Benketol

Package leaflet: information for the patient

BENKETOL 30 mg/ml injectable solution

Ketorolac tromethamine
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 pharmacist.
• 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 may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What BENKETOL 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.
BENKETOL is indicated for the treatment:

• of short duration (maximum two days) of moderate to severe acute pain following surgical procedures (postoperative pain);
• of pain caused by renal colic.

This medicinal product 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 taking BENKETOL

Do not take BENKETOL

• 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, drugs that inhibit the synthesis of inflammatory substances (prostaglandins), 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 breathing or swallowing (angioedema);
• if you have difficulty breathing (bronchospasm);
• if you suffer from asthma (asthmatic attacks);
• if you currently have, have previously had, or suspect you may have a stomach or intestinal disorder (peptic ulcer, perforation);
• if you have had gastrointestinal bleeding;
• if you have a severe heart condition (severe heart failure);
• if you have moderate or severe kidney problems, or if you are at risk of kidney problems due to reduced blood volume (hypovolemia) or lack of water (dehydration);
• if you have severe liver disease (hepatic cirrhosis or severe hepatic insufficiency);
• if you have a tendency to bleed (hemorrhagic diathesis) or a disorder due to a blood coagulation defect;
• if you currently have or suspect 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 (coagulation disorders);
• if you are taking lithium salts (used for mood disorders), probenecid (used to reduce blood uric acid levels), diuretics (used to eliminate fluids via urine), or anticoagulants such as pentoxifylline (used to prevent blood clot formation in blood vessels) (see section “Other medicines and BENKETOL”);
• for pain prevention (analgesia) before or during surgical procedures, as this medicine increases the risk of bleeding;
• if the person to be treated 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. Warning: The use of injections via the epidural or intrathecal (neuraxial) route is contraindicated because the product contains ethanol.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using BENKETOL.
Use BENKETOL only under strict medical supervision, as this medicine must not be used for the treatment of mild or chronic pain.
Avoid concomitant use with other non-steroidal anti-inflammatory drugs (NSAIDs). Use this medicine at the lowest effective dose and for the shortest possible duration to minimize the occurrence of adverse effects.
Use this medicine with great caution and under strict medical supervision if:

• you are a woman planning to become pregnant, as it may impair fertility;
• you are elderly or debilitated, as this increases the risk of stomach and intestinal injuries and bleeding, which may be life-threatening. In such cases, your doctor may decide to reduce the dose and increase the interval between administrations (see section “How to use BENKETOL”);
• you currently have or have previously had gastrointestinal disorders;
• you suffer from asthma or are predisposed to it, as you may experience respiratory crises (bronchospasm), allergic reactions, or shock;
• you currently have or have previously had heart problems, high blood pressure, reduced blood flow to the legs, or reduced oxygen supply to the brain. Inform your doctor before using BENKETOL, as it may increase the risk of heart attack or stroke;
• you believe you are at risk of cardiovascular disease (high blood pressure, diabetes, high cholesterol levels, or smoking). Inform your doctor before using BENKETOL, as it may increase the risk of heart attack or stroke;
• you currently have or have previously had kidney problems;
• you have liver problems;
• you have previously experienced swelling of the face, lips, mouth, tongue, or throat causing breathing or swallowing difficulties (angioedema), breathing difficulties (e.g., asthma), or nasal polyps, as you may develop severe, potentially life-threatening allergic reactions.

Inform your doctor if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract before receiving/using BENKETOL, as BENKETOL may occasionally impair intestinal wound healing after surgery.
Discontinue treatment with this medicine and consult your doctor if:

• you develop gastrointestinal bleeding or ulcers;
• you experience impaired liver function;
• you develop a skin rash, mucosal lesions, or any other sign of an allergic reaction.

Cases of bruising after surgery and bleeding from surgical wounds have been reported following the use of BENKETOL before or after surgical procedures. Therefore, inform your doctor if you are scheduled for tonsillectomy, prostate surgery, or cosmetic surgery.

Children
This medicine is not recommended for children and adolescents under 16 years of age.
BENKETOL 30 mg/ml injectable solution contains ethanol
This medicine contains 12.3% vol ethanol, i.e., up to 100 mg of ethyl alcohol per vial, equivalent to approximately 2.5 ml of beer and 1.0 ml of wine per dose. It may be harmful to alcoholics.
This should be considered in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy. The alcohol content in this medicine may alter the effects of other medicines.
The alcohol content in this medicine may impair your ability to drive vehicles or operate machinery.
For athletes: The use of medicines containing ethyl alcohol may result in a positive anti-doping test, depending on the blood alcohol concentration limits set by certain sports federations.

Other medicines and BENKETOL
Inform your doctor, pharmacist, or nurse if you are currently using, have recently used, or might use 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. If you are taking any of the following medicines, inform your doctor, as they may interact with BENKETOL:
• corticosteroids, used to treat inflammatory conditions. This combination increases the risk of gastrointestinal adverse effects.
• anticoagulants (warfarin, heparin, dextran, antiplatelet agents, aspirin, pentoxifylline), used to prevent blood clot formation in blood vessels, or selective serotonin reuptake inhibitors (SSRIs), used to treat mood disorders, as they may increase the risk of gastrointestinal bleeding;
• methotrexate, a chemotherapeutic agent;
• lithium, used to treat depression and similar disorders;
• digoxin, used to treat heart conditions;
• antihypertensives or diuretics, medicines used to control blood pressure or heart disorders, as BENKETOL may reduce their effectiveness. In such cases, the risk of developing kidney problems may increase if kidney damage is already present (e.g., in elderly or dehydrated patients). Consult your doctor, as dose adjustments, increased fluid intake, and periodic kidney function monitoring may be necessary.
• probenecid, used to promote the urinary excretion of uric acid.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Fertility
BENKETOL may cause fertility problems in women. Consult your doctor if you are planning a pregnancy.
Pregnancy
Do not take BENKETOL during the last trimester of pregnancy. It may cause problems for the baby and delivery. It may cause kidney and heart problems in the newborn. It may affect your and your baby’s tendency to bleed and may cause delayed or prolonged labor.
You should not take BENKETOL during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while planning a pregnancy, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from the 20th week of pregnancy onwards, BENKETOL may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If prolonged treatment is required, your doctor may recommend additional monitoring.
Breastfeeding
Do not use this medicine if you are breastfeeding, as ketorolac passes into breast milk.
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 vehicles or operating machinery.

3. How to use BENKETOL

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 by a doctor or nurse via intramuscular injection or intravenous injection. Intravenous administration must only be performed in hospitals and other medical facilities.
Do not use BENKETOL for epidural or intrathecal administration, and do not mix this medicine in the same syringe with morphine, meperidine, promethazine, or hydroxyzine.
Do not use this medicine for longer than 2 days if the dose is administered all at once (bolus administration), or for longer than 1 day if the dose is administered by infusion (continuous infusion).
Use this medicine at the lowest effective dose according to your condition.

Use in adults
The recommended initial dose for intramuscular or intravenous administration is 10 mg; subsequently, the dose is 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. Do not exceed the recommended maximum dose.
If your body weight is less than 50 kg, the dose should be reduced.
For renal colic, the recommended dose is one 30 mg vial, administered intramuscularly or intravenously.

Use in elderly patients over 65 years of age
Your doctor will determine the dose and may consider dose reduction. Do not exceed the maximum daily dose of 60 mg.

Use in children and adolescents
This medicine must not be administered to children and adolescents under 16 years of age. The safety and efficacy in children have not been established.

If you take more BENKETOL than you should
If you (or someone else) have taken an excessive dose of BENKETOL, or if you suspect that a child has taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
After an overdose of this medicine, abdominal pain, nausea, vomiting, increased breathing rate (hyperventilation), gastrointestinal problems, kidney problems (of varying severity), and severe allergic reactions may occur. Rare cases of increased blood pressure, respiratory depression, and coma have been reported.

If you forget to use BENKETOL
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, 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 BENKETOL are:
Not known (frequency cannot be established from the 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 in breathing (bronchospasm), widening of blood vessels (vasodilation), skin irritation (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 disorder (depression), sleep disturbance (insomnia), feelings of worry or fear (anxiety), irritability, nervousness, mental disorders (psychotic reactions), abnormal dreams (abnormal dream activity), hallucinations, feeling of well-being (euphoria), difficulty in concentration, drowsiness, confusion;

• headache (cephalalgia), dizziness, seizures, disturbances in sensation of arms, legs or other body parts (paresthesia), increased movements (hyperkinesia), disturbances in taste;

• visual disturbances;

• ringing in the ears (tinnitus), hearing loss, vertigo;

• increased awareness of heartbeat (palpitations), reduced heartbeat (bradycardia), inability of the heart to pump adequate blood (heart failure), swelling in various parts of the body due to fluid accumulation (edema), heart disorders (hypertension and cardiac failure), reduction in blood pressure (hypotension), bruising (hematomas), sudden sensation of warmth (flushing), 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), noisy expulsion of gas from the stomach through the mouth (eructation), 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 due to fluid accumulation around the mouth and eyes (angioedema), skin lesions (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis), increased sweating, red spots on the skin (maculopapular rash), skin irritation (urticaria), itching, rupture of capillaries under the skin (purpura), appearance of blisters on the skin (bullous reactions);

• muscle pain (myalgia);

• increased urine production (polyuria), frequent passage of small amounts of urine (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 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, alterations 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 www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BENKETOL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
The reconstituted solution must be used immediately, and any remaining unused portion must be discarded.
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 you no longer use. This will help protect the environment.

6. Package contents and other information

What BENKETOL contains

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

Description of the appearance of BENKETOL and contents of the pack
Injectable solution.
Carton pack containing 3 glass vials of 1 ml.
Marketing Authorization Holder
Pharmaber S.r.l., Corso Magenta 32 – 20123 Milano - Italy
Manufacturer
ESSETI Farmaceutici S.r.l. - Via Campobello, 15 - 00071 Pomezia (Rome) - Italy

Patient Information Leaflet

BENKETOL 20 mg/ml oral drops, solution

Ketorolac tromethamol
Equivalent medicinal product
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to 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 or pharmacist. See section 4.

Contents of this leaflet:

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

1. What BENKETOL is and what it is used for

This medicine 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.
BENKETOL is indicated only for short-term treatment (maximum five days) of moderate pain following
surgical procedures (postoperative pain).

2. What you need to know before taking BENKETOL

Do not take BENKETOL

• 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, drugs that block the synthesis of inflammatory substances (prostaglandins), or other non-steroidal anti-inflammatory drugs (NSAIDs);
• if you have a respiratory disease characterized by the presence of nasal polyps (nasal polyposis);
• if you have swelling due to fluid accumulation around the mouth and eyes (angioedema);
• if you have difficulty breathing (bronchospasm);
• if you suffer from asthma;
• if you currently have, have had, or suspect you may have a stomach or intestinal disorder (peptic ulcer, gastrointestinal bleeding or perforation), even if this occurred following previous treatment with non-steroidal anti-inflammatory drugs;
• if you have a serious heart condition (severe heart failure);
• if you have kidney problems (moderate or severe renal insufficiency), or if you are at risk of kidney problems due to reduced blood volume (hypovolemia) or lack of water (dehydration);
• if you have a severe 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 currently have or suspect you may have a brain hemorrhage (stroke), or if you have had one in the past; if you have undergone high-risk surgical procedures for bleeding or incomplete stopping of bleeding (incomplete hemostasis);
• if you have any other bleeding disorder;
• if you are taking acetylsalicylic acid, other non-steroidal anti-inflammatory drugs, drugs to prevent blood clot formation in vessels (anticoagulants, e.g., pentoxifylline), drugs for mood disorders (lithium salts), drugs used to reduce uric acid levels in blood (probenecid), or drugs to eliminate fluids through urine (diuretics) (see section "Other medicines and BENKETOL");
• for pain prevention (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;
• in cases where pain is mild or chronic.

Warnings and precautions
Talk to your doctor or pharmacist before taking BENKETOL.
Take BENKETOL under direct medical supervision because 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. Inform your doctor before taking this medicine:

• if you currently have or have previously had stomach or intestinal disorders;
• 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 BENKETOL");
• if you currently have or are predisposed to bronchial inflammatory disease called bronchial asthma, as you may experience respiratory attacks (bronchospasm) or allergic reactions;
• if you have previously experienced swelling due to fluid accumulation around the mouth and eyes (angioedema), asthma, bronchospasm, or respiratory problems (nasal polyposis), as you may experience severe allergic reactions that could be life-threatening;
• if you currently have or have previously had heart problems, high blood pressure (hypertension), reduced blood flow to the legs (peripheral arterial disease) or to the brain (cerebrovascular disease), or if you think you may be at risk for these conditions (e.g., if you have high blood pressure, diabetes, high blood lipid levels, or if you smoke). In these cases, the risk of heart attack or stroke may increase;
• if you currently have or have previously had kidney problems;
• if you are allergic to acetylsalicylic acid, other non-steroidal anti-inflammatory drugs (NSAIDs), or ketorolac, as you may experience severe allergic reactions;
• if you currently have or have previously had liver problems;
• if you have blood coagulation disorders, as this medicine may increase the risk of bleeding;
• if you are scheduled for surgery, as this medicine interferes with blood coagulation;
• if you are a woman with fertility issues and are planning a pregnancy, as this medicine may interfere with fertility.

Inform your doctor if you have recently undergone or are scheduled to undergo stomach or intestinal
surgery before receiving/using/taking BENKETOL, as BENKETOL may sometimes impair wound
healing in the intestine following surgery.
Avoid taking this medicine in the following cases:

• if you are taking medicines that may cause stomach or intestinal problems, or medicines that promote fluid elimination through urine (diuretics) (see section "Other medicines and BENKETOL").

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

• you experience symptoms of an allergic reaction;
• you experience bleeding (hemorrhages), or lesions (ulcers) in the stomach or intestine;
• you experience liver problems;
• you develop skin problems characterized by irritation, peeling, blistering, or bleeding of the lips, eyes, mouth, nose, and genitals. Cases of bruising (hematomas) after surgery (post-operative period) and bleeding from wounds following use of BENKETOL before 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. BENKETOL may cause stomach and intestinal problems, especially when used for prolonged periods or without observing proper warnings and precautions.

Children and adolescents
This medicine is not recommended for children and adolescents under 16 years of age.
Other medicines and BENKETOL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take this medicine if you are taking:

• non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid (aspirin), as they increase the risk of adverse effects. If you are taking any of the following medicines, inform your doctor as they may interact with BENKETOL:
• corticosteroids, medicines used to treat inflammatory conditions, as they increase the risk of gastrointestinal adverse effects;
• anticoagulants (e.g., warfarin, heparin, dextrans, pentoxifylline), medicines used to prevent blood clot formation in vessels, or selective serotonin reuptake inhibitors (SSRIs), medicines used to treat mood disorders, as they may increase the risk of gastrointestinal bleeding;
• digoxin, a medicine used to treat heart problems;
• 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 disorders, as BENKETOL may reduce their effectiveness;
• probenecid, a medicine used to promote urinary excretion of uric acid.

BENKETOL contains methyl parahydroxybenzoate and propyl parahydroxybenzoate
This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause
allergic reactions (including delayed reactions).
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult
your doctor or pharmacist before taking this medicine.
Fertility
BENKETOL may cause fertility problems in women. Therefore, if you plan to become pregnant, you must inform your doctor, as this medicine may reduce fertility.
Pregnancy
Do not take BENKETOL during the last trimester of pregnancy. It may cause problems for the baby and delivery.
It may cause kidney and heart problems in the unborn child. It may affect your and your baby’s tendency to bleed and may cause delayed or prolonged labor.
You must not take BENKETOL during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while planning pregnancy, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from the 20th week of pregnancy onwards, BENKETOL may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment for more than a few days is required, your doctor may recommend additional monitoring.
Breastfeeding
Do not take this medicine if you are breastfeeding, as it passes into breast milk.
Driving and using 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.

3. How to take BENKETOL

Take this medicine exactly as instructed 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 based on your condition. The maximum dose is 40 mg per day. Do not exceed the recommended maximum dose.
If your body weight is less than 50 kg, the dose should be reduced.
Use in elderly (age over 65 years):
Your doctor will determine the dose and assess whether dose reduction is necessary.
Use in children and adolescents:
Do not administer this medicine to children and adolescents under 16 years of age. The safety and efficacy in these populations have not been established.
Instructions for opening and using the bottle:

1. To open the bottle, press down on the cap and simultaneously unscrew it.

2. Hold the bottle in an upright position and dispense the drops into a glass. Do not shake the bottle. If drops do not flow easily, tap gently on the bottom of the bottle.

3. Replace the cap and screw it tightly to close the bottle.

The oral drop formulation is particularly suitable for patients with swallowing difficulties.
If you take more BENKETOL than you should:
If you (or someone else) have taken an excessive dose of BENKETOL, or if you suspect that a child may have ingested this medicine, contact your doctor immediately or go to the nearest hospital Emergency Department. After taking an excessive dose of this medicine, symptoms such as 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 initiate appropriate treatment.
Take this leaflet, the bottle, and its container with you to the hospital or doctor so that they know which medicine has been taken.
If you forget to take BENKETOL:
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 everyone experiences them.
Side effects that may occur with BENKETOL are:
Not known (frequency cannot be estimated from the available data)

• central nervous system infection (aseptic meningitis);
• reduced platelet count (thrombocytopenia);
• nosebleed (epistaxis);
• severe allergic reactions (anaphylactic/anaphylactoid reactions), allergic reactions (hypersensitivity reactions): difficulty breathing (bronchospasm), widening of blood vessels (vasodilation), skin irritation (rash), reduced 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 disorder (depression), sleep disturbance (insomnia), feelings of worry or fear (anxiety), irritability, nervousness, mental disorders (psychotic reactions), abnormal dreams (abnormal dream activity), hallucinations, feeling of well-being (euphoria), difficulty concentrating, drowsiness, confusion;
• headache (cephalalgia), dizziness, seizures, disturbance of sensation in arms and legs or other parts of the body (paraesthesia), increased movement (hyperkinesia), taste disturbances;
• visual disturbances;
• ringing in the ear (tinnitus), hearing loss, vertigo;
• increased awareness of heartbeat (palpitations), reduced heart rate (bradycardia), inability of the heart to pump adequate blood (heart failure), swelling in various parts of the body due to fluid accumulation (edema), heart disorders (hypertension and heart failure), reduced blood pressure (hypotension), bruising (hematomas), sudden sensation of heat (hot flushes), skin 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, passing gas from the intestine (flatulence), constipation, digestive difficulties (dyspepsia), abdominal pain/discomfort, feeling of fullness, passage of dark stools (melena), rectal bleeding, vomiting blood (hematemesis), inflammation of the mouth (stomatitis and ulcerative stomatitis), inflammation of the esophagus (esophagitis), noisy release of gas from the stomach through the mouth (eructation), 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 liver to intestine with yellowing of the skin (cholestatic jaundice);
• swelling due to fluid accumulation around the mouth and eyes (angioedema), skin lesions (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis),
  increased sweating, red spots on the skin (maculopapular rash), skin irritation (urticaria), itching, rupture of capillaries under the skin (purpura), appearance of blisters on the skin (bullous reactions);
• increased urine production (polyuria), frequent passage of small amounts of urine (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 presence of blood in urine (hematuria) or increase/decrease in non-protein nitrogen levels in 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, abnormalities in liver function tests.

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

5. How to store BENKETOL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store in the original packaging to protect the product from light.
Period of validity after first opening of the bottle
The product must be used within 6 months of 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 no longer in use. This will help protect the environment.

6. Package contents and other information

What BENKETOL contains

• The active substance is ketorolac trometamol: 1 ml of solution contains 20 mg of ketorolac trometamol.
• The other components are: anhydrous citric acid, sodium dihydrogen phosphate dihydrate, methylparahydroxybenzoate, propyl-parahydroxybenzoate, sodium hydroxide, purified water.

Description of the appearance of BENKETOL and contents of the pack
The pack contains a 10 ml bottle.
Marketing Authorization Holder
Pharmaber S.r.l., Corso Magenta 32 – 20123 Milano - Italy
Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo 1- 03012 Anagni (FR) - Italy