Ketorolac Doc Generici

Patient Information Leaflet

KETOROLAC DOC Generici 20 mg/ml oral drops, solution

Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Contents of this leaflet:

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

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

2. What you should know before taking KETOROLAC DOC Generics

Do not take KETOROLAC DOC Generics

• if you are allergic to ketorolac or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously experienced 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 currently suffer from, have suffered from, or suspect you may have a stomach or intestinal disorder (peptic ulcer, gastrointestinal bleeding or perforation), even if these occurred during previous treatment with non-steroidal anti-inflammatory drugs;
• if you have a serious heart condition (severe heart failure);
• 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 experience difficulty breathing (bronchospasm);
• if you suffer from asthma;
• if you suffer from kidney problems (moderate or severe renal impairment), 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 hepatitis);
• if you have a tendency to bleed (hemorrhagic diathesis) or a disorder due to a blood coagulation defect;
• if you currently have or suspect you are having a brain hemorrhage (stroke), or if you have had one in the past;
• if you have undergone high-risk surgical procedures involving bleeding or incomplete hemostasis;
• if you have any other bleeding disorders;
• if you are taking acetylsalicylic acid, other non-steroidal anti-inflammatory drugs, drugs used to prevent blood clot formation in 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 DOC Generics”);
• for pain prevention (analgesia) before or during surgery, because this medicine increases the risk of bleeding;
• if the person taking 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 DOC Generics.
Take KETOROLAC DOC Generics under direct medical supervision because this medicine
must not be used in the treatment of mild or chronic pain. Your doctor will prescribe the lowest
effective dose and the shortest duration appropriate for your condition, in order to reduce the
occurrence of adverse effects.
Inform your doctor before taking this medicine:

• if you currently suffer from or have previously suffered from stomach or intestinal disorders (peptic ulcer, gastrointestinal bleeding, ulcerative colitis, Crohn’s disease);
• if you are elderly or debilitated, as this increases the risk of potentially life-threatening stomach or intestinal injuries or bleeding. In such cases, your doctor may decide to reduce the dose or increase the interval between doses (see section “How to use KETOROLAC DOC Generics”). Your doctor may also recommend taking this medicine together with drugs that protect the stomach;
• if you are currently taking any of the medicines listed in the section “Other medicines and KETOROLAC DOC Generics”, as this may increase the risk of adverse effects;
• if you currently suffer from or are predisposed to 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 a respiratory disease characterized by nasal polyps (nasal polyposis), as you may develop severe, potentially life-threatening allergic reactions;
• if you currently suffer from or have previously suffered from heart problems (heart failure, ischemic heart disease), 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 currently suffer from or have previously 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 currently suffer from or have previously suffered from liver problems;
• if you suffer from blood coagulation disorders, as this medicine may increase the risk of bleeding;
• if you are scheduled for surgery, because this medicine interferes with blood coagulation;
• if you think you may be pregnant. In any case, while taking this medicine, you must use adequate contraceptive measures;
• if you are a woman with fertility issues and planning a pregnancy, as this medicine may interfere with fertility.

Inform your doctor if you have recently undergone or are about to undergo surgery
on the stomach or intestinal tract before receiving/taking/using KETOROLAC DOC
Generics, as KETOROLAC DOC Generics may sometimes impair wound healing
in the intestine following surgery.
Stop treatment with this medicine and contact your doctor immediately if:

• you experience symptoms of an allergic reaction;
• you experience bleeding (hemorrhages), or lesions (ulcers) of the stomach or intestine. The risk of these adverse effects is higher if you take the medicine for prolonged periods without following appropriate precautions. These adverse effects may occur at any time, with or without warning symptoms, and may be life-threatening, especially if you are elderly or have previously suffered from stomach or intestinal problems. During treatment with this medicine, report any unusual stomach or intestinal symptoms to your doctor, particularly if they occur at the beginning of treatment;
• you experience liver problems. During treatment with KETOROLAC DOC Generics, changes in liver function may occur;
• you experience skin problems characterized by irritation, peeling, blistering, or bleeding of the lips, eyes, mouth, nose, and genitals.

Adverse effects can be minimized by using the lowest effective dose for the shortest duration
necessary to control symptoms (see section “How to use KETOROLAC DOC Generics”).
Children and adolescents
This medicine must not be used in children and adolescents under 16
years of age.
Other medicines and KETOROLAC DOC Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine.
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 because they may
interact with KETOROLAC DOC Generics:

• corticosteroids, medicines used to treat inflammatory conditions or certain immune system disorders, as they increase the risk of gastrointestinal adverse effects;
• anticoagulants (e.g. warfarin, heparin, dextrans, pentoxifylline), medicines used to prevent blood clot formation in vessels, or selective serotonin reuptake inhibitors (SSRIs), medicines used to treat mood disorders, as they may increase the risk of gastrointestinal bleeding;
• lithium, used to treat depression and similar disorders, or methotrexate, a chemotherapeutic agent, as their toxicity may increase;
• antihypertensives or diuretics (e.g. furosemide), medicines used to control blood pressure or heart conditions, as KETOROLAC DOC Generics may reduce their effectiveness;
• probenecid, a medicine used to promote urinary excretion of uric acid.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take KETOROLAC DOC Generics 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 delay or prolong labor beyond
normal. You should not take KETOROLAC DOC Generics 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 DOC Generics may cause kidney problems in the
fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding
the baby (oligohydramnios) or causing constriction of a blood vessel (ductus arteriosus) in the
baby's heart. If treatment is required for more than a few days, your doctor may recommend
additional monitoring.
Breastfeeding
Do not take this medicine if you are breastfeeding, as it passes into breast milk.
Fertility
KETOROLAC DOC Generics may cause fertility problems in women. Therefore, if you plan to
become pregnant, you must inform your doctor, as this medicine may reduce fertility.
Driving and using machines
This medicine may cause drowsiness, dizziness, vertigo, sleep disturbances (insomnia), or mood
disorders (depression). If these effects occur, avoid driving or operating machinery.
KETOROLAC DOC Generics contains methyl parahydroxybenzoate and propyl parahydroxybenzoate
This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which
may cause allergic reactions (including delayed reactions).

3. How to take KETOROLAC DOC Generici

Take this medicine exactly as directed 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 assess whether dosage reduction is necessary.
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 populations have not been established.
Instructions for opening and using the bottle:

1. To open the bottle, press down on the cap and simultaneously unscrew it.
2. Hold the bottle in an upright position and dispense the drops into a glass. Do not shake the bottle.
   If drops do not flow easily, tap gently on the bottom of the bottle.
3. Replace the cap and screw it back on to close the bottle.

If you take more KETOROLAC DOC Generici than you should
If you (or someone else) have taken an excessive dose of KETOROLAC DOC Generici, or if you suspect that a child may have ingested this medicine, contact your doctor immediately or go to the nearest hospital emergency department. Bring this leaflet, the bottle, and its packaging with you so that the medical staff can identify the medicine taken.
After taking an excessive dose of this medicine, abdominal pain, nausea, vomiting, increased breathing rate (hyperventilation), stomach or intestinal problems, kidney problems, and severe allergic reactions may occur. Rare cases of increased blood pressure (hypertension), impaired lung function (respiratory depression), and coma have been reported.
If you forget to take KETOROLAC DOC Generici
Do not take a double dose to make up for the forgotten dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
The side effects that may occur with KETOROLAC DOC Generici are:
Not known (frequency cannot be established from the available data)

• central nervous system infection (aseptic meningitis);
• reduced platelet count (thrombocytopenia), nosebleed (epistaxis);
• severe allergic reactions (anaphylactic/anaphylactoid reactions), allergic reactions (hypersensitivity reactions): difficulty in breathing (bronchospasm), widening of blood vessels (vasodilation), flushing, skin rash, reduction in blood pressure (hypotension), swelling of the throat (laryngeal edema);
• loss of appetite (anorexia), increased potassium levels in the blood (hyperkalemia), reduced sodium levels in the blood (hyponatremia);
• abnormal thoughts, mood disturbances (depression), sleep disturbances (insomnia), feelings of worry or fear (anxiety), nervousness, mental disorders (psychotic reactions), abnormal dreams, hallucinations, feeling of well-being (euphoria), difficulty concentrating, drowsiness, confusion;
• headache (cephalalgia), dizziness, seizures, disturbance in sensation of legs, arms or other body parts (paraesthesia), increased motor activity (hyperkinesia), taste disturbances;
• visual disturbances;
• ringing in the ears (tinnitus), hearing loss, vertigo;
• increased awareness of heartbeat (palpitations), reduced heart rate (bradycardia), swelling in various parts of the body due to fluid accumulation (edema), heart disorders (heart failure), increased blood pressure (hypertension), widening of blood vessels (vasodilation), reduced blood pressure (hypotension), bruising (hematomas), flushing, paleness of the skin, bleeding from surgical wounds after operations (post-operative wound bleeding), heart attack, stroke;
• accumulation of fluid in the lungs (pulmonary edema), difficulty in 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 disturbances (dyspepsia), abdominal pain/discomfort, feeling of fullness, passage of black stools (melena), rectal bleeding, vomiting blood (hematemesis), inflammation of the mouth (stomatitis and ulcerative stomatitis), inflammation of the esophagus (esophagitis), belching, 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), itching, rupture of capillaries under the skin (purpura), appearance of blisters on the skin (bullous reactions), urticaria;
• muscle pain (myalgia);
• increased urine production (polyuria), frequent passage of small amounts of urine (pollakiuria), reduced urine output (oliguria), kidney problems (acute kidney 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 the urine (hematuria));
• female infertility;
• tiredness (asthenia), fever, swelling (edema), chest pain (thoracic pain), excessive thirst;
• laboratory test abnormalities: prolonged bleeding time, increased serum urea, increased creatinine, abnormalities in liver function tests, increase/decrease in non-protein nitrogen levels in the blood (azotemia), increased potassium.

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 the website
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store KETOROLAC DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Period of validity after first opening of the bottle
The product must be used within 4 months of first opening the bottle.
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 DOC Generici contains

• The active substance is ketorolac tromethamine: 1 ml of solution contains 20 mg of ketorolac tromethamine.
• The other components are: citric acid monohydrate, dibasic sodium phosphate dihydrate, sodium methyl-4-hydroxybenzoate, sodium propyl-4-hydroxybenzoate, purified water.

Description of the appearance of KETOROLAC DOC Generici and contents of the pack
The pack contains one 10 ml vial.
Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milan - Italy.
Manufacturer
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe 1 – 29016 Cortemaggiore (Piacenza) - Italy.

Patient Information Leaflet: Information for the User

KETOROLAC DOC Generici 30 mg/ml injectable solution

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, 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, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What KETOROLAC DOC Generici 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 DOC Generici is indicated for the treatment:

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

This medicinal product may also be used, when administered intravenously, in addition to opioid or opioid-like analgesic medicines, for the treatment of severe pain or in cases of major surgical interventions.

2. What you need to know before using KETOROLAC DOC Generici

Do not use KETOROLAC DOC Generici

• 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 inhibit the synthesis of inflammatory substances (prostaglandins), or other non-steroidal anti-inflammatory drugs (NSAIDs);
• if you currently have, have previously 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 severe heart condition (severe heart failure);
• if you suffer from nasal polyps, a respiratory disease characterized by the presence of nasal polyps;
• 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 currently 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 disorder;
• if you have kidney problems (moderate or severe renal insufficiency) or are at risk of kidney problems due to reduced blood volume (hypovolemia) or lack of water (dehydration);
• if you have a serious liver disease (hepatic cirrhosis or severe hepatitis);
• if you have a predisposition to bleeding (hemorrhagic diathesis) or a disorder due to a blood coagulation defect;
• if you are taking acetylsalicylic acid, other non-steroidal anti-inflammatory drugs, mood disorder medications (lithium salts), drugs used to reduce blood uric acid levels (probenecid), diuretics (medications used to eliminate fluids via urine), or anticoagulants (medications used to prevent blood clot formation in vessels, e.g., pentoxifylline) (see section “Other medicines and KETOROLAC DOC Generici”);
• for prevention of pain (analgesia) before or during surgical procedures, as this medicine increases the risk of bleeding;
• if the person taking this medicine is a child or adolescent under 16 years of age;
• during the last 3 months of pregnancy, near or during childbirth;
• if you are breastfeeding.

Additionally, this medicine must not be used:

• in cases where pain is mild or chronic in nature;
• via epidural or intrathecal injections, as it contains ethyl alcohol.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using KETOROLAC DOC Generici.
Use KETOROLAC DOC Generici 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 shortest duration of treatment appropriate for your condition, in order to minimize the
occurrence of adverse effects.
Inform your doctor before using this medicine:

• if you currently have or have previously had stomach or intestinal disorders (peptic ulcer, gastrointestinal bleeding, ulcerative colitis, Crohn's disease);

• 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 DOC Generici”). Your doctor may also recommend concomitant use of medications that protect the stomach;

• if you are currently taking any of the medicines listed in section “Other medicines and KETOROLAC DOC Generici”, as this may increase the risk of adverse effects;

• if you currently have or are predisposed to bronchial asthma, as you may experience respiratory crises (bronchospasm) or allergic reactions;

• if you have previously experienced swelling due to fluid accumulation around the mouth and eyes (angioedema), asthma, bronchospasm, or a respiratory disease characterized by nasal polyps (nasal polyposis), as you may develop severe, potentially life-threatening allergic reactions;

• if you currently have or have previously had heart problems (heart failure, ischemic heart disease), 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 currently have or have previously 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 currently have or have previously 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 think you may be pregnant. In any case, while taking this medicine, you must use adequate contraceptive measures;

• if you are a woman with fertility issues and planning a pregnancy, as this medicine may interfere with fertility.

Inform your doctor if you have recently undergone or are about to undergo stomach or intestinal surgery before receiving/using KETOROLAC DOC Generici, as KETOROLAC DOC Generici may occasionally impair intestinal wound healing following surgery.
Stop treatment with this medicine and contact your doctor immediately if:

• you develop symptoms of an allergic reaction;
• you experience bleeding (hemorrhages), or lesions (ulcers) of the stomach or intestine. The risk of these adverse effects is higher if the medicine is taken for prolonged periods without proper precautions. These adverse effects may occur at any time, with or without warning symptoms, and may be life-threatening, especially if you are elderly or have previously had stomach or intestinal problems. During treatment with this medicine, report any unusual stomach or intestinal symptoms to your doctor, particularly if they occur at the beginning of treatment;
• you develop liver problems. Indeed, liver function abnormalities may occur during treatment with KETOROLAC DOC Generici;
• you develop skin problems characterized by irritation, peeling, blistering, or bleeding of the lips, eyes, mouth, nose, and genitals.

Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section “How to use KETOROLAC DOC Generici”).
Children and adolescents
This medicine must not be used in children and adolescents under 16 years of age.
Other medicines and KETOROLAC DOC Generici
Inform your doctor, pharmacist, or nurse if you are currently using, have recently used, or might use any other medicines.
Do not use this medicine if you are taking:

• non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid (aspirin), as this increases the risk of adverse effects.

If you are taking any of the following medicines, inform your doctor, as they may interact with
KETOROLAC DOC Generici:

• corticosteroids, medications used to treat inflammatory conditions or certain immune system disorders, as they increase the risk of gastrointestinal adverse effects;
• anticoagulants (e.g., warfarin, heparin, dextrans, pentoxifylline), medications used to prevent blood clot formation in vessels, or selective serotonin reuptake inhibitors (SSRIs), medications used to treat mood disorders, as they may increase the risk of gastrointestinal bleeding;
• lithium, used to treat depression and similar disorders, or methotrexate, a chemotherapeutic agent, as their toxicity may increase;
• antihypertensives or diuretics (e.g., furosemide), medications used to control blood pressure or heart conditions, as KETOROLAC DOC Generici may reduce their effectiveness;
• probenecid, a medication used to promote urinary excretion of uric acid.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not take KETOROLAC DOC Generici 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 beyond normal. You should not take KETOROLAC DOC Generici 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 DOC Generici may cause kidney problems in the fetus if taken for more than a few days, thereby 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 required for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Do not take this medicine if you are breastfeeding, as it passes into breast milk.
Fertility
KETOROLAC DOC Generici may cause fertility problems in women. Therefore, if you are planning a pregnancy, inform your doctor, as this medicine may reduce fertility.
Driving and using machines
This medicine may cause drowsiness, dizziness, vertigo, sleep disturbances (insomnia), or mood disorders (depression). If any of these effects occur, avoid driving vehicles or operating machinery.
KETOROLAC DOC Generici contains ethanol (ethyl alcohol) and sodium

• This medicine contains 12.7% vol ethanol (alcohol), i.e., 100 mg per vial, equivalent to 2.5 ml of beer or 1.1 ml of wine per vial. It may be harmful to alcoholics. This should be considered in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.
• This medicine contains less than 23 mg (1 mmol) of sodium per vial, i.e., it is practically 'sodium-free'.

3. How to use KETOROLAC DOC Generici

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

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

Do not use KETOROLAC DOC Generici for epidural or intrathecal administration.

Do not mix this medicine in the same syringe with: morphine, meperidine, promethazine, or hydroxyzine.

Do not use this medicine for longer than 2 days if the dose is administered all at once (bolus administration), or for longer than 1 day if the dose is administered by infusion (continuous infusion).

Use in adults
The recommended initial dose for intramuscular or intravenous administration is 10 mg, followed by doses of 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.

One vial of KETOROLAC DOC Generici contains 30 mg of ketorolac.

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 (age over 65 years)
Your doctor will determine the dose and may consider reducing it. Do not exceed the maximum daily dose of 60 mg.

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

If you use more KETOROLAC DOC Generici than you should
If you accidentally use too much of this medicine, contact your doctor immediately or go to the nearest hospital emergency department. Take this leaflet, the vial, and its container with you to the hospital or doctor so they know which medicine has been taken.

After administration of an excessive dose of this medicine, symptoms such as abdominal pain, nausea, vomiting, increased breathing rate (hyperventilation), stomach or intestinal problems, kidney problems, and severe allergic reactions may occur. Rare cases of increased blood pressure (hypertension), impaired lung function (respiratory depression), and coma have been reported.

If you forget to use KETOROLAC DOC Generici
Do not use a double dose to make up for the missed dose.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

• central nervous system infection (aseptic meningitis);
• reduction in the number of platelets (thrombocytopenia), nosebleeds (epistaxis);
• severe allergic reactions (anaphylactic/anaphylactoid reactions), allergic reactions (hypersensitivity reactions): difficulty in breathing (bronchospasm), widening of blood vessels (vasodilation), flushing, skin rash, reduction in blood pressure (hypotension), swelling of the throat (laryngeal edema);
• loss of appetite (anoresis), increased potassium levels in the blood (hyperkalemia), reduced sodium levels in the blood (hyponatremia);
• abnormal thoughts, mood disturbances (depression), sleep disorders (insomnia), feelings of worry or fear (anxiety), nervousness, mental disturbances (psychotic reactions), abnormal dreams, hallucinations, feeling of well-being (euphoria), difficulty concentrating, drowsiness, confusion;
• headache (cephalalgia), dizziness, seizures, disturbances 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), swelling in various parts of the body due to fluid accumulation (edema), heart problems (heart failure), increased blood pressure (hypertension), widening of blood vessels (vasodilation), reduced blood pressure (hypotension), bruising (hematomas), flushing, paleness of the skin (pallor), bleeding from wounds after surgery (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, passing gas from the intestine (flatulence), constipation, digestive difficulties (dyspepsia), abdominal pain/discomfort, feeling of fullness, passage of blood in stool (melena), rectal bleeding, vomiting blood (hematemesis), inflammation of the mouth (stomatitis and ulcerative stomatitis), inflammation of the esophagus (esophagitis), belching, 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), itching, rupture of capillaries under the skin (purpura), appearance of blisters on the skin (bullous reactions), urticaria;
• muscle pain (myalgia);
• increased urine production (polyuria), passing small amounts of urine frequently (pollakiuria), reduced urine output (oliguria), kidney problems (acute kidney failure), blood and kidney disorders (hemolytic-uremic 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));
• 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,

increase/decrease in non-protein nitrogen levels in the blood (azotemia), increased potassium levels.
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
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store KETOROLAC DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack. 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What KETOROLAC DOC Generici contains

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

Description of the appearance of KETOROLAC DOC Generici and contents of the pack
The pack contains 3 vials of 1 ml each.
Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milan - Italy.
Manufacturers
Doppel Farmaceutici S.r.l. - Via Volturno 48 - Quinto de’ Stampi (Rozzano) – Milan - Italy.
Esseti Farmaceutici S.r.l. - Via Campobello 15 - 00071 Pomezia (Rome) – Italy.