DEXKETOPROFEN NORMON 50 mg/2 ml Injectable Solution and Perfusion Solution

Introduction

Package Leaflet: Information for the Patient

Dexketoprofen NORMON 50 mg/2 ml Solution for Injection and Infusion EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

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

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

Dexketoprofeno NORMON is a pain reliever 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 pain in the kidney), and lower back pain (lumbago), when oral administration is not appropriate.

2. What you need to know before you use Dexketoprofen Normon

Do not use Dexketoprofeno NORMON:

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to acetylsalicylic acid or to another non-steroidal anti-inflammatory drug;
• If you have had asthma attacks, acute rhinitis (a short period of nasal mucosa inflammation), 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 previous use of a 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 impairment, or severe hepatic impairment;
• 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 diseases (ulcerative colitis, Crohn's disease) in the past;
• Suffer or have suffered from stomach or intestinal problems in the past;
• Take medications that increase the risk of gastrointestinal ulcers or bleeding, e.g., oral corticosteroids, some antidepressants (of the SSRI type: Selective Serotonin Reuptake Inhibitors), agents that prevent clot formation such as acetylsalicylic acid or anticoagulants like 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 stroke, or think you may be at risk for these disorders (e.g., you have high blood pressure, suffer from diabetes, have high cholesterol, or are a smoker). You should consult your treatment with your doctor or pharmacist. Medications like Dexketoprofeno NORMON may be associated with a small increased risk of suffering heart attacks ("myocardial infarction") or stroke. This risk is higher when high doses and prolonged treatments are used. Do not exceed the recommended dose or treatment duration;
• Are elderly, as you may suffer from a higher incidence of side effects (see section 4). If these occur, consult your doctor immediately;
• Suffer from any allergy or have had allergy problems in the past;
• Have kidney, liver, or heart disease (hypertension and/or heart failure), fluid retention, or have suffered from these problems in the past;
• Are taking diuretics or suffer from dehydration and reduced blood volume due to excessive fluid loss (e.g., due to excessive urination, diarrhea, or vomiting);
• Are a woman with fertility problems (Dexketoprofeno NORMON may decrease your fertility, so you should not use it if you are planning to become pregnant or if you are undergoing fertility studies);
• Are in the first or second trimester of pregnancy;
• Suffer from a blood disorder or blood cell disorder;
• Have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect connective tissue);
• Are under 18 years old.

Children and adolescents

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

Using Dexketoprofeno NORMON with other medicines

Tell your doctor or pharmacist that you are using, have recently used, or might use any other medicines.

Some medicines should not be taken together. Other medicines may need a dose change if taken together.

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

Not recommended combinations:

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

Combinations that require caution:

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

Combinations to be taken into account:

• Quinolones (e.g., ciprofloxacin, levofloxacin) used for bacterial infections.
• Cyclosporin or tacrolimus, used to treat immune system diseases and organ transplants.
• Streptokinase and other thrombolytic and fibrinolytic medications; i.e., medications used to dissolve clots.
• Probenecid, used for gout.
• Digoxin, used in the treatment of chronic heart failure.
• Mifepristone, used for abortion.
• 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 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 tendency to bleed and delay or prolong delivery more than expected. You should 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 the 20th week of pregnancy, Dexketoprofeno NORMON may cause kidney problems in your fetus if taken for more than a few days, which can cause low levels of amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional checks.

Driving and using machines

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

Dexketoprofeno NORMON contains ethanol and sodium

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

This medicine is harmful to people with alcoholism.

The alcohol content should be taken into account in the case of 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; i.e., it is essentially "sodium-free".

3. How to use Dexketoprofen Normon

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

Your doctor will indicate 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 administration of the first.

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 2 days. Switch to an oral analgesic when possible.

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

Method of use and administration routes:

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

When administering Dexketoprofeno NORMON by intramuscular route, the solution should be injected immediately after extraction from the topaz-colored 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 medicine, inform your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Always carry the medication package 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 medicine 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 when scheduled (according to section 3 "How to use Dexketoprofeno NORMON).

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

4. Possible side effects

Like all medicines, Dexketoprofeno NORMON can cause side effects, although not everybody gets them.

Possible side effects are listed below by 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 bleeding.

Uncommon side effects:

Anemia, headache, dizziness, sleep disorders, 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, and fever.

Rare side effects:

Laryngeal edema, increased blood glucose, decreased blood glucose, increased blood triglycerides, tingling, fainting, tinnitus, extrasystole (cardiac arrhythmia), tachycardia (increased heart rate), high blood pressure, superficial thrombophlebitis, slow breathing, stomach ulcers, gastrointestinal bleeding or perforation, 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 protein in urine), menstrual disorders, prostate disorders, chills, fluid retention, abnormal liver tests.

Very rare side effects:

Hematological reactions (decrease in white blood cell count, decrease in platelet count), anaphylactic reaction including anaphylactic shock, difficulty breathing, liver, pancreatic, or kidney damage, severe skin reactions, mouth, eyes, and genital area (Stevens-Johnson syndrome, Lyell syndrome), other skin reactions due to sun exposure, localized inflammation in the face, lips, and/or tongue (angioedema).

Tell your doctor immediately if you notice any gastrointestinal side effects at the start of treatment (e.g., stomach pain or heartburn or bleeding) or if you have previously suffered from these side 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 detect the appearance of skin rash or any mucosal lesion (e.g., inside the mouth) or any sign 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 like Dexketoprofeno NORMON may be associated with a small increased risk of suffering a heart attack ("myocardial infarction") or stroke.

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

Tell 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 it is a side effect not listed in this leaflet.

5. Storing Dexketoprofeno Normon

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

Store in the original packaging to protect it from light.

Do not use this medicine after the expiration date that appears on the packaging after EXP. 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 intended for use as a single-dose preparation and should be injected immediately after extraction from the topaz-colored ampoule. The unused solution should be discarded.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and medicines you no longer need in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Container Content and Additional 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 injectable preparations.

Appearance of the Product and Container Content:

Dexketoprofen NORMON 50 mg is presented in topaz-colored ampoules. Each container contains 6 ampoules or 100 ampoules (clinical container).

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON S.A.

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

This leaflet was approved in August 2023

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

INFORMATION FOR HEALTHCARE PROFESSIONALS

Intravenous Use:

• Intravenous infusion: the content of one ampoule (2 ml) of Dexketoprofen NORMON should be diluted in a volume of 30 to 100 ml with saline, glucose, or Ringer lactate solution.
  • 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 content of one ampoule (2 ml) of Dexketoprofen NORMON can be administered as a slow intravenous bolus, over a period of no less than 15 seconds.

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

Instructions for Proper Use

When administering Dexketoprofen NORMON via intravenous bolus, the solution should be injected immediately after extraction from the topaz-colored ampoule.

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

Only a clear and colorless solution should be used.

Compatibilities

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 correctly diluted injectable solution is transparent.

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

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