Package Leaflet: Information for the User

Amoxicilina/Ácido clavulánico Sandoz 500 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 pass it on to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Amoxicilina/Ácido clavulánico Sandoz

3. How to take Amoxicilina/Ácido clavulánico Sandoz

4. Possible side effects

5. Storage of Amoxicilina/Ácido clavulánico Sandoz

6. Contents of the pack and additional information

Amoxicilina/Ácido clavulánico Sandoz is 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 may sometimes lose its effectiveness (become inactivated). The other component (ácido clavulánico) prevents this from happening.

Amoxicilina/ácido clavulánico 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.

Do not take Amoxicilina/Ácido clavulánico Sandoz

• if you are allergic to amoxicilina, ácido clavulánico, penicilinas, or any of the other

components of this medication (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 throat or neck,

• if you have ever had liver problems or jaundice (yellowing of the skin) when taking an

antibiotic.

Do not take Amoxicilina/Ácido clavulánico Sandoz if you are included in any of the above

points.Before starting treatment with Amoxicilina/Ácido clavulánico Sandoz, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication 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 amoxicilina/ácido clavulánico.

In some cases, your doctor may investigate the type of bacteria causing your infection.

Depending on the results, your doctor may prescribe a different presentation of Amoxicilina/Ácido clavulánico or another medication.

Be aware of the following symptoms

Amoxicilina/ácido clavulánico may worsen existing conditions or cause severe side effects.

These include allergic reactions, convulsions, and inflammation of the large intestine.

You should be aware of certain symptoms while taking amoxicilina/ácido clavulánico to reduce the risk of problems.

Blood and urine tests

If you are undergoing 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 taking amoxicilina/ácido clavulánico.

This is because amoxicilina/ácido clavulánico may alter the results of these types of tests.

Use of Amoxicilina/Ácido clavulánico Sandoz with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those acquired without a prescription and herbal medications.

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

Probenecid (used to treat gout), concomitant use of probenecid may reduce amoxicilina excretion and is not recommended.

If you are taking anticoagulants (such as warfarin) with amoxicilina/ácido clavulánico, more blood tests will be required.

Metotrexato (a medication used to treat cancer and severe psoriasis), penicilinas may reduce metotrexato excretion and cause a potential increase in adverse effects.

Amoxicilina/ácido clavulánico may affect how micofenolato de mofetilo (a medication used to prevent organ rejection in transplant patients) works.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Amoxicilina/ácido clavulánico may cause side effects, and symptoms may make you unable todrive.Do not drive or operate machinery unless you feel well.

Amoxicilina/Ácido clavulánico Sandoz contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”

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

Use in adults and children 40 kg or more

The recommended dose is:

• 1 tablet three times a day.

Use in children under 40 kg of weight

It is preferable to treat children 6 years or less with oral suspension of Amoxicillin/Clavulanic Acid or the sachets.

Ask your doctor or pharmacist for advice when administering amoxicillin/clavulanic acid tablets to children weighing less than 40 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.

Presentación diferente u otro medicamento.

• If you have liver problems, you will have more frequent blood tests to check how your liver is working.

How to take Amoxicillin/Clavulanic Acid Sandoz

• Swallow the tablets whole with a glass of water with meals.
• Space the doses throughout the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
• Do not take Amoxicillin/Clavulanic Acid Sandoz for more than 2 weeks. If you continue to feel unwell, consult your doctor.

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

If you take too much amoxicillin/clavulanic acid, you may experience symptoms such as stomach discomfort (nausea, vomiting, or diarrhea) or convulsions. Consult your doctor as soon as possible. Bring the packaging with you to show your doctor.

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 take Amoxicillin/Clavulanic Acid Sandoz

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.

Do not take a double dose to make up for the missed doses.

If you interrupt the treatment with Amoxicillin/Clavulanic Acid Sandoz

Continue taking Amoxicillin/Clavulanic Acid until you complete 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 you to get the infection again.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 may 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 throat (angioedema), which causes difficulty breathing,
• collapse.

?Contact your doctor immediatelyif you experience any of these symptoms.

Stop taking Amoxicilina/Ácido clavulánicoco Sandoz.

Colitis

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

?Contact your doctor as soon as possibleto advise you, if you have these symptoms.

Very common side effects(may affect more than 1 in 10 patients)

May affect more than 1 in 10 patients:

• diarrhea (in adults).

Common side effects(may affect up to 1 in 10 patients)

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 Amoxicilina/Ácido clavulánico Sandoz before meals,

• vomiting,
• diarrhea (in children).

Uncommon side effects(may affect up to 1 in 100 patients)

May affect 1 in 100 patients:

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

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)

May affect up to 1 in 1,000 patients

• skin rash, 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 have any of these symptoms, see 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.

Side effects of unknown frequency(cannot be estimated from available data)

Other side effects that have occurred in a very small number of patients and whose

exact frequency is unknown:

• allergic reactions (see above),
• chest pain in the context of allergic reactions, which may be a symptom of allergic-induced heart attack (Kounis syndrome),
• Drug-induced enterocolitis syndrome (DIES): DIES has been reported mainly in children taking 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.
• colitis (see above),
• crystals in the urine that cause acute kidney injury.
• inflammation of the protective membrane surrounding the brain (aseptic meningitis),
• acute inflammation of the pancreas (acute pancreatitis) If you have intense and persistent pain in the abdominal area, this could be a sign of acute pancreatitis,
• skin rash with blisters arranged in a circle with a central crust or like a pearl necklace (IgA linear disease),
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis),
• severe skin reactions:

• generalized 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),

• generalized rash with small blisters with pus (vesicular exfoliative dermatitis),
• red rash, with lumps under the skin and blisters (pustular exanthema).
• flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (such as elevated white blood cell count (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 turn the skin and white of the eyes yellow,
• inflammation of the kidney tubes,
• delayed blood clotting,
• hyperactivity,
• seizures (in patients taking high doses of Amoxicilina/Ácido clavulánico or with kidney problems),
• black tongue that appears hairy,

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

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

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 Vigilance 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.

Do not store above 25°C.

Store in the original packaging to protect it from light and humidity.

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

Do not use this medication after the expiration date that appears on the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Amoxicilina/Ácido clavulánico Sandoz

The active principles are amoxicilina and ácido clavulánico. Each tablet contains 500 mg of amoxicilina (trihidrato) and 125 mg of ácido clavulánico (potassium salt).

The other components are:

• Tablet core: magnesium stearate, talc, povidone K25, microcrystalline cellulose and sodium croscarmellose.
• Coating:triacetyl citrate, ethylcellulose, sodium lauryl sulfate, cetyl alcohol, hypromellose, talc and titanium dioxide.

Appearance of the product and content of the container

Coated tablet, white, oval, biconvex and scored on both sides.

Amoxicilina/Ácido clavulánico Sandoz is presented in containers with Al/PVC/Al blisters or Al/PE/Al strips of 30 and 100 coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing:

Sandoz GmbH

Biochemiestrasse, 10

A-6250 (Kundl)

Austria

Date of the last review of thisleaflet:February 2023

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/