Amoxicillin and clavulanic acid ABC

Package leaflet: Information for the patient

Amoxicillin and Clavulanic Acid ABC 875 mg / 125 mg film-coated tablets

Amoxicillin / Clavulanic Acid
Equivalent 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 effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Amoxicillin and Clavulanic Acid ABC is an antibiotic that works by killing the bacteria that cause infections. It contains two different active ingredients called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of antibiotic medicines called "penicillins", whose activity can sometimes be blocked (i.e. rendered inactive). The other active component (clavulanic acid) prevents this from happening.
Amoxicillin and Clavulanic Acid ABC is used in adults and children to treat the following infections:

• 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 and Clavulanic Acid ABC

Do not take Amoxicillin and Clavulanic Acid ABC if:

• you are allergic to amoxicillin, clavulanic acid, penicillin, or any of the components of this medicine (listed in section 6);
• you have had a severe allergic reaction to any other antibiotic. This may include a skin rash or swelling of the face or throat;
• you have had liver problems or jaundice (yellowing of the skin) when taking an antibiotic. Do not take Amoxicillin and Clavulanic Acid ABC if any of these situations apply to you. If you have any doubts, speak with your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid ABC.

Warnings and precautions
Talk to your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid ABC if you:

• have infectious mononucleosis;
• have previously been treated for liver or kidney problems;
• do not urinate regularly.

If you are unsure whether any of the above situations apply to you, discuss this with your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid ABC.
Do not use this medicine for a long period of time, as antibiotic-resistant organisms may develop.
During prolonged treatment, it is advisable to periodically monitor the general function of all organs, including kidney, liver, and bone marrow function.
Take this medicine with caution and inform your doctor in the following cases:

• if you have a viral infection called mononucleosis, and experience symptoms such as fever, fatigue, and general malaise;
• if you have or have had liver or kidney problems;
• if you have difficulty urinating;
• if you develop severe diarrhoea during treatment. In this case, stop treatment and inform your doctor, as it may be due to inflammation of the intestine (colitis);
• for treating infections caused by penicillin-resistant S. pneumoniae.

In some cases, your doctor may perform tests to identify the type of bacteria causing your infection.
Based on the results, they may prescribe a different dosage of Amoxicillin and Clavulanic Acid ABC or a different medicine.
Conditions to which you should pay attention
Amoxicillin and Clavulanic Acid ABC may worsen certain pre-existing conditions or cause serious adverse effects. These may include allergic reactions, seizures, and inflammation of the intestine. You should be aware of certain symptoms while taking Amoxicillin and Clavulanic Acid ABC, in order to reduce any risk. See “Conditions to which you should pay attention” in Section 4.
Behavioural hygiene
Antibiotics are used to treat bacterial infections. They are not effective against infections caused by viruses. Sometimes, a bacterial infection does not respond to treatment because the bacteria causing the infection are resistant to the antibiotic being used. This means that the bacteria survive and multiply despite the antibiotic.
Bacteria become resistant to antibiotics for various reasons.
Use antibiotics appropriately to reduce the development of bacterial resistance.
When your doctor prescribes an antibiotic treatment, it is intended only for the illness you currently have.
Please follow these recommendations to help prevent the emergence of bacterial resistance, which can lead to loss of antibiotic effectiveness:

1. it is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the correct number of days. Read the instructions in the package leaflet, and if anything is unclear, ask your doctor or pharmacist for clarification;
2. do not take antibiotics unless they have been specifically prescribed for you, and use them only for the infection for which they were prescribed;
3. do not take antibiotics prescribed for other people, even if you have an infection similar to theirs;
4. do not give your prescribed antibiotics to anyone else;
5. if you have leftover antibiotics after completing your treatment, return them to your pharmacist for proper disposal.

Blood and urine tests
If you are scheduled for blood tests (for example, checks on red blood cells or liver function tests) or urine tests (for glucose), inform your doctor or nurse that you are taking this medicine, as Amoxicillin and Clavulanic Acid ABC may affect the results of these tests.
Other medicines and Amoxicillin and Clavulanic Acid ABC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are taking allopurinol (used for gout) together with Amoxicillin and Clavulanic Acid ABC, you are very likely to develop a skin allergic reaction.
If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of Amoxicillin and Clavulanic Acid ABC.
If you are taking medicines such as warfarin (which help prevent blood clots) together with Amoxicillin and Clavulanic Acid ABC, additional blood tests may be required.
Amoxicillin and Clavulanic Acid ABC may affect how methotrexate (a medicine used to treat tumours or rheumatic diseases) works.
Amoxicillin and Clavulanic Acid ABC may affect the action of mycophenolate mofetil (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, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Amoxicillin and Clavulanic Acid ABC may cause adverse effects, and symptoms may impair your ability to drive.
Do not drive or operate machinery unless you feel well.
Amoxicillin and Clavulanic Acid ABC film-coated tablets contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Amoxicillin and Clavulanic Acid ABC

Take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, ask your doctor or pharmacist.
Adults and children weighing 40 kg or more

• Usual dose – 1 tablet twice daily
• Higher dose – 1 tablet three times daily

Children weighing less than 40 kg
Children up to 6 years of age should preferably be treated with amoxicillin and clavulanic acid oral suspension.
Ask your doctor or pharmacist for advice on administering amoxicillin and clavulanic acid 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 need to be adjusted. Your doctor may choose a different dosage or a different medicine.
• If you have liver problems, your doctor will monitor you closely and you may need more frequent liver function tests.

How to take Amoxicillin and Clavulanic Acid ABC

• Take with food
• Swallow the tablet whole with a glass of water. The tablets may be divided along the break line to make swallowing easier. Both parts of the tablet should be taken immediately.
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
• Do not take Amoxicillin and Clavulanic Acid ABC for longer than 2 weeks. If you still do not feel better, you should see your doctor.

If you take more Amoxicillin and Clavulanic Acid ABC than you should
If you (or someone else) have taken an excessive dose of Amoxicillin and Clavulanic Acid ABC, or if you suspect a child may have taken this medicine, symptoms may include stomach disturbances (nausea, vomiting or diarrhoea) or seizures. Contact your doctor immediately or go to the nearest hospital emergency department.
Take the medicine pack with you to show the doctor.
If you forget to take Amoxicillin and Clavulanic Acid ABC
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too early, but wait approximately 4 hours. Do not take a double dose to make up for a forgotten dose.
If you stop taking Amoxicillin and Clavulanic Acid ABC
Continue taking Amoxicillin and Clavulanic Acid ABC for the full duration of treatment, even if you start to feel better. You need every dose to fight the infection. If some bacteria survive, they may cause the infection to return.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. The following side effects may occur with this medicine.
Conditions you should pay attention to
Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis), which may appear as raised red or purple spots on the skin, but may affect other parts of the body
• fever, joint pain, swelling of glands in the neck, armpits, or groin
• swelling, sometimes of the face or throat (angioedema), causing difficulty in breathing
• collapse
• chest pain in the context of allergic reactions, which may be a symptom of an allergy-triggered heart attack (Kounis syndrome)
  Contact your doctor immediately if any of these symptoms occur. Stop taking Amoxicillin and Clavulanic Acid ABC.

Inflammation of the large intestine
Inflammation of the large intestine, causing watery diarrhoea usually accompanied by blood and mucus, stomach pain and/or fever.
Acute inflammation of the pancreas (acute pancreatitis)
If you have severe and persistent stomach pain, this could be a sign of acute pancreatitis.
Drug-induced enterocolitis syndrome (DIES):
DIES has been reported mainly in children treated with amoxicillin/clavulanate. It is a type of allergic reaction with the main symptom being vomiting occurring approximately 1–4 hours after taking the medicine.
Additional symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.
Contact your doctor as soon as possible for advice if these symptoms occur.
Very common (may affect more than 1 in 10 people):

• diarrhoea (in adults)

Common (may affect up to 1 in 10 people):

• thrush (candida, a fungal infection of the vagina, mouth, or skin folds)
• nausea, especially when taking high doses (if affected, take Amoxicillin and Clavulanic Acid ABC with food)
• vomiting
• diarrhoea (in children)
  Uncommon (may affect up to 1 in 100 people):
• skin rashes, itching
• raised, itchy rash (urticaria)
• indigestion
• dizziness
• headache
  Uncommon side effects may be detected through blood tests:
• increased levels of certain proteins (enzymes) produced by the liver

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

• skin rashes, which may appear as blisters and resemble small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge—erythema multiforme). If you notice any of these symptoms, contact your doctor urgently.
  Rare side effects may be detected through blood tests:
• low number of cells involved in blood clotting
• low number of white blood cells

Frequency not known (frequency cannot be estimated from the available data):

• allergic reactions (see above)
• intestinal inflammation (see above)
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• severe skin reactions:
• widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form causing extensive skin detachment (more than 30% of body surface—toxic epidermal necrolysis)
• widespread red rash with small blisters containing pus (exfoliative bullous dermatitis)
• red rash with crusts, swellings under the skin, and blisters (pustular eruption)
• 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)
• rash with blistering arranged in a ring-like pattern with a central crust or resembling a string of pearls (linear IgA disease)

If you experience any of these symptoms, contact your doctor immediately

• inflammation of the liver (hepatitis)
• jaundice, caused by increased bilirubin levels 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
• blood takes longer to clot
• hyperactivity
• seizures (in people taking high doses of Amoxicillin and Clavulanic Acid ABC or who have kidney problems)
• black, hairy-looking tongue
  Side effects that may be detected through blood or urine tests:
• severe reduction in white blood cell count
• low number of red blood cells (haemolytic anaemia)
• crystals in urine leading to acute kidney injury

Reporting suspected adverse reactions
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the website:
https://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 ABC

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Expiry”.
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture, at a temperature not exceeding 25 °C.
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 ABC 875 mg + 125 mg film-coated tablets contains
The active substances are amoxicillin and clavulanic acid.
Each tablet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.
The other components are: anhydrous colloidal silica, magnesium stearate, sodium starch glycolate (Type A), microcrystalline cellulose, hypromellose, talc, titanium dioxide, diethyl phthalate, dimethicone.
Description of the appearance of Amoxicillina e Acido Clavulanico ABC and contents of the pack
Carton containing 12 film-coated tablets
Marketing Authorization Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Torino
Manufacturer
Elpen SA – 95 Marathonos Avenue – 19009 Pikermi Attika – Greece

Package leaflet: Information for the patient

Amoxicillin and Clavulanic Acid ABC 875 mg / 125 mg powder for oral suspension

Amoxicillin / Clavulanic Acid
Equivalent 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

7. What Amoxicillin and Clavulanic Acid ABC is and what it is used for
8. What you need to know before taking Amoxicillin and Clavulanic Acid ABC
9. How to take Amoxicillin and Clavulanic Acid ABC
10. Possible side effects
11. How to store Amoxicillin and Clavulanic Acid ABC
12. Package contents and other information

7. What Amoxicillin and Clavulanic Acid ABC is and what it is used for

Amoxicillin and Clavulanic Acid ABC is an antibiotic that works by killing bacteria that cause infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of antibiotic medicines known as "penicillins", whose activity can sometimes be blocked (i.e. rendered inactive). The other active component (clavulanic acid) prevents this from happening.

Amoxicillin and Clavulanic Acid ABC is used in adults and children to treat the following infections:

• ear and sinus infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections, including dental infections
• bone and joint infections

8. What you need to know before taking Amoxicillin and Clavulanic Acid ABC

Do not take Amoxicillin and Clavulanic Acid ABC if:

• you are allergic to amoxicillin, clavulanic acid, penicillin, or any of the ingredients of this medicine (listed in section 6);
• you have had a severe allergic reaction to any other antibiotic. This may include a skin rash or swelling of the face or neck;
• you have had liver problems or jaundice (yellowing of the skin) when previously taking an antibiotic.

Do not take Amoxicillin and Clavulanic Acid ABC if any of the above apply to you. If you are in doubt, speak with your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid ABC.
Warnings and precautions
Do not use this medicine for a prolonged period, as antibiotic-resistant organisms may develop.
During long-term treatment, it is advisable to periodically monitor the general function of all organs, including kidney, liver, and bone marrow function.
Talk to your doctor, pharmacist, or nurse before taking this medicine if you:

• have infectious mononucleosis;
• have previously been treated for liver or kidney problems;
• do not urinate regularly.

If you are unsure whether any of the above conditions apply to you, consult your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid ABC.
In some cases, your doctor may perform tests to identify the type of bacteria causing your infection.
Based on the results, they may prescribe a different dosage of Amoxicillin and Clavulanic Acid ABC or a different medicine.
Conditions to which you should pay attention
Amoxicillin and Clavulanic Acid ABC may worsen certain pre-existing conditions or cause serious side effects. These may include allergic reactions, seizures, and inflammation of the intestine. You should be alert to certain symptoms while taking Amoxicillin and Clavulanic Acid ABC in order to reduce any risk. See “Conditions to which you should pay attention” in section 4.
Behavioural hygiene
Antibiotics are used to treat bacterial infections. They are not effective against infections caused by viruses. Sometimes, a bacterial infection does not respond to treatment because the bacteria causing the infection are resistant to the antibiotic being used. This means that the bacteria survive and multiply despite the antibiotic.
Bacteria become resistant to antibiotics for various reasons.
Use antibiotics appropriately to reduce the emergence of bacterial resistance.
When your doctor prescribes an antibiotic, it is intended only for the illness you currently have.
Please follow these recommendations to help prevent the development of bacterial resistance, which can render antibiotics ineffective:

6. it is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the correct number of days. Read the instructions in the package leaflet and, if anything is unclear, ask your doctor or pharmacist for clarification;
7. do not take antibiotics unless they have been specifically prescribed for you, and use them only for the infection for which they were prescribed;
8. do not use antibiotics prescribed for other people, even if you have a similar infection;
9. do not give your prescribed antibiotics to anyone else;
10. if you have leftover antibiotics after completing your treatment, return them to your pharmacist for proper disposal.

Blood and urine tests
If you are due to have blood tests (for example, checks on red blood cells) or urine tests (for glucose), inform your doctor or nurse that you are taking this medicine, as Amoxicillin and Clavulanic Acid ABC may affect the results of these tests.
Other medicines and Amoxicillin and Clavulanic Acid ABC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are taking allopurinol (used for gout) together with Amoxicillin and Clavulanic Acid ABC, you are very likely to develop a skin allergic reaction.
If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of Amoxicillin and Clavulanic Acid ABC.
If you are taking medicines such as warfarin (which help prevent blood clots) together with Amoxicillin and Clavulanic Acid ABC, additional blood tests may be required.
Amoxicillin and Clavulanic Acid ABC may affect how methotrexate (a medicine used to treat tumours or rheumatic diseases) works.
Amoxicillin and Clavulanic Acid ABC may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Amoxicillin and Clavulanic Acid ABC may cause side effects, and the symptoms may make you unfit to drive.
Do not drive or operate machinery unless you feel well.
Amoxicillin and Clavulanic Acid ABC oral suspension powder contains aspartame
This medicine contains 12.5 mg of aspartame per sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder that causes phenylalanine to accumulate because the body cannot eliminate it properly.

9. How to take Amoxicillin and Clavulanic Acid ABC

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

Adults and children weighing 40 kg or more

• Recommended dose – 1 sachet twice daily
• Higher dose – 1 sachet three times daily

Children weighing less than 40 kg
Amoxicillin and Clavulanic Acid ABC powder for oral suspension in sachets is not recommended.

Patients with kidney or liver problems

• If you have kidney problems, your dose may need to be adjusted. Your doctor may choose a different dosage or a different medicine.
• If you have liver problems, you may need more frequent blood tests to monitor your liver function.

How to take Amoxicillin and Clavulanic Acid ABC

• Just before taking Amoxicillin and Clavulanic Acid ABC, open the sachet and mix the contents with half a glass of water;
• Take at the beginning of a meal or just before eating;
• Space doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
• Do not take Amoxicillin and Clavulanic Acid ABC for longer than 2 weeks. If you still do not feel better, you should see your doctor again.

If you take more Amoxicillin and Clavulanic Acid ABC than you should
If you (or someone else) have taken an excessive dose of Amoxicillin and Clavulanic Acid ABC, or if you think a child may have taken this medicine, symptoms may include stomach disturbances (nausea, vomiting, or diarrhoea) or seizures. Contact your doctor as soon as possible or go to the nearest hospital emergency department.
Take the medicine package with you to show the doctor.

If you forget to take Amoxicillin and Clavulanic Acid ABC
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too soon; wait approximately 4 hours.

If you stop taking Amoxicillin and Clavulanic Acid ABC
Continue taking Amoxicillin and Clavulanic Acid ABC until the treatment is complete, even if you feel better. You need every dose to fight the infection. 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, pharmacist, or nurse.

10. Possible side effects

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

Conditions you should pay attention to

Allergic reactions:

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

Contact your doctor immediately if any of these symptoms occur.
Stop taking Amoxicillin and Clavulanic Acid ABC

Inflammation of the large intestine
Inflammation of the large intestine, causing watery diarrhoea usually accompanied by blood and mucus, stomach ache 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 reported mainly in children treated with amoxicillin/clavulanate. It is a type of allergic reaction with the main symptom being repeated vomiting (1–4 hours after taking the medicine).
Further symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.
Contact your doctor as soon as possible for advice if these symptoms occur.

The following side effects may also occur:

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

• diarrhoea (in adults)

Common (may affect up to 1 in 10 people):

• thrush (candida, a fungal infection of the vagina, mouth or skin folds)
• nausea, especially when taking high doses (if affected, take Amoxicillin and Clavulanic Acid ABC with meals)
• vomiting
• diarrhoea (in children)

Uncommon (may affect up to 1 in 100 people):

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

Uncommon side effects may be detected by blood tests:

• increase in certain proteins (enzymes) produced by the liver

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

• skin rashes, which may appear as blisters and look like small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge) (erythema multiforme). If you notice any of these symptoms, contact your doctor urgently.

Rare side effects may be detected by blood enzyme tests:

• low number of cells involved in blood clotting
• low number of white blood cells in the blood

Frequency not known (frequency cannot be estimated from the available data):

• allergic reactions (see above)
• intestinal inflammation (see above)
• 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 a more severe form causing extensive peeling of the skin (more than 30% of body surface area – toxic epidermal necrolysis)
  • widespread red rash with small blisters containing pus (exfoliative bullous dermatitis)
  • red rash with crusts, swellings under the skin and blisters (pustular exanthema)
  • flu-like symptoms with rash, fever, swollen glands and abnormal blood test results (including increased number of white blood cells (eosinophilia) and elevated liver enzymes (Drug Reaction with Eosinophilia and Systemic Symptoms - DRESS)
  • rash with blistering arranged in a ring-shaped pattern with a central crust or resembling a string of pearls (linear IgA disease)

If you experience any of these symptoms, contact your doctor immediately

• inflammation of the liver (hepatitis)
• jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may cause yellowing of the skin and whites of the eyes
• inflammation of the kidney tubules
• blood takes longer to clot
• hyperactivity
• seizures (in people taking high doses of Amoxicillin and Clavulanic Acid ABC or who have kidney problems)
• black, hairy-looking tongue
• tooth staining (in children), usually removable by brushing

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

• severe reduction in the number of white blood cells
• low number of red blood cells (haemolytic anaemia)
• crystals in the urine leading to acute kidney damage

Reporting of suspected adverse reactions
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

11. How to store Amoxicillin and Clavulanic Acid ABC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Expiry".
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture, at a temperature not exceeding 25 °C.
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.

12. Package contents and other information

What Amoxicillina e Acido Clavulanico ABC 875 mg + 125 mg powder for oral suspension contains
The active substances are amoxicillin and clavulanic acid.
Each sachet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin and potassium clavulanate
equivalent to 125 mg of clavulanic acid.
The other components are: hydrated colloidal silica, orange flavour, aspartame.
Description of the appearance of Amoxicillina e Acido Clavulanico ABC and contents of the pack
Carton pack containing 12 sachets of powder for oral suspension.
Marketing Authorization Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Torino
Manufacturer
Elpen SA – 95 Marathonos Avenue – 19009 Pikermi Attika – Greece