Ketorolac tromethamine Qualigen 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ketorolac tromethamol Qualigen 10 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking 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 should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

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

2. What you need to know before starting Ketorolac tromethamine Qualigen

Do not take ketorolac tromethamine Qualigen

• if you have active peptic 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)

• if you have complete or partial nasal polyp syndrome (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 (reduced circulating blood volume in the body) or dehydration (lack of body water)

• if you have hemorrhagic diathesis (tendency to bleed), coagulation disorders (abnormalities in blood 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)

• concomitantly with other NSAIDs (non-steroidal anti-inflammatory drugs), including acetylsalicylic acid and selective cyclooxygenase-2 (COX-2) inhibitors

• if you are being treated with anticoagulants at high doses

• 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

Warnings and precautions

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

• If you have suffered from 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 a similar condition.

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

• Rarely, serious skin reactions (such as erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis) may occur with ketorolac use. These are more likely to appear early in treatment. Discontinue administration at the first sign of 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, you must stop treatment immediately and inform your doctor as soon as possible.

• If you experience difficulty in becoming pregnant or are undergoing fertility treatment.

• If you develop skin redness, mucosal lesions, or any other sign of hypersensitivity or anaphylactic reaction, discontinue treatment and contact your doctor immediately.

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

Consult your doctor, even if any of the above circumstances occurred in the past.

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

Severe allergic reactions (including a serious reaction known as anaphylactic shock) have been reported when ketorolac is administered by injection. Although information on this reaction with ketorolac tablets is limited, inform your doctor immediately if you experience symptoms such as swelling, difficulty breathing, or a sudden drop in blood pressure.

Children and adolescents

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

Other medicines and ketorolac tromethamine Qualigen

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Concomitant administration is contraindicated with:

• Other 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 (such as acetylsalicylic acid, ticlopidine, or clopidogrel): may increase the risk of gastrointestinal bleeding.
• Pentoxifylline, probenecid
• Lithium (a medicine used to treat bipolar disorder)

Exercise special caution 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, labor, and breastfeeding.

Ketorolac is contraindicated during labor because, by inhibiting prostaglandin synthesis, it may impair fetal circulation and inhibit uterine contractions.

For women of childbearing potential, it should be noted that drugs of the ketorolac type have been associated with reduced fertility.

Driving and use of machines:

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

Ketorolac tromethamine Qualigen contains lactose:

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

3. How to take ketorolac tromethamine Qualigen

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Treatment with ketorolac should be initiated in a hospital setting, and the total duration of treatment must not exceed 7 days. If injectable ketorolac has previously been administered in the postoperative period, the total duration of treatment with ketorolac must 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 pain, without exceeding 4 tablets per day (40 mg/day).

The duration of oral treatment must not exceed 7 days.

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

Your doctor will determine the duration of your treatment with this medicine. Do not stop treatment prematurely.

Administration with morphine

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

Elderly patients (> 65 years):

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

Children and adolescents (<16 years)

This medicine must not be given to children or adolescents. (See section 2).

Renal impairment

Ketorolac must not be used if you have moderate or severe renal impairment. If you have mild kidney disease, you should receive reduced doses of ketorolac (half the recommended dose, without exceeding a total daily dose of 60 mg), and periodic renal function tests should be performed.

If you take more ketorolac tromethamine Qualigen than you should

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

Symptoms may include abdominal pain, nausea, vomiting, hyperventilation (increased pulmonary ventilation), gastroduodenal ulcer, erosive gastritis, and renal dysfunction, which resolve upon discontinuation of the medicine.

If you forget to take ketorolac tromethamine Qualigen

Do not take a double dose to make up for a missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects, although not everyone will experience 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.

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

Gastrointestinal disorders
These are the most frequent adverse effects. The following may occur:

• peptic ulcer, gastrointestinal perforation, or gastrointestinal bleeding, sometimes fatal, particularly in elderly patients;
• nausea, vomiting;
• diarrhoea, flatulence, constipation;
• dyspepsia (digestive disturbance), gastritis (inflammation of the stomach lining), abdominal pain;
• melaena (blood in stools), haematemesis (vomiting of blood);
• ulcerative stomatitis (mouth ulcers);
• exacerbation (worsening) of ulcerative colitis and Crohn's disease (inflammatory bowel diseases);
• abdominal discomfort;
• belching;
• feeling of fullness;
• oesophagitis (inflammation of the oesophagus), pancreatitis (inflammation of the pancreas);
• rectal bleeding;
• dysgeusia (disturbance of taste).

Metabolism and nutrition disorders:

• anorexia (loss of appetite);
• hyperkalaemia (increased blood potassium levels);
• hyponatraemia (decreased blood sodium levels).

Nervous and musculoskeletal system disorders:

• aseptic meningitis (inflammation of the meninges);
• seizures;
• dizziness;
• dry mouth;
• headache;
• hyperkinesia (excessive activity);
• myalgia (muscle pain);
• paraesthesia (loss of sensation);
• sweating.

Psychiatric disorders:

• abnormal dreams;
• disturbance of thinking;
• anxiety, depression, insomnia;
• euphoria, hallucinations, psychotic reactions;
• somnolence;
• decreased concentration ability;
• restlessness.

Renal and urinary disorders:

• acute renal failure, "kidney pain" with haematuria (blood in urine) and hyperazotaemia (accumulation of nitrogen in blood), or without them;

• pollakiuria (frequent urination in small amounts);

• urinary retention;

• interstitial nephritis (kidney inflammation);

• nephrotic syndrome (abnormal excretion of protein in urine);

• oliguria (reduced urine production).

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

Cardiovascular disorders:

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

Reproductive system and breast disorders: female infertility.

Respiratory, thoracic and mediastinal disorders:

• bronchial asthma;
• dyspnoea (shortness of breath);
• pulmonary oedema (fluid accumulation in the lungs);
• bronchospasm (difficulty breathing);
• epistaxis (nosebleed).

Hepatobiliary disorders:

• abnormal liver function tests;
• hepatitis (liver inflammation);
• cholestatic jaundice (yellowing of the skin);
• hepatic failure (liver dysfunction).

Skin and subcutaneous tissue disorders:

• Very rarely, skin hypersensitivity reactions of the vesiculobullous type 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 (swelling beneath the skin);
• facial erythema (facial redness).

Immune system disorders:

• hypersensitivity reactions (allergy);
• anaphylaxis (allergic reaction);
• laryngeal oedema (swelling of the larynx);
• anaphylactoid reactions (acute allergic-type reactions). Anaphylactoid reactions, like anaphylaxis, can be fatal.

Blood and lymphatic system disorders:

• purpura (bleeding under the skin);
• thrombocytopenia (reduced platelet count);
• haemolytic uraemic syndrome (anaemia and blood in stools);
• pallor.

Eye disorders: visual disturbances.

Ear and labyrinth disorders:

• tinnitus (ringing in the ears);
• hypoacusis (reduced hearing);
• vertigo.

General disorders and administration site conditions:

• asthenia (lack of energy);
• oedema (swelling due to fluid accumulation);
• injection site reactions;
• fever;
• polydipsia (increased thirst).

Additional investigations:

• increased serum urea and creatinine levels;
• increased potassium levels;
• weight gain;
• prolonged bleeding time;
• abnormal liver function tests.

Injury, poisoning and procedural complications:

• haematomas (bruises);
• postoperative haemorrhage (bleeding after surgery).

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ketorolac tromethamine 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 expiry date stated on the carton after EXP:.

The expiry date refers to 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 medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

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

The active substance is ketorolac tromethamine. Each tablet contains 10 mg of ketorolac tromethamine.

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 pack

Round, biconvex, white film-coated tablets.

Available in cardboard packs containing 10, 20 and 500 tablets in aluminum/aluminum blisters. The clinical pack of 500 tablets consists of 5 boxes of 100 tablets each.

Only certain pack 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 most recent revision of this leaflet: January 2026

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