Amoxicillin and clavulanic acid Ibigen: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

AMOXICILLIN AND CLAVULANIC ACID IBIGEN 1000 mg + 200 mg

Powder for injectable solution for intravenous use
Amoxicillin/Clavulanic acid
Generic medicine
Read this leaflet carefully before taking this medicine

Keep this leaflet. You may need to read it again
If you have any questions, ask your doctor, pharmacist, or nurse
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, contact your doctor, pharmacist, or nurse

Contents of this leaflet:

What Amoxicillin and Clavulanic Acid Ibigen is and what it is used for
What you need to know before taking Amoxicillin and Clavulanic Acid Ibigen
How to take Amoxicillin and Clavulanic Acid Ibigen
Possible side effects
How to store Amoxicillin and Clavulanic Acid Ibigen
Contents of the pack and other information

1. WHAT AMOXICILLIN AND CLAVULANIC ACID IBIGEN IS AND WHAT IT IS USED FOR

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

severe ear, nose and throat infections
respiratory tract infections
urinary tract infections
skin and soft tissue infections, including dental infections
bone and joint infections
abdominal infections
female genital organ infections

Amoxicillin and Clavulanic Acid Ibigen is used in adults and children to prevent infections associated with major surgical procedures.

2. WHAT YOU SHOULD KNOW BEFORE TAKING AMOXICILLIN AND CLAVULANIC ACID IBIGEN

DO NOT TAKE AMOXICILLIN AND CLAVULANIC ACID IBIGEN:

if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin
if you have had a severe allergic reaction (hypersensitivity) to any other antibiotic. This may include a skin rash or swelling of the face or neck
if you have had liver problems or jaundice (yellowing of the skin) when taking an antibiotic

DO NOT TAKE AMOXICILLIN AND CLAVULANIC ACID IBIGEN IF ANY OF THESE
CASES APPLY TO YOU.
If you have any doubts, speak with your doctor, pharmacist, or nurse before taking Amoxicillin
and Clavulanic Acid Ibigen.
TAKE SPECIAL CARE WITH AMOXICILLIN AND CLAVULANIC ACID IBIGEN
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 cases apply to you, consult your doctor, pharmacist, or nurse before taking Amoxicillin and Clavulanic Acid Ibigen. In some cases, your doctor may carry out tests to identify the type of bacteria causing your infection. Based on the results, they may prescribe a different dose of Amoxicillin and Clavulanic Acid Ibigen or a different medicine. Conditions to which you should pay attention Amoxicillin and Clavulanic Acid Ibigen 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 Ibigen in order to reduce any risks. See “Conditions to which you should pay attention” in Section 4. Blood and urine tests If you are due to have blood tests (for example, checks on red blood cells or liver function tests), inform your doctor or nurse that you are taking Amoxicillin and Clavulanic Acid Ibigen. This is because Amoxicillin and Clavulanic Acid Ibigen may affect the results of these tests. Taking with other medicines Inform your doctor, pharmacist, or nurse if you are currently using or have recently used any other medicines, including those purchased without a prescription and herbal products. If you are taking allopurinol (used for gout) together with Amoxicillin and Clavulanic Acid Ibigen, 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 Ibigen. If you are taking medicines such as warfarin (which help prevent blood clots) together with Amoxicillin and Clavulanic Acid Ibigen, additional blood tests may be required. Amoxicillin and Clavulanic Acid Ibigen may affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works. Amoxicillin and Clavulanic Acid Ibigen may affect the action of Mycophenolate Mofetil (a drug used to prevent rejection of transplanted organs). Pregnancy and breastfeeding If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

AMOXICILLIN AND CLAVULANIC ACID IBIGEN contains sodium and potassium
Amoxicillin and Clavulanic Acid Ibigen 1000 mg/200 mg contains approximately 62.9 mg
(2.7 mmol) of sodium (main component of table salt) per vial. This corresponds to 3.15%
of the maximum daily dietary intake recommended for an adult.
Amoxicillin and Clavulanic Acid Ibigen 1000 mg/200 mg contains approximately 39.3 mg
(1.0 mmol) of potassium per vial.
This should be taken into account in patients with reduced kidney function or in
patients following a low-potassium diet.

3. HOW TO TAKE AMOXICILLIN AND CLAVULANIC ACID IBIGEN

Never take this medicine on your own initiative. This medicine will be administered to you by a
qualified person, such as a doctor or nurse.
The usual doses are:
Adults and children weighing equal to or more than 40 kg

Standard dose	1000 mg/200 mg every 8 hours
To prevent infection during and after surgery	1000 mg/200 mg before surgery, when receiving anesthesia. The dose may vary depending on the type of surgery you are having. Your doctor may repeat the dose if the surgery lasts longer than 1 hour.

Children weighing less than 40 kg

All doses are calculated based on the child's body weight expressed in kilograms

Children aged 3 months and over:	25 mg/5 mg per kg of body weight every 8 hours
Children under 3 months or weighing less than 4 kg	25 mg/5 mg per kg of body weight every 12 hours

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, more frequent blood tests may be required to monitor your liver function.

How AMOXICILLIN AND CLAVULANIC ACID IBIGEN will be administered to you

Amoxicillin and Clavulanic Acid Ibigen will be administered to you by intravenous injection or intravenous infusion.
Make sure you drink an adequate amount of fluids while receiving Amoxicillin and Clavulanic Acid Ibigen.
Do not take Amoxicillin and Clavulanic Acid Ibigen for longer than 2 weeks. If you do not feel well, you should return to your doctor.

If you take more AMOXICILLIN AND CLAVULANIC ACID IBIGEN than you should
It is very unlikely that this will happen, but if you think it has occurred, contact your doctor, pharmacist, or nurse immediately. Symptoms may include gastrointestinal disturbances (nausea, vomiting, or diarrhoea) or seizures.
If you have any doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Amoxicillin and Clavulanic Acid Ibigen may cause adverse reactions,
although not everyone experiences them.
Conditions you should pay attention to
Allergic reactions:

skin rashes
inflammation of blood vessels ( vasculitis ), which may appear as 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 mouth ( angioedema ), causing difficulty 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 you experience any of these symptoms.
Stop taking Amoxicillin and Clavulanic Acid Ibigen.

Intestinal inflammation
Intestinal inflammation, 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 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/clavulanate. It is a type of allergic reaction with the main symptom being repeated vomiting (1–4 hours after drug administration). Additional symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.
If you experience these symptoms, contact your doctor as soon as possible for advice.

Common adverse reactions (may affect up to 1 in 10 people)

oral, vaginal, or skin fold fungal infection ( candidiasis )
diarrhoea

Uncommon adverse reactions (may affect up to 1 in 100 people)

skin rash, itching
raised itchy rash ( urticaria )
nausea, especially when high doses are taken
if you are affected, take Amoxicillin and Clavulanic Acid Ibigen before food
vomiting
indigestion
dizziness
headache

Uncommon adverse reactions may be detected through blood tests:

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

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

skin rash, which may appear as blisters and resemble "target lesions" (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
swelling and redness along the vein, with increased pain on touch

Rare adverse reactions may be detected through blood tests:

low number of platelets (cells involved in blood clotting)
low number of white blood cells

Other adverse reactions
Other adverse reactions occur in a very small number of people, but their exact frequency is unknown.

Allergic reactions (see above)
Intestinal inflammation (see above)
Inflammation of the protective membrane surrounding the brain and spinal cord (aseptic meningitis)
Crystals in the urine leading to acute kidney injury
Severe skin reactions:
- widespread rash with blisters and skin peeling, 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 )
- skin rash with ring-shaped blisters with central crusts or resembling a string of pearls (linear IgA disease)
- widespread red rash with small pus-filled blisters ( exfoliative bullous dermatitis )
- skin rash, red 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 white blood cell count (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms – DRESS)
  If you experience any of these symptoms, contact your doctor immediately.
liver inflammation ( hepatitis )
jaundice, caused by increased blood levels of bilirubin (a substance produced in the liver), which may cause yellowing of the skin and whites of the eyes
inflammation of the kidney tubules
blood takes longer to clot
seizures (in people receiving high doses of Amoxicillin and Clavulanic Acid Ibigen or with kidney problems)

Adverse reactions 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 the urine

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse. You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE AMOXICILLIN AND CLAVULANIC ACID IBIGEN

Store below 25°C in the original container to protect the product from
light, moisture and heat.
Keep this medicine out of the sight and reach of children.
Do not use Amoxicillin and Clavulanic Acid Ibigen after the expiry date stated on the packaging.
The expiry date refers to the last day of that month.
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. PACKAGING CONTENTS AND OTHER INFORMATION

What AMOXICILLINA E ACIDO CLAVULANICO IBIGEN contains
.
Amoxicillina e Acido Clavulanico Ibigen 1000 mg + 200 mg Powder for injectable solution for intravenous use contains:
Active substances:
amoxicillin sodium 1060.2 mg equivalent to 1000 mg amoxicillin
potassium clavulanate 238.25 mg equivalent to 200 mg clavulanic acid

Description of the appearance of AMOXICILLINA E ACIDO CLAVULANICO IBIGEN and packaging contents
Amoxicillina e Acido Clavulanico Ibigen 1000 mg + 200 mg Powder for injectable solution for intravenous use contains:
Carton containing:

10 vials of powder 1000 mg + 200 mg

Marketing Authorization Holder
IBIGEN S.r.l.
Via Fossignano, 2
04011 Aprilia (LT)
Italy
e-mail: [email protected]

Manufacturer
Istituto Biochimico Italiano G. Lorenzini S.p.A.
Via Fossignano, 2 - Aprilia (LT)

The following information is intended for physicians and healthcare professionals:
Refer to the Summary of Product Characteristics for further information

Administration
Amoxicillina e Acido Clavulanico Ibigen can be administered either intravenously (by slow injection over 3–4 minutes) or directly into the vein via infusion or by infusion lasting 30 to 40 minutes.
Amoxicillina e Acido Clavulanico Ibigen must not be administered by intramuscular route.

Reconstitution
Amoxicillina e Acido Clavulanico Ibigen must be reconstituted as described for injection:

The usual solvent is Water for Injections Ph. Eur. Amoxicillina e Acido Clavulanico Ibigen 1000 mg/200 mg must be dissolved in 20 ml of solvent. This yields approximately 20.9 ml of solution for a single dose. A transient pinkish hue may develop during reconstitution. Reconstituted solutions are normally colourless or pale yellow.
The reconstituted solution must be immediately added to 100 ml of infusion fluid using a minibag or burette.

Stability of the prepared solution
Amoxicillina e Acido Clavulanico Ibigen must be administered within 20 minutes after reconstitution.

INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

AMOXICILLIN AND CLAVULANIC ACID IBIGEN 2000 mg/200 mg

Powder for solution for infusion
Amoxicillin/clavulanic acid
Read this leaflet carefully before taking this medicine

Keep this leaflet. You may need to read it again
If you have any questions, ask your doctor, pharmacist, or nurse
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 not listed in this leaflet, contact your doctor, pharmacist, or nurse

Contents of this leaflet:

What Amoxicillin and Clavulanic Acid Ibigen is and what it is used for
What you need to know before taking Amoxicillin and Clavulanic Acid Ibigen
How to take Amoxicillin and Clavulanic Acid Ibigen
Possible side effects
How to store Amoxicillin and Clavulanic Acid Ibigen
Package contents and other information

1. WHAT AMOXICILLIN AND CLAVULANIC ACID IBIGEN IS AND WHAT IT IS USED FOR

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

severe ear, nose and throat infections
respiratory tract infections
urinary tract infections
skin and soft tissue infections, including dental infections
bone and joint infections
abdominal infections
genital infections in women

Amoxicillin and Clavulanic Acid Ibigen is used in adults and children to prevent infections associated with major surgical procedures.

2. WHAT YOU SHOULD KNOW BEFORE TAKING AMOXICILLIN AND CLAVULANIC ACID IBIGEN

Do not take AMOXICILLIN AND CLAVULANIC ACID IBIGEN:

if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, or penicillin
if you have previously had a severe allergic reaction (hypersensitivity) to any other antibiotic. This may include a skin rash or swelling of the face or neck
if you have had liver problems or jaundice (yellowing of the skin) while taking an antibiotic

Do not take AMOXICILLIN AND CLAVULANIC ACID IBIGEN if any of the above apply to you.
If you have any doubts, speak with your doctor, pharmacist, or nurse before taking Amoxicillin and Clavulanic Acid Ibigen.

Take special care with AMOXICILLIN AND CLAVULANIC ACID IBIGEN
Talk to your doctor, pharmacist, or nurse before taking this medicine if:

you have infectious mononucleosis
you have previously been treated for liver or kidney problems
you do not urinate regularly

If you are unsure whether any of the above conditions apply to you, consult your doctor, pharmacist, or nurse before taking Amoxicillin and Clavulanic Acid Ibigen. In some cases, your doctor may carry out 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 Ibigen or an alternative medicine.

Conditions to be aware of
Amoxicillin and Clavulanic Acid Ibigen 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 alert to certain symptoms while taking Amoxicillin and Clavulanic Acid Ibigen in order to minimize any risks. See “Conditions to be aware of” in Section 4.

Blood and urine tests
If you are scheduled for blood tests (such as red blood cell counts or liver function tests), inform your doctor or nurse that you are taking Amoxicillin and Clavulanic Acid Ibigen. This medicine may affect the results of these tests.

Taking with other medicines
Inform your doctor, pharmacist, or nurse if you are currently taking, or have recently taken, any other medicines, including those available without a prescription and herbal products.
If you are taking allopurinol (used for gout) together with Amoxicillin and Clavulanic Acid Ibigen, you are at increased risk of developing a skin allergic reaction.
If you are taking probenecid (also used for gout), your doctor may decide to adjust your dose of Amoxicillin and Clavulanic Acid Ibigen.
If you are taking medications such as warfarin (which help prevent blood clots) together with Amoxicillin and Clavulanic Acid Ibigen, additional blood tests may be required.
Amoxicillin and Clavulanic Acid Ibigen may affect the action of methotrexate (a medicine used to treat cancer or rheumatic diseases).
Amoxicillin and Clavulanic Acid Ibigen may interfere with the effectiveness of mycophenolate mofetil (a drug used to prevent rejection of transplanted organs).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.

AMOXICILLIN AND CLAVULANIC ACID IBIGEN contains sodium and potassium
Amoxicillin and Clavulanic Acid Ibigen 2000 mg/200 mg contains approximately 125.9 mg (5.5 mmol) of sodium (a main component of table salt) per vial. This corresponds to 6.3% of the maximum daily dietary intake recommended for an adult.
Amoxicillin and Clavulanic Acid Ibigen 2000 mg/200 mg contains approximately 39.3 mg (1.0 mmol) of potassium per vial.
This should be taken into account in patients with reduced kidney function or in those following a low-potassium diet.

3. HOW TO TAKE AMOXICILLIN AND CLAVULANIC ACID IBIGEN

Standard dose	1000 mg/100 mg every 8 - 12 hours.
Higher dose	1000 mg/100 mg every 8 hours or 2000 mg/200 mg every 12 hours. For very severe infections, the dose may be increased up to 2000 mg/200 mg every 8 hours.
To prevent infection during and after surgery	From 1000 mg/100 mg to 2000 mg/200 mg before surgery, administered when anesthesia is being given. The dose may vary depending on the type of surgery you are undergoing. Your doctor may repeat the dose if the surgery lasts longer than one hour.

Children weighing less than 40 kg

All doses are calculated based on the child's body weight expressed in kilograms.

Children aged 3 months and older	50 mg/5 mg per kg of body weight every 8 hours
Children under 3 months of age or weighing less than 4 kg	50 mg/5 mg per kg of body weight every 12 hours

Patients with kidney and 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, more frequent blood tests may be required to monitor how well your liver is functioning

How AMOXICILLIN AND CLAVULANIC ACID IBIGEN will be administered to you

Amoxicillin and Clavulanic Acid Ibigen will be administered to you by intravenous injection or intravenous infusion
Make sure you drink an adequate amount of fluids while receiving Amoxicillin and Clavulanic Acid Ibigen
Do not take Amoxicillin and Clavulanic Acid Ibigen for longer than 2 weeks. If you do not feel better, you must return to your doctor

If you take more AMOXICILLIN AND CLAVULANIC ACID IBIGEN than you should
It is very unlikely that this will happen, but if you i believe this has occurred, contact your doctor, pharmacist, or nurse immediately. Symptoms may include gastrointestinal disturbances (nausea, vomiting, or diarrhea) or seizures.
If you have any doubts about the use of this product, consult your doctor, pharmacist, or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Amoxicillin and Clavulanic Acid Ibigen may cause adverse reactions,
although not everyone experiences them.
Conditions you should pay attention to
Allergic reactions:

skin rashes
inflammation of blood vessels ( vasculitis ), which may appear as 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 mouth ( angioedema ), causing difficulty in breathing
collapse
chest pain occurring during allergic reactions, which may be a symptom of allergy-triggered heart attack (Kounis syndrome)

Contact your doctor immediately if you experience any of these symptoms. Stop taking
Amoxicillin and Clavulanic Acid Ibigen.
Intestinal inflammation
Intestinal inflammation 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 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 recurrent vomiting (1-4 hours after administration of the drug). Additional symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.
If you experience these symptoms, contact your doctor as soon as possible for advice.

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

Thrush (candida – a fungal infection of the vagina, mouth or skin folds)
Diarrhoea

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

Skin rashes, itching
Raised itchy rash (urticaria)
Nausea, especially when taking high doses
If you experience this, take Amoxicillin and Clavulanic Acid Ibigen before food
Vomiting
Indigestion
Dizziness
Headache

Uncommon side effects may be detected in blood tests:

Increase in certain proteins (enzymes) produced by the liver

Rare side effects (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.
Swelling and redness along the vein, with increased pain on touch

Rare side effects may be detected in blood tests:

Low number of cells involved in blood clotting
Low number of white blood cells

Other side effects
Other side effects occur in a very limited number of people, but their exact frequency is unknown.

Allergic reactions (see above)
Inflammation of the intestine (see above)
Crystals in the urine leading to acute kidney damage
Inflammation of the protective membrane surrounding the brain and spinal cord (aseptic meningitis)
Severe skin reactions:
- A 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 skin detachment (more than 30% of body surface – toxic epidermal necrolysis)
- Rash with blisters arranged in a ring-shaped pattern with a central crust or resembling a string of pearls (linear IgA disease)
- Widespread red rash with small blisters containing pus (exfoliative bullous dermatitis)
- A 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)

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

inflammation of the liver (hepatitis)
jaundice, caused by an increase in bilirubin levels in the blood (a substance produced in the liver), which may cause the skin and the whites of the eyes to appear yellow
inflammation of the kidney tubules
blood takes longer to clot
seizures (in people taking high doses of Amoxicillin and Clavulanic Acid Ibigen or who have kidney problems)

Undesirable effects that may be detected through blood or urine tests:

severe reduction in the number of white blood cells
low number of red blood cells (hemolytic anemia)
crystals in the urine.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse.
You can also report adverse reactions directly through the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. HOW TO STORE AMOXICILLINA E ACIDO CLAVULANICO IBIGEN

Store at a temperature not exceeding 25°C in the original container to protect the product from
light, moisture, and heat.
Keep this medicine out of the sight and reach of children.
Do not use Amoxicillina e Acido Clavulanico Ibigen after the expiry date stated on the
packaging. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What AMOXICILLINA E ACIDO CLAVULANICO IBIGEN contains
Amoxicillina e Acido Clavulanico Ibigen 2000 mg + 200 mg powder for solution for infusion
Each vial contains:
Active substances: sodium amoxicillin 2120.4 mg equivalent to amoxicillin 2000 mg
potassium clavulanate 238.25 mg equivalent to clavulanic acid 200 mg

Description of the appearance of AMOXICILLINA E ACIDO CLAVULANICO IBIGEN and contents of the package
Carton pack containing:

10 vials of 20 ml powder 2000 mg + 200 mg

Marketing Authorization Holder
IBIGEN S.r.l.
Via Fossignano, 2
04011 Aprilia (LT)
Italy
e-mail: [email protected]

Manufacturer
Istituto Biochimico Italiano G. Lorenzini S.p.A.
Via Fossignano, 2 - Aprilia (LT)

The following information is intended for physicians and healthcare professionals:
Refer to the Summary of Product Characteristics for further information

Administration
Amoxicillina e Acido Clavulanico Ibigen 2000 mg/200 mg is for intravenous use.
Amoxicillina e Acido Clavulanico Ibigen 2000 mg/200 mg must be administered by intravenous infusion over 30 to 40 minutes. Amoxicillina e Acido Clavulanico Ibigen is not suitable for intramuscular administration.
Amoxicillina e Acido Clavulanico Ibigen 2000 mg/200 mg must not be used for bolus injection.

Reconstitution
Amoxicillina e Acido Clavulanico Ibigen 2000 mg/200 mg must be dissolved in 20 ml of Water for Injections Ph.Eur. (minimum required volume). A transient pinkish discoloration may occur during reconstitution. Reconstituted solutions are normally colourless or yellowish. The reconstituted solution must be immediately added to 100 ml of infusion fluid, using a minisack or a burette.
The vials of Amoxicillina e Acido Clavulanico Ibigen 2000 mg/200 mg are not suitable for multi-dose use.

Stability of the prepared solution
Amoxicillina e Acido Clavulanico Ibigen 2000 mg/200 mg must be administered within 20 minutes after reconstitution.