for the treatment of your current illness. Paying attention to the following advice will help you prevent the development of resistant bacteria, which could make antibiotics ineffective.

1. It is very important to take the antibiotic at the correct dose, at the prescribed times, and for the full prescribed duration. Read the labeling instructions carefully and, if you do not understand something, ask your doctor or pharmacist.
2. You should not take an antibiotic unless it has been specifically prescribed for you, and you should use it only for the infection it was prescribed to treat.
3. Do not take antibiotics that have been prescribed for other people, even if they have the same or a similar infection to yours.
4. Do not give antibiotics prescribed for you to other people.
5. If you have leftover antibiotics after completing your treatment, return all unused medicines to your pharmacy to ensure proper disposal.