Package Leaflet: Information for the User

Amoxicilina/Ácido clavulánico Sandoz 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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

2. What you need to know before 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 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 sometimes

may lose its effectiveness (become inactive). The other component (ácido clavulánico) prevents this

from occurring.

Amoxicilina/ácido clavulánico is 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 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 face or throat,

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

previously. Before starting treatment with amoxicilina/ácido clavulánico, if you are unsure,

consult with 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 if any of the above conditions affect you, communicate with 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, you may be prescribed a different presentation of

amoxicilina/ácido clavulánico or another medication.

Be aware of 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. See “Be aware of symptoms” in section 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 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 taking, have taken recently, or may have to take any other medication.

If you are taking allopurinol (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 the excretion of amoxicilina and is not recommended.

If you are taking anticoagulants (such as warfarin) with amoxicilina/ácido clavulánico you will

need more blood tests.

Methotrexate (a medication used to treat cancer and severe psoriasis), penicilinas may reduce the excretion of methotrexate and cause a potential increase in side effects.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become 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 that may make you

not able to drive.

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; this 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..

Adults and children 40 kg or more

• Usual dose–1 tablet administered twice a day.
• Higher dose–1 tablet administered three times a day.

Children under 40 kg of weight

It is preferable to treat children 6 years or less with the oral suspension of Amoxicilina/Ácido clavulánico Sandoz or the sachets.

Ask your doctor or pharmacist for advice when administering amoxicilina/ácido clavulánico to children who weigh less than 40 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 functioning.

Check how your liver is functioning.

How to take Amoxicilina/Ácido clavulánico Sandoz

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

If you take more Amoxicilina/Ácido clavulánico Sandoz than you should

If you take too much amoxicilina/ácido clavulánico, you may experience symptoms such as stomach discomfort (nausea, vomiting, or diarrhea) or convulsions. Consult your doctor as soon as possible.

Take the packaging with you to show it to 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 Amoxicilina/Ácido clavulánico 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.

If you interrupt the treatment with Amoxicilina/Ácido clavulánico Sandoz

Continue taking Amoxicilina/Ácido clavulánico 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 have the infection again.

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

Like all medicines, this medicine can 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 throat (angioedema), which causes difficulty breathing,
• collapse.

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

Stop taking Amoxicilina/Ácido clavulánico 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(can affect more than 1 in 10 people):

• diarrhea (in adults).

Common side effects(can affect up to 1 in 10 people):

• thrush (candida – fungal infection of the vagina, mouth, or mucous membranes),
• nausea, especially when taking high doses,

?if this happens, take Amoxicilina/Ácido clavulánico with meals,

• vomiting,
• diarrhea (in children).

Uncommon side effects(can affect 1 in 100 people):

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 people):

skin rash, which may form blisters that look like small darts (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),
  • colitis (see above),
  • inflammation of the protective membrane surrounding the brain (aseptic meningitis),
• chest pain in the context of allergic reactions, which can 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 medication). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure,
• crystals in the urine that cause acute kidney injury,
• 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),
• acute pancreatitis. If you have severe and persistent pain in the abdominal area, this could be a sign of acute pancreatitis,
• severe skin reactions:
• generalized rash 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 rash with small blisters with pus (exfoliative bullous dermatitis),
• red rash, with lumps under the skin and blisters (pustular exanthem).
• flu-like symptoms with skin rash, fever, swollen lymph nodes, and abnormal blood test results (such as increased eosinophils 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) that can turn the skin and white of the eyes yellow,

• inflammation of the kidney tubules,
• delayed blood clotting,
• hyperactivity,
• seizures (in patients taking high doses of amoxicillin/acid clavulanic or

who have kidney problems),

• black tongue that looks hairy,
• stained teeth (in children), which usually disappears with brushing.

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 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 Amoxicilina/Clavulanic Acid after the expiration date that appears

on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe color changes. If the tablet is broken, consume it immediately, as its exposure to the environment under these conditions may cause color changes.

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

Composition of Amoxicilina/Ácido clavulánico Sandoz

• The active principles are amoxicilina and ácido clavulánico.Each tablet contains 875 mg of amoxicilina (as trihydrate) and 125 mg of ácido clavulánico (as clavulanate potassium).
• The other components (excipients) are:Tablet core:anhydrous colloidal silica, magnesium stearate, talc, povidone (K 25), sodium croscarmellose, microcrystalline cellulose.Coating::triacetyl citrate, ethylcellulose, hypromellose, talc, titanium dioxide, and purified water.

Appearance of the product and content of the packaging

Coated tablet with a white or pale yellow film, oblong, scored on both sides.

It is presented in packaging with 20, 30, and 500 coated tablets in Al/PVC/Al blisters and aluminum foil strips Al/PE/Al.

Only some packaging sizes may be commercially marketed.

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

Last review date of this prospectus:February 2023

The detailed and updated information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/