Package Leaflet: Information for the User

Ketorolac tromethamine Qualigen 10 mg Film-Coated Tablets

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• 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 others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Ketorolaco trometamol Qualigen contains ketorolaco trometamol as the active ingredient, which belongs to the group of nonsteroidal anti-inflammatory drugs.

This medication is used for the short-term treatment of mild or moderate pain after surgery.

Do not take ketorolaco trometamol Qualigen

• if you have an active peptic 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
• if you have a complete or partial nasal polyp syndrome (a sac-like mass formed by nasal mucosa), angioedema (hives), or bronchospasm (bronchiole constriction)
• 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) or dehydration (lack of bodily fluids)
• if you have a bleeding diathesis (tendency to bleed), coagulation disorders (alteration of clot formation), or cerebral hemorrhage (bleeding in the brain)
• if you are undergoing surgical procedures with a high risk of bleeding or incomplete hemostasis (blood flow cessation)
• with other nonsteroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid and cyclooxygenase-2 (COX-2) inhibitors
• if you are being treated with high doses of anticoagulants.
• if you are being treated with probenecid, lithium salts, or pentoxifylline.
• 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

Warnings and precautions

• if you have or have had gastrointestinal bleeding, ulcers, or perforations. This may

result in severe gastrointestinal toxicity, including gastrointestinal irritation, bleeding, ulceration, and perforation.

• 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, pentoxifylline, corticosteroids, thrombolytics, and antidepressants (selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake 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 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, you should immediately suspend treatment and inform your doctor as soon as possible.
• if you experience difficulty becoming pregnant or are undergoing fertility treatment
• if you experience skin redness, mucosal lesions, or any other sign of hypersensitivity or anaphylactic reaction, you should discontinue treatment and immediately inform your doctor.
• if you are taking other medications, such as methotrexate, as ketorolaco may modify or potentiate the effect of these medications.

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

Inform your doctor if you have recently undergone or are about to undergo a stomach or intestinal surgical intervention before taking Ketorolaco trometamol Qualigen, as Ketorolaco trometamol Qualigen may sometimes worsen intestinal wound healing after a surgical intervention.

Children and adolescents

The efficacy and safety of ketorolaco in children and adolescents have not been established. Therefore, its administration is not recommended in children under 16 years old.

Other medications and ketorolaco trometamol Qualigen

Inform your pharmacist if you are taking, have taken recently, or may need to take any other medication.

Concomitant administration is contraindicated:

• with other nonsteroidal anti-inflammatory drugs (including acetylsalicylic acid), as it may increase the risk of gastrointestinal ulcers and bleeding
• with anticoagulants (dicumarinics, heparin), as it may potentiate the effects on bleeding time
• with antiplatelet agents (such as acetylsalicylic acid, ticlopidine, or clopidogrel): may increase the risk of gastrointestinal bleeding

• Pentoxifylline, probenecid
• Lithium (medication used to treat manic-depressive disorder)

Be especially cautious if you are being treated with:

• Corticosteroids
• Thrombolytics
• Antidepressants
• Methotrexate
• Antihypertensives
• Furosemide

Pregnancy, lactation, and fertility

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

Ketorolaco is contraindicated during pregnancy, childbirth, or lactation.

Ketorolaco is contraindicated during childbirth as it may harm fetal circulation and inhibit uterine contractions.

For fertile patients, it should be noted that medications of the type ketorolaco have been associated with a decrease in the ability to conceive.

Driving and operating machinery:

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

Ketorolaco trometamol Qualigen contains lactose:

This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

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

Ketorolaco treatment should begin in a hospital setting and the total duration of treatment should not exceed 7 days. In the case of previous administration, in the postoperative period, ketorolaco injectable, the total duration of ketorolaco treatment should not exceed 7 days.

The recommended oral dose is 1 tablet (10 mg of ketorolaco) every 4 to 6 hours, according to the intensity of the pain, not exceeding 4 tablets per day (40 mg/day).

The duration of oral treatment should not exceed 7 days.

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

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

Administration with morphine

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

Elderly patients (> 65 years):

Since elderly patients may eliminate ketorolaco poorly and be more sensitive to the side effects of NSAIDs (nonsteroidal anti-inflammatory drugs), precautions should be taken and lower doses should be used in these patients (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

This medication should not be administered to children or adolescents. (see section 2).

Renal insufficiency

Ketorolaco should not be used if you have moderate or severe renal insufficiency. If you have a mild kidney disease, you should receive lower doses of ketorolaco (half the recommended dose, not exceeding a total daily dose of 60 mg) and periodic renal function tests should be performed.

If you take more ketorolaco trometamol Qualigen than you should

If you have taken more ketorolaco than you should, consult your doctor or pharmacist immediately. In case of overdose or accidental ingestion, contact the Toxicological Information Service. Phone 91.562.04.20.

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

If you forgot to take ketorolaco trometamol Qualigen

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 medications, this medication may 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 disordersare the most frequent side effects. You may experience:

• peptic ulcer, perforation, or gastrointestinal bleeding, which can be fatal, especially in elderly patients.
• nausea, vomiting,
• diarrhea, flatulence, constipation,
• indigestion (digestive disorder), gastritis (inflammation of the stomach lining), abdominal pain,
• melena (blood in stool), hematemesis (blood in vomit),
• ulcerative stomatitis (mouth lesions),
• exacerbation (worsening) of ulcerative colitis and Crohn's disease (inflammatory bowel diseases),
• abdominal discomfort,
• eructation,
• feeling of fullness,
• esophagitis (inflammation of the esophagus), pancreatitis (inflammation of the pancreas),
• rectal bleeding,
• disgeusia (alteration of taste).

Metabolic and nutritional disorders:

• anorexia (loss of appetite),
• hyperkalemia (elevated potassium levels in blood),
• hyponatremia (decreased sodium levels in blood).

Nervous system and musculoskeletal disorders:

• aseptic meningitis (inflammation of the meninges),
• seizures,
• dizziness,
• xerostomia (dry mouth),
• headache,
• hyperkinesia (excessive activity),
• mialgia (muscle pain),
• paresthesia (loss of sensation),
• sweating.

Psychiatric disorders:

• abnormal dreams,
• thought disorder,
• anxiety, depression, insomnia,
• euphoria, hallucinations, psychotic reactions,
• drowsiness,
• decreased concentration ability,
• nervousness.

Renal and urinary disorders:

• acute renal failure, "kidney pain" with hematuria (blood in urine) and hyperazotemia (nitrogen accumulation in blood) or without them,
• polyuria (frequent small-volume urination),
• urinary retention,
• interstitial nephritis (renal inflammation),

• nephrotic syndrome (abnormal protein excretion in urine),
• oliguria (decreased urine production).

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

Cardiovascular disorders:

• edema (swelling due to fluid accumulation),
• hypertension (high blood pressure),
• heart failure, associated with NSAID treatment.
• bradycardia (decreased heart rate),
• palpitations,
• hypotension (low blood pressure),
• chest pain (any discomfort or abnormal sensation in the chest).

Reproductive and mammary disorders: female infertility.

Respiratory, thoracic, and mediastinal disorders:

• asthma,
• shortness of breath,
• pulmonary edema (fluid accumulation in lungs),
• bronchospasm (difficulty breathing),
• epistaxis (nosebleed).

Hepatobiliary disorders:

• liver function test abnormalities,
• hepatitis (liver inflammation),
• jaundice (yellow discoloration of skin),
• liver insufficiency (liver dysfunction).

Dermatological and subcutaneous tissue disorders:

• Very rarely, cutaneous hypersensitivity reactions (allergies) may occur, including toxic epidermal necrolysis (Lyell's disease) and Stevens-Johnson syndrome (skin and mucous membrane lesions).
• exfoliative dermatitis (skin peeling),
• maculopapular exanthema (rash),
• pruritus (itching), urticaria (hives),
• angioedema (hives),
• erythema (redness) of the face.

Immune system disorders:

• hypersensitivity reactions (allergies),
• anaphylaxis (allergic reaction),
• laryngeal edema (inflammation of the larynx),
• anaphylactoid reactions (acute allergic reactions). Anaphylactoid reactions, like anaphylaxis, can be fatal.

Blood and lymphatic system disorders::

• purpura (skin hemorrhages),
• thrombocytopenia (decreased platelet count in blood),
• hemolytic-uremic syndrome (anemia and blood in stool),
• pallor.

Ocular disorders: visual disturbances.

Vestibular and labyrinthine disorders::

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

General disorders and administration site conditions::

• asthenia (weakness),
• edema (swelling due to fluid accumulation),
• reactions at the injection site,
• fever,
• polydipsia (increased thirst).

Complementary examinations::

• elevated serum urea and creatinine levels,
• elevated potassium levels,
• weight gain,
• prolonged bleeding time,
• liver function test abnormalities.

Traumatic injuries, intoxications, and complications of therapeutic procedures::

• hematomas (bruises),
• surgical site bleeding (after surgery).

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

This product does not require special conditions for conservation.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD:.

The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medication that you no longer need. In this way, you will help protect the environment.

Composition of ketorolaco trometamol Qualigen 10 mg coated tablets EFG:

The active ingredient is ketorolaco trometamol. Each tablet contains 10 mg of ketorolaco trometamol.

The other components are lactose monohydrate, microcrystalline cellulose, magnesium stearate, hypromellose, titanium dioxide (E-171) and macrogol.

Appearance of the product and contents of the packaging

Coated, round, biconvex white tablets.

Available in carton packaging with 10, 20 and 500 tablets conditioned in aluminum/aluminum blisters. The clinical packaging of 500 tablets consists of 5 boxes of 100 units each.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Last review date of this leaflet: July 2023

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