КЕТОРОЛАК ДОК ЖЕНЕРИКИ 30 мг/мл Инъекционный раствор

Содержание инструкции

1. KETOROLAC DOC Generici 20 mg/ml oral drops, solution
   1. What is KETOROLAC DOC Generici and what is it used for?
   2. What you need to know before you take 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
2. KETOROLAC DOC Generici 30 mg/ml injectable solution
   1. What is KETOROLAC DOC Generici and what is it 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. Contents of the pack and other information

KETOROLAC DOC Generici 20 mg/ml oral drops, solution

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 could be harmful.
• If you get any side effects, even 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 you take 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 is KETOROLAC DOC Generici 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 DOC Generici 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 DOC Generici

Do not take 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 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 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 occurred following previous therapy with non-steroidal anti-inflammatory drugs;
• if you have a severe heart problem (severe heart failure);
• 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 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 severe liver disease (liver cirrhosis or severe hepatitis);
• if you have a predisposition to bleeding (bleeding diathesis) or a problem due to a defect in blood coagulation;
• if you have or suspect you have a cerebral hemorrhage (stroke) or if you have had one in the past;
• if you have undergone surgery at high risk of bleeding or incomplete cessation of blood loss (incomplete hemostasis);
• if you have any other bleeding problems;
• if you are taking acetylsalicylic acid, other non-steroidal anti-inflammatory drugs, medicines to prevent blood clot formation 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 urine (diuretics) (see section “Other medicines and KETOROLAC DOC Generici”);
• for the prevention of pain (analgesia) before or during surgical operations, because this medicine increases the risk of bleeding;
• if the person who has 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
Talk to your doctor or pharmacist before taking KETOROLAC DOC Generici.

Take KETOROLAC DOC Generici under the direct supervision of your doctor because this medicine
should not be used in the treatment of mild or chronic pain. The doctor will prescribe
the dose and duration of therapy that is most appropriate for your problem, in order to reduce the appearance of
undesirable effects.
Tell your doctor before taking this medicine:

• if you suffer from or have suffered from stomach or intestinal disorders (peptic ulcer, bleeding in the stomach or intestines, ulcerative colitis, Crohn's disease);
• if you are elderly or debilitated, as this increases the possibility of injury or bleeding in the stomach or intestines, potentially fatal. In this case, the doctor may decide to reduce the dose or increase the time interval between administrations (see section “How to use KETOROLAC DOC Generici”). The doctor may also advise you to associate this medicine with medicines that protect the stomach;
• if you are taking one of the medicines listed in section “Other medicines and KETOROLAC DOC Generici” at the same time, as this may increase the risk of side effects;
• if you suffer from or are predisposed to a disease 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 a respiratory disease characterized by the presence of polyps in the nose (nasal polyposis), as you may experience severe allergic reactions that may be life-threatening;
• if you suffer from or have suffered from heart problems (heart failure, ischemic heart disease), 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 going to undergo surgery, because this medicine interferes with blood coagulation;
• if you think you are pregnant. In any case, during the intake of this medicine, you must use adequate contraceptive measures;
• if you are a woman with fertility problems and are planning a pregnancy, as this medicine may interfere with your fertility;

Tell 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
Generici, as KETOROLAC DOC Generici may sometimes worsen wound healing
in the intestine following surgery.

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

• if you experience symptoms of an allergic reaction;
• if you experience blood loss (hemorrhage), lesions (ulcers) of the stomach or intestines. The risk of these side effects occurring is higher if you take the medicine for prolonged periods and without respecting the due warnings. These side effects can occur at any time with or without warning symptoms, and can be life-threatening, especially if you are elderly or have already suffered from stomach or intestinal problems. During treatment with this medicine, report any unusual symptoms in the stomach or intestines to your doctor, especially if they occur at the beginning of treatment;
• if you experience liver problems. During treatment with KETOROLAC DOC Generici, alterations in liver function may occur;
• if you experience skin problems characterized by irritation, scaling, blistering and bleeding of the lips, eyes, mouth, nose and genitals.

Side effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control the symptoms (see section
“How to use KETOROLAC DOC generici”).

Children and adolescents
This medicine should not be used in children and adolescents under the age of 16
years.

Other medicines and KETOROLAC DOC Generici
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 drugs (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 they can
interact with KETOROLAC DOC Generici:

• corticosteroids, medicines used for the treatment of inflammatory states or certain immune system diseases, because they increase the risk of side effects on the stomach and intestines;
• anticoagulants(for example warfarin, heparin, dextrans, pentoxifylline), medicines used to prevent blood clot formation in the vessels, or selective serotonin reuptake inhibitors, medicines used for the treatment of mood disorders, because they may increase the risk of bleeding in the stomach or intestines;
• lithium, used for the treatment of depression and similar disorders, or methotrexate, a chemotherapeutic agent, because their toxicity may increase;
• antihypertensivesor diuretics (for example furosemide), medicines used to control blood pressure or heart disorders, because KETOROLAC DOC Generici may reduce their effects.
• probenecid, a medicine 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 taking this medicine.

Pregnancy
Do not take KETOROLAC DOC Generici 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 DOC Generici 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 DOC Generici 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 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 to
become pregnant, you should inform your doctor because 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 vehicles
and using machinery.

KETOROLAC DOC Generici contains methylparahydroxybenzoate and propylparahydroxybenzoate
This medicine contains methylparahydroxybenzoate and propylparahydroxybenzoate which
may cause allergic reactions (also delayed).

3. How to take KETOROLAC DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have 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. The doctor will indicate the dose according to
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 establish the dose and evaluate 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 in case of difficulty dripping.
• 3) reposition the cap and screw it 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 think
a child may have taken this medicine, immediately notify your doctor or go to
the Emergency Room of the nearest hospital. Bring this leaflet, the bottle and its
container to the hospital or doctor so they know which medicine was taken.
Following the intake of an excessive dose of this medicine, abdominal pain may occur
nausea, vomiting, increased breathing rate (hyperventilation), problems with the
stomach or intestines, kidney problems and severe allergic reactions. Rare cases of
increased blood pressure (hypertension), altered 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 a missed dose.
If you have any doubts 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 everyone will experience them.
The side effects that may occur with KETOROLAC DOC Generici are:

Not known(frequency cannot be estimated based on available data)

• infection of the central nervous system (aseptic meningitis);
• reduction in the number of platelets (thrombocytopenia), nosebleeds (epistaxis);
• severe allergic reactions (anaphylactic/anaphylactoid reactions), allergic reactions (hypersensitivity reactions): difficulty breathing (bronchospasm), increased blood vessel volume (vasodilation), flushing, 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 disorders (depression), sleep disorders (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, dizziness, convulsions, numbness 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), slowed heartbeat (bradycardia), swelling in various parts of the body due to fluid accumulation (edema), heart disorders (heart failure), increased blood pressure (hypertension), increased blood vessel volume (vasodilation), decreased blood pressure (hypotension), bruising (hematomas), flushing, pale skin, bleeding from wounds after surgery (post-operative wound bleeding), heart attack, stroke;
• fluid accumulation 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, passage of gas from the intestine (flatulence), constipation, digestive difficulties (dyspepsia), abdominal pain/discomfort, feeling of fullness, blood in the 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 (maculo-papular rash), itching, rupture of capillaries under the skin (purpura), blistering of the skin (bullous reactions), hives;
• muscle pain (myalgia);
• increased urine production (polyuria), frequent urination in small amounts (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 in the urine (nephrotic syndrome), flank pain (with or without blood in the urine (hematuria);
• female infertility;
• fatigue (asthenia), fever, swelling (edema), chest pain, excessive thirst;
• changes in laboratory tests: increased bleeding time, increased serum urea, increased creatinine, alterations in liver function tests, increased/decreased amount of non-protein nitrogen in the blood (azotemia), increased potassium.

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
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 which is stated on the packaging. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.

Shelf life after first opening of the vial
The product must be used within 4 months of first opening the vial.
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 DOC Generici contains

• The active ingredient is ketorolac tromethamine: 1 ml of solution contains 20 mg of ketorolac tromethamine.
• The other ingredients are: citric acid monohydrate, disodium phosphate dihydrate, sodium methylparaben, sodium propylparaben, purified water.

Description of the appearance of KETOROLAC DOC Generici and contents of the pack
The pack contains a 10 ml bottle.

Marketing Authorisation Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milano - Italy.

Manufacturer
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe 1 – 29016 Cortemaggiore (Piacenza) - Italy.

KETOROLAC DOC Generici 30 mg/ml injectable solution

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 may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell 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 you use KETOROLAC DOC Generici
• 3. How to use KETOROLAC DOC Generici
• 4. Possible side effects
• 5. How to store KETOROLAC DOC Generici
• 6. Contents of the pack and other information

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

• of short duration (maximum two days) of acute pain, of moderate or severe degree, after surgical operations;
• of pain caused by renal colic.

This medicine can also be used, when administered intravenously, in
addition to pain relievers derived from opium or similar to it (opioid analgesics), for the
treatment of very intense 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 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 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 occurred following previous therapy with non-steroidal anti-inflammatory drugs;
• if you have a serious heart problem (severe heart failure);
• 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 due to fluid accumulation around the mouth and eyes (angioedema);
• if you have difficulty breathing (bronchospasm);
• if you suffer from asthma;
• if you have or suspect you have a cerebral hemorrhage (stroke), or if you have had one in the past;
• if you have undergone surgery with a high risk of bleeding or incomplete cessation of blood loss (incomplete hemostasis);
• if you have any other bleeding problems;
• if you suffer from kidney problems (moderate or severe renal insufficiency) or 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 (hemorrhagic diathesis) or a problem due to a defect in blood coagulation;
• if you are taking acetylsalicylic acid, other non-steroidal anti-inflammatory drugs, medicines for mood disorders (lithium salts), medicines used to reduce uric acid levels in the blood (probenecid), medicines to eliminate fluids with urine (diuretics) or medicines to prevent blood clot formation in the vessels (anticoagulants, e.g. pentoxifylline) (see section “Other medicines and KETOROLAC DOC Generici”);
• for the prevention of pain (analgesia) before or during surgery, because this medicine increases the risk of bleeding;
• if the person who needs 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 addition, this medicine should not be used:

• in cases where the pain is mild or chronic
• by epidural or intrathecal injections, because it contains ethyl alcohol.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using KETOROLAC DOC Generici.

Use KETOROLAC DOC Generici under the direct supervision of your doctor because this medicine should not be used in the treatment of mild or chronic pain. The doctor will prescribe you the dose and duration of the minimum therapy suitable for your problem, in order to reduce the occurrence of undesirable effects.
Tell your doctor before using this medicine:

• if you suffer from or have suffered from stomach or intestinal disorders (peptic ulcer, bleeding in the stomach or intestines, ulcerative colitis, Crohn's disease);
• if you are elderly or debilitated, as it 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 one administration and the next (see section “How to use KETOROLAC DOC Generici”). The doctor may also advise you to combine this medicine with medicines that protect the stomach;
• if you are taking one of the medicines listed in section “Other medicines and KETOROLAC DOC Generici” at the same time, as it may increase the risk of side effects;
• if you suffer from or are predisposed to a disease 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 a disease of the respiratory system characterized by the presence of polyps in the nose (nasal polyposis), as you may experience severe allergic reactions that may be life-threatening;
• if you suffer from or have suffered from heart problems (heart failure, ischemic heart disease), 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, it may increase the risk of heart attack or stroke;

• 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 going to undergo surgery, because this medicine interferes with blood coagulation;
• if you think you are pregnant. In any case, during the intake of this medicine, you must use adequate contraceptive measures;
• if you are a woman with fertility problems and are planning a pregnancy, as this medicine may interfere with your fertility.

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

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

• if you experience symptoms of an allergic reaction;
• if you experience blood loss (bleeding), lesions (ulcers) of the stomach or intestines. The risk of these side effects occurring is higher if you take the medicine for prolonged periods and without observing the due warnings. These side effects can occur at any time with or without warning symptoms, and can be life-threatening, especially if you are elderly or have already suffered from stomach or intestinal problems. During treatment with this medicine, report any unusual symptoms in the stomach or intestines to your doctor, especially if they occur at the beginning of treatment;
• if you experience liver problems. Alterations in liver function may occur during treatment with KETOROLAC DOC Generici;
• if you experience skin problems characterized by irritation, scaling, blistering or bleeding of the lips, eyes, mouth, nose and genitals.

Side effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control the symptoms (see section “How to use KETOROLAC DOC generici”).

Children and adolescents
This medicine should not be used in children and adolescents under the age of 16.

Other medicines and KETOROLAC DOC Generici
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) 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 they may interact with KETOROLAC DOC Generici:

• corticosteroids, medicines used for the treatment of inflammatory states or certain diseases of the immune system, because they increase the risk of side effects on the stomach and intestines;
• anticoagulants(e.g. warfarin, heparin, dextrans, pentoxifylline), medicines used to prevent blood clot formation in the vessels, or selective serotonin reuptake inhibitors, medicines used for the treatment of mood disorders, because they may increase the risk of bleeding in the stomach or intestines;
• lithium, used for the treatment of depression and similar disorders, or methotrexate, a chemotherapeutic agent, because their toxicity may increase;
• antihypertensivesor diuretics (e.g. furosemide), medicines used to control blood pressure or heart disorders, because KETOROLAC DOC Generici may reduce their effects;
• probenecid, a medicine 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 to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Do not take KETOROLAC DOC Generici in the last 3 months of pregnancy, as it may harm the fetus or cause problems during childbirth. It may cause problems with the fetus's kidneys and heart. It may affect your and the baby's tendency to bleed and delay or prolong labor more than expected. You should not take KETOROLAC DOC Generici 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 DOC Generici 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, your doctor may advise 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 to become pregnant, you should 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 you experience these effects, avoid driving vehicles and using 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, 1.1 ml of wine per vial. It may be harmful to alcoholics. This should be taken into consideration in pregnant or breastfeeding women, children and high-risk groups such as people with liver or epilepsy diseases.
• 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 following exactly the instructions of your doctor, pharmacist or
nurse. If you have any doubts, ask your 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). Intravenous injection can only be
performed in hospitals and other medical facilities.
Do not use KETOROLAC DOC Generici for epidural or intrathecal administrations.

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 to you all at once
(bolus administration) or for more than 1 day if the dose is administered to you via
drip (continuous infusion).
Use in adults
The recommended initial dose for intramuscular or intravenous administrations is 10 mg, followed by
doses of 10-30 mg every 4-6 hours. The doctor will indicate the dose according to your condition. The maximum
dose is 90 mg per day.
One vial of KETOROLAC DOC Generici contains 30 mg of ketorolac.
If your body weight is less than 50 kg, the dose must be reduced.
For renal colic, the recommended dose is one 30 mg vial, for administration into the muscle
or vein.

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

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.

If you use more KETOROLAC DOC Generici than you should
In case of accidental use of an excessive dose of this medicine, immediately
inform your doctor or go to the nearest hospital emergency room. Bring this leaflet, the vial
and its container to the hospital or doctor so they know which medicine has been
taken.
Following the administration of an excessive dose of this medicine, abdominal pain may occur,
nausea, vomiting, increased breathing rate (hyperventilation), problems with the
stomach or intestines, kidney problems and severe allergic reactions. 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 a missed dose.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The side effects that may occur with KETOROLAC DOC Generici are:

Not known(frequency cannot be estimated based on available data)

• infection of the central nervous system (aseptic meningitis);
• reduction in the number of platelets (thrombocytopenia), nosebleeds (epistaxis);
• severe allergic reactions (anaphylactic/anaphylactoid reactions), allergic reactions (hypersensitivity reactions): difficulty breathing (bronchospasm), increased blood vessel volume (vasodilation), flushing, 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 disorders (depression), sleep disorders (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, 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 ears (tinnitus), hearing loss, vertigo;
• increased perception of heartbeat (palpitations), slowed heartbeat (bradycardia), swelling in various parts of the body due to fluid retention (edema), heart disorders (heart failure), increased blood pressure (hypertension), increased blood vessel volume (vasodilation), decreased blood pressure (hypotension), bruising (hematomas), flushing, pale skin, bleeding from wounds after surgery (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, passage of gas from the intestine (flatulence), constipation, indigestion (dyspepsia), abdominal pain/discomfort, feeling of fullness, blood in stools (melena), blood from the rectum, blood in vomit (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 retention 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), itching, rupture of capillaries under the skin (purpura), blistering of the skin (bullous reactions), hives;
• muscle pain (myalgia);
• increased urine production (polyuria), frequent urination (pollachiuria), decreased urine output (oliguria), kidney problems (acute renal failure), blood and kidney problems (hemolytic uremic syndrome), kidney inflammation (interstitial nephritis), inability of the bladder to empty (urinary retention), protein loss in urine (nephrotic syndrome), flank pain (with or without blood in urine (hematuria);
• female infertility;
• fatigue (asthenia), fever, injection site reactions, swelling (edema), chest pain, excessive thirst;
• changes in laboratory tests: increased bleeding time, increased serum urea, increased creatinine, altered liver function tests,

increase/decrease in the amount of non-protein nitrogen in the blood (azotemia), increased
potassium.

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
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 which is stated on the packaging. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.
Do not dispose of any medicine in waste water 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 DOC Generici contains

• The active ingredient is ketorolac tromethamine: 1 vial contains 30 mg of ketorolac tromethamine.
• The other ingredients are: ethyl alcohol, 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.

Marketing Authorisation Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milano -Italy.

Manufacturers
Doppel Farmaceutici S.r.l. - Via Volturno 48 - Quinto de’ Stampi (Rozzano) – Milano - Italy.
Esseti Farmaceutici S.r.l. - Via Campobello 15 - 00071 Pomezia (Roma) – Italy.