Ketorolac Mylan

Package leaflet: Information for the patient

Ketorolac Mylan 20 mg/ml oral drops, solution

ketorolac tromethamine
Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Ketorolac Mylan 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 Mylan is indicated only for short-term treatment (up to five days) of moderate pain following surgical procedures (postoperative pain).

2. What you need to know before taking Ketorolac Mylan

Inform your doctor if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract before receiving/using/taking Ketorolac Mylan, as Ketorolac Mylan may sometimes impair wound healing in the intestine following surgery.

Do not take Ketorolac Mylan

• if you are allergic to ketorolac or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously had an allergic reaction after taking acetylsalicylic acid, drugs that block the synthesis of inflammatory substances (prostaglandins), or other non-steroidal anti-inflammatory drugs (NSAIDs);
• if you have a respiratory disease characterized by the presence of nasal polyps (nasal polyposis);
• if you have swelling due to fluid accumulation around the mouth and eyes (angioedema);
• if you have difficulty breathing (bronchospasm);
• if you suffer from asthma;
• if you have, have 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 (haemorrhagic diathesis) or a disorder due to a blood coagulation defect;
• if you 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 disorder;
• if you are taking acetylsalicylic acid, other non-steroidal anti-inflammatory drugs, drugs to prevent blood clot formation in blood vessels (anticoagulants, e.g. pentoxifylline), mood disorder medications (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 Ketorolac Mylan”);
• for pain prevention (analgesia) before or during surgical procedures, as this medicine increases the risk of bleeding;
• 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, 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 Ketorolac Mylan.
Take Ketorolac Mylan under direct medical supervision, as 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 have or have 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 Ketorolac Mylan”);
• if you have or are predisposed to bronchial inflammatory disease 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, potentially life-threatening allergic reactions;
• if you have or have 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 have or have 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 have or have had liver problems;
• if you have blood coagulation disorders, as this medicine may increase the risk of bleeding;
• if you are scheduled for surgery, as this medicine interferes with blood coagulation;
• if you are a woman with fertility problems and are planning a pregnancy, as this medicine may interfere with fertility.

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 Ketorolac Mylan”);

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

• you experience symptoms of an allergic reaction;
• you experience bleeding (haemorrhages), or lesions (ulcers) of the stomach or intestine;
• you develop liver problems;
• you develop skin problems characterized by irritation, peeling, blistering, or bleeding of the lips, eyes, mouth, nose, and genitals.

Cases of bruising (hematomas) after surgery (post-operative period) and bleeding from surgical wounds following the use of Ketorolac Mylan 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.
Ketorolac Mylan may cause stomach and intestinal problems, especially when used for prolonged periods 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 Ketorolac Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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 Ketorolac Mylan:

• corticosteroids, medicines used to treat inflammatory conditions, as they increase the risk of gastrointestinal adverse effects;
• anticoagulants (e.g. warfarin, heparin, dextrans, pentoxifylline), medicines used to prevent blood clot formation in 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 problems;
• lithium, used to treat depression and similar disorders, or methotrexate, a chemotherapeutic agent, as their toxicity may increase;
• antihypertensives or diuretics, medicines used to control blood pressure or heart conditions, as Ketorolac Mylan may reduce their effectiveness;
• probenecid, a medicine used to promote urinary excretion of uric acid.

Pregnancy, breastfeeding and fertility

If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Fertility
Ketorolac Mylan may cause fertility problems in women. Therefore, if you are planning a pregnancy, you should inform your doctor, as this medicine may reduce fertility.

Pregnancy
Do not take Ketorolac Mylan 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 labour beyond expected duration. You should not take Ketorolac Mylan 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 Mylan may cause kidney problems in the fetus if taken for more than a few days, thereby reducing amniotic fluid levels surrounding the baby (oligohydramnios), or cause narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for more than a few days is required, your doctor may recommend additional monitoring.

Breastfeeding
Do not take this medicine if you are breastfeeding, as it passes into breast milk.

Driving and using machines
This medicine may cause drowsiness, dizziness, vertigo, sleep disturbances (insomnia), or mood disorders (depression). If you experience these effects, avoid driving or operating machinery.

Ketorolac Mylan 20 mg/ml oral drops, solution contains sodium, sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate.

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 10 drops of solution, i.e. essentially 'sodium-free'.

Sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate
May cause allergic reactions (including delayed reactions).

3. How to take Ketorolac Mylan

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 will 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. Safety and
efficacy in these individuals have not been established.
Instructions for opening and using the bottle:

1. To open the bottle, press down on the cap and simultaneously twist it off.
2. Hold the bottle in an upright position and dispense the drops into a glass. Do not shake the bottle.
   If drops are not flowing properly, tap the bottom of the bottle gently.
3. Replace the cap and screw it back on to close the bottle securely.

If you take more Ketorolac Mylan than you should
If you (or someone else) have taken an excessive dose of Ketorolac Mylan, 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 decide on
appropriate treatment.
Take this leaflet, the bottle, and its container with you to the hospital or doctor so that they know
which medicine has been taken.
If you forget to take Ketorolac Mylan
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 everybody gets them.
The side effects that may occur with Ketorolac Mylan are:
Not known (frequency cannot be estimated from the available data)

• central nervous system infection (aseptic meningitis);
• reduced number of platelets (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), reduced blood pressure (hypotension), swelling of the throat (laryngeal edema);
• loss of appetite (anorexia), increased potassium in the blood (hyperkalemia), reduced sodium in the blood (hyponatremia);
• abnormal thoughts, mood 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, disturbance in sensation of arms, legs or other parts of the body (paraesthesia), increased movement (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), reduced blood pressure (hypotension), bruising (haematomas), sudden sensation of heat (hot flushes), loss of skin colour (pallor), bleeding from surgical wounds (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, diarrhoea, 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 (haematemesis), inflammation of the mouth (stomatitis and ulcerative stomatitis), inflammation of the oesophagus (oesophagitis), 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 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), passing small amounts of urine frequently (pollakiuria), reduced urine output (oliguria), kidney problems (acute renal failure), blood and kidney problems (uremic-haemolytic syndrome), inflammation of the kidneys (interstitial nephritis), inability of the bladder to empty (urinary retention), loss of protein in the urine (nephrotic syndrome), flank pain (with or without presence of blood in the urine (haematuria) or increased/decreased levels of non-protein nitrogen in the 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, talk to your doctor or pharmacist.
You can 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 Mylan

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

6. Package contents and other information

What Ketorolac Mylan 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 hydrate, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, sodium hydroxide, purified water.

Description of the appearance of Ketorolac Mylan and contents of the pack
The pack contains one 10 ml vial.
Marketing Authorization Holder
Mylan S.p.A. - Via Vittor Pisani 20 - 20124 Milano
Manufacturer
Special Product’s Line S.p.A., via Fratta Rotonda vado Largo, 1, 03012 Anagni (FR)

Package leaflet: information for the user

Ketorolac Mylan 30 mg/ml solution for injection

ketorolac tromethamine
Generic 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Ketorolac Mylan is and what it is used for
2. What you need to know before using Ketorolac Mylan
3. How to use Ketorolac Mylan
4. Possible side effects
5. How to store Ketorolac Mylan
6. Package contents and other information

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

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

This medicine 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 prolonged surgical procedures (major surgery).

2. What you need to know before using Ketorolac Mylan

Inform your doctor if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract before receiving/using Ketorolac Mylan, as Ketorolac Mylan may sometimes impair wound healing in the intestine following surgery.

Do not use Ketorolac Mylan

• if you are allergic to ketorolac tromethamine or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously had an allergic reaction after taking acetylsalicylic acid, drugs that block the synthesis of inflammatory substances (prostaglandins), or other non-steroidal anti-inflammatory drugs (NSAIDs);
• if you are currently taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• if you suffer from nasal polyps, a respiratory disease characterized by the presence of nasal polyps;
• if you experience swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty breathing or swallowing (angioedema);
• if you have breathing difficulties (bronchospasm);
• if you suffer from asthma (asthmatic attacks);
• if you 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 a severe heart condition (severe heart failure);
• if you have reduced blood volume (hypovolemia) or 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 (hepatic cirrhosis or severe liver failure);
• if you have a tendency to bleed (hemorrhagic diathesis) or a disorder due to a blood coagulation defect;
• if you have or suspect you have had a brain hemorrhage (stroke), or if you have had one in the past;
• 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 blood uric acid levels), diuretics (used to eliminate fluids in urine), or anticoagulants such as pentoxifylline (used to prevent blood clot formation in vessels) (see section “Other medicines and Ketorolac Mylan”);
• for pain prevention (analgesia) before or during surgical procedures, as this medicine increases the risk of bleeding;
• if the person to receive 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: Use by epidural or intrathecal (neuraxial) injection is contraindicated because this medicine contains ethanol.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Ketorolac Mylan.

Use Ketorolac Mylan only under strict medical supervision, as this medicine should 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 gastrointestinal injury and bleeding, which may be life-threatening. In such cases, your doctor may decide to reduce the dose and increase the interval between administrations (see section “How to use Ketorolac Mylan”);
• you have or have had gastrointestinal disorders;
• you suffer from asthma or are predisposed to it, as you may experience respiratory crises (bronchospasm), allergic reactions, or shock;
• you 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 Ketorolac Mylan, 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 Ketorolac Mylan, as it may increase the risk of heart attack or stroke;
• you have or have had kidney problems;
• you have liver problems;
• you have previously experienced swelling of the face, lips, mouth, tongue, or throat causing breathing or swallowing difficulties (angioedema), breathing difficulties (e.g., asthma), or nasal polyps, as you may develop severe, potentially life-threatening allergic reactions.

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

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

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

Children

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

Other medicines and Ketorolac Mylan

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

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 Ketorolac Mylan:

• corticosteroids, used to treat inflammatory conditions. This combination increases the risk of gastrointestinal adverse effects;
• anticoagulants (warfarin, heparin, dextran, antiplatelet agents, aspirin, pentoxifylline), used to prevent blood clot formation in 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 Ketorolac Mylan may reduce their effectiveness. In such cases, the risk of kidney problems may increase, especially if pre-existing kidney damage is 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 urinary excretion of uric acid.

Pregnancy, breastfeeding, and fertility

If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Fertility

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

Pregnancy

Do not take Ketorolac Mylan 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 Mylan 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 Mylan may cause fetal kidney problems if taken for more than a few days, leading to reduced amniotic fluid levels (oligohydramnios) or 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.

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.

Ketorolac Mylan 30 mg/ml injectable solution contains ethanol (96%) and sodium.

Ethanol

This medicine contains 96 mg of alcohol (ethanol) per vial, equivalent to 1.92 mg/kg. The volume amount of this medicine is equivalent to less than 3 ml of beer or 2 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.

Do not use this medicine for epidural or intrathecal injections.

It may be harmful to alcoholics.

This should be taken into account in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.

(See also sections “Do not use Ketorolac Mylan”, “Warnings and precautions”, and “Pregnancy and breastfeeding”.)

Sodium

This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e., essentially “sodium-free”.

3. How to use Ketorolac Mylan

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

Use in adults
The recommended initial dose for intramuscular or intravenous administration is 10 mg; thereafter, the dose is 10–30 mg every 4–6 hours. Your doctor will determine the appropriate dose based on your condition. The maximum daily dose is 90 mg. Do not exceed the recommended maximum dose.
If your body weight is less than 50 kg, the dose should be reduced.
For renal colic, the recommended dose is one 30 mg vial, administered intramuscularly or intravenously.

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

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

If you use more Ketorolac Mylan than you should
If you (or someone else) have taken an excessive dose of Ketorolac Mylan, 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 and intestinal 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 Ketorolac Mylan
Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects that may occur with Ketorolac Mylan are:
Not known (frequency cannot be estimated from the available data):

• central nervous system infection (aseptic meningitis);

• decrease in platelet count (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), decreased sodium levels in the blood (hyponatremia);

• abnormal thoughts, mood disturbances (depression), sleep disturbances (insomnia), feelings of worry or fear (anxiety), irritability, nervousness, mental disorders (psychotic reactions), abnormal dreams (abnormal dream activity), hallucinations, sensation of well-being (euphoria), difficulty concentrating, drowsiness, confusion;

• headache (cephalalgia), dizziness, seizures, disturbances in sensation of arms, legs or other body parts (paresthesia), increased movement (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 heat (hot flushes), paleness of the skin, bleeding from surgical wounds (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), rectal bleeding, vomiting blood (hematemesis), inflammation of the mouth (stomatitis and ulcerative stomatitis), inflammation of the esophagus (esophagitis), noisy release of gas from the stomach through the mouth (eructation), inflammation of the pancreas (pancreatitis), dry mouth, worsening of intestinal inflammation (colitis and Crohn's disease), inflammation of the stomach (gastritis);

• liver problems (hepatitis, liver failure), reduced flow of bile from the liver to the intestine causing 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 output (oliguria), kidney problems (acute renal failure), blood and kidney problems (uremic-hemolytic 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 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 can 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 Mylan

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 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 Mylan contains

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

Description of the appearance of Ketorolac Mylan and contents of the pack
Carton pack containing 3 vials of 1 ml each.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
Esseti Farmaceutici S.r.l., Via Campobello 15, 00040 Pomezia (Roma)