Enandol 25 mg granulado para soluciÓn oral

Package Insert: Information for the UserEnandol 25 mg Powder for Oral Solution

Dexketoprofen

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

Follow exactly the administration instructions for the medicine 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 side 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 you worsen or do not improve after 4 days.

This medication is a pain reliever belonging to the group of medications known as non-steroidal 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 in the nasal cavity 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 phototoxic or photoallergic 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 a stomach ulcer, stomach or intestinal bleeding, or have had stomach or intestinal bleeding, ulceration, or perforation 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 of these conditions (e.g., high blood pressure, diabetes, high cholesterol, or smoking) consult this treatment with your doctor or pharmacist. Enandol medications may be associated with a small increase in the 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 (immune system diseases affecting connective tissue);

-If you have had or have had chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);

-If you have had or have had 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 stomach ulcers or bleeding, for example, oral corticosteroids, some antidepressants (type ISRS, Selective Serotonin Reuptake Inhibitors), agents that prevent blood clotting in the blood, such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin or acenocoumarol (Sintrom). 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 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

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 skin infections related to varicella caused by bacteria. 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 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.

Use of Enandol with other medications

Inform your doctor or pharmacist if you are taking or have taken 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 if taken together.

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

Not recommended associations:

-Acetylsalicylic acid, corticosteroids, and other anti-inflammatory drugs;

-Warfarin or acenocoumarol (Sintrom), heparin, or 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:

-Inhibitors of the ECA, 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 15mg/week.

Associations to be taken into account:

-Quinolones (e.g., ciprofloxacin, levofloxacin), used for bacterial infections;

-Ciclosporin or tacrolimus, used to treat immune system 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 in the treatment of chronic heart failure;

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

-Antidepressants of the type Inhibitors Selective of Serotonin Reuptake (ISRS);

-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.

Enandol with food, drinks, and alcohol

In general, 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 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.

The use of 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 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 effects of treatment. If you notice these effects, do not use machines or drive until these symptoms disappear. Consult your doctor.

Enandol contains saccharose

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

It contains 2,418 g of saccharose per dose, which should be taken into account in patients with diabetes mellitus.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

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

The most effective dose should be used for the shortest duration 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 aged 18 years and older

Generally, the recommended dose is 1 tablet (25 mg of dexketoprofen) every 8 hours, not exceeding 3 tablets per day (75 mg).

Patients with advanced age or renal or hepatic insufficiency

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

In elderly patients, this initial dose may 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

Dissolve the entire content of a tablet in a glass of water; agitate/shake to help dissolve. The resulting solution should be taken immediately after reconstitution.

The medication can be taken with or without food. Taking the medication with food helps to reduce the risk of gastrointestinal disturbances, however, if your pain is more intense and you need faster relief, take the tablet with 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

Treatment should not exceed 4 days. If the pain persists after this period of time, worsens, or other symptoms appear, you should interrupt treatment and consult 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 due (in accordance with section 3 “How to take Enandol”).

If you have any other doubts about the use of this medication, ask 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 granulated oral solution is absorbed faster than tablets, it is possible that the actual frequency of side effects (gastrointestinal) may be higher in the granulated oral solution.

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 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 disorders, prostate disorders, abnormal liver function tests (blood analysis), liver cell damage (hepatitis), acute renal insufficiency.

Very rare side effects: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 (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or lip and throat swelling (angioedema), respiratory difficulty 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 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 Enandol 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, anaphylactic reactions (pneumonitis, anemia aplastic and hemolytic, 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 leaflet.You can also report them directly through the Spanish 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 medications you no longer need at the SIGRE collection point at 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 Enandol

• The active ingredient is dexketoprofen (as dexketoprofen trometamol). Each sachet contains 25 mg of dexketoprofen.
• The other components are: ammonium glycyrrhizate, neohesperidin dihydrochalcone, quinoline yellow (E-104), lemon aroma, sucrose (see section 2, Enandol contains sucrose).

Appearance of Enandol and content of the container

Yellow lemon-colored granule.

The oral solution granule is presented in single-dose, thermosealed, stucco-aluminum-polyethylene sachets.

Available in containers of 10 sachets.

Marketing authorization holder

MENARINI CONSUMER HEALTHCARE, S.A.U.

Guifré, 724 - 08918 Badalona (Barcelona) Spain

Responsible manufacturer

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//.