Amoxicillin/clavulanic acid Tarbis 500 mg/125 mg powder for oral suspension in sachets EFG

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amoxicillin/Clavulanic acid Tarbis 500 mg/125 mg powder for oral suspension in sachets EFG

Read the entire 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 you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Contents of the leaflet:

1. What Amoxicillin/Clavulanic acid Tarbis is and what it is used for.
2. What you need to know before taking Amoxicillin/Clavulanic acid Tarbis.
3. How to take Amoxicillin/Clavulanic acid Tarbis.
4. Possible side effects.
5. How to store 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 kills bacteria causing 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 adults and children to treat the following infections:

• Middle ear infections 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 taking Amoxicillin/Clavulanic Acid Tarbis

Do not take Amoxicillin/Clavulanic Acid Tarbis

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, 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 skin rash or swelling of the face or neck
• if you have ever had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.

? Do not take Amoxicillin/Clavulanic Acid Tarbis if any of the above apply to you. Before starting treatment with Amoxicillin/Clavulanic Acid Tarbis, if you are unsure, consult your doctor or pharmacist.

Take special care with Amoxicillin/Clavulanic Acid Tarbis

Tell 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 conditions apply to you, inform your doctor or pharmacist before taking Amoxicillin/Clavulanic Acid Tarbis.

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

Symptoms to watch for

Amoxicillin/Clavulanic Acid Tarbis may worsen certain existing conditions or cause serious adverse effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should be aware of certain symptoms while taking Amoxicillin/Clavulanic Acid Tarbis to reduce the risk of complications. See “Symptoms to watch for” in section 4.

Blood and urine tests

If you are having blood tests (such as studies of red blood cell status or liver function tests) or urine tests (to monitor glucose levels), inform your doctor or nurse that you are taking Amoxicillin/Clavulanic Acid Tarbis. This is because Amoxicillin/Clavulanic Acid Tarbis may alter the results of these types of tests.

Using Amoxicillin/Clavulanic Acid Tarbis with other medicines

Tell your doctor or pharmacist if you are using or have recently used any 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 develop 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 anticoagulants (such as warfarin) are taken 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 methotrexate excretion and cause a potential increase in adverse effects.

Pregnancy and breastfeeding

If you are pregnant, think you might be pregnant, or are breastfeeding, speak with your doctor or pharmacist.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Amoxicillin/Clavulanic acid Tarbis may have adverse effects, and the symptoms may mean you should not drive.

Do not drive or operate machinery unless you feel well.

Important information about some components of Amoxicilina/Ácido clavulánico Tarbis 500 mg/125 mg powder for oral suspension in sachets

This medicine contains sucrose and glucose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Amoxicillin/Clavulanic acid Tarbis

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Adults and children weighing 40 kg or more

The usual dose is:

• 1 sachet taken three times a day

Children weighing less than 40 kg

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

Patients with kidney or liver problems

• If you have kidney problems, your dose may need to be adjusted. Your doctor may choose a different formulation or another medicine.
• If you have liver problems, you will have blood tests more frequently to monitor liver function.

How to take Amoxicillin/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 beginning of meals or shortly before eating.
• Space the doses evenly throughout the day, at least 4 hours apart. Do not take two doses within one hour.
• Do not take Amoxicillin/Clavulanic acid Tarbis for longer than 2 weeks. If you still feel unwell, consult your doctor.

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

If you take too much Amoxicillin/Clavulanic acid Tarbis, symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures may occur. Contact your doctor as soon as possible and bring the packaging with you to show the doctor.

You may also call the Toxicology Information Service at telephone number 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 following dose.

If you stop taking Amoxicillin/Clavulanic acid Tarbis

Continue taking Amoxicillin/Clavulanic acid Tarbis for the full duration of treatment, even if you start to feel better. You need to complete the full course to cure the infection. If you do not, surviving bacteria may cause the infection to return.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Amoxicilina/Ácido clavulánico Tarbis may produce adverse effects, although not everyone experiences them. The adverse effects described below may occur when taking this medicine.

Symptoms you should be aware of

Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may 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), causing difficulty breathing
• collapse.

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

Inflammation of the large intestine

Inflammation of the large intestine, causing watery diarrhoea, 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 adverse effects

May affect more than 1 in 10 patients

• diarrhoea (in adults).

Common adverse effects

May affect up to 1 in 10 patients

• thrush (candida – fungal 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
• diarrhoea (in children).

Uncommon adverse effects

May affect 1 in 100 patients

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

Uncommon adverse effects that may appear in your blood tests:

• Increase in certain substances (enzymes) produced by the liver.

Rare adverse effects

May affect up to 1 in 1,000 patients

• skin rash that may blister and resemble small targets (a dark central 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 adverse effects that may appear in your blood tests:

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

Frequency not known (cannot be estimated from available data)

• Chest pain in the context of allergic reactions, which may be a symptom of allergy-triggered heart attack (Kounis syndrome).
• Drug-induced enterocolitis syndrome (DIES): DIES has been reported mainly in children receiving amoxicillin. It is a 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, diarrhoea, and low blood pressure.
• Crystals in urine causing acute kidney injury.
• Blistering rash arranged in a ring with central crust or resembling a string of pearls (linear IgA disease).
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

Acute inflammation of the pancreas (acute pancreatitis). If you have severe and persistent pain in the stomach area, this could be a sign of acute pancreatitis.

Other adverse effects

Other adverse effects that have occurred in a very small number of patients and whose exact frequency is unknown:

• 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 skin peeling (more than 30% of body surface – toxic epidermal necrolysis)

• widespread rash with small pus-filled blisters (bullous exfoliative dermatitis)

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

• 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.

• inflammation of the liver (hepatitis)

• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver), which may cause the skin and whites of the eyes to turn yellow

• inflammation of kidney ducts

• delayed blood clotting

• hyperactivity

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

• black, hairy-looking tongue

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

Adverse effects that may appear in blood or urine tests:

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

If you experience adverse effects

• If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform 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 packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amoxicillin/Clavulanic Acid Tarbis 500 mg/125 mg powder for oral suspension in sachets

• The active substances 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 flavour (contains glucose in maltodextrin derived from maize), and strawberry flavour (contains glucose in maltodextrin derived from maize).

Appearance of the product and contents of the pack

Whiteish powder.

Pack sizes: 30 and 500 sachets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028-Barcelona

Manufacturer:

Laboratorios Reig Jofré, S.A.

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

This leaflet was approved in January 2023

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 this occurs is because 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 appropriately can reduce the likelihood of bacteria becoming resistant to them.

When your doctor prescribes an antibiotic, it is intended solely for the treatment of your current illness. Following the advice below will help you prevent the emergence of resistant bacteria, which could make antibiotics ineffective.

1. It is very important to take the antibiotic at the correct dose, at the prescribed times, and for the full duration of treatment. Read the labelling instructions carefully 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 use it only 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 prescribed for you to other people.
5. If you have any antibiotic left over after completing your treatment, return all unused medicines to your pharmacy to ensure proper disposal.

Reconstitution instructions

Empty the contents of the sachet into 10–20 mL of water, shake until a suspension is formed, and take immediately.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.