Dexketoprofen Normon 50 mg/2 ml solution for injection and infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dexketoprofeno Normon 50 mg/2 ml solution for injection and infusion EFG

Read the entire leaflet carefully before you start using 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 only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.

Leaflet contents:

1. What Dexketoprofeno Normon is and what it is used for
2. What you need to know before using Dexketoprofeno Normon
3. How to use Dexketoprofeno Normon
4. Possible side effects
5. How to store Dexketoprofeno Normon
6. Contents of the pack and other information

1. What Dexketoprofeno Normon is and what it is used for

Dexketoprofeno Normon is an analgesic belonging to the family of non-steroidal anti-inflammatory drugs (NSAIDs).

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

2. What you need to know before starting to use Dexketoprofeno Normon

Do not use Dexketoprofeno Normon:

• If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
• If you are allergic to acetylsalicylic acid or to any other non-steroidal anti-inflammatory drug (NSAID);
• If you have experienced asthma attacks, acute rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (fleshy growths inside the nose due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips, or tongue, or difficulty breathing), or wheezing (noisy breathing due to bronchial spasm) after taking acetylsalicylic acid or another non-steroidal anti-inflammatory drug;
• If you have or have had gastrointestinal ulcers;
• If you have or have had stomach or duodenal bleeding due to prior use of any non-steroidal anti-inflammatory drug (NSAID);
• If you have digestive problems (e.g. indigestion, heartburn) or chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis);
• If you have severe heart failure, moderate to severe renal failure, or severe hepatic failure;
• If you have bleeding disorders or blood coagulation disorders;
• If you suffer or have suffered from 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 previously suffered from chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
• Suffer or have previously suffered from stomach or intestinal problems;
• Are simultaneously taking medications that increase the risk of gastrointestinal ulcer or bleeding, e.g., oral corticosteroids, certain antidepressants (SSRIs: Selective Serotonin Reuptake Inhibitors), agents that prevent clot formation such as acetylsalicylic acid, or anticoagulants such as warfarin. In these cases, consult your doctor before using Dexketoprofeno Normon: your doctor may prescribe an additional medicine to protect your stomach (e.g., misoprostol or other medicines that block stomach acid production);
• Have heart problems, a history of stroke ("cerebrovascular accident"), or think you may be at risk of these conditions (e.g., you have high blood pressure, diabetes, elevated cholesterol, or are a smoker). You should discuss your treatment with your doctor or pharmacist. Medicines such as Dexketoprofeno Normon may be associated with a small increased risk of heart attacks ("myocardial infarction") or strokes ("cerebrovascular accident"). This risk is higher when high doses or prolonged treatments are used. Do not exceed the recommended dose or duration of treatment;
• Are elderly, as you may be more susceptible to adverse effects (see section 4). If these occur, consult your doctor immediately;
• Suffer from any allergies or have had allergic reactions in the past;
• Have kidney, liver, or heart disease (hypertension and/or heart failure), fluid retention, or have previously experienced these problems;
• Are taking diuretics or are dehydrated and have 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 fertility, so you should not use it if you are planning to become pregnant or undergoing fertility investigations);
• Are in the first or second trimester of pregnancy;
• Suffer from a disorder affecting blood and blood cell formation;
• Have systemic lupus erythematosus or mixed connective tissue disease (autoimmune diseases affecting connective tissue);
• Are under 18 years of age.

Allergic reactions to dexketoprofen, including respiratory problems, swelling of the face and neck area (angioedema), and chest pain, have been reported. Immediately discontinue treatment with Dexketoprofeno Normon and contact your doctor or nearest emergency service immediately if you experience any of these symptoms.

Children and adolescents

Do not take Dexketoprofeno Normon if you are under 18 years of age.

Use of Dexketoprofeno Normon with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

Some medicines should not be taken together. Others may require a dosage adjustment if taken concurrently.

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

Combinations not recommended:

• Acetylsalicylic acid, corticosteroids, and other non-steroidal anti-inflammatory drugs (NSAIDs).
• Warfarin, heparin, and other medicines used to prevent clot formation.
• Lithium, used to treat certain mood disorders.
• Methotrexate, used for rheumatoid arthritis and cancer.
• Hydantoins and phenytoin, used for epilepsy.
• Sulfamethoxazole, used for bacterial infections.

Combinations requiring caution:

• ACE inhibitors, diuretics, beta-blockers, and angiotensin II antagonists, used for high blood pressure and heart conditions.
• 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 for diabetes.

Combinations to be aware of:

• Quinolones (e.g., ciprofloxacin, levofloxacin), used for bacterial infections.
• Cyclosporine or tacrolimus, used to treat immune system disorders and in organ transplantation.
• Streptokinase and other thrombolytic and fibrinolytic medicines; i.e., medicines used to dissolve clots.
• Probenecid, used for gout.
• Digoxin, used in the treatment of chronic heart failure.
• Mifepristone, used for termination of pregnancy.
• Antidepressants of the SSRI type (Selective Serotonin Reuptake Inhibitors).
• Antiplatelet agents used to reduce platelet aggregation and clot formation.

If you have any doubts about taking other medicines 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 medicine, as Dexketoprofeno Normon may not be suitable for you.

Do not take Dexketoprofeno Normon if you are breastfeeding.

Do not take Dexketoprofeno Normon during 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 tendency to bleed and may delay or prolong labor more than expected. You should not take Dexketoprofeno Normon during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest possible 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 lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Driving and using machines

Dexketoprofeno Normon may slightly affect your ability to drive or operate machinery, as it may cause drowsiness or dizziness. If you experience these effects, do not drive or operate machinery until these symptoms have resolved. Seek advice from your doctor.

Dexketoprofeno Normon contains ethanol and sodium

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

This medicine may be harmful to individuals suffering from alcoholism.

The alcohol content should be considered in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.

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

3. How to use Dexketoprofeno Normon

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

Your doctor will determine the dose of Dexketoprofeno Normon you need, depending on 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 may be administered 6 hours after the first dose.

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 as soon as possible.

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

Method of administration and routes of administration:

Dexketoprofeno Normon may be administered by intramuscular or intravenous route (technical details for intravenous administration are described in section 7).

When Dexketoprofeno Normon is administered by intramuscular route, the solution must be injected immediately after withdrawal from the amber-colored ampoule, by slow and deep injection into the muscle.

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

If you use more Dexketoprofeno Normon than you should:

If you have used too much medicine, inform your doctor or pharmacist immediately or go to the nearest hospital emergency department. Always bring the medication pack or this leaflet with you.

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

If you forget to use Dexketoprofeno Normon

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

Use the next dose as scheduled (according to section 3 "How to use Dexketoprofeno NORMON").

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Dexketoprofeno Normon may produce adverse effects, although not all people will experience them.

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

Frequent adverse effects:

Nausea and/or vomiting, and pain at the injection site, injection site reactions including inflammation, bruising, or bleeding.

Uncommon adverse effects:

Anemia, headache, dizziness, sleep disorders, somnolence, blurred vision, low blood pressure, hot flushes, abdominal pain, indigestion, diarrhea, constipation, vomiting of blood, dry mouth, rash, itching, dermatitis, increased sweating, fatigue, chills, low-grade fever, and swelling.

Rare adverse effects:

Laryngeal edema, increased blood glucose, decreased blood glucose, increased blood triglycerides, tingling, fainting, tinnitus (ringing in the ears), extrasystoles (cardiac arrhythmia), tachycardia (increased heart rate), elevated blood pressure, superficial thrombophlebitis, slow breathing, stomach ulcer, gastrointestinal bleeding or perforations, liver cell damage (hepatitis), jaundice, urticaria, acne, muscle stiffness or cramps, joint stiffness, lower back pain, acute renal failure, excessive urination, kidney pain, ketonuria (presence of ketone bodies in urine), proteinuria (presence of proteins in urine), menstrual disorders, prostate disorders, chills, fluid retention, abnormal liver function tests.

Very rare adverse effects:

Hematological reactions (decreased number of white blood cells, decreased number of platelets), anaphylactic reaction including anaphylactic shock, breathing difficulty, liver, pancreatic or kidney damage, severe skin reactions involving the mouth, eyes and genital area (Stevens-Johnson syndrome, Lyell syndrome), other sun-induced skin reactions, localized swelling of the face, lips and/or tongue (angioedema).

Frequency not known: frequency cannot be estimated from the available data

Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Drug-induced fixed eruption

Allergic skin reaction known as fixed drug eruption, which may include round or oval red patches and skin swelling, blisters and itching. Darkening of the skin in affected areas may also occur, which can persist after healing. Fixed drug eruption usually reappears in the same location or locations if the medication is taken again.

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

Stop using Dexketoprofeno Normon as soon as you notice the appearance of a skin rash or any mucosal lesions (e.g., inside the mouth) or any signs of allergy.

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

Medicines such as Dexketoprofeno Normon may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke ("cerebrovascular accident").

In patients with systemic lupus erythematosus or mixed connective tissue disease, anti-inflammatory medicines 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 any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet.

5. Storage of Dexketoprofeno Normon

Keep this medicine out of sight and reach of children.

Store in the original packaging to protect it from light.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Do not use Dexketoprofeno Normon if the solution is not clear and colourless, or if it shows other signs of deterioration (e.g. particles). Dexketoprofeno Normon is intended for single-dose use and must be injected immediately after withdrawal from the amber glass ampoule. Any unused solution must be discarded.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dexketoprofen Normon:

Each ampoule contains 50 mg of Dexketoprofen (as dexketoprofen trometamol).

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

Presentation of the product and pack contents:

Dexketoprofen Normon 50 mg is presented in amber-coloured ampoules. Each pack contains 6 ampoules or 100 ampoules (hospital pack).

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON S.A.

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

This leaflet was approved in September 2025

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

You can access detailed and current information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging.

You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/77504/P_77504.html.

INFORMATION FOR HEALTHCARE PROFESSIONALS

Intravenous use:

• Intravenous infusion: the contents of one ampoule (2 ml) of Dexketoprofen NORMON should be diluted in a volume of 30 to 100 ml with saline solution, glucose solution, or Ringer's lactate.

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

• Intravenous bolus: if necessary, the contents of one ampoule (2 ml) of Dexketoprofen Normon may be administered as a slow intravenous bolus, over no less than 15 seconds.

Dexketoprofen Normon is contraindicated for intrathecal or epidural administration due to its ethanol content.

Instructions for proper use

When Dexketoprofen Normon is administered as an intravenous bolus, the solution should be injected immediately after withdrawal from the amber-coloured ampoule.

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

Only clear, colourless solutions should be used.

Compatibility

Dexketoprofen Normon has been shown to be compatible when mixed in small volumes (e.g., in a syringe) with injectable solutions of heparin, lidocaine, morphine and theophylline.

The properly diluted injectable solution is clear.

Diluted Dexketoprofen Normon in a volume of 100 ml of saline or glucose infusion solution is compatible with the following injectable solutions: dopamine, heparin, hydroxyzine, lidocaine, morphine, pethidine and theophylline.

No adsorption of the active substance has been observed when diluted solutions of Dexketoprofen Normon have been stored in plastic bags or administration devices made of Ethylene Vinyl Acetate (EVA), Cellulose Propionate (CP), Low-Density Polyethylene (LDPE) and Polyvinyl Chloride (PVC).