PATIENT INFORMATION LEAFLET

Amoxicillin/Clavulanic Acid Tarbis 875 mg/125 mg Oral Powder for Suspension in EFG Blister Packs

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 experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

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 inactive). The other component (ácido clavulánico) prevents this from happening.

Amoxicilina/Ácido clavulánico Tarbisis 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 clavulánico Tarbis

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins, 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 (yellowing 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 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 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, they may prescribe a different presentation of Amoxicilina/Ácido clavulánico or another medicine.

Symptoms to be aware of

Amoxicilina/Ácido clavulánico Tarbismay 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 Tarbisto 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 tests) 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 Tarbismay alter the results of these types of tests.

Use of Amoxicilina/Ácido clavulánico Tarbis with other medicines

Inform 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 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 amoxicillin and is not recommended.

If you are taking anticoagulants (such as warfarin) with Amoxicilina/Ácido clavulánico Tarbisyou will need more blood tests.

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 adverse effects.

Pregnancy and Breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

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

Do not drive or operate machinery unless you feel well.

Important information about some components ofAmoxicilina/Ácido clavulánico Tarbis875 mg/125 mg powder for oral suspension in sachets

This medicine contains saccharose and glucose. If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

Patients with diabetes mellitus should note that this medicine contains 4 g of saccharose per sachet.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults and children 40 kg or more

Children under 40 kg of weight

Amoxicilina/Ácido clavulánico Tarbis 875 mg/125 mg tablets, is not recommended.

Patients with kidney and liver problems

How to take Amoxicilina/Ácido clavulánico Tarbis

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 discomfort (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 takeAmoxicilina/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 interrupt the treatment with 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 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 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. The side effects described below may occur when taking this medicine.

Symptoms to be aware of

Allergic reactions:

• Skin rash
• Swelling 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 in the face or mouth (angioedema), which causes difficulty breathing
• Collapsing

• Contact your doctor immediatelyif 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 possiblefor 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 patientsthrush (candida infection in the vagina, mouth, or mucous membranes)

• Nausea, especially when taking high doses
• • If this happens, take Amoxicilina/Ácido clavulánico Tarbisbefore meals
• Vomiting
• Diarrhea (in children).

Uncommon side effects

May affect 1 in 100 patients

• Skin rash, itching
• Increased skin rash (urticarial hives)
• Indigestion
• Dizziness
• Headache.

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 rash, which may form blisters that look like small darts (erythema multiforme)

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

Side effects that may appear in blood tests:

• Low count of cells involved in blood clotting
• Low count of white blood cells

Not known(cannot be estimated from available data)

• Angina pectoris in the context of allergic reactions, which may be a symptom of allergic-induced myocardial infarction (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 injury.
• Urticarial rash with blisters arranged in a circle with a central crust or as a pearl necklace (IgA linear disease).
• Meningitis, an inflammation of the membranes surrounding the brain and spinal cord.
• Acute pancreatitis. If you have severe and persistent pain in the abdominal area, this could be a sign of acute pancreatitis.

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 (more than 30% of the body surface – toxic epidermal necrolysis)

• generalized rash with small blisters containing pus (dermatitis exfoliativa bullosa)

• red rash with bumps under the skin and urticaria (pustulosis exanthemática).
• Symptoms similar to the flu 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 your 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 can turn the skin and the white of the eyes yellow
• Renal tubular inflammation
• Delayed blood clotting
• Hypervigilance
• 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:

• Significant reduction in the number of white blood cells
• Low count of red blood cells (hemolytic anemia)
• Crystals in the urine.

If you experience side effects

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

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

No special storage conditions are required.

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.

Do not use this medicationif the packets are torn or damaged.

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

Composition ofAmoxicilina/Ácido clavulánico Tarbis875 mg/125 mg powder for oral suspension in sachets

• The active principles are amoxicilina and ácido clavulánico. Each sachet contains: Amoxicilina (as amoxicilina trihydrate) 875 mg and of Ácido clavulánico (as clavulanate potassium) 125 mg.

• The other components (excipients) are: sacarose, silicon dioxide (E-551), xanthan gum, lemon flavoring (contains glucose in maltodextrin from corn) and strawberry flavoring (contains glucose in maltodextrin from corn).

Appearance of the product and contents of the package

White powder

Packages of 20, 30 and 500 sachets

Marketing Authorization Holder

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028-Barcelona

Manufacturer responsible:

Laboratorios Reig Jofré, S.A.

Jarama, 111 (Industrial Polygon) - 45007 Toledo

This leaflet was approved in January 2023

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Instructions for reconstitution

Empty the contents of the sachet into 10-20 ml of water, shake until a suspension is obtained, and take immediately.

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/.