AMOXICILLIN/CLAVULANIC ACID SANDOZ 500 mg/125 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Amoxicillin/Clavulanic Acid Sandoz 500 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 and other information:

1. What is Amoxicillin/Clavulanic Acid Sandoz and what is it used for
2. What you need to know before you take Amoxicillin/Clavulanic Acid Sandoz
3. How to take Amoxicillin/Clavulanic Acid Sandoz
4. Possible side effects
5. Storage of Amoxicillin/Clavulanic Acid Sandoz
6. Pack contents and further information

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

Amoxicillin/Clavulanic Acid Sandoz is an antibiotic that eliminates the bacteria that cause infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to the group of medicines known as "penicillins" which can sometimes lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

Amoxicillin/clavulanic acid 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 you take Amoxicillin/Clavulanic Acid Sandoz

Do not take Amoxicillin/Clavulanic Acid Sandoz

• if you are allergic to amoxicillin, clavulanic acid, 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 a 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 Amoxicillin/Clavulanic Acid Sandoz if you are included in any of the above points.

Before starting treatment with Amoxicillin/Clavulanic Acid Sandoz, if you are not sure, 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 not sure if any of the above symptoms affect you, inform your doctor or pharmacist before taking amoxicillin/clavulanic acid.

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, convulsions, 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 tests) 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.

Using Amoxicillin/Clavulanic Acid Sandoz with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription and herbal medicines.

If you are taking allopurinol (used for gout) with amoxicillin/clavulanic acid, 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 amoxicillin and is not recommended.

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

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

Amoxicillin/clavulanic acid may affect how mycophenolate mofetil (a medicine 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Amoxicillin/clavulanic acid 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 Sandoz contains sodium

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

3. How to take Amoxicillin/Clavulanic Acid Sandoz

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

Use in adults and children over 40 kg

The recommended dose is:

• 1 tablet three times a day.

Use in children under 40 kg

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

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

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.

• 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 out the doses during 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 are still feeling 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 upset (nausea, vomiting, or diarrhea) or convulsions. Consult your doctor as soon as possible. Bring the package with you to show the doctor.

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 taken.

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 forgotten doses.

If you stop taking Amoxicillin/Clavulanic Acid Sandoz

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 further 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. 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 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 throat (angioedema), which can cause difficulty breathing,
• collapse.

Contact your doctor immediatelyif you experience any of these symptoms.

Stop taking Amoxicillin/Clavulanic Acid Sandoz.

Inflammation of the large intestine

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

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)

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 in the vagina, mouth, or mucous membranes),
• nausea, especially when taking high doses,

if this happens, take Amoxicillin/Clavulanic Acid 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 (urticaria),
• 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)

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).

Contact a doctor urgentlyif you have any of these symptoms.

Rare side effects that may appear in your blood tests:

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

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

Other side effects that have occurred in a very small number of patients and whose exact frequency is not known:

• allergic reactions (see above),
• chest pain in the context of allergic reactions, which can be a symptom of allergy-induced heart attack (Kounis syndrome),
• Drug-Induced Enterocolitis Syndrome (DIES): DIES has been reported mainly in children receiving 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.
• inflammation of the large intestine (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 severe and persistent pain in the stomach area, this could be a sign of acute pancreatitis,
• blistering rash arranged in a circle with a central crust or like a string of pearls (linear IgA disease),
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis),
• severe 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 peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis),

• widespread rash with small blisters containing pus (vesicular exfoliative dermatitis),
• red rash with bumps under the skin and blisters (pustular exanthematous),
• 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)).

Contact a doctor immediatelyif 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 can make the skin and whites of the eyes turn yellow,
• inflammation of the kidney ducts,
• delayed blood clotting,
• hyperactivity,
• convulsions (in patients taking high doses of Amoxicillin/Clavulanic Acid or with kidney problems),
• black hairy tongue,

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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Vigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicillin/Clavulanic Acid Sandoz

Do not store above 25°C.

Keep in the original packaging to protect from light and moisture.

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

Do not use this medicine after the expiry date stated on the packaging after CAD/EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and unused medicine. This will help protect the environment.

6. Pack contents and further information

Composition of Amoxicillin/Clavulanic Acid Sandoz

The active substances are amoxicillin and clavulanic acid. Each tablet contains 500 mg of amoxicillin (trihydrate) and 125 mg of clavulanic acid (potassium salt).

The other ingredients are:

• Core of the tablet: magnesium stearate, talc, povidone K25, microcrystalline cellulose, and sodium croscarmellose.
• Coating: triethyl citrate, ethylcellulose, sodium lauryl sulfate, cetyl alcohol, hypromellose, talc, and titanium dioxide.

Appearance of the product and pack contents

Film-coated tablet, white, oval, biconvex, and scored on both sides.

Amoxicillin/Clavulanic Acid Sandoz is available in blister packs of Al/PVC/Al or Al/PE/Al strips of 30 and 100 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

Sandoz GmbH

Biochemiestrasse, 10

A-6250 (Kundl)

Austria

Date of last revision of this leaflet:February 2023

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