Leaflet: information for the user

Fenodex 12.5 mg film-coated tablets

Fenodex 25 mg film-coated tablets

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, 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 leaflet.See section 4.

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

It is used in adults to treat mild to moderate pain, such as muscle pain, painful menstruation (dysmenorrhea), toothache.

Consult a doctor if it worsens or does not improve after 3-4 days.

Do not take Fenodex

• If you are allergic to dexketoprofen trometamol 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 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, 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 this medication:

• 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. Medications like this may be associated with a small increased risk of heart attacks or strokes. This 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 (dexketoprofen may reduce your fertility, so do not take it if you are planning to become pregnant or undergoing fertility studies);
• If you have a disorder in 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 chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you have had or have gastrointestinal or intestinal disorders;
• If you have chickenpox, as NSAIDs may exacerbate the infection;
• If you are taking other medications that increase the risk of peptic ulcers or bleeding, such as oral corticosteroids, some antidepressants (SSRI type), anticoagulants like acetylsalicylic acid (aspirin), or warfarin. In these cases, consult your doctor before taking dexketoprofen: 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 rhinitis or chronic sinusitis, and/or nasal polyps, as you have a higher risk of allergy 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.

Children and adolescents

Dexketoprofen 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.

Taking Fenodex with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. There are some medications that should not be taken together, and other medications that may require a dose change when taken together.

Inform your doctor, dentist, or pharmacist if, in addition to dexketoprofen, 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 medication and immunosuppressant), used at high doses of 15 mg/week;
• Hidantoins and phenytoin, used for epilepsy;
• Sulfamethoxazole, used for bacterial infections;

Associations requiring caution:

• ACE inhibitors, diuretics, beta-blockers, 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 15 mg/week;

Associations to consider:

• 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 dissolve blood clots;
• Probenecid, used for gout;
• Digoxin, used to treat chronic heart failure;
• Mifepristone, used as an abortifacient (to terminate pregnancy);
• SSRI-type antidepressants;
• Antiplatelet agents used to reduce platelet aggregation and blood clotting;
• Beta-blockers, used to control high blood pressure and heart conditions;
• Tenofovir, deferasirox, pemetrexed.

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

Taking Fenodex with food and drinks

Take the tablets with an adequate amount of water. Take the tablets with food, as this helps to reduce the risk of stomach or intestinal side effects. However, in case of acute pain, take the tablets on an empty stomach; that is, at least 30 minutes before meals, as this facilitates the medication's action a bit faster.

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 taking this medication, as this medication may not be suitable for you.

Do not take Fenodex if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It 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 Fenodex during the first 6 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 time possible. From week 20 of pregnancy, Fenodex 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). If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Women planning to become pregnant or who are pregnant should avoid using this medication. Treatment at any stage of pregnancy should only take place under a doctor's instructions.

This medication is not recommended for use while trying to conceive or while studying fertility problems. Regarding potential effects on female fertility, see also section 2, “Warnings and precautions”.

Driving and operating machines

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

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

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

The recommended dose is usually 1 tablet (25 mg) every 8 hours, not exceeding 3 tablets a day (75 mg).

The recommended dose is usually 1 tablet (12.5 mg) every 4-6 hours, not exceeding 6 tablets a day (75 mg).

Consult your doctor if 3-4 days have passed and you do not feel better or worse. Your doctor will tell you how many tablets to take per day and for how long. The dose of this medication you need depends on the type, severity, and duration of your pain.

If you are an elderly patient or suffer from kidney or liver disease, it is recommended to start therapy with a daily total dose of no more than 2 tablets of 25 mg or 4 tablets of 12.5 mg (50 mg).

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

If your pain is intense and you need quick relief, take the tablets on an empty stomach (at least 30 minutes before eating) as they will be absorbed more easily (see section 2 “Taking Fenodex with food and drinks”).

Use in children and adolescents

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

If you take more Fenodex than you should

If you have taken too much medication, inform your doctor or pharmacist immediately or go to the emergency service of your nearest hospital. Please remember to always carry the medication box or this leaflet with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91562 04 20, indicating the medication and the amount ingested.

If you forgot to take Fenodex

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

If you have any other questions 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 according to their frequency.

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 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 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 beginning 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 an elderly patient.

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 this may be associated with a small increase in the 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, they may cause 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 or pharmacist, 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: https://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 after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C. Store in the original packaging to protect it from light and moisture.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of 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 Fenodex

• The active ingredient is dexketoprofen trometamol. Each tablet contains 12.5 mg or 25 mg of dexketoprofen as dexketoprofen trometamol.
• The other components are: microcrystalline cellulose PH101, microcrystalline cellulose PH102, sodium carboxymethyl starch (potato type A), cornstarch, glyceryl diestearate (type 1), white Opadry 03G280003 (macrogol, titanium dioxide, propylene glycol, hypromellose), yellow iron oxide (Only in the 12.5 mg dose)

Appearance of the product and contents of the package

Fenodex 12.5 mg film-coated tablets are yellow, round, biconvex with a diameter of 7 mm.

Fenodex 25 mg film-coated tablets are white, round, biconvex, scored and with the inscription "MC" in relief with a diameter of 10 mm.

The 25 mg tablets can be divided into equal doses.

Fenodex12.5 mg:Available in boxes of 10, 20, 30, 40, 50 or 500 tablets in PVC / PVDC / Aluminum blisters.

Fenodex25 mg:Available in boxes of 4, 10, 20, 30, 50 or 500 tablets in PVC / PVDC / Aluminum blisters.

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible for Manufacturing:

Marketing Authorization Holder:

Medochemie Limited

1-10 Constantinoupoleos Street

3011 Limassol

Cyprus

Responsible for Manufacturing:

Medochemie Ltd.(Central Factory),

1-10 Constantinoupoleos street,

3011 Limassol,

Cyprus

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Local Representative:

Medochemie Iberia S.A., Sucursal en España

Avenida de las Águilas, nº 2 B; planta 5 oficina 6,

28044 Madrid

SPAIN

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

Last review date of this leaflet: January 2023

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