KETOROLAC 30 mg /Ml Roztwór Do Wstrzykiwań

Treść ulotki

1. Ketorolac Mylan 20 mg/ml oral drops, solution
   1. What is Ketorolac Mylan and what is it used for?
   2. What you need to know before you take Ketorolac Mylan
2. Ketorolac Mylan 20 mg/ml oral drops, solution contains sodium, methyl-parahydroxybenzoate
   1. How to take Ketorolac Mylan
   2. Possible side effects
   3. How to store Ketorolac Mylan
   4. Contents of the pack and other information
3. Ketorolac Mylan 30 mg/ml injectable solution
   1. What is Ketorolac Mylan and what is it 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. Contents of the pack and other information

Ketorolac Mylan 20 mg/ml oral drops, solution

ketorolac tromethamine

Generic medicine
Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, 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 you take 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 is Ketorolac Mylan and what is it used for?

This medicine contains the active ingredient 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 the short-term treatment (maximum five days) of
moderate pain after surgical operations (post-operative pain).

2. What you need to know before you take Ketorolac Mylan

Tell your doctor if you have recently had or are about to have surgery
on the stomach or intestinal tract before receiving/taking/using Ketorolac Mylan, as
Ketorolac Mylan may sometimes worsen 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 had an allergic reaction in the past after taking acetylsalicylic acid, medicines that block the synthesis of inflammatory substances (prostaglandins) or other non-steroidal anti-inflammatory medicines;
• if you have a respiratory disease characterized by the presence of polyps in the nose (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 suffer from, have suffered from or suspect you suffer from a problem with your stomach or intestines (peptic ulcer, gastrointestinal bleeding or perforation), even when this has manifested following previous therapy with non-steroidal anti-inflammatory medicines;
• if you have a serious heart problem (severe heart failure);
• if you suffer from kidney problems (moderate or severe renal insufficiency) if you are at risk of kidney problems due to reduced blood volume (hypovolemia) or water deficiency (dehydration);
• if you have a serious liver disease (liver cirrhosis or severe hepatitis);
• if you have a predisposition to bleeding (haemorrhagic diathesis) or a problem due to a defect in blood coagulation;
• if you have or suspect you have a cerebral haemorrhage (stroke) or have had one in the past;
• if you have undergone surgery with a high risk of bleeding or incomplete cessation of blood loss (incomplete haemostasis);
• if you have any other bleeding problems;
• if you are taking acetylsalicylic acid, other non-steroidal anti-inflammatory medicines, medicines to prevent blood clots in the vessels (anticoagulants, e.g. pentoxifylline), medicines for mood disorders (lithium salts), medicines used to reduce uric acid levels in the blood (probenecid), medicines to eliminate fluids with the urine (diuretics) (see section “Other medicines and Ketorolac Mylan”);
• for the prevention of pain (analgesia) before or during surgical operations, because this medicine increases the risk of bleeding;
• if the person who is to take this medicine is a child or adolescent under the age of 16;
• if you are in the last 3 months of pregnancy, near or during childbirth;
• if you are breastfeeding;
• in cases where the pain is mild or chronic.

Warnings and precautions
Consult your doctor or pharmacist before taking Ketorolac Mylan.
Take Ketorolac Mylan under the direct supervision of your doctor because this medicine should not
be used in the treatment of mild or chronic pain. Your doctor will prescribe the dose and
duration of therapy that is most appropriate for your problem, in order to reduce the occurrence of
undesirable effects.

Tell your doctor before taking this medicine:

• if you suffer from or have suffered from disorders of the stomach or intestines;
• if you are elderly or debilitated, as this increases the possibility of injury or bleeding in the stomach or intestines, which can be life-threatening. In this case, the doctor may

decide to reduce the dose or increase the time interval between administrations (see section “How to use Ketorolac Mylan”);

• if you suffer from or are predisposed to an inflammatory disease of the bronchi called bronchial asthma, as you may experience breathing crises (bronchospasm) or allergic reactions;
• if you have suffered in the past from swelling due to fluid accumulation around the mouth and eyes (angioedema), asthma, bronchospasm or breathing problems (nasal polyposis), as you may experience severe allergic reactions that can be life-threatening;
• if you suffer from or have suffered from heart problems, high blood pressure (hypertension), reduced blood flow to the legs (peripheral arteriopathy) or to the brain (cerebrovascular disease) or think you may be at risk for these conditions (e.g. if you have high blood pressure, diabetes, high levels of fats in the blood or if you smoke). In these cases, the risk of heart attack or stroke may increase;
• if you suffer from or have suffered from 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 suffer from or have suffered from liver problems;
• if you suffer from blood coagulation disorders, as this medicine may increase the risk of blood loss;
• if you are to undergo surgery, because 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 your fertility.

Avoid taking this medicinein the following cases:

• if you are taking medicines that can cause problems with the stomach or intestines, medicines that promote the elimination of fluids with the urine (diuretics) (see section “Other medicines and Ketorolac Mylan”);

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

• if you experience symptoms of an allergic reaction;
• if you experience blood loss (haemorrhage), lesions (ulcers) of the stomach or intestines;
• if you experience liver problems;
• if you experience skin problems characterized by irritation, scaling, blistering and bleeding of the lips, eyes, mouth, nose and genitals.

Cases of bruising (haematomas) have been reported after surgical operations (post-
operative period) and blood loss from wounds following the use of Ketorolac Mylan before or after
surgical operations (peri-operative period). Therefore, inform your doctor if you are to undergo
tonsillectomy, prostate surgery (prostate resection) or cosmetic surgery.
Ketorolac Mylan can cause problems with the stomach and intestines, especially when used for
prolonged periods and without observing the due warnings and precautions.

Children and adolescents
This medicine is not recommended in children and adolescents under the age of 16.

Other medicines and Ketorolac Mylan
Tell 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 medicines (NSAIDs), including acetylsalicylic acid (aspirin) because they increase the risk of side effects.

If you are taking any of the following medicines, tell your doctor because these can
interact with Ketorolac Mylan:

• corticosteroids, medicines used for the treatment of inflammatory states, because they increase the risk of side effects to the stomach and intestines;
• anticoagulants(e.g. warfarin, heparin, dextrans, pentoxifylline), medicines used to prevent blood clots in the vessels, or selective serotonin reuptake inhibitors, medicines used for the treatment of mood disorders, because they can increase the risk of bleeding in the stomach or intestines; digoxin, a medicine used for the treatment of heart problems;
• lithium, used for the treatment of depression and similar disorders, or methotrexate, a chemotherapeutic agent, because their toxicity may increase;
• antihypertensivesor diuretics, medicines used for the control of blood pressure or heart disorders, because Ketorolac Mylan may reduce their effects.
• probenecid, a medicine used to promote the elimination of uric acid with the urine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Fertility
Ketorolac Mylan may cause fertility problems in women. Therefore, if you are planning to become
pregnant, you should inform your doctor because this medicine may reduce fertility.

Pregnancy
Do not take Ketorolac Mylan in the last 3 months of pregnancy, as it may harm the fetus
or cause problems during childbirth. It may cause problems with the kidneys and heart of the fetus. It may
affect your and your baby's tendency to bleed and delay or prolong labour more than
expected. You should not take Ketorolac Mylan in the first 6 months of pregnancy, unless absolutely
necessary and under the advice of your doctor. If treatment is needed during this period or during attempts
to conceive, the minimum dose should be used for the shortest possible time. From the 20th week of
pregnancy, Ketorolac Mylan may cause kidney problems in the fetus, if taken for more than a few days,
reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing the narrowing of a
blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for more than a few days, the
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 can cause drowsiness, dizziness, vertigo, sleep disturbances (insomnia) or
mood disorders (depression). If you experience these effects, avoid driving vehicles
and using machines.

Ketorolac Mylan 20 mg/ml oral drops, solution contains sodium, methyl-parahydroxybenzoate

sodium and propyl-parahydroxybenzoate sodium.

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

Methyl-parahydroxybenzoate sodium and propyl-parahydroxybenzoate sodium
May cause allergic reactions (including delayed reactions).

3. How to take Ketorolac Mylan

Always take this medicine exactly as your doctor or pharmacist has told you.
If you have doubts, ask 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. The doctor will indicate the dose depending on
your condition. The maximum dose is 40 mg per day. Do not exceed the maximum recommended
dose. If you have a body weight of less than 50 kg, the dose must be reduced.

Use in the elderly (over 65 years of age)
The doctor will determine the dose and assess whether to reduce the dosage.

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

Instructions for opening and using the bottle:

• 1) to open the bottle, press on the cap and unscrew simultaneously.
• 2) hold the bottle in a vertical position and pour the drops into a glass. Do not shake the bottle. Tap on the bottom of the bottle if there are difficulties with dripping.
• 3) reposition the cap and screw it on to close the bottle.

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 think a
child may have taken this medicine, immediately inform your doctor or go to the
Emergency Room of the nearest hospital.
Following the intake of an excessive dose of this medicine, abdominal pain, nausea, vomiting, increased breathing rate (hyperventilation), problems with the
stomach or intestines (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. The doctor will establish appropriate therapy.
Bring 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 missed dose.
If you have any doubts about the use of this medicine, ask 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(the frequency of which cannot be estimated from available data)

• infection of the central nervous system (aseptic meningitis);
• reduced number of platelets (thrombocytopenia);
• nosebleed (epistaxis);
• severe allergic reactions (anaphylactic/anaphylactoid reactions), allergic reactions (hypersensitivity reactions): difficulty breathing (bronchospasm), increased blood vessel volume (vasodilation), skin irritation (rash), decreased blood pressure (hypotension), swelling of the throat (laryngeal edema);
• loss of appetite (anorexia), increased potassium in the blood (hyperkalemia), decreased sodium in the blood (hyponatremia);
• abnormal thoughts, mood disorder (depression), sleep disorder (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, dizziness, convulsions, altered sensation in legs and arms or other parts of the body (paresthesia), increased movements (hyperkinesia), altered taste;
• visual disturbances;
• ringing in the ear (tinnitus), hearing loss, vertigo;
• increased awareness of heartbeats (palpitations), decreased heart rate (bradycardia), inability of the heart to pump an adequate amount of blood (heart failure), swelling in different parts of the body due to fluid accumulation in the body (edema), heart disorders (hypertension and heart failure), decreased blood pressure (hypotension), bruising (hematoma), sudden feeling of warmth (hot flushes), decreased skin color (pallor), blood loss from wounds after operations (post-operative wound bleeding), heart attack, stroke;
• increased 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 can be life-threatening, nausea, vomiting, diarrhea, emission of gas from the intestine (flatulence), constipation, digestive difficulties (dyspepsia), abdominal pain/discomfort, feeling of fullness, emission of dark stools (melena), blood loss from the rectum, vomiting blood (hematemesis), inflammation of the mouth (stomatitis and ulcerative stomatitis), inflammation of the esophagus (esophagitis), noisy release of stomach gas through the mouth (eructation), inflammation of the pancreas (pancreatitis), dry mouth, worsening of intestinal inflammation (colitis and Crohn's disease), inflammation of the stomach (gastritis);
• liver problems (hepatitis, hepatic failure), reduced flow of bile from the liver to the intestine with yellowing of the skin (cholestatic jaundice);
• swelling due to fluid accumulation around the mouth and eyes (angioedema), skin lesions (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis), increased sweating, red spots on the skin (maculo-papular 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), emission of small amounts of urine with high frequency (pollakiuria), decreased urine output (oliguria), kidney problems (acute renal failure), blood and kidney problems (uremic-hemolytic syndrome), kidney inflammation (interstitial nephritis), inability of the bladder to empty (urinary retention), protein loss with urine (nephrotic syndrome), flank pain (with or without blood in the urine (hematuria) or increased/decreased amount of non-protein nitrogen in the blood (azotemia), increased creatinine and potassium;
• female infertility;
• fatigue (asthenia), fever, reactions at the injection site, swelling (edema), chest pain, excessive thirst;
• changes in laboratory tests: increased bleeding time, increased serum urea, increased creatinine, alterations in liver function tests.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
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 which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Store in the original package to protect the product from light.

Shelf life after first opening of the vial
The product must be used within 6 months from the date of first opening of the vial.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ketorolac Mylan contains

• The active ingredient is ketorolac tromethamine: 1 ml of solution contains 20 mg of ketorolac tromethamine.
• The other ingredients are: anhydrous citric acid, sodium dihydrogen phosphate hydrate, methyl parahydroxybenzoate sodium, propyl parahydroxybenzoate sodium, sodium hydroxide, purified water.

Description of the appearance of Ketorolac Mylan and contents of the pack
The pack contains a 10 ml bottle.

Marketing Authorisation Holder
Mylan S.p.A. - Via Vittor Pisani 20 - 20124 Milan

Manufacturer
Special Product’s Line S.p.A., via Fratta Rotonda vado Largo, 1, 03012 Anagni (FR)

Ketorolac Mylan 30 mg/ml injectable solution

ketorolac tromethamine

Generic medicine
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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use Ketorolac Mylan
• 3. How to use Ketorolac Mylan
• 4. Possible side effects
• 5. How to store Ketorolac Mylan
• 6. Contents of the pack and other information

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

This medicine contains the active ingredient ketorolac tromethamine, belonging 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 acute moderate-to-severe pain after surgical operations (post-operative pain);
• of pain caused by renal colic.

This medicine is also used, when administered intravenously, in addition to pain-relieving medicines
derived from opium or similar to it (opioid analgesics), for the treatment of very intense pain or in cases of long-duration surgical procedures (major surgery).

2. What you need to know before using Ketorolac Mylan

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

Do not use Ketorolac Mylan

• if you are allergic to ketorolac trometamine or any of the other ingredients of this medicine (listed in section 6);
• if you have had an allergic reaction in the past after taking acetylsalicylic acid, medicines that block the synthesis of inflammatory substances (prostaglandins) or other non-steroidal anti-inflammatory drugs;
• if you are taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• if you suffer from nasal polyps, a disease of the respiratory system characterized by the presence of polyps in the nose;
• if you have swelling of the face, lips, mouth, tongue or throat that can cause difficulty breathing and swallowing (angioedema);
• if you have difficulty breathing (bronchospasm);
• if you suffer from asthma (asthmatic attacks);
• if you suffer from, have suffered from or suspect you suffer from a problem with your stomach or intestine (peptic ulcer, perforation);
• if you have had bleeding in your stomach or intestine;
• if you have a severe heart problem (severe heart failure);
• if you have a decrease in blood volume (hypovolemia) or fluids in the body (dehydration);
• if you have moderate or severe kidney problems or if you are at risk of kidney problems due to reduced blood volume (hypovolemia) or lack of water (dehydration);
• if you have a severe liver disease (liver cirrhosis or severe liver failure);
• if you have a predisposition to bleeding (bleeding diathesis) or a problem due to a defect in blood coagulation;
• if you have or suspect a cerebral hemorrhage (stroke), or if you have had one in the past;
• if you have undergone surgeries at high risk of bleeding or incomplete cessation of blood loss (incomplete hemostasis);
• if you have any other bleeding problems (coagulation disorders);
• if you are taking lithium salts (used for mood disorders), probenecid (used to reduce uric acid levels in the blood), diuretics (used to eliminate fluids with urine), anticoagulants such as pentoxifylline (used to prevent blood clots in the vessels) (see section “Other medicines and Ketorolac Mylan”);
• for the prevention of pain (analgesia) before or during surgical operations, because this medicine increases the risk of bleeding;
• if the person who is to take this medicine is a child or adolescent under the age of 16;
• if you are in the last 3 months of pregnancy, near or during childbirth;
• if you are breastfeeding with breast milk.

Caution:use for injections via the epidural or intrathecal route (neuraxial route) is contraindicated because it contains ethanol.

Warnings and precautions
Consult your doctor, pharmacist or nurse before using Ketorolac Mylan.
Use Ketorolac Mylan only under strict medical supervision because this medicine should not be used in the treatment of mild or chronic pain.
Avoid concomitant use with other non-steroidal anti-inflammatory drugs (NSAIDs).
Use this medicine at the lowest doses and for short periods of time to reduce the occurrence of undesirable effects.
Use this medicine with great caution and under strict medical supervision if:

• you are a woman and intend to become pregnant, as it may impair fertility;
• you are elderly or debilitated, as it increases the possibility of injury and bleeding in the stomach and intestine, which can be life-threatening. In this case, the doctor may decide to reduce the dose and increase the time interval between administrations (see section “How to use Ketorolac Mylan”).
• you suffer from or have suffered from disorders of the stomach and intestine;
• you suffer from or are predisposed to asthma, as you may experience respiratory crises (bronchospasm), allergic reactions or shock;
• you suffer from or have suffered from heart problems, high blood pressure, reduced blood flow to the legs and the amount of oxygen to the brain. Inform your doctor before using Ketorolac Mylan as it may increase the risk of heart attack or stroke.
• you think you are at risk of cardiovascular disease (high blood pressure, diabetes, high cholesterol levels or smoke). Inform your doctor before using Ketorolac Mylan as it may increase the risk of heart attack or stroke.
• you suffer from or have suffered from kidney problems;
• you suffer from liver problems;
• you have had swelling of the face, lips, mouth, tongue or throat in the past, which can cause difficulty breathing and swallowing (angioedema), difficulty breathing (e.g. asthma), nasal polyps, as you may experience severe allergic reactions that can be life-threatening.

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

• if you experience blood loss (bleeding) and lesions (ulcers) of the stomach and intestine;
• if an alteration of liver function occurs;
• if you experience skin rash, mucosal lesions and any other sign of an allergic reaction.

Cases of bruising after operations and blood loss from wounds have been reported following the use of Ketorolac Mylan before or after surgical operations. Therefore, inform your doctor if you are to undergo tonsil removal, prostate surgery or cosmetic surgery.

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

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), because they increase the risk of side effects.

If you are taking any of the following medicines, inform your doctor because these may interact with Ketorolac Mylan:

• corticosteroids, used for the treatment of inflammatory states. This association increases the risk of side effects to the stomach and intestine.
• anticoagulants (warfarin, heparin, dextrans, antiplatelet agents, aspirin, pentoxifylline), used to prevent blood clots in the vessels or selective serotonin reuptake inhibitors, used for the treatment of mood disorders, because they may increase the risk of bleeding in the stomach and intestine;
• methotrexate, a chemotherapeutic agent;
• lithium, used for the treatment of depression and similar disorders;
• digoxin, used for the treatment of heart problems;
• antihypertensives or diuretics, medicines used to control blood pressure or heart disorders, because Ketorolac Mylan may reduce their effects. In this case, the risk of developing kidney problems may increase if a kidney injury is already present (e.g. if you are elderly or dehydrated). Consult your doctor because dose adjustments, water intake and periodic checks of kidney function may be necessary.
• probenecid, used to promote the elimination of uric acid with urine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice 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 in the last 3 months of pregnancy, as it may harm the fetus or cause problems during childbirth. It may cause problems with the kidneys and heart of the fetus. It may affect your and your baby's tendency to bleed and delay or prolong labor more than expected. You should not take Ketorolac Mylan in the first 6 months of pregnancy unless absolutely necessary and under the advice of a doctor. If treatment is needed during this period or during attempts to conceive, the minimum dose should be used for the shortest possible time. From the 20th week of pregnancy, Ketorolac Mylan may cause kidney problems in the fetus if taken for more than a few days, reducing the 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.

Breastfeeding
Do not use this medicine if you are breastfeeding, because ketorolac passes into breast milk.

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

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

Ethanol
This medicine contains 96 mg of alcohol (ethanol) in each vial, which is equivalent to 1.92 mg/kg. The volume 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 injections via the epidural or intrathecal route.
It may be harmful to alcoholics.
To be taken into consideration in pregnant or breastfeeding women, children and high-risk groups such as people with liver or epilepsy diseases.
(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 following exactly the instructions of the doctor, pharmacist or
nurse. If you have doubts, consult the doctor, pharmacist or nurse.
This medicine will be administered to you by a doctor or a nurse, through injection into the
muscle (intramuscular) or injection into a vein (intravenous). The intravenous injection can be
performed only in hospitals and other medical facilities.
Do not use Ketorolac Mylan for epidural or intrathecal administrations and do not mix this
medicine in the same syringe with morphine, meperidine, promethazine or hydroxyzine.
Do not use this medicine for more than 2 days if the dose is administered all at once (bolus administration) and 1 day if the dose is administered via intravenous drip
(continuous infusion).
Use this medicine at the lowest effective dose in relation to your condition.

Use in adults
The recommended initial dose for intramuscular or intravenous administrations is 10 mg; subsequently the
dose will be 10-30 mg every 4-6 hours. The doctor will indicate the dose depending on your conditions. The
maximum dose is 90 mg per day. Do not exceed the recommended maximum dose.
If you have a body weight less than 50 kg, the dose must be reduced.
For renal colic, the recommended dose is one vial of 30 mg, for administration into the muscle
or into a vein.

Use in the elderly over 65 years of age
The doctor will establish the dose and evaluate whether to reduce the dosage. Do not exceed the maximum dose of 60 mg per
day.

Use in children and adolescents
This medicine should not be administered to children and adolescents under 16 years of
age. 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 think a
child may have taken this medicine, immediately notify the doctor or go to the
Emergency Room of the nearest hospital.
Following the administration of an excessive dose of this medicine, abdominal pain may occur,
nausea, vomiting, increased breathing rate (hyperventilation), problems with the stomach
and intestines, kidney problems (of varying severity) and severe allergic reactions. Rare cases of increased blood pressure, respiratory depression and coma have been reported.

If you forget to use Ketorolac Mylan
Do not use a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult the doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The side effects that may occur with Ketorolac Mylan are:

Not known(whose frequency cannot be established on the basis of available data):

• central nervous system infection (aseptic meningitis);
• reduction in the number of platelets (thrombocytopenia);
• nosebleed (epistaxis);
• severe allergic reactions (anaphylactic/anaphylactoid reactions), allergic reactions (hypersensitivity reactions): difficulty breathing (bronchospasm), increased blood vessel volume (vasodilation), skin irritation (rash), decreased blood pressure (hypotension), swelling of the throat (laryngeal edema);
• loss of appetite (anorexia), increased potassium in the blood (hyperkalemia), decreased sodium in the blood (hyponatremia);
• abnormal thoughts, mood disorder (depression), sleep disorder (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, convulsions, altered sensation of legs and arms or other parts of the body (paresthesia), increased movements (hyperkinesia), altered taste;
• visual disturbances;
• ringing in the ears (tinnitus), hearing loss, vertigo;
• increased perception of heartbeat (palpitations), decreased heartbeat (bradycardia), inability of the heart to pump an adequate amount of blood (heart failure), swelling in various parts of the body due to fluid accumulation in the body (edema), heart disorders (hypertension and heart failure), decreased blood pressure (hypotension), bruising (hematomas), sudden feeling of warmth (hot flashes), decrease in

skin color (pallor), bleeding from wounds after operations (post-operative wound bleeding), heart attack, stroke;

• increased 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, emission of gas from the intestine (flatulence), constipation, digestive difficulties (dyspepsia), abdominal pain/discomfort, feeling of fullness, emission of dark stools (melena), bleeding from the rectum, bleeding with vomiting (hematemesis), inflammation of the mouth (stomatitis and ulcerative stomatitis), inflammation of the esophagus (esophagitis), noisy emission through the mouth of gases present in the stomach (eructation), inflammation of the pancreas (pancreatitis), dry mouth, worsening of intestinal inflammation (colitis and Crohn's disease), inflammation of the stomach (gastritis);
• liver problems (hepatitis, liver failure), reduced flow of bile from the liver to the intestine with yellowing of the skin (cholestatic jaundice);
• swelling due to fluid accumulation around the mouth and eyes (angioedema), skin lesions (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis), increased sweating, red spots on the skin (maculopapular rash), skin irritation (urticaria), itching, rupture of capillaries under the skin (purpura), appearance of blisters on the skin (bullous reactions);
• muscle pain (myalgia);
• increased urine production (polyuria), emission of small amounts of urine with high frequency (pollakiuria), decreased urine output (oliguria), kidney problems (acute renal failure), blood and kidney problems (uremic-hemolytic syndrome), kidney inflammation (interstitial nephritis), inability of the bladder to empty (urinary retention), protein loss with urine (nephrotic syndrome), flank pain (with or without the presence of blood in the urine (hematuria) or increase/decrease in the amount of non-protein nitrogen in the blood (azotemia), increased creatinine and potassium;
• female infertility;
• fatigue (asthenia), fever, reactions at the injection site, swelling (edema), chest pain (chest pain), excessive thirst;
• changes in laboratory tests: increased bleeding time, increased serum urea, increased creatinine, alterations in liver function tests.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse. By reporting side effects you can contribute to providing more information
about 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 which is 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 in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ketorolac Mylan contains

• The active ingredient is ketorolac tromethamine. Each vial contains 30 mg of ketorolac tromethamine.
• The other ingredients are: ethyl alcohol, sodium chloride, water for injections.

Description of the appearance of Ketorolac Mylan and contents of the pack
Pack of 3 vials of 1 ml.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan

Manufacturer
Esseti Farmaceutici S.r.l.-, Via Campobello 15, 00040 Pomezia (Rome)