Amoxicillin and clavulanic acid Sandoz: detailed information

PATIENT INFORMATION LEAFLET

Amoxicillin/Clavulanic Acid Sandoz 875 mg/125 mg film-coated tablets
amoxicillin/clavulanic acid
Generic medicine
Please read all of this leaflet carefully before you take this medicine, as 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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Amoxicillin/Clavulanic Acid Sandoz is and what it is used for
What you need to know before taking Amoxicillin/Clavulanic Acid Sandoz
How to take Amoxicillin/Clavulanic Acid Sandoz
Possible side effects
How to store Amoxicillin/Clavulanic Acid Sandoz
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 works by killing bacteria causing infections. It contains two different active substances, called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins", whose activity can sometimes be blocked (i.e. the medicines are rendered ineffective). The other active component (clavulanic acid) prevents this from happening.
Amoxicillin/Clavulanic Acid Sandoz 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, penicillin, or any of the other ingredients of this medicine (listed in section 6)
if you have previously had a severe allergic reaction to any other antibiotic. These reactions may include skin rash or swelling of the face or throat
if you have previously experienced liver problems or jaundice (yellowing of the skin) while taking an antibiotic.

If any of these apply to you, do not take Amoxicillin/Clavulanic Acid Sandoz. If you
have any doubts, consult your doctor or pharmacist before taking Amoxicillin/Clavulanic Acid Sandoz.
Warnings and precautions
Talk to your doctor or pharmacist before taking Amoxicillin/Clavulanic Acid Sandoz if:

you have glandular fever
you are undergoing treatment for liver or kidney disorders and are not urinating regularly. If you are unsure whether any of the conditions listed above apply to you, consult your doctor or pharmacist before taking Amoxicillin/Clavulanic Acid Sandoz.

In some cases, your doctor may perform tests to identify the type of bacteria causing
the infection. Depending on the results, they may prescribe a different dose of Amoxicillin/Clavulanic Acid
Sandoz, or even a different medicine.
Symptoms to watch for
Amoxicillin/Clavulanic Acid Sandoz may worsen certain pre-existing conditions or
cause serious adverse effects. These may include allergic reactions, seizures (epileptic fits), and inflammation of the large intestine. During treatment with Amoxicillin/Clavulanic Acid
Sandoz, you should pay attention to certain specific symptoms in order to reduce the risk of potential problems.
See Symptoms to watch for in section 4.
Blood and urine tests
If you are due to have blood tests (such as red blood cell counts or liver function tests) or urine tests (for glucose), inform your doctor or nurse that you are taking
Amoxicillin/Clavulanic Acid Sandoz. This is because Amoxicillin/Clavulanic Acid Sandoz may
affect the results of these types of tests.
Other medicines and Amoxicillin/Clavulanic Acid Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
If you are taking allopurinol (used to treat gout) together with Amoxicillin/Clavulanic Acid Sandoz, you are very likely to develop a skin allergic reaction.
If you are taking probenecid (used to treat gout), concomitant use with probenecid may reduce the excretion of amoxicillin and is not recommended.
If you are taking medicines that help prevent blood clots (such as warfarin) together with Amoxicillin/Clavulanic Acid Sandoz, additional blood tests may be required.
Methotrexate (used to treat cancer, rheumatic diseases, and severe psoriasis), penicillins
may reduce the excretion of methotrexate, potentially increasing its side effects.
Amoxicillin/Clavulanic Acid Sandoz may affect how mycophenolate mofetil works (a medicine used to prevent rejection of transplanted organs).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Amoxicillin/Clavulanic Acid Sandoz may cause adverse effects, the symptoms of which may 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 1 mmol (23 mg) of sodium per film-coated tablet, i.e.,
essentially "sodium-free".

3. How to take Amoxicillin/Clavulanic Acid Sandoz

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults and children weighing 40 kg or more

Normal dose – one tablet twice daily
High dose – one tablet three times daily

Children weighing less than 40 kg
Children aged 6 years and younger should preferably be treated with Amoxicillin/Clavulanic Acid Sandoz oral suspension or sachets.
Regarding the administration of Amoxicillin/Clavulanic Acid Sandoz tablets to children weighing less than 40 kg, please consult your doctor or pharmacist. 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 need to be adjusted. Your doctor may prescribe a different dosage or an alternative medicine.
If you have liver problems, you may need to have blood tests more frequently to monitor liver function.

How to take Amoxicillin/Clavulanic Acid Sandoz

Swallow the tablet whole with a glass of water, with a meal.
The tablets may be divided along the break line to facilitate swallowing. You must take both parts of the tablet at the same time.
Space your doses evenly throughout the day, at intervals of at least 4 hours. Do not take 2 doses within one hour.
Do not take Amoxicillin/Clavulanic Acid Sandoz for longer than 2 weeks. If you continue to feel unwell, you should consult your doctor again.

If you take more Amoxicillin/Clavulanic Acid Sandoz than you should
If you take more Amoxicillin/Clavulanic Acid Sandoz than prescribed, symptoms may include stomach problems (feeling sick, vomiting or diarrhoea) or seizures.
Contact your doctor as soon as possible. Bring the medicine pack or container with you to show the doctor.
If you forget to take Amoxicillin/Clavulanic Acid Sandoz
If you forget to take a dose, take it as soon as you remember. However, do not take the next dose too soon: wait approximately 4 hours before taking the next dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Amoxicillin/Clavulanic Acid Sandoz
Continue taking Amoxicillin/Clavulanic Acid Sandoz for the full duration of treatment, even if you feel better. To fight the infection, you need to take all the doses. If some bacteria survive, they may cause the infection to return.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Symptoms to watch for
Allergic reactions

skin rashes
inflammation of blood vessels (vasculitis), which may appear as raised red or purple spots on the skin, but may also affect other parts of the body
fever, joint pain, swelling of the glands in the neck, armpits or groin
swelling, sometimes of the face or throat (angioedema), causing difficulty in breathing
collapse
chest pain during allergic reactions, which may be a symptom of an allergy-triggered heart attack (Kounis syndrome).

If you develop any of these symptoms, contact a doctor immediately. Stop taking Amoxicillin/Clavulanic Acid Sandoz.

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

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.

Drug-induced enterocolitis syndrome (DIES):
DIES has been mainly reported in children treated with amoxicillin. It is a type of allergic reaction with the main symptom being repeated vomiting (1-4 hours after taking the medicine).
Additional symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.
If you develop these symptoms, consult your doctor as soon as possible.

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

diarrhoea (in adults)

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

oral, vaginal or skin thrush (candidiasis – a yeast infection in the folds of the vagina, mouth or skin)
feeling unwell (nausea), especially when taking high doses. In this case, take Amoxicillin/Clavulanic Acid Sandoz with food
vomiting
diarrhoea (in children)

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

skin rash, itching
itchy, raised skin rash (urticaria)
indigestion
dizziness
headache

Uncommon side effects that may be revealed by blood tests:

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

Rare side effects (may affect up to 1 in 1,000 people)

skin rash, possibly with blistering, appearing as small "target" lesions (dark central spots surrounded by paler areas, with a dark ring around the edge – erythema multiforme); if you notice any of these symptoms, contact a doctor urgently.

Rare side effects that may be revealed by blood tests:

low count of cells involved in blood clotting (thrombocytes)
low white blood cell count

Frequency not known (frequency cannot be estimated from the available data)
In a very small number of people, other side effects have occurred, the exact frequency of which is unknown.

allergic reactions (see above)
inflammation of the large intestine (see above)
inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
severe skin reactions: widespread rash with blistering and peeling, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing extensive skin peeling (over 30% of body surface – toxic epidermal necrolysis), or widespread red rash with small pus-filled blisters (exfoliative bullous dermatitis), or red, scaly rash with raised areas under the skin and blisters (exanthematous pustulosis), or flu-like symptoms with rash, fever, swollen glands and abnormal blood test results (including increased white blood cell count (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)); or red rash commonly seen on both sides of the buttocks, upper inner thighs, armpits and neck (Symmetrical Drug-Related Intertriginous and Flexural Erythema (SDRIFE))
blistering rash arranged in circles with central crusts or resembling a string of pearls (linear IgA disease)
crystals in the urine leading to acute kidney injury

If you develop any of these symptoms, contact a doctor immediately:

liver inflammation (hepatitis)
jaundice, caused by increased bilirubin in the blood (a substance produced by the liver), which may cause yellowing of the skin and whites of the eyes
inflammation of the kidney tubules
prolonged blood clotting time
hyperactivity
seizures (in patients taking high doses of Amoxicillin/Clavulanic Acid Sandoz or who have kidney problems)
black, hairy-looking tongue

Side effects that may be revealed by blood or urine tests:

severe reduction in white blood cell count
low red blood cell count (haemolytic anaemia)

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amoxicillin/Clavulanic Acid Sandoz

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and packaging, following "Exp". The expiry date refers to the last day of that month.
Do not store above 25°C. Keep in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Amoxicillin/Clavulanic Acid Sandoz contains

The active substances are amoxicillin and clavulanic acid. Each film-coated tablet contains 875 mg of amoxicillin (as trihydrate) and 125 mg of clavulanic acid (as potassium clavulanate).
Other components are: Anhydrous colloidal silica, magnesium stearate (E 572), talc, povidone (K25), sodium croscarmellose, microcrystalline cellulose, triethyl citrate, ethylcellulose, sodium lauryl sulfate, cetyl alcohol, hypromellose, talc, titanium dioxide (E171).

Description of the appearance of Amoxicillin/Clavulanic Acid Sandoz and package contents
The film-coated tablets are oblong, white to light yellow in colour, with a break line on both sides.
The break line is intended only to facilitate tablet splitting for easier swallowing and is not intended to divide the tablet into equal parts.
The film-coated tablets are packaged in sealed aluminum strips with a polyethylene coating, placed in a carton box.
Pack sizes:
Single packs containing 6, 8, 10, 12, 14, 15, 16, 20 and 100 film-coated tablets
Hospital packs containing 40, 50, 100 and 500 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy
Manufacturer
Sandoz GmbH – Biochemiestrasse, 10 – 6250 Kundl – Austria.
This medicinal product is authorized in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria Curam 875 mg/125 mg filmtabletten
Belgium Amoxiclav Sandoz 875 mg filmomhulde tabletten
Finland Bioclavid 875/125 mg tabletti, kalvoäällysteinen
Greece Bioclavid 875/125 mg
Italy Amoxicillin and Clavulanic Acid Sandoz
Portugal Amoxicillin + Clavulanic Acid Sandoz 875 + 125 mg coated tablets
Sweden Bioclavid 875 mg/125 mg filmdragerade tabletter
Hungary Curam DUO 875 mg/125 mg
Medical recommendations/education

Antibiotics are used to treat infections caused by bacteria. They have no effect against infections caused by viruses.
Sometimes, a bacterial infection does not respond to a course of antibiotic treatment: one of the most common reasons being that the bacteria causing the infection are resistant to the administered antibiotic. This means that they can survive, and even multiply, despite the presence of the antibiotic.
Bacteria can become resistant to antibiotics for many reasons. Using antibiotics carefully and cautiously helps reduce the risk of bacteria developing resistance.
When a doctor prescribes a course of antibiotic treatment, the medicine is intended solely for treating the current condition. By following the recommendations below, you can help prevent the emergence of resistant bacteria, which could render antibiotics ineffective.

It is very important to take the antibiotic at the correct dose, at the right time, and for the correct number of days. Read the instructions on the label carefully and, if anything is unclear, consult your doctor or pharmacist.
Do not take an antibiotic unless it has been specifically prescribed for you; use the antibiotic only to treat the infection for which it was prescribed.
Do not take antibiotics that have been prescribed for other people, even if their infection appears similar to yours.
Do not give your prescribed antibiotics to other people.
If, after completing the prescribed treatment course, you have leftover antibiotics, return them to the pharmacy for proper disposal.

Patient Information Leaflet

Amoxicillin and Clavulanic Acid Sandoz 400 mg + 57 mg/5 ml powder for oral suspension

amoxicillin/clavulanic acid
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. 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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of this leaflet

What Amoxicillin and Clavulanic Acid Sandoz is and what it is used for
What you need to know before taking Amoxicillin and Clavulanic Acid Sandoz
How to take Amoxicillin and Clavulanic Acid Sandoz
Possible side effects
How to store Amoxicillin and Clavulanic Acid Sandoz
Contents of the pack and other information
What Amoxicillin and Clavulanic Acid Sandoz is and what it is used for
Amoxicillin and Clavulanic Acid Sandoz is an antibiotic that works by killing 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 be inactivated (by interference with their function). The other active component (clavulanic acid) prevents this inactivation from occurring.

Amoxicillin and Clavulanic Acid Sandoz 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 should know before administering Amoxicillin and Clavulanic Acid Sandoz

Do not administer Amoxicillin and Clavulanic Acid Sandoz to your child:

if he/she is allergic to amoxicillin, clavulanic acid, penicillins, or any of the other ingredients of this medicine (listed in section 6)
if he/she has ever had a severe allergic reaction to any other antibiotic. Allergic reactions may include skin rash or swelling of the face or throat
if he/she has ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

If any of these conditions apply, do not administer Amoxicillin and Clavulanic Acid Sandoz to your child. If you are unsure, consult your doctor or pharmacist before administering Amoxicillin and Clavulanic Acid Sandoz.

Warnings and precautions

Consult your doctor or pharmacist before administering this medicine to your child if he/she:

has glandular fever (infectious mononucleosis)
is being treated for liver or kidney disorders
does not urinate regularly.

If you are unsure whether any of these conditions apply, consult your doctor or pharmacist before administering Amoxicillin and Clavulanic Acid Sandoz.

In some cases, the doctor may analyze the type of bacteria causing the child's infection. Depending on the results, a different formulation of Amoxicillin and Clavulanic Acid Sandoz or another medicine may be prescribed.

Situations requiring attention

Amoxicillin and Clavulanic Acid Sandoz may worsen certain pre-existing conditions or cause serious side effects. These include allergic reactions, seizures (epileptic fits), and inflammation of the large intestine. While your child is being treated with Amoxicillin and Clavulanic Acid Sandoz, you should be alert to certain symptoms in order to reduce the risk of potential problems. See “Situations requiring special attention” in section 4.

Blood and urine tests

If your child needs to undergo blood tests (such as tests for red blood cell status or liver function tests) or urine tests (for glucose), inform the doctor or nurse that he/she is taking Amoxicillin and Clavulanic Acid Sandoz. This is because Amoxicillin and Clavulanic Acid Sandoz may alter the results of these tests.

Other medicines and Amoxicillin and Clavulanic Acid Sandoz

Inform the doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.

If allopurinol (used to treat gout) is taken together with Amoxicillin and Clavulanic Acid Sandoz, your child may be more likely to develop a skin allergic reaction.

If your child is taking probenecid (used to treat gout), concomitant use with Amoxicillin and Clavulanic Acid Sandoz may reduce the excretion of amoxicillin and is not recommended.

If medicines that help prevent blood clots (such as warfarin) are taken together with Amoxicillin and Clavulanic Acid Sandoz, additional blood tests may be required.

Methotrexate (used to treat cancer, rheumatic diseases, and severe psoriasis): penicillins may reduce the excretion of methotrexate, potentially increasing its side effects.

Amoxicillin and Clavulanic Acid Sandoz may affect how mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs) works.

Pregnancy, breastfeeding and fertility

If your child who is to take this medicine is pregnant, suspects she may be pregnant, is planning a pregnancy, or is breastfeeding, consult your doctor or pharmacist before taking this medicine.

Amoxicillin and Clavulanic Acid Sandoz contains aspartame, sorbitol, glucose, benzyl alcohol and sodium.

This medicine contains 1.7 mg of aspartame per 1 ml of reconstituted suspension. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder causing phenylalanine to accumulate because the body cannot eliminate it properly.

This medicine contains 0.03 mg of sorbitol and 0.21 mg of glucose per 1 ml of reconstituted suspension.

If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

This medicine contains 0.11 mg of benzyl alcohol per 1 ml of reconstituted suspension.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you have liver or kidney disease, as large amounts of benzyl alcohol may accumulate in the body and cause undesirable effects (such as metabolic acidosis).

Consult your doctor or pharmacist if you are pregnant or breastfeeding, as large amounts of benzyl alcohol may accumulate in the body and cause undesirable effects (such as metabolic acidosis).

This medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of reconstituted suspension, i.e. essentially "sodium-free".

3. How to take Amoxicillin and Clavulanic Acid Sandoz

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Adults and children weighing 40 kg or more

This suspension is generally not recommended for adults and children weighing 40 kg or more. Please consult your doctor or pharmacist for advice.

Children weighing less than 40 kg
All doses are based on the child's body weight in kilograms.

Your doctor will tell you how much Amoxicillin and Clavulanic Acid Sandoz to give your child.
The package contains a plastic oral syringe or dosing spoon, which must be used to administer the correct dose to the child.
Usual dose – from 25 mg/3.6 mg to 45 mg/6.4 mg per kilogram of body weight per day, divided into two separate doses.
Higher dose – up to 70 mg/10 mg per kilogram of body weight per day, divided into two separate doses.

Patients with kidney or liver problems

If the child has kidney problems, the dose may need to be adjusted. The doctor may choose an alternative formulation or a different medicine.
If the child has liver problems, more frequent blood tests may be needed to monitor liver function.

How to take Amoxicillin and Clavulanic Acid Sandoz

Always shake the bottle well before administering each dose.
Take with a meal.
Doses should be evenly spaced throughout the day, at least 4 hours apart. Do not administer two doses within one hour.
Do not give Amoxicillin and Clavulanic Acid Sandoz to the child for longer than 2 weeks. If the child still feels unwell, he/she must be seen again by the doctor.

If you take more Amoxicillin and Clavulanic Acid Sandoz than you should
If you give the child too much Amoxicillin and Clavulanic Acid Sandoz, symptoms may include stomach upset (feeling sick, vomiting or diarrhoea) or seizures. Contact your doctor as soon as possible. Bring the medicine bottle with you to show the doctor.

If you forget to take Amoxicillin and Clavulanic Acid Sandoz
If you forget to give a dose to the child, give it as soon as you remember. However, do not give the next dose too soon; wait approximately 4 hours before giving the next dose. Do not give a double dose to make up for a missed dose.

If the child stops treatment with Amoxicillin and Clavulanic Acid Sandoz
Continue giving Amoxicillin and Clavulanic Acid Sandoz to the child for the full duration of treatment, even if he/she feels better. The child needs every dose to fight the infection. Surviving bacteria may cause the infection to return.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

Situations requiring special attention

Allergic reactions

skin rash
inflammation of blood vessels (vasculitis), which may appear as raised red or purple spots on the skin, but may also 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 breathing difficulties
collapse
chest pain during allergic reactions, which may be a symptom of allergy-triggered heart attack (Kounis syndrome).

If you experience any of these symptoms, contact a doctor immediately. Stop administering Amoxicillin and 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.

Acute inflammation of the pancreas (acute pancreatitis)
If you have severe and persistent stomach pain, this may be a sign of acute pancreatitis.

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

diarrhoea (in adults)

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

thrush (candida – a yeast infection of the vagina, mouth or skin folds)
feeling unwell (nausea), especially when taking high doses. In this case, take Amoxicillin and Clavulanic Acid Sandoz with food.
vomiting
diarrhoea (in children)

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

skin rash, itching
itchy, raised skin rash (urticaria)
indigestion
dizziness
headache

Uncommon side effects that may be detected by blood tests:

increase in certain substances (enzymes) produced by the liver

Rare side effects (may affect up to 1 in 1,000 people)

skin rash, possibly with blisters, appearing as small "targets" (dark central spots surrounded by a paler area and a dark ring at the edge – erythema multiforme)
If you notice any of these symptoms, consult a doctor urgently.

Rare side effects that may be detected by blood tests:

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

Frequency not known (frequency cannot be estimated from the available data)
In a very small number of people, other side effects have occurred, but their exact frequency is unknown.

allergic reactions (see above)
inflammation of the large intestine (see above)
inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
severe skin reactions: widespread rash with blisters and peeling, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing extensive skin peeling (more than 30% of body surface, toxic epidermal necrolysis)
widespread red rash with small pus-filled blisters (exfoliative bullous dermatitis)
red, scaly rash with raised areas under the skin and blisters (exanthematous pustulosis)
flu-like symptoms with rash, fever, swollen glands and abnormal blood test results (including increased white blood cell count (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
red rash commonly seen on both sides of the buttocks, upper inner thighs, armpits, neck (Symmetrical Drug-Related Intertriginous and Flexural Erythema (SDRIFE))
blistering rash arranged in rings with a central crust or resembling a string of pearls (linear IgA disease)
crystals in the urine leading to acute kidney injury

If your child experiences any of these symptoms, consult a doctor immediately.

inflammation of the liver (hepatitis)
jaundice, caused by increased bilirubin in the blood (a substance produced by the liver), which may cause the child’s skin and whites of the eyes to turn yellow
inflammation of the kidney tubules
prolonged blood clotting time
hyperactivity
seizures (in patients taking high doses of Amoxicillin and Clavulanic Acid Sandoz or with kidney disorders)
black, hairy-looking tongue
stained teeth (in children), a condition that usually resolves with brushing.

Side effects that may be detected by blood or urine tests:

severe reduction in white blood cell count
low red blood cell count (haemolytic anaemia)

Reporting of side effects
If your child experiences any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amoxicillin and Clavulanic Acid Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry date refers to the last day of that month.
Store in the original container. Keep the container tightly closed.
The reconstituted suspension must be stored in a refrigerator (2-8°C) and must be used within 7 days.
Do not use this medicine if particles of powder are visible in the vial before reconstitution.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Amoxicillina e Acido Clavulanico Sandoz Contains
The active substances are amoxicillin and clavulanic acid.
Each ml of reconstituted suspension contains:
80 mg of amoxicillin (as trihydrate) and
11.4 mg of clavulanic acid (as potassium clavulanate).
The other components are: anhydrous citric acid, anhydrous trisodium citrate, aspartame (E951), talc, guar gum, silicon dioxide, lemon flavour (natural flavouring substances, flavouring substances identical to natural ones, dextrose, maltodextrin, butylhydroxyanisole (E320), sorbitol syrup (E420), acacia gum (E414); peach-apricot flavour (natural flavouring substances, flavouring substances identical to natural ones, maltodextrin, butylhydroxyanisole (E320), sorbitol syrup (E420), acacia gum (E414), orange flavour (flavouring substances identical to natural ones, artificial flavouring substances), maltodextrin, alpha-tocopherol (E307), benzyl alcohol).

Description of the Appearance of Amoxicillina e Acido Clavulanico Sandoz and Contents of the Pack
Amoxicillina e Acido Clavulanico Sandoz powder for oral suspension is a white/ivory coloured powder.
The powder for oral solution is supplied in amber glass bottles (Type III) with a screw cap, available in 60, 120 and 150 ml sizes.
Screw cap with child-resistant closure and a tamper-evident seal.
Graduated syringe (5 ml) for 60 ml bottles (for packs providing 35, 50 and 60 ml of suspension)
Dosing cup (5 ml) for 120 ml bottles (for packs providing 70, 75 and 100 ml of suspension) and
150 ml bottles (for the pack providing 140 ml of suspension)
Original pack sizes for the preparation of 35, 50, 60, 70, 75, 100 and 140 ml of suspension.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Responsible Producer for Batch Release
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl – Austria

This medicinal product is authorized in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under the following names:
Finland Bioclavid 80 mg/ml jauhe oraalisuspensiota varten
Italy Amoxicillina e Acido clavulanico Sandoz
Portugal Amoxicillina + Acido Clavulanico Sandoz
United Kingdom Co-Amoxiclav 400/57 mg/5 ml powder for oral suspension
Hungary Curam DUO 400 mg/57 mg/5 ml

Instructions for Reconstitution
At the time of administration, the powder must be reconstituted to form an oral suspension, as specified below:
After removing the screw cap, check that the bottle seal is intact and securely attached to the rim of the bottle. Do not use if not intact. Carefully and completely remove the membrane and discard it before reconstituting the product. Fill the bottle with water up to just below the mark on the label and immediately shake well. Then add water exactly up to the mark and shake again vigorously.
Shake the bottle well before each withdrawal.

Add 31.9 ml of water to obtain 35 ml of ready-to-use oral suspension
Add 45.5 ml of water to obtain 50 ml of ready-to-use oral suspension
Add 54.6 ml of water to obtain 60 ml of ready-to-use oral suspension
Add 63.7 ml of water to obtain 70 ml of ready-to-use oral suspension
Add 68.3 ml of water to obtain 75 ml of ready-to-use oral suspension
Add 89.3 ml of water to obtain 100 ml of ready-to-use oral suspension
Add 125.0 ml of water to obtain 140 ml of ready-to-use oral suspension.

Do not use the reconstituted suspension if the colour is not white/ivory.