Gabapentin mesilate Bioindustria L.I.M.

Patient Information Leaflet: Information for the User

GABESATO MESILATO Bioindustria L.I.M. 100 mg/5 ml powder and solvent

for infusion solution
gabapentin mesilate
Generic Medicine
Please read all of this leaflet carefully before you start using 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 nurse.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What GABESATO MESILATO Bioindustria L.I.M. is and what it is used for

GABESATO MESILATO is a medicinal product belonging to the class of protease inhibitors (enzymes that degrade proteins).
This medicine is indicated for the treatment of acute inflammation of the pancreas (acute pancreatitis), as it acts by inhibiting the activity of pancreatic proteases, which are the main agents causing damage to the organ.

2. What you need to know before using GABESATO MESILATO Bioindustria L.I.M.

Do not use GABESATO MESILATO Bioindustria L.I.M.

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

Warnings and precautions
Talk to your doctor or nurse before using GABESATO MESILATO Bioindustria L.I.M.
This medicine can only be used in suitable medical facilities (hospitals, clinics, and nursing homes) and must be administered by specialized healthcare personnel who will monitor you throughout the treatment.
If you notice any of the following symptoms, inform your doctor immediately. The doctor will assess the necessary intervention:

• low blood pressure (hypotension)
• sensation of pressure in the chest (precordial oppression)
• difficulty breathing (dyspnea)
• loss of consciousness
• swelling due to fluid retention (edema) in the pharynx or larynx
• itching or general malaise
• headache (cephalalgia)
• tendency to bleed
• nausea, vomiting, diarrhea
• skin rash, itching, or facial congestion

This medicine may have an anticoagulant effect (blood thinning).
Shock (extreme drop in blood pressure due to heart failure) and severe allergic reactions (anaphylactic shock, anaphylactoid reactions) may occur.
Pain (which tends to increase and radiate along the vein), signs of swelling, redness, and inflammation at the injection site, sensation of warmth and burning (symptoms of phlebitis) may also occur. Inform your doctor immediately so appropriate measures can be taken.

Other medicines and GABESATO MESILATO Bioindustria L.I.M.
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are known.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or nurse for advice before administration of this medicine.
This medicine should not be administered during pregnancy unless absolutely necessary.
There are no available data regarding its excretion in breast milk.

Driving and using machines
GABESATO MESILATO Bioindustria L.I.M. will be administered to you only in a hospital setting.

3. How to use GABESATO MESILATO Bioindustria L.I.M.

This medicine will be administered to you by a doctor or another healthcare professional. If you have any doubts, consult your doctor or nurse.
The dosage will be determined by the doctor according to the severity of your condition.
The recommended dose for initial treatment is 1–3 vials (100 to 300 mg of gabesato mesilato) per day, which will subsequently be reduced according to improvement in your condition.
If necessary, the above dosage may be increased by 1–3 vials within the same day.
This medicine will be administered to you by direct intravenous injection (intravenous infusion) drop by drop.

Use in the elderly
Dosage should be appropriately reduced in case of reduced physiological functions.

If you use more GABESATO MESILATO Bioindustria L.I.M. than you should
This medicine will be administered by a doctor or trained healthcare staff; therefore, it is unlikely that you will receive an excessive dose. However, if you think you have been given too much, inform your doctor or another healthcare professional immediately.
In case of overdose, you may experience headache (cephalalgia), coagulation disorders, tendency to bleed, reduction in blood pressure (hypotension), nausea, vomiting, diarrhoea, skin rash, itching, or facial swelling and redness (facial congestion). If you experience these symptoms, inform your doctor, as it may be necessary to reduce the dose or discontinue treatment.

If you have any doubts about how to use this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur:
Common (may affect up to 1 in 10 people):

• injection site lesions (necrotic ulcers)
• inflammation of blood vessels (phlebitis) and stiffness
• superficial pain and redness at the injection site.

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

• reduction in blood pressure
• nausea and vomiting
• altered liver function (increase in transaminases)
• allergic reactions (skin rashes, itching, inflammation at injection site)

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

• decrease in white blood cells (leucopenia, granulocytopenia)

• increased tendency to bleeding (reduced partial thromboplastin time)

• yellowing of the skin and whites of the eyes (jaundice)

• fever

• facial flushing
  Not known (frequency cannot be estimated from available data):

• severe allergic reactions (anaphylactic shock, anaphylactoid reactions)

• sudden drop in blood pressure

• sensation of pressure in the chest (precordial oppression)

• difficulty breathing (dyspnoea)

• severe decrease in a type of white blood cells called granulocytes (agranulocytosis)

• decrease in platelets (thrombocytopenia)

• increase in certain white blood cells (eosinophilia)

• headache (cephalalgia)

• increased total bilirubin

• loss of consciousness

• general malaise

• fluid accumulation associated with swelling of the throat and breathing difficulties (pharyngeal/laryngeal oedema)

• increased potassium levels in the blood (hyperkalaemia)

• decreased sodium levels in the blood (hyponatraemia).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly via 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 GABESATO MESILATO Bioindustria L.I.M.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXPIRY".
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. Package contents and other information

What GABESATO MESILATO Bioindustria L.I.M. contains

• The active substance is gabexate mesilate. Each vial of powder contains 100 mg of gabexate mesilate.
• The other component is water for injections.

Description of the appearance of GABESATO MESILATO Bioindustria L.I.M. and contents of the pack
Each pack of GABESATO MESILATO Bioindustria L.I.M. powder and solvent for solution for
infusion contains 1 sterile powder vial of 100 mg + 1 solvent ampoule of 5 ml.
Marketing Authorization Holder and Manufacturer
Bioindustria Laboratorio Italiano Medicinali S.p.A.
(Bioindustria L.I.M.)
Via De Ambrosiis n. 2 , 15067 Novi Ligure (AL) - Italy

Package leaflet: information for the physician

GABESATO MESILATO Bioindustria L.I.M. 100 mg/5 ml powder and solvent

for infusion solution
gabesato mesilate
Equivalent Medicine
The following information is intended exclusively for physicians or healthcare professionals

Dosage and method of administration
Begin treatment with 1–3 vials per day (100–300 mg of gabesato mesilate) by intravenous infusion as a slow drip, at a rate not exceeding 8 ml/minute, and subsequently reduce the dosage according to clinical improvement.
If necessary, the above dosage may be increased by 1–3 vials within the same day.
The sterile powder contained in the vial must be reconstituted using the solvent ampoule (water for injectable preparations).
The resulting solution should then be further diluted in 500 ml of lactated Ringer's solution or 5% glucose solution.
After reconstitution, the solution must be used immediately and any unused residue should be discarded.
It is advisable to administer the infusion solution slowly by intravenous route, adjusting the infusion rate so that it does not exceed 2.5 mg of gabesato mesilate per kg of body weight per hour.
Dosage should be appropriately adjusted according to the patient's clinical symptoms.

Elderly patients
Dosage should be appropriately reduced in cases of impaired physiological function.

Incompatibilities
When concomitant parenteral therapy with other medicinal products is required, gabesato mesilate must be administered separately.

Special warnings and precautions for use
Administration of this medicinal product at high doses may cause necrotic ulcers at the injection site and along blood vessels, potentially damaging the vascular wall and causing phlebitis and vessel rigidity.
Patients should be monitored accordingly.
If pain, redness, or inflammation occurs at the injection site, treatment must be discontinued or the injection site changed, and appropriate measures must be taken.
The patient must be continuously monitored during administration.
Shock, anaphylactic shock, and anaphylactoid reactions may occur.
If arterial hypotension, precordial oppression, dyspnea, loss of consciousness, pharyngeal/laryngeal edema, pruritus, or malaise occur, treatment must be immediately discontinued and appropriate measures taken.
Patients should also be closely monitored for possible occurrence of agranulocytosis, leucopenia, thrombocytopenia, and hyperkalemia.
If abnormal values are detected, treatment must be discontinued; in the case of hyperkalemia, appropriate corrective measures must be taken.
If any of the following occur—headache, reduced partial thromboplastin time, tendency to bleeding, hypotension, nausea, vomiting, diarrhea, skin rash, pruritus, or facial flushing—the dosage should be reduced. If symptoms persist, treatment must be permanently discontinued.
The medicinal product may exert an anticoagulant effect.