Enantyum 50 mg/2 ml solution for injection and for infusion

Patient Information Leaflet

Introduction

Patient Information Leaflet

Enantyum 50 mg/2 ml solution for injection and infusion

dexketoprofen

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Enantyum is and what it is used for.

2. What you need to know before using Enantyum.

3. How to use Enantyum.

4. Possible adverse effects.

5. How to store Enantyum.

6. Package contents and additional information.

1. What Enantyum is and what it is used for

Enantyum 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 using Enantyum:

Do not use Enantyum:

• If you are allergic to dexketoprofen 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 asthma or have previously 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 NSAID;
• If you have previously experienced photoallergic or phototoxic reactions (a special type of redness or sunburn-like skin lesions on sun-exposed skin) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to reduce blood fat levels);
• If you have peptic ulcer, gastrointestinal bleeding, or have previously experienced stomach or intestinal bleeding, ulceration, or perforation;
  • If you have gastrointestinal problems (e.g., indigestion, heartburn);
  • If you have or have previously had bleeding or perforation of the stomach or duodenum due to prior use of NSAIDs for pain relief;
  • If you have 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 are severely dehydrated (have lost a large amount of body fluid) due to vomiting, diarrhea, or insufficient fluid intake;
  • If you are in the third trimester of pregnancy or breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before using Enantyum if:

• You have previously suffered from chronic inflammatory bowel diseases (ulcerative colitis, Crohn’s disease);
• You currently suffer or have previously suffered from stomach or intestinal problems;
• You are taking medications that increase the risk of gastrointestinal ulceration or bleeding, e.g., oral corticosteroids, certain antidepressants (SSRIs: Selective Serotonin Reuptake Inhibitors), or agents that prevent blood clotting such as acetylsalicylic acid or anticoagulants like warfarin. In such cases, consult your doctor before taking Enantyum: your doctor may prescribe an additional medicine to protect your stomach (e.g., misoprostol or other drugs that inhibit gastric acid production);
• You have heart problems, a history of stroke ("cerebrovascular accident"), or think you may be at risk of such conditions (e.g., high blood pressure, diabetes, high cholesterol, or if you smoke). You should discuss your treatment with your doctor or pharmacist. Medicines like Enantyum may be associated with a small increased risk of heart attacks ("myocardial infarction") or strokes ("cerebrovascular accident"). This risk is higher with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment;
• You are elderly, as you may be more susceptible to adverse effects (see section 4). If these occur, consult your doctor immediately;
• You have any allergies or have previously experienced allergic reactions;
• You have kidney, liver, or heart disease (hypertension and/or heart failure), fluid retention, or have previously experienced these conditions;
• You are taking diuretics or are dehydrated with reduced blood volume due to excessive fluid loss (e.g., excessive urination, diarrhea, or vomiting);
• You are a woman with fertility problems (Enantyum may reduce fertility, so you should not use it if you are planning to become pregnant or undergoing fertility investigations);
• You are in the first or second trimester of pregnancy;
• You have a disorder affecting blood or blood cell formation;
• You have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• You have an infection; see the section "Infections" below;
• You have asthma combined with chronic rhinitis or sinusitis, and/or nasal polyps, as you are at higher risk of being allergic to acetylsalicylic acid and/or NSAIDs than the general population. Administration of this medicine may trigger asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Infections

Enantyum may mask signs of infection such as fever and pain. Therefore, Enantyum may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor immediately.

It is advisable to avoid using this medicine during chickenpox.

Kounis Syndrome

Cases of allergic reaction to dexketoprofen, including respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Immediately discontinue treatment with Enantyum and contact your doctor or nearest emergency service if you experience any of these symptoms.

Children and adolescents

Enantyum has not been studied in children or adolescents. Therefore, safety and efficacy have not been established, and the product should not be used in children or adolescents.

Use of Enantyum with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines, including those obtained without a prescription. Some medicines should not be taken together. Others may require dose adjustments when used concomitantly.

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

Not recommended combinations:

• Acetylsalicylic acid, corticosteroids, and other non-steroidal anti-inflammatory drugs (NSAIDs);
• Warfarin, heparin, and other medicines used to prevent blood clotting;
• Lithium, used to treat certain mood disorders;
• Methotrexate (a cancer and immunosuppressive drug), when used at high doses of 15 mg/week;
• Hydantoins and phenytoin, used for epilepsy;
• Sulfamethoxazole, used for bacterial infections.

Combinations requiring caution:

• ACE inhibitors, diuretics, and angiotensin II antagonists, used for high blood pressure and heart disorders;
• Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers;
• Zidovudine, used to treat viral infections;
• Aminoglycoside antibiotics, used to treat bacterial infections;
• Sulfonylureas (e.g., chlorpropamide and glibenclamide), used for diabetes;
  • Methotrexate, when used at low doses, less than 15 mg/week.

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 (Selective Serotonin Reuptake Inhibitors) type;
• Antiplatelet agents used to reduce platelet aggregation and clot formation;
  • Beta-blockers, used for high blood pressure and heart disorders;
  • Tenofovir, deferasirox, pemetrexed.

If you have any doubts about taking other medicines with Enantyum, 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 or pharmacist before using this medicine.

Do not use Enantyum during the last three months of pregnancy or while breastfeeding. It may cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and may delay or prolong labor more than expected.

You should not take Enantyum during the first six months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest effective dose for the shortest possible time.

From week 20 of pregnancy, Enantyum may cause kidney problems in your unborn baby if taken for more than a few days, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

Use of Enantyum is not recommended while trying to conceive or while undergoing fertility investigations.

Regarding potential effects on female fertility, see also section 2, "Warnings and precautions."

Driving and using machines

Enantyum may slightly affect your ability to drive or use machines, as it may cause drowsiness or dizziness. If you experience these effects, do not drive or operate machinery until symptoms resolve. Seek advice from your doctor.

Enantyum contains ethanol and sodium

This medicine contains up to 200 mg of alcohol (ethanol) in each 2 ml ampoule, equivalent to 3 mg/kg/dose (10% w/v). The amount in one ampoule (2 ml) of this medicine is equivalent to less than 5 ml of beer or 2 ml of wine.

The small amount of alcohol contained in this medicine does not produce any perceptible effect.

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

3. How to use Enantyum

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

The lowest effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

Your doctor will determine the dose of Enantyum 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 Enantyum (3 ampoules) be exceeded.

Do not use Enantyum 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 Enantyum (1 ampoule).

Method of administration and routes of administration

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

When Enantyum is administered intramuscularly, the solution must be injected immediately after withdrawal from the amber-coloured ampoule as a slow and deep injection into the muscle.

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

Use in children and adolescents

This medicine must not be used in children and adolescents (under 18 years of age).

If you use more Enantyum than you should

If you have used too much medicine, inform your doctor or pharmacist immediately or go to the nearest hospital emergency department, or call the Toxicology Information Service at 91.562.04.20, stating the medicine and the amount taken. Please remember to always carry the medicine carton or this leaflet with you.

If you forget to use Enantyum

Do not take a double dose to make up for missed doses. Take the next dose as scheduled (according to section 3, “How to use Enantyum”).

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

4. Possible adverse effects

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

The possible adverse effects are listed below according to their frequency.

Frequent adverse effects (may affect up to 1 in 10 people):

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

Uncommon adverse effects (may affect up to 1 in 100 people):

Vomiting blood, low blood pressure, fever, blurred vision, dizziness, drowsiness, sleep disorders, headache, anemia, abdominal pain, constipation, indigestion, diarrhea, dry mouth, hot flushes, rash, dermatitis, itching, increased sweating, fatigue, pain, feeling cold.

Rare adverse effects (may affect up to 1 in 1,000 people):

Peptic ulcer, hemorrhagic peptic ulcer or perforated peptic ulcer, high blood pressure, fainting, slow breathing, inflammation of a superficial vein due to a blood clot (superficial thrombophlebitis), isolated heartbeat (extrasystole), increased heart rate, peripheral edema, laryngeal edema, loss of appetite (anorexia), abnormal sensation, feeling feverish and chills, ringing in the ears (tinnitus), itchy rash, jaundice, acne, lower back pain, kidney pain, frequent urination, menstrual disorders, prostate disorders, muscle stiffness, joint stiffness, muscle cramps, abnormal liver function tests (blood test), increased blood glucose (hyperglycemia), decreased blood glucose (hypoglycemia), increased blood triglycerides (hypertriglyceridemia), ketones in urine (ketonuria), protein in urine (proteinuria), liver cell damage (hepatitis), acute kidney failure.

Very rare adverse effects (may affect up to 1 in 10,000 people):

Anaphylactic reaction (hypersensitivity reaction which may also lead to collapse), skin ulcers affecting the mouth, eyes and genital area (Stevens-Johnson syndrome, Lyell's syndrome), facial swelling, swelling of lips and throat (angioedema), breathing difficulty due to contraction of respiratory muscles (bronchospasm), breathing difficulty, pancreatitis, photosensitivity skin reactions and skin hypersensitivity upon exposure to light, kidney damage, decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

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 eruption (fixed drug 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 may persist after healing. Fixed drug eruption usually recurs in the same location or locations if the medicine 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 sensation or bleeding), or if you have previously experienced any of these adverse effects due to prolonged treatment with non-steroidal anti-inflammatory drugs. This is especially important if you are elderly.

Stop taking Enantyum 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 Enantyum may be associated with a small increased risk of having a 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.

The most commonly observed adverse effects are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or gastrointestinal bleeding, sometimes fatal, may occur, particularly in elderly patients.

Following administration, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, and worsening of colitis and Crohn's disease have been reported. Less frequently, inflammation of the stomach lining (gastritis) has been observed.

As with other NSAIDs, hematological reactions may occur (purpura, aplastic and hemolytic anemia, and more rarely agranulocytosis and bone marrow hypoplasia).

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, 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 Enantyum

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

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

Store the ampoule in the original packaging to protect it from light.

Do not use this medicine if the solution is not clear and colourless, or if other signs of deterioration are observed (e.g. / particles). Enantyum injectable and infusion solution is intended for single-dose use and must be injected immediately after withdrawal from the amber-coloured ampoule. Any unused solution must be discarded (see next section “Disposal”).

Medicines must not be disposed of via wastewater or household waste. Return unused containers and medicines to the SIGRE Point at your 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 Enantyum

• The active substance is dexketoprofen (as dexketoprofen trometamol). Each ampoule contains 50 mg of dexketoprofen.
• The other components are alcohol (ethanol; see section 2, Enantyum contains ethanol), sodium chloride, sodium hydroxide, and water for injection.

Nature of the medicinal product and pack contents:

Enantyum is presented as a solution for injection and infusion.

It is available in packs containing 1, 5, 6, 10, 20, 50, and 100 Type I amber glass ampoules with 2 ml of clear, colourless solution.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

LABORATORIOS MENARINI, S.A.

Alfons XII, 587 - Badalona (Barcelona), Spain

Manufacturer

Alfasigma S.p.A.

Via Enrico Fermi, 1

65020 Alanno (Pescara)

Italy

or

• MENARINI MANUFACTURING LOGISTICS AND SERVICES, s.r.l.

Via Sette Santi n.3 – Florence – Italy

or

Zambon S.p.A.

via della Chimica, 9

36100 Vicenza

Italy

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Spain (EMR), Italy: Enantyum

Latvia: Ketesse

Greece: Viaxal

Date of the most recent revision of this package leaflet: September 2025

Other sources of information

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

1. Information for healthcare professionals

This information is intended exclusively for healthcare professionals:

Intravenous use:

- Intravenous infusion: the contents of one ampoule (2 ml) of Enantyum should be diluted in a volume of 30 to 100 ml of 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 contents of one ampoule (2 ml) of Enantyum may be administered as a slow intravenous bolus over no less than 15 seconds.

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

Instructions for proper use: When Enantyum is administered as an intravenous bolus, the solution should be injected immediately after withdrawal from the amber glass ampoule.

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

Only clear, colourless solutions should be used.

Compatibility

Enantyum 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 clear.

Diluted Enantyum in a volume of 100 ml of 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 substance has been observed when diluted solutions of Enantyum 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).