PATIENT INFORMATION LEAFLET:INFORMATION FOR THE USER

Amoxicillin/Clavulanic Acid Tarbis500 mg/125 mg powder for oral suspension in EFG sachets

Read this leaflet carefully before you start taking the 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 should not be given to others, even if they have the same 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 bacteriathat 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 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 takeAmoxicilina/Ácido clavulánico Tarbis

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins, or any of the other components ofAmoxicilina/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 takeAmoxicilina/Ácido clavulánico Tarbisif you fall into any of the above categories. Before starting treatment withAmoxicilina/Ácido clavulánico Tarbis, if you are unsure, consult your doctor or pharmacist.

Be especially careful withAmoxicilina/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 takingAmoxicilina/Ácido clavulánico Tarbis.

In some cases, your doctor may investigate the type of bacteria causing your infection. Depending on the results, they may prescribe a different presentation of Amoxicilina/Ácido clavulánicoor another medicine.

Be aware of the following symptoms

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 the following symptoms while taking Amoxicilina/Ácido clavulánico Tarbisto reduce the risk of problems. See “Be aware of the following symptoms” in thesection 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 takingAmoxicilina/Ácido clavulánico Tarbis. This is becauseAmoxicilina/Ácido clavulánico Tarbismay affect the results of these types of tests.

Use ofAmoxicilina/Ácido clavulánico Tarbis withother 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) withAmoxicilina/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 side 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 have side effects and symptoms may make you unable to drive.

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

Important information about some components ofAmoxicilina/Ácido clavulánico Tarbis500 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 with them before taking this medicine.

Patients with diabetes mellitus should note that this medicine contains 2.3 g of saccharose per sachet.

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

Adults and children 40 kg or more

The usual dose is:

• 1 sachet administered three times a day

Children under 40 kg of weight

Amoxicilina/Ácido clavulánico Tarbis 500 mg/125 mg sachets are not recommended.

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 working.

How to takeAmoxicilina/Ácido clavulánico Tarbis

•Just before takingAmoxicilina/Ácido clavulánico Tarbisopen the sachet and mix the contents in half a glass of water

•Take it at the beginning of meals or a little earlier

• Space the doses throughout the day, at least 4 hours apart. Do not take 2 doses in 1 hour.

•Do not takeAmoxicilina/Ácido clavulánico Tarbisfor more than 2 weeks. If you continue to feel unwell, consult your doctor.

If you take moreAmoxicilina/Ácido clavulánico Tarbisthan you should

If you take too muchAmoxicilina/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 it to your 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 withAmoxicilina/Ácido clavulánico Tarbis

Continue takingAmoxicilina/Ácido clavulánico Tarbisuntil 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 have 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

• 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 possibleto advise you, 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 rash (urticarial rash)
• indigestion
• dizziness
• headache.

Side effects that may appear in blood tests:

• increase in some 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 (central dark spot surrounded by a lighter area, with a dark ring around the edge – 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)

• Dyspnea 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 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.
• Urticarial rash in a circular pattern with a central crust or as a pearl necklace (IgA linear disease).
• Menigitis aséptica, 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 with pus (dermatitis exfoliativa bullosa)

• red rash, with bumps under the skin and blisters (pustulosis exanthemática).

• Symptoms of a flu-like illness 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.

• hepatitis, inflammation of the liver
• 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
• inflammation of the kidney tubules
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses of Amoxicilina/Ácido clavulánico or with kidney problems)
• black tongue that looks hairy
• stained teeth (in children), which usually disappears with brushing.

Side effects that may appear in blood or urine tests:

• significantly reduced 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 severeor 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 medicationafter the expiration datethat 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 ofAmoxicillin/Clavulanic Acid Tarbis500 mg/125 mg powder for oral suspension in sachets

• The active principles are amoxicillin and clavulanic acid. Each sachet contains: 500 mg of amoxicillin (as amoxicillin trihydrate) and 125 mg of clavulanic acid (as potassium clavulanate).
• The other components (excipients) are: sucrose, silicon dioxide (E-551), lemon flavoring (contains glucose in maltodextrin derived from corn) and strawberry flavoring (contains glucose in maltodextrin derived from corn).

Appearance of the product and contents of the package

White powder.

Packages of 30 and 500 sachets

Holder of the marketing authorization and responsible for manufacturing

Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028-Barcelona

Responsible for manufacturing:

Laboratorios Reig Jofré, S.A.

Jarama, s/n (Industrial Estate) - 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/.