Amoxicillin/clavulanic acid TAD 875 mg/125 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amoxicillin/Clavulanic acid TAD 875 mg/125 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Amoxicillin/Clavulanic acid TAD is and what it is used for
2. What you need to know before taking Amoxicillin/Clavulanic acid TAD
3. How to take Amoxicillin/Clavulanic acid TAD
4. Possible side effects
5. How to store Amoxicillin/Clavulanic acid TAD
6. Contents of the pack and other information

1. What Amoxicilina/Ácido clavulánico TAD is and what it is used for

Amoxicilina/Ácido clavulánico TAD 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 become ineffective (inactivated). The other component (clavulanic acid) prevents this from happening.

Antibiotics are used to treat bacterial infections and are not effective against viral infections, such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Amoxicilina/Ácido clavulánico TAD 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 starting to take Amoxicillin/Clavulanic acid TAD

Do not take Amoxicillin/Clavulanic acid TAD

• if you are allergic to amoxicillin, clavulanic acid, penicillins, or to any of the other ingredients of this medicine (listed in 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 TAD if any of the above apply to you. Before starting treatment with Amoxicillin/Clavulanic acid TAD, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Talk to 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 this medicine.

In some cases, your doctor may investigate the type of bacteria causing your infection. Depending on the results, they may prescribe a different formulation of amoxicillin/clavulanic acid or another medicine.

Symptoms to watch out for

Amoxicillin/clavulanic acid 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 to reduce the risk of problems. See "Symptoms to watch out 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. This is because amoxicillin/clavulanic acid may alter the results of these types of tests.

Other medicines and Amoxicillin/Clavulanic acid TAD

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

If you are taking allopurinol (used for gout) together with amoxicillin/clavulanic acid, you may be more likely to develop a skin allergic reaction.

If you are taking probenecid (used for gout), your doctor may adjust the dose of amoxicillin/clavulanic acid.

If anticoagulants (such as warfarin) are taken with amoxicillin/clavulanic acid, more blood tests will be needed.

Amoxicillin/clavulanic acid may affect the action of methotrexate (a medicine used to treat cancer or rheumatic diseases).

Amoxicillin/Clavulanic acid may affect the function of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).

Taking Amoxicillin/Clavulanic acid TAD with food and drink

Take amoxicillin/clavulanic acid at the beginning of meals or slightly before, and swallow the tablets with a full glass of water.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

This medicine may cause adverse effects, and the symptoms may mean you should not drive. Do not drive or operate machinery unless you feel well.

Amoxicillin/Clavulanic acid TAD contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, essentially "sodium-free".

3. How to take Amoxicillin/Clavulanic Acid TAD

Follow exactly the instructions given by your doctor or pharmacist 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:

• Normal dose: 1 tablet twice a day
• High dose: 1 tablet three times a day

Use in children

Children weighing less than 40 kg:

Children aged 6 years or younger should preferably be treated orally with amoxicillin/clavulanic acid suspension.

Consult your doctor or pharmacist when administering amoxicillin/clavulanic acid tablets to children weighing less than 40 kg. The tablets are not suitable for children weighing less than 25 kg.

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 TAD

• Swallow the tablets whole with a glass of water at the beginning of a meal or shortly before.
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take two doses within one hour.
• Do not take amoxicillin/clavulanic acid for longer than 2 weeks. If you still feel unwell, consult your doctor.

If you take more Amoxicillin/Clavulanic Acid TAD than you should

If you take too much amoxicillin/clavulanic acid, symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures may occur.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Amoxicillin/Clavulanic Acid TAD

Do not take a double dose to make up for a missed dose. If you forget 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 treatment with Amoxicillin/Clavulanic Acid TAD

Continue taking amoxicillin/clavulanic acid until the end of the prescribed treatment, even if you 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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Symptoms to watch for

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
• chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (Kounis syndrome).

Contact your doctor immediately if you experience any of these symptoms. Stop taking Amoxicillin/Clavulanic Acid TAD.

Inflammation of the large intestine

Inflammation of the large intestine, causing watery diarrhea, usually with blood and mucus, stomach pain and/or fever.

Acute pancreatitis

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

Drug-induced enterocolitis syndrome (DIES)

DIES has been reported mainly in children receiving amoxicillin/clavulanic acid. It is a type of allergic reaction with the main symptom being repeated vomiting (1–4 hours after taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

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

• diarrhea (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 high doses are taken
• if this happens, take this medicine before meals
• vomiting
• diarrhea (in children)

Uncommon adverse effects: may affect up to 1 in 100 patients

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

Uncommon adverse effects that may appear in 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 develop into blisters resembling 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 a doctor urgently.

Rare adverse effects that may appear in blood tests:

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

Frequency not known: frequency cannot be estimated from available data

• Allergic reactions (see above)

• Inflammation of the large intestine (see above)

• Inflammation of the membranes covering the brain and spinal cord (aseptic meningitis)

• 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 (exfoliative bullous or vesicular dermatitis)

• red rash with bumps under the skin and blisters (pustular exanthem)

• 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))

• red rash typically seen on both sides of the buttocks, upper inner thighs, armpits, and neck (drug-related intertriginous and flexural exanthema (SDRIFE))

Contact a doctor immediately if you have any of these symptoms.

• blistering rash arranged in circles with central crusts or resembling a string of pearls (IgA linear dermatosis)
• liver inflammation (hepatitis)
• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver), which may cause yellowing of the skin and whites of the eyes
• inflammation of kidney tubules
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses of amoxicillin/clavulanic acid or with kidney problems)
• black, hairy-looking tongue

Adverse effects that may appear in blood or urine tests:

• significant decrease in white blood cell count
• low red blood cell count (hemolytic anemia)
• crystals in the urine causing acute kidney injury

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicillin/Clavulanic Acid TAD

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

Do not use this medicine after the expiry date stated on the carton and blister pack after CAD/EXP. The expiry date refers to the last day of the month indicated.

Blister pack and tray

Do not store above 25°C.

Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly 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 TAD

• The active substances are amoxicillin and clavulanic acid.

Each film-coated tablet contains 875 mg of amoxicillin (as amoxicillin trihydrate) and 125 mg of clavulanic acid (as potassium clavulanate).

• The other components are: microcrystalline cellulose (E460), sodium carboxymethylstarch (type A) (derived from potato starch), colloidal anhydrous silica (E551), and magnesium stearate (E470b) in the core; and titanium dioxide (E171), hypromellose (E464), propylene glycol (E1520), talc (E553b), and ethylcellulose (E642) in the coating.

See section 2, “Amoxicillin/Clavulanic Acid TAD contains sodium”.

Nature of the product and contents of the container

Film-coated tablet, capsule-shaped, white to almost white, engraved with the letters “I 07” on one side and smooth on the other. Tablet length: 21.70 ± 0.10 mm.

Amoxicillin/Clavulanic Acid TAD film-coated tablets EFG are available in packs of:

• 10, 12, 14, 16, 20, 21, 24, 30, 100 or 500 film-coated tablets in strips.
• 10, 12, 14, 16, 20, 21, 24, 30, 100 or 500 film-coated tablets in blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

TAD PHARMA GMBH, Heinz Lohmann strasse, 5, D-27472, Cuxhaven-Germany

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Str. 5, 27472 Cuxhaven, Germany

For more information about this medicine, you may contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: August 2025

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

Medical advice/education

Antibiotics are used to treat bacterial infections. They are not effective against viral infections.

Sometimes an infection caused by bacteria does not respond to antibiotic treatment. One of the most common reasons this occurs 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 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. Paying attention to the following advice will help you prevent the development of resistant bacteria that could make the antibiotic ineffective.

1. It is very important to take the antibiotic at the correct dose, at the specified times, and for the full prescribed duration. Read the labeling instructions carefully, and if you do not understand something, ask your doctor or pharmacist.

2. You should not take an antibiotic unless it has been specifically prescribed for you, and you should use it only for the infection for which it was prescribed.

3. You should not take antibiotics that have been prescribed for other people, even if they have the same or a similar infection to yours.

4. You should not give antibiotics prescribed for you to other people.

5. If you have any antibiotic left after completing your treatment, return all unused medicines to your pharmacy to ensure proper disposal requirements are met.