Tora-Dol

Package leaflet: Information for the patient

Tora-Dol 10 mg film-coated tablets, 20 mg/ml oral drops, solution

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

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

Contents of this leaflet:

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

1. What Tora-Dol is and what it is used for

Tora-Dol 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, including an important role in pain control.
Tora-Dol is used only for the short-term treatment (maximum 5 days) of moderate pain
following surgical intervention (post-operative pain).

2. What you need to know before taking Tora-Dol

Do not take Tora-Dol

• if you are allergic to ketorolac tromethamine or any of the other ingredients of this medicine (listed in section 6)
• if you have mild or long-lasting pain (chronic-type 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 nasal polyps (complete or partial nasal polyposis syndrome)
• if you have swelling in 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 stomach or intestinal pain and burning (active peptic ulcer)
• if you have serious heart problems (severe heart failure)
• if you have had or suspect you have had bleeding in the brain (cerebrovascular bleeding)
• if you have reduced blood volume (hypovolemia) or lack of body water (dehydration)
• if you have moderate or severe kidney problems (moderate or severe renal insufficiency)
• if you have severe liver damage or inflammation (hepatic cirrhosis or severe hepatitis)
• if you tend to bleed easily (hemorrhagic diathesis, coagulation disorders)
• if you are being treated with blood-thinning medicines (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 Tora-Dol")
• if you are being treated with 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), in labor, giving birth, or breastfeeding (see "Pregnancy, breastfeeding and fertility").

Warnings and precautions
Talk to your doctor or pharmacist before taking Tora-Dol:

• if you have or have had stomach or intestinal diseases, as the risk of toxicity is high, especially if you take Tora-Dol outside the approved indications and/or for prolonged periods (see also “What Tora-Dol is and what it is used for”, “Do not take Tora-Dol” and “How to take Tora-Dol”)
• if you are taking other anti-inflammatory medicines (see "Other medicines and Tora-Dol")
• if you are elderly or very weak (debilitated), as you may be more likely to experience certain adverse effects caused by Tora-Dol, 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 substances (see "Other medicines and Tora-Dol")
• if you have severe allergic reactions (anaphylactic reactions, bronchial spasms, skin redness, rashes, low blood pressure, throat swelling, or swelling in the legs, arms, face, mouth or tongue), which may occur in patients with or without a history of allergy to Tora-Dol, 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 pump enough blood (mild to moderate congestive heart failure)
• if you have blood vessel problems affecting 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 abnormal liver function tests may occur during Tora-Dol use. If you develop a serious liver function impairment, inform your doctor immediately, who will stop treatment with Tora-Dol
• 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 a pregnancy
• if you have fertility problems or are undergoing fertility investigations.

Tell your doctor if you have recently had or are about to have surgery on the stomach or intestinal tract before using Tora-Dol, as Tora-Dol may sometimes worsen wound healing in the intestine after surgery.
Tora-Dol does not cause dependence. Withdrawal symptoms have not been observed after abrupt discontinuation of treatment.
Although Tora-Dol has not been shown to increase events such as heart attack, this risk cannot be ruled out.
Caution: Tora-Dol 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
Tora-Dol is contraindicated in children and adolescents under 16 years of age.
Other medicines and Tora-Dol
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use of Tora-Dol 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 serious stomach and intestinal injuries and bleeding (see "Warnings and precautions")
• anticoagulants (medicines that thin the blood), as Tora-Dol 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 Tora-Dol in the body
• methotrexate (a medicine for cancer and immune system disorders), as it remains in the body longer, increasing its potential toxicity
• lithium (a medicine for mental health conditions), as its blood levels may rise when taken together with Tora-Dol
• diuretics, ACE inhibitors, and angiotensin II antagonists (medicines to lower blood pressure), as their effect may be reduced when taken with Tora-Dol and the risk of kidney damage may increase in some dehydrated or elderly patients with already impaired kidney function
• furosemide (a medicine to increase urine output), as its effect may be reduced.

Tora-Dol reduces the need for opioid-derived medicines to control post-surgical pain.
Tora-Dol with food
A high-fat meal reduces the effect of Tora-Dol tablets and delays it by about 1 hour.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of Tora-Dol is contraindicated during the last three months of pregnancy (third trimester).
Do not take Tora-Dol during the last three months of pregnancy, as it may harm the fetus or cause problems 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.
Do not take Tora-Dol during the first and second trimesters of pregnancy unless absolutely necessary and under medical advice.
If treatment is needed 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 onwards, ketorolac 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.
If you are of childbearing age, you should avoid possible pregnancy before starting and during treatment with Tora-Dol by using an effective contraceptive method.
Labor and delivery
Tora-Dol is contraindicated during labor and delivery.
Breastfeeding
Tora-Dol is contraindicated during breastfeeding.
Fertility
The use of Tora-Dol may reduce fertility and is not recommended if you are planning a pregnancy. If you have difficulty becoming pregnant or are undergoing fertility tests, you should consider discontinuing Tora-Dol.
Driving and using machines
You may experience drowsiness, dizziness, vertigo, sleep disturbances (insomnia), or mood disorders (depression) while taking Tora-Dol. If you experience these or similar adverse effects, avoid activities requiring alertness.
Therefore, caution is advised when driving vehicles or operating machinery.
Tora-Dol film-coated tablets contain:

• sodium. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

Tora-Dol oral drops, solution contains:

• methyl parahydroxybenzoate and propyl parahydroxybenzoate. These may cause allergic reactions (including delayed ones).
• sodium. This medicine contains less than 1 mmol (23 mg) of sodium per ml of solution, i.e., essentially "sodium-free".

3. How to take Tora-Dol

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Caution: 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 1 film-coated tablet or 10 drops of solution), as needed,
every 4-6 hours, up to a maximum of 40 mg per day.
When switching from injectable therapy to oral therapy with Tora-Dol, your doctor will advise you on
the appropriate dosing regimen (the total daily dose must not exceed 90 mg, remembering 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 (aged 65 years or older)
If you are elderly, your doctor will carefully determine the dose you should take.
Use in children and adolescents
The use of this medicine is contraindicated in individuals under 16 years of age.
Tora-Dol oral drops, solution is particularly suitable for those who have difficulty swallowing tablets.
Instructions for opening the bottle:

If you take more Tora-Dol than you should
If you take an excessive dose of Tora-Dol, contact your doctor immediately or go to the nearest hospital.
Some symptoms of overdose may include abdominal pain, nausea, vomiting, increased breathing rate
(hyperventilation), damage to the stomach or intestinal wall and/or inflammation which may be
accompanied by bleeding (peptic ulcer and/or erosive gastritis, gastrointestinal bleeding), kidney problems
(renal dysfunction), severe and rapid generalized allergic reactions (anaphylactoid reactions). Rarely,
elevated blood pressure (hypertension), kidney disease (acute renal failure), breathing difficulties
(respiratory depression), and coma may occur.
If you forget to take Tora-Dol
Do not take a double dose to make up for the missed dose.
If you stop taking Tora-Dol
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 everyone experiences them.

The following side effects may occur (frequencies are unknown because these effects have been reported voluntarily by an unspecified number of individuals 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 body (purpura)
• nosebleeds (epistaxis)
• severe and rapid generalized allergic reactions (anaphylaxis, anaphylactoid reactions)
• allergic reactions such as bronchial constriction causing breathing difficulties (bronchospasm)
• dilation of blood vessels (vasodilation)
• hot flushes
• skin rash (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 of mental equilibrium (psychotic reactions)
• abnormal dreams
• hallucinations
• euphoria
• reduced concentration ability
• decreased sensitivity and sluggish reflexes (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 (cardiac failure)
• swelling (edema)
• increased blood pressure (hypertension) or reduced blood pressure (hypotension)
• heart problems (heart failure)
• bruising (hematomas)
• flushing
• pallor
• bleeding from a surgical wound after an operation (post-operative hemorrhage)
• heart attack
• damage to blood vessels in the brain (stroke)
• accumulation of fluid 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 pain/discomfort (dyspepsia), abdominal pain/discomfort, feeling of fullness
• blood in the stool (melena) and from the lower part 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 the legs, arms, face, or tongue (angioedema)
• skin inflammation with peeling (exfoliative dermatitis)
• sweating
• skin rash with redness and bumps (maculopapular rash)
• urticaria, itching
• blistering reactions including a condition called Stevens-Johnson syndrome, with severe skin, mouth, and other body lesions accompanied by high fever, vomiting, diarrhea, 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, hemolytic-uremic 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, altered 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 may also report side effects directly via the national reporting system at the website 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 Tora-Dol

Film-coated tablets: do not store above 30°C.
Oral drops, solution: keep in the original packaging to protect the medicine from light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines via 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 package and other information

What Tora-Dol contains
Tora-Dol 10 mg film-coated tablets

• The active substance is ketorolac tromethamine. Each tablet contains 10 mg of ketorolac tromethamine.
• The other components are microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, magnesium stearate, hypromellose, titanium dioxide, macrogol 8000.

Tora-Dol 20 mg/ml oral drops, solution

• 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, sodium dihydrogen phosphate dihydrate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium hydroxide up to pH 6.5 ± 0.5, purified water.

Description of the appearance of Tora-Dol and contents of the pack
Tora-Dol is available as:

• 10 mg film-coated tablets for oral use. Packaged in a blister pack containing 10 tablets.
• Oral drops, solution 20 mg/ml. Supplied in a 10 ml glass bottle.

Marketing Authorization Holder and Manufacturer
RECORDATI Industria Chimica e Farmaceutica S.p.A. - Via Matteo Civitali, 1 – 20148 Milano.
Marketing Authorization Holder: Innova Pharma S.p.A. - Via Matteo Civitali, 1 – 20148 Milano.

Package leaflet: information for the patient

Tora-Dol 10 mg/ml injectable solution, 30 mg/ml injectable solution

ketorolac tromethamine
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 other people, 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Tora-Dol is and what it is used for

Tora-Dol 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, with an important role in pain control.
Tora-Dol 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 through 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 Tora-Dol

Do not use Tora-Dol

• 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 long-lasting pain (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 in 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 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 hemorrhage)
• if you have reduced blood volume (hypovolemia) or lack of body water (dehydration)
• if you have moderate or severe kidney problems (moderate or severe renal failure)
• if you have severe liver damage or inflammation (liver cirrhosis or severe hepatitis)
• if you tend to bleed easily (hemorrhagic diathesis, coagulation disorders)
• if you are being treated with blood-thinning medicines (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 Tora-Dol”)
• 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), in labor, giving birth, or breastfeeding (see “Pregnancy, breastfeeding and fertility”)
• if a specific route of administration is required (neuraxial use: epidural or intrathecal).

Warnings and precautions
Talk to your doctor or pharmacist before using Tora-Dol:

• if you have or have had stomach or intestinal diseases, as the risk of toxicity is high, especially if you use Tora-Dol outside the approved indications and/or for prolonged periods (see also “What Tora-Dol is and what it is used for”, “Do not use Tora-Dol” and “How to use Tora-Dol”)

• if you are taking other anti-inflammatory medicines (see “Other medicines and Tora-Dol”)

• if you are elderly or very weak (debilitated), as you may be more likely to experience certain adverse effects caused by Tora-Dol, 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 Tora-Dol”)

• 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 Tora-Dol, 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 pump enough blood (mild to moderate congestive heart failure)

• if you have blood vessel diseases affecting 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 abnormal liver function tests may occur with Tora-Dol use. If you develop severe liver dysfunction, inform your doctor immediately, who will discontinue treatment with Tora-Dol

• if you have bleeding disorders

• if you experience 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.

Inform your doctor if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract before using Tora-Dol, as Tora-Dol may sometimes impair wound healing in the intestine following surgery.
Tora-Dol does not cause dependence. Withdrawal symptoms have not been observed after abrupt discontinuation of treatment.
Although Tora-Dol has not been shown to increase events such as heart attack, this risk cannot be ruled out.
Warning: Tora-Dol 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
Tora-Dol is contraindicated in children and adolescents under 16 years of age.
Other medicines and Tora-Dol
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicine.
Concomitant use of Tora-Dol 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 (blood-thinning medicines), as Tora-Dol 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 Tora-Dol 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 Tora-Dol
• diuretics, ACE inhibitors, and angiotensin II antagonists (medicines to lower blood pressure), as their effect may be reduced when taken with Tora-Dol 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.

Tora-Dol 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, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
The use of Tora-Dol is contraindicated during the last three months of pregnancy (third trimester).
Do not use Tora-Dol during the last three 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.
Do not use Tora-Dol during the first and second trimesters of pregnancy unless absolutely necessary and under medical advice.
If treatment is required during this period or during attempts to conceive, the lowest effective dose for the shortest possible duration should be used. From week 20 of pregnancy onwards, ketorolac 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.
If you are of childbearing age, you should avoid pregnancy before starting and during treatment with Tora-Dol by using an effective contraceptive method.
Labor and delivery
Tora-Dol is contraindicated during labor and delivery.
Breastfeeding
Tora-Dol is contraindicated during breastfeeding.
Fertility
The use of Tora-Dol 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 Tora-Dol.
Driving and use of machinery
You may experience drowsiness, dizziness, vertigo, sleep disturbances (insomnia), or mood disorders (depression) when using Tora-Dol. If you experience these or similar side effects, avoid activities requiring alertness.
Therefore, caution is advised when driving vehicles or operating machinery.
Tora-Dol 30 mg/ml injectable solution contains:

• ethanol. This medicine contains 100 mg of alcohol (ethanol) per vial, equivalent to 100 mg/ml (10% w/v). The amount in one vial is equivalent to less than 3 ml of beer or 2 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.
• sodium. This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e., essentially “sodium-free”.

Tora-Dol 10 mg/ml injectable solution contains:

• ethanol. This medicine contains 100 mg of alcohol (ethanol) per vial, equivalent to 100 mg/ml (10% w/v). The amount in one vial is equivalent to less than 3 ml of beer or 2 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.
• sodium. This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e., essentially “sodium-free”. This medicine contains 27 mg of sodium (main component of table salt) per 9 vials (maximum daily dose). This corresponds to 1.35% of the maximum recommended daily dietary intake for an adult.

3. How to use Tora-Dol

Use this medicine exactly as instructed 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 your 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 to oral therapy with Tora-Dol (the total daily dose must not exceed 90 mg per day, remembering that the maximum oral dose must not exceed 40 mg).
The dose will be appropriately reduced by your doctor in patients weighing less than 50 kg.
Elderly (aged 65 years or older)
If you are elderly, your doctor will carefully determine the dose you should take.
The maximum daily dose must not exceed 60 mg per day.

• Administration into a vein (intravenous)

INTRAVENOUS USE OF THIS MEDICINE IS RESERVED FOR HOSPITALS AND
CLINICAL FACILITIES.
Adults
In case of 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 daily dose must not exceed 90 mg.
Elderly (aged 65 years or 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
The use of this medicine is contraindicated in individuals under 16 years of age.

If you use more Tora-Dol than you should
If you take too much Tora-Dol, contact your doctor immediately or go to the nearest hospital.
Some symptoms of overdose may include abdominal pain, nausea, vomiting, increased breathing rate (hyperventilation), damage to the stomach or intestinal lining and/or inflammation which may be 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 Tora-Dol
Do not take a double dose to make up for the missed dose.

If you stop treatment with Tora-Dol
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):

• inflammation of the membranes covering the brain (aseptic meningitis)
• decrease in a type of blood cell (thrombocytopenia)
• red spots on the body (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 (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 balance (psychotic reactions)
• abnormal dreams
• hallucinations
• euphoria
• reduced concentration ability
• 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 decreased blood pressure (hypotension)
• heart problems (cardiac failure)
• bruising (hematomas)
• redness
• pallor
• bleeding from a surgical wound after an operation (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 be perforated and accompanied by bleeding (peptic ulcer, ulcer, gastrointestinal perforation or hemorrhage)
• nausea
• vomiting
• diarrhea
• passage of gas from the anus (flatulence)
• constipation
• stomach pain/discomfort (dyspepsia), abdominal pain/discomfort, feeling of fullness
• blood in the stool (melena) and from the lower part 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 bumps (maculopapular rash)
• hives, 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, diarrhea, and joint pain
• skin death (toxic epidermal necrolysis)
• muscle pain (myalgia)
• increased urine volume (polyuria), increased frequency of urination, decreased urine volume (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 changes in certain blood tests (increased urea, increased creatinine, altered 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 may 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 Tora-Dol

This medicine does not require any special storage conditions.
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 pack after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of medicines 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 Tora-Dol contains
Tora-Dol 10 mg/ml injectable solution

• The active substance is ketorolac tromethamine. Each 1 ml vial contains 10 mg of ketorolac tromethamine.
• The other components are ethanol, sodium chloride, sodium hydroxide, water for injectable preparations, pH adjusters (sodium hydroxide, hydrochloric acid to pH 7.4 ± 0.2).

Tora-Dol 30 mg/ml injectable solution

• The active substance is ketorolac tromethamine. Each 1 ml vial contains 30 mg of ketorolac tromethamine.
• The other components are ethanol, sodium chloride, sodium hydroxide, water for injectable preparations, pH adjusters (sodium hydroxide, hydrochloric acid to pH 7.4 ± 0.2).

Description of the appearance of Tora-Dol and contents of the pack
Tora-Dol is presented as an injectable solution for intramuscular or intravenous use.
It is available in the following pack sizes:
10 mg/ml injectable solution: 6 vials of 1 ml.
30 mg/ml injectable solution: 3 vials of 1 ml.

Marketing Authorization Holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. - Via Matteo Civitali, 1 – 20148 Milan.
Marketing Authorization Holder's Sales Licensee: Innova Pharma S.p.A. - Via Matteo Civitali, 1 – 20148 Milan.

Manufacturer
Biologici Italia Laboratories S.r.l. – Via F. Serpero, 2 – 20060 Masate (MI).
For 30 mg/ml vials also:
Esseti Farmaceutici S.r.l. – Via Campobello, 15 – 00071 Pomezia (RM).

The following information is intended exclusively for physicians or healthcare professionals:
Warning: the injectable solution contains ethanol; therefore, neuraxial (epidural or intrathecal) administration is contraindicated.
Tora-Dol is compatible with aminophylline, lidocaine, morphine, meperidine, dopamine, insulin, and heparin when mixed together in a solution within an intravenous infusion bag; however, it must not be mixed with morphine, meperidine, promethazine, or hydroxyzine in the same syringe.
Injections must be performed according to strict standards of sterilization, asepsis, and antisepsis.
The administered dose should be the lowest effective dose according to the severity of pain and the patient's response.