Package Leaflet: Information for the User

Enantyum 25 mg Oral Solution in a Blister

dexketoprofene

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

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

It is used for the short-term symptomatic treatment of mild to moderate acute pain, such as acute muscle pain or joint pain, menstrual pain (dysmenorrhea), dental pain.

This medication is indicated for adult patients.

Do not take Enantyum

-If you are allergic (hypersensitive) to dexketoprofen 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 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 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 the use of ketoprofen (a nonsteroidal anti-inflammatory drug) or fibrates (medications used to reduce blood lipid levels);

-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 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 stroke, or think you may be at risk of these conditions (e.g., high blood pressure, diabetes, high cholesterol, or smoking) consult this treatment with your doctor or pharmacist. Enantyum and similar medications may increase the risk of heart attacks ("myocardial infarction") or strokes ("cerebrovascular accident"). 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 an elderly patient, 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 (This medication may reduce your fertility, so do not take it if you are planning to become pregnant or are undergoing fertility studies);

-If you have a disorder in 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 gastrointestinal or intestinal disorders;

-If you have an infection; see the "Infections" section below.

Infections

Dexketoprofen 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 bacterial skin infections related to chickenpox. If you take this medication while having an infection and the infection symptoms persist or worsen, consult your doctor without delay.

Children and adolescents

Dexketoprofen 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 medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription. There are some medications that should not be taken together, and other medications that may require a dose change when taken together.

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

Non-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 medication and immunosuppressant), 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 to control 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;

-Sulfonilureas (e.g., chlorpropamide and glibenclamide), used for diabetes;

• Metotrexate, used at low doses, less than 15mg/week.

Associations to be taken into account:

-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 dissolve blood clots;

-Probenecid, used for gout;

-Digoxin, used in the treatment of chronic heart failure;

-Mifepristone, used as an abortifacient (to interrupt pregnancy);

-Selective serotonin reuptake inhibitors (SSRIs);

-Antiplatelet agents used to reduce platelet aggregation and blood clot formation.

• 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.

Taking Enantyum with food, drinks, and alcohol

It is recommended to take the medication with meals to reduce the possibility of causing gastrointestinal disturbances (see also section 3, "Form of administration").

Do not drink alcohol while using this medication. Some side effects, such as those affecting the gastrointestinal tract or the central nervous system, are more likely to occur when alcohol is taken at the same time as Enantyum.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Do not take this medication during the last three months of pregnancy or during breastfeeding.This medication may cause kidney and heart problems in your fetus. It may affect your predisposition and that of your baby to bleeding and delay or prolong delivery more than expected.

Do not take this medication 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, this medication 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.

It is not recommended to use this medication while trying to conceive or while studying a fertility problem.

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

Driving and operating machinery

This medication may slightly affect your ability to drive and operate machinery, as it may cause dizziness, somnolence, and visual disturbances as side effects. If you notice these effects, do not use machinery or drive until these symptoms disappear. Consult your doctor.

Enantyum contains sodium

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

Enantyum contains parahydroxybenzoic acid methyl ester (E 218)

It may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoic acid methyl ester.

Enantyum contains sucrose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Patients with diabetes mellitus should note that this medication contains 2g of sucrose per dose.

Follow exactly the administration instructions for this medication as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist.

The dose you need may vary, depending on the type, intensity, and duration of pain. Your doctor will tell you how many sachets to take per day and for how long.

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

Adults 18 years of age and older

Generally, it is recommended to take 1 sachet (25 mg of dexketoprofen) every 8 hours, without exceeding 3 sachets per day (75 mg).

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

In elderly patients, this initial dose may be increased later in accordance with the recommended general dose (75 mg) if dexketoprofen has been well tolerated.

Use in children and adolescents

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

Administration form

The oral solution can be taken directly from the sachet or after removing the contents from a glass of water. Once the sachet is opened, consume all its contents.

Take the sachets with food, as it helps to reduce the risk of gastrointestinal side effects (see also section 2). If the pain is intense and you need faster relief, take the sachets on an empty stomach, i.e., at least 15 minutes before meals, as this helps the medication to start acting a bit faster.

If you take more Enantyum than you should

If you have taken too much medication, immediately inform your doctor or pharmacist or go to the emergency service of your nearest hospital or call the Toxicological Information Service, phone: 91.562.04.20, indicating the medication and the amount taken. Please remember to always carry the medication packaging or this leaflet with you.

If you forgot to take Enantyum

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

If you have any 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, according to their likelihood of occurring.

Due to the higher plasma concentration levels of dexketoprofen achieved with the oral solution formulation compared to the tablets, a potential increase in the risk of adverse reactions (gastrointestinal) cannot be ruled out.

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

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

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

Rotatory sensation (dizziness), dizziness, 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 edema (e.g., swelling of ankles), laryngeal edema, loss of appetite (anorexia), abnormal sensation, pruritic rash, acne, increased sweating, lower back pain, frequent urination, menstrual irregularities, 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 may also lead to collapse), skin ulcers, mouth, eye, and genital area ulcers (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or lip and throat swelling (angioedema), respiratory difficulty due to airway constriction (bronchospasm), shortness of breath, tachycardia, low blood pressure, pancreatitis inflammation, blurred vision, 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, bleeding), if you have previously experienced any of these side effects due to prolonged treatment with anti-inflammatory agents, and especially if you are an elderly patient.

Stop taking this medicine immediately if you notice the appearance of a skin rash or any lesions within the mouth or 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 increase in the risk of suffering a heart attack ("myocardial infarction") or stroke ("cerebrovascular accident").

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, meningitis may occur, which may predominantly occur in patients with systemic lupus erythematosus or mixed connective tissue disease, and hematological reactions (purpura, aplastic anemia, and hemolytic anemia, and more rarely agranulocytosis and medullary hypoplasia).

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 leaflet.

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 use this medication after the expiration date that appears on the packaging and on the carton after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications 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 point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Enantyum

• The active ingredient is dexketoprofen (as dexketoprofen trometamol). Each sachet of oral solution contains 25 mg of dexketoprofen as dexketoprofen trometamol.
• The other components are: ammonium glycyrrhizinate, neohesperidin dihydrochalcone, methyl parahydroxybenzoate (E-218), sodium saccharin, sucrose, macrogol 400, lemon aroma, povidone K-90, anhydrous disodium phosphate, dihydrogen phosphate dihydrate, purified water (see section 2, Enantyum contains sucrose).

Appearance of Enantyumand contents of the packaging

Clear solution, with a lemon odor and a sweet, lemon-citrus taste.

It is presented in packaging containing 2, 4, 10, 20, and 500 sachets.

Not all packaging sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS MENARINI, S.A.

Alfons XII, 587 - Badalona (Barcelona) Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Hungary, Italy, Spain: Enantyum

Estonia, Latvia, Lithuania: Ketesse

Greece: Viaxal

Poland: Ketesse

Date of the last review of this leaflet:March 2023

Other sources of information

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