Package leaflet: Information for the user

Ketorolac Aurobindo 30 mg/ml solution for injection

Generic medicine
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 may 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:

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

1. What Ketorolac Aurobindo 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.
Ketorolac Aurobindo is indicated for the treatment:

of short duration (maximum two days) of moderate to severe acute pain following surgical operations (postoperative pain), administered into a muscle (intramuscularly) or through a vein (intravenously);
of pain caused by renal colic.

This medicinal product is also used, when administered intravenously, in addition to opioid or opioid-like painkillers (opioid analgesics), for the treatment of severe pain or in cases of major surgical procedures (major surgery).

2. What you need to know before using Ketorolac Aurobindo

Do not use Ketorolac Aurobindo

if you are allergic to ketorolac tromethamine or any of the other ingredients of this medicine (listed in section 6);
if you have mild or long-lasting (chronic) pain;
if you are allergic to other NSAIDs (non-steroidal anti-inflammatory drugs);
if you have previously experienced a severe and sudden allergic reaction (anaphylactic reaction) after taking aspirin (acetylsalicylic acid) or other medicines that inhibit the production of inflammatory substances (prostaglandins);
if you suffer from nasal polyps (growths inside the nose);
if you have swelling due to fluid accumulation in the legs, arms, face, tongue, or around the mouth and eyes (angioedema);
if you have difficulty breathing (bronchospasm);
if you suffer from asthma (asthmatic attacks);
if you currently have, have had, or suspect gastrointestinal bleeding, perforation, or injury, or have stomach or intestinal pain and burning (active peptic ulcer);
if you have a serious heart condition (severe heart failure);
if you currently have, have had, or suspect bleeding in the brain (cerebrovascular hemorrhage);
if you have moderate or severe kidney problems (renal failure with serum creatinine values greater than 442 µmol/L), or if you are at risk of kidney problems due to reduced blood volume (hypovolemia) or lack of water (dehydration);
if you have severe liver damage or inflammation (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 are being treated with blood-thinning medicines (anticoagulants);
if you are currently taking aspirin (acetylsalicylic acid), other non-steroidal anti-inflammatory drugs, mood disorder medicines (lithium salts), medicines used to reduce uric acid levels in the blood (probenecid), diuretics (medicines that increase urine output), or medicines to prevent blood clot formation in blood vessels (anticoagulants, e.g., pentoxifylline) (see section “Other medicines and Ketorolac Aurobindo”);
for pain prevention (analgesia) before or during surgical procedures, as this medicine increases the risk of bleeding;
if you have undergone high-risk surgical procedures with a significant risk of bleeding or incomplete control of bleeding (incomplete hemostasis);
if the person to take this medicine is a child or adolescent under 16 years of age;
if you are in the last 3 months of pregnancy (third trimester), during labor, delivery, or breastfeeding (see “Pregnancy, breastfeeding and fertility”);
if a specific route of administration is required (neuraxial administration: epidural or intrathecal use).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Ketorolac Aurobindo:
Use Ketorolac Aurobindo under medical supervision, as this medicine must not be used for the treatment of mild or chronic pain.
Ketorolac Aurobindo may cause more gastrointestinal problems than other non-steroidal anti-inflammatory drugs (NSAIDs), especially when used for prolonged periods and without observing proper warnings and precautions.
Gastrointestinal bleeding, ulceration, or perforation, even fatal cases, have been reported during treatment with all NSAIDs, including ketorolac, at any time during therapy, with or without warning symptoms or previous serious gastrointestinal events. The risk increases with higher doses and longer duration of treatment.
Use this medicine at the lowest effective dose and for the shortest possible time to minimize the occurrence of adverse effects.
Inform your doctor:

if you have or have had stomach or intestinal diseases. In such cases, treatment should begin under close medical supervision with the lowest available dose, and you should report any unusual gastrointestinal symptoms, especially during the initial stages of treatment. If gastrointestinal bleeding or ulceration occurs, treatment must be discontinued.
if you are taking other non-steroidal anti-inflammatory drugs (NSAIDs) (see “Other medicines and Ketorolac Aurobindo”).
if you are elderly or severely debilitated, as you may be more likely to experience adverse effects from Ketorolac Aurobindo, such as bleeding and perforations of the stomach and intestines, which can be fatal. In this case, your doctor may decide to reduce the dose or increase the interval between doses (see section “How to use Ketorolac Aurobindo”);
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 its analogs (see “Other medicines and Ketorolac Aurobindo”), as these may increase the risk of ulceration or bleeding;
if you have severe allergic reactions (anaphylactic reactions, bronchospasm, skin flushing, rashes, drop in 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, other NSAIDs, or aspirin;
if you suffer from or are predisposed to bronchial asthma, as you may experience breathing difficulties (bronchospasm) or develop nasal polyps;
if you have high blood pressure and/or your heart does not pump adequate blood (mild to moderate congestive heart failure);
if you have heart vessel diseases (chronic ischemic heart disease), leg vessels (peripheral arterial disease), or brain vessels (cerebrovascular disease), or have risk factors such as high blood pressure, diabetes, high blood lipid levels, or if you smoke. The use of Ketorolac Aurobindo cannot exclude the risk of heart attack or stroke;
if you have kidney problems (reduced kidney function), as Ketorolac Aurobindo may cause nephrotoxicity (glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome, acute renal failure);
if you have liver problems, as abnormal liver function tests may occur with the use of Ketorolac Aurobindo;
if you have bleeding disorders. Cases of bruising after surgery and bleeding from wounds have been reported following the use of Ketorolac Aurobindo. Therefore, inform your doctor if you are scheduled for tonsillectomy, prostate surgery (prostate resection), or cosmetic surgery;
if you have recently undergone or are about to undergo stomach or intestinal surgery before receiving/using Ketorolac Aurobindo, as Ketorolac Aurobindo may sometimes impair wound healing in the intestine following surgery;
if you develop skin reactions (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, rash, mucosal lesions) or any other sign of allergy. In such cases, Ketorolac Aurobindo must be stopped immediately;
if you have fertility problems or are undergoing fertility investigations.

Ketorolac Aurobindo does not cause dependence. Withdrawal symptoms have not been observed after abrupt discontinuation of treatment.
For athletes: the use of medicines containing ethanol may result in positive anti-doping tests, depending on the blood alcohol concentration limits set by certain sports federations.
Children and adolescents
This medicine is contraindicated in children and adolescents under 16 years of age.
Other medicines and Ketorolac Aurobindo
Inform your doctor, pharmacist, or nurse if you are 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) and other 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 damage and bleeding (see “Warnings and precautions”);
anticoagulants (blood-thinning medicines), as Ketorolac Aurobindo may enhance the effects of anticoagulants such as warfarin, heparin, and dextrans;
antiplatelet agents (aspirin or similar medicines) and selective serotonin reuptake inhibitors (antidepressants), as they may increase the risk of stomach bleeding;
pentoxifylline (a medicine to improve blood circulation), as it increases the tendency to bleed;
digoxin, a medicine used to treat heart conditions;
probenecid (a medicine for gout), as it increases the amount and duration of Ketorolac Aurobindo in the body;
methotrexate (a medicine for cancer and immune system diseases), as it remains longer in the body, potentially increasing its toxicity;
lithium (a medicine for mental health disorders), as its blood levels may increase when taken together with Ketorolac Aurobindo;
diuretics, ACE inhibitors, and angiotensin II antagonists (medicines to lower blood pressure), as their effect may be reduced when taken with Ketorolac Aurobindo, and the risk of kidney damage may increase in some dehydrated patients or elderly patients with pre-existing kidney impairment. In such cases, consult your doctor, as dose adjustments, increased fluid intake, and kidney function monitoring may be necessary;
furosemide (a medicine used to increase urine output), as its effect may be reduced.

Ketorolac Aurobindo 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, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use Ketorolac Aurobindo during the last 3 months of pregnancy, as it may harm the fetus or cause complications during childbirth. It may cause problems with the heart, lungs, or kidneys of the fetus. It may affect your or your baby's tendency to bleed and may delay or prolong labor beyond expectations.
You should not take Ketorolac Aurobindo 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 week 20 of pregnancy, Ketorolac Aurobindo may cause kidney problems in the fetus if taken for more than a few days, leading to reduced levels of amniotic fluid surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
If you are of childbearing age, you should avoid possible pregnancy before starting and during treatment with Ketorolac Aurobindo and use an effective contraceptive method.
Breastfeeding
Do not take this medicine if you are breastfeeding, as it passes into breast milk.
Fertility
Ketorolac Aurobindo may reduce fertility and is not recommended if you are planning a pregnancy. If you have difficulty becoming pregnant or are undergoing fertility investigations, consider discontinuing Ketorolac Aurobindo.
Driving and using machines
This medicine may cause drowsiness, dizziness, vertigo, sleep disturbances (insomnia), or mood disorders (depression). If you experience these or similar adverse effects, avoid driving or operating machinery.
Ketorolac Aurobindo contains ethanol and sodium
This medicine contains 10 vol% ethanol (alcohol), e.g., up to 100 mg per vial, equivalent to 14 ml of beer or 6 ml of wine per vial. It may be harmful to alcoholics. This should be considered in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e., it is essentially 'sodium-free'.

3. How to use Ketorolac Aurobindo

Use this medicine exactly as instructed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.

This medicine will be administered by a doctor or nurse via intramuscular injection (into the muscle) or intravenous injection (into a vein). The intravenous injection may only be performed in hospitals and other medical facilities.

Ketorolac Aurobindo must not be used for epidural or intrathecal administration and must not be mixed in the same syringe with morphine, meperidine, promethazine, or hydroxyzine.

This medicine must not be used for more than 2 days if the dose is administered all at once (bolus administration), and for no more than 1 day if the dose is administered by infusion (continuous infusion).

Your doctor will prescribe the lowest effective dose according to the severity of pain and your response to treatment.

Administration into a muscle (intramuscular)

Adults
The recommended initial dose is 10 mg. Subsequently, the dose is 10–30 mg every 4–6 hours as needed, up to a maximum of 90 mg per day, using the lowest effective dose. Do not exceed the maximum recommended dose.
The duration of treatment must not exceed 2 days.
The dose will be appropriately reduced by the doctor in patients weighing less than 50 kg.

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

Administration into a vein (intravenous)

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 and 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 30 mg vial administered intramuscularly or intravenously.

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

If you use more Ketorolac Aurobindo than you should
If you accidentally use or ingest too much of this medicine, contact your doctor immediately or go to the nearest hospital Emergency Department.

After administration of an excessive dose of this medicine, symptoms such as abdominal pain, nausea, vomiting, increased breathing rate (hyperventilation), damage to the stomach or intestinal lining and/or inflammation possibly accompanied by bleeding (peptic ulcer, erosive gastritis, gastrointestinal bleeding), kidney problems (renal dysfunction), and severe, rapid-onset generalized allergic reactions (anaphylactoid reactions) may occur. Rare cases of increased blood pressure (hypertension), kidney disease (acute renal failure), impaired lung function (respiratory depression), and coma have been reported. Your doctor will determine appropriate treatment.

If you forget to use Ketorolac Aurobindo
Do not use a double dose to make up for the 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 everybody will experience them.
The side effects that may occur with Ketorolac Aurobindo are:
Not known (frequency cannot be estimated from the available data)

infection of the membranes surrounding the brain (aseptic meningitis);
reduced number of platelets (thrombocytopenia);
red spots on the body (purpura);
nosebleeds (epistaxis); severe and rapid general allergic reactions (anaphylactic/anaphylactoid reactions);
allergic reactions (hypersensitivity reactions) such as bronchospasm (difficulty breathing); increased blood vessel size (vasodilation); flushing; skin rash; reduced blood pressure (hypotension); throat swelling (laryngeal edema);
loss of appetite (anorexia);
increased potassium in the blood (hyperkalemia), reduced sodium in the blood (hyponatremia);
abnormal thoughts;
mood disturbances (depression);
sleep disorders (insomnia);
anxiety, irritability, nervousness;
severe mental disturbances (psychotic reactions);
abnormal dreams;
hallucinations;
feeling of well-being (euphoria);
difficulty concentrating;
drowsiness;
confusion;
headache (cephalalgia);
dizziness;
seizures;
altered sensation in arms, legs or other body parts, tingling (paresthesia);
increased motor activity (hyperkinesia);
taste disturbances;
vision disorders, altered vision (abnormal vision);
ringing in the ears (tinnitus), hearing loss;
vertigo;
irregular or rapid heartbeat (palpitations);
reduced heart rate (bradycardia);
reduced heart function (cardiac failure);
swelling (edema);
increased blood pressure (hypertension) or reduced blood pressure (hypotension);
heart problems (heart failure); increased blood vessel size (vasodilation);
bruising (hematomas);
flushing;
paleness of the skin (pallor);
bleeding from surgical wounds after operations (postoperative wound bleeding);
heart attack;
damage to blood vessels in the brain (stroke);
accumulation of fluid in the lungs (pulmonary edema);
difficulty breathing (dyspnea, asthma);
injury to the lining of the stomach or intestine, which may even be perforated and accompanied by bleeding (peptic ulcer, ulcer, intestinal perforation or hemorrhage);
nausea;
vomiting;
diarrhea;
gas release from the intestine (flatulence);
constipation;
stomach discomfort or pain (dyspepsia), abdominal pain/discomfort, feeling of fullness;
blood in the stool (melena) and (rectal bleeding);
vomiting blood (hematemesis);
inflammation of the mouth (stomatitis and ulcerative stomatitis) and esophagus (esophagitis), gastrointestinal ulcers;
belching;
inflammation of the pancreas (pancreatitis);
dry mouth;
worsening of colon inflammation (exacerbation of colitis), stomach inflammation (gastritis);
worsening of a chronic inflammatory bowel disease (Crohn's disease);
liver problems (hepatitis, liver failure);
yellowing of the skin and eyes (cholestatic jaundice);
rapid swelling due to fluid accumulation in legs, arms, face, tongue, or around the mouth and eyes (angioedema);
skin inflammation with peeling (exfoliative dermatitis);
sweating;
red spots on the skin with redness and swelling (maculopapular rash);
urticaria, itching;
severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis);
muscle pain (myalgia);
increased urine production (polyuria), frequent passage of small amounts of urine (pollakiuria), reduced urine excretion (oliguria);
kidney problems (acute renal failure, hemolytic-uremic syndrome, interstitial nephritis, nephrotic syndrome, flank pain); inability of the bladder to empty (urinary retention);
female infertility;
fatigue (asthenia);
fever;
injection site reactions;
chest pain (thoracic pain);
excessive thirst;
prolonged bleeding time and changes in certain blood tests (increased serum urea, increased creatinine, changes in liver function tests).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at 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 Aurobindo

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 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 Ketorolac Aurobindo 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 Aurobindo and pack contents
Carton pack containing 3 vials of 1 ml.
Marketing Authorization Holder
Eugia Pharma (Malta) Limited
Vault 14, Level 2,
Valletta Waterfront,
Floriana FRN 1914, Malta
Manufacturer
Biomedica Foscama Industria Chimico-Farmaceutica SpA
Via Morolense, 87
03013 Ferentino (FR)
Italy