Leaflet: information for the user

Enantyum 25 mg hard capsules

Dexketoprofen

Read this 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 only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Enantyum is and what it is used for

2.What you need to know before you start taking Enantyum

3.How to take Enantyum

4.Possible side effects

5Storage of Enantyum

6.Contents of the pack and additional information

Enantyum is a pain reliever belonging to the group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs).

It is used in adults for the short-term symptomatic treatment of mild to moderate acute pain, such as muscle pain or joint pain, menstrual pain, and toothache pain.

Do not take Enantyum

• If you are allergic to dexketoprofen or any of the other components of this medication (listed in section 6);
• If you are allergic to acetylsalicylic acid or another nonsteroidal anti-inflammatory drug;
• If you have asthma or have had asthma attacks, acute allergic rhinitis (a short period of nasal mucosa inflammation), nasal polyps (fleshy formations in the nasal interior due to allergy), urticaria (skin eruption), angioedema (face, eye, lip, or tongue swelling, or difficulty breathing) or chest wheezing after taking acetylsalicylic acid (aspirin) or other nonsteroidal anti-inflammatory drugs;
• If you have had photoallergic or phototoxic reactions (a special form of skin redness or burns exposed to sunlight) during ketoprofen (a nonsteroidal anti-inflammatory drug) or fibrate (medications used to reduce blood fat levels) use;
• If you have peptic ulcers, stomach or intestinal bleeding, or have had these conditions in the past;
• If you have chronic digestive problems (e.g., indigestion, stomach burning);
• If you have had stomach or intestinal bleeding, ulceration, or perforation due to previous use of nonsteroidal anti-inflammatory drugs (NSAIDs) used for pain;
• If you have 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 clotting disorders;
• If you are severely dehydrated (have lost a lot of body fluid) due to vomiting, diarrhea, or inadequate fluid intake;
• If you are in the third trimester of pregnancy or breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Enantyum:

• If you are allergic or have had allergic reactions in the past;
• If you have kidney, liver, or heart diseases (hypertension and/or heart failure), or have had these conditions in the past;
• If you are taking diuretics or have inadequate hydration and reduced blood volume due to excessive fluid loss (e.g., excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of strokes, or think you may be at risk for these conditions (e.g., high blood pressure, diabetes, high cholesterol, or smoking), consult this treatment with your doctor or pharmacist. Enantyum medications may be associated with a small increased risk of heart attacks or strokes. Any risk is more likely to occur when high doses and prolonged treatments are used. Do not exceed the recommended dose or treatment duration;
• If you are elderly, you may be more likely to experience adverse effects (see section 4). If these occur, consult your doctor immediately;
• If you are a woman with fertility problems (see section 2, "Pregnancy, lactation, and fertility");
• If you have a disorder in blood and blood cell production;
• If you have systemic lupus erythematosus or mixed connective tissue disease (autoimmune diseases affecting connective tissue);
• If you have had or have chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you have had or have stomach or intestinal disorders;
• If you have an infection, see the "Infections" heading below;
• If you are taking other medications that increase the risk of peptic ulcers or bleeding, for example, oral corticosteroids, some antidepressants (SSRI type), blood clotting agents like acetylsalicylic acid (aspirin) or warfarin. In these cases, consult your doctor before taking this medication: your doctor may prescribe an additional medication to protect your stomach (e.g., misoprostol or other acid-blocking medications);
• If you have asthma, combined with chronic rhinitis or sinusitis, and/or nasal polyps, as you have a higher risk of being allergic to acetylsalicylic acid and/or NSAIDs than the general population. Administration of this medication may cause asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Infections

Enantyum may mask the signs of an infection, such as fever and pain. Therefore, it is possible that this medication may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to varicella. If you take this medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Avoid using this medicationif you have varicella.

Children and adolescents

This medication has not been studied in children or adolescents. Therefore, safety and efficacy have not been established and should not be used in children or adolescents.

Other medications and Enantyum

Informyour doctor or pharmacist if you are taking, have taken recently, or may need to take any othermedication, including those purchased without a prescription. There are some medications that should not be taken together and other medications that may requireadosage change if taken together.

Inform your doctor, dentist, or pharmacist if, in addition to this medication, you are taking any of the following medications:

Not recommended associations:

• Acetylsalicylic acid, corticosteroids, and other anti-inflammatory drugs;
• Warfarin, heparin, and other medications used to prevent blood clotting;
• Lithium, used to treat mood disorders;
• Metotrexate (cancer and immunosuppressant medication), used at high doses of 15mg/week;
• Hidantoins and phenytoin, used for epilepsy;
• Sulfamethoxazole, used for bacterial infections;

Associations requiring caution:

• ACE inhibitors, diuretics, 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 for bacterial infections;
• Sulfonilureas (e.g., chlorpropamide and glibenclamide), used for diabetes;
• Metotrexate, used at low doses, less than 15 mg/week;

Associations to consider:

• Quinolones (e.g., ciprofloxacin, levofloxacin) used for 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 break down blood clots;
• Probenecid, used for gout;
• Digoxin, used for chronic heart failure;
• Mifepristone, used as an abortifacient (to interrupt pregnancy);
• SSRI-type antidepressants;
• Antiplatelet agents used to reduce platelet aggregation and blood clotting;
• Beta-blockers, used for high blood pressure and heart conditions;
• Tenofovir, deferasirox, pemetrexed.

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

Enantyum with food, drinks, and alcohol

Generally, it is recommended to take the medication with meals to reduce the possibility of causing stomach problems (see also section 3, "Administration form").

The use of NSAIDs in combination with alcohol may worsen the adverse reactions caused by the active ingredient.

Pregnancy, lactation, and fertility

Do not take this medication during the last three months of pregnancy or while breastfeeding.

It may cause kidney and heart problems in your fetus. It may affect your predisposition and that of your baby to bleed and delay or prolong delivery more than expected.

Do not take Enantyum during the first six 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, Enantyum 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) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

This medication may harm fertility, so it is not recommended to use this medication while trying to conceive or while studying a fertility problem.

Driving and using machines

This medication may slightly affect your ability to drive and use machines, as it may cause drowsiness, dizziness, and blurred vision as adverse treatment effects. If you notice these effects, do not use machines or drive until these symptoms disappear. Consult your doctor.

Enantyum contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. The necessary dose of the medication may vary, depending on the type, intensity, and duration of the pain.

Your doctor will tell you how many capsules you should take per day and for how long.

The effective dose should be used for the shortest time necessary to alleviate symptoms. If you have an infection, consult a doctor as soon as possible if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults 18 years and older

Generally, the recommended dose is 1 capsule (25 mg of dexketoprofen) every 8 hours, without exceeding 3 capsules per day (75 mg).

Patients with advanced age or renal or hepatic insufficiency

If you are an elderly patient, or you suffer from mild renal problems or mild to moderate liver problems, it is recommended to start treatment with a maximum of 2 capsules per day (50 mg of dexketoprofen).

In elderly patients, this initial dose can be increased later according to the general recommended dose (75 mg of dexketoprofen) if the medication has been well tolerated.

You should not use dexketoprofen if you have moderate or severe renal problems or severe liver problems. Consult your doctor or pharmacist if you are unsure.

Use in children and adolescents

This medication should not be used in children and adolescents (under 18 years old).

Administration form

Take the capsules with an adequate amount of water.

The medication can be taken with or without food. Taking the medication with food helps to reduce the risk of gastrointestinal disorders, however, if your pain is more intense and you need faster relief, take the capsule with an empty stomach (at least 15 minutes before any food or ingestion of food) because it will be absorbed more easily (see section 2 "Taking Enantyum with food, drinks, and alcohol").

If you take more Enantyum than you should

Consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Enantyum

Do not take a double dose to compensate for the missed doses. Take the next dose when it is due (according to section 3 “How to take Enantyum”).

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The possible side effects are listed below in order of frequency. Since the list is based in part on the side effects observed with the use of dexketoprofen tablets, and since dexketoprofen in capsules is absorbed more quickly than tablets, it is possible that the actual frequency of side effects (gastrointestinal) may be higher with capsules.

Frequent side effects: may affect up to 1 in 10 people

Nausea and/or vomiting, mainly upper abdominal pain, diarrhea, digestive disorders (dyspepsia).

Less frequent side effects: may affect up to 1 in 100 people

Dizziness, vertigo, drowsiness, sleep disorders, nervousness, headache, palpitations, hot flashes, stomach wall inflammation (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, feverish sensation, and chills, general discomfort.

Rare side effects: may affect up to 1 in 1,000 people

Peptic ulcer, perforation of a peptic ulcer or bleeding (which may manifest with vomiting blood or black stools), fainting, high blood pressure, slow breathing, fluid retention and peripheral swelling (e.g., swelling of ankles), laryngeal edema, loss of appetite (anorexia), abnormal sensation, pruritic rash, acne, increased sweating, lower back pain, frequent urination, menstrual disorders, prostate disorders, abnormal liver function tests (blood analysis), liver cell damage (hepatitis), acute renal insufficiency.

Very rare: may affect up to 1 in 10,000 people

Anaphylactic reaction (hypersensitivity reaction that can also lead to collapse), skin ulcers, mouth, eye, and genital area (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or swelling of the lips and throat (angioedema), difficulty breathing due to narrowing of the airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, pancreatitis inflammation, blurred vision, ringing in the ears (tinnitus), sensitive skin, light sensitivity, itching, kidney problems. Decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

Inform your doctor immediately if you notice any gastrointestinal side effects at the start of treatment (e.g., stomach pain or burning, or bleeding), if you have previously experienced any of these side effects due to prolonged treatment with anti-inflammatory agents, and especially if you are elderly.

Stop taking this medicine immediately if you notice the appearance of a skin rash or any lesions inside the mouth or on the genitals, or any other 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 Enantyum may be associated with a small increased risk of suffering a heart attack ("myocardial infarction") or a stroke ("cerebral infarction").

In patients with autoimmune disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory drugs may rarely cause fever, headache, and neck stiffness.

The most commonly observed side effects are of a gastrointestinal nature. They may cause peptic ulcers, perforation, or gastrointestinal bleeding, sometimes fatal, especially in elderly patients.

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

Like other NSAIDs, hematological reactions (purpura, aplastic and hemolytic anemia, and more rarely agranulocytosis and medullary hypoplasia) may appear.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not usethis medicationafter the expiration date that appears on the packaging and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C. Store the blister packs in the original packaging to protect them from light.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Enantyum

- The active ingredient is dexketoprofen (as dexketoprofen trometamol). Each capsule contains 25 mg of dexketoprofen.

- The other components are:

Content of the capsule: microcrystalline cellulose, cornstarch, glyceryl distearate, and carboxymethylstarch sodium (Type A) (potato starch).

Composition of the capsule (body and cap): gelatin, titanium dioxide (E171), water, quinoline yellow (E104), and patent blue V (E131).

Appearance of Enantyum and content of the packaging

Durable gelatin capsules of green color, containing a white granulate.

The capsules are packaged in Aclar/PVC/Aluminum blisters.

It is presented in packaging that contains 20 and 500 hard capsules.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Menarini, S.A.

Alfons XII, 587

08918 Badalona (Barcelona) Spain

Date of the last review of this leaflet: April 2023.

Other sources of information

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