Amoxicillin/Clavulanic Acid TARBIS 500 mg/125 mg Oral Suspension Powder in Sachets

Introduction

PACKAGE LEAFLET:INFORMATION FOR THE USER

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

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 (or your child) only. Do not pass it on to others, as 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. What you need to know before you take Amoxicillin/Clavulanic Acid Tarbis.
3. How to take Amoxicillin/Clavulanic Acid Tarbis.
4. Possible side effects.
5. Storage of Amoxicillin/Clavulanic Acid Tarbis.
6. Contents of the pack and other 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 drugs called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins" that can sometimes lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

Amoxicillin/Clavulanic Acid Tarbis is used in adults and children 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. What you need to know before you take Amoxicillin/Clavulanic Acid Tarbis

Do not takeAmoxicillin/Clavulanic Acid Tarbis

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, to penicillins or to 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 or yellowing of the skin (jaundice) while taking an antibiotic.

Do not takeAmoxicillin/Clavulanic Acid Tarbisif you are included in any of the above points. Before starting treatment with Amoxicillin/Clavulanic Acid Tarbis, if you are not sure, consult your doctor or pharmacist.

Be especially careful withAmoxicillin/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 symptoms affect you, inform 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), inform your doctor or nurse that you are taking Amoxicillin/Clavulanic Acid Tarbis. This is because Amoxicillin/Clavulanic Acid Tarbis can alter the results of these types of tests.

UsingAmoxicillin/Clavulanic Acid Tarbis withother 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 frequent 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 make you unfit to drive or operate machinery.

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

Important information about some components ofAmoxicillin/Clavulanic Acid Tarbis500 mg/125 mg powder for oral suspension in sachets

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

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

3. How to take Amoxicillin/Clavulanic Acid Tarbis

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults and children over 40 kg

The usual dose is:

• 1 sachet administered three times a day.

Children under 40 kg

Amoxicillin/Clavulanic Acid Tarbis 500 mg/125 mg sachets are not recommended.

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 takeAmoxicillin/Clavulanic Acid Tarbis

• Just before taking Amoxicillin/Clavulanic Acid Tarbis, open the sachet and mix the contents in half a glass of water.
• Take it at the start of meals or a while before.
• Space out the doses during the day, at least 4 hours apart. Do not take 2 doses in 1 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 moreAmoxicillin/Clavulanic Acid Tarbisthan you should

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

You can also call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to takeAmoxicillin/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 takingAmoxicillin/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 have the infection again.

If you have any further 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. 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 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 takingAmoxicillin/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 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 patients.

• thrush (candida - fungal infection of 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 patients.

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

Uncommon side effects that may appear in your 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 that can form blisters, which look like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge - erythema multiforme).

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

Rare side effects that may appear in your blood tests:

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

Not known(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 surrounding the brain and spinal cord (aseptic meningitis).

Acute pancreatitis (inflammation of the pancreas). If you have severe and persistent stomach pain, 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 not known:

• Allergic reactions (see above).
• Inflammation of the large intestine (see above).
• Serious 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).
• 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 an increase in bilirubin in the blood (a substance produced by the liver) that can make the skin and the 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 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 mentioned in this leaflet, tell your doctor or pharmacist.

5. Storage of Amoxicillin/Clavulanic Acid Tarbis

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if the sachets are broken or damaged.

Medicines should not be disposed of via wastewater or household waste. Return the pack and any unused medicine to a pharmacy for disposal. By doing this, you will help protect the environment.

6. Container Content and Additional Information

Composition ofAmoxicillin/Clavulanic Acid Tarbis500 mg/125 mg powder for oral suspension in sachets

• The active ingredients 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 from corn) and strawberry flavoring (contains glucose in maltodextrin from corn).

Appearance of the Product and Container Content

White powder.

Packaging of 30 and 500 sachets

Marketing Authorization Holder and Manufacturer

Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028-Barcelona

Manufacturer:

Laboratorios Reig Jofré, S.A.

Jarama, s/n (Polígono Industrial) - 45007 Toledo

This leaflet was approved in January 2023

Medical Advice/Education

Antibiotics are used for the treatment of 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. You should not take an antibiotic unless it has been specifically prescribed for you, and you should only use it for the infection for which it was prescribed.
2. You should not take antibiotics that have been prescribed for other people, even if they have the same or a similar infection to yours.
3. You should not give antibiotics that have been prescribed for you to other people.
4. If you still have antibiotic left after completing the treatment, return all unused medication to your pharmacy to ensure that disposal requirements are met.

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Reconstitution Instructions

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

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.