Ketorolac EG

Italy
Brand name Ketorolac EG
Form solution for injection
Active substance / Dosage
KETOROLAC TROMETHAMINE
Prescription type Prescription only – non-repeatable
ATC code
M01AB15
Registration number 037849
Manufacturer EG S.P.A.
Ketorolac EG solution for injection

Table of Contents

Patient Information Leaflet

Ketorolac EG 20 mg/ml oral drops, solution

Generic medicine
Please read all of this leaflet carefully before you start 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 they have the same symptoms as you, because it could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ketorolac EG is and what it is used for

Ketorolac EG contains the active substance ketorolac tromethamine. It belongs to a group of medicines called non-steroidal anti-inflammatory/anti-rheumatic drugs (NSAIDs), which have various actions, including an important role in pain control.
Ketorolac EG is indicated only for the short-term treatment (maximum 5 days) of moderate pain following surgical intervention (postoperative pain).

2. What you need to know before taking Ketorolac EG

Do not take Ketorolac EG

  • if you are allergic to ketorolac tromethamine, to similar medicines (“NSAIDs”), or to any of the other ingredients of this medicine (listed in section 6);
  • if you have mild or long-lasting pain (chronic pain);
  • if you have had or currently have severe and sudden allergic reactions (anaphylactic reactions) to aspirin (acetylsalicylic acid) or to other medicines in the same class (prostaglandin synthesis inhibitors);
  • if you have nasal polyps (complete or partial nasal polyposis syndrome);
  • if you have swelling due to fluid retention in the legs, arms, face, mouth, or tongue (angioedema);
  • if you have difficulty breathing (bronchospasm, asthma);
  • if you have a history of bleeding, perforation, or injury, or have pain and burning in the stomach or intestine (active peptic ulcer);
  • if you have a serious heart condition (severe heart failure);
  • if you have had or are suspected of having bleeding in the brain (cerebrovascular hemorrhage);
  • if you have moderate or severe kidney problems (moderate or severe renal insufficiency) or are at risk of kidney problems;
  • if you have reduced blood volume (hypovolemia) or lack of body water (dehydration);
  • if you have severe liver injury or inflammation (liver cirrhosis or severe hepatitis);
  • if you are prone to easy bleeding (hemorrhagic diathesis, coagulation disorders);
  • if you have undergone surgery with a high risk of bleeding (hemorrhage or incomplete hemostasis);
  • if you have any other bleeding disorders;
  • if you are being treated with blood-thinning medicines (anticoagulants);
  • if you are currently taking aspirin (acetylsalicylic acid), other NSAIDs, lithium salts (for mental health conditions), probenecid (for gout treatment), pentoxifylline (to improve blood circulation), diuretics (medicines that increase urine production), or methotrexate (a chemotherapeutic agent) (see “Other medicines and Ketorolac EG”);
  • if you are trying to prevent pain (analgesia) before or during surgery, as this medicine increases the risk of bleeding;
  • if you are a child or adolescent under 16 years of age;
  • if you are pregnant, about to go into labor, in labor, or breastfeeding (see “Fertility, pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Ketorolac EG.
Take Ketorolac EG 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 shortest duration appropriate for your
condition, in order to minimize the occurrence of adverse effects.
Avoid consecutive or simultaneous use with other non-steroidal anti-inflammatory drugs (NSAIDs).
Take this medicine with great caution and under close medical supervision:

  • if you have or have had stomach or intestinal disorders, as the risk of toxicity is high, especially if you take Ketorolac EG outside authorized indications and/or for prolonged periods (see also “What Ketorolac EG is and what it is used for”, “Do not take Ketorolac EG”, and “How to take Ketorolac EG”);
  • if you are taking other anti-inflammatory medicines (see “Other medicines and Ketorolac EG”);
  • if you are elderly or very weak (debilitated), as you may be more likely to experience adverse effects from Ketorolac EG such as bleeding and perforation of the stomach or intestine, which can be potentially fatal. In such cases, your doctor may decide to reduce the dose or increase the interval between doses (see section “How to use Ketorolac EG”);
  • if you suffer from or have suffered from stomach or intestinal disorders (such as peptic ulcer, gastrointestinal bleeding);
  • if you have chronic inflammatory bowel diseases (ulcerative colitis, Crohn’s disease);
  • if you are taking anti-inflammatory hormones (oral corticosteroids), blood-thinning medicines (anticoagulants such as warfarin), antidepressants (selective serotonin reuptake inhibitors), or medicines such as aspirin or its analogs (see “Other medicines and Ketorolac EG”);
  • if you suffer from or are predisposed to bronchial inflammation known as bronchial asthma, as you may experience breathing difficulties (bronchospasm), or if you have severe allergic reactions (anaphylactic reactions, skin redness, rashes, low blood pressure, throat swelling, or swelling of the legs, arms, face, mouth, or tongue), which may occur in patients with or without a history of allergy to Ketorolac EG, other NSAIDs, or aspirin;
  • if you have had or have previously experienced swelling due to fluid retention in the legs, arms, face, mouth, or tongue (angioedema), breathing difficulties (bronchospasm, asthma), or nasal polyps, as you may develop severe, potentially fatal allergic reactions;
  • if you have or have previously had heart conditions (mild to moderate congestive heart failure, chronic ischemic heart disease, cardiac decompensation), high blood pressure (hypertension), reduced blood flow to the legs (peripheral arterial disease), or reduced oxygen supply to the brain (cerebrovascular disease), or if you think you may be at risk of these conditions (e.g., if you have high blood pressure, diabetes, high cholesterol levels, high blood fat levels (hyperlipidemia), or if you smoke). Inform your doctor before taking Ketorolac EG, as it may increase the risk of heart attack or stroke;
  • if you have or have had kidney problems (nephrotoxicity, renal hypoperfusion, glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome, acute renal failure, reduced kidney function);
  • if you have liver problems, detectable through specific blood tests, as Ketorolac EG may cause abnormalities in liver function tests. If you develop severe liver dysfunction, inform your doctor immediately, who will discontinue treatment with Ketorolac EG;
  • if you have bleeding disorders;
  • if you experience skin reactions (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, skin rash, mucosal lesions) or any other signs of allergy;
  • if you are planning a pregnancy;
  • if you have fertility problems or are undergoing fertility investigations.

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

  • you develop symptoms of an allergic reaction;
  • you experience bleeding (hemorrhages) or lesions (ulcers) in the stomach or intestine;
  • liver function becomes impaired;
  • you develop skin irritation or peeling, blisters, or bleeding of the lips, eyes, mouth, nose, or genitals, or any other symptom of an allergic reaction.

Ketorolac EG is not addictive. Withdrawal symptoms have not been observed after abrupt discontinuation of treatment.
Although Ketorolac EG has not been shown to increase the risk of events such as heart attack, this risk cannot be ruled out.
Warning: Ketorolac EG cannot be considered a simple painkiller and must be used under strict medical supervision. It should not be used for the treatment of mild or chronic pain.
Cases of bruising (hematomas) after surgery (post-operative period) and bleeding from wounds following the use of Ketorolac EG 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.
Inform your doctor if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract before receiving/using Ketorolac EG, as Ketorolac EG may sometimes impair wound healing in the intestine after surgery.
Ketorolac EG may cause stomach and intestinal problems, especially when used for prolonged periods without observing proper warnings and precautions.

Children and adolescents
Ketorolac EG is contraindicated in children and adolescents under 16 years of age.

Other medicines and Ketorolac EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use of Ketorolac EG with the following should be avoided:

  • non-steroidal anti-inflammatory drugs (NSAIDs) and medicines of the same class as aspirin (ASA), as they increase the risk of serious adverse effects;
  • corticosteroids (hormones used against inflammation), as they increase the risk of severe stomach and intestinal injuries and bleeding (see “Warnings and precautions”);
  • anticoagulants (warfarin, heparin, dextrans), platelet aggregation inhibitors, aspirin, or similar medicines), drugs used to prevent blood clot formation in blood vessels, as Ketorolac EG may enhance the effects of anticoagulants, or selective serotonin reuptake inhibitors (medicines for depression), as they may increase the risk of stomach or intestinal bleeding and prolong bleeding time;
  • pentoxifylline (a medicine to improve blood circulation), as it increases the tendency to bleed;
  • digoxin, a medicine used to treat heart conditions;
  • lithium (a medicine for mental health conditions), as its blood levels may increase when taken together with Ketorolac EG;
  • methotrexate (a medicine for cancer and immune system disorders), as it remains in the body longer, potentially increasing its toxicity;
  • antihypertensives or diuretics, ACE inhibitors and angiotensin II receptor antagonists (medicines to lower blood pressure), as their effect may be reduced when taken with Ketorolac EG, increasing the risk of kidney damage in some elderly or dehydrated patients who already have impaired kidney function. In such cases, consult your doctor, as dose adjustments, increased fluid intake, and kidney function monitoring may be necessary;
  • furosemide (a medicine to increase urine output), as its effect may be reduced;
  • probenecid (a medicine for gout), as it increases the amount and duration of Ketorolac EG in the body.

Ketorolac EG reduces the need for opioid-derived medicines to control post-surgical pain.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
The use of Ketorolac EG is contraindicated during pregnancy.
Do not take Ketorolac EG if you are pregnant, as it may harm the fetus or cause complications during childbirth. NSAIDs may cause kidney and heart problems in the fetus. They may affect the bleeding tendency in both mother and child and delay or prolong labor beyond normal duration.
From the 20th week of pregnancy onwards, NSAIDs may cause kidney problems in the fetus, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios), or cause narrowing of a blood vessel (ductus arteriosus) in the baby’s heart.
If you are of childbearing age, avoid possible pregnancy before starting and during treatment with Ketorolac EG by using an effective contraceptive method.

Labour and delivery
Ketorolac EG is contraindicated during labor and delivery.

Breastfeeding
Do not take this medicine if you are breastfeeding, as it passes into breast milk.
Ketorolac EG is contraindicated during breastfeeding.

Fertility
The use of Ketorolac EG may reduce fertility in women and is not recommended if you are planning a pregnancy. If you have difficulty becoming pregnant or are undergoing fertility investigations, consider discontinuing Ketorolac EG.
Your doctor will advise you on appropriate contraceptive measures.

Driving and using machines
You may experience drowsiness, dizziness, vertigo, sleep disturbances (insomnia), or mood changes (depression) while taking Ketorolac EG. If you experience these or similar adverse effects, avoid activities requiring alertness. Therefore, caution is advised when driving or operating machinery.

Ketorolac EG contains methyl-parahydroxybenzoate, propyl-parahydroxybenzoate, and sodium
This medicine contains parahydroxybenzoates, which may cause allergic reactions (including delayed reactions).
This medicine contains less than 1 mmol (23 mg) of sodium per maximum dose (40 mg), i.e., essentially “sodium-free”.

3. How to take Ketorolac EG

Take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, consult your doctor or pharmacist.
Warning: The duration of treatment must not exceed 5 days.
Adults:
Your doctor will prescribe the lowest effective dose according to the severity of your pain and your
response to treatment.
The recommended dose is 10 mg (equivalent to 10 drops of solution), as needed, every 4–6 hours,
up to a maximum of 40 mg per day. Do not exceed the recommended maximum dose.
When switching from injectable therapy to oral therapy with Ketorolac EG, your doctor will advise
you on the appropriate dosing regimen (the total daily dose must not exceed 90 mg, keeping in mind
that the maximum oral dose must not exceed 40 mg).
Your doctor will appropriately reduce the dose in patients with body weight below 50 kg.
Elderly patients (aged 65 years and older):
If you are elderly, your doctor will carefully determine the dose you should take.
Use in children and adolescents:
This medicine is contraindicated in individuals under 16 years of age. The safety and efficacy in
children have not been established.
Instructions for opening and using the bottle:

Three diagrams illustrate how to open by pressing and unscrewing the bottle, hold it vertically without shaking, and close by screwing the cap back on

If you take more Ketorolac EG than you should:
If you (or someone else) have taken an excessive dose of Ketorolac EG, or if you suspect that a child
may have ingested this medicine, contact your doctor immediately and go to the nearest hospital
Emergency Department.
Some symptoms of overdose may include abdominal pain, nausea, vomiting, rapid breathing
(hyperventilation), damage to the stomach or intestinal lining and/or inflammation, possibly with
bleeding (peptic ulcer and/or erosive gastritis, gastrointestinal bleeding), kidney problems (renal
dysfunction), severe and rapid generalized allergic reactions (anaphylactoid reactions). Rarely, high
blood pressure (hypertension), kidney disease (acute renal failure), breathing difficulties
(respiratory depression), and coma may occur. Your doctor will initiate appropriate treatment.
Take this leaflet, the bottle, and its packaging with you to the hospital or doctor so that they know
which medicine has been taken.
If you forget to take Ketorolac EG:
Do not take a double dose to make up for the missed dose.
If you stop taking Ketorolac EG:
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur (frequencies are unknown because these effects have been reported voluntarily by an unquantifiable number of individuals after the medicine was placed on the market):

  • severe and rapid generalized allergic reactions (anaphylactic/anaphylactoid reactions),
  • allergic reactions such as bronchial constriction causing breathing difficulties (bronchospasm),
  • dilation of blood vessels (vasodilatation),
  • sudden sensation of warmth (hot flushes),
  • skin rash,
  • swelling of the throat (laryngeal edema),
  • inflammation of the membranes surrounding the brain (aseptic meningitis),
  • rapid swelling due to fluid accumulation in legs, arms, face, or tongue (angioedema),
  • skin inflammation with peeling (exfoliative dermatitis),
  • blistering reactions including a condition called Stevens-Johnson syndrome with severe skin, mouth, and other body part lesions accompanied by high fever, vomiting, diarrhea, and joint pain,
  • death of the skin (toxic epidermal necrolysis),
  • sweating,
  • skin rash with redness and swellings (maculopapular rash),
  • urticaria, itching,
  • injury to the wall of the stomach or intestine, which may even perforate and be accompanied by bleeding (peptic ulcer, ulcer, gastrointestinal perforation or hemorrhage), which may be life-threatening,
  • nausea,
  • vomiting,
  • diarrhea,
  • passage of gas from the intestine (flatulence),
  • constipation,
  • pain/discomfort in the stomach area (dyspepsia), abdominal pain/discomfort, feeling of fullness,
  • blood in the stool (melena) and from the lower part of the intestine (rectal bleeding),
  • vomiting blood (hematemesis),
  • inflammation of the mouth (stomatitis and ulcerative stomatitis) and esophagus (esophagitis),
  • belching,
  • inflammation of the pancreas (pancreatitis),
  • dry mouth,
  • worsening of inflammation in a part of the intestine called the colon (exacerbation of colitis), or of the stomach (gastritis),
  • worsening of a chronic inflammatory bowel disease (Crohn's disease),
  • decrease in a type of blood cells (thrombocytopenia),
  • red spots on the body (purpura),
  • nosebleeds (epistaxis),
  • loss of appetite (anorexia),
  • increased potassium levels in the blood (hyperkalemia), reduced sodium levels in the blood (hyponatremia),
  • abnormal thinking,
  • mood disturbances (depression),
  • sleep disorders (insomnia), feelings of worry or fear (anxiety), irritability, nervousness,
  • severe disturbances in mental equilibrium (psychotic reactions),
  • abnormal dreams,
  • hallucinations,
  • sensation of well-being (euphoria),
  • reduced ability to concentrate,
  • decreased sensitivity and reflex responsiveness (stupor),
  • confusion,
  • headache (cephalalgia),
  • dizziness,
  • seizures,
  • altered skin sensation, tingling (paresthesia),
  • excessive movements (hyperkinesia),
  • taste disturbances,
  • vision disorders, altered vision (abnormal vision),
  • ringing in the ears (tinnitus), hearing loss,
  • vertigo,
  • kidney disorders (renal failure, hemolytic-uremic syndrome, interstitial nephritis, urinary retention, nephrotic syndrome, flank pain with or without blood in the urine (hematuria) or increased/decreased levels of non-protein nitrogen in the blood (azotemia)),
  • increased urine output (polyuria), increased frequency of urination, decreased urine output (oliguria),
  • irregular or rapid heartbeat (palpitations),
  • reduced heart rate (bradycardia),
  • reduced heart function (heart failure),
  • swelling (edema),
  • increased blood pressure (hypertension) or reduced blood pressure (hypotension),
  • heart problems (cardiac failure),
  • bruising (hematomas),
  • redness,
  • paleness,
  • bleeding from wounds after surgery (postoperative hemorrhage),
  • heart attack,
  • damage to blood vessels in the brain (stroke),
  • infertility in women,
  • fluid accumulation in the lungs (pulmonary edema),
  • breathing difficulties (dyspnea, asthma),
  • liver inflammation (hepatitis),
  • impaired liver function (hepatic failure),
  • yellowing of the skin and eyes (cholestatic jaundice),
  • muscle pain (myalgia),
  • muscle weakness (asthenia),
  • fever,
  • chest pain,
  • excessive thirst,
  • prolonged bleeding time and abnormalities in certain blood tests (increased urea, increased creatinine and potassium, liver function test abnormalities).

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 Ketorolac EG

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.
The product should be used within 4 months after first opening of the bottle; any remaining product must be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ketorolac EG contains

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

Description of the appearance of Ketorolac EG and contents of the pack
Pack containing one 10 ml vial.
Marketing Authorization Holder
EG S.p.A. – Via Pavia, 6 – 20136 Milan
Manufacturer
Doppel Farmaceutici s.r.l., Via Martiri della Foibe 1 - 29016 Cortemaggiore (PC)

Patient information leaflet

Ketorolac EG 30 mg/ml solution for injection

Equivalent medicinal product
Please read this leaflet carefully before 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, pharmacist or nurse.
  • 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 could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Ketorolac EG is and what it is used for

Ketorolac EG contains the active substance ketorolac tromethamine. It belongs to a group of medicines called non-steroidal anti-inflammatory/anti-rheumatic drugs (NSAIDs), which have various actions, with an important role in pain control.
Ketorolac EG is used:

  • for the short-term treatment (maximum 2 days) of moderate to severe acute pain following surgery (postoperative pain), administered into a muscle (intramuscularly) or through a vein (intravenously);
  • as an adjunct to opioid-based pain therapy in cases of major surgery or very intense pain, administered intravenously;
  • for the treatment of pain due to renal colic, at a dosage of 30 mg/ml.

2. What you need to know before using Ketorolac EG

Do not use Ketorolac EG

  • if you are allergic to ketorolac tromethamine or to any of the other ingredients of this medicine (listed in section 6);
  • if you have mild or long-lasting pain (chronic pain);
  • if you are allergic to other NSAIDs;
  • if you have had or have severe and sudden allergic reactions (anaphylactic reactions) to aspirin (acetylsalicylic acid) or to other medicines of the same class (prostaglandin synthesis inhibitors);
  • if you have nasal polyps (complete or partial nasal polyposis syndrome);
  • if you have swelling in the legs, arms, face, mouth or tongue (angioedema);
  • if you have difficulty breathing (bronchospasm, asthma);
  • if you have a history of bleeding, perforation, or injury, or pain and burning in the stomach or intestine (active peptic ulcer);
  • if you have serious heart problems (severe heart failure);
  • if you have had or are suspected to have bleeding in the brain (cerebrovascular haemorrhage);
  • if you have reduced blood volume (hypovolemia) or lack of water in the body (dehydration);
  • if you have moderate or severe kidney problems (moderate or severe renal insufficiency);
  • if you have severe liver injury or inflammation (hepatic cirrhosis or severe hepatitis);
  • if you tend to bleed easily (haemorrhagic diathesis, coagulation disorders);
  • if you have undergone surgery with a high risk of bleeding (haemorrhage or incomplete haemostasis);
  • if you have any other bleeding disorders;
  • if you are being treated with blood-thinning medicines (anticoagulants);
  • if you are currently taking aspirin (acetylsalicylic acid), other NSAIDs, lithium salts (for mental health conditions), probenecid (for gout treatment), or pentoxifylline (to improve blood circulation) (see section “Other medicines and Ketorolac EG”);
  • if you are being treated with medicines that greatly increase urine production;
  • if you need to prevent pain before or during surgery, because this medicine increases the risk of bleeding;
  • if you are a child or adolescent under 16 years of age;
  • if you are pregnant, about to give birth (in labour), giving birth, or breastfeeding (see section “Pregnancy, breastfeeding and fertility”);
  • if a special administration route is required (neuraxial use: epidural or intrathecal).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Ketorolac EG.
Warning: Ketorolac EG is not a simple painkiller and must be used under strict medical supervision. It should not be used to treat 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 reduce the risk of adverse effects.
Avoid using other non-steroidal anti-inflammatory drugs (NSAIDs) consecutively or simultaneously.
Use this medicine with great caution and under close medical supervision:

  • if you have or have had stomach or intestinal diseases (such as peptic ulcer, gastrointestinal bleeding), as the risk of toxicity is high, especially if you use Ketorolac EG outside the approved indications and/or for prolonged periods (see also “What Ketorolac EG is and what it is used for”, “Do not use Ketorolac EG”, and “How to use Ketorolac EG”);
  • if you are taking other anti-inflammatory medicines (see “Other medicines and Ketorolac EG”);
  • if you are elderly or very weak (debilitated), as you may be more likely to experience adverse effects from Ketorolac EG, such as bleeding and perforation of the stomach and intestine, which can 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 Ketorolac EG”);
  • if you have chronic inflammatory bowel diseases (ulcerative colitis and Crohn’s disease);
  • if you are taking anti-inflammatory hormones (oral corticosteroids), blood-thinning medicines (anticoagulants such as warfarin), antidepressants (selective serotonin reuptake inhibitors), or medicines such as aspirin or similar substances (see “Other medicines and Ketorolac EG”);
  • if you have severe allergic reactions (anaphylactic reactions, bronchospasm, skin redness, rashes, low blood pressure, throat swelling, or swelling of the legs, arms, face, mouth or tongue), which may occur in patients with or without a history of allergy to Ketorolac EG, other NSAIDs or aspirin;
  • if you have a history of swelling due to fluid retention in the legs, arms, face, mouth or tongue (angioedema), breathing difficulties (asthma, bronchospasm), or nasal polyps, as you may experience severe, potentially life-threatening allergic reactions;
  • if you have high blood pressure (hypertension) and/or your heart does not pump adequate blood (mild to moderate congestive heart failure), if you have heart vessel diseases (chronic ischaemic heart disease), leg vessel diseases (peripheral arterial disease), or brain vessel diseases (cerebrovascular disease), or if you think you may be at risk of these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol levels, or if you smoke);
  • if you have or have had kidney problems (nephrotoxicity, renal hypoperfusion, glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome, acute renal failure, reduced kidney function);
  • if you have liver problems, detectable through specific blood tests, as Ketorolac EG may cause abnormalities in liver function tests. If you develop severe liver impairment, inform your doctor immediately, who will discontinue treatment with Ketorolac EG;
  • if you have bleeding disorders;
  • if you experience potentially life-threatening skin reactions (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, skin rash, mucosal lesions) or any other signs of allergy;
  • if you are planning a pregnancy;
  • if you have fertility problems or are undergoing fertility investigations. Ketorolac EG does not cause dependence. No withdrawal symptoms have been observed after abrupt discontinuation of treatment.

Although Ketorolac EG has not been shown to increase the risk of events such as heart attack, this risk cannot be ruled out.
Cases of bruising (haematomas) after surgery (post-operative period) and bleeding from surgical wounds following the use of Ketorolac EG 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.
Inform your doctor if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract before receiving/using Ketorolac EG, as Ketorolac EG may sometimes impair wound healing in the intestine after surgery.
Ketorolac EG may cause stomach and intestinal problems, particularly when used for prolonged periods and without observing the necessary warnings and precautions.

Children and adolescents
Ketorolac EG is contraindicated in children and adolescents under 16 years of age.

Other medicines and Ketorolac EG
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Concomitant use of Ketorolac EG with the following should be avoided:

  • non-steroidal anti-inflammatory drugs (NSAIDs) and medicines of the same class as aspirin (ASA), as they increase the risk of serious adverse effects;
  • corticosteroids (hormones used against inflammation), as they increase the risk of severe stomach and intestinal injury and bleeding (see “Warnings and precautions”);
  • anticoagulants (medicines that thin the blood), as Ketorolac EG may enhance the effects of anticoagulants such as warfarin, heparin, and dextrans;
  • antiplatelet agents (aspirin or similar medicines) and selective serotonin reuptake inhibitors (medicines for depression), as they may increase the risk of stomach and intestinal bleeding and prolong bleeding time;
  • pentoxifylline (a medicine to improve blood circulation), as it increases the tendency to bleed;
  • digoxin, a medicine used to treat heart conditions;
  • lithium (a medicine for mental health conditions), as its blood levels may increase when taken together with Ketorolac EG;
  • methotrexate (a medicine for cancer and autoimmune diseases);
  • antihypertensives or diuretics, ACE inhibitors and angiotensin II antagonists (medicines to lower blood pressure), as their effect may be reduced when taken with Ketorolac EG and the risk of kidney damage may increase in some dehydrated or elderly patients who already have impaired kidney function;
  • furosemide (a medicine to increase urine output), as its effect may be reduced;
  • probenecid (a medicine for gout), as it increases the amount and duration of Ketorolac EG in the body.

Ketorolac EG reduces the need for opioid-derived medicines to control post-surgical pain.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
The use of Ketorolac EG is contraindicated during pregnancy.
Do not use Ketorolac EG if you are pregnant, as it may harm the fetus or cause complications during childbirth. NSAIDs may cause kidney and heart problems in the fetus. They may affect the bleeding tendency in both mother and baby and may delay or prolong labour beyond normal duration.
From the 20th week of pregnancy onwards, NSAIDs may cause kidney problems in the fetus, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios), or cause narrowing of a blood vessel (ductus arteriosus) in the baby’s heart.

If you are of childbearing age, you should avoid becoming pregnant before starting and during treatment with Ketorolac EG and use an effective contraceptive method.

Labour and delivery
Ketorolac EG is contraindicated during labour and delivery.

Breastfeeding
Do not use this medicine if you are breastfeeding, as it passes into breast milk. Ketorolac EG is contraindicated during breastfeeding.

Fertility
The use of Ketorolac EG may reduce fertility in women and is not recommended if you are planning a pregnancy. If you have difficulty becoming pregnant or are undergoing infertility investigations, you should consider discontinuing Ketorolac EG.
Your doctor will advise you on appropriate contraceptive measures.

Driving and using machines
You may experience drowsiness, dizziness, vertigo, sleep disturbances (insomnia), or mood disorders (depression) while using Ketorolac EG. If you experience these or similar side effects, avoid activities requiring alertness.
Therefore, caution is advised when driving vehicles or operating machinery.

Ketorolac EG contains ethanol and sodium
This medicine contains 96 mg of alcohol (ethanol) per vial, equivalent to 12% alcohol.
The amount in 1 ml of this medicine is equivalent to less than 3 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.
This medicine contains less than 23 mg (1 mmol) of sodium per vial, i.e. essentially 'sodium-free'.

3. How to use Ketorolac EG

Use this medicine exactly as directed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
The duration of treatment must not exceed 2 days in case of rapid administration (bolus injection)
and 1 day in case of slow administration (continuous infusion).
Your doctor will prescribe the lowest effective dose according to the severity of your pain and your response to treatment.
Use this medicine following strict hygiene practices.
This medicine will be administered to you by a doctor or nurse via injection into the muscle (intramuscular) or into a vein (intravenous).

Administration into a muscle (intramuscular)
Adults
The recommended initial dose is 10 mg, followed by doses of 10–30 mg every 4–6 hours as needed, up to a maximum of 90 mg per day, using the lowest effective dose. The duration of treatment must not exceed 2 days.
Your doctor will advise you on how to switch from injectable treatment to oral treatment with Ketorolac EG (the total daily dose must not exceed 90 mg per day, bearing in mind that the maximum oral dose must not exceed 40 mg).
Your doctor will appropriately reduce the dose in patients weighing less than 50 kg.

Elderly (aged 65 years or older)
If you are elderly, your doctor will carefully determine the dose you should take. The maximum daily dose must not exceed 60 mg per day.

Administration into a vein (intravenous)
INTRAVENOUS USE OF THIS MEDICINE IS RESERVED FOR HOSPITALS AND CARE FACILITIES.
Adults
In case of severe acute pain, the recommended initial dose is 10 mg, followed by doses of 10–30 mg repeated every 4–6 hours as needed, using the lowest effective dose. If necessary, treatment may continue at longer intervals, but the total daily dose must not exceed 90 mg.

Elderly (aged 65 years or older)
The maximum daily dose must not exceed 60 mg per day.

Renal colic
If you suffer from renal colic, the recommended dose is one vial of 30 mg administered intramuscularly or intravenously.

Use in children and adolescents
The use of this medicine is contraindicated in individuals under 16 years of age.

If you use more Ketorolac EG than you should
If you take an excessive dose of Ketorolac EG, inform your doctor immediately or go to the nearest hospital Emergency Department. Some symptoms of overdose may include abdominal pain, nausea, vomiting, rapid breathing (hyperventilation), damage to the stomach or intestinal lining and/or inflammation that may be accompanied by bleeding (peptic ulcer and/or erosive gastritis, gastrointestinal bleeding), kidney problems (renal dysfunction), and severe, rapid generalized allergic reactions (anaphylactoid reactions).
Rarely, increased blood pressure (hypertension), kidney disease (acute renal failure), breathing difficulties (respiratory depression), and coma may occur.

If you forget to use Ketorolac EG
Do not take a double dose to make up for the missed dose.

If you stop treatment with Ketorolac EG
If you have any doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur (frequencies are not known because these effects have been reported voluntarily by an unquantifiable number of individuals after the medicine was placed on the market):

  • severe and rapid generalized allergic reactions (anaphylactic/anaphylactoid reactions),
  • allergic reactions such as bronchial constriction causing breathing difficulties (bronchospasm),
  • dilation of blood vessels (vasodilation),
  • sudden sensation of warmth (flushing),
  • skin rash,
  • swelling of the throat (laryngeal edema),
  • inflammation of the membranes surrounding the brain (aseptic meningitis),
  • rapid swelling due to fluid accumulation in the legs, arms, face, or tongue (angioedema),
  • skin inflammation with peeling (exfoliative dermatitis),
  • sweating,
  • skin rash with redness and raised areas (maculopapular rash),
  • urticaria, itching,
  • blistering reactions including a condition known as Stevens-Johnson syndrome with severe skin, mouth, and other body part lesions accompanied by high fever, vomiting, diarrhea, and joint pain,
  • death of the skin (toxic epidermal necrolysis),
  • damage to the wall of the stomach or intestine, which may even perforate and be accompanied by bleeding (peptic ulcer, ulcer, gastrointestinal perforation or hemorrhage), which can be life-threatening,
  • nausea,
  • vomiting,
  • diarrhea,
  • passage of intestinal gas (flatulence),
  • constipation,
  • stomach pain/discomfort (dyspepsia), abdominal pain/discomfort, feeling of fullness,
  • blood in the stool (melena) and from the lower intestinal tract (rectal bleeding),
  • vomiting blood (hematemesis),
  • inflammation of the mouth (stomatitis and ulcerative stomatitis) and of the esophagus (esophagitis),
  • belching,
  • inflammation of the pancreas (pancreatitis),
  • dry mouth,
  • worsening of inflammatory conditions in a part of the intestine called the colon (exacerbation of colitis), of the stomach (gastritis),
  • worsening of a chronic inflammatory bowel disease (Crohn's disease),
  • decrease in a type of blood cells (thrombocytopenia),
  • red spots on the body (purpura),
  • nosebleeds (epistaxis),
  • loss of appetite (anorexia),
  • increased potassium levels in the blood (hyperkalemia) and decreased sodium levels in the blood (hyponatremia),
  • abnormal thinking,
  • mood disturbances (depression),
  • sleep disorders (insomnia),
  • feelings of worry or fear (anxiety), irritability, nervousness,
  • severe disturbances in mental equilibrium (psychotic reactions),
  • abnormal dreams,
  • hallucinations,
  • sensation of well-being (euphoria),
  • reduced ability to concentrate,
  • decreased sensitivity and reflex responsiveness (stupor),
  • confusion,
  • headache,
  • dizziness,
  • seizures,
  • altered skin sensation, tingling (paresthesia),
  • excessive movement (hyperkinesia),
  • taste disturbances,
  • vision disorders, altered vision (abnormal vision),
  • ringing in the ears (tinnitus), hearing loss,
  • vertigo,
  • kidney problems (acute renal failure),
  • increased urine volume (polyuria), increased frequency of urination, decreased urine volume (oliguria),
  • kidney diseases (renal failure, hemolytic-uremic syndrome, interstitial nephritis, urinary retention, nephrotic syndrome, blood and kidney problems, flank pain with or without presence of blood in the urine (hematuria) or increased/decreased levels of non-protein nitrogen in the blood (azotemia)),
  • irregular or rapid heartbeat (palpitations),
  • reduced heart rate (bradycardia),
  • reduced heart function (cardiac decompensation),
  • heart problems (heart failure),
  • increased blood pressure (hypertension) or decreased blood pressure (hypotension), bruising (hematomas),
  • redness,
  • pallor,
  • bleeding from a surgical wound (post-operative hemorrhage),
  • heart attack,
  • damage to blood vessels in the brain (stroke),
  • infertility in women,
  • presence of fluid in the lungs (pulmonary edema),
  • breathing difficulties (dyspnea, asthma),
  • liver inflammation (hepatitis),
  • impaired liver function (hepatic failure),
  • yellowing of the skin and eyes (cholestatic jaundice),
  • muscle pain (myalgia),
  • muscle weakness (asthenia),
  • fever,
  • injection site reactions,
  • swelling (edema),
  • chest pain,
  • excessive thirst,
  • prolonged bleeding time and alteration of certain blood tests, increased serum urea, increased creatinine and potassium levels, alterations 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 the following website: 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 Ketorolac EG

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.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Ketorolac EG contains

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

Description of the appearance of Ketorolac EG and contents of the package
Carton containing 3 vials of 1 ml each.
Marketing Authorization Holder
EG S.p.A. – Via Pavia, 6 – 20136 Milan
Manufacturer
Doppel Farmaceutici S.r.l. - Via Volturno, 48 - Quinto de’ Stampi (Rozzano) - Milan

The following information is intended exclusively for physicians or healthcare professionals:
Warning: the injectable solution contains ethanol; therefore, neuraxial (epidural or intrathecal) administration is contraindicated.
Ketorolac is compatible with aminophylline, lidocaine, morphine, meperidine, dopamine, insulin, and heparin when administered simultaneously in a solution contained in an intravenous infusion bag; however, it must not be mixed with morphine, meperidine, promethazine, or hydroxyzine in a syringe.
Injections must be performed according to strict standards of sterilization, asepsis, and antisepsis.
The administered dose should be the lowest effective dose according to the severity of pain and the patient's response.