Patient Information Leaflet

EUMAT 20 mg/ml oral drops, solution

Ketorolac tromethamine
Equivalent medicine
Please read all of this leaflet carefully before taking 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 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:

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

1. What Eumat is and what it is used for

This medicinal product contains the active substance ketorolac tromethamine, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs ("NSAIDs"), used to reduce pain caused by inflammation.
Eumat is indicated only for the short-term treatment (up to five days) of moderate pain following surgical procedures (postoperative pain).

2. What you need to know before taking Eumat

Do not take Eumat

if you are allergic to ketorolac or to any of the other ingredients of this medicine (listed in section 6);
if you have previously had an allergic reaction after taking acetylsalicylic acid (aspirin), medicines that block the synthesis of inflammatory substances (prostaglandins), and/or other non-steroidal anti-inflammatory drugs (NSAIDs);
if you suffer from nasal polyps, a respiratory disease characterized by the presence of nasal polyps;
if you have swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing and breathing (angioedema);
if you have difficulty breathing (bronchospasm);
if you suffer from asthma;
if you have skin irritation (urticaria) or nasal congestion (rhinitis);
if you currently suffer from, have previously suffered from, or suspect you may have a stomach or intestinal problem (active peptic ulcer, gastrointestinal bleeding or perforation);
if you have a serious heart condition (severe heart failure);
if you have or suspect you have had, or have previously had, a brain hemorrhage (stroke);
if you have undergone surgical procedures with a high risk of bleeding or incomplete control of blood loss (incomplete hemostasis);
if you have any other bleeding disorder;
if you have kidney problems (moderate or severe renal failure with serum creatinine levels greater than 442 μmol/L), or if you are at risk of kidney problems due to reduced blood volume (hypovolemia) or fluid deficiency (dehydration);
if you have a serious liver disease (hepatic cirrhosis or severe hepatitis);
if you have a predisposition to bleeding (hemorrhagic diathesis) or a condition due to a blood coagulation defect;
if you are taking acetylsalicylic acid (aspirin), other non-steroidal anti-inflammatory drugs, mood disorder medications (lithium salts), medicines used to lower uric acid levels in the blood (probenecid), diuretics (medicines used to eliminate fluids via urine), or medicines to prevent blood clot formation in blood vessels (anticoagulants, e.g., pentoxifylline) (see section "Other medicines and Eumat");
for prevention of pain (analgesia) before or during surgical procedures, as this medicine increases the risk of bleeding;
if the person taking this medicine is a child or adolescent under 16 years of age;
if you are in the last 3 months of pregnancy, near or during childbirth;
if you are breastfeeding.

Additionally, this medicine should not be used for mild or chronic pain.
Warnings and precautions
Talk to your doctor or pharmacist before taking Eumat.
Take Eumat under direct medical supervision, as this medicine must not be used for the treatment of mild or chronic pain. Your doctor will prescribe the lowest effective dose and the shortest duration of treatment appropriate for your condition, in order to minimize the occurrence of adverse effects.
Avoid consecutive or simultaneous use with other non-steroidal anti-inflammatory drugs (NSAIDs).
Take this medicine at the lowest possible doses and for the shortest possible duration to reduce the risk of adverse effects.
Take this medicine with extreme caution and under strict medical supervision:

if you currently suffer from or have previously suffered from stomach or intestinal disorders (peptic ulcer, gastrointestinal bleeding, ulcerative colitis, Crohn's disease);
if you are elderly or debilitated, as this increases the risk of stomach or intestinal injury or bleeding, which may be life-threatening. In such cases, your doctor may consider reducing the dose or increasing the interval between doses (see section "How to take Eumat");
if you currently suffer from or are predisposed to bronchial inflammation known as bronchial asthma, as you may experience respiratory attacks (bronchospasm) or allergic reactions;
if you have previously experienced swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing and breathing (angioedema), asthma, bronchospasm, or respiratory problems (complete or partial nasal polyp syndrome), as you may develop severe, potentially life-threatening allergic reactions;
if you currently suffer from or have previously suffered from heart problems (congestive heart failure, chronic ischemic heart disease, cardiac decompensation), high blood pressure (hypertension), reduced blood flow to the legs (peripheral arterial disease), or reduced oxygen supply to the brain (cerebrovascular disease), or if you believe you may be at risk for these conditions (e.g., if you have high blood pressure, diabetes, high cholesterol levels, or smoke). In such cases, the risk of heart attack or stroke may increase;
if you currently suffer from or have previously suffered from certain kidney problems (nephrotoxicity, renal hypoperfusion, glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome, acute renal failure, reduced kidney function);
if you are a woman with fertility problems and are planning a pregnancy, as this medicine may interfere with fertility.

Be especially vigilant and inform your doctor if, during treatment, you experience:

swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing and breathing (angioedema), difficulty breathing (bronchospasm), allergic reactions (hypersensitivity), or a respiratory disease characterized by nasal polyps (complete or partial nasal polyposis syndrome), as you may develop severe, potentially life-threatening allergic reactions;
liver problems;
a severe, potentially fatal skin reaction (exfoliative dermatitis, Stevens-Johnson syndrome, or toxic epidermal necrolysis).

Stop treatment with this medicine and contact your doctor immediately if:

you develop symptoms of an allergic reaction;
you experience bleeding (hemorrhage), or stomach or intestinal ulcers;
you develop skin problems characterized by irritation, peeling, blistering, or bleeding of the lips, eyes, mouth, nose, or genitals.

During treatment with ketorolac, minor transient increases in certain liver function tests and elevations in transaminase levels may occur. These abnormalities may be transient, remain unchanged, or progress with continued therapy. If significant increases in transaminases occur along with symptoms of liver damage—such as loss of appetite, yellowing of the skin or eyes (jaundice), dark urine, itching, or abdominal pain—discontinue treatment and consult your doctor immediately.

Cases of bruising (hematomas) and bleeding from surgical wounds have been reported after administration of injectable Eumat solution during or after surgery (perioperative and postoperative periods). Therefore, inform your doctor if you are scheduled for tonsillectomy, prostate surgery (prostate resection), or cosmetic surgery.

Eumat may cause stomach and intestinal problems, especially when used for prolonged periods without observing the necessary warnings and precautions.

Inform your doctor if you have recently undergone or are about to undergo stomach or intestinal surgery before using Eumat, as Eumat may occasionally impair intestinal wound healing following surgery.

Children and adolescents
This medicine must not be used in children and adolescents under 16 years of age.

Other medicines and Eumat
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.

Do not take this medicine if you are taking:

non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid (aspirin), as they increase the risk of adverse effects from Eumat;
lithium salts (used to treat depression), probenecid (used to promote uric acid excretion in urine), diuretics (used to eliminate fluids in urine), or medicines to prevent blood clot formation in blood vessels (anticoagulants, e.g., pentoxifylline).

If you are taking any of the following medicines, inform your doctor, as they may interact with Eumat:

corticosteroids, medicines used to treat inflammatory conditions, as they increase the risk of gastrointestinal toxicity from Eumat;
anticoagulants (e.g., warfarin, heparin, dextrans, antiplatelet agents, aspirin, pentoxifylline), medicines used to prevent blood clot formation in blood vessels, or selective serotonin reuptake inhibitors (SSRIs), medicines used to treat mood disorders, as they may increase bleeding time and the risk of gastrointestinal bleeding;
lithium, used to treat depression and similar disorders, or methotrexate, a chemotherapeutic agent, as their toxicity may increase;
antihypertensives or diuretics, medicines used to control blood pressure or heart conditions, as Eumat may reduce their effectiveness. In such cases, the risk of developing kidney problems (acute renal failure) may increase if kidney function is already impaired (e.g., if you are elderly or dehydrated). In this case, consult your doctor, as dose adjustments, increased fluid intake, and kidney function monitoring may be required;
probenecid, a medicine used to promote uric acid excretion in urine.

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

Pregnancy
Do not take Eumat during the last 3 months of pregnancy, as it may harm the fetus or cause complications during childbirth.
It may cause kidney and heart problems in the fetus. It may affect your or your baby's tendency to bleed and delay or prolong labor beyond normal duration.
You should not take Eumat during the first 6 months of pregnancy unless absolutely necessary and under medical advice.
If treatment is required during this period or during attempts to conceive, the lowest effective dose for the shortest possible duration should be used. From week 20 of pregnancy, Eumat may cause fetal kidney problems if taken for more than a few days, leading to reduced amniotic fluid levels surrounding the baby (oligohydramnios) or constriction of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding
Do not take this medicine if you are breastfeeding, as it passes into breast milk.

Fertility
Eumat may cause fertility problems in women. Therefore, if you are planning to become pregnant, inform your doctor, as this medicine may reduce fertility.
Your doctor will advise you on appropriate contraceptive measures.

Driving and using machines
This medicine may cause drowsiness, dizziness, vertigo, sleep disturbances (insomnia), or mood disorders (depression). If you experience any of these effects, avoid driving or operating machinery.

Eumat contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, and sodium
This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).
This medicine contains less than 23 mg (1 mmol) of sodium per dose and is therefore practically 'sodium-free'.

3. How to take Eumat

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Do not take this medicine for more than 5 days.
Use in adults
The recommended dose is 10 mg (10 drops) every 4–6 hours. Your doctor will determine the appropriate dose according to your condition. The maximum dose is 40 mg per day. Do not exceed the maximum recommended dose.
If your body weight is less than 50 kg, the dose should be reduced.
Use in elderly (over 65 years of age)
Your doctor will determine the dose, possibly considering a reduction of the dosage mentioned above.
Use in children and adolescents
Do not administer this medicine to children and adolescents under 16 years of age. The safety and efficacy in children have not been established.
If you take more Eumat than you should
After taking an excessive dose of this medicine, abdominal pain, nausea, vomiting, increased breathing rate (hyperventilation), stomach or intestinal problems (peptic ulcer, erosive gastritis, gastrointestinal bleeding), kidney problems, and severe allergic reactions (anaphylactoid reactions) may occur. Rare cases of increased blood pressure (hypertension), impaired lung function (respiratory depression), and coma have been reported. Your doctor will decide on appropriate treatment.
If you accidentally take too much of this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
If you forget to take Eumat
Do not take a double dose to make up for the missed dose.
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 everybody will experience them.
The side effects that may occur with Eumat are:
Not known (frequency cannot be estimated from the available data)

infection of the central nervous system (aseptic meningitis);
reduction in platelet count (thrombocytopenia), nosebleeds (epistaxis);
severe allergic reactions (anaphylactic/anaphylactoid reactions), allergic reactions (hypersensitivity reactions): difficulty breathing (bronchospasm), widening of blood vessels (vasodilation), flushing, skin rash, reduction in blood pressure (hypotension), swelling of the throat (laryngeal edema);
loss of appetite (anorexia), increased potassium in the blood (hyperkalemia), reduced sodium in the blood (hyponatremia);
abnormal thoughts, mood disorders (depression), sleep disturbances (insomnia), feelings of worry or fear (anxiety), nervousness, mental disorders (psychotic reactions), abnormal dreams, hallucinations, feeling of well-being (euphoria), difficulty concentrating, drowsiness, stupor, confusion;
headache (cephalalgia), dizziness, seizures, disturbance of sensation in legs, arms, or other parts of the body (paraesthesia), increased movement (hyperkinesia), altered taste;
visual disturbances;
ringing in the ears (tinnitus), hearing loss, vertigo;
increased awareness of heartbeat (palpitations), reduced heart rate (bradycardia), swelling in various parts of the body due to fluid accumulation (edema), heart disorders (heart failure), increased blood pressure (hypertension), widening of blood vessels (vasodilation), reduced blood pressure (hypotension), bruising (hematomas), sudden sensation of heat (hot flushes), loss of skin color (pallor), bleeding from wounds after surgery (post-operative wound bleeding), heart attack, stroke;
accumulation of fluid in the lungs (pulmonary edema), difficulty breathing (dyspnea), asthma;
stomach or intestinal disorders (peptic ulcers, perforation or bleeding from the stomach or intestine, which may be life-threatening), nausea, vomiting, diarrhea, passage of gas from the intestine (flatulence), constipation, digestive difficulties (dyspepsia), abdominal pain/discomfort, feeling of fullness, passage of black stools (melena), rectal bleeding, vomiting blood (hematemesis), inflammation of the mouth (stomatitis and ulcerative stomatitis), inflammation of the esophagus (esophagitis), belching, inflammation of the pancreas (pancreatitis), dry mouth, worsening of intestinal inflammation (colitis and Crohn's disease), inflammation of the stomach (gastritis);
liver problems (hepatitis, liver failure), reduced bile flow from the liver to the intestine with yellowing of the skin (cholestatic jaundice);
swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing and breathing (angioedema), skin lesions (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis), increased sweating, red spots on the skin (maculopapular rash), itching, rupture of capillaries under the skin (purpura), appearance of blisters on the skin (bullous reactions), skin irritation (urticaria);
muscle pain (myalgia);
increased urine production (polyuria), passing small amounts of urine frequently (pollakiuria), reduced urine excretion (oliguria), kidney problems (acute kidney failure), blood and kidney problems (hemolytic uremic syndrome), inflammation of the kidneys (interstitial nephritis), inability of the bladder to empty (urinary retention), loss of protein in urine (nephrotic syndrome), flank pain with or without blood in the urine (hematuria) or changes in the level of non-protein nitrogen in the blood (azotemia), increased creatinine and potassium levels;
female infertility;
fatigue (asthenia), fever, injection site reactions, swelling (edema), chest pain (thoracic pain), excessive thirst;
laboratory test abnormalities: prolonged bleeding time, increased serum urea, increased creatinine, changes in liver function tests.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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 Eumat

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 "Exp.". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
The product should be used within 4 months after the first opening of the bottle.
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 Eumat contains

The active substance is ketorolac tromethamine: 1 ml of solution contains 20 mg of ketorolac tromethamine.
The other components are: citric acid monohydrate, disodium hydrogen phosphate dihydrate, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, purified water q.s.

Description of the appearance of Eumat and contents of the pack
Eumat is a clear, colourless or slightly yellow solution contained in an amber glass vial closed with a polypropylene closure.
It is available in packs containing 1 bottle of 10 ml.

Marketing Authorisation Holder
Epifarma S.r.l. – Via San Rocco, 6 – 85033 Episcopia (PZ)

Manufacturer

Doppel Farmaceutici S.r.l. - Via Martiri della Foibe, 1 - 29016 Cortemaggiore (PC)
Vamfarma S.r.l - Via Kennedy, 5 - 26833 - Comazzo (LO)

Patient information leaflet

EUMAT 30 mg/ml injectable solution

Ketorolac tromethamine
Equivalent medicine
Please 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:

What Eumat is and what it is used for
What you need to know before using Eumat
How to use Eumat
Possible side effects
How to store Eumat
Contents of the pack and other information

1. What Eumat is and what it is used for

of short-term (up to two days) moderate to severe acute pain following surgical procedures (postoperative pain);
of pain caused by renal colic.

This medicine is also used, when administered intravenously, in addition to opioid or opioid-like analgesic medicines, for the treatment of severe pain or in cases of prolonged surgical procedures (major surgery).

2. What you should know before using Eumat

Do not use Eumat

if you are allergic to ketorolac or to any of the other ingredients of this medicine (listed in section 6);
if you have previously experienced an allergic reaction after taking acetylsalicylic acid (aspirin), drugs that block the synthesis of inflammatory substances (prostaglandins), and/or other non-steroidal anti-inflammatory drugs (NSAIDs);
if you suffer from nasal polyps, a respiratory disease characterized by the presence of nasal polyps;
if you have swelling of the face, lips, mouth, tongue, or throat that may cause difficulty in swallowing and breathing (angioedema);
if you have difficulty breathing (bronchospasm);
if you suffer from asthma;
if you have skin irritation (urticaria) or nasal congestion (rhinitis);
if you currently have, have had, or suspect you may have a stomach or intestinal disorder (active peptic ulcer, gastrointestinal bleeding or perforation);
if you have a serious heart condition (severe heart failure);
if you have or suspect you have had a cerebral hemorrhage (stroke), or if you have had one in the past;
if you have undergone high-risk surgical procedures for bleeding or incomplete control of bleeding (incomplete hemostasis);
if you have any other bleeding disorder;
if you have moderate to severe kidney problems (moderate or severe renal failure with serum creatinine levels greater than 442 µmol/L), or if you are at risk of kidney problems due to reduced blood volume (hypovolemia) or fluid deficiency (dehydration);
if you have a serious liver disease (hepatic cirrhosis or severe hepatitis);
if you have a tendency to bleed (hemorrhagic diathesis) or a disorder due to a blood coagulation defect;
if you are taking acetylsalicylic acid (aspirin), other non-steroidal anti-inflammatory drugs, mood disorder medications (lithium salts), medicines used to reduce blood uric acid levels (probenecid), medicines to eliminate fluids through urine (diuretics), or medicines to prevent blood clot formation in blood vessels (anticoagulants, e.g., pentoxifylline) (see section “Other medicines and Eumat”);
for prevention of pain (analgesia) before or during surgical procedures, as this medicine increases the risk of bleeding;
if the person using this medicine is a child or adolescent under 16 years of age;
if you are in the last 3 months of pregnancy, near or during childbirth;
if you are breastfeeding.

Additionally, this medicine must not be used:

in cases where pain is mild or chronic;
by epidural or intrathecal injection, as it contains ethyl alcohol.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Eumat.
Use Eumat under direct medical supervision, as this medicine must not be used for the treatment of mild or
chronic pain. Your doctor will prescribe the lowest effective dose and the shortest duration of treatment
appropriate for your condition, in order to minimize the occurrence of adverse effects.
Avoid consecutive or simultaneous use with other non-steroidal anti-inflammatory drugs (NSAIDs).
This medicine will be administered at the lowest possible doses and for short periods of time to reduce the
occurrence of adverse effects.
Use this medicine with great caution and under strict medical supervision:

if you currently have or have had gastrointestinal disorders (peptic ulcer, gastrointestinal bleeding, ulcerative colitis, Crohn's disease);
if you are elderly or debilitated, as this increases the risk of stomach or intestinal injuries or bleeding, which may be life-threatening. In such cases, your doctor may decide to reduce the dose or increase the interval between doses (see section “How to use Eumat”);
if you currently have or are predisposed to bronchial inflammatory disease called bronchial asthma, as you may experience respiratory crises (bronchospasm) or allergic reactions;
if you have previously experienced swelling of the face, lips, mouth, tongue, or throat causing difficulty in swallowing and breathing (angioedema), asthma, bronchospasm, or respiratory problems (complete or partial aspirin-exacerbated respiratory disease with nasal polyps), as you may experience severe, potentially life-threatening allergic reactions;
if you currently have or have had heart problems (congestive heart failure, chronic ischemic heart disease, cardiac decompensation), high blood pressure (hypertension), reduced blood flow to the legs (peripheral arterial disease), or reduced oxygen supply to the brain (cerebrovascular disease), or
if you think you may be at risk of these conditions (e.g., if you have high blood pressure, diabetes, high cholesterol levels, or if you smoke). In such cases, the risk of heart attack or stroke may increase;
if you currently have or have had certain kidney problems (nephrotoxicity, renal hypoperfusion, glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome, acute renal failure, reduced kidney function);
if you are a woman with fertility problems and are planning a pregnancy, as this medicine may interfere with fertility.

Be especially careful and inform your doctor if you experience any of the following during treatment:

swelling of the face, lips, mouth, tongue, or throat causing difficulty in swallowing and breathing (angioedema), difficulty breathing (bronchospasm), allergic reactions (hypersensitivity), or a respiratory disorder characterized by nasal polyps (complete or partial aspirin-exacerbated respiratory disease), as you may experience severe, potentially life-threatening allergic reactions;
liver problems;
a severe, potentially fatal skin reaction (exfoliative dermatitis, Stevens-Johnson syndrome, or toxic epidermal necrolysis).

Stop treatment with this medicine and contact your doctor immediately if:

you experience symptoms of an allergic reaction;
you experience bleeding (hemorrhages), or stomach or intestinal lesions (ulcers);
you develop skin problems characterized by irritation, peeling, blisters, or bleeding of the lips, eyes, mouth, nose, or genitals.

During treatment with ketorolac, minor transient increases in certain liver function tests and elevations in transaminases may occur. These abnormalities may be transient, remain unchanged, or progress with continued therapy. If significant increases in transaminases occur along with symptoms of liver damage—such as loss of appetite, yellowing of the skin or eyes (jaundice), dark urine, itching, or abdominal pain—discontinue treatment and consult your doctor.
Cases of bruising (hematomas) after surgery (post-operative period) and bleeding from surgical wounds following the use of Eumat during or after surgical procedures (peri-operative period) have been reported. Therefore, inform your doctor if you are scheduled for tonsillectomy, prostate surgery (prostate resection), or cosmetic surgery.
Eumat may cause stomach and intestinal problems, especially when used for prolonged periods without following the necessary warnings and precautions.
Inform your doctor if you have recently undergone or are scheduled for stomach or intestinal surgery before using Eumat, as Eumat may sometimes impair intestinal wound healing after surgery.
For athletes: Medicines containing ethanol may lead to positive anti-doping test results, depending on the alcohol concentration limits set by certain sports federations.

Children and adolescents
This medicine must not be used in children and adolescents under 16 years of age.

Other medicines and Eumat
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicine.
Do not use this medicine if you are taking:

non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid (aspirin), as they increase the risk of adverse effects of Eumat;
lithium salts (used to treat depression), probenecid (used to promote urinary excretion of uric acid), diuretics (used to eliminate fluids in urine), or medicines to prevent blood clot formation in blood vessels (anticoagulants, e.g., pentoxifylline).

If you are taking any of the following medicines, inform your doctor as they may interact with Eumat:

corticosteroids, medicines used to treat inflammatory conditions, as they increase the risk of gastrointestinal toxicity from Eumat;
anticoagulants (e.g., warfarin, heparin, dextrans, antiplatelet agents, aspirin, pentoxifylline), medicines used to prevent blood clot formation in blood vessels, or selective serotonin reuptake inhibitors (SSRIs), medicines used to treat mood disorders, as they may increase bleeding time and the risk of gastrointestinal bleeding;
lithium, used to treat depression and similar disorders, or methotrexate, a chemotherapeutic agent, as their toxicity may increase;
antihypertensives or diuretics, medicines used to control blood pressure or heart conditions, as Eumat may reduce their effectiveness. In such cases, the risk of developing kidney problems (acute renal failure) may increase if kidney function is already impaired (e.g., in elderly or dehydrated patients). In such cases, consult your doctor, as dose adjustments, increased fluid intake, and kidney function monitoring may be necessary;
injectable ketorolac may interact with furosemide, reducing its diuretic effect; therefore, particular caution is required in patients with heart failure;
probenecid, a medicine used to promote urinary excretion of uric acid.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use Eumat during the last 3 months of pregnancy, as it may harm the fetus or cause complications during childbirth.
It may cause kidney and heart problems in the fetus. It may affect your and your baby's tendency to bleed and may delay or prolong labor.
You should not use Eumat during the first 6 months of pregnancy unless absolutely necessary and under medical advice.
If treatment is required during this period or during attempts to conceive, the lowest effective dose for the shortest possible duration should be used. From week 20 of pregnancy, Eumat may cause fetal kidney problems if used for more than a few days, leading to reduced amniotic fluid levels surrounding the baby (oligohydramnios) or causing constriction of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Do not use this medicine if you are breastfeeding, as it passes into breast milk.
Fertility
Eumat may cause fertility problems in women. Therefore, if you are planning a pregnancy, inform your doctor, as this medicine may reduce fertility.
Your doctor will advise you on appropriate contraceptive measures.

Driving and use of machines
This medicine may cause drowsiness, dizziness, vertigo, sleep disturbances (insomnia), or mood disorders (depression). If you experience these effects, avoid driving or operating machinery.

Eumat contains ethanol and sodium
This medicine contains 96 mg of alcohol (ethanol) per vial, equivalent to 12.7% alcohol.
One milliliter of this medicine is equivalent to less than 3 ml of beer and 1 ml of wine.
The small amount of alcohol in this medicine is unlikely to produce significant effects.
This medicine contains less than 23 mg (1 mmol) of sodium per vial, i.e., it is practically 'sodium-free'.

3. How to use Eumat

Use this medicine exactly as instructed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine will be administered to you by a doctor or a nurse, via injection into the muscle (intramuscular) or injection into the vein (intravenous). The intravenous injection can only be performed in hospitals and other medical facilities.
Eumat must not be administered epidurally or intrathecally.
Do not use this medicine for more than 2 days if the dose is administered all at once (bolus administration), and for more than 1 day if the dose is administered via infusion (continuous infusion).

Use in adults
The recommended initial dose for intramuscular or intravenous administration is 10 mg. Subsequently, the dose will be 10–30 mg every 4–6 hours. Your doctor will determine the appropriate dose based on your condition. The maximum dose is 90 mg per day.
If your body weight is less than 50 kg, the dose should be reduced.
For renal colic, the recommended dose is one vial of 30 mg, administered intramuscularly or intravenously.

Use in elderly patients (over 65 years of age)
Your doctor will determine the dose, possibly considering a reduction of the above-mentioned dosage. However, the maximum dose must not exceed 60 mg per day.

Use in children and adolescents
Do not administer this medicine to children and adolescents under 16 years of age. The safety and efficacy in children have not been established.

If you use more Eumat than you should
After administration of an excessive dose of this medicine, abdominal pain, nausea, vomiting, increased breathing rate (hyperventilation), stomach or intestinal problems (peptic ulcer, erosive gastritis, gastrointestinal bleeding), kidney problems, and severe allergic reactions (anaphylactoid reactions) may occur. Rare cases of increased blood pressure (hypertension), impaired lung function (respiratory depression), and coma have been reported. Your doctor will decide on appropriate treatment.
In case of accidental overdose or ingestion, contact your doctor immediately or go to the nearest hospital emergency department.

If you forget to use Eumat
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects that may occur with Eumat are:
Not known (frequency cannot be estimated from the available data)

infection of the central nervous system (aseptic meningitis);
reduction in the number of platelets (thrombocytopenia), nosebleed (epistaxis);
severe allergic reactions (anaphylactic/anaphylactoid reactions), allergic reactions (hypersensitivity reactions): difficulty in breathing (bronchospasm), increase in blood vessel size (vasodilation), flushing, skin rash, reduction in blood pressure (hypotension), swelling of the throat (laryngeal edema);
loss of appetite (anorexia), increased potassium in the blood (hyperkalemia), reduced sodium in the blood (hyponatremia);
abnormal thoughts, mood disorders (depression), sleep disorders (insomnia), feelings of worry or fear (anxiety), nervousness, mental disorders (psychotic reactions), abnormal dreams, hallucinations, feeling of well-being (euphoria), difficulty in concentration, drowsiness, stupor, confusion;
headache (cephalalgia), dizziness, seizures, disturbance in sensation of legs, arms or other parts of the body (paraesthesia), increased movement (hyperkinesia), taste disturbances;
vision disorders;
ringing in the ears (tinnitus), hearing loss, vertigo;
increased awareness of heartbeat (palpitations), reduced heart rate (bradycardia), swelling in various parts of the body due to fluid accumulation (edema), heart disorders (heart failure), increased blood pressure (hypertension), increased size of blood vessels (vasodilation), reduced blood pressure (hypotension), bruising (hematomas), sudden sensation of heat (hot flushes), loss of skin color (pallor), bleeding from wounds after surgery (post-operative wound bleeding), heart attack, stroke;
accumulation of fluid in the lungs (pulmonary edema), difficulty in breathing (dyspnea), asthma;
stomach or intestinal disorders (peptic ulcers, perforation or bleeding from the stomach or intestine which may be life-threatening), nausea, vomiting, diarrhea, passage of gas from the intestine (flatulence), constipation, digestive difficulties (dyspepsia), abdominal pain/discomfort, feeling of fullness, passage of dark stools (melena), bleeding from the rectum, vomiting blood (hematemesis), inflammation of the mouth (stomatitis and ulcerative stomatitis), inflammation of the esophagus (esophagitis), belching, inflammation of the pancreas (pancreatitis), dry mouth, worsening of intestinal inflammation (colitis and Crohn's disease), inflammation of the stomach (gastritis);
liver problems (hepatitis, liver failure), reduced flow of bile from the liver to the intestine with yellowing of the skin (cholestatic jaundice);
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing and breathing (angioedema), skin lesions (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis), increased sweating, red spots on the skin (maculopapular rash), itching, rupture of capillaries under the skin (purpura), appearance of blisters on the skin (bullous reactions), skin irritation (urticaria);
muscle pain (myalgia);
increased urine production (polyuria), passing small amounts of urine frequently (pollakiuria), reduced urine excretion (oliguria), kidney problems (acute kidney failure), blood and kidney problems (hemolytic-uremic syndrome), inflammation of the kidneys (interstitial nephritis), inability of the bladder to empty (urinary retention), loss of protein in the urine (nephrotic syndrome), flank pain with or without presence of blood in the urine (hematuria) or
increase/decrease in the amount of non-protein nitrogen in the blood (azotemia), increased
creatinine and potassium;
female infertility;
tiredness (asthenia), fever, injection site reactions, swelling (edema), chest pain (thoracic pain), excessive thirst;
laboratory test abnormalities: prolonged bleeding time, increased serum urea, increased creatinine, changes in liver function tests.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist.
You can 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 Eumat

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 "Exp.". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of medicines 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 Eumat contains

The active substance is ketorolac tromethamine: 1 vial contains 30 mg of ketorolac tromethamine.
The other components are: ethanol, sodium chloride, sodium hydroxide, water for injections.

Description of the appearance of Eumat and contents of the pack
Eumat is a clear, colourless or yellowish solution contained in an amber glass container.
It is available in packs of 3 vials of 1 ml each.
Marketing Authorization Holder
Epifarma S.r.l. – Via San Rocco, 6 – 85033 Episcopia (PZ)
Manufacturer
Doppel Farmaceutici S.r.l. – Via Volturno, 48 – Quinto de Stampi (Rozzano) - Milano