AMOXICILLIN/CLAVULANIC ACID TAD 875 mg/125 mg FILM-COATED TABLETS

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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Amoxicillin/Clavulanic Acid TAD is and what it is used for
2. What you need to know before you take Amoxicillin/Clavulanic Acid TAD
3. How to take Amoxicillin/Clavulanic Acid TAD
4. Possible side effects

5 Conservation of Amoxicillin/Clavulanic Acid TAD

1. Contents of the pack and other information

1. What Amoxicillin/Clavulanic Acid TAD is and what it is used for

Amoxicillin/Clavulanic Acid TAD 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.

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

It is essential to follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or into the trash.

Amoxicillin/Clavulanic Acid TAD is used in children and adults 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 TAD

Do not takeAmoxicillin/Clavulanic Acid TAD

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 this medicine.

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 be aware of

Amoxicillin/clavulanic acid can worsen certain existing conditions or cause serious side 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 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 studies) or urine tests (to check glucose levels), inform your doctor or nurse that you are taking amoxicillin/clavulanic acid. This is because amoxicillin/clavulanic acid can alter the results of these types of tests.

Other medicines and Amoxicillin/Clavulanic Acid TAD

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

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

If you are taking anticoagulants (such as warfarin) 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 functioning of mycophenolate mofetil (a medicine used to prevent organ transplant rejection).

Taking Amoxicillin/Clavulanic Acid TAD with food and drinks

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

Pregnancy and breastfeeding

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

Driving and using machines

This medicine may have side effects, and the symptoms can make you unfit to 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; this is essentially "sodium-free".

3. How to take Amoxicillin/Clavulanic Acid TAD

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

Adults and children over 40 kg

The usual dose is:

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

Use in children

Children under40 kgof weight:

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

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

Patients 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 TAD

• Swallow the tablets whole with a full glass of water at the beginning of meals or a little before.
• Space out the doses during the day, at least 4 hours apart. Do not take two doses in one hour.
• Do not take amoxicillin/clavulanic acid for more than 2 weeks. If you are still feeling unwell, consult your doctor.

If you take moreAmoxicillin/Clavulanic Acid TADthan 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to takeAmoxicillin/Clavulanic Acid TAD

Do not take a double dose to make up for the forgotten dose. 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 taking Amoxicillin/Clavulanic Acid TAD

Continue taking amoxicillin/clavulanic acid until you finish 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 the infection to return.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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
• chest pain in the context of allergic reactions, which can be a symptom of an allergy-induced heart attack (Kounis syndrome).

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

Inflammation of the large intestine

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

Acute pancreatitis

If you have severe and persistent stomach pain, 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 certain type of allergic reaction with the main symptom of repeated vomiting (1-4 hours after administering the medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

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 in the vagina, mouth, or mucous membranes)
• nausea, especially when taking high doses, if this happens take this medicine before meals
• vomiting
• diarrhea (in children).

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

• skin rash, itching
• increased pruritic rash (urticarial rash)
• 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, which can form blisters that look like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge - erythema multiforme).

If you experience any of these symptoms, consult a doctor urgently.

Rare side effects that may appear in your blood or urine tests:

• significant decrease in the number of white blood cells
• low red blood cell count (hemolytic anemia)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Amoxicillin/Clavulanic Acid TAD

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

Do not use this medicine after the expiration date stated on the carton and blister after CAD/EXP. The expiration date is the last day of the month indicated.

Blister pack

Do not store above 25°C.

Keep in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Container contents and additional information

Composition ofAmoxicillin/Clavulanic AcidTAD

• The active ingredients 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 ingredients are: microcrystalline cellulose (E460), sodium carboxymethyl starch (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 (E462) in the coating.

See section 2 "Amoxicillin/Clavulanic Acid TAD contains sodium".

Appearance of the product and container contents

Film-coated tablet with a capsule shape, white to almost white in color, engraved with the letter "I 07" on one side and smooth on the other, tablet length: 21.70 ± 0.10 mm.

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

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

Only some 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

You can request more information about this medicine by contacting 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 last revision of this leaflet:January 2024

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 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.

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

1. You should not give antibiotics that have been prescribed for you to other people.

1. If you still have antibiotic left after completing treatment, return all unused medication to your pharmacy to ensure that disposal requirements are met.