Package leaflet: Information for the patient

Ketorolac S.A.L.F. 30 mg/ml solution for injection

ketorolac tromethamine
EQUIVALENT MEDICINE
Please read this leaflet carefully before using 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 could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ketorolac S.A.L.F. is and what it is used for

Ketorolac S.A.L.F. 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 S.A.L.F. is used:

for the short-term treatment (maximum 2 days) of moderate to severe acute pain following surgical intervention (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 the dosage of 30 mg/ml.

2. What you need to know before using Ketorolac S.A.L.F.

Do not use Ketorolac S.A.L.F.:

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if you have mild or persistent pain over time (chronic-type pain);
if you are allergic to other NSAIDs;
if you have allergic reactions, even severe and sudden ones (anaphylactic reactions), to aspirin (acetylsalicylic acid) or to other medicines of the same class (prostaglandin synthesis inhibitors);
if you have droplet-shaped nodules inside the nose (complete or partial nasal polyposis syndrome);
if you have swelling in the legs, arms, face, mouth, or tongue (angioedema);
if you experience difficulty breathing (bronchospasm, asthma);
if you have a history of bleeding, perforation, or injury, or have pain and burning in the stomach or intestines (active peptic ulcer);
if you have serious heart problems (severe heart failure);
if you have or have had bleeding in the brain or even a suspected bleeding (cerebrovascular hemorrhage);
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 (liver cirrhosis or severe hepatitis);
if you tend to bleed easily (hemorrhagic diathesis, coagulation 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 “Other medicines and Ketorolac S.A.L.F.”);
if you are undergoing treatment with medicines that greatly increase urine production;
if you need to prevent pain before or during surgery;
if you have undergone surgery with a high risk of bleeding (hemorrhage or incomplete hemostasis);
if you are a child or adolescent under 16 years of age;
if you are in the last three months of pregnancy (third trimester of pregnancy), about to give birth (labor), giving birth, or breastfeeding (see “Pregnancy, breastfeeding and fertility”);
if a specific administration route is required ( neuraxial use: epidural or intrathecal ).

Warnings and precautions
Before using this medicine, check that the solution is clear, colorless or slightly yellow, and free of visible particles.
Talk to your doctor or pharmacist before using Ketorolac S.A.L.F.:

if you have or have had stomach or intestinal diseases, as the risk of toxicity is high, especially if you use Ketorolac S.A.L.F. outside the approved indications and/or for prolonged periods (see also “What Ketorolac S.A.L.F. is and what it is used for”, “Do not use Ketorolac S.A.L.F.” and “How to use Ketorolac S.A.L.F.”);
if you are taking other anti-inflammatory medicines (see “Other medicines and Ketorolac S.A.L.F.”);
if you are elderly or very weak (debilitated), as you may be more likely to experience certain adverse effects caused by Ketorolac S.A.L.F., such as bleeding and perforation of the stomach and intestines;
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), medicines for depression (selective serotonin reuptake inhibitors), or medicines such as aspirin or similar agents (see “Other medicines and Ketorolac S.A.L.F.”);
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 S.A.L.F., other NSAIDs, or aspirin;
if you have a history of swelling in the legs, arms, face, mouth, or tongue (angioedema) or breathing difficulties (bronchospasm, asthma), or presence of droplet-shaped nodules inside the nose (nasal polyps);
if you have high blood pressure and/or your heart does not provide adequate blood flow (mild to moderate congestive heart failure);
if you have blood vessel problems affecting the heart (chronic ischemic heart disease), legs (peripheral arterial disease), or brain (cerebrovascular disease);
if you have high levels of fat in the blood (hyperlipidemia);
if you have diabetes;
if you smoke;
if you have kidney problems;
if you have liver problems, as use of Ketorolac S.A.L.F. may cause abnormalities in liver function tests;
if you have bleeding disorders;
if you have skin reactions (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, skin rash, mucosal lesions) or any other sign of allergy;
if you are planning pregnancy;
if you have fertility problems or are undergoing fertility investigations.

Inform your doctor if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract before receiving Ketorolac S.A.L.F., as Ketorolac S.A.L.F. may sometimes worsen wound healing in the intestine following surgery.
Ketorolac S.A.L.F. does not cause dependence. Withdrawal symptoms have not been observed after abrupt discontinuation of treatment.
Although Ketorolac S.A.L.F. has not been shown to increase the risk of events such as heart attack, this risk cannot be ruled out.
Warning: Ketorolac S.A.L.F. 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-type pain.
Children and adolescents
Ketorolac S.A.L.F. is contraindicated in children and adolescents under 16 years of age.
Other medicines and Ketorolac S.A.L.F.
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicine.
Concurrent use of Ketorolac S.A.L.F. 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 (medicines that thin the blood), as Ketorolac S.A.L.F. 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;
probenecid (a medicine for gout), as it increases the amount and duration of Ketorolac S.A.L.F. in the body;
methotrexate (a medicine for cancer and immune system disorders), as it remains in the body longer, potentially increasing its toxicity;
lithium (a medicine for mental health conditions), as its blood levels may rise when taken together with Ketorolac S.A.L.F.;
diuretics, ACE inhibitors, and angiotensin II antagonists (medicines to lower blood pressure), as their effect may be reduced when taken with Ketorolac S.A.L.F. and may increase the risk of kidney damage 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.

Ketorolac S.A.L.F. reduces the need for opioid-derived drugs 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 S.A.L.F. is contraindicated during the last three months of pregnancy (third trimester of pregnancy).
Do not take Ketorolac S.A.L.F. during the last trimester of pregnancy, as it may harm the unborn baby or cause complications during delivery. It may cause kidney and heart problems in the newborn. It may affect the bleeding tendency in both mother and baby and may delay or prolong labor. You should not take Ketorolac S.A.L.F. during the first six months of pregnancy unless strictly necessary and as directed by your doctor. If taken for more than a few days from the 20th week of pregnancy onwards, Ketorolac S.A.L.F. may cause kidney problems in the unborn child and may lead to low levels of amniotic fluid surrounding your baby (oligohydramnios) or narrowing of blood vessels (ductus arteriosus) in the baby’s heart. If you require treatment for more than a few days, your doctor may recommend additional monitoring.
If you are trying to conceive, or during the first and second trimesters of pregnancy, the dose and duration of treatment with Ketorolac S.A.L.F. should be kept as low as possible.
If you are of childbearing age, you should avoid possible pregnancy before starting and during treatment with Ketorolac S.A.L.F. by using an effective contraceptive method.
Labor and delivery
Ketorolac S.A.L.F. is contraindicated during labor and delivery.
Breastfeeding
Ketorolac S.A.L.F. is contraindicated during breastfeeding.
Fertility
The use of Ketorolac S.A.L.F. may reduce fertility and is not recommended if you are planning a pregnancy. If you have difficulty becoming pregnant or are undergoing fertility tests, you should consider stopping Ketorolac S.A.L.F.
Driving and using machines
You may experience drowsiness, dizziness, vertigo, sleep disturbances (insomnia), or mood changes (depression) while using Ketorolac S.A.L.F. If you experience these or similar adverse effects, avoid activities requiring alertness.
Therefore, caution is advised when driving vehicles or operating machinery.
Ketorolac S.A.L.F. injectable solution contains ethanol and sodium
This medicine contains 12.7 vol% ethanol (alcohol), equivalent to approximately 2.5 ml of beer and 1.1 ml of wine per 100 mg dose.
If you are an alcoholic, Ketorolac S.A.L.F. may be harmful.
If you are pregnant or breastfeeding, if you are a child, or if you have liver disease or seizures (epilepsy), consider the alcohol content of this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e., it is practically ‘sodium-free’.

3. How to use Ketorolac S.A.L.F.

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

Administration into a muscle (intramuscular)
Adults
The recommended initial dose is 10 mg, followed by doses of 10–30 mg repeated every 4–6 hours as needed, up to a maximum of 90 mg per day, using the lowest effective dose. For the initial 10 mg dose, your doctor will prescribe another medicine containing Ketorolac at this dosage.
The duration of treatment must not exceed 2 days.
Your doctor will advise you on how to switch from injectable to oral treatment by prescribing Ketorolac tablets (the total daily dose must not exceed 90 mg per day, remembering 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 and over)
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)
INTRAVENOUS USE IS RESERVED FOR HOSPITALS AND CLINICAL CARE FACILITIES.
Adults
In case of severe acute pain, the recommended initial dose is 10 mg, administered using a medicine containing Ketorolac at this dosage, 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 over)
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 for intramuscular or intravenous administration.

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

If you use more Ketorolac S.A.L.F. than you should
If you take an excessive dose of Ketorolac S.A.L.F., contact your doctor immediately or go to the nearest hospital.
Some symptoms of overdose may include abdominal pain, nausea, vomiting, frequent breathing (hyperventilation), damage to the stomach or intestinal lining and/or inflammation which may be accompanied by bleeding (peptic ulcer and/or erosive gastritis, gastrointestinal bleeding), kidney problems (renal dysfunction), severe and 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 S.A.L.F.
Do not take a double dose to make up for the missed dose.

If you stop treatment with Ketorolac S.A.L.F.
If you have any questions 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 not known because these effects have been reported voluntarily by an unquantifiable number of individuals after the medicine was placed on the market):

inflammation of the membranes surrounding the brain (aseptic meningitis)
decrease in a type of blood cells (thrombocytopenia)
red spots on the body (purpura)
nosebleeds (epistaxis)
severe and rapid generalized allergic reactions (anaphylaxis, anaphylactoid reactions)
allergic reactions such as bronchial constriction causing breathing difficulties (bronchospasm)
dilation of blood vessels (vasodilation)
hot flushes
skin rash
throat swelling (laryngeal edema)
loss of appetite (anorexia)
increased potassium levels (hyperkalemia) and reduced sodium levels in the blood (hyponatremia)
abnormal thinking
mood disturbances (depression)
sleep disorders (insomnia)
anxiety, irritability, nervousness
severe disturbances in mental equilibrium (psychotic reactions)
abnormal dreams
hallucinations
euphoria
reduced ability to concentrate
decreased sensitivity and sluggish reflexes (stupor)
confusion
headache (cephalalgia)
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
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)
bruising (hematomas)
redness
pallor
bleeding from surgical wound after an operation (postoperative hemorrhage)
heart attack
damage to blood vessels in the brain (stroke)
fluid accumulation in the lungs (pulmonary edema)
breathing difficulties (dyspnea, asthma)
injury to the stomach or intestinal wall, which may even perforate and be accompanied by bleeding (peptic ulcer, ulcer, gastrointestinal perforation or hemorrhage)
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 end of the intestine (rectal bleeding)
vomiting blood (hematemesis)
inflammation of the mouth (stomatitis, 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)
inflammation of the liver (hepatitis)
yellowing of the skin and eyes (cholestatic jaundice)
impaired liver function (hepatic failure)
rapid swelling of legs, arms, face or tongue (angioedema)
skin inflammation with peeling (exfoliative dermatitis)
sweating
skin rash with redness and bumps (maculopapular rash)
hives, itching
blistering skin reactions including a condition known as Stevens-Johnson syndrome, with severe lesions affecting the skin, mouth and other body parts, accompanied by high fever, vomiting, diarrhea and joint pain
skin death (toxic epidermal necrolysis)
muscle pain (myalgia)
increased urine output (polyuria), increased frequency of urination, decreased urine output (oliguria)
kidney disorders (renal failure, hemolytic-uremic syndrome, interstitial nephritis, urinary retention, nephrotic syndrome, flank pain)
infertility in women
muscle weakness (asthenia)
fever
injection site reactions
chest pain
excessive thirst
prolonged bleeding time and abnormalities in certain blood tests (increased urea, increased creatinine, altered 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: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ketorolac S.A.L.F.

Keep the medicine in the original packaging to protect it from light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.". The expiry date refers to the last day of that month.
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 S.A.L.F. contains

The active substance is ketorolac tromethamine. One 1 ml vial contains 30 mg of ketorolac tromethamine.
The other components are ethanol, sodium chloride, hydrochloric acid and sodium hydroxide (pH regulators), water for injections.

Description of the appearance of Ketorolac S.A.L.F. and package contents
Ketorolac S.A.L.F. is presented as an injectable solution for intramuscular or intravenous use.
It is available in the following pack: 5 vials of 1 ml.

Marketing Authorisation Holder and Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico – Via Marconi, 2 - Cenate Sotto (BG)

The following information is intended exclusively for physicians or healthcare professionals:
Warning: the injectable solution contains ethanol; therefore, use by neuraxial route
(epidural or intrathecal) is contraindicated.
Ketorolac S.A.L.F. is compatible with aminophylline, lidocaine, morphine, meperidine, dopamine, insulin, and
heparin when mixed together in a solution contained in an intravenous infusion bag for intravenous administration; however,
it must not be mixed with morphine, meperidine, promethazine, or hydroxyzine in the same syringe.
Injections must be performed according to strict rules 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.
For further information, consult the Summary of Product Characteristics.