Package Leaflet: Information for the User

Amoxicillin/Clavulanic Acid TAD 875 mg/125 mg Film-Coated Tablets EFG

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

• 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 only. Do not give it to others, even if they have the same symptoms as you, 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. See section 4.

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

2. What you need to know before you start taking Amoxicillin/Clavulanic Acid TAD

3. How to take Amoxicillin/Clavulanic Acid TAD

4. Possible side effects

5. Storage of Amoxicillin/Clavulanic Acid TAD

6. Contents of the pack and additional information

Amoxicilina/Ácido clavulánico TADis an antibiotic that eliminates the bacteria that 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 inactive). The other component (ácido clavulánico) prevents this from happening.

Amoxicilina/Ácido clavulánico TADis used in children and adults 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 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 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 TADif you are included in any of the above points. Before starting treatment withAmoxicilina/Ácido clavulánico 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 takingthis 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 presentation ofamoxicilina/ácido clavulánicoor another medicine.

Symptoms to be aware of

Amoxicilina/ácido clavulánicomay worsen existing conditions or cause serious side effects. These include allergic reactions, convulsions, and inflammation of the large intestine. Be aware of certain symptoms while takingamoxicilina/ácido clavulánicoto reduce the risk of problems. See “Symptoms to be aware of” in thesection 4.

Blood and urine tests

If you are having blood tests (such as red blood cell studies or liver function studies) or urine tests (to control glucose levels), inform your doctor or nurse that you are takingamoxicilina/ácido clavulánico. This is becauseamoxicilina/ácido clavulánicomay alter the results of these types of tests.

Other medicines and Amoxicilina/Ácido clavulánico TAD

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

If you are taking allopurinol (used for gout) withamoxicilina/ácido clavulánico, you may be more likely to suffer a skin allergic reaction.

If you are taking probenecid (used for gout), your doctor may adjust the dose ofamoxicilina/ácido clavulánico.

If you are taking anticoagulants (such as warfarin) withamoxicilina/ácido clavulánicoyou will need more blood tests.

Amoxicilina/ácido clavulánicomay affect the action of methotrexate (a medicine used to treat cancer or rheumatic diseases).

Amoxicilina/Ácido clavulánico may affect the functioning of micophenolate mofetil (a medicine used to prevent organ transplant rejection).

Taking Amoxicilina/Ácido clavulánico TAD with food and drink

Take amoxicilina/ácido clavulánico at the beginning of meals or a little 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 intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

This medicinemay have side effects and symptoms may make you unable to drive. Do not drive or operate machinery unless you feel well.

Amoxicilina/Ácido clavulánico TAD contains sodium

This medicine contains less than 1 mmolof sodium (23 mg) per tablet; this is essentially “sodium-free”.

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

Adults and children 40 kg or more

The usual dose is:

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

Use in children

Children under40 kgweight:

Children 6 years old or less should be treated orally preferably with amoxicillin/clavulanate suspension.

Consult your doctor or pharmacist when administering tablets ofamoxicillin/clavulanateto children weighing less than40 kg. Tablets are not suitable for children weighing 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 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 takeAmoxicillin/Clavulanate TAD

• Swallow the tablets whole with a glass of water at the beginning of meals or a little before.
• Space the doses throughout the day, at least 4 hours apart. Do not take two doses in one hour.
• Do not takeamoxicillin/clavulanatefor more than 2 weeks. If you continue to feel unwell, consult your doctor.

If you take moreAmoxicillin/Clavulanate TADthan you should

If you take too muchamoxicillin/clavulanate, you may experience symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeAmoxicillin/Clavulanate TAD

Do not take a double dose to make up for the missed 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 interrupt the treatment with Amoxicillin/Clavulanate TAD

Continue takingamoxicillin/clavulanateuntil you complete the treatment, even if you feel better. You need to take the full treatment to cure the infection. If you do not, the surviving bacteria may cause you to get the infection again.

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

Like all medicines,this medicinecan cause side effects, although not everyone will experience them.

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

Contact your doctor immediatelyif you experience any of these symptoms.Stop taking Amoxicilina/Ácido clavulánico TAD.

Colitis

Colitis, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

Acute pancreatitis

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

Drug-induced enterocolitis syndrome (DIES)

DIES has been mainly reported in children taking amoxicilina/ácido clavulánico. It is a certain type of allergic reaction with the main symptom of repeated vomiting (1-4 hours after administering the medication). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

Contact your doctor as soon as possibleso that they can advise you, if you experience these symptoms.

Very common side effects:can affect more than 1 in 10 patients

• diarrhea (in adults).

Common side effects:can affect up to 1 in 10 patients

• mouth ulcers (candida – fungal infection in the vagina, mouth, or mucous membranes)
• nausea, especially when taking high doses, si if you experience this, take this medicine before meals
• vomiting
• diarrhea (in children).

Uncommon side effects:can affect 1 in 100 patients

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

Side effects that may appear in your blood tests:

• increase in some substances (enzymes) produced by the liver.

Rare side effects:can affect up to 1 in 1,000 patients

• skin eruption, which may form blisters that appear as small dianas (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 a doctor urgently.

Side effects that may appear in your blood tests:

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

Frequency not known: the frequency cannot be estimated from the available data

• Allergic reactions (see above)
• Colitis (see above)
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• Eruption with blisters arranged in a circle with a central crust or as a pearl necklace (IgA linear disease)
• Severe skin reactions:

• generalized eruption 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 eruption with small blisters with pus (exfoliative vesicular dermatitis)
• red eruption, with lumps under the skin and blisters (pustular exanthema)
• flu-like symptoms with skin eruption, fever, swollen lymph nodes, and abnormal blood test results (such as increased eosinophils (eosinophilia) and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).

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

Side effects that may appear in your blood or urine tests:

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medicationafter the expiration date that appears on the box and the blister pack after CAD/EXP. The expiration date is the last day of the month indicated.

Box and blister

Do not store above 25°C.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

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 components are: microcrystalline cellulose (E460), sodium carboxymethyl starch (type A) (from potato starch), anhydrous colloidal silica (E551) and magnesium stearate (E470b) in the core andtitania dioxide (E171), hypromellose (E464), propylene glycol (E1520), talc (E553b) and ethylcellulose (E642) in thecoating.

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

Appearance of the product and contents of the pack

Film-coated tablet in capsule shape, white to almost white, 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 EFGis 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 some pack sizes may be marketed.

Marketing authorization holder

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

Responsible person for manufacturing

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

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

You can obtain more information about this medicinal product 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 medicinal product is authorized in the Member States of the European Economic Area, with the following names:

Last update of this leaflet:January 2024

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 advice will help prevent the emergence of resistant bacteria that may make the antibiotic ineffective.

1. It is very important to take the antibiotic in the correct dose, at the right times and for the correct number of days. Read the label instructions and if you do not understand something, ask your doctor or pharmacist.

2. Do not take an antibiotic unless you have been prescribed it specifically for you and use it only for the infection for which it has been 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 that have been prescribed for you to other people.

5. If you still have antibiotics left over after completing treatment, hand in all unused medicines to your pharmacy to ensure that the disposal requirements are met.