AMOXICILLIN/CLAVULANIC ACID TARBIS 875 mg/125 mg FILM-COATED TABLETS

Introduction

PATIENT INFORMATION LEAFLET

Amoxicillin/Clavulanic Acid Tarbis875 mg/125 mg film-coated tablets

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What Amoxicillin/Clavulanic Acid Tarbis is and what it is used for
2. Before taking Amoxicillin/Clavulanic Acid Tarbis
3. How to take Amoxicillin/Clavulanic Acid Tarbis
4. Possible side effects

5 Storage of Amoxicillin/Clavulanic Acid Tarbis

1. Further information

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

Amoxicillin/Clavulanic Acid Tarbis 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.

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, 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 a skin rash or swelling of the face or neck
• if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not take Amoxicillin/Clavulanic Acid Tarbis if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before starting treatment with Amoxicillin/Clavulanic Acid Tarbis.

Be especially careful with Amoxicillin/Clavulanic Acid Tarbis

Tell your doctor or pharmacist before taking this medicine if:

• you have infectious mononucleosis
• you are being treated for liver or kidney problems
• you do not urinate regularly.

If you are not sure if any of the above applies to you, tell your doctor or pharmacist before taking Amoxicillin/Clavulanic Acid Tarbis.

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

Symptoms to be aware of

Amoxicillin/Clavulanic Acid Tarbis can worsen certain existing conditions or cause serious side effects. These include allergic reactions, convulsions, 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 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 tests) or urine tests (to check glucose levels), tell your doctor or nurse that you are taking Amoxicillin/Clavulanic Acid Tarbis. This is because Amoxicillin/Clavulanic Acid Tarbis may affect the results of these types of tests.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used 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 experience 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 Tarbis, more 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.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Amoxicillin/Clavulanic Acid Tarbis may have side effects that can affect your ability to drive or use machines.

Do not drive or operate machinery unless you feel well.

3. How to take Amoxicillin/Clavulanic Acid Tarbis

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

Adults and children over 40 kg

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

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 Tarbis to children who weigh less than 40 kg.

Patient with kidney and liver problems

• If you have kidney problems, your dose may be changed. Your doctor may choose a different formulation or another medicine.
• If you have liver problems, you will have more frequent blood tests to check how your liver is working.

How to take Amoxicillin/Clavulanic Acid Tarbis

• Swallow the tablets whole with a glass of water at the start of meals or a little before.
• Space out the doses during the day, at least 4 hours apart. Do not take two doses in one hour.
• Do not take Amoxicillin/Clavulanic Acid Tarbis for more than 2 weeks. If you are still feeling unwell, consult your doctor.

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

If you take too much Amoxicillin/Clavulanic Acid Tarbis, you may experience symptoms such as stomach upset (nausea, vomiting, or diarrhea) or convulsions. Consult your doctor as soon as possible. Take the package with you to show the doctor.

You can also contact the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine 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 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 other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Amoxicillin/Clavulanic Acid Tarbis can cause side effects, although not everybody gets them.

Symptoms to be aware of

Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis) that can appear as red or purple spots on the skin, but can 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), which can cause 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, which causes watery diarrhea, 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 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 in the vagina, mouth, or mucous membranes)
• nausea, especially when taking high doses

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

• vomiting
• diarrhea (in children).

Uncommon side effects

May affect up to 1 in 100 people

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

Uncommon side effects that may appear in your blood tests:

Increased levels of certain substances (enzymes) produced by the liver.

Rare side effects

May affect up to 1 in 1,000 people

• skin rash, which can form blisters that look like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge - erythema multiforme)

? Consult a doctor urgently if you have any of these symptoms.

Rare side effects that may appear in your blood tests:

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

Unknown frequency(cannot be estimated from the available data)

• Chest pain in the context of allergic reactions, which can be a symptom of allergy-induced heart attack (Kounis syndrome).
• Drug-induced enterocolitis syndrome (DIES): DIES has been reported mainly in children receiving amoxicillin. 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.
• Crystals in the urine that cause acute kidney injury.
• Blistering rash arranged in a circle with a central crust or like a string of pearls (linear IgA disease).
• Inflammation of the membranes that surround the brain and spinal cord (aseptic meningitis).

Other side effects

Other side effects that have occurred in a very small number of patients and whose exact frequency is not known:

• Allergic reactions (see above)
• Inflammation of the large intestine (see above)
• Severe skin reactions:
  • widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and in its most severe form, causing widespread peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis)
  • widespread rash with small blisters containing pus (bullous exfoliative dermatitis)
  • red rash with bumps under the skin and blisters (pustular exanthematous eruption)
  • flu-like symptoms with skin rash, fever, gland inflammation, and abnormal blood test results (such as increased white blood cell count and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).

? Contact a doctor immediately if you have any of these symptoms.

• inflammation of the liver (hepatitis)
• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver) that can make the skin and whites of the eyes turn yellow
• inflammation of the kidney ducts
• delayed blood clotting
• hyperactivity
• convulsions (in patients taking high doses of Amoxicillin/Clavulanic Acid or with kidney problems)
• black hairy tongue
• stained teeth (in children), which usually disappears with brushing.

Side effects that may appear in your blood or urine tests:

• significant reduction in the number of white blood cells
• low red blood cell count (hemolytic anemia)
• crystals in the urine.

If you experience side effects

? If you think any of the side effects you are experiencing are serious or if you notice any side effects not listed in this leaflet, tell 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 expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicines to the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Further information

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 ingredients (excipients) are: magnesium stearate, colloidal silica, potato starch glycolate, microcrystalline cellulose. Coating: titanium dioxide, hypromellose, macrogol 4000, macrogol 6000, dimethicone, purified water.

Appearance and packaging of the product

Oval, white or almost white tablets.

Packaging of 20, 30, and 500 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization 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 updated information on this medicine is available on the website of the Spanish Agency for 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 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 chances 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 tips will help you prevent the appearance of resistant bacteria that can make the antibiotic not work.

1. It is very important that you take the antibiotic in the correct dose, at the indicated times, and for the correct number of days. Read the label instructions and if you do not understand something, ask your doctor or pharmacist.
2. Do not take an antibiotic unless it has been specifically prescribed for you, and only use it for the infection for which it was prescribed.
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 that have been prescribed for you to other people.
5. If you still have antibiotic left after completing the treatment, return all unused medicines to your pharmacy to ensure that disposal requirements are met.