Amoxicillin/clavulanic acid Sandoz 500 mg/125 mg film-coated tablets EFG

Package Leaflet: Information for the User

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, as 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 and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Amoxicillin/Clavulanic acid Sandoz is and what it is used for
2. What you need to know before taking Amoxicillin/Clavulanic acid Sandoz
3. How to take Amoxicillin/Clavulanic acid Sandoz
4. Possible side effects
5. How to store Amoxicillin/Clavulanic acid Sandoz
6. Contents of the pack and other information

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

Amoxicillin/Clavulanic Acid Sandoz is an antibiotic that kills bacteria causing infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins," which can sometimes become ineffective (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 taking Amoxicillin/Clavulanic Acid Sandoz

Do not take Amoxicillin/Clavulanic Acid Sandoz

• 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 throat or neck,
• if you have ever had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.

?Do not take Amoxicillin/Clavulanic Acid Sandoz if any of the above apply to you. Before starting treatment with Amoxicillin/Clavulanic Acid Sandoz, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 conditions apply to 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, they may prescribe a different formulation of Amoxicillin/Clavulanic Acid or another medicine.

Symptoms to watch for

Amoxicillin/clavulanic acid may worsen certain existing conditions or cause
serious adverse 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 complications. See “Symptoms to watch for” in section 4.

Blood and urine tests

If you are having blood tests (such as studies of red blood cell status or liver function tests) or urine tests (to monitor glucose levels), inform your doctor or nurse that you are taking amoxicillin/clavulanic acid. This is because amoxicillin/clavulanic acid may alter the results of these types of tests.

Taking Amoxicillin/Clavulanic Acid Sandoz with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 develop a skin allergic reaction.

Probenecid (used to treat gout): concomitant use with probenecid may reduce the excretion of amoxicillin and is not recommended.

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

Metotrexate (a medicine used to treat cancer and severe psoriasis): penicillins may reduce the excretion of methotrexate and potentially increase adverse 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Talk to your doctor or pharmacist before using any medicine.

Driving and using machines

Amoxicillin/clavulanic acid may cause adverse effects, and symptoms may make it unsafe for you 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; essentially “sodium-free.”

3. How to take Amoxicillin/Clavulanic Acid Sandoz

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Use in adults and children weighing 40 kg or more

The recommended dose is:

• 1 tablet three times a day.

Use in children weighing less than 40 kg

It is preferable to treat children aged 6 years or younger with amoxicillin/clavulanic acid oral suspension or sachets.

Seek advice from your doctor or pharmacist when administering amoxicillin/clavulanic acid tablets to children weighing less than 40 kg.

The tablets are not suitable for children weighing less than 25 kg.

Patients with kidney or liver problems

• If you have kidney problems, your dose may be adjusted. Your doctor may choose a different formulation or another medicine.
• If you have liver problems, you will have blood tests more frequently to monitor liver function.

How to take Amoxicillin/Clavulanic Acid Sandoz

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

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

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine 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 forgotten doses.

If you stop taking Amoxicillin/Clavulanic Acid Sandoz

Continue taking Amoxicillin/Clavulanic Acid until the course is finished, even if you feel better. You need to complete the full course to cure the infection. If you do not, 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. The adverse effects described below may occur when taking this medicine.

Symptoms you should be aware of

Allergic reactions:

• skin rash,
• inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may 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), causing difficulty breathing,
• collapse.

?Contact your doctor immediately if you experience any of these symptoms.

Stop taking Amoxicillin/Clavulanic Acid Sandoz.

Inflammation of the large intestine

Inflammation of the large intestine, causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.

?Contact your doctor as soon as possible for advice if you have these symptoms.

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

May affect more than 1 in 10 patients:

• diarrhoea (in adults).

Common adverse 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,
• diarrhoea (in children).

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

May affect up to 1 in 100 patients:

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

Uncommon adverse effects that may appear in blood tests:

• increased levels of certain substances (enzymes) produced by the liver.

Rare adverse effects (may affect up to 1 in 1,000 patients)

May affect up to 1 in 1,000 patients:

• skin rash, which may blister and resemble targets (a dark central 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 adverse effects that may appear in blood tests:

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

Adverse effects with unknown frequency (cannot be estimated from available data)

Other adverse 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 an allergic-triggered heart attack (Kounis syndrome),

• Drug-Induced Enterocolitis Syndrome (DIES): DIES has mainly been reported in children receiving amoxicillin. It is a 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, diarrhoea, and low blood pressure.

• inflammation of the large intestine (see above),

• crystals in the urine causing 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 stomach pain, this could be a sign of acute pancreatitis,

• blistering rash arranged in rings with central crusts or resembling a string of pearls (linear IgA disease),

• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis),

• serious skin reactions:

• widespread rash with blisters and peeling skin, 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 body surface area – toxic epidermal necrolysis),

• widespread rash with small pus-filled blisters (exfoliative vesicular dermatitis),
• red rash with bumps under the skin and blisters (exanthematous pustulosis).
• 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 immediately if you experience 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 cause the skin and whites of the eyes to turn yellow,
• inflammation of the kidney tubules,
• delayed blood clotting,
• hyperactivity,
• seizures (in patients taking high doses of Amoxicillin/Clavulanic Acid or with kidney problems),
• black, hairy-looking tongue,

Adverse effects that may appear in blood or urine tests:

• significant decrease in white blood cell count,
• low red blood cell count (haemolytic anaemia),

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 container after CAD/EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other 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 components are:

• Tablet core: 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 contents of the pack

Film-coated tablet, whitish, oval, biconvex, with a score line on both sides.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sandoz Farmacéutica, S.A.
Parque Norte Business Centre
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer:

Sandoz GmbH
Biochemiestrasse, 10
A-6250 (Kundl)
Austria

Date of the most recent review of the package leaflet: February 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/