Enandol 25 mg solucion oral en sobres

Package Insert: Information for the User

Enandol 25 mg Oral Solution in Blister Packs

Dexketoprofen

Read this package insert carefully before starting to take this medication, as it contains important information for you.

Follow exactly the administration instructions contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 4 days.

Contents of the package and additional information

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

Enandol is used in adults for the short-term symptomatic treatment of mild to moderate acute pain, such as muscle pain or joint pain (e.g., back pain, sprains, and acute trauma), menstrual pain, and dental pain.

Do not take Enandol

-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 inside the nose 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 the use of ketoprofen (a nonsteroidal anti-inflammatory drug) or fibrates (medications used to reduce blood fat levels);

• If you have peptic ulcers, stomach or intestinal bleeding, or have had stomach or intestinal bleeding 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 Enandol:

-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 smoker) consult this treatment with your doctor or pharmacist. Enandol may be associated with a small increased risk of heart attacks ("myocardial infarction") or strokes ("cerebral vascular 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 (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 that affect 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" 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), agents that prevent blood clotting such as 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 medications that block stomach acid production);

-If you have asthma, combined with allergic rhinitis or chronic 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

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

Avoid using this medication if you have chickenpox.

Children and adolescents

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

Use of Enandol with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take 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 if taken together.

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 some 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 for bacterial infections;

-Sulfonylureas (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);

-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 Enandol, consult your doctor or pharmacist.

Taking Enandol 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 Enandol 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, Enandol may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in your 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 it while trying to conceive or while studying a fertility problem.

Driving and operating machines

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

Enandol contains parahydroxybenzoic acid methyl ester (E-218), saccharose, sodium, benzyl alcohol, and ethanol

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

This medication contains saccharose.If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

It contains 2g of dextrose per dose, which should be taken into account in patients with diabetes mellitus.

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

This medication contains 4.8mg of benzyl alcohol per dose.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney diseases. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

This medication contains less than 0.002% ethanol (alcohol), which corresponds to less than 0.2mg/dose.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

The necessary dose of the medication may vary depending on the type, intensity, and duration of pain.

The effective dose should be used for the shortest time necessary to alleviate 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 and older

Generally, the recommended dose is 1 tablet (25 mg of dexketoprofen) every 8 hours, not exceeding 3 tablets a 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 tablets a day (50 mg of dexketoprofen).

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

You should not use dexketoprofen if you suffer from 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).

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.

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 sachet on an empty stomach (at least 15 minutes before any meal or ingestion of food) because it will be absorbed more easily (see section 2 "Taking Enandol with food, drinks, and alcohol").

Treatment duration

The treatment should not exceed 4 days. If the pain persists after this period of time, worsens, or other symptoms appear, you should interrupt the treatment and consult with your doctor or pharmacist.

If you take more Enandol 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 Enandol

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

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 oral use of tablets, and since the oral solution in sachets is absorbed more quickly than tablets, it is possible that the actual frequency of side effects (gastrointestinal) may be higher in the oral solution in sachets.

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)

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 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 tests), 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, eyes, and genital area (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or swelling of lips and throat (angioedema), difficulty breathing due to narrowing of airways (bronchospasm), lack of air, 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, 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 Enandol may be associated with a small increase in the risk of suffering a heart attack ("myocardial infarction") or stroke ("cerebrovascular accident").

In patients with immune system 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 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 aséptica may appear, which may predominantly occur in patients with systemic lupus erythematosus or mixed connective tissue disease, and hematological reactions (purpura, aplastic 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 prospectus. You can also report them directly through theSpanish System for 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 overwrap 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 unused medications 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 Enandol

• The active ingredient is dexketoprofen (as dexketoprofen trometamol). Each oral solution sachet 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 flavor (contains benzyl alcohol and ethanol), povidone K-90, anhydrous disodium phosphate, dihydrogen phosphate dihydrate, purified water, (see section 2).

Appearance of Enandol and contents of the packaging

Sachets containing a clear solution, with a lemon odor and a sweet lemon-citrus taste.

Available in packs of 10 sachets.

Marketing Authorization Holder

Menarini Consumer Healthcare, S.A.U.

Guifré, 08918 Badalona

(Barcelona) Spain

Responsible Person for Manufacturing

LABORATORIOS MENARINI, S.A.

Alfons XII, 587 – 08918 Badalona (Barcelona) Spain

Last review date of this leaflet:April 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.