Label: information for the user

TORADOL 30 mg/1 ml injectable solution

Ketorolaco trometamol

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• • If you have any doubts, consult your doctor or pharmacist.
  • This medication has been prescribed only to you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is Toradol and how it is used

2. What you need to know before starting to use Toradol

3. How to use Toradol

4. Possible adverse effects

5. Storage of Toradol

6. Contents of the package and additional information

Toradol 30 mg/1 ml injectable solution contains ketorolac tromethamine as its active ingredient, which belongs to a group of medications known as analgesics, anti-inflammatory agents, and antipyretics.

Your doctor has prescribed Toradol for the short-term treatment of moderate to severe pain after surgery or for the treatment of pain caused by kidney colic.

Inform your doctor if you have recently undergone or are about to undergo stomach or intestinal surgery before receiving/taking/using Toradol, as Toradol may sometimes worsen the healing of intestinal wounds after surgery.

Do not use Toradol

• if you have an active peptic ulcer,
• if you have a history of gastrointestinal ulceration, bleeding, or perforation,
• if you vomit blood, have black stools, or have bloody diarrhea,
• if you are allergic (hypersensitive) to ketorolac tromethamine or other nonsteroidal anti-inflammatory drugs, or to any of the other components of this medication (listed in section 6),
• if you have had asthma attacks (difficulty breathing), acute rhinitis (inflammation of the nasal mucosa), urticaria (allergic skin reaction with itching), angioneuritic edema (swelling of the face, tongue, or throat that causes difficulty breathing) or other allergic reactions after using substances with similar action (e.g. acetylsalicylic acid, ibuprofen, or other nonsteroidal anti-inflammatory drugs),
• if you have severe heart failure (your heart does not function properly),
• if you have moderate to severe renal insufficiency (your kidney does not function correctly),
• if you have a bleeding tendency, coagulation disorders, or cerebral hemorrhage (bleeding in the brain),
• if you have bleeding or coagulation disorders, or are taking anticoagulants (medications used to "thin" the blood). If necessary, your doctor will perform coagulation tests,
• during childbirth,
• if you are in the third trimester of pregnancy,
• if you are breastfeeding your baby,
• as a preventive analgesic before or during surgery, given the risk of bleeding,
• the injectable form of Toradol should not be used for epidural or intrathecal administration, as it contains alcohol.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Toradol.

Severe skin reactions have been reported with the use of NSAIDs, which manifest as red patches, generalized redness of the skin, ulcers, or widespread rash accompanied by symptoms similar to the flu, including fever (see section 4). The rash may progress to generalized blisters or skin peeling. The highest risk of severe skin reactions is in the first weeks of treatment, but they may start to develop several months after medication administration (see section 4). If you have developed any severe skin reaction after using Toradol, do not restart treatment at any time. If you develop a skin rash or these skin symptoms, interrupt Toradol treatment and contact your doctor or seek immediate medical attention.

Be especially careful with Toradol

• If you experience gastrointestinal pain (irritation, ulceration, or perforation), rectal bleeding, or vomiting, you should immediately stop treatment and inform your doctor.
• If you are over 65 years old or debilitated, extreme caution should be taken and the minimum effective doses should be used.
• If you are taking medications that increase the risk of ulcers or gastrointestinal bleeding, such as heparin, antiplatelet agents, pentoxifylline, corticosteroids, thrombolytics, and selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors.
• 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.
• Toradol may cause fluid retention, be especially careful if you have heart failure or hypertension (high blood pressure).
• If you are taking anticoagulants (medications used to "thin" the blood: dicumarinics or heparin).
• If you experience some symptoms of liver dysfunction such as itching or skin redness during treatment, you should immediately stop treatment and inform your doctor as soon as possible.
• If you experience skin redness, mucous membrane lesions, or any other sign of hypersensitivity or anaphylactic reaction (severe allergic reaction), you should interrupt treatment and immediately inform your doctor.
• If you have a complete or partial nasal polyp syndrome (a disease that affects the inside of the nose and sinuses by the growth of benign tumors that obstruct breathing), angioedema (hives, a superficial swelling), or bronchospasm (difficulty breathing).
• If you are taking other medications, such as methotrexate, as Toradol may modify or potentiate their effect.

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

Cardiovascular precautions

Medications like Toradol may be associated with a moderate increase in the risk of suffering heart attacks ("myocardial infarctions") or strokes. This risk is more likely to occur when high doses and prolonged treatments are used. Do not exceed the recommended dose or treatment duration.

If you have heart problems, a history of strokes, or think you may be at risk for these conditions (e.g. you have high blood pressure, suffer from diabetes, have high cholesterol, or are a smoker) you should consult this treatment with your doctor or pharmacist.

These types of medications may also cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Precautions during pregnancy and in fertile women

Due to the administration of medications like Toradol being associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimesters of pregnancy, unless it is strictly necessary. In these cases, the dose and duration should be limited to the minimum possible.

During the third trimester, the administration of Toradol is contraindicated.

During lactation, the administration of Toradol is contraindicated.

For fertile women, it should be taken into account that medications like Toradol have been associated with a decrease in the ability to conceive.

Other medications and Toradol

Inform your doctor or pharmacist if you are using or have recently used or may need to use any other medication.

Do not recommend using Toradol with: other nonsteroidal anti-inflammatory drugs (including acetylsalicylic acid and cyclooxygenase-2 inhibitors), anticoagulants (dicumarinics or heparin at full doses), antiplatelet agents (such as acetylsalicylic acid, ticlopidine, or clopidogrel), pentoxifylline, probenecid, or lithium salts.

Be especially cautious if you are being treated with any of the following medications: corticosteroids, thrombolytics (medications administered to favor the elimination of blood clots), antidepressants, metotrexate, antihypertensives, or furosemide (a diuretic, used to increase urine elimination).

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Do not take Toradol if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your tendency and that of your baby to bleed and delay or prolong delivery more than expected. Do not take Toradol during the first 6 months of pregnancy unless it is strictly necessary and your doctor indicates it. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest time possible. From week 20 of pregnancy, Toradol may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios). If you need treatment for a period longer than a few days, your doctor may recommend additional controls.

Consult your doctor if you are trying to become pregnant or are undergoing fertility treatment, as the use of this medication may affect your ability to have children.

Do not use Toradol during pregnancy, as it may be harmful to your baby (see section precautions during pregnancy and in fertile women).

Small amounts of the medication may appear in breast milk, therefore do not use Toradol if you are breastfeeding.

Do not use Toradol during delivery.

Driving and using machines

Caution is recommended when driving or using machines, especially at the beginning of treatment, as you may experience drowsiness, dizziness, vertigo, insomnia, or depression during Toradol treatment.

Toradol contains ethanol

This medication contains 100 mg of alcohol (ethanol) per ml, which is equivalent to 100 mg/ml (10% v/v). The amount in 1 ml of this medication is equivalent to less than 3 ml of beer or 1 ml of wine.

The small amount of alcohol in this medication does not produce any perceptible effect.

This medication contains less than 1 mmol of sodium (23 mg) per ml; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The dose of Toradol 30 mg/1 ml injectable solution should be adjusted according to the severity of pain and the patient's response, administering the minimum effective dose. The initial recommended dose of Toradol 30 mg/1 ml injectable solution via im or iv 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 ketorolac.

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

Remember to use your medication.

Your doctor will indicate the duration of your treatment with Toradol. Do not discontinue treatment before.

Treatment with Toradol 30mg /1 ml injectable solution should begin in a hospital setting. The maximum duration of treatment should not exceed 2 days. In the case of subsequent transition to oral treatment, the total duration of treatment with ketorolac should not exceed 7 days.

In the treatment of pain caused by nephritic colic, a single dose of 30 mg via im or iv is recommended.

If you have received ketorolac via parenteral and are switched to oral treatment, the total daily combined dose of both oral and parenteral presentations should not exceed 90 mg in adults and 60 mg in the elderly.

In most patients, intramuscular or intravenous therapy with ketorolac provides adequate analgesia. However, analgesic opioids may be used in combination when, due to the intensity of pain, the maximum recommended doses of ketorolac are not sufficient or to reduce opioid requirements.

When administering morphine in association with ketorolac, the daily required dose of morphine is significantly reduced.

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

If you are over 65 years old, it is recommended to exercise caution and use lower doses. It is recommended not to exceed a total daily dose of 60 mg.

You should not use ketorolac if you have moderate or severe renal insufficiency. If you have mild renal insufficiency, you should receive lower doses of ketorolac (half the recommended dose, without exceeding a total daily dose of 60 mg) and periodic renal function tests will be performed.

Use in children and adolescents

It is not recommended for administration in children under 16 years old.

If you use more Toradol than you should

If you have used more Toradol than you should, consult your doctor or pharmacist immediately.

Abdominal pain, nausea, vomiting, hyperventilation (increased pulmonary ventilation), gastric ulcers, erosive gastritis, gastrointestinal bleeding, and renal dysfunction may appear and resolve upon discontinuing the medication.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91.562.04.20.

If you forgot to use Toradol

Do not use a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause 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.

The frequency of adverse reactions is unknown due to the fact that it cannot be estimated from the available information.

Gastrointestinal disorders: These are the most common side effects. You may experience:

Metabolic and nutritional disorders:

Nervous system and musculoskeletal disorders:

Psychiatric disorders:

Renal and urinary disorders:

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

Cardiovascular disorders:

Reproductive and mammary disorders: female infertility.

Respiratory, thoracic, and mediastinal disorders:

Hepatobiliary disorders:

Dermatological and subcutaneous tissue disorders:

Immune system disorders:

Blood and lymphatic system disorders:

Eye disorders:

Ear and labyrinth disorders:

• tinnitus (ringing in the ears),
• hypacusia (decreased hearing),
• vertigo.

General disorders and administration site conditions:

Complementary examinations:

Traumatic injuries, intoxications, and complications of therapeutic procedures:

If you notice any other reaction not described in this leaflet, consult your doctor or

pharmacist.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not mentioned in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Store the ampoules in the original packaging to protect them from light.

Keep this medication out of sight and reach of children.

Do not use Toradol after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Toradol

• The active ingredient is ketorolaco trometamol. Each ampoule contains 30 mg of ketorolaco trometamol.
• The other components are ethanol, sodium chloride, water for injectable preparations and sodium hydroxide.

Appearance of the product and contents of the packaging

Toradol 30 mg/1 ml injectable solution is available in carton packaging with 6 glass ampoules of 1 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Atnahs Pharma Netherlands B.V.

Copenhagen Towers

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Responsible for manufacturing

Atnahs Pharma Denmark ApS

Copenhagen Towers

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Last review date of this leaflet: January 2024

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices(AEMPS) http://www.aemps.gob.es”http://www.aemps.gob.es/”