Package leaflet: Information for the patient

KEVINDOL 20 mg/ml oral drops, solution

ketorolac tromethamine
Equivalent medicine
Please 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 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 adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Kevindol 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.
Kevindol is indicated only for the short-term treatment (maximum five days) of moderate pain following surgical operations (postoperative pain).

2. What you need to know before taking Kevindol

Do not take Kevindol

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 inhibit 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, rhinitis, or urticaria;
if you currently have, have previously had, or suspect you may have a stomach or intestinal disorder (peptic ulcer, gastrointestinal bleeding or perforation), even if it occurred during 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 serious liver disease (liver 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 have, or have previously had, a brain hemorrhage (stroke); if you have undergone high-risk surgical procedures with a risk of bleeding or incomplete control of bleeding (incomplete hemostasis);
if you have any other bleeding disorder;
if you are taking acetylsalicylic acid, other non-steroidal anti-inflammatory drugs, drugs used to prevent blood clot formation in blood vessels (anticoagulants, e.g. pentoxifylline), drugs used for mood disorders (lithium salts), drugs used to reduce uric acid levels in the blood (probenecid), or drugs used to eliminate fluids through urine (diuretics) (see section “Other medicines and Kevindol”);
for the 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;
in cases where pain is mild or chronic.

Warnings and precautions
Talk to your doctor or pharmacist before taking Kevindol.
Take Kevindol 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 injury 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 Kevindol”);
if you currently have 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 due to fluid accumulation around the mouth and eyes (angioedema), asthma, bronchospasm, or respiratory problems (nasal polyposis), as you may develop 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. Use of Kevindol may alter certain tests assessing liver function.
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.
if you have recently undergone or are about to undergo stomach or intestinal surgery before receiving/using/taking Kevindol, as Kevindol 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 Kevindol”).

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

if you develop symptoms of an allergic reaction;
if you experience bleeding (hemorrhages), or lesions (ulcers) in the stomach or intestine;
if you show clear clinical signs of liver dysfunction;
if 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 surgical wounds following the use of Kevindol before or after surgery (peri-operative period) have been reported. Therefore, inform your doctor if you are scheduled for tonsillectomy, prostate surgery (prostate resection), or cosmetic surgery.
Kevindol may cause stomach and intestinal problems, especially when used for prolonged periods and without observing the necessary warnings and precautions.
Children and adolescents
This medicine is not recommended for children and adolescents under 16 years of age.
Other medicines and Kevindol
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 Kevindol:

corticosteroids, medicines used to treat inflammatory conditions, as they increase the risk of adverse effects on the stomach and intestine;
anticoagulants (e.g. warfarin, heparin, dextrans, 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 the risk of gastrointestinal bleeding;
digoxin, a medicine used to treat heart conditions;
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 Kevindol may reduce their effectiveness;
probenecid, a medicine used to promote the urinary excretion of uric acid.

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
Kevindol may cause fertility problems in women. Therefore, if you plan to become pregnant, you should inform your doctor, as this medicine may reduce fertility.
Pregnancy
Do not take Kevindol during the last 3 months of pregnancy, as it may harm the fetus or cause problems 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 beyond normal. You should not take ketorolac tromethamine 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 possible dose for the shortest possible time should be used. From the 20th week of pregnancy, ketorolac tromethamine may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid 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.
Take Kevindol during the first 6 months of pregnancy only if absolutely necessary and under direct medical supervision.
Breastfeeding
Do not take this medicine if you are breastfeeding, as it passes into breast milk.
Driving and use of machinery
This medicine may cause drowsiness, dizziness, vertigo, sleep disorders (insomnia), or mood disturbances (depression). If you experience any of these effects, avoid driving or operating machinery.
Kevindol contains methyl parahydroxybenzoate and propyl parahydroxybenzoate

This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially "sodium-free".

3. How to take Kevindol

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 patients (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 individuals have not been established.
Instructions for opening and using the bottle:

To open the bottle, press down on the cap and at the same time unscrew it.

Diagram showing two downward-pointing arrows indicating the removal of the cap from a medicine vial, with a curved lateral arrow

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 the bottom of the bottle.

A hand pouring the contents of a vial into a glass held by another hand

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

Schematic drawing of a medicine vial with a curved arrow indicating the direction

The oral drop formulation is particularly suitable for patients with swallowing difficulties.
If you take more Kevindol than you should
If you (or someone else) have taken an excessive dose of Kevindol, or if you suspect that a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital Emergency Department.
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 determine appropriate treatment.
Bring this leaflet, the bottle, and its container with you to the hospital or doctor so they know which medicine has been taken.
If you forget to take Kevindol
Do not take a double dose to make up for a forgotten 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.
The side effects that may occur with Kevindol are:
Not known (frequency cannot be established from the available data)

central nervous system infection (aseptic meningitis);
reduction in the number of platelets (thrombocytopenia);
nosebleeds (epistaxis);
severe allergic reactions (anaphylactic/anaphylactoid reactions), allergic reactions (hypersensitivity reactions): difficulty 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 levels in the blood (hyperkalemia), reduced sodium levels in the blood (hyponatremia);
abnormal thoughts, mood disturbance (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, disturbances in sensation of limbs or other body parts (paresthesia), increased motor activity (hyperkinesia), taste disturbances;
visual disturbances;
ringing in the ears (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), reduction in blood pressure (hypotension), bruising (hematomas), sudden sensation of warmth (hot flushes), loss of skin color (pallor), bleeding from wounds after surgery (postoperative 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 dark stools (melena), bleeding from the rectum, 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 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);
increased urine production (polyuria), frequent passage of small amounts of urine (pollakiuria), decreased 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 increased/decreased levels of non-protein nitrogen in 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, abnormalities in liver function tests.

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

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 product from light.
Period of validity after first opening of the bottle
The product must be used within 6 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 Kevindol contains

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

Description of the appearance of Kevindol and contents of the pack
The pack contains one 10 ml glass vial.
Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22 – 00071 Pomezia (Rome) - Italy
Manufacturer
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR) - Italy

Patient information leaflet

Kevindol 30 mg/ml injectable solution

ketorolac tromethamine
Generic medicine
Please 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 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 side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

of short-term (maximum two days) 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 need to know before taking Kevindol

Do not take Kevindol

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, medicines that block the synthesis of inflammatory substances (prostaglandins), or other non-steroidal anti-inflammatory drugs (NSAIDs);
if you suffer from nasal polyposis, 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 breathing or swallowing difficulties (angioedema);
if you have breathing difficulties (bronchospasm);
if you suffer from asthma (asthma attacks), rhinitis, or urticaria;
if you currently have, have had, or suspect you may have a stomach or intestinal disorder (peptic ulcer, perforation);
if you have experienced gastrointestinal bleeding;
if you have severe heart problems (severe heart failure);
if you have reduced blood volume (hypovolemia) or body fluid levels (dehydration);
if you have moderate or severe kidney problems or are at risk of kidney problems due to reduced blood volume (hypovolemia) or lack of water (dehydration);
if you have severe liver disease (liver 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 have previously had a brain hemorrhage (stroke);
if you have undergone high-risk surgical procedures with a risk of bleeding or incomplete control of bleeding (incomplete hemostasis);
if you have any other bleeding disorders (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 Kevindol”);
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.

Warning: The use of epidural or intrathecal (neuraxial) injections is contraindicated
because the product contains ethanol.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Kevindol.
Use Kevindol 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 close 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 doses (see section “How to use Kevindol”);
you currently have or have had stomach or intestinal disorders;
you suffer from asthma or are predisposed to it, as you may experience respiratory attacks (bronchospasm), allergic reactions, or shock;
you currently have or have had heart problems, high blood pressure, reduced blood flow to the legs, or reduced oxygen supply to the brain. Inform your doctor before using Kevindol, 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 Kevindol, as it may increase the risk of heart attack or stroke;
you currently have or have had kidney problems;
you currently have or have had liver problems. The use of Kevindol may cause abnormalities in certain liver function tests.
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 experience severe, potentially life-threatening allergic reactions.

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

you experience bleeding (hemorrhage) or ulcers in the stomach or intestines;
you show clear clinical signs of liver dysfunction;
you develop a skin rash, mucosal lesions, or any other signs of an allergic reaction.

Cases of bruising after surgery and bleeding from surgical wounds have been reported following the use of Kevindol before or after surgical procedures. Therefore, inform your doctor if you are scheduled for tonsillectomy, prostate surgery, or cosmetic surgery.
Children and adolescents
This medicine is not recommended for children and adolescents under 16 years of age.
Other medicines and Kevindol
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 Kevindol:

corticosteroids, used to treat inflammatory conditions. This combination increases the risk of gastrointestinal adverse effects.
anticoagulants (warfarin, heparin, dextrans, 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 Kevindol may reduce their effectiveness. In such cases, the risk of 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
Kevindol may cause fertility problems in women. Consult your doctor if you are planning a pregnancy.
Pregnancy
Do not take Kevindol 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 take ketorolac tromethamine 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 the 20th week of pregnancy, ketorolac tromethamine may cause fetal kidney problems if taken for more than a few days, leading to reduced levels of amniotic fluid surrounding the baby (oligohydramnios) or constriction of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring. Take Kevindol during the first 6 months of pregnancy only if strictly necessary and under direct medical supervision.
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 these effects, avoid driving or operating machinery.
Important information on certain excipients
This medicine contains 100 mg of ethanol (alcohol) per vial, equivalent to 10% p/v, corresponding to 1 ml of wine or 2.5 ml of beer. Therefore, the product may be harmful to alcoholics and should be administered with caution in at-risk patient groups such as those with liver disease or epilepsy. Injections must be performed according to strict sterilization, aseptic, and antiseptic procedures.
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e., essentially sodium-free.

3. How to use Kevindol

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 nurse via injection into the muscle (intramuscular) or into the vein (intravenous). Intravenous injection can only be performed in hospitals and other medical facilities.
Do not use Kevindol 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 more than 2 days if the dose is administered all at once (bolus administration), or for more than 1 day if the dose is administered via 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; thereafter, the dose will be 10–30 mg every 4–6 hours. Your doctor will determine the 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 assess whether dose reduction is necessary. 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 use more Kevindol than you should
If you (or someone else) have taken an excessive dose of Kevindol, or if you suspect that a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital Emergency Department.
After administration of an excessive dose 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 Kevindol
Do not use a double dose to make up for a forgotten dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
The adverse effects that may occur with Kevindol are:
Not known (frequency cannot be established 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 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, disturbance of sensation in legs, arms, or other parts of the body (paraesthesia), increased movement (hyperkinesia), disturbances of taste;
visual disturbances;
ringing in the ears (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 cardiac failure), reduction in blood pressure (hypotension), bruising (hematomas), sudden sensation of warmth (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 intestinal gas (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, hepatic failure), reduced bile flow 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 renal 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;
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 adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store Kevindol

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.
The reconstituted solution must be used immediately, and any unused portion must be discarded.
Store in the original packaging to protect the medicine from light.
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 Kevindol contains

The active substance is ketorolac trometamol. Each vial contains 30 mg of ketorolac trometamol.
The other components are: ethyl alcohol, sodium chloride, water for injections.

Description of the appearance of Kevindol and contents of the pack
Injectable solution.
Carton pack containing 3 glass vials of 1 ml.
The solution is clear and slightly yellowish; this colouration does not affect the efficacy and safety of the medicinal product.

Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (Rome) - Italy

Manufacturer
ESSETI Farmaceutici S.r.l.
Via Campobello, 15
00071 Pomezia (Rome) - Italy

BIOMEDICA FOSCAMA INDUSTRIA CHIMICO-FARMACEUTICA S.P.A.
Via Morolense, 87
03013 Ferentino (FR)
Italy

Patient Information Leaflet

Kevindol 30 mg/ml injection solution

ketorolac tromethamine
Equivalent medicine
Please 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 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 side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Kevindol is and what it is used for

This medicinal product contains the active substance ketorolac trometamol, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs ("NSAIDs"), used to reduce pain caused by inflammation.
Kevindol is indicated for the treatment:

of short duration (maximum two days) of moderate to severe acute pain following surgical operations (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 need to know before taking Kevindol

Do not take Kevindol

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, medicines that block 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 breathing or swallowing (angioedema);
if you have difficulty breathing (bronchospasm);
if you suffer from asthma (asthmatic attacks), rhinitis, or urticaria;
if you currently have, have had, or suspect you may have a stomach or intestinal problem (peptic ulcer, perforation);
if you have had gastrointestinal bleeding;
if you have a severe heart condition (severe heart failure);
if you have reduced blood volume (hypovolemia) or reduced body fluids (dehydration);
if you have moderate or severe kidney problems or are at risk of kidney problems due to reduced blood volume (hypovolemia) or lack of water (dehydration);
if you have severe liver disease (liver cirrhosis or severe hepatic insufficiency);
if you have a tendency to bleed (hemorrhagic diathesis) or a condition due to a blood coagulation disorder;
if you currently have or suspect you have, or have previously had, a brain hemorrhage (stroke);
if you have undergone high-risk surgical procedures with a risk of bleeding or incomplete hemostasis;
if you have any other bleeding disorders (coagulation disorders);
if you are taking lithium salts (used for mood disorders), probenecid (used to reduce uric acid levels in the blood), diuretics (used to eliminate fluids via urine), or anticoagulants such as pentoxifylline (used to prevent blood clot formation in vessels) (see section "Other medicines and Kevindol");
for the 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 delivery;
if you are breastfeeding.

Warning: The use of epidural or intrathecal (neuraxial) injections is contraindicated because this medicine contains ethanol.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Kevindol.
Use Kevindol 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 risk of adverse effects.
Use this medicine with great caution and under close 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 doses (see section "How to use Kevindol");
you currently have or have previously had stomach or intestinal 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 Kevindol, 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 Kevindol, as it may increase the risk of heart attack or stroke;
you currently have or have previously had kidney problems;
you currently have or have previously had liver problems. The use of Kevindol may cause abnormalities in certain liver function tests;
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 stomach or intestinal surgery before receiving or using Kevindol, as Kevindol 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 show clear clinical signs of liver dysfunction;
you develop a skin rash, mucosal lesions, or any other signs of an allergic reaction.

Children and adolescents
This medicine is not recommended for children and adolescents under 16 years of age.

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

other 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 Kevindol:

corticosteroids, used to treat inflammatory conditions. This combination increases the risk of gastrointestinal adverse effects;
anticoagulants (warfarin, heparin, dextrans, antiplatelet agents, aspirin, pentoxifylline), used to prevent blood clot formation in 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 conditions, as Kevindol 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, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Fertility
Kevindol may cause fertility problems in women. Consult your doctor if you are planning a pregnancy.

Pregnancy
Do not take Kevindol during the last 3 months of pregnancy, as it may harm the fetus or cause complications during delivery. 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 more than expected. You should not take ketorolac tromethamine 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 possible dose for the shortest possible duration should be used. From week 20 of pregnancy, ketorolac tromethamine may cause kidney problems in the fetus if taken 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 required for more than a few days, your doctor may recommend additional monitoring. Take Kevindol during the first 6 months of pregnancy only if absolutely necessary and under direct medical supervision.

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 or operating machinery.

Important information about certain excipients
This medicine contains 100 mg of ethanol (alcohol) per vial, equivalent to 10% p/v, corresponding to 1 ml of wine or 2.5 ml of beer. Therefore, the product may be harmful to alcoholics and should be administered with caution in at-risk patient groups, such as those with liver disease or epilepsy. Injections must be performed according to strict sterilization, aseptic, and antiseptic procedures.
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e., essentially sodium-free.

3. How to use Kevindol

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 nurse via injection into the muscle (intramuscular) or into the vein (intravenous). Intravenous injection can only be performed in hospitals and other medical facilities.
Do not use Kevindol 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 1 day if the dose is administered via 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 will be 10–30 mg every 4–6 hours. Your doctor will determine the 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 reducing it. 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 use more Kevindol than you should
If you (or someone else) have taken an excessive dose of Kevindol, or if you suspect that a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
After administration of an excessive dose 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 Kevindol
Do not use a double dose to make up for a forgotten 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 everyone will experience them.
The side effects that may occur with Kevindol are:
Not known (frequency cannot be established from the available data):

central nervous system infection (aseptic meningitis);
decrease in 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), reduction in blood pressure (hypotension);
swelling of the throat (laryngeal edema);
loss of appetite (anorexia), increased potassium levels in the blood (hyperkalemia), decreased sodium levels in the blood (hyponatremia);
abnormal thoughts, mood disturbance (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, disturbances in sensation of legs, arms or other body parts (paraesthesia), increased movement (hyperkinesia), disturbances in taste;
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), reduction in blood pressure (hypotension), bruising (hematomas), sudden sensation of warmth (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 dark stools (melena), bleeding from the rectum, 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);
muscle pain (myalgia);
increased urine production (polyuria), frequent passage of small amounts of urine (pollakiuria), decreased 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 increased/decreased levels of non-protein nitrogen in blood (azotemia), increased creatinine and potassium levels;
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, 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 Kevindol

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.
The reconstituted solution must be used immediately, and any remaining residues 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 Kevindol contains

The active substance is ketorolac trometamol. Each vial contains 30 mg of ketorolac trometamol.
The other components are: ethyl alcohol, sodium chloride, water for injections.

Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (Rome) - Italy

Manufacturer
ESSETI Farmaceutici S.r.l.
Via Campobello, 15
00071 Pomezia (Rome) - Italy

BIOMEDICA FOSCAMA INDUSTRIA CHIMICO-FARMACEUTICA S.P.A.
Via Morolense, 87
03013 Ferentino (FR)
Italy