PATIENT INFORMATION LEAFLET

Ketorolaco trometamol Normon 30 mg/ml injectable solution EFG

Ketorolaco trometamol

Read this leaflet carefully before you start using the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Additional information

Ketorolaco trometamol Normon 30 mg/ml injectable solution is a medication that belongs to the group of nonsteroidal anti-inflammatory drugs.

Ketorolaco trometamol Normon 30 mg/ml injectable solution is indicated for:

• Short-term treatment of moderate to severe pain in the postoperative period.
• Treatment of pain caused by nephrolithic colic (acute pain due to the presence of stones in the tube that goes from the kidneys to the urinary tract).

• Do not use ketorolaco trometamol Normon:

• If you have an active peptic ulcer (gastroduodenal ulcer).
• If you have a history of gastrointestinal ulceration, bleeding, or perforation.
• If you are allergic (hypersensitive) to ketorolaco trometamol or other nonsteroidal anti-inflammatory drugs or to any of the other components of ketorolaco trometamol NORMON.
• If you have a complete or partial syndrome of nasal polyps (a sac-like mass formed by nasal mucosa), angioedema (hives), or bronchospasm (bronchiole constriction).
• If you have asthma.
• If you have a severe heart disease.
• If you have a moderate to severe kidney disease.
• If you have hypovolemia (decreased circulating blood volume in the body) or dehydration (lack of body water).
• If you have a bleeding diathesis (tendency to bleeding), coagulation disorders (alteration of clot formation), or cerebral hemorrhage (bleeding in the brain).
• If you are undergoing surgical interventions with a high risk of bleeding or incomplete hemostasis (blood flow stoppage).
• If you are taking other NSAIDs (nonsteroidal anti-inflammatory drugs), including acetylsalicylic acid and COX-2 inhibitors.
• If you are being treated with high-dose anticoagulants.
• If you are being treated with probenecid, lithium salts, or pentoxifilina.
• If you are pregnant or breastfeeding.
• If you are under 16 years old.
• As a preventive analgesic before or during surgical intervention, due to the risk of bleeding.
• The injectable form of ketorolaco trometamol Normon should not be used for epidural or intrathecal administration (administration in the spinal cord or brain fluid), as it contains alcohol.

• Be especially careful with ketorolaco trometamol Normon:

• If you have or have had gastrointestinal bleeding, ulcers, or perforations. Severe gastrointestinal toxicity, including gastrointestinal irritation, bleeding, ulceration, and perforation, may occur.
• If you have a history of inflammatory bowel disease (ulcerative colitis, Crohn's disease).
• If you have kidney disease, your doctor may consider performing certain tests during treatment with this medication.
• If you have heart disease, high blood pressure, or similar pathology.
• If you are taking medications that increase the risk of gastrointestinal ulcers or bleeding, such as heparin, antiplatelet agents, pentoxifilina, corticosteroids, thrombolytics, and antidepressants (SSRI or SNRI inhibitors).
• If you are being treated with anticoagulants (dicumarinics or heparin).
• In elderly patients, precautions will be taken and the minimum effective dose of ketorolaco trometamol Normon will be used during its use.
• With the use of ketorolaco, severe skin alterations (erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis) may rarely occur. Their appearance is more likely at the beginning of treatment. Discontinue administration at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
• If you experience systemic manifestations of liver dysfunction, such as itching or skin redness during treatment, discontinue treatment immediately and inform your doctor as soon as possible.
• If you experience difficulty getting pregnant or are undergoing fertility treatment.
• If you experience skin redness, mucosal lesions, or any other sign of hypersensitivity or anaphylactic reaction (severe allergic reaction), discontinue treatment and inform your doctor immediately.
• If you are taking other medications, such as methotrexate, as ketorolaco trometamol NORMON may modify or potentiate the effect of these medications.
• Inform your doctor if you have recently undergone or are about to undergo a surgical intervention of the stomach or intestinal tract before receiving/taking/using ketorolaco trometamol Normon, as ketorolaco trometamol Normon may sometimes worsen the healing of intestinal wounds after a surgical intervention.

Consult your doctor, even if any of the circumstances mentioned above have occurred at any time.

• Use of other medications

Inform your doctor or pharmacist if you are using or have used any other medication, including those acquired without a prescription.

Concomitant administration is contraindicated:

• Other NSAIDs (nonsteroidal anti-inflammatory drugs), including acetylsalicylic acid, as it may increase the risk of gastrointestinal ulcers and bleeding.
• Anticoagulants (dicumarinics, heparin), as it may potentiate the effects on bleeding time.
• Antiplatelet agents (medications used to prevent blood clot formation) (such as acetylsalicylic acid, ticlopidine, or clopidogrel): may increase the risk of gastrointestinal bleeding.
• Pentoxifilina (medication that improves blood flow through blood vessels), probenecid (medication for treating gout).
• Lithium (medication used for treating manic-depressive disorder).

Be especially cautious if you are using or being treated with:

• Corticosteroids (anti-inflammatory medications).
• Trombolotics (medications that dissolve blood clots).
• Antidepressants.
• Methotrexate (anti-rheumatic medication).
• Anti-hypertensives.
• Furosemide (medication used to eliminate excess fluids and treat high blood pressure).

• Pregnancy

Consult your doctor or pharmacist before using any medication.

Ketorolaco trometamol Normon is contraindicated during pregnancy.

• Lactation

Consult your doctor or pharmacist before using any medication.

Ketorolaco trometamol Normon is contraindicated during lactation.

• Childbirth

Consult your doctor or pharmacist before using any medication.

Ketorolaco trometamol Normon is contraindicated during childbirth, as it may inhibit uterine contractions and affect fetal circulation.

• Driving and operating machinery

Some patients may experience drowsiness, dizziness, vertigo, insomnia, or depression during treatment with ketorolaco trometamol NORMON. Therefore, especially at the beginning of treatment, caution should be exercised when driving vehicles or operating machinery.

• Ketorolaco trometamol Normon contains ethanol and sodium

This medication contains 12.25% ethanol (alcohol), which corresponds to 98 mg/ampoule.

This medication contains less than 23 mg of sodium (1 mmol) per ampoule, which is essentially "sodium-free".

Follow these instructions, unless your doctor has given you different instructions.

Ketorolaco trometamol Normon treatment should start in a hospital setting. The maximum treatment duration should not exceed 2 days. If you are later switched to oral treatment, the total treatment duration with ketorolaco should not exceed 7 days.

For pain caused by nephritic colic, a single dose of 30 mg is recommended via intramuscular or intravenous administration.

The dose of ketorolaco trometamol Normon should be adjusted according to the severity of pain and the patient's response, aiming to administer the minimum effective dose. The initial recommended dose of ketorolaco trometamol Normon via intramuscular or intravenous administration is 10 mg, followed by doses of 10-30 mg every 4 to 6 hours, as needed to control pain. In cases of intense or very intense pain, the initial recommended dose is 30 mg of ketorolaco.

The maximum recommended daily dose is 90 mg for non-elderly adults and 60 mg for the elderly.

In patients who have received ketorolaco via parenteral administration and are switched to oral treatment, the total daily combined dose of the two oral and parenteral presentations should not exceed 90 mg in adults and 60 mg in the elderly.

The intramuscular injection should be administered slowly and deeply into the muscle.

Administration with morphine

In most patients, intramuscular or intravenous ketorolaco therapy provides adequate analgesia. However, opioid analgesics may be used in combination when the maximum recommended doses of ketorolaco are insufficient or when it is desired to reduce opioid requirements.

When morphine is administered in combination with ketorolaco, the daily required dose of morphine is significantly reduced.

Elderly (≥ 65 years)

Since the elderly may eliminate ketorolaco poorly and be more sensitive to the side effects of NSAIDs, caution should be exercised and lower doses should be used in the elderly (at the lower end of the recommended dosage interval). It is recommended not to exceed a total daily dose of 60 mg.

Children and adolescents (<16 years)

Ketorolaco trometamol Normon should not be administered to children or adolescents.

Renal insufficiency

Ketorolaco is contraindicated in moderate or severe renal impairment. In patients with lesser degrees of renal impairment, lower doses of ketorolaco (half the recommended dose, not exceeding a total daily dose of 60 mg) should be administered, with periodic determinations of renal function tests.

• If you use more ketorolaco trometamol Normon than you should

Since treatment should start in a hospital setting, it is unlikely that you will be given too much ketorolaco trometamol Normon. However, if this happens, contact your doctor or pharmacist as soon as possible. In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20.

In case of overdose or accidental ingestion, abdominal pain, nausea, vomiting, hyperventilation (increased pulmonary ventilation), gastric ulcers, erosive gastritis, and renal dysfunction may appear, which resolve upon discontinuing the medication.

Like all medicines, ketorolaco trometamol Normon can have side effects, although not everyone will experience them.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Gastrointestinal disorders:The most frequently observed side effects are of a gastrointestinal nature. Ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhea, flatulence, constipation, digestive disorders, stomach mucosa inflammation, abdominal pain, blood in stools, blood in vomit, ulcerative stomatitis (mouth lesions), exacerbation of ulcerative colitis and Crohn's disease (inflammatory intestinal diseases), abdominal discomfort, belching, feeling of fullness, esophageal inflammation, pancreatitis, rectal bleeding, alteration of taste.

Metabolic and nutritional disorders:Loss of appetite, increased potassium in the blood and decreased sodium in the blood.

Nervous system and musculoskeletal disorders:Aspirate meningitis (inflammation of the meninges), convulsions, dizziness, somnolence, dry mouth, headache, excessive activity, decreased concentration ability, insomnia, muscle pain, nervousness, loss of sensitivity, sweating.

Psychiatric disorders:Abnormal dreams, thought alteration, anxiety, depression, euphoria, hallucinations, psychotic reactions.

Renal and urinary disorders:Acute renal insufficiency, "kidney pain" with blood in urine and accumulation of nitrogen in the blood or without them, frequent small-volume urination, urinary retention, interstitial nephritis (renal inflammation), nephrotic syndrome (abnormal protein excretion in urine), decreased urine production.

Like with other prostaglandin synthesis inhibitors, signs of renal insufficiency (e.g. elevated creatinine and potassium concentrations) may appear after a dose of ketorolaco trometamol Normon.

Cardiovascular disorders:Edema (swelling due to fluid accumulation), high blood pressure and heart failure, associated with non-steroidal anti-inflammatory drug treatment. Decreased heart rate, palpitations, shortness of breath, decreased blood pressure, chest pain.

Reproductive and mammary disorders:Infertility.

Respiratory, thoracic and mediastinal disorders:Asthma, feeling of lack of air, pulmonary edema (fluid accumulation in the lungs), bronchospasm (bronchiole contraction), nasal bleeding.

Hepatobiliary disorders:Alteration of liver function tests, liver inflammation, cholestatic jaundice (yellow skin discoloration), liver insufficiency (liver alterations).

Dermatological and subcutaneous tissue disorders:Rarely, cutaneous hypersensitivity reactions (allergies) of vesiculobullous type, including toxic epidermal necrolysis (Lyell's disease) and Stevens-Johnson syndrome (skin and mucous membrane lesions). Exfoliative dermatitis, maculopapular exanthema (skin rash with small bumps), pruritus, urticaria, facial erythema (face redness).

Immune system disorders:Hypersensitivity reactions, anaphylaxis (severe allergic reaction), laryngeal edema (larynx inflammation), angioedema (hives), anaphylactoid reactions (acute allergic reaction). Anaphylactoid reactions, like anaphylaxis, can be fatal.

Blood and lymphatic system disorders:Skin hemorrhages, decreased platelets in the blood, anemia, blood in stools, pallor.

Eye disorders:Vision alterations.

Ear disorders:Tinnitus, decreased hearing, vertigo.

General disorders and administration site conditions:Loss of strength, edema (swelling due to fluid accumulation), injection site reactions, fever, increased thirst.

Complementary examinations:Elevated serum urea and creatinine concentrations, elevated potassium concentrations, weight gain, prolonged bleeding time.

Traumatic injuries, intoxications and complications of therapeutic procedures:Hematomas, post-surgical hemorrhage.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Keep out of reach and sight of children.

Store below 25°C. Store in the original container to protect it from light.

Do not use ketorolaco trometamol Normon after the expiration date that appears on the container after “Cad”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

Ketorolaco Trometamol Normon 30 mg/ml Injectable Solution Composition

The active ingredient is ketorolaco trometamol. Each ml of solution contains 30 mg of ketorolaco trometamol.

The other components are: sodium chloride, ethanol, sodium hydroxide, and water for injection.

Ketorolaco Trometamol Normon may be administered as a direct bolus injection lasting no less than 15 seconds in duration. The injectable is compatible with saline solution, dextrose 5% solutions, Ringer, Ringer with lactate, or Plasmalyte solutions. Ketorolaco Trometamol Normon is pharmacologically compatible with aminophylline, lidocaine hydrochloride, morphine sulfate, meperidine hydrochloride, dopamine hydrochloride, insulin, and sodium heparin when mixed in intravenous solutions in standard infusion bags or bottles. Do not mix ketorolaco with morphine sulfate, meperidine, promethazine hydrochloride, or hydroxyzine hydrochloride in the same syringe as it may cause precipitation of ketorolaco from the solution.

Product Appearance and Packaging Contents

Ketorolaco Trometamol Normon is an injectable solution presented in 1 ml ampoules. Each package contains six or one hundred ampoules.

Marketing Authorization Holder and Responsible Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6-28760 Tres Cantos –Madrid (SPAIN)

Last Review Date of this Prospectus:June 2023