KETOROLAC TROMETHAMINE QUALIGEN 10 mg FILM-COATED TABLETS

Introduction

Leaflet: Information for the user

Ketorolac trometamol Qualigen 10 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

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

Contents of the leaflet:

1. What is ketorolac trometamol Qualigen and what is it used for.
2. What you need to know before taking ketorolac trometamol Qualigen.
3. How to take ketorolac trometamol Qualigen.
4. Possible side effects.
5. Storage of ketorolac trometamol Qualigen.
6. Contents of the pack and additional information.

1. What is Ketorolac trometamol Qualigen and what is it used for

Ketorolac trometamol Qualigen contains the active substance ketorolac trometamol, which belongs to the group of non-steroidal anti-inflammatory drugs.

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

2. What you need to know before starting to take Ketorolac trometamol Qualigen

Do not take ketorolac 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 ketorolac trometamol or other non-steroidal anti-inflammatory drugs.
• if you have a complete or partial syndrome of nasal polyps (a sac-like mass formed by the nasal mucosa), angioedema (hives), or bronchospasm (constriction 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 blood volume) 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 high-risk surgical interventions with a high risk of bleeding or incomplete hemostasis (stoppage of blood flow)
• with other non-steroidal anti-inflammatory drugs (NSAIDs), 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 old

• As a preventive analgesic before or during surgical intervention, given the risk of bleeding

Warnings and precautions

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

If you have had 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 disease, high blood pressure, or similar conditions.
• If you are taking medications that increase the risk of ulcers or gastrointestinal bleeding, such as heparin, antiplatelet agents, pentoxifylline, corticosteroids, thrombolytics, and antidepressants (of the type 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 ketorolac will be used during treatment.
• Rarely, serious skin reactions (erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis) may occur with the use of ketorolac. Their appearance is more likely at the start of treatment. Administration should be discontinued at the first appearance of a skin rash, mucosal lesions, or any other sign of hypersensitivity.
• If you experience systemic manifestations of liver dysfunction, such as itching or reddening of the skin during treatment, you should discontinue treatment immediately and inform your doctor as soon as possible.
• If you have difficulty getting pregnant or are undergoing fertility treatment.
• If you experience skin reddening, mucosal lesions, or any other sign of hypersensitivity or anaphylactic reaction, you should discontinue treatment and inform your doctor immediately.
• If you are taking other medications, such as methotrexate, as ketorolac may modify or enhance the effect of these medications.

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

Inform your doctor if you have recently undergone or are going to undergo stomach or intestinal surgery before taking Ketorolac trometamol Qualigen, as Ketorolac trometamol Qualigen may sometimes worsen wound healing in the intestine after surgery.

Children and adolescents

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

Other medicines and ketorolac trometamol Qualigen

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

Concomitant administration of the following is contraindicated:

• Other non-steroidal anti-inflammatory drugs (including acetylsalicylic acid), as they may increase the risk of gastrointestinal ulcers and bleeding.
• Anticoagulants (dicumarinics, heparin), as they may potentiate the effects on bleeding time.
• Antiplatelet agents (such as acetylsalicylic acid, ticlopidine, or clopidogrel): may increase the risk of gastrointestinal bleeding.

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

Be careful if you are being treated with:

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

Pregnancy, breastfeeding, and fertility

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

Ketorolac is contraindicated during pregnancy, childbirth, or breastfeeding.

Ketorolac is contraindicated during childbirth, as it may inhibit prostaglandin synthesis, harming fetal circulation and inhibiting uterine contractions.

For women of childbearing age, it should be noted that medications of the ketorolac type have been associated with decreased fertility.

Driving and using machines

Some patients may experience drowsiness, dizziness, vertigo, insomnia, or depression during treatment with this medicine. For this reason, especially at the start of treatment, caution is recommended when driving vehicles or using machinery.

Ketorolac trometamol Qualigen contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take ketorolac trometamol Qualigen

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

Treatment with ketorolac should be started in a hospital setting, and the total duration of treatment should not exceed 7 days. If ketorolac injectable has been previously administered in the postoperative period, the total duration of treatment with ketorolac should not exceed 7 days.

The recommended oral dose is 1 tablet (10 mg of ketorolac) 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 ketorolac by parenteral route and are switched to oral treatment, the total daily combined dose of the two presentations, oral and parenteral, should not exceed 90 mg in adults and 60 mg in elderly patients.

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

Administration with morphine

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

Elderly patients (> 65 years):

Since elderly patients may eliminate ketorolac more poorly and be more sensitive to the side effects of non-steroidal anti-inflammatory drugs (NSAIDs), precautions should be taken and lower doses should be used in these patients (at the lower end of the recommended dosage range). It is recommended not to exceed a total daily dose of 60 mg.

Children and adolescents (<16 years)< p>

This medicine should not be administered to children or adolescents. (See section 2).

Renal insufficiency

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

If you take more ketorolac trometamol Qualigen than you should

If you have taken more ketorolac than you should, consult your doctor or pharmacist immediately. In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91.562.04.20.

Abdominal pain, nausea, vomiting, hyperventilation (increased pulmonary ventilation), gastroduodenal ulcer, erosive gastritis, and renal dysfunction may occur, which will resolve upon discontinuation of the medication.

If you forget to take ketorolac trometamol Qualigen

Do not use a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

The frequency of adverse reactions is unknown, as it cannot be estimated from the available information.

Gastrointestinal disordersare the most frequent adverse effects. The following may occur:

• peptic ulcer, perforation, or gastrointestinal bleeding, sometimes fatal, especially in elderly patients.
• nausea, vomiting,
• diarrhea, flatulence, constipation,
• dyspepsia (digestive disorder), gastritis (inflammation of the stomach mucosa), abdominal pain,
• melena (blood in stool), hematemesis (blood in vomit),
• ulcerative stomatitis (mouth lesions),
• worsening of ulcerative colitis and Crohn's disease (inflammatory bowel diseases),
• abdominal discomfort,
• belching,
• feeling of fullness,
• esophagitis (inflammation of the esophagus), pancreatitis (inflammation of the pancreas),
• rectal bleeding (bleeding from the rectum),
• dysgeusia (alteration of taste).

Metabolic and nutritional disorders:

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

Nervous system and musculoskeletal disorders:

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

Psychiatric disorders:

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

Renal and urinary disorders:

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

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

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

Cardiovascular disorders:

• edema (swelling due to fluid accumulation),
• hypertension (high blood pressure),
• heart failure, are associated with treatment with non-steroidal anti-inflammatory drugs.
• bradycardia (decreased heart rate),
• flushing, palpitations,
• hypotension (low blood pressure),
• chest pain (any unusual discomfort or sensation in the chest).

Reproductive system and breast disorders: female infertility.

Respiratory, thoracic, and mediastinal disorders:

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

Hepatobiliary disorders:

• alteration of liver function tests,
• hepatitis (inflammation of the liver),
• cholestatic jaundice (yellowing of the skin),
• liver failure (liver dysfunction).

Skin and subcutaneous tissue disorders:

• Rarely, skin hypersensitivity reactions of the vesiculobullous type, including toxic epidermal necrolysis (Lyell's disease) and Stevens-Johnson syndrome (lesions on the skin and mucous membranes), may occur.
• Exfoliative dermatitis (skin peeling),
• maculopapular exanthema (rash),
• pruritus (itching), urticaria (hives),
• angioedema (hives),
• facial erythema (redness of the face).

Immune system disorders:

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

Blood and lymphatic system disorders:

• purpura (bleeding into the skin),
• thrombocytopenia (decreased platelets in the blood),
• hemolytic-uremic syndrome (anemia and blood in stool),
• pallor.

Eye disorders: vision disturbances.

Ear and labyrinth disorders:

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

General disorders and administration site conditions:

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

Investigations:

• elevated serum urea and creatinine levels,
• elevated potassium levels,
• weight gain,
• prolonged bleeding time,
• alteration of liver function tests.

Injury, poisoning, and procedural complications:

• hematomas (bruises),
• postoperative hemorrhage (after surgery).

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

Reporting of side effects

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

5. Storage of ketorolac trometamol Qualigen

No special storage conditions are required.

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

Do not use this medicine after the expiration date stated on the carton after EXP:

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of ketorolac trometamol Qualigen 10 mg film-coated tablets EFG:

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

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

Appearance of the Product and Packaging Content

White, round, biconvex film-coated tablets.

Available in cardboard boxes of 10, 20, and 500 tablets packaged in aluminum/aluminum blisters. The clinical package of 500 tablets consists of 5 boxes of 100 units each.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Date of the Last Revision of this Leaflet: July 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/