Maxivanil

Patient Information Leaflet: Information for the user

MAXIVANIL 250 mg Hard Capsules

Vancomycin
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What MAXIVANIL is and what it is used for

MAXIVANIL is an antibiotic that belongs to a group of antibiotics known as "glycopeptides".
Vancomycin works by eliminating certain bacteria that cause infections. Vancomycin is used in
adults and adolescents aged 12 years and older for the treatment of infections of the mucosa of
the small and large intestine with mucosal damage (pseudomembranous colitis) caused by the
bacterium Clostridium difficile.

2. What you need to know before taking MAXIVANIL

Do not take MAXIVANIL:

• if you are allergic to vancomycin or to any of the other ingredients of this medicine (listed in section 6);

Warnings and precautions
Talk to your doctor or pharmacist before taking MAXIVANIL.
If you suffer from an inflammatory disease of the gastrointestinal tract (you may be at risk of
adverse effects, especially if you also have kidney disease).
Vancomycin capsules are not suitable for children under 12 years of age or adolescents who are
unable to swallow them. Other forms of this medicine may be more appropriate for children; please
consult your doctor or pharmacist.
In some patients with inflammatory processes of the intestinal mucosa (including those affected by a
type of colon inflammation called Clostridium difficile pseudomembranous colitis), absorption may
be significant, with the risk of developing the same adverse effects observed during parenteral
administration of the drug. Therefore, it is advisable to carefully monitor drug blood levels. This
risk is increased in elderly patients or in those with kidney problems (renal insufficiency), since in
these cases the total systemic and renal clearance of vancomycin is reduced.
Patients with impaired renal function and patients over 60 years of age should undergo periodic
hearing function tests and blood concentration monitoring of the drug (serum vancomycin levels
can be determined by the modified Rammelkamp method using Streptococcus C 203 as indicator).
Patients at risk with renal dysfunction or receiving concomitant therapy with aminoglycosides
(antibiotics) should undergo periodic monitoring of renal function.
Other medicines and MAXIVANIL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Appropriate monitoring is advisable when vancomycin is administered concomitantly or sequentially
with other antibiotics potentially toxic to the kidneys (nephrotoxic), such as:

• aminoglycosides;
• cephaloridine;
• paramomycin;
• polymyxin B;
• colistin.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are
breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of vancomycin in pregnant women, during breastfeeding, and in early infancy has not
been established; therefore, the drug should be administered only when absolutely necessary and
when, in the physician's judgment, the potential benefits outweigh the possible risks.
Driving and using machines
It is not known whether MAXIVANIL affects the ability to drive vehicles or operate machinery.

3. How to use MAXIVANIL

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Adults and adolescents (from 12 years of age)
The recommended dose is 125 mg every 6 hours. In some cases, your doctor may decide to prescribe a higher daily dose, up to 500 mg every 6 hours. The maximum daily dose must not exceed 2 g.
If you have previously experienced further episodes (mucosal infection), you may require a different dose and duration of treatment.
Method of administration
For oral use.
Swallow the capsules whole with water.
The usual duration of treatment is 10 days, but may vary depending on the individual response to treatment for each patient.
If you take more MAXIVANIL than you should
In case of accidental ingestion/overdose of MAXIVANIL, inform your doctor immediately or go to the nearest hospital.
Your doctor will recommend supportive therapy and maintaining a process involving the passage of water and other substances through the kidneys, known as “glomerular filtration”.
If you forget to take MAXIVANIL
Do not take a double dose to make up for the forgotten capsule.
If you stop treatment with MAXIVANIL
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Vancomycin may cause allergic reactions, although severe allergic reactions (anaphylactic
shock) are rare. Inform your doctor immediately if you experience sudden wheezing, difficulty
breathing, redness of the upper body, rash, or itching.
Absorption of vancomycin from the gastrointestinal tract is negligible. Therefore, adverse events following oral capsule administration are unlikely.
However, if you have an inflammatory disease of the gastrointestinal tract, especially if you also have kidney disease, side effects similar to those occurring when vancomycin is administered by infusion may appear. For this reason, the side effects and frequencies reported for infused vancomycin are included here.

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

• Lowered blood pressure
• Shortness of breath, noisy breathing (a high-pitched sound caused by obstruction of airflow in the upper airways)
• Inflammation and rash inside the mouth, itching, itchy rash, hives
• Kidney problems, which may mainly be detected through blood tests
• Redness of the upper body and face, inflammation of a vein

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

• Temporary or permanent hearing loss

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

• Decrease in white blood cells, red blood cells, and platelets (blood cells responsible for clotting)
• Increase in certain white blood cells in the blood
• Loss of balance, ringing in the ears, dizziness
• Inflammation of blood vessels
• Nausea (feeling of sickness)
• Kidney inflammation and kidney failure
• Chest and back muscle pain
• Fever, chills

Very rare side effects (may affect up to 1 in 10,000 people):

• Sudden onset of a severe skin allergic reaction with blistering or peeling of the skin. This may be accompanied by high fever and joint pain
• Cardiac arrest
• Inflammation of the intestine causing abdominal pain and diarrhoea, which may contain blood

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

• Vomiting, diarrhoea
• Confusion, dizziness, loss of energy, swelling, fluid retention, decreased urination
• Rash with swelling or pain behind the ears, in the neck, groin, under the chin, and armpits (swollen lymph nodes), abnormal liver function and blood tests
• Rash with blisters and fever

Reporting of side effects
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 national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MAXIVANIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging under "Exp.".
The expiry date refers to the last day of that month.
Do not store above 30 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What MAXIVANIL contains
MAXIVANIL 250 mg hard capsules
Each capsule contains:

• Active substance: vancomycin hydrochloride 256 mg, equivalent to vancomycin 250 mg;
• Other component: polyethylene glycol 6000.

Description of the appearance of MAXIVANIL and pack contents
250 mg hard capsules.
Pack size: 4 capsules.
Marketing Authorization Holder
Genetic S.p.A., Via G. Della Monica n. 26, 84083 Castel San Giorgio (SA)
Manufacturer
Genetic S.p.A., Contrada Canfora - 84084 Fisciano (SA)
This leaflet was last updated on
Other sources of information
Medical advice/information
Antibiotics are used to treat bacterial infections. They are ineffective against viral infections.
If your doctor has prescribed antibiotics, they are specifically intended for your current illness.
Despite antibiotic treatment, some bacteria may survive or multiply. This phenomenon is known as resistance: some antibiotic treatments become ineffective.
The misuse of antibiotics increases resistance. It may also help bacteria become resistant, thereby delaying treatment or reducing antibiotic effectiveness if the appropriate:

• dosage
• schedule
• duration of treatment

is not followed.
Therefore, to maintain the effectiveness of this medicine:
1 - Use antibiotics only when prescribed.
2 - Follow instructions strictly.
3 - Do not reuse an antibiotic without a medical prescription, even if you wish to treat a similar illness.
4 - Never give antibiotics to another person; they may not be suitable for their condition.
5 - After completion of treatment, return all unused medicines to a pharmacy for proper disposal.

PATIENT LEAFLET: INFORMATION FOR THE USER

MAXIVANIL 500 mg powder for infusion solution and for oral solution, 1 g powder for infusion solution and for oral solution

Vancomycin
Please read this leaflet carefully before using this medicine

• 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. Never give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

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

1. WHAT MAXIVANIL IS AND WHAT IT IS USED FOR

MAXIVANIL is an antibiotic belonging to a group of antibiotics known as "glycopeptides".
Vancomycin works by eliminating certain bacteria that cause infections.
Vancomycin powder is reconstituted into a solution for infusion or into an oral solution.
MAXIVANIL is used to treat:

• severe infections caused by bacteria sensitive to vancomycin and resistant (insensitive) to many other antibiotics
• patients who are allergic to penicillins and cephalosporins.

Vancomycin is administered by infusion in all age groups for the treatment of the following serious infections:

• Infections of the skin and underlying tissue.
• Infections of bones and joints.
• Lung infection known as "pneumonia".
• Infection of the inner lining of the heart (endocarditis), and to prevent endocarditis in at-risk patients undergoing major surgical procedures.
• Bloodstream infection related to the above-mentioned infections.

Vancomycin is used orally in adults and children for the treatment of infections of the mucosa of the small and large intestine with mucosal damage (pseudomembranous colitis), caused by the bacterium Clostridium difficile.

2. WHAT YOU SHOULD KNOW BEFORE USING MAXIVANIL

Do not use MAXIVANIL

• if you are allergic to vancomycin

Warnings and precautions
Talk to your doctor, hospital pharmacist, or nurse before using vancomycin if:

• you have previously had an allergic reaction to the medicine teicoplanin, as this may mean you are also allergic to vancomycin.
• you have a hearing disorder, especially if you are elderly (you may need hearing tests during treatment).
• you have kidney disease (you will need blood and kidney function tests during treatment).
• you are receiving vancomycin by infusion for the treatment of Clostridium difficile-associated diarrhea rather than orally.

Talk to your doctor, hospital pharmacist, or nurse during treatment with
vancomycin:

• if you have received vancomycin for a prolonged period (you may need liver and kidney blood tests during treatment).
• if you develop any skin reaction during treatment.
• if you develop severe and persistent diarrhea during or after taking vancomycin, contact your doctor immediately. This could be a sign of inflammation of the intestine (pseudomembranous colitis), which may occur following antibiotic treatment.

Take special care with MAXIVANIL especially in the following cases
Before treatment with vancomycin, make sure your doctor is aware of your
medical history, especially in the following cases:

• if you have low blood cell counts
• if you are pregnant or planning to become pregnant
• if you are breastfeeding
• if you are about to undergo surgery

Children
Vancomycin will be used with particular caution in premature infants and newborns, as their
kidneys are not fully developed and may accumulate vancomycin in the blood.
This age group requires blood tests to monitor vancomycin levels in the blood.
Concomitant administration of vancomycin and anesthetic agents has been associated with
skin flushing (erythema) and allergic reactions in children. Similarly, concomitant use with other medicines such as aminoglycoside antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen), or amphotericin B (a medicine for fungal infections) may increase the risk of kidney damage, and therefore more frequent blood and kidney function tests may be required.
Other medicines and MAXIVANIL
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
When taken together, certain medicines may interact with vancomycin, for example medicines used to treat:

• bacterial infections (streptomycin, neomycin, gentamicin, kanamycin, amikacin, bacitracin, tobramycin, polymyxin B, colistin),
• tuberculosis (viomycin),
• fungal infections (amphotericin B),
• cancer (cisplatin), and
• medicines used for muscle relaxation
• anesthetic agents (if you are to undergo general anesthesia).

If vancomycin is administered concomitantly with other drugs, your doctor may need to monitor your blood levels and adjust dosages accordingly.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant or suspect you may be pregnant, inform your doctor. Vancomycin should
be administered during pregnancy only if strictly necessary.
Breastfeeding
Inform your doctor if you are breastfeeding, as MAXIVANIL passes into breast milk. Your doctor
will decide whether vancomycin is absolutely necessary or whether you should discontinue
breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
It is not known whether MAXIVANIL affects the ability to drive or use machinery.

3. HOW TO USE MAXIVANIL

Vancomycin will be administered to you by medical staff while you are in hospital. Your doctor will decide how much of this medicine you should receive each day and how long your treatment will last.

Dosage
The dose administered will depend on:

• your age,
• your body weight,
• the type of infection you have,
• your kidney function,
• your hearing ability,
• other medicines you are taking.

Intravenous administration
Adults and adolescents (from 12 years of age)
The dose will be calculated based on your body weight. The usual infusion dose is 15–20 mg per kg of body weight. It is generally administered every 8–12 hours. In some cases, your doctor may decide to administer an initial dose of up to 30 mg per kg of body weight. The maximum daily dose must not exceed 2 g.

Use in children
Children from 1 month up to 12 years of age
The dose will be calculated based on body weight. The usual infusion dose is 10–15 mg per kg of body weight. It is generally administered every 6 hours.

Premature infants and newborns (from 0 to 27 days of age)
Dosage will be calculated based on postmenstrual age [(time elapsed from the first day of the last menstrual period to birth (gestational age) plus the time elapsed after birth (postnatal age))].

Elderly patients, pregnant women, and patients with kidney disease, including those on dialysis, may require a different dose.

Oral administration
For adults and adolescents (from 12 to 18 years of age)
The recommended dose is 125 mg every 6 hours. In some cases, your doctor may decide to prescribe a higher daily dose, up to 500 mg every 6 hours. The maximum daily dose must not exceed 2 g.
If you have previously experienced further episodes (mucosal infection), you may require a different dose and duration of therapy.

Use in children
Newborns, infants, and children under 12 years of age
The recommended dose is 10 mg per kg of body weight. It is generally administered every 6 hours. The maximum daily dose must not exceed 2 g.

Method of administration
Intravenous infusion means that the medicine flows from an infusion bottle or bag through a tube into one of your blood vessels. Your doctor or nurse will always administer vancomycin into your bloodstream, and never into muscle.

Vancomycin must be administered intravenously over at least 60 minutes.

If administered for the treatment of gastrointestinal disorders (so-called pseudomembranous colitis), the medicine should be given as an oral solution (you will take the medicine by mouth).

Duration of treatment
The duration of treatment depends on the infection you have and may last several weeks.
The length of therapy may vary depending on individual response to treatment for each patient.

During treatment, you may need to undergo blood tests; you may also be asked to provide urine samples and undergo hearing tests to monitor for possible adverse effects.

If you are given more MAXIVANIL than you should
Since this medicine is administered to you in a hospital setting, it is unlikely that you will receive an excessive amount of vancomycin.

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 gets them.
Vancomycin may cause allergic reactions, although severe allergic reactions (anaphylactic shock) are rare. Inform your doctor immediately if you experience sudden wheezing, difficulty breathing, redness of the upper body, rash, or itching.
Oral use
Absorption of vancomycin from the gastrointestinal tract is negligible. However, if you have an inflammatory disease of the digestive tract, especially if you also have kidney disease, side effects may occur that are typically seen when vancomycin is administered by infusion.
Common side effects (may affect up to 1 in 10 people):

• Decrease in blood pressure
• Shortness of breath, noisy breathing (a high-pitched sound caused by obstruction of airflow in the upper airways)
• Inflammation and rash inside the mouth, itching, itchy rash, hives
• Kidney problems, which may mainly be detected through blood tests
• Redness of the upper body and face, inflammation of a vein

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

• Temporary or permanent hearing loss

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

• Decrease in white blood cells, red blood cells, and platelets (blood cells responsible for clotting)
• Increase in certain white blood cells in the blood
• Loss of balance, ringing in the ears, dizziness
• Inflammation of blood vessels
• Nausea (feeling of disgust)
• Kidney inflammation and kidney failure
• Chest and back muscle pain
• Fever, chills

Very rare side effects (may affect up to 1 in 10,000 people):

• Sudden onset of severe allergic reaction with blistering or peeling of the skin. This may be associated with high fever and joint pain.
• Cardiac arrest
• Inflammation of the intestine, causing abdominal pain and diarrhoea which may contain blood.

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

• Vomiting, diarrhoea
• Confusion, dizziness, loss of energy, swelling, fluid retention, decreased urination
• Rash with swelling or pain behind the ears, neck, groin, under the chin, and armpits (swollen lymph nodes), abnormal liver function and blood test results
• Rash with blisters and fever.

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

5. HOW TO STORE MAXIVANIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Exp.”. The expiry date refers to the last day of that month.
Storage after dilution: see section “How to use MAXIVANIL”.
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. PACK CONTENT AND OTHER INFORMATION

What MAXIVANIL contains
MAXIVANIL 500 mg powder for solution for intravenous infusion and for oral solution
Each vial:
Active substance: vancomycin hydrochloride 512.57 mg equivalent to vancomycin 500 mg.
MAXIVANIL 1 g powder for solution for intravenous infusion and for oral solution
Each vial:
Active substance: vancomycin hydrochloride 1025.14 mg equivalent to vancomycin 1 g.

Description of the appearance of MAXIVANIL and pack contents
Powder for solution for intravenous infusion and for oral solution available in packs containing:
one vial containing 500 mg of vancomycin.
one vial containing 1 g of vancomycin.

MARKETING AUTHORISATION HOLDER
Genetic S.p.A., Via G. Della Monica 26, Castel San Giorgio (SA)

Manufacturer
Hikma Italia S.p.A. - Viale Certosa, 10 - 27100 PAVIA

This leaflet was last updated on

Other sources of information
Medical advice/information
Antibiotics are used to treat bacterial infections. They are ineffective against viral infections.
If your doctor has prescribed antibiotics, they are specifically intended for your current illness.
Despite antibiotic treatment, some bacteria may survive or grow. This phenomenon is known as resistance: some antibiotic treatments become ineffective.
The misuse of antibiotics increases resistance. It may also help bacteria to become resistant, thereby delaying treatment or reducing antibiotic effectiveness if the appropriate:

• dosage
• schedule
• duration of treatment

is not followed.

Therefore, to maintain the effectiveness of this medicine:
1 - Use antibiotics only when prescribed.
2 - Follow instructions strictly.
3 - Do not reuse an antibiotic without a medical prescription, even if you wish to treat a similar illness.