Ketorolac ABC

Package leaflet: Information for the user

KETOROLAC ABC 30 mg/ml injectable solution

ketorolac tromethamine
Equivalent medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

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

Contents of this leaflet:

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

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

Ketorolac ABC contains the active substance ketorolac tromethamine.
It belongs to a group of medicines called non-steroidal anti-inflammatory/anti-rheumatic drugs (NSAIDs), which
have several actions, including an important role in pain control.
Ketorolac ABC is used:

• for the short-term treatment (maximum 2 days) of moderate to severe acute pain following surgery (postoperative pain), administered into a muscle (intramuscularly) or into a vein (intravenously)
• as an adjunct to opioid-based pain therapy in cases of major surgery or very intense pain, administered intravenously
• for the treatment of pain due to renal colic, at a dosage of 30 mg/ml.

2. What you need to know before using Ketorolac ABC

Do not use Ketorolac ABC

• if you are allergic to ketorolac tromethamine or to any of the other ingredients of this medicine (listed in section 6)
• if you have mild or ongoing (chronic) pain
• if you are allergic to other NSAIDs
• if you have allergic reactions, even severe and sudden ones (anaphylactic reactions), to aspirin (acetylsalicylic acid) or to other medicines of the same class (prostaglandin synthesis inhibitors)
• if you have drop-shaped nodules inside the nose (complete or partial nasal polyposis syndrome)
• if you have swelling of the legs, arms, face, mouth, or tongue (angioedema)
• if you have difficulty breathing (bronchospasm, asthma)
• if you have a history of bleeding, perforation, or injury, or have pain and burning in the stomach or intestines (active peptic ulcer)
• if you have serious heart problems (severe heart failure)
• if you have or have had bleeding in the brain or even suspected bleeding (cerebrovascular bleeding)
• if you have reduced blood volume (hypovolemia) or lack of water in the body (dehydration)
• if you have moderate or severe kidney problems (moderate or severe renal insufficiency)
• if you have severe liver injury or inflammation (hepatic cirrhosis or severe hepatitis)
• if you tend to bleed easily (hemorrhagic diathesis, coagulation disorders)
• if you are being treated with medicines that thin the blood (anticoagulants)
• if you are currently taking aspirin (acetylsalicylic acid), other NSAIDs, lithium salts (for mental health conditions), probenecid (for gout treatment), or pentoxifylline (to improve blood circulation) (see “Other medicines and Ketorolac ABC”)
• if you are being treated with medicines that greatly increase urine production
• if you need to prevent pain before or during surgery
• if you have undergone surgery with a high risk of bleeding (hemorrhage or incomplete hemostasis)
• if you are a child or adolescent under 16 years of age
• if you are in the last three months of pregnancy (third trimester of pregnancy), in labor, giving birth, or breastfeeding (see “Pregnancy, breastfeeding and fertility”)
• if a special administration route is required ( neuraxial administration: epidural or intrathecal ).

Warnings and precautions
Talk to your doctor or pharmacist before using Ketorolac ABC:

• if you have or have had stomach or intestinal diseases, as the risk of toxicity is high, especially if you use Ketorolac ABC outside the approved indications and/or for prolonged periods (see also “What Ketorolac ABC is and what it is used for”, “Do not use Ketorolac ABC”, and “How to use Ketorolac ABC”)
• if you are taking other anti-inflammatory medicines (see “Other medicines and Ketorolac ABC”)
• if you are elderly or very weak (debilitated), as you may be more likely to experience certain adverse effects caused by Ketorolac ABC, such as bleeding and perforation of the stomach and intestines
• if you have chronic inflammatory bowel diseases (ulcerative colitis and Crohn’s disease)
• if you are taking anti-inflammatory hormones (oral corticosteroids), blood-thinning medicines (anticoagulants such as warfarin), antidepressants (selective serotonin reuptake inhibitors), or medicines such as aspirin or similar agents (see “Other medicines and Ketorolac ABC”)
• if you have severe allergic reactions (anaphylactic reactions, bronchospasm, skin redness, rashes, drop in blood pressure, throat swelling, or swelling of the legs, arms, face, mouth, or tongue), which may occur in patients with or without a history of allergy to Ketorolac ABC, other NSAIDs, or aspirin
• if you have a history of swelling in the legs, arms, face, mouth, or tongue (angioedema), breathing difficulties (bronchospasm, asthma), or presence of drop-shaped nodules inside the nose (nasal polyps)
• if you have high blood pressure and/or your heart does not supply adequate blood flow (mild to moderate congestive heart failure)
• if you have problems with blood vessels in the heart (chronic ischemic heart disease), legs (peripheral arterial disease), or brain (cerebrovascular disease)
• if you have high levels of fat in the blood (hyperlipidemia)
• if you have diabetes
• if you smoke
• if you have kidney problems
• if you have liver problems, as abnormalities in liver function tests may occur with the use of Ketorolac ABC. If you develop a severe impairment in liver function, inform your doctor immediately, who will discontinue treatment with Ketorolac ABC
• if you have bleeding problems
• if you have skin reactions (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, skin rash, mucosal lesions) or any other signs of allergy
• if you are planning a pregnancy
• if you have fertility problems or are undergoing fertility investigations. Ketorolac ABC does not cause dependence. No withdrawal symptoms have been observed following abrupt discontinuation of treatment.

Although Ketorolac ABC has not been shown to increase events such as heart attack, this risk cannot be ruled out.
Caution: Ketorolac ABC cannot be considered a simple painkiller and must be used under strict medical supervision. It should not be used for the treatment of mild or chronic pain.
Children and adolescents
Ketorolac ABC is contraindicated in children and adolescents under 16 years of age.
Other medicines and Ketorolac ABC
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
Concomitant use of Ketorolac ABC with the following should be avoided:

• non-steroidal anti-inflammatory drugs (NSAIDs) and medicines of the same class as aspirin (ASA), as they increase the risk of serious adverse effects
• corticosteroids (hormones used against inflammation), as they increase the risk of severe stomach and intestinal injuries and bleeding (see “Warnings and precautions”)
• anticoagulants (medicines that thin the blood), as Ketorolac ABC may enhance the effects of anticoagulants such as warfarin, heparin, and dextrans
• antiplatelet agents (aspirin or similar medicines) and selective serotonin reuptake inhibitors (medicines for depression), as they may increase the risk of stomach and intestinal bleeding and prolong bleeding time
• pentoxifylline (a medicine to improve blood circulation), as it increases the tendency to bleed
• probenecid (a medicine for gout), as it increases the amount and duration of Ketorolac ABC in the body
• methotrexate (a medicine for cancer and immune system disorders), as it remains in the body longer, potentially increasing its toxicity
• lithium (a medicine for mental health conditions), as its blood levels may increase when taken together with Ketorolac ABC
• diuretics, ACE inhibitors, and angiotensin II antagonists (medicines to lower blood pressure), as their effect may be reduced when taken with Ketorolac ABC, and the risk of kidney damage may increase in some dehydrated or elderly patients who already have impaired kidney function
• furosemide (a medicine to increase urine output), as its effect may be reduced. Ketorolac ABC reduces the need for opioid-derived medicines to control post-surgical pain.

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
The use of Ketorolac ABC is contraindicated during the last three months of pregnancy (third trimester of pregnancy).
Do not use Ketorolac ABC during the first and second trimesters of pregnancy unless strictly necessary.
If you are trying to conceive, or during the first and second trimesters of pregnancy, the dose and duration of treatment with Ketorolac ABC should be kept as low as possible.
If you are of childbearing age, you should avoid possible pregnancy before starting treatment and use effective contraception during treatment with Ketorolac ABC.
Labour and delivery
Ketorolac ABC is contraindicated during labour and delivery.
Breastfeeding
Ketorolac ABC is contraindicated during breastfeeding.
Fertility
The use of Ketorolac ABC may reduce fertility and is not recommended if you are planning a pregnancy. If you have difficulty becoming pregnant or are undergoing fertility investigations, you should consider discontinuing Ketorolac ABC.
Driving and using machines
You may experience drowsiness, dizziness, vertigo, sleep disturbances (insomnia), or mood disorders (depression) while using Ketorolac ABC. If you experience these or similar adverse effects, avoid performing tasks requiring attention.
Therefore, caution is advised when driving vehicles or operating machinery.
Ketorolac ABC 30 mg/ml injectable solution contains:

• ethanol. This medicine contains 100 mg of alcohol (ethanol) per vial. The amount of alcohol per vial of this medicine is equivalent to less than 3 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.
• sodium. This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e., essentially 'sodium-free'.

3. How to use Ketorolac ABC

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The duration of treatment must not exceed 2 days in case of rapid administration (bolus injection) and 1 day in case of slow administration (continuous infusion).
Your doctor will prescribe the lowest effective dose according to the severity of pain and your response to treatment.
Use this medicine following strict hygiene rules.

• Administration into a muscle (intramuscular)
  Adults
  The recommended initial dose is 10 mg, followed by doses of 10–30 mg repeated every 4–6 hours as needed, up to a maximum of 90 mg per day, using the lowest effective dose.
  The duration of treatment must not exceed 2 days.
  Your doctor will advise you on how to switch from injectable therapy to oral therapy with Ketorolac ABC (the total daily dose must not be exceeded, remembering that the maximum oral dose must not exceed 40 mg per day). The dose will be appropriately reduced by your doctor in patients weighing less than 50 kg.

Elderly (aged 65 years and older)
If you are elderly, your doctor will carefully determine the appropriate dose.
The maximum daily dose must not exceed 60 mg per day.

• Administration into a vein (intravenous)
  INTRAVENOUS USE OF THIS PREPARATION IS RESERVED FOR HOSPITALS AND CARE HOMES.
  Adults
  For severe acute pain, the recommended initial dose is 10 mg, followed by doses of 10–30 mg repeated every 4–6 hours as needed, using the lowest effective dose. If necessary, treatment may continue at longer intervals, but the total daily dose must not exceed 90 mg.
  Elderly (aged 65 years and older)
  The maximum daily dose must not exceed 60 mg per day.
  Renal colic
  If you suffer from renal colic, the recommended dose is one vial of 30 mg administered intramuscularly or intravenously.

Use in children and adolescents
This medicine is contraindicated in individuals under 16 years of age.

• If you use more Ketorolac ABC than you should
  If you take an excessive dose of Ketorolac ABC, inform your doctor immediately or go to the nearest hospital.
  Some symptoms of overdose may include abdominal pain, nausea, vomiting, rapid breathing (hyperventilation), damage to the stomach or intestinal lining and/or inflammation, possibly accompanied by bleeding (peptic ulcer and/or erosive gastritis, gastrointestinal bleeding), kidney problems (renal dysfunction), severe and rapid generalized allergic reactions (anaphylactoid reactions). Rarely, increased blood pressure (hypertension), kidney disease (acute renal failure), breathing difficulties (respiratory depression), and coma may occur.

• If you forget to use Ketorolac ABC
  Do not take a double dose to make up for the missed dose.

• If you stop treatment with Ketorolac ABC
  If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur (frequencies are not known because these effects have been reported voluntarily by an unquantifiable number of individuals after the medicine was placed on the market):

• infection of the membranes surrounding the brain (aseptic meningitis)
• decrease in a type of blood cells (thrombocytopenia)
• red spots on the body (purpura)
• nosebleed (epistaxis)
• severe and rapid generalized allergic reactions (anaphylaxis, anaphylactic reactions)
• allergic reactions such as bronchial constriction causing breathing difficulties (bronchospasm)
• dilation of blood vessels (vasodilation)
• hot flushes
• skin rash
• throat swelling (laryngeal edema)
• loss of appetite (anorexia)
• increased potassium levels (hyperkalemia) and reduced sodium levels in the blood (hyponatremia)
• abnormal thinking
• mood disorders (depression)
• sleep disturbances (insomnia)
• anxiety, irritability, nervousness
• severe disturbances in mental equilibrium (psychotic reactions)
• abnormal dreams
• hallucinations
• euphoria
• reduced ability to concentrate
• decreased sensitivity and reflex responsiveness (stupor)
• confusion
• headache (cephalalgia)
• dizziness
• seizures
• altered skin sensation, tingling (paresthesia)
• excessive movement (hyperkinesia)
• taste disturbances
• vision disorders, altered vision (abnormal vision)
• ringing in the ears (tinnitus), hearing loss
• vertigo
• irregular or rapid heartbeat (palpitations)
• reduced heart rate (bradycardia)
• reduced heart function (heart failure)
• swelling (edema)
• increased blood pressure (hypertension) or reduced blood pressure (hypotension)
• heart problems (cardiac insufficiency)
• bruising (hematomas)
• redness
• paleness
• bleeding from the wound after surgery (post-operative hemorrhage)
• heart attack
• damage to blood vessels in the brain (stroke)
• fluid accumulation in the lungs (pulmonary edema)
• breathing difficulties (dyspnea, asthma)
• injury to the stomach or intestinal wall, which may even perforate and be accompanied by bleeding (peptic ulcer, ulcer, gastrointestinal perforation or hemorrhage)
• nausea
• vomiting
• diarrhea
• passage of gas from the anus (flatulence)
• constipation
• stomach discomfort or pain (dyspepsia), abdominal pain/discomfort, feeling of fullness
• blood in the stool (melena) and from the lower end of the intestine (rectal bleeding)
• vomiting blood (hematemesis)
• inflammation of the mouth (stomatitis, ulcerative stomatitis) and esophagus (esophagitis)
• belching
• inflammation of the pancreas (pancreatitis)
• dry mouth
• worsening of inflammation in a part of the intestine called the colon (exacerbation of colitis), or of the stomach (gastritis)
• worsening of a chronic inflammatory bowel disease (Crohn's disease)
• inflammation of the liver (hepatitis)
• yellowing of the skin and eyes (cholestatic jaundice)
• impaired liver function (hepatic failure)
• rapid swelling of legs, arms, face, or tongue (angioedema)
• skin inflammation with peeling (exfoliative dermatitis)
• sweating
• skin rash with redness and swelling (maculopapular rash)
• hives, itching
• blistering skin reactions including a condition known as Stevens-Johnson syndrome, with severe skin, mouth, and other body lesions accompanied by high fever, vomiting, diarrhea, and joint pain
• death of the skin (toxic epidermal necrolysis)
• muscle pain (myalgia)
• increased urine output (polyuria), increased frequency of urination, decreased urine output (oliguria)
• kidney disorders (renal failure, hemolytic-uremic syndrome, interstitial nephritis, urinary retention, nephrotic syndrome, flank pain)
• infertility in women
• muscle weakness (asthenia)
• fever
• injection site reactions
• chest pain
• excessive thirst
• prolonged bleeding time and alterations in certain blood tests (increased urea, increased creatinine, alterations in liver function tests)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ketorolac ABC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ketorolac ABC contains:

• The active substance is ketorolac tromethamine. Each 1 ml vial contains 30 mg of ketorolac tromethamine.
• The other components are ethyl alcohol, sodium chloride, sodium hydroxide, water for injections.

Description of the appearance of Ketorolac ABC and contents of the pack
Ketorolac ABC is available as a solution for injection for intramuscular or intravenous use.
It is available in the following pack:
30 mg/ml solution for injection: 3 vials of 1 ml.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Turin
Manufacturers
Doppel Farmaceutici S.r.l. – Via Volturno 48 – Quinto de Stampi (Rozzano) – Milan
Esseti Farmaceutici S.r.l. – Via Campobello, 15 – 00071 Pomezia (RM)

Patient Information Leaflet

KETOROLAC ABC 20 mg/ml oral drops, solution

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

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

Contents of this leaflet:

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

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

Ketorolac ABC contains the active substance ketorolac tromethamine.
It belongs to a group of medicines called non-steroidal anti-inflammatory/anti-rheumatic drugs (NSAIDs), which
have various actions, with an important role in pain control.
Ketorolac ABC is used only for the short-term treatment (maximum 5 days) of moderate pain
following surgery (postoperative pain).

2. What you need to know before taking Ketorolac ABC

Do not take Ketorolac ABC

• if you are allergic to ketorolac tromethamine or to any of the other ingredients of this medicine (listed in section 6)
• if you have mild or persistent pain over time (chronic-type pain)
• if you are allergic to other NSAIDs (non-steroidal anti-inflammatory drugs)
• if you have allergic reactions, even severe and sudden ones (anaphylactic reactions), to aspirin (acetylsalicylic acid) or to other medicines of the same class (prostaglandin synthesis inhibitors)
• if you have nasal polyps (complete or partial nasal polyposis syndrome)
• if you have swelling of the legs, arms, face, mouth or tongue (angioedema)
• if you have difficulty breathing (bronchospasm, asthma)
• if you have a history of bleeding, perforation or injury, or have pain and burning in the stomach or intestine (active peptic ulcer)
• if you have serious heart problems (severe heart failure)
• if you have or have had bleeding in the brain or even a suspected bleeding (cerebrovascular bleeding)
• if you have reduced blood volume (hypovolemia) or lack of water (dehydration)
• if you have moderate or severe kidney problems (moderate or severe renal impairment)
• if you have severe liver injury or inflammation (liver cirrhosis or severe hepatitis)
• if you have a tendency to bleed easily (hemorrhagic diathesis, coagulation disorders)
• if you are taking medicines that thin the blood (anticoagulants)
• if you are currently taking aspirin (acetylsalicylic acid), other NSAIDs, lithium salts (for mental health conditions), probenecid (for gout treatment), or pentoxifylline (to improve blood circulation) (see “Other medicines and Ketorolac ABC”)
• if you are taking medicines that greatly increase urine production
• if you are trying to prevent pain before or during surgery
• if you have undergone surgery with a high risk of bleeding (hemorrhage or incomplete hemostasis)
• if you are a child or adolescent under 16 years of age
• if you are in the last three months of pregnancy (third trimester of pregnancy), in labor, giving birth, or breastfeeding (see “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Ketorolac ABC:

• if you have or have had stomach or intestinal diseases, as the risk of toxicity is high, especially if you take Ketorolac ABC outside the approved indications and/or for prolonged periods (see also “What Ketorolac ABC is and what it is used for”, “Do not take Ketorolac ABC” and “How to take Ketorolac ABC”)
• if you are taking other anti-inflammatory medicines (see “Other medicines and Ketorolac ABC”)
• if you are elderly or very weak (debilitated), as you may be more likely to experience some of the adverse effects caused by Ketorolac ABC, such as bleeding and perforation of the stomach and intestine
• if you have chronic inflammatory bowel diseases (ulcerative colitis and Crohn's disease)
• if you are taking anti-inflammatory hormones (oral corticosteroids), blood-thinning medicines (anticoagulants such as warfarin), antidepressants (selective serotonin reuptake inhibitors), or medicines such as aspirin or similar substances (see “Other medicines and Ketorolac ABC”)
• if you have severe allergic reactions (anaphylactic reactions, bronchospasm, skin redness, rashes, low blood pressure, throat swelling, or swelling of the legs, arms, face, mouth or tongue), which may occur in patients with or without a history of allergy to Ketorolac ABC, other NSAIDs or aspirin
• if you have a history of swelling in the legs, arms, face, mouth or tongue (angioedema), breathing difficulties (bronchospasm, asthma), or nasal polyps
• if you have high blood pressure and/or your heart does not supply adequate blood flow (mild to moderate congestive heart failure)
• if you have heart blood vessel diseases (chronic ischemic heart disease), leg blood vessel diseases (peripheral arterial disease), or brain blood vessel diseases (cerebrovascular disease)
• if you have high levels of fat in the blood (hyperlipidemia)
• if you have diabetes
• if you smoke
• if you have kidney problems
• if you have liver problems, as use of Ketorolac ABC may cause abnormalities in liver function tests. If you develop a severe liver function impairment, inform your doctor immediately, who will discontinue treatment with Ketorolac ABC
• if you have bleeding disorders
• if you have skin reactions (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, skin rash, mucosal lesions) or any other signs of allergy
• if you are planning pregnancy
• if you have fertility problems or are undergoing fertility investigations.

Ketorolac ABC does not cause dependence. Withdrawal symptoms have not been observed after abrupt discontinuation of treatment.
Although Ketorolac ABC has not been shown to increase events such as heart attack, this risk cannot be ruled out.
Warning: Ketorolac ABC cannot be considered a simple painkiller and must be used under strict medical supervision. It should not be used for the treatment of mild or chronic-type pain.
Children and adolescents
Ketorolac ABC is contraindicated in children and adolescents under 16 years of age.
Other medicines and Ketorolac ABC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concurrent use of Ketorolac ABC with the following should be avoided:

• non-steroidal anti-inflammatory drugs (NSAIDs) and other medicines of the same class as aspirin (ASA), as they increase the risk of serious adverse effects
• corticosteroids (hormones used against inflammation), as they increase the risk of serious stomach and intestinal injuries and bleeding (see “Warnings and precautions”)
• anticoagulants (medicines that thin the blood), as Ketorolac ABC may enhance the effects of anticoagulants such as warfarin, heparin, and dextrans
• antiplatelet agents (aspirin or similar medicines) and selective serotonin reuptake inhibitors (medicines for depression), as they may increase the risk of stomach and intestinal bleeding and prolong bleeding time
• pentoxifylline (a medicine to improve blood circulation), as it increases the tendency to bleed
• probenecid (a medicine for gout), as it increases the amount and duration of Ketorolac ABC in the body
• methotrexate (a medicine for cancer and immune system diseases), as it remains longer in the body, increasing the risk of toxicity
• lithium (a medicine for mental health conditions), as its blood levels may increase when taken together with Ketorolac ABC
• diuretics, ACE inhibitors, and angiotensin II antagonists (medicines to lower blood pressure), as their effect may be reduced when taken with Ketorolac ABC and may increase the risk of kidney damage in some dehydrated or elderly patients who already have impaired kidney function
• furosemide (a medicine to increase urine output), as its effect may be reduced.

Ketorolac ABC reduces the need for opioid-derived medicines to control post-surgical pain.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of Ketorolac ABC is contraindicated during the last three months of pregnancy (third trimester of pregnancy).
Do not take Ketorolac ABC during the first and second trimesters of pregnancy unless strictly necessary.
If you are trying to conceive, or during the first and second trimesters of pregnancy, the dose and duration of treatment with Ketorolac ABC should be kept as low as possible.
If you are of childbearing age, you should avoid possible pregnancy before starting treatment and use effective contraception during treatment with Ketorolac ABC.
Labour and delivery
Ketorolac ABC is contraindicated during labour and delivery.
Breastfeeding
Ketorolac ABC is contraindicated during breastfeeding.
Fertility
The use of Ketorolac ABC may reduce fertility and is not recommended if you are planning a pregnancy. If you have difficulty becoming pregnant or are undergoing fertility investigations, you should consider discontinuing Ketorolac ABC.
Driving and using machines
You may experience drowsiness, dizziness, vertigo, sleep disturbances (insomnia), or mood disorders (depression) while taking Ketorolac ABC. If you experience these or similar adverse effects, avoid performing tasks requiring alertness.
Therefore, caution is advised when driving vehicles or operating machinery.
Ketorolac ABC oral drops, solution contains:

• methyl parahydroxybenzoate and propyl parahydroxybenzoate. These may cause allergic reactions (including delayed reactions).
• sodium. This medicine contains less than 1 mmol (23 mg) of sodium per 40 mg dose (corresponding to 40 drops of solution), i.e., essentially “sodium-free”.

3. How to take Ketorolac ABC

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Warning: The duration of treatment must not exceed 5 days.
Adults
Your doctor will prescribe the lowest effective dose according to the severity of pain and your response to
treatment.
The recommended dose is 10 mg (equivalent to 10 drops of solution), as needed, every 4–6 hours, up to a
maximum of 40 mg per day.
If switching from injectable therapy to oral treatment with Ketorolac ABC, your doctor will advise you on how
to proceed with dosing (the total daily dose must not exceed 90 mg, bearing in mind that the maximum oral
dose must not exceed 40 mg). Your doctor will appropriately reduce the dose in patients weighing less than
50 kg.
Elderly patients (aged 65 years and older)
If you are elderly, your doctor will carefully determine the dose you should take.
Use in children and adolescents
This medicine is contraindicated in individuals under 16 years of age.
Ketorolac ABC oral drops, solution is particularly suitable for patients with swallowing difficulties.
Instructions for opening and using the bottle

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

Fig. 1 Fig. 2 Fig. 3
If you take more Ketorolac ABC than you should
If you take too much Ketorolac ABC, contact your doctor immediately or go to the nearest hospital.
Symptoms of overdose may include abdominal pain, nausea, vomiting, rapid breathing (hyperventilation),
damage to the stomach or intestinal lining and/or inflammation, possibly accompanied by bleeding (peptic
ulcer and/or erosive gastritis, gastrointestinal bleeding), kidney problems (renal dysfunction), or severe and
rapid generalized allergic reactions (anaphylactoid reactions). Rarely, increased blood pressure
(hypertension), kidney disease (acute renal failure), breathing difficulties (respiratory depression), and coma
may occur.
If you forget to take Ketorolac ABC
Do not take a double dose to make up for the missed dose.
If you stop taking Ketorolac ABC
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.

The following side effects may occur (frequencies are not known because these effects have been reported voluntarily by an unquantifiable number of people after the medicine was placed on the market):

• inflammation of the membranes surrounding the brain (aseptic meningitis)
• decrease in a type of blood cells (thrombocytopenia)
• red spots on the skin (purpura)
• nosebleeds (epistaxis)
• severe and rapid general allergic reactions (anaphylaxis, anaphylactoid reactions)
• allergic reactions such as bronchial constriction causing breathing difficulties (bronchospasm)
• dilation of blood vessels (vasodilatation)
• hot flushes
• skin rash (rash)
• throat swelling (laryngeal oedema)
• loss of appetite (anorexia)
• increased potassium levels (hyperkalaemia) and reduced sodium levels in the blood (hyponatraemia)
• abnormal thinking
• mood disorders (depression)
• sleep disturbances (insomnia)
• anxiety, irritability, nervousness
• severe disturbances in mental equilibrium (psychotic reactions)
• abnormal dreams
• hallucinations
• euphoria
• reduced ability to concentrate
• decreased sensitivity and slowness of reflexes (stupor)
• confusion
• headache (cephalalgia)
• dizziness
• seizures
• altered skin sensation, tingling (paraesthesia)
• excessive movement (hyperkinesia)
• taste disturbances
• vision disorders, altered vision (abnormal vision)
• ringing in the ears (tinnitus), hearing loss
• vertigo
• irregular or rapid heartbeat (palpitations)
• reduced heart rate (bradycardia)
• reduced heart function (heart failure)
• swelling (oedema)
• increased blood pressure (hypertension) or reduced blood pressure (hypotension)
• heart problems (cardiac failure)
• bruising (haematomas)
• redness
• pallor
• bleeding from the surgical wound after an operation (post-operative haemorrhage)
• heart attack
• damage to blood vessels in the brain (stroke)
• presence of fluid in the lungs (pulmonary oedema)
• breathing difficulties (dyspnoea, asthma)
• injury to the stomach or intestinal wall, which may even perforate and be accompanied by bleeding (peptic ulcer, ulcer, gastrointestinal perforation or haemorrhage)
• nausea
• vomiting
• diarrhoea
• passage of gas from the anus (flatulence)
• constipation
• pain/discomfort in the stomach area (dyspepsia), abdominal pain/discomfort, feeling of fullness
• blood in the stools (melena) and from the lower part of the intestine (rectal bleeding)
• vomiting blood (haematemesis)
• inflammation of the mouth (stomatitis, ulcerative stomatitis) and oesophagus (oesophagitis)
• belching
• inflammation of the pancreas (pancreatitis)
• dry mouth
• worsening of inflammation in a part of the intestine called colon (exacerbation of colitis), of the stomach (gastritis)
• worsening of a chronic inflammatory bowel disease (Crohn's disease)
• inflammation of the liver (hepatitis)
• yellowing of the skin and eyes (cholestatic jaundice)
• impaired liver function (hepatic failure)
• rapid swelling of legs, arms, face or tongue (angioedema)
• skin inflammation with peeling (exfoliative dermatitis)
• sweating
• skin rash with redness and swelling (maculopapular rash)
• urticaria, itching
• blistering skin reactions including a condition called Stevens-Johnson syndrome, with severe lesions of the skin, mouth and other body parts, accompanied by high fever, vomiting, diarrhoea and joint pain
• skin death (toxic epidermal necrolysis)
• muscle pain (myalgia)
• increased urine output (polyuria), increased frequency of urination, decreased urine output (oliguria)
• kidney disorders (renal failure, haemolytic-uraemic syndrome, interstitial nephritis, urinary retention, nephrotic syndrome, flank pain)
• infertility in women
• muscle weakness (asthenia)
• fever
• chest pain
• excessive thirst
• prolonged bleeding time and changes in certain blood tests (increased urea, increased creatinine, alterations in liver function tests).

Reporting of suspected adverse reactions
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ketorolac ABC

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.
The product must be used within 4 months after 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 ABC contains

• The active substance is ketorolac tromethamine. Each ml of solution (1 ml = 20 drops) contains 20 mg of ketorolac tromethamine.
• The other components are citric acid monohydrate, disodium phosphate dihydrate, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, purified water.

Description of the appearance of Ketorolac ABC and package contents
Pack containing one 10 ml bottle.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Turin
Manufacturers
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe 1 – 29016 Cortemaggiore (PC)
ABC Farmaceutici S.p.A. – Canton Moretti 29 – 10015 San Bernardo d’Ivrea (TO)