PATIENT INFORMATION LEAFLET

Amoxicilina/Ácido clavulánico Tarbis875 mg/125 mg Film-coated Tablets EFG

Read this leaflet carefully before you start taking this medicine.

• 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(or your child)and should not be given to others, even if they have similar symptoms, as it may harm them.
• If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

1.What isAmoxicilina/Ácido clavulánico Tarbisand what it is used for

2.Before takingAmoxicilina/Ácido clavulánico Tarbis

3.How to takeAmoxicilina/Ácido clavulánico Tarbis

4.Possible side effects

5Storage ofAmoxicilina/Ácido clavulánico Tarbis

6.Further information

Amoxicilina/Ácido clavulánico Tarbisis 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 inactivated). The other component (ácido clavulánico) prevents this from happening.

Amoxicilina/Ácido clavulánico Tarbisis used in children and adults 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 clavulánico Tarbis:

•if you are allergic (hypersensitive) to amoxicilina, ácido clavulánico, penicilinas, or any of the other components of Amoxicilina/ Ácido clavulánico 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 (yellow discoloration of the skin) when taking an antibiotic.

Do not take Amoxicilina/Ácido clavulánico Tarbis if you are included in any of the above points. Before starting treatment with Amoxicilina/ Ácido clavulánico Tarbis, if you are unsure, consult your doctor or pharmacist.

Be especially careful with Amoxicilina/Ácido clavulánico Tarbis

Inform your doctor or pharmacist before taking 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 taking Amoxicilina/ Ácido clavulánico Tarbis.

Your doctor may investigate the type of bacteria causing your infection. Depending on the results, your doctor may prescribe a different presentation of Amoxicilina/Ácido clavulánico or another medication.

Symptoms to be aware of

Amoxicilina/Ácido clavulánico Tarbis may worsen certain 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 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 studies or liver function studies) or urine tests (to control glucose levels), inform your doctor or nurse that you are taking Amoxicilina/Ácido clavulánico Tarbis. This is because Amoxicilina/ Ácido clavulánico Tarbis may alter the results of these types of tests.

Use of other medications

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

If you are taking alopurinol (used for gout) with Amoxicilina/Ácido clavulánico Tarbis, you may be more likely to suffer a skin allergic reaction.

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

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

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

Driving and operating machinery

Amoxicilina/Ácido clavulánico Tarbis may have side effects and symptoms that may make you unable to drive.

Do not drive or operate machinery unless you are feeling well.

Follow exactly the administration instructions for Amoxicilina/Ácido clavulánico Tarbis as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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 6 years old or less with the oral suspension of Amoxicilina/Ácido clavulánico or the sachets.

Seek advice from your doctor or pharmacist when administering Amoxicilina/Ácido clavulánico Tarbis to children weighing less than 40 kg.

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 functioning.

How to take Amoxicilina/Ácido clavulánico Tarbis

•Swallow the tablets whole with a glass of water at the beginning of meals or a little before.

•Space the doses throughout the day, at least 4 hours apart. Do not take two doses in one hour.

•Do not take Amoxicilina/Ácido clavulánico Tarbis for more than 2 weeks. If you continue to feel unwell, consult your doctor.

If you take more Amoxicilina/Ácido clavulánico Tarbis than you should

If you take too much Amoxicilina/Ácido clavulánico Tarbis, 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.

You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Amoxicilina/Ácido clavulánico 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 Amoxicilina/Ácido clavulánico Tarbis

Continue taking Amoxicilina/Ácido clavulánico Tarbis until you complete the treatment, even if you feel better. You need to take the full 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 doubts about the use of this product, ask your doctor or pharmacist.

Like all medicines, Amoxicilina/Ácido clavulánico Tarbis can cause side effects, although not everyone will experience them.

Symptoms to be aware of

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 mouth (angioedema), which causes difficulty breathing

•collapse.

?Contact your doctor immediately if you experience any of these symptoms. Stop taking Amoxicilina/Ácido clavulánico Tarbis.

Colitis:

• Colitis, 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 patients

•diarrhea (in adults).

Common side effects

May affect up to 1 in 10 patients

•thrush (candida infection in the vagina, mouth, or mucous membranes)

•nausea, especially when taking high doses

→if this happens, take Amoxicilina/Ácido clavulánico Tarbis before meals

•vomiting

•diarrhea (in children).

Uncommon side effects

May affect 1 in 100 patients

•skin rash, itching

•increased pruritic eruption (urticarial hives)

•indigestion

•dizziness

•headache.

Uncommon side effects that may appear in blood tests:

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

Rare side effects

May affect up to 1 in 1,000 patients

•skin eruption, which may form blisters that resemble small darts (erythema multiforme)

?if you experience any of these symptoms, consult a doctor urgently

Uncommon side effects that may appear in blood tests:

•low count of cells involved in blood clotting

•low count of white blood cells

Unknown(cannot be estimated from available data)

• 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 receiving 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 injury.
• Rash with blisters arranged in a circle with a central crust or as a pearl necklace (IgA linear disease).
• Inflammation of the membranes surrounding 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 unknown:

•Allergic reactions (see above)

•Colitis (see above)

•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 (toxic epidermal necrolysis)

-generalized rash with small blisters with pus (exfoliative bullous dermatitis)

-red rash, with bumps under the skin and blisters (pustular exanthema)

-flu-like symptoms with skin 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.

•liver inflammation (hepatitis)

•jaundice, caused by increased bilirubin in the blood (a substance produced by the liver) that may turn the skin and white of the eyes yellow

•kidney tubule inflammation

•delayed blood clotting

•hyperactivity

•seizures (in patients taking high doses of Amoxicilina/Ácido clavulánico or with kidney problems)

•black tongue that appears hairy

•stained teeth (in children), which usually disappears with brushing.

Side effects that may appear in blood or urine tests:

•significantly reduced white blood cell count

•low red blood cell count (hemolytic anemia)

•crystals in the urine.

If you have side effects

?If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

No requires special conservation conditions.

Keep in the original packaging to protect it from light and humidity.

Keep out of the reach and sight of children.

Do not use Amoxicilina/Clavulanic Acid Tarbis after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Amoxicillin/Clavulanic Acid Tarbis 875 mg/125 mg Film-Coated Tablets

The active ingredients 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 silica, sodium starch glycolate, microcrystalline cellulose. Coating: titanium dioxide, hydroxypropylmethylcellulose, macrogol 4000, macrogol 6000, dimethicone, purified water.

Appearance of the Product and Contents of the Package

Oval-shaped, white or almost white tablets.

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

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028-Barcelona

Responsible for Manufacturing:

Laboratorio Reig Jofré, S.A

C/ Jarama 111

45007 Toledo

This leaflet was approved in 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/.

Medical Advice/Counseling

Antibiotics are used for the treatment of bacterial infections. They are not effective against viral infections.

Occasionally, 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 likelihood 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 guidelines will help prevent the emergence of resistant bacteria that may make the antibiotic ineffective.

1. It is very important to take the antibiotic in the correct dose, at the indicated hours, 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 you have been prescribed it specifically for you and use it only for the infection for which it was prescribed.

3. Do not take antibiotics that have been prescribed for others, even if they have the same or a similar infection to yours.

4. Do not give antibiotics that have been prescribed for you to others.

5. If you still have antibiotics left over after completing treatment, return all unused medications to your pharmacy to ensure that the disposal requirements are met.