UNASYN 375 mg Coated Tablet

Зміст інструкції

1. UNASYN 375 mg coated tablets, 750 mg coated tablets
   1. What is Unasyn and what is it used for
   2. What you need to know before using Unasyn
   3. How to use Unasyn
   4. Possible side effects
   5. How to store Unasyn
   6. Contents of the pack and other information
2. Unasyn 250 mg + 500 mg powder for injectable/infusion solution, 500 mg + 1 g/ powder for injectable/infusion solution, 1 g + 2 g powder for injectable solution for intravenous use
   1. What is Unasyn and what is it used for
   2. What you need to know before you are given Unasyn
   3. How to administer Unasyn
   4. Possible side effects
   5. How to store Unasyn
   6. Contents of the pack and other information

UNASYN 375 mg coated tablets, 750 mg coated tablets

Sultamicillin

Read this leaflet carefully before using this medicine as 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 the doctor treating your child, or your pharmacist.
• This medicine has been prescribed only for you or your child. Do not give it to other people, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, ask your doctor or the doctor treating your child, or your pharmacist. See section 4.

Contents of this leaflet:

• 1. What Unasyn is and what it is used for
• 2. What you need to know before you use Unasyn
• 3. How to use Unasyn
• 4. Possible side effects
• 5. How to store Unasyn
• 6. Contents of the pack and other information

1. What is Unasyn and what is it used for

Unasyn contains the active ingredient sultamicillin. Sultamicillin belongs to a group of medicines
called “systemic antibacterial agents” and works against infections that can affect different parts
of the body. In the body, sultamicillin is divided into two substances, sulbactam and ampicillin. These
two substances together are able to kill various types of bacteria, even those that have become resistant to penicillin and
other antibiotics belonging to the same class as penicillin (such as ampicillin).
Unasyn is used for the treatment of:

• infectionscaused by bacteria that have become resistant to ampicillin.
• severe infectionsthat are suspected to be caused by bacteria that have become resistant to ampicillin.

Unasyn tablets can also be used for patients who have followed a therapy with
Unasyn injections into a muscle (intramuscularly) or into a vein (intravenously) and who need to
continue treatment orally with the same medicine.

2. What you need to know before using Unasyn

Do not use Unasyn:

• if you or your child are allergic to sultamicillin, to other antibiotics of the penicillin class, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or the doctor caring for your child, or your pharmacist beforeusing Unasyn.
Tell your doctor or the doctor caring for your child if you think that any of the following conditions
applies to you or your child:

• you have had an allergic reaction to penicillin, cephalosporins or other similar antibiotics. If you or your child have previously had an allergic reaction to these antibiotics and/or other allergens, it is more likely that a new, even serious, allergic reaction may occur after

administration of Unasyn. In case of an allergic reaction, stop immediatelytreatment
with Unasyn and consult your doctor (see also section 4 “Possible side effects”);

• you have a viral infection called "infectious mononucleosis". Unasyn is an antibiotic, and as such it does not work against viruses. If you or your child take Unasyn during infectious mononucleosis, it is very likely that a rash may occur.

Consult your doctor or the doctor caring for your child, or your pharmacist if you or your child
develop the following condition aftertaking Unasyn (see also section 4 “Possible side
effects”):

• the onset of diarrhea, which may be mild, but in some cases can be fatal (fatal colitis). Diarrhea can occur with the use of almost all antibiotics, including Unasyn, and is due to the alteration of the normal bacterial flora of the intestine which allows the excessive growth of a bacterium called Clostridium difficile. In case of diarrhea, your doctor or your child's doctor will subject you or your child to careful checks because infection with Clostridium difficilecan occur even two months after the end of treatment with this medicine.
• In case of abdominal pain, itching, dark urine, yellowish discoloration of the skin or eyes, nausea (feeling unwell) or if you do not feel well in general, tell your doctor immediately. These signs may indicate liver damage that can occur with the use of ampicillin/sulbactam.
• Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported in association with Unasyn treatment. Stop taking Unasyn and consult your doctor immediately if you notice any of the symptoms described in section 4. If one or more of these conditions occur, stop immediatelytreatment with Unasyn and consult your doctor immediately (see also section 4 “Possible side effects”).

Duringtreatment with Unasyn your doctor will subject you or your child to frequent checks to
assess:

• the onset of infections caused by microorganisms resistant to Unasyn (superinfection), including infections caused by fungi. In case of superinfection, treatment with Unasyn must be stopped immediatelyand treatment with other medicines must be started;
• the functioning of the kidneys, liver and bone marrow that produces all blood cells.

Infants and children
Children eliminate Unasyn from the body, through the kidneys, in a greater quantity than adults.
In newborns, however, the kidneys are not yet fully developed and the elimination of the medicine
from the body is lower. These conditions must be taken into account when starting treatment with
Unasyn in newborns.

Other medicines and Unasyn
Tell your doctor or the doctor caring for your child, or your pharmacist if you or your child are
taking, have recently taken or might take any other medicines.
Tell your doctor or the doctor caring for your child, or your pharmacist if you or your child are
taking any of the following medicines together with Unasyn because caution is necessary:

• allopurinol(medicine for gout and uric acid build-up). If you take this medicine together with Unasyn, rashes may occur more frequently;
• anticoagulants(medicines that slow down or stop the blood clotting process). Unasyn may increase the action of anticoagulants and may alter the results of laboratory tests that assess blood clotting;
• chloramphenicol, erythromycin, sulfonamides, tetracyclines(antibiotics). Concomitant administration with Unasyn is not recommended as these medicines may interfere with the activity of Unasyn against bacterial infections;
• oral contraceptivescontaining estrogens. Taking Unasyn may decrease the effectiveness of oral contraceptives containing estrogens and unwanted pregnancies may therefore occur. In this case, it is recommended to adopt alternative or additional contraceptive measures;
• methotrexate(medicine for tumors and autoimmune diseases). Unasyn may increase the toxic effects of methotrexate. Your doctor will monitor you carefully if the two drugs are administered to you at the same time. It may be necessary to increase the doses of calcium folinate and prolong the time of administration;
• acetylsalicylic acid, indometacin, phenylbutazone(anti-inflammatory medicines) and probenecid(medicine for gout and uric acid build-up). These medicines may increase the toxic effects of Unasyn.

Unasyn may alter the result of some laboratory tests. If you or your child have to undergo
laboratory tests (e.g. blood or urine tests), you must inform your doctor or the doctor caring for
your child about the treatment with Unasyn.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with breast milk
ask your doctor or pharmacist for advice before taking this medicine.

Fertility
Currently, no adverse effects on human fertility are known following the administration of Unasyn.

Pregnancy
Unasyn crosses the placenta and reaches the fetus. However, the safety of use during pregnancy has not been
established. If actually necessary, the doctor will evaluate the benefits of treatment with this medicine
compared to the possible risks.

Breastfeeding
Unasyn passes into breast milk. If you take this medicine during breastfeeding,
allergies, diarrhea, skin rashes and infections with a fungus called Candidamay occur in the newborn.

The use of this medicine during breastfeeding is not recommended.

Driving and operating machinery
Donot drive or operate machinery if you experience dizziness during treatment with Unasyn.

Unasyn contains lactose
The coated tablets of Unasyn 375 mg and 750 mg contain lactose, a type of sugar. If your
doctor has diagnosed you with an intolerance to some sugars, contact him before taking this medicine.

Unasyn contains sodium
Unasyn 375 mg and 750 tablets contain less than 1 mmol (23 mg) of sodium per tablet, i.e.
essentially ‘sodium-free’.

3. How to use Unasyn

Use this medicine following the instructions of your doctor or the doctor caring for your child exactly as prescribed. If you have any doubts, consult your doctor.
Unasyn must be taken orally.

Adults and the elderly
The recommended dose is 1 tablet(375 mg or 750 mg) every 12 hours.
In the case of gonorrhea (a sexually transmitted infection not complicated by other infections), the recommended
dose is 6 tablets of 375 mg or 3 tablets of 750 mg taken all together.
Unasyn may be combined with probenecid, a medicine that prolongs its duration of action.

Children
The dose of Unasyn varies according to the child's weight, as shown in the following table:

Duration of treatment
In both adults and children, it is recommended to continue treatment with Unasyn for 48 hours after the
fever and all other symptoms of infection have disappeared.
In general, the duration of treatment varies between 5 and 14 days, but sometimes a longer period may be
necessary. If the infection is caused by a bacterium called Group A beta-hemolytic Streptococcus
(also known as Streptococcus pyogenes), treatment with Unasyn must be continued
for at least 10 days.

If you use more Unasyn than you should
It is important that you or your child never take more medicine than prescribed. In case of
overdose, the side effects caused by Unasyn may occur more intensely. If
taken at very high doses, this medicine may cause convulsions. In case of convulsions, the doctor
may administer a sedative (e.g. diazepam).

If you forget to use Unasyn
If you forget to take a dose or give it to your child, take or give it to your child as soon as you
remember. Do not use a double dose to make up for a missed dose. If you think you have forgotten
more than one dose, consult your doctor or the doctor caring for your child.

If you stop the treatment with Unasyn
If you or your child prematurely interrupt the treatment with Unasyn, the outcome of the therapy may
be compromised. Consult your doctor before interrupting or ending treatment with Unasyn.
If you have any doubts about the use of this medicine, consult your doctor or the doctor caring for your
child or your pharmacist.

4. Possible side effects

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

Serious side effects
Stop taking this medicine immediately and urgently consult a doctor if you experience any of the following serious side effects:

• swelling of the face, lips, tongue or throat, difficulty swallowing or breathing (angioedema), severe itchy skin rash, low blood pressure and fast, strong or irregular heartbeat as symptoms of severe allergic reactions (anaphylactic shock) and hypersensitivity reactions (frequency not known)
• chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (Kounis syndrome) (frequency not known)
• severe decrease in the number of a type of white blood cells ( agranulocytosis) resulting in a high risk of serious infection (frequency not known)*
• reddish, non-raised, target- or circular-shaped spots on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis) (frequency not known)
• widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity) (frequency not known)
• widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment ( acute generalized exanthematous pustulosis) (frequency not known)*
• severe and widespread skin inflammation with scaling and delamination of the skin (exfoliative dermatitis) (frequency not known)
• rapid and involuntary muscle contractions causing uncontrolled tremors of the body ( convulsions) (rare frequency)*
• severe and persistent diarrhea with blood and mucus in the stool caused by a severe inflammation of the last part of the intestine called the colon (pseudomembranous colitis) (frequency not known)
• abdominal pain and cramps, diarrhea and fever sometimes accompanied by nausea and vomiting as symptoms of inflammation of the small and large intestine (enterocolitis) (rare frequency)
• passing of black stools due to the presence of digested blood (melena) (uncommon frequency)
• fatigue and nausea, skin reaction, abdominal pain, itching, dark urine, yellowing of the skin or whites of the eyes, which may be symptoms of liver damage ( cholestatic hepatitis) (frequency not known)*
• abdominal pain, nausea and vomiting as symptoms of bile retention ( cholestasis) (frequency not known)*
• decrease or increase in the amount of urine, nighttime urination, flank pain potentially accompanied by fever and rash as symptoms of kidney inflammation ( tubulointerstitial nephritis) (rare frequency)*
• formation of pathogens resistant to sultamicillin (pathogen resistance) (frequency not known)

*The side effects reported in italics may occur while taking sultamicillin because they have been observed with intramuscular and intravenous administration of ampicillin and/or sulbactam/ampicillin.

Other side effects
Contact your doctor if you notice any of the following side effects:

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

• diarrhea
• nausea
• vomiting
• abdominal pain
• symptoms in different parts of the body caused by a fungal (yeast) infection (Candida infection)
• headache
• skin rashes
• itching

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

• dizziness
• fatigue, malaise
• inflammation of the oral mucosa (stomatitis)
• joint pain (arthralgia)
• bleeding of the inner wall (mucosa) of the stomach or intestine

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

• excessive reduction of all blood cells, such as red blood cells, white blood cells and platelets (pancytopenia)
• excessive increase in the time normally required for blood to clot
• reduction of platelets in the blood which increases the risk of bleeding or bruising (thrombocytopenia)
• lack or reduction of appetite (anorexia)
• low levels of potassium in the blood ( hypokalaemia)*
• toxicity to the central nervous system (neurotoxicity)
• drowsiness
• sedation
• allergic reaction affecting blood vessels, with possible damage to the skin and other organs (allergic vasculitis)
• difficulty breathing (dyspnea)
• difficulty digesting
• increase in blood levels of a substance produced by the liver ( bilirubin)*
• inflammation of the entire intestine characterized by bleeding of the inner wall (mucosa) of the intestine
• dry mouth due to insufficient saliva
• pain in the upper abdomen (epigastric pain)
• distortion or impairment of the sense of taste (dysgeusia)
• excessive production of gas in the intestine (flatulence)
• urticaria
• erythema
• a skin reaction that causes red spots or patches on the skin that may look like a target or “bull’s-eye” with a dark red center surrounded by rings of lighter red color (erythema multiforme)
• rash with blisters arranged in circles with central crusts or like a string of pearls ( linear IgA disease)*
• alteration of the color of the tongue
• yellowing of the skin or whites of the eyes (jaundice)
• liver function abnormalities
• blood tests showing changes in how the liver is working (increased alanine aminotransferase, increased aspartate aminotransferase)

*The side effects reported in italics may occur while taking sultamicillin because they have been observed with intramuscular and intravenous administration of ampicillin and/or sulbactam/ampicillin.

Reporting of side effects
If you or your child gets any side effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at
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 Unasyn

Keep this medicine out of sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date which is stated on the package and on the blister after “Exp.”. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Unasyn contains
The active ingredient is sultamicillin (as sultamicillin tosylate).
Each Unasyn 375 mg coated tablet contains 375 mg of sultamicillin (corresponding to 520.80
mg of sultamicillin tosylate), equivalent to 147 mg of sulbactam and 220 mg of ampicillin.
Each Unasyn 750 mg coated tablet contains 750 mg of sultamicillin (corresponding to 1012.60
mg of sultamicillin tosylate), equivalent to 294 mg of sulbactam and 440 mg of ampicillin.
The other ingredients are: lactoseanhydrous(see section 2 “Unasyn tablets contains lactose”),
dried corn starch, sodium glycolate starch, hydroxypropylcellulose, magnesium stearate, macrogol 6000,
hypromellose, titanium dioxide (E171), talc.

Description of the appearance of Unasyn and contents of the packs
Unasyn 375 mg coated tablets are available in blisters in packs of 12 tablets.
Unasyn 750 mg coated tablets are available in blisters in packs of 8 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina

Manufacturer
Haupt Pharma Latina S.r.l.
S.S. 156, Km 47,600 – Borgo San Michele,
04100 Latina

Unasyn 250 mg + 500 mg powder for injectable/infusion solution, 500 mg + 1 g/ powder for injectable/infusion solution, 1 g + 2 g powder for injectable solution for intravenous use

Sulbactam/Ampicillin

Read this leaflet carefully before this medicine is administered as 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 the doctor treating your child or your pharmacist.
• This medicine has been prescribed only for you or your child. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, ask your doctor or the doctor treating your child or your pharmacist. See section 4.

Contents of this leaflet:

• 7. What Unasyn is and what it is used for
• 8. What you need to know before Unasyn is administered
• 9. How to administer Unasyn
• 10. Possible side effects
• 11. How to store Unasyn
• 12. Contents of the pack and other information

1. What is Unasyn and what is it used for

Unasyn contains two active ingredients: ampicillin (an antibiotic) and sulbactam (a medicine that blocks bacteria
in the production of substances that inactivate antibiotics). Unasyn belongs to a group of medicines
called “antibacterials for systemic use” and acts against infections that can affect different parts
of the body.
Unasyn is used for the treatment of:

• infectionscaused by bacteria that have become resistant to ampicillin.
• infectionsthat are suspected to be caused by bacteria that have become resistant to ampicillin.

2. What you need to know before you are given Unasyn

Unasyn must not be given to you or your child:

• if you are allergic to sulbactam, ampicillin, other antibiotics of the same class as penicillin, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or the doctor caring for your child or your pharmacist before you are given
Unasyn.
Tell your doctor or the doctor caring for your child if you think that any of the following conditions apply to
you or your child:

• you have had an allergic reaction to penicillin, cephalosporins or other similar antibiotics. If you or your child have previously had an allergic reaction to these antibiotics and/or other allergens, it is more likely that a new, even serious, allergic reaction may occur after administration of Unasyn. In case of an allergic reaction, treatment with Unasyn must be immediatelystopped (see also section 4 “Possible side effects”);
• you suffer from severe kidney problems (severe renal insufficiency). In this case, Unasyn must be administered with caution and the frequency of administrations will be reduced (see section 3 “How to administer Unasyn”). If you or your child are undergoing dialysis, Unasyn must be administered after the hemodialysis session;
• you have a viral infection called “infectious mononucleosis”. If Unasyn is administered during infectious mononucleosis, it is very likely that a skin rash may occur;

Consult your doctor or the doctor caring for your child or your pharmacist if you or your child
develop the following conditions afteradministration of Unasyn (see also section 4 “Possible
side effects”):

• infection caused by microorganisms resistant to Unasyn (superinfection), including infections caused by fungi. In this case, treatment with Unasyn must be stoppedand replaced with more appropriate therapy;
• the onset of diarrhea, which may be mild, but in some cases can be fatal (fatal colitis). Diarrhea can occur with the use of almost all antibiotics, including Unasyn, and is due to the alteration of the normal intestinal bacterial flora which allows the excessive growth of a bacterium called Clostridium difficile. If diarrhea occurs, your doctor will subject you or your child to careful monitoring because infection with Clostridium difficilecan occur even two months after the end of treatment with this medicine.
• in case of abdominal pain, itching, dark urine, yellowish discoloration of the skin or eyes, nausea (feeling unwell) or if you do not feel well in general, inform your doctor immediately. These signs may indicate liver damage that can occur with the use of ampicillin/sulbactam.
• Severe skin reactions have been reported in association with Unasyn treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). Contact your doctor immediately if you notice any of the symptoms described in section 4.

If any of these conditions occur, consult your doctor immediately(see also
section 4 “Possible side effects”).

Duringtreatment with Unasyn, your doctor will subject you or your child to frequent medical checks to
assess the functioning of the kidneys, liver and bone marrow which produces all blood cells.

Newborns and children
Newborns, especially if born before the 37th week of pregnancy (premature babies), and
children must be kept under strict medical supervision during treatment with Unasyn.

Other medicines and Unasyn
Tell your doctor or the doctor caring for your child or your pharmacist if you or your child are
taking, have recently taken or might take any other medicine.
Tell your doctor or the doctor caring for your child or your pharmacist if you or your child are
taking any of the following medicines together with Unasyn because caution is necessary:

• allopurinol(medicine for gout and uric acid build-up). If you take this medicine together with Unasyn, skin rashes may occur more frequently;
• aminoglycosides(antibiotics). Aminoglycosides and ampicillin inactivate each other. Therefore, in case of simultaneous administration, the two antibiotics must be administered in two different sites of the body and at least 1 hour apart;
• anticoagulants(medicines that slow down or stop the blood clotting process). Unasyn may increase the action of anticoagulants and may alter the results of laboratory tests that assess blood clotting;
• chloramphenicol, erythromycin, sulfonamidesand tetracyclines(antibiotics). Concomitant administration with Unasyn is not recommended as these medicines may interfere with the activity of Unasyn against bacterial infections;
• oral contraceptivescontaining estrogens. The administration of Unasyn may decrease the effectiveness of oral contraceptives containing estrogens and unwanted pregnancies may therefore occur. It is recommended to adopt alternative or additional contraceptive measures;
• methotrexate(medicine for tumors and autoimmune diseases). Unasyn may increase the toxic effects of methotrexate. Your doctor will subject you to careful monitoring if the two drugs are administered to you simultaneously. It may be necessary to increase the doses of calcium folinate and prolong the time of its administration;
• probenecid(medicine for gout and uric acid build-up). This medicine may increase the toxic effects of Unasyn.

Unasyn can alter the result of some laboratory tests. If you or your child need to undergo
laboratory tests (e.g. blood or urine tests), you must inform the doctor of the treatment with Unasyn.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Unasyn crosses the placenta and reaches the fetus. However, the safety of use during pregnancy has not
been established. If necessary, your doctor will assess the benefits of treatment with this medicine
against the possible risks.

Breastfeeding
Unasyn passes into breast milk. The use of Unasyn by women who are breastfeeding may
cause adverse effects in the infant such as allergy, diarrhea, intestinal disorders, skin rashes and
infections by a fungus called Candida. Therefore, if you are breastfeeding, your doctor will prescribe
treatment with Unasyn only if strictly necessary.

Driving and operating machinery
There are no known adverse effects of Unasyn on the ability to drive vehicles or operate machinery.

Donot drive or operate machinery if you experience dizziness during treatment with Unasyn.
If you have any doubts, consult your doctor or pharmacist.

Unasyn contains sodium
Unasyn 250 mg/500 mg powder for injection contains 57.55 mg of sodium (the main component
of table salt) per vial. This is equivalent to 2.9% of the maximum recommended daily intake
of sodium by an adult. Talk to your doctor or pharmacist if you need 7 or more
vials per day for a prolonged period, especially if you have been advised to follow a low-sodium diet.
Unasyn 500 mg/1000 mg powder for injection contains 115.1 mg of sodium (the main
component of table salt) per vial. This is equivalent to 5.8% of the maximum recommended daily
intake of sodium by an adult. Talk to your doctor or pharmacist if you need 4 or more
vials per day for a prolonged period, especially if you have been advised to follow a low-sodium diet.
Unasyn 1000 mg/2000 mg powder for injection contains 230.2 mg of sodium (the main
component of table salt) per vial. This is equivalent to 11.5% of the maximum recommended daily
intake of sodium by an adult. Talk to your doctor or pharmacist if you need 2 or more
vials per day for a prolonged period, especially if you have been advised to follow a low-sodium diet.

3. How to administer Unasyn

Use this medicine following exactly the instructions of the doctor or the doctor caring for your child. If you have any doubts, consult the doctor or the doctor caring for your child or the pharmacist.
Unasyn 500 mg + 1 g powder for injectable solution/for infusion and Unasyn 1 g + 2 g powder for injectable solution for intravenous use must be administered only by experienced healthcare personnel in suitable facilities (e.g. hospital).

Adults
The recommended dose varies from 3 to 12 grams per day, according to the severity of the infection, as reported in the following table:

The maximum daily dose that can be reached for sulbactam is 4 g. The recommended dosage of Unasyn for intramuscular injection is 1.5 grams every 12 hours (3 grams per day).
In case of gonorrhea (a sexually transmitted infection not complicated by other infections), the recommended dose is 1.5 grams administered in a single injection, associated with 1 gram of probenecid, a medicine that prolongs the duration of action of Unasyn.

Children
The recommended dose varies depending on the weight and age of the child, as reported in the following table:

Renal insufficiency
If you or your child have serious kidney problems (severe renal insufficiency), the doctor will subject you to less frequent administrations of Unasyn than normal.

Instructions for use
Unasyn 250 mg + 500 mg powder for injectable solution/for infusion can be administered by injection into a muscle (intramuscularly) or into a vein (intravenously).
Unasyn 500 mg + 1 g powder for injectable solution/for infusion can be administered by injection into a muscle (intramuscularly) or into a vein (intravenously).
Unasyn 1 g + 2 g powder for injectable solution for intravenous use must be administered only by injection into a vein (intravenously).

Intramuscular injection
Unasyn 250 mg + 500 mg: Aspirate with a syringe the liquid contained in a vial of solvent containing 1.6 ml of water for injectable preparations and inject it into the vial containing the powder.
Unasyn 500 mg + 1 g: Aspirate with a syringe the liquid contained in a vial of solvent containing 3.2 ml of water for injectable preparations or lidocaine 0.5%.
Shake the vial well until the powder is completely dissolved.
Unasyn must be administered by deep injection into the thickness of a buttock or the anterior area of a thigh.
Use the medicine within one hour of reconstitution.

Intravenous injection
Reconstitute the powder with a compatible solution. Let it rest until completely dissolved.
Unasyn can be administered into a vein slowly (infusion lasting approximately 15-30 minutes) or rapidly (in bolus).

Duration of treatment
In both adults and children, it is recommended to continue treatment with Unasyn for 48 hours after the disappearance of fever and all other symptoms of infection.
In general, the duration of treatment varies between 5 and 14 days, but sometimes a longer period may be necessary.

If more Unasyn than prescribed is administered
It is important that you or your child are never administered more medicine than prescribed. In case of overdose, the side effects caused by Unasyn may occur more intensely. If administered at very high doses, this medicine can cause convulsions.

If a dose of Unasyn is forgotten
If you or your child have not been administered the prescribed dose, it should be administered as soon as possible. A double dose should not be administered to compensate for the forgotten dose. If you think more than one dose has been forgotten, consult the doctor or the doctor caring for your child.

If you stop the treatment with Unasyn
If you or your child prematurely interrupt the treatment with Unasyn, the outcome of the therapy may be compromised. Consult the doctor before interrupting or terminating the treatment with Unasyn.
If you have any doubts about the use of this medicine, consult the doctor or the doctor caring for your child or the pharmacist.

4. Possible side effects

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

Serious side effects
Seek medical attention urgently if you notice any of the following serious side effects:

• swelling of the face, lips, tongue or throat, difficulty swallowing or breathing (angioedema), severe itchy skin rash, low blood pressure and fast, strong or irregular heartbeat as symptoms of severe allergic reactions (anaphylactic shock) and hypersensitivity reactions (frequency not known)
• chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (Kounis syndrome) (frequency not known)
• severe decrease in the number of a type of white blood cells (agranulocytosis) with consequent high risk of serious infection (frequency not known)
• reddish, non-raised, target- or circular-shaped spots on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis) (frequency not known)
• widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity) (frequency not known)
• widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) (frequency not known)
• severe and widespread skin inflammation with scaling and delamination of the skin (exfoliative dermatitis) (frequency not known)
• rapid and involuntary muscle contractions causing uncontrolled tremors of the body (convulsions) (frequency not known)
• severe and persistent diarrhea with blood and mucus in the stool caused by severe inflammation of the last part of the intestine, called the colon (pseudomembranous colitis) (frequency not known)
• abdominal pain and cramps, diarrhea and fever sometimes accompanied by nausea and vomiting as symptoms of inflammation of the small and large intestine (enterocolitis) (frequency not known)
• passing black stools due to digested blood (melena) (frequency not known)
• fatigue and nausea, skin reaction, abdominal pain, itching, dark urine, yellowing of the skin or the white of the eyes, which may be symptoms of liver damage (cholestatic hepatitis) (frequency not known)
• abdominal pain, nausea and vomiting as symptoms of bile retention (cholestasis) (frequency not known)
• decrease or increase in the amount of urine, nocturnal urination, flank pain potentially accompanied by fever and rash as symptoms of kidney inflammation (tubulointerstitial nephritis) (frequency not known)
• anemia due to excessive destruction of red blood cells (hemolytic anemia) (frequency not known)
• onset of superinfection by resistant organisms or fungi (frequency not known)

Other side effects
See a doctor if you notice any of the following side effects.
See a doctor if you or your child experience any of the following side effects:

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

• reduction of circulating hemoglobin in the blood (anemia)
• excessive reduction of platelets in the blood (thrombocytopenia)
• excessive increase of some white blood cells (eosinophils) in the blood (eosinophilia)
• inflammation of a vein (phlebitis)
• diarrhea
• excessive increase in the blood of some substances normally produced by the liver (bilirubin, alanine-aminotransferase, aspartate-aminotransferase)
• pain at the injection site

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

• excessive reduction of all white blood cells in the blood (leucopenia) or some white blood cells (neutropenia)
• symptoms in different parts of the body caused by a fungal (yeast) infection (Candida infection)
• headache
• vomiting
• skin rash
• itching
• feeling unwell
• fatigue

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

• nausea
• inflammation of the tongue (glossitis)
• abdominal pain

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

• decrease in the number of platelets in the blood and appearance of reddish spots on the skin (thrombocytopenic purpura)
• low levels of potassium in the blood (hypokalaemia)
• dizziness
• numbness
• drowsiness
• sedation
• difficulty breathing (dyspnea)
• inflammation of the mucous membrane of the entire mouth (stomatitis)
• alteration of the color of the tongue
• difficulty digesting
• inflammation of the liver (hepatitis)
• abnormal liver function
• yellowing/yellowish discoloration of the skin and mucous membranes (jaundice)
• a skin reaction that causes spots or patches on the skin that look like a target or a bull's-eye with a dark red center surrounded by rings of lighter red color (erythema multiforme)
• rash with the formation of small bumps and reddish spots (maculopapular rashes)
• rash with blisters arranged in a circle with central crusts or like a string of pearls (linear IgA disease)
• urticaria
• skin inflammation (dermatitis)
• erythema
• joint pain (arthralgia)
• excessive increase in blood levels of nitrogen (elevated azotemia)
• excessive increase in blood creatinine, a substance produced by muscles (elevated creatinine)
• various alterations at the injection site
• fever
• excessive weakness (asthenia)

Reporting of side effects
If you or your child experience any side effects, including those not listed in this
leaflet, tell your doctor or the doctor caring for your child or your pharmacist. You can also
report side effects directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can
contribute to providing more information on the safety of this medicine.

5. How to store Unasyn

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package, on the vial after “Exp.”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Unasyn 500 mg + 1 g powder for injectable solution/for infusion
The solution must be used within one hour of reconstitution.
Unasyn 1 g + 2 g powder for injectable solution for intravenous use
For the stability and storage conditions of the reconstituted solution with various solutions see
paragraph “The following information is intended exclusively for doctors or healthcare professionals”.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Unasyn contains
The active ingredients are sulbactam (as sulbactam sodium) and ampicillin (as ampicillin sodium).
Unasyn 250 mg + 500 mg powder for injectable solution/for infusion
Each vial of powder contains 250 mg of sulbactam (corresponding to 273.5 mg of sulbactam sodium) and
500 mg of ampicillin (corresponding to 531.5 mg of ampicillin sodium).
Unasyn 500 mg + 1 g powder for injectable solution/for infusion
Each vial of powder contains 500 mg of sulbactam (corresponding to 547 mg of sulbactam sodium) and 1 g
of ampicillin (corresponding to 1,063 mg of ampicillin sodium).
Unasyn 1 g + 2 g powder for injectable solution for intravenous use
Each vial of powder contains 1 g of sulbactam (corresponding to 1,099 mg of sulbactam sodium) and 2 g of
ampicillin (corresponding to 2,132 mg of ampicillin sodium).

Description of the appearance of Unasyn and contents of the packs
Unasyn 250 mg + 500 mg powder for injectable solution/for infusion
Each pack contains 1 glass vial containing the powder.
Unasyn 500 mg + 1 g powder for injectable solution/for infusion
Each pack contains 1 glass vial containing the powder.
Unasyn 1 g + 2 g powder for injectable solution for intravenous use
Each pack contains 1 glass vial containing the powder.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina

Manufacturer
Haupt Pharma Latina S.r.l.
S.S. 156, Km 47,600 – Borgo San Michele,
04100 Latina

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The following information is intended exclusively for doctors or healthcare professionals:
Unasyn 250 mg + 500 mg powder for injectable solution/for infusion
Unasyn 500 mg + 1 g powder for injectable solution/for infusion
Unasyn 1 g + 2 g powder for injectable solution for intravenous use
Instructions for preparing the solution:

Unasyn 250 mg + 500 mg powder for injectable solution/for infusion, Unasyn 500 mg + 1 g powder for
injectable solution/for infusion and Unasyn 1 g + 2 g powder for injectable solution for intravenous use
must only be administered by experienced healthcare personnel in suitable facilities (e.g. hospital).

Recommendations for dosage

• Unasyn 1 g + 2 g powder for injectable solution for intravenous use must be administered intravenously at a maximum final concentration of 125-250 mg/ml.

Incompatibilities
The reconstituted solution is incompatible with:

• blood products
• protein hydrolysates
• aminoglycosides (see section 2 “Other medicines and Unasyn”)

Compatibility and stability
The reconstituted solution is compatible with the following solutions:

• physiological saline solution
• sodium lactate
• Ringer’s lactate solution

The reconstituted solution is less stable in solutions containing glucose, dextrose or other carbohydrates. In this
case the reconstituted solution must be used within 2-4 hours of reconstitution.
The stability of the reconstituted solution with the various infusion solutions is reported in the table below: