Ketorolac tromethamine Normon 30 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ketorolac tromethamine Normon 30 mg/ml injection solution EFG

Ketorolac tromethamine

Read the entire leaflet carefully before you start using this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you think any of the side effects you experience is serious or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What ketorolac tromethamine Normon 30 mg/ml injection solution is and what it is used for
2. Before you use ketorolac tromethamine Normon 30 mg/ml injection solution
3. How to use ketorolac tromethamine Normon 30 mg/ml injection solution
4. Possible side effects
5. How to store ketorolac tromethamine Normon 30 mg/ml injection solution

Additional information

1. What Ketorolac Tromethamine Normon 30 mg/ml Injectable Solution Is and What It Is Used For

Ketorolac Tromethamine Normon 30 mg/ml Injectable Solution is a medicine that belongs to the group of non-steroidal anti-inflammatory drugs.

Ketorolac Tromethamine Normon 30 mg/ml Injectable Solution is indicated for:

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

2. Before using Ketorolac tromethamine Normon 30 mg/ml injectable solution

• Do not use ketorolac tromethamine Normon:

• If you have active peptic ulcer (gastroduodenal ulcer).

• If you have a history of gastrointestinal ulceration, bleeding, or perforation.

• If you are allergic (hypersensitive) to ketorolac tromethamine or other non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the other components of ketorolac tromethamine Normon.

• If you have complete or partial nasal polyposis (sac-like growths formed by nasal mucosa), angioedema (hives), or bronchospasm (narrowing of the bronchi).

• If you have asthma.

• If you have severe heart disease.

• If you have 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 hemorrhagic diathesis (tendency to bleed), coagulation disorders (impaired clot formation), or cerebral hemorrhage (bleeding in the brain).

• If undergoing surgical procedures with high risk of bleeding or incomplete hemostasis (cessation of blood flow).

• If you are taking other NSAIDs (non-steroidal anti-inflammatory drugs), including acetylsalicylic acid and selective cyclooxygenase-2 (COX-2) inhibitors.

• If you are being treated with high-dose anticoagulants.

• If you are being treated with probenecid, lithium salts, or pentoxifylline.

• If you are pregnant or breastfeeding.

• If you are under 16 years of age.

• As a preventive analgesic before or during surgery due to the risk of bleeding.

• The injectable form of ketorolac tromethamine Normon must not be used for epidural or intrathecal administration (administration into the spinal or cerebral fluid), as it contains alcohol.

• Take special care with ketorolac tromethamine Normon:

• If you currently have or have previously had gastrointestinal bleeding, ulcers, and/or gastrointestinal perforations. Severe gastrointestinal toxicity may occur, including gastrointestinal irritation, bleeding, ulceration, and perforation.

• If you have had or currently have inflammatory bowel disease (ulcerative colitis, Crohn's disease).

• If you have kidney disease, your doctor may consider it necessary to perform certain tests during treatment with this medicine.

• If you have heart disorders, high blood pressure, or similar conditions.

• If you are taking medications that increase the risk of gastrointestinal ulcer or bleeding, such as heparin, antiplatelet agents, pentoxifylline, corticosteroids, thrombolytics, and antidepressants (selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors).

• If you are being treated with anticoagulants (dicoumarols or heparin).

• In elderly patients, extra precautions will be taken and the lowest effective dose of ketorolac tromethamine Normon will be used.

• Very rarely, serious skin reactions may occur with ketorolac use (e.g., erythema multiforme (skin redness), exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis). These are more likely to appear at the beginning of treatment. Treatment must be discontinued at the first sign of a skin rash, mucosal lesions, or any other sign of hypersensitivity.

• If you experience systemic signs of liver dysfunction such as itching or skin redness during treatment, treatment must be stopped immediately and you must inform your doctor as soon as possible.

• If you have difficulty becoming 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), you must stop treatment and inform your doctor immediately.

• If you are taking other medicines such as methotrexate, as ketorolac tromethamine Normon may alter or enhance their effects.

• Inform your doctor if you have recently undergone or are about to undergo stomach or intestinal surgery before receiving/using ketorolac tromethamine Normon, as ketorolac tromethamine Normon may sometimes impair wound healing in the intestine after surgery.

Consult your doctor, even if any of the above-mentioned circumstances occurred only once in the past.

• Use of other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines, including those obtained without a prescription.

Concomitant administration is contraindicated with:

• Other NSAIDs (non-steroidal anti-inflammatory drugs), including acetylsalicylic acid, as this may increase the risk of gastrointestinal ulcers and bleeding.
• Anticoagulants (dicoumarols, heparin), as they may potentiate effects on bleeding time.
• Antiplatelet agents (medicines used to prevent thrombus formation) (such as acetylsalicylic acid, ticlopidine, or clopidogrel): may increase the risk of gastrointestinal bleeding.
• Pentoxifylline (a medicine that improves blood flow through blood vessels), probenecid (a medicine used to treat gout).
• Lithium (a medicine used to treat bipolar disorder).

Exercise special caution if you are using or being treated with:

• Corticosteroids (anti-inflammatory medicines).

• Thrombolytics (medicines that dissolve clots).

• Antidepressants.

• Methotrexate (an anti-rheumatic medicine).

• Antihypertensives.

• Furosemide (a medicine used to eliminate excess fluid and to treat high blood pressure).

• Pregnancy

Consult your doctor or pharmacist before using any medicine.

Ketorolac tromethamine Normon is contraindicated during pregnancy.

• Breastfeeding

Consult your doctor or pharmacist before using any medicine.

Ketorolac tromethamine Normon is contraindicated during breastfeeding.

• Labour and delivery

Consult your doctor or pharmacist before using any medicine.

Ketorolac tromethamine Normon is contraindicated during labour and delivery, as by inhibiting prostaglandin synthesis, it may impair fetal circulation and inhibit uterine contractions.

• Driving and using machines

Some patients may experience drowsiness, dizziness, vertigo, insomnia, or depression during treatment with ketorolac tromethamine Normon. For this reason, especially at the beginning of treatment, caution is advised when driving vehicles or operating machinery.

• Ketorolac tromethamine Normon contains ethanol and sodium

This medicine contains 12.25% ethanol (alcohol); this small amount corresponds to 98 mg per ampoule.

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

3. How to use Ketorolac tromethamine Normon 30 mg/ml injectable solution

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

Treatment with ketorolac tromethamine Normon should be initiated in a hospital setting. The maximum duration of treatment should not exceed 2 days. If switching to oral therapy, the total duration of treatment with ketorolac must not exceed 7 days.

For the treatment of pain due to renal colic, a single dose of 30 mg administered intramuscularly or intravenously is recommended.

The dose of ketorolac tromethamine Normon should be adjusted according to the severity of pain and the patient's response, aiming to administer the lowest effective dose. The recommended initial dose of ketorolac tromethamine Normon is 10 mg administered intramuscularly or intravenously, followed by doses of 10–30 mg every 4 to 6 hours as needed to control pain. In cases of severe or very severe pain, the recommended initial dose is 30 mg of ketorolac.

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

In patients who have received parenteral ketorolac and are switched to oral therapy, the total combined daily dose from both oral and parenteral formulations must not exceed 90 mg in adults and 60 mg in elderly patients.

Intramuscular injection should be administered slowly and deeply into the muscle.

Administration with morphine

In most patients, intramuscular or intravenous ketorolac therapy provides adequate analgesia. However, opioid analgesics may be used concomitantly when, due to the intensity of pain, the recommended maximum doses of ketorolac are insufficient, or when a reduction in opioid requirements is desired.

When morphine is administered in combination with ketorolac, the daily dose of morphine required is considerably reduced.

Elderly (≥ 65 years)

Since elderly patients may eliminate ketorolac less efficiently and may be more sensitive to the adverse effects of NSAIDs (non-steroidal anti-inflammatory drugs), extreme caution is recommended and lower doses should be used in the elderly (at the lower end of the recommended dosage range). A total daily dose exceeding 60 mg should not be administered.

Children and adolescents (< 16 years)

Ketorolac tromethamine Normon should not be administered to children or adolescents.

Renal impairment

Ketorolac is contraindicated in moderate or severe renal impairment. In patients with mild renal impairment, reduced doses of ketorolac (half the recommended dose, without exceeding a total daily dose of 60 mg) should be administered, with periodic monitoring of renal function tests.

• If you use more ketorolac tromethamine Normon than you should

Since administration should begin in a hospital setting, it is unlikely that an excessive amount of ketorolac tromethamine Normon will be administered. However, if this occurs, contact your doctor or pharmacist as soon as possible. In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone 91 562 04 20.

In case of overdose or accidental ingestion, symptoms such as abdominal pain, nausea, vomiting, hyperventilation (increased pulmonary ventilation), gastroduodenal ulcer, erosive gastritis, and renal dysfunction may occur; these symptoms usually resolve upon discontinuation of the medication.

4. Possible adverse effects

Like all medicines, ketorolac tromethamine Normon can have adverse effects, although not everyone experiences them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Gastrointestinal disorders: The most frequently observed adverse effects are gastrointestinal in nature. Peptic ulcer, gastrointestinal perforation, or gastrointestinal bleeding, sometimes fatal, may occur, particularly in the elderly. Nausea, vomiting, diarrhoea, flatulence, constipation, digestive disturbance, gastric mucosal inflammation, abdominal pain, blood in stools, blood in vomit, ulcerative stomatitis (mouth lesions), exacerbation of ulcerative colitis and Crohn's disease (inflammatory bowel diseases), abdominal discomfort, belching, sensation of fullness, oesophagitis, pancreatitis, rectal bleeding, and taste disturbances may occur.

Metabolism and nutrition disorders: Loss of appetite, increased blood potassium levels, and decreased blood sodium levels.

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

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

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

As with other inhibitors of prostaglandin synthesis, signs of renal impairment (e.g., elevated creatinine and potassium levels) may occur after a single dose of ketorolac tromethamine Normon.

Cardiovascular disorders: Edema (swelling due to fluid accumulation), high blood pressure, and heart failure, which are associated with treatment with non-steroidal anti-inflammatory drugs. Decreased heart rate, hot flushes, palpitations, low blood pressure, chest pain.

Reproductive system and breast disorders: Infertility.

Respiratory, thoracic and mediastinal disorders: Bronchial asthma, shortness of breath, pulmonary edema (fluid accumulation in the lungs), bronchospasm (bronchial constriction), nosebleeds.

Hepatobiliary disorders: Abnormal liver function tests, liver inflammation, cholestatic jaundice (yellowing of the skin), hepatic failure (liver dysfunction).

Skin and subcutaneous tissue disorders: Skin hypersensitivity reactions (allergy) of the vesiculobullous type may very rarely occur, including toxic epidermal necrolysis (Lyell's disease) and Stevens-Johnson syndrome (skin and mucous membrane lesions). Exfoliative dermatitis, maculopapular exanthema (red, small bumps on the skin), pruritus, urticaria, facial erythema (facial redness).

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

Blood and lymphatic system disorders: Skin bleeding, decreased platelet count in blood, anaemia, blood in stools, pallor.

Eye disorders: Visual disturbances.

Ear disorders: Tinnitus, decreased hearing, vertigo.

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

Complementary investigations: Increased serum urea and creatinine concentrations, increased potassium levels, weight gain, prolonged bleeding time.

Injury, poisoning and procedural complications: Bruising, post-surgical bleeding.

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Ketorolac trometamol Normon 30 mg/ml injection solution

Keep out of the reach and sight of children.

Store below 25°C. Keep in the original packaging to protect from light.

Do not use ketorolac trometamol Normon after the expiry date stated on the packaging after "Exp". The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Additional Information

Composition of ketorolac tromethamine Normon 30 mg/ml injectable solution

The active substance is ketorolac tromethamine. Each ml of solution contains 30 mg of ketorolac tromethamine.

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

Ketorolac tromethamine Normon may be administered as a direct bolus injection over no less than 15 seconds. The injectable solution is compatible with saline solution, 5% dextrose solutions, Ringer's solution, Ringer's lactate solution, or Plasmalyte solutions. Ketorolac tromethamine Normon is pharmaceutically compatible with aminophylline, hydrochloride lidocaine, morphine sulfate, meperidine hydrochloride, dopamine hydrochloride, insulin, and sodium heparin when mixed in intravenous solutions in standard infusion bottles or bags. However, ketorolac should not be mixed in the same syringe with morphine sulfate, meperidine, promethazine hydrochloride, or hydroxyzine hydrochloride, as precipitation of ketorolac from the solution may occur.

Appearance of the product and contents of the container

Ketorolac tromethamine Normon is an injectable solution supplied in 1 ml ampoules. Each package contains either six or one hundred ampoules.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 - 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent review of this leaflet: June 2023