EUMAT 30 mg /Ml Injectable Solution

Зміст інструкції

1. EUMAT 20 mg/ml oral drops, solution
   1. What is Eumat and what is it used for
   2. What you need to know before you take Eumat
   3. How to take Eumat
   4. Possible side effects
   5. How to store Eumat
   6. Contents of the pack and other information
2. EUMAT 30 mg/ml injectable solution
   1. What is Eumat and what is it used for
   2. What you need to know before using Eumat
   3. How to use Eumat
   4. Possible side effects
   5. How to store Eumat
   6. Contents of the pack and other information

EUMAT 20 mg/ml oral drops, solution

Ketorolac tromethamine
Generic medicine

Read 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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Eumat and what is it used for

This medicine contains the active ingredient 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 (maximum five days) of moderate pain
after surgical operations (post-operative pain).

2. What you need to know before you take 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 had an allergic reaction in the past after taking acetylsalicylic acid (aspirin), medicines that block the synthesis of inflammatory substances (prostaglandins) and/or other non-steroidal anti-inflammatory medicines;
• if you suffer from nasal polyps, a disease of the respiratory system characterized by the presence of polyps in the nose;
• if you have swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing and breathing (angioedema);
• if you have difficulty breathing (bronchospasm);
• if you suffer from asthma;
• if you have skin irritation (urticaria) or if you have nasal congestion (rhinitis);
• if you suffer from, have suffered from or suspect you suffer from a problem with your stomach or intestine (active peptic ulcer, gastrointestinal bleeding or perforation);
• if you have a serious heart problem (severe heart failure);
• if you have or suspect you have a cerebral hemorrhage (stroke), or if you have had one in the past;
• if you have undergone surgery with a high risk of bleeding or incomplete cessation of blood loss (incomplete hemostasis);
• if you have any other bleeding problems;
• if you suffer from kidney problems (moderate or severe renal insufficiency 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 severe liver disease (liver cirrhosis or severe hepatitis);
• if you have a predisposition to bleeding (hemorrhagic diathesis) or a problem due to a defect in blood coagulation;
• if you are taking acetylsalicylic acid (aspirin), other non-steroidal anti-inflammatory medicines, medicines for mood disorders (lithium salts), medicines used to reduce uric acid levels in the blood (probenecid), medicines to eliminate fluids with urine (diuretics) or medicines to prevent blood clots in the vessels (anticoagulants, e.g. pentoxifylline) (see section “Other medicines and Eumat”);
• for the prevention of pain (analgesia) before or during surgical operations, because this medicine increases the risk of bleeding;
• if the person who is to take this medicine is a child or adolescent under the age of 16;
• if you are in the last 3 months of pregnancy, near or during childbirth;
• if you are breastfeeding.

In addition, this medicine should not be used in cases where the pain is mild or chronic.
Warnings and precautions
Consult your doctor or pharmacist before taking Eumat.

Take Eumat under the direct supervision of your doctor because this medicine should not be
used in the treatment of mild or chronic pain. The doctor will prescribe the dose and
duration of the minimum therapy suitable for your problem, in order to reduce the occurrence of
undesirable effects.
Avoid the consecutive or simultaneous use with other non-steroidal anti-inflammatory drugs (NSAIDs).
Take this medicine at the lowest doses and for short periods of time to reduce the occurrence
of side effects.

Take this medicine with great caution and under strict medical supervision:

• if you suffer from or have 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 possibility of injury or bleeding in the stomach or intestine, which can be life-threatening. In this case, the doctor may decide to reduce the dose or increase the time interval between administrations (see section “How to take Eumat”);
• if you suffer from or are predisposed to an inflammatory disease of the bronchi called bronchial asthma, as you may experience breathing crises (bronchospasm) or allergic reactions;
• if you have suffered in the past from swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing and breathing (angioedema), asthma, bronchospasm or respiratory problems (complete or partial nasal polyposis syndrome), as you may experience severe allergic reactions that can be life-threatening;
• if you suffer from or have suffered from heart problems (congestive heart failure, chronic ischemic heart disease, heart failure), high blood pressure (hypertension), reduced blood flow to the legs (peripheral arteriopathy) and the amount of oxygen to the brain (cerebrovascular disease) or 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 these cases, the risk of heart attack or stroke may increase;
• if you suffer from or have suffered from some kidney problems (nephrotoxicity, renal hypoperfusion, glomerulonephritis, interstitial nephritis, papillary necrosis, 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 your fertility.

Pay particular attention and inform your doctor if you experience during treatment:

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

Stop treatment with this medicine and consult your doctor immediately in the
following cases:

• if you experience symptoms of an allergic reaction;
• if you experience bleeding (hemorrhages), lesions (ulcers) of the stomach or intestine;
• if you experience skin problems characterized by irritation, flaking, blistering or bleeding of lips, eyes, mouth, nose and genitals.

During treatment with Ketorolac, small transient increases in some liver tests may occur
and also increases in transaminases. These abnormalities may be transient,
remain unchanged, or progress with continued therapy. In case of significant increases in
transaminases and symptoms of liver damage, such as loss of appetite, yellowing of the skin and
eyes, dark urine, itching or abdominal tenderness, stop treatment and consult your
doctor.
Cases of bruising (hematomas) have been reported after surgical operations (post-
operative period) and bleeding from wounds following the use of Eumat injectable solution during
or after surgical operations (peri-operative period). Therefore, inform your doctor if you are to
undergo tonsil removal, prostate surgery (prostate resection)
or cosmetic surgery.

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

Other medicines and Eumat
Tell your doctor or pharmacist if you are 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) because they increase the risk of side effects of Eumat
• lithium salts (used to treat depression), probenecid (used to promote the elimination of uric acid with urine), diuretics (used to eliminate fluids with urine), or medicines to prevent blood clots in the vessels (anticoagulants, e.g. pentoxifylline).

If you are taking any of the following medicines, inform your doctor because these can
interact with Eumat:

• corticosteroids, medicines used to treat inflammatory states, because they increase the risk of toxic effects of Eumat on the stomach and intestine;
• anticoagulants(for example warfarin, heparin, dextrans, antiplatelet agents, aspirin, pentoxifylline), medicines used to prevent blood clots in the vessels or selective serotonin reuptake inhibitors, medicines used to treat mood disorders, because they can increase bleeding time and the risk of bleeding in the stomach or intestine;
• lithium, used to treat depression and similar disorders or methotrexate, a chemotherapeutic agent, because their toxicity may increase;
• antihypertensives or diuretics, medicines used to control blood pressure or heart disorders, because Eumat may reduce their effects. In this case, the risk of developing kidney problems (acute renal failure) may increase if kidney function is already altered (e.g. if you are elderly or dehydrated). In this case, consult your doctor, as dose adjustments, water intake and kidney function tests are necessary;
• probenecid, a medicine used to promote the elimination of uric acid with urine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Eumat during the last 3 months of pregnancy, as it may harm the fetus or
cause problems during childbirth.
It may cause problems with the kidneys and heart of the fetus. It may affect your and the
baby's tendency to bleed and delay or prolong labor more than expected.
You should not take Eumat in the first 6 months of pregnancy unless absolutely necessary and
under the advice of a doctor.
If treatment is necessary during this period or during attempts to conceive, the minimum dose should be used for the shortest possible time. From the 20th week of pregnancy,
Eumat may cause kidney problems in the fetus, if taken for more than a few days, reducing
the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing a narrowing of
a blood vessel (ductus arteriosus) in the baby's heart. If treatment is necessary 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, you should inform your doctor because this medicine may reduce fertility.
The doctor will inform you about all measures regarding effective contraception.

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

Eumat contains methylparaben, propylparaben and sodium
This medicine contains methylparaben and propylparaben which
may cause allergic reactions (including delayed reactions).
This medicine contains less than 23 mg (1 mmol) of sodium per dose, i.e. it is practically ‘sodium-free’.

3. How to take Eumat

Take this medicine following exactly the instructions of 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. The 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 must be reduced.

Use in the elderly (over 65 years of age)
The doctor will determine the dose, considering a possible reduction of the above dosage.

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
Following the intake of an excessive dose of this medicine, abdominal pain may occur,
nausea, vomiting, increased breathing rate (hyperventilation), problems with the
stomach or intestines (peptic ulcer, erosive gastritis, gastrointestinal bleeding),
kidney problems and severe allergic reactions (anaphylactoid reactions). Rare cases of
increased blood pressure (hypertension), impaired lung function
(respiratory depression) and coma have been reported. The doctor will establish an adequate therapy.
In case of accidental intake of an excessive dose of this medicine, immediately notify
your doctor or go to the Emergency Room of the nearest hospital.

If you forget to take Eumat
Do not take a double dose to make up for a missed dose.
If you have any doubts 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.
The side effects that may occur with Eumat are:

Not known(frequency cannot be estimated from available data)

• infection of the central nervous system (aseptic meningitis);
• reduction in the number of platelets (thrombocytopenia), nosebleeds (epistaxis);
• severe allergic reactions (anaphylactic/anaphylactoid reactions), allergic reactions (hypersensitivity reactions): difficulty breathing (bronchospasm), increased blood vessel volume (vasodilation), flushing, rash, decreased blood pressure (hypotension), swelling of the throat (laryngeal edema);
• loss of appetite (anorexia), increased potassium in the blood (hyperkalemia), decreased sodium in the blood (hyponatremia);
• abnormal thoughts, mood disorders (depression), sleep disorders (insomnia), feelings of worry or fear (anxiety), nervousness, mental disorders (psychotic reactions), dreams

abnormal, feeling of well-being (euphoria), difficulty concentrating,
drowsiness, states of torpor, confusion;

• headache, dizziness, convulsions, sensory disturbance of legs and arms or other parts of the body (paresthesia), increased movements (hyperkinesia), altered taste;
• visual disturbances;
• ringing in the ear (tinnitus), hearing loss, vertigo;
• increased perception of heartbeat (palpitations), decreased heartbeat (bradycardia), swelling in various parts of the body due to fluid retention (edema), heart disorders (heart failure), increased blood pressure (hypertension), increased blood vessel volume (vasodilation), decreased blood pressure (hypotension), bruising (hematomas), sudden feeling of warmth (hot flashes), decreased skin color (pallor), bleeding from wounds after surgery (post-operative wound bleeding), heart attack, stroke;
• increased 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 can be life-threatening), nausea, vomiting, diarrhea, emission of gas from the intestine (flatulence), constipation, digestive difficulties (dyspepsia), abdominal pain/discomfort, feeling of fullness, passing 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 inflammation of the intestine (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 that can 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), blistering of the skin (bullous reactions), skin irritation (urticaria);
• muscle pain (myalgia);
• increased urine production (polyuria), frequent urination with small amounts of urine (pollakiuria), decreased urine output (oliguria), kidney problems (acute renal failure), blood and kidney problems (hemolytic uremic syndrome), kidney inflammation (interstitial nephritis), inability of the bladder to empty (urinary retention), protein loss in the urine (nephrotic syndrome), flank pain with or without blood in the urine (hematuria) or increased/decreased non-protein nitrogen in the blood (azotemia), increased creatinine and potassium;
• female infertility;
• fatigue (asthenia), fever, reactions at the injection site, swelling (edema), chest pain, excessive thirst;
• changes in laboratory tests: increased bleeding time, increased serum urea, increased creatinine, changes in liver function tests.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or 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 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 which is 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 must be used within 4 months of the first opening of the bottle.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Eumat contains

• The active ingredient is ketorolac tromethamine: 1 ml of solution contains 20 mg of ketorolac tromethamine.
• The other ingredients are: citric acid monohydrate, sodium dihydrogen phosphate monobasic, sodium methyl-parahydroxybenzoate, sodium propyl-parahydroxybenzoate, purified water q.s.

Description of the appearance of Eumat and contents of the pack
Eumat presents as a clear, colorless or yellowish solution, contained in an amber glass container with a polypropylene closure.
It is available in a pack of 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)

EUMAT 30 mg/ml injectable solution

Ketorolac tromethamine
Generic medicine

Read this leaflet carefully before you use 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Eumat and what is it used for

This medicine contains the active ingredient ketorolac tromethamine, belonging to a group
of medicines called non-steroidal anti-inflammatory drugs (“NSAIDs”), used to reduce pain
caused by inflammation.
Eumat is indicated for the treatment:

• of short duration (maximum two days) of acute moderate-to-severe pain after surgical operations (post-operative pain);
• of pain caused by renal colic.

This medicine is also used, when administered intravenously, in addition to pain-relieving medicines
derived from opium or similar to it (opioid analgesics), for the treatment of very intense pain or in cases of long-duration surgical interventions (major surgery).

2. What you need to know before using Eumat

Do not use Eumat

• if you are allergic to ketorolac or any of the other ingredients of this medicine (listed in section 6);
• if you have had an allergic reaction in the past after taking acetylsalicylic acid (aspirin), medicines that block the synthesis of inflammatory substances (prostaglandins) and/or other non-steroidal anti-inflammatory drugs;
• if you suffer from nasal polyps, a disease of the respiratory system characterized by the presence of polyps in the nose;
• if you have swelling of the face, lips, mouth, tongue or throat that can 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 if you have nasal congestion (rhinitis);
• if you suffer from, have suffered from or suspect you suffer from a problem with your stomach or intestines (active peptic ulcer, gastrointestinal bleeding or perforation);
• if you have a serious heart problem (severe heart failure);
• if you have or suspect you have a cerebral hemorrhage (stroke), or if you have had one in the past;
• if you have undergone surgery with a high risk of bleeding or incomplete cessation of blood loss (incomplete hemostasis);
• if you have any other bleeding problems;
• if you suffer from kidney problems (moderate or severe renal insufficiency 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 severe liver disease (liver cirrhosis or severe hepatitis);
• if you have a predisposition to bleeding (hemorrhagic diathesis) or a problem due to a defect in blood coagulation;
• if you are taking acetylsalicylic acid (aspirin), other non-steroidal anti-inflammatory drugs, medicines for mood disorders (lithium salts), medicines used to reduce uric acid levels in the blood (probenecid), medicines to eliminate fluids through the urine (diuretics) or medicines to prevent the formation of blood clots in the vessels (anticoagulants, e.g. pentoxifylline) (see section “Other medicines and Eumat”);
• for the prevention of pain (analgesia) before or during surgical procedures, because this medicine increases the risk of bleeding;
• if the person who needs to use this medicine is a child or adolescent under the age of 16;
• if you are in the last 3 months of pregnancy, near or during childbirth;
• if you are breastfeeding.

In addition, this medicine should not be used:

• in cases where the pain is mild or chronic;
• by injection via the epidural or intrathecal route, because it contains ethyl alcohol.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Eumat.

Use Eumat, under the direct supervision of your doctor because this medicine should not be used
in the treatment of mild or chronic pain. The doctor will prescribe the dose and duration
of the minimum therapy suitable for your problem, in order to reduce the occurrence of undesirable effects.
Avoid the consecutive or simultaneous use with other non-steroidal anti-inflammatory drugs (NSAIDs).
This medicine will be administered to you at the lowest doses and for short periods of time to
reduce the occurrence of side effects.

Use this medicine with great caution and under strict medical supervision:

• if you suffer from or have 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 possibility of injury or bleeding in the stomach or intestines, which can be life-threatening. In this case, the doctor may decide to reduce the dose or increase the time interval between administrations (see section “How to use Eumat”);
• if you suffer from or are predisposed to an inflammatory disease of the bronchi called bronchial asthma, as you may experience breathing crises (bronchospasm) or allergic reactions;
• if you have previously suffered from swelling of the face, lips, mouth, tongue or throat that can cause difficulty in swallowing and breathing (angioedema), asthma, bronchospasm or respiratory problems (complete or partial syndrome of nasal polyposis), as you may experience severe allergic reactions that can be life-threatening;
• if you suffer from or have suffered from heart problems (congestive heart failure, chronic ischemic heart disease, heart failure), high blood pressure (hypertension), reduced blood flow to the legs (peripheral arteriopathy) and the amount of oxygen to the brain (cerebrovascular disease) or 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 these cases, the risk of heart attack or stroke may increase;
• if you suffer from or have suffered from some kidney problems (nephrotoxicity, renal hypoperfusion, glomerulonephritis, interstitial nephritis, papillary necrosis, 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 your fertility.

Pay particular attention and tell your doctor if you experience during treatment:

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

Stop treatment with this medicine and see your doctor immediately in the
following cases:

• if you experience symptoms of an allergic reaction;
• if you experience bleeding (hemorrhage), lesions (ulcers) of the stomach or intestines;
• if you experience skin problems characterized by irritation, scaling, blistering or bleeding of the lips, eyes, mouth, nose and genitals.

During treatment with Ketorolac, small transient increases in some liver tests may occur
and also increases in transaminases. These abnormalities may be transient,
remain unchanged, or progress with continued therapy. In case of significant increases in
transaminases and symptoms of liver damage, such as loss of appetite, yellowing of the skin and
eyes, dark urine, itching or abdominal tenderness, stop treatment and consult your
doctor.
Cases of bruising (hematomas) have been reported after surgical operations (post-
operative period) and bleeding from wounds following the use of Eumat during or after surgical
procedures (peri-operative period). Therefore, inform your doctor if you are to undergo
tonsil removal surgery, prostate surgery (prostate resection) or cosmetic surgery.
Eumat can cause problems with the stomach and intestines, especially when used for
prolonged periods and without respecting the due warnings and precautions.
Tell your doctor if you have recently undergone or are about to undergo surgery
on the stomach or intestinal tract before using Eumat, as Eumat may sometimes
worsen wound healing in the intestine following surgery.
For those who play sports: the use of medicines containing ethyl alcohol may determine
positive results in doping tests in relation to the alcohol concentration limits indicated by some
sports federations.

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

Other medicines and Eumat
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or
may take any other medicine.

Do not use this medicine if you are taking:

• non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid (aspirin) because they increase the risk of side effects of Eumat
• lithium salts (used for the treatment of depression), probenecid (used to promote the elimination of uric acid with the urine), diuretics (used to eliminate fluids with the urine), or medicines to prevent the formation of blood clots in the vessels (anticoagulants, e.g. pentoxifylline).

If you are taking any of the following medicines, tell your doctor because these may
interact with Eumat:

• corticosteroids, medicines used for the treatment of inflammatory states, because they increase the risk of toxic effects of Eumat on the stomach and intestines;
• anticoagulants(for example warfarin, heparin, dextrans, antiplatelet agents, aspirin, pentoxifylline), medicines used to prevent the formation of blood clots in the vessels or selective serotonin reuptake inhibitors, medicines used for the treatment of mood disorders, because they may increase bleeding time and the risk of bleeding in the stomach or intestines;
• lithium, used for the treatment of depression and similar disorders or methotrexate, a chemotherapeutic agent, because their toxicity may increase;
• antihypertensivesor diuretics, medicines used for the control of blood pressure or heart disorders, because Eumat may reduce their effects. In this case, the risk of developing kidney problems (acute renal insufficiency) may increase if kidney function is already altered (e.g. if you are elderly or dehydrated). In this case, consult your doctor, as dose adjustments, water intake and kidney function checks are necessary;
• Ketorolac injectable solution may interact with furosemide, decreasing its diuretic action, therefore particular attention should be paid in patients with heart failure;
• probenecid, a medicine used to promote the elimination of uric acid with the urine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Do not use Eumat in the last 3 months of pregnancy, as it may harm the fetus or cause
problems during childbirth.
It may cause problems with the kidneys and heart of the fetus. It may affect your and the
child's tendency to bleed and delay or prolong labor more than expected.
You should not use Eumat in the first 6 months of pregnancy unless absolutely necessary and
under the advice of a doctor.
If treatment is necessary during this period or during attempts to conceive, the minimum dose should be used for the shortest possible time. From the 20th week of pregnancy,
Eumat may cause kidney problems in the fetus, if used for more than a few days, reducing
the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing a narrowing 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 plan to become
pregnant, you should inform your doctor because this medicine may reduce fertility.
The doctor will inform you about all measures regarding effective contraception.

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

Eumat contains ethanol and sodium
This medicine contains 96 mg of alcohol (ethanol) per vial, which is equivalent to 12.7% alcohol.
The amount of 1 ml 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 will not 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 following the instructions of your doctor, pharmacist or
nurse exactly. If you have any doubts, consult your doctor, pharmacist or nurse.
This medicine will be administered to you by a doctor or nurse, through injection into the
muscle (intramuscular) or injection into a vein (intravenous). The intravenous injection can be
performed only 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
drip (continuous infusion).
Use in adults
The recommended initial dose for intramuscular or intravenous administrations is 10 mg, followed by a
dose of 10-30 mg every 4-6 hours. The doctor will determine the appropriate dose depending on your
condition. The maximum dose is 90 mg per day.
If your body weight is less than 50 kg, the dose must be reduced.
For renal colic, the recommended dose is one 30 mg vial, for administration into the muscle
or vein.

Use in the elderly (over 65 years of age)
The doctor will determine the dose, evaluating a possible reduction of the above dosage. The maximum
dose, however, should 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. Safety and
efficacy in children have not been established.

If you use more Eumat than you should
Following the administration of an excessive dose of this medicine, abdominal pain may occur,
nausea, vomiting, increased breathing rate (hyperventilation), problems with the
stomach or intestines (peptic ulcer, erosive gastritis, gastrointestinal bleeding),
kidney problems and severe allergic reactions (anaphylactoid reactions). Rare cases of
increased blood pressure (hypertension), impaired lung function
(respiratory depression) and coma have been reported. The doctor will establish adequate therapy.
In case of accidental use/ingestion of an excessive dose of this medicine, immediately inform
your doctor or go to the Emergency Room of the nearest hospital.

If you forget to use Eumat
Do not use a double dose to make up for a missed 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 available data)

• infection of the central nervous system (aseptic meningitis);
• reduction in the number of platelets (thrombocytopenia), nosebleeds (epistaxis);
• severe allergic reactions (anaphylactic/anaphylactoid reactions), allergic reactions (hypersensitivity reactions): difficulty breathing (bronchospasm), increased blood vessel volume (vasodilation), flushing, rash, decreased blood pressure (hypotension), swelling of the throat (laryngeal edema);
• loss of appetite (anorexia), increased potassium in the blood (hyperkalemia), decreased 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 concentrating, drowsiness, states of stupor, confusion;
• headache, dizziness, convulsions, numbness of legs and arms or other parts of the body (paresthesia), increased movements (hyperkinesia), altered taste;
• visual disturbances;
• ringing in the ear (tinnitus), hearing loss, vertigo;
• increased awareness of heartbeat (palpitations), decreased heartbeat (bradycardia), swelling in various parts of the body due to fluid retention (edema), heart disorders (heart failure), increased blood pressure (hypertension), increased blood vessel volume (vasodilation), decreased blood pressure (hypotension), bruising (hematoma), sudden feeling of warmth (hot flushes), decreased skin color (pallor), bleeding from wounds after surgery (post-operative wound bleeding), heart attack, stroke;
• increased 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 can be life-threatening), nausea, vomiting, diarrhea, passage of gas from the intestine (flatulence), constipation, indigestion (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 inflammation of the intestine (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 that can 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), blistering of the skin (bullous reactions), skin irritation (urticaria);
• muscle pain (myalgia);
• increased urine production (polyuria), frequent urination in small amounts (pollakiuria), decreased urine output (oliguria), kidney problems (acute renal failure), blood and kidney problems (hemolytic uremic syndrome), kidney inflammation (interstitial nephritis), inability of the bladder to empty (urinary retention), protein loss with urine (nephrotic syndrome), flank pain with or without blood in the urine (hematuria) or increased/decreased non-protein nitrogen in the blood (azotemia), increased creatinine and potassium;
• female infertility;
• fatigue (asthenia), fever, injection site reactions, swelling (edema), chest pain, excessive thirst;
• changes in laboratory tests: increased bleeding time, increased serum urea, increased creatinine, changes in liver function tests.

Reporting of side effects
If you get any side effects, 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 Eumat

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is 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 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 Eumat contains

• The active ingredient is ketorolac tromethamine: 1 vial contains 30 mg of ketorolac tromethamine.
• The other ingredients are: ethyl alcohol, sodium chloride, sodium hydroxide, water for injections.

Description of the appearance of Eumat and contents of the pack
Eumat is presented as a clear, colorless or yellowish solution contained in a
amber glass container.
It is available in packs of 3 vials of 1 ml.

Marketing Authorisation 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