Package Insert: Information for the Patient

Dexketoprofene NORMON 50 mg/2 ml Injectable Solution and for Infusion EFG

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others who 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 package insert.

Dexketoprofeno NORMON is a nonsteroidal anti-inflammatory drug (NSAID) analgesic.

It is indicated for the symptomatic treatment of moderate to severe acute pain, such as postoperative pain, severe renal colic, and lower back pain (lumbago), when oral administration is not appropriate.

Do not use Dexketoprofeno NORMON:

• If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).
• If you are allergic to acetylsalicylic acid or to another nonsteroidal anti-inflammatory drug;
• If you have had asthma attacks, acute rhinitis (a short period of nasal mucosa inflammation), nasal polyps (fleshy formations in the nasal cavity due to allergy), urticaria (skin eruption), angioedema (face, eye, lip, or tongue swelling, or difficulty breathing) or wheezing (noisy breathing due to bronchial spasm) after taking acetylsalicylic acid or another nonsteroidal anti-inflammatory drug;
• If you have or have had gastrointestinal ulcers;
• If you have or have had stomach or duodenal hemorrhage due to previous use of a nonsteroidal anti-inflammatory drug (NSAID);
• If you have digestive problems (e.g. indigestion, stomach burning) or chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis);
• If you have severe heart failure, moderate to severe renal insufficiency, or severe liver insufficiency;
• If you have bleeding disorders or blood coagulation disorders;
• If you have bronchial asthma;
• If you are in the third trimester of pregnancy or breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Dexketoprofeno NORMON if you:

• Have had chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) in the past;
• Suffer or have suffered from stomach or intestinal problems;
• Take medications that increase the risk of gastrointestinal ulcers or bleeding, e.g. oral corticosteroids, some antidepressants (SSRI type: Selective Serotonin Reuptake Inhibitors), anticoagulants such as acetylsalicylic acid or warfarin. In these cases, consult your doctor before using Dexketoprofeno NORMON: your doctor may prescribe an additional medication to protect your stomach (e.g. misoprostol or other medications that block stomach acid production);
• Have heart problems, a history of strokes ("cerebrovascular accident"), or think you may be at risk for these conditions (e.g. high blood pressure, diabetes, high cholesterol, or smoking). You should consult your treatment with your doctor or pharmacist. Medications like Dexketoprofeno NORMON may be associated with a small increase in the risk of heart attacks ("myocardial infarction") or strokes ("cerebrovascular accident"). This risk is greater when high doses and prolonged treatments are used. Do not exceed the recommended dose or treatment duration;
• Are elderly, as you may be more likely to experience adverse effects (see section 4). If these occur, consult your doctor immediately;
• Suffer from allergies or have had allergic problems in the past;
• Have kidney, liver, or heart diseases (hypertension and/or heart failure), fluid retention, or have had these problems in the past;
• Are taking diuretics or suffer from dehydration and reduced blood volume due to excessive fluid loss (e.g. excessive urination, diarrhea, or vomiting);
• Are a woman with fertility problems (Dexketoprofeno NORMON may reduce your fertility, so do not use it if you are planning to become pregnant or undergoing fertility studies);
• Are in the first or second trimester of pregnancy;
• Suffer from a disorder of blood and blood cell formation;
• Have systemic lupus erythematosus or mixed connective tissue disease (autoimmune diseases affecting connective tissue);
• Are under 18 years old.

Children and adolescents

Do not take Dexketoprofeno NORMON if you are under 18 years old.

Use of Dexketoprofeno NORMON with other medications

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

Some medications should not be taken together. Other medications may require a dose change if taken together.

It is especially important to inform your doctor, dentist, or pharmacist if, in addition to Dexketoprofeno NORMON, you are taking any of the following medications:

Not recommended associations:

• Acetylsalicylic acid, corticosteroids, and other nonsteroidal anti-inflammatory drugs.
• Warfarin, heparin, and other medications used to prevent blood clotting.
• Lithium, used to treat some mood disorders.
• Methotrexate, used to treat rheumatoid arthritis and cancer.
• Hydantoins and phenytoin, used to treat epilepsy.
• Sulfamethoxazole, used to treat bacterial infections.

Associations that require caution:

• ACE inhibitors, diuretics, beta-blockers, and angiotensin II antagonists, used to treat high blood pressure and heart disease.
• Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers.
• Zidovudine, used to treat viral infections.
• Aminoglycoside antibiotics, used to treat bacterial infections
• Chlorpropamide and glibenclamide, used to treat diabetes.

Associations to be considered:

• Quinolones (e.g. ciprofloxacin, levofloxacin), used to treat bacterial infections.
• Ciclosporin or tacrolimus, used to treat autoimmune diseases and organ transplants.
• Streptokinase and other thrombolytic and fibrinolytic medications; that is, medications used to dissolve blood clots.
• Probenecid, used to treat gout.
• Digoxin, used to treat chronic heart failure.
• Mifepristone, used to terminate pregnancy.
• SSRI-type antidepressants.
• Antiplatelet medications used to reduce platelet aggregation and blood clot formation.

If you have any doubts about taking other medications with Dexketoprofeno NORMON, consult your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication, as Dexketoprofeno NORMON may not be suitable for you.

Do not take Dexketoprofeno NORMON if you are breastfeeding.

Do not take Dexketoprofeno NORMON 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 and your baby's predisposition to bleeding and delay or prolong delivery more than expected. Do not take Dexketoprofeno NORMON during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From week 20 of pregnancy, Dexketoprofeno NORMON 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 monitoring.

Driving and operating machinery

Dexketoprofeno NORMON may slightly affect your ability to operate machinery and drive, as it may cause drowsiness or dizziness. If you notice these effects, do not use machinery or drive until they disappear. Consult your doctor.

Dexketoprofeno NORMON contains ethanol and sodium

This medication contains 10% ethanol (alcohol), which corresponds to 200 mg per ampoule, equivalent to 5 ml of beer or 2.08 ml of wine.

This medication is harmful to people with alcoholism.

The alcohol content should be taken into account in the case of pregnant women, breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy.

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

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

Your doctor will tell you the dose of Dexketoprofeno NORMON you need, according to the type, severity, and duration of your symptoms. The recommended dose is generally 1 ampoule (50 mg) every 8 – 12 hours. If necessary, a second ampoule can be administered 6 hours after the first administration.

Under no circumstances should the maximum daily dose of 150 mg of Dexketoprofeno NORMON (3 ampoules) be exceeded.

Do not take Dexketoprofeno NORMON for more than two days. Switch to an oral analgesic when possible.

Elderly patients with reduced renal function and patients with kidney or liver dysfunction should not exceed a total daily dose of 50 mg of Dexketoprofeno NORMON (1 ampoule).

Form of use and administration routes:

Dexketoprofeno NORMON can be administered via intramuscular or intravenous routes (the technical details for intravenous administration are described in section 7).

When administered via intramuscular route, the solution should be injected immediately after extraction from the amber-colored injection ampoule by slow and deep injection into the muscle.

It should only be used if the solution is transparent and colorless.

If you use more Dexketoprofeno NORMON than you should:

If you have used too much medication, immediately inform your doctor or pharmacist or go to the emergency service of your nearest hospital. Always carry the medication packaging or this leaflet with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Dexketoprofeno NORMON

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

Use the next dose when due (according to section 3 “How to use Dexketoprofeno NORMON).

If you have doubts about the use of this medication, consult your doctor or pharmacist.

Like all medicines, Dexketoprofeno NORMON may cause side effects, although not everyone will experience them.

The possible side effects are listed below according to their frequency. The following table indicates how many patients may experience these side effects:

Frequent side effects:

Nausea and/or vomiting and pain at the injection site, reactions at the injection site, including inflammation, hematoma, or hemorrhage.

Infrequent side effects:

Anemia, headache, dizziness, sleep disturbances, drowsiness, blurred vision, low blood pressure, hot flashes, abdominal pain, difficult digestion, diarrhea, constipation, vomiting blood, dry mouth, skin rash, itching, dermatitis, increased sweating, fatigue, chills, fever, and inflammation.

Rare side effects:

Edema of the larynx. Increased blood glucose, decreased blood glucose, increased triglycerides in the blood, tingling, fainting, ringing in the ears, extrasystole (cardiac arrhythmia), tachycardia (increased heart rate), high blood pressure, superficial thrombophlebitis, slow breathing, stomach ulcer, gastrointestinal hemorrhage or perforation, liver cell damage (hepatitis), jaundice, urticaria, acne, muscle stiffness or cramps, joint stiffness, lower back pain, acute renal insufficiency, excessive urine production, renal pain, ketonuria (presence of ketone bodies in urine), proteinuria (presence of proteins in urine), menstrual irregularities, prostatic irregularities, chills, fluid retention, abnormal liver function tests.

Very rare side effects:

Hematological reactions (decreased white blood cell count, decreased platelet count), anaphylactic reaction including anaphylactic shock, difficulty breathing, liver, pancreatic, or renal damage, severe skin, mouth, eye, and genital area reactions (Stevens-Johnson syndrome, Lyell syndrome), other sun exposure-related skin reactions, localized inflammation on the face, lips, and/or tongue (angioedema).

Inform your doctor immediately if you notice any digestive side effects at the beginning of treatment (e.g., stomach pain or burning, bleeding) or if you have previously experienced any of these side effects due to prolonged use of anti-inflammatory medications. This is especially important if you are elderly.

Stop using Dexketoprofeno NORMON as soon as you detect the appearance of skin rash or any mucous membrane lesions (e.g., inside the mouth) or any sign of allergy.

During treatment with nonsteroidal anti-inflammatory drugs, cases of fluid retention and swelling (especially in ankles and legs), increased blood pressure, and heart failure have been reported.

Medicines like Dexketoprofeno NORMON may be associated with a small increased risk of suffering a heart attack (“myocardial infarction”) or stroke (“cerebrovascular accident”).

In patients with systemic lupus erythematosus or mixed connective tissue disease, anti-inflammatory medications may exceptionally cause isolated cases of fever, headache, and neck stiffness.

Inform your doctor immediately if signs of infection appear or worsen while taking Dexketoprofeno NORMON.

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus.

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

Store in the original packaging to protect it from light.

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

Do not use Dexketoprofeno NORMON if you notice that the solution is not transparent or colorless, or if it shows other signs of deterioration (e.g. particles). Dexketoprofeno NORMON is indicated for single-dose use and must be injected immediately after its extraction from the vial. Unused solution must be discarded.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the 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 Dexketoprofeno NORMON:

Each ampoule contains 50 mg of Dexketoprofeno (as dexketoprofeno trometamol).

The other components are: alcohol (ethanol), sodium chloride, sodium hydroxide, hydrochloric acid, and water for injection preparations.

Appearance of the product and contents of the package:

Dexketoprofeno NORMON 50 mg is presented in amber-colored ampoules. Each package contains 6 ampoules or 100 ampoules (clinical package).

Holder of the marketing authorization and responsible for manufacturing

Laboratorios NORMON S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos- Madrid (SPAIN)

This leaflet was approved in August 2023

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

INFORMATION FOR HEALTH PROFESSIONALS

Intravenous use:

- Intravenous infusion:The contents of one ampoule (2 ml) of Dexketoprofeno NORMON should be diluted in a volume of 30 to 100 ml with saline solution, glucose, or Ringer lactate.

• The diluted solution should be administered by intravenous infusion slowly over 10 – 30 minutes. The solution should always be protected from natural light.

• Intravenous bolus:If necessary, the contents of one ampoule (2 ml) of Dexketoprofeno NORMON can be administered as an intravenous bolus slowly, in a time not less than 15 seconds.

Dexketoprofeno NORMON is contraindicated for intrathecal or epidural administration due to its ethanol content.

Instructions for proper use

When administering Dexketoprofeno NORMON by intravenous bolus, the solution should be injected immediately after extraction from the amber-colored ampoule.

For intravenous infusion administration, the solution should be diluted aseptically and protected from natural light.

Only transparent and colorless solution should be used.

Compatibilities

Dexketoprofeno NORMON has been shown to be compatible whenmixed in small volumes(e.g., in a syringe) with injectable solutions of heparin, lidocaine, morphine, and theophylline.

The correctly diluted injectable solution is transparent.

Dexketoprofeno NORMON dilutedin a volume of 100 mlof saline solution or glucose for infusion is compatible with the following injectable solutions: dopamine, heparin, hydrocortisone, lidocaine, morphine, pethidine, and theophylline.

No adsorption of the active principle has been observed when diluted solutions of Dexketoprofeno NORMON have been stored in plastic bags or administration devices made from Ethylvinalacetate (EVA), Propionato de Celulosa (CP), Low-Density Polyethylene (LDPE), and Chlorinated Polyvinyl Chloride (PVC).