FENODEX 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Fenodex 12.5 mg film-coated tablets EFG

Fenodex 25 mg film-coated tablets EFG

dexketoprofen

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Fenodex and what is it used for.
2. What you need to know before you take Fenodex.
3. How to take Fenodex.
4. Possible side effects.
5. Storing Fenodex.
6. Pack contents and further information.

1. What is Fenodex and what is it used for

Fenodex contains dexketoprofen, which is a pain reliever belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

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

You should consult a doctor if it worsens or does not improve after 3-4 days.

2. What you need to know before you take Fenodex

Do not take Fenodex

• If you are allergic to dexketoprofen trometamol or any of the other ingredients of this medicine (listed in section 6);
• If you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory medicines;
• If you have asthma or have suffered from asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (fleshy growths inside the nose due to allergy), hives (rash on the skin), angioedema (swelling of the face, eyes, lips, or tongue, or difficulty breathing) or wheezing in the chest after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• If you have suffered from photoallergic or phototoxic reactions (a special form of redness or sunburn on exposed skin) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to reduce blood fat levels);
• If you have a peptic ulcer, stomach or intestinal bleeding, or if you have had a history of bleeding, ulceration, or perforation of the stomach or intestine;
• If you have chronic digestive problems (e.g., indigestion, heartburn);
• If you have had a history of stomach or intestinal bleeding or perforation due to previous use of non-steroidal 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 kidney failure, or severe liver failure;
• If you have bleeding disorders or blood coagulation disorders;
• If you are severely dehydrated (have lost a lot of body fluid) due to vomiting, diarrhea, or insufficient 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 this medicine:

• If you are allergic or have had allergy problems in the past;
• If you have kidney, liver, or heart disease (hypertension and/or heart failure), or fluid retention or have had any of these diseases in the past;
• If you are taking diuretics or have insufficient hydration and reduced blood volume due to excessive fluid loss (e.g., due to excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of strokes, or think you may be at risk of suffering from these disorders (e.g., you have high blood pressure, suffer from diabetes, have high cholesterol, or are a smoker) you should consult your doctor or pharmacist about this treatment. Medicines like this one can be associated with a small increase in the risk of suffering from heart attacks ("myocardial infarction") or strokes ("cerebrovascular accident"). This risk is more likely to occur when high doses and prolonged treatments are used. Do not exceed the recommended dose or duration of treatment;
• If you are an elderly patient, you may suffer from a higher incidence of side effects (see section 4).
• If these occur, consult your doctor immediately;
• If you are a woman with fertility problems (dexketoprofen may decrease your fertility, so you should not take it if you are planning to become pregnant or if you are undergoing fertility studies);
• If you suffer from a blood disorder and blood cell production disorder;
• If you have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect connective tissue);
• If you suffer or have suffered in the past from chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you suffer or have suffered in the past from stomach or intestinal disorders;
• If you have chickenpox, as non-steroidal anti-inflammatory drugs (NSAIDs) can exceptionally worsen the infection;
• If you are taking other medicines that increase the risk of peptic ulcers or bleeding, for example, oral corticosteroids, some antidepressants (of the SSRI type, Selective Serotonin Reuptake Inhibitors), agents that prevent clot formation such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin. In these cases, consult your doctor before taking dexketoprofen: it may be that your doctor prescribes an additional medicine to protect your stomach (e.g., misoprostol or other medicines that block gastric 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 rest of the population. The administration of this medicine 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 medicine should not be used in children or adolescents.

Taking Fenodex with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. There are some medicines that should not be taken together, and other medicines that may need a dose change if taken together.

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

Not recommended combinations:

• Acetylsalicylic acid, corticosteroids, and other anti-inflammatory drugs;
• Warfarin, heparin, and other medicines used to prevent clot formation;
• Lithium, used to treat some mood disorders;
• Methotrexate (cancer and immunosuppressive medicine), used at high doses of 15 mg/week;
• Hydantoins and phenytoin, used for epilepsy;
• Sulfamethoxazole, used for bacterial infections;

Combinations that require caution:

• ACE inhibitors, diuretics, beta-blockers, and angiotensin II antagonists, used for high blood pressure and heart disorders;
• 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;
• Methotrexate, used at low doses, less than 15 mg/week;

Combinations to be taken into account:

• Quinolones (e.g., ciprofloxacin, levofloxacin) used for bacterial infections;
• Cyclosporin or tacrolimus, used to treat immune system diseases and organ transplants;
• Streptokinase and other thrombolytic and fibrinolytic medicines; i.e., medicines used to dissolve clots;
• Probenecid, used for gout;
• Digoxin, used in the treatment of chronic heart failure;
• Mifepristone, used as an abortifacient (for pregnancy termination).
• Antidepressants of the SSRI type (Selective Serotonin Reuptake Inhibitors);
• Antiplatelet agents used to reduce platelet aggregation and clot formation.
• Beta-blockers, used for high blood pressure and heart disorders.
• Tenofovir, deferasirox, pemetrexed.

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

Taking Fenodex with food and drinks

Take the tablets with a sufficient amount of water. Take the tablets with food, as this helps to reduce the risk of suffering from adverse effects in the stomach or intestine. However, in case of acute pain, take the tablets on an empty stomach; i.e., at least 30 minutes before meals, as this facilitates the action of the medicine a little faster.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine, as this medicine 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 can cause kidney and heart problems in your fetus. It can affect your and your baby's tendency to bleed and delay or prolong labor more than expected. You should 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 possible time. From the 20th week of pregnancy, Fenodex may cause kidney problems in your fetus if taken for more than a few days, which can cause low levels of amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional checks.

Women who are planning a pregnancy or are pregnant should avoid using this medicine. Treatment at any time during pregnancy should only be done under the guidance of a doctor.

It is not recommended to use this medicine while trying to conceive or while studying a fertility problem. Regarding the potential effects on female fertility, see also section 2, "Warnings and precautions".

Driving and using machines

This medicine may slightly affect your ability to drive or use machines, as it can cause drowsiness or dizziness as side effects of treatment. If you notice these effects, do not use machines or drive until these symptoms disappear. Ask your doctor for advice.

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

3. How to take Fenodex

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Generally, the recommended dose is 1 tablet (12.5 mg) every 4-6 hours, not exceeding 6 tablets per day (75 mg).

Consult your doctor if 3-4 days have passed and you do not feel better or worse. Your doctor will indicate how many tablets you should take per day and for how long. The dose of this medicine 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 total daily 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 may be increased later according to the generally recommended dose (75 mg) if the medicine 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 meals) as they will be absorbed more easily (see section 2 "Taking Fenodex with food and drinks").

Use in children and adolescents

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

If you take more Fenodex than you should

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

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

If you forget to take Fenodex

Take the next dose when it is due (according to section 3 "How to take Fenodex"). Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The possible side effects are listed below according to their frequency.

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

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

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

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

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

Peptic ulcer, perforation of peptic ulcer, or gastrointestinal 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 the 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 kidney failure.

Very rare side effects(may affect up to 1 in 10,000 people):

Anaphylactic reaction (hypersensitivity reaction that can also lead to collapse), skin ulcers, mouth ulcers, eye ulcers, or genital ulcers (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, blurred vision, ringing in the ears (tinnitus), sensitive skin, sensitivity to light, itching, kidney problems. Decreased number of white blood cells (neutropenia), decreased number of platelets (thrombocytopenia).

Tell your doctor immediately if you notice any gastrointestinal side effects at the start of treatment (e.g., stomach pain or heartburn or bleeding), if you have previously suffered from any of these side effects due to prolonged treatment with anti-inflammatory drugs, and especially if you are an elderly patient.

Stop taking this medicine immediately if you notice the appearance of a skin rash or any lesion 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 this one can be associated with a small increase in the risk of suffering from a heart attack ("myocardial infarction") or a stroke ("cerebrovascular accident").

In patients with immune system disorders that affect connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory medicines can rarely cause fever, headache, and neck stiffness.

The most common side effects observed are of a gastrointestinal nature. Peptic ulcers, perforation, or gastrointestinal bleeding may occur, sometimes fatally, 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, inflammation of the stomach wall (gastritis) has been observed.

As with other NSAIDs, hematological reactions (purpura, aplastic anemia, and hemolytic anemia, and more rarely agranulocytosis and bone marrow hypoplasia) may appear.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fenodex

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

Do not use this medicine after the expiry date which is stated on the carton after CAD. The expiry date is the last day of the month stated.

Do not store above 30°C. Store in the original package to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Fenodex

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

Appearance and packaging of the product

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 engraved with "MC" in relief with a diameter of 10 mm.

The 25 mg tablets can be divided into equal doses.

Fenodex 12.5 mg: Available in boxes of 10, 20, 30, 40, 50 or 500 tablets in PVC/PVDC/Aluminum blisters.

Fenodex 25 mg: Available in boxes of 4, 10, 20, 30, 50 or 500 tablets in PVC/PVDC/Aluminum blisters.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Medochemie Limited

1-10 Constantinoupoleos Street

3011 Limassol

Cyprus

Manufacturer:

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 under the following names:

Date of last revision of this leaflet: January 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/