Unasin

Leaflet attached to the packaging: patient information

Unasyn, 375 mg, film-coated tablets

Sultamicillin

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Unasyn and what is it used for

Unasyn contains sultamicillin, which belongs to beta-lactam antibiotics.
Unasyn is used to treat the following infections caused by microorganisms susceptible to sultamicillin:

• upper respiratory tract infections, including sinusitis, otitis media, and tonsillitis;
• lower respiratory tract infections, including bacterial pneumonia and bronchitis;
• urinary tract infections and pyelonephritis;
• skin and soft tissue infections;
• gonorrheal infections. Unasyn may also be used in patients who require treatment with sulbactam and ampicillin after an initial treatment period with parenteral forms of these medicines.

2. Important information before using Unasyn

When not to use Unasyn

• if the patient is allergic to sultamicillin or any of the other ingredients of this medicine (listed in section 6).
• if the patient has a known hypersensitivity to penicillins.

Warnings and precautions

• Particular caution should be exercised when using Unasyn in patients with a history of hypersensitivity to medicines and multiple allergens.
• If the patient experiences severe skin reactions, they should discontinue Unasyn and consult a doctor for appropriate treatment (see section 4 "Possible side effects").
• If the patient develops a superinfection with microorganisms resistant to the action of the medicine, including fungi, the administration of the medicine should be discontinued. Appropriate treatment may be necessary.
• If the patient experiences diarrhea associated with the use of the medicine (which may occur even 2 months after the end of treatment), they should immediately consult a doctor. During the use of almost any antibacterial medicine, including sultamicillin, harmful bacteria may overgrow, causing colitis. This complication may range from mild diarrhea to life-threatening pseudomembranous colitis. Discontinuation of the medicine and/or specific treatment may be necessary.
• If the following side effects occur: abdominal pain, itching, dark urine, yellowing of the skin or eyes, nausea (vomiting) or general malaise, the patient should immediately inform their doctor. These symptoms may indicate liver damage caused by the use of ampicillin with sulbactam.
• If the patient has infectious mononucleosis, Unasyn should not be used. This medicine breaks down in the body into sulbactam and ampicillin, which in patients with mononucleosis may cause a skin rash.
• Unasyn should be used with caution in newborns, as their renal function is not fully developed, and the kidneys are the primary route of elimination of the active substances after oral administration of Unasyn.
• During long-term use, the doctor will recommend periodic monitoring of renal, liver, and hematopoietic system function.

Using Unasyn in patients with renal impairment
In patients with severe renal impairment, the doctor will recommend an appropriate dose modification - see section 3 "How to use Unasyn".

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before using this medicine.
Sulbactam and ampicillin cross the placenta. The safety of using Unasyn in pregnant women has not been studied. Therefore, Unasyn should not be used during pregnancy unless the expected benefit outweighs the risk.
Caution should be exercised when using Unasyn in breastfeeding women. Small amounts of sulbactam and ampicillin pass into human milk. Using Unasyn in breastfeeding women may lead to sensitization, diarrhea, candidiasis, and rash in the breastfed child. Unasyn should not be used during breastfeeding.

Driving and using machines

The possibility of dizziness should be taken into account.

Unasyn and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Particular caution is recommended when using the following medicines.
Allopurinol(a medicine used, among other things, to treat gout) - concomitant use with Unasyn may be associated with the occurrence of a rash.
Anticoagulant medicines(medicines that slow down blood clotting, used to treat blood clots) - Unasyn may enhance the effect of these medicines.
Bacteriostatic medicines, such as chloramphenicol, erythromycin, sulfonamides, and tetracyclines (medicines that inhibit the growth of microorganisms), may interfere with the bactericidal effect of penicillins.
Oral contraceptives containing estrogens, such as ethinyl estradiol - during the use of Unasyn, the patient should use another or additional contraceptive method .
Methotrexate(a cytostatic medicine used, among other things, to treat cancer and some rheumatic diseases); concomitant use with Unasyn increases the risk of toxicity.
Nonsteroidal anti-inflammatory medicines, such as acetylsalicylic acid, indomethacin, phenylbutazone (medicines used to treat fever and pain of minor or moderate severity); concomitant use with Unasyn prolongs its action.
Probenecid(a medicine used, among other things, to treat gout) - concomitant use with Unasyn increases the risk of toxicity.
Effect on laboratory test results
In patients taking Unasyn, false-positive glucose values in urine may occur when using certain reagents (Benedict's, Fehling's, or Clinitest). In pregnant women, after administration of ampicillin, a transient decrease in the concentration of total conjugated estriol, glucuronide estriol, conjugated estrone, and estradiol has been observed.

Unasyn contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Unasyn contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to use Unasyn

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, the patient should consult their doctor.
Do not stop treatment without consulting a doctor. In case of doubts, the patient should consult their doctor again.
The recommended dose of sultamicillin in adults (including elderly patients) is 375-750 mg (1 or 2 tablets) administered orally twice a day.
In adults and children, treatment is usually continued for 48 hours after the disappearance of fever and other symptoms of the disease. The treatment period usually lasts from 5 to 14 days, but the doctor may extend it if necessary.
In the treatment of uncomplicated gonorrhea, the doctor may recommend a single dose of 2.25 g (6 tablets) of sultamicillin. To prolong the time of maintaining high concentrations of sulbactam and ampicillin in serum, the doctor will recommend concomitant administration of 1 g of probenecid.
In the treatment of gonorrhea, if the doctor suspects a concomitant syphilis infection, before administering sultamicillin, the doctor will recommend a dark-field examination of the discharge, and then monthly, for at least 4 months - serological tests.
It is recommended that the treatment of infections caused by bacteria of the hemolytic streptococcal group last at least 10 days to prevent acute rheumatic fever or glomerulonephritis.
Use in children and infants
In the treatment of most infections in children with a body weight below 30 kg, the dose of sultamicillin is 25-50 mg/kg body weight per day, depending on the severity of the infection and the doctor's assessment, in two divided doses administered orally.
In children with a body weight above 30 kg, the dosing is the same as in adults.
Use in patients with renal impairment
In patients with severe renal impairment (creatinine clearance ≤ 30 ml/min), the doctor will recommend an increase in the intervals between individual doses.
Using a higher dose of Unasyn than recommended
In case of using a higher dose than recommended, the patient should consult their doctor or pharmacist. The doctor will recommend appropriate symptomatic treatment if necessary.
Missing a dose of Unasyn
Do not take a double dose to make up for a missed dose.

4. Possible side effects

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

If any of the following serious side effects occur, the patient should immediately consult their doctor

• symptoms of severe allergic reactions, such as swelling of the face, lips, tongue, or other parts of the body (angioedema), shortness of breath, wheezing, or difficulty breathing (anaphylactic shock, anaphylactoid reactions, hypersensitivity reactions) and (or) symptoms of sudden severe chest pain associated with any of the above symptoms (also known as Kounis syndrome or allergic myocardial infarction)
• severe rash, including redness and swelling of the skin (urticaria), blisters, or peeling, accompanied by throat pain, fever, ulcers in the mouth, throat, nose, genital area, hands, or feet [toxic epidermal necrolysis (Lyell's syndrome), bullous erythema multiforme (Stevens-Johnson syndrome), erythema multiforme (see section 2), exfoliative dermatitis, acute generalized exanthematous pustulosis]. These are symptoms of severe allergic skin reactions
• yellowing of the skin or whites of the eyes, dark urine, abdominal pain, malaise, and itching ( hyperbilirubinemiaor increased bilirubin concentration (see section 2), cholestatic hepatitis, cholestasis, jaundice, liver function disorders (see section 2)
• severe or persistent diarrhea, even if it occurs up to 2 months after the end of treatment (pseudomembranous colitis)
• seizures ( convulsions)

Other side effects:
Very common(may occur in more than 1 in 10 people):

• diarrhea

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

• candidiasis (fungal infection)
• headache
• vomiting, nausea, abdominal pain
• rash, itching

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

• drowsiness
• fatigue, malaise
• glossitis, stomatitis
• hyperbilirubinemia(increased bilirubin concentration) (see section 2)
• joint pain

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

• dizziness
• colitis
• interstitial nephritis
• exfoliative dermatitis(severe skin reactions, characterized by peeling or shedding of the skin) (see section 2)

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

• pseudomembranous colitis
• reduced susceptibility of pathogenic bacteria to the used antibiotic
• aplastic anemia, prolonged bleeding time, decreased granulocyte count, hemolytic anemia, thrombocytopenia(change in the number of different types of blood cells), decreased white blood cell count, decreased granulocyte count, eosinophilia, anemia, thrombocytopenia(platelet deficiency affecting blood clotting)
• anaphylactic shock, anaphylactoid reactions, Kounis syndrome (allergic myocardial infarction), hypersensitivity reactions
• anorexia
• seizures, symptoms of nervous system damage (including mood changes, excitement, insomnia, depression, psychosis, vision disturbances, tinnitus)
• allergic vasculitis
• shortness of breath
• bloody vomiting, gastrointestinal bleeding, dry mouth, abdominal pain, taste disturbances, bloating, black hairy tongue, tongue discoloration
• cholestatic hepatitis, cholestasis, jaundice, liver function disorders (see section 2)
• toxic epidermal necrolysis (Lyell's syndrome), bullous erythema multiforme (Stevens-Johnson syndrome), erythema multiforme (see section 2)
• facial swelling, lip swelling, tongue swelling, and (or) throat swelling with difficulty swallowing or breathing (angioedema), rash, blisters, skin inflammation, redness, or cyanosis (urticaria), acute generalized exanthematous pustulosis
• platelet aggregation disorder, increased alanine aminotransferase activity, increased aspartate aminotransferase activity

Side effects written in italicsare related to the use of ampicillin alone and (or) sulbactam with ampicillin administered parenterally or intravenously.
Side effects related to the use of sultamicillin and ampicillin and (or) sulbactam, ampicillin administered parenterally or intravenously.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Unasyn

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Protect from moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

6. Contents of the packaging and other information

What Unasyn contains

• The active substance of Unasyn is sultamicillin. One film-coated tablet contains 375 mg of sultamicillin, in the form of sultamicillin tosylate, which is a mutual prodrug of sulbactam and ampicillin and corresponds to 147 mg of sulbactam and 220 mg of ampicillin.
• Other ingredients are: lactose (see section 2 "Unasyn contains lactose"), cornstarch, sodium carboxymethylcellulose (see section 2 "Unasyn contains sodium"), hydroxypropylcellulose, magnesium stearate; coating: polyethylene glycol 6000, hypromellose (hydroxypropylmethylcellulose), titanium dioxide, talc.

What Unasyn looks like and what the packaging contains

Blisters of PCV/PVDC/Aluminum/PVDC.
The packaging contains 12 tablets - 2 blisters of 6 tablets.

Marketing authorization holder:

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer:

Haupt Pharma Latina S.r.l.
Latina (LT)
Strada Statale 156 Km 47,600
04100 Borgo San Michele
Italy
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Pfizer Polska Sp. z o.o.
phone: 22 335 61 00

Date of last revision of the leaflet: 04/2021

Other sources of information

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products http://urpl.gov.pl