Leaflet: information for the user

Dexketoprofen MABO-FARMA 25 mg film-coated tablets

Dexketoprofen

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

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

• Keep this leaflet, as you may need to read 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 leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 4 days

1. What is Dexketoprofen MABO-FARMA and what it is used for

2. What you need to know before starting to take Dexketoprofen MABO-FARMA

3. How to take Dexketoprofen MABO-FARMA

4. Possible side effects

5. Storage of Dexketoprofen MABO-FARMA

6. Contents of the pack and additional information

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

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

Do not take Dexketoprofeno MABO-FARMA:

-If you are allergic 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, ulcers, 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 dexketoprofen:

-If you are allergic or have had allergy problems 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 Dexketoprofeno MABO-FARMA may be associated with a small increase in the risk of heart attacks ("myocardial infarction") or strokes ("cerebrovascular accident"). Any risk is more likely to occur when using high doses and prolonged treatments. 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, breastfeeding, 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 affecting connective tissue);

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

-If you have had or have stomach 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 (type ISRS, Selective Serotonin Reuptake Inhibitors), agents that prevent blood clot formation such as acetylsalicylic acid (aspirin) or anticoagulants like 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).

Infections

Dexketoprofeno MABO-FARMA 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, increasing the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to varicella. 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 Dexketoprofeno MABO-FARMA 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 when 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 clot formation;

-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:

-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 15 mg/week;

Associations to be considered:

-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 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 (ISRSs);

-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 Dexketoprofeno MABO-FARMA, consult your doctor or pharmacist.

Taking Dexketoprofeno MABO-FARMA 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, breastfeeding, and fertility

Do not take Dexketoprofeno MABO-FARMA if you are in the last three 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 Dexketoprofeno MABO-FARMA 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, Dexketoprofeno MABO-FARMA 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 checks.

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication, as it may not be suitable for you.

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

The use of this medication may affect fertility, so it is not recommended to use this medication 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.

Dexketoprofeno MABO-FARMA contains sodium

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

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 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).

The tablets can be divided into equal doses.

Adults aged 18 years and older

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

Older adults or those with renal or hepatic insufficiency

If you are an older adult, or have mild renal problems or mild to moderate hepatic problems, it is recommended to start treatment with a maximum of 2 tablets per day (50 mg of dexketoprofen).

In older adults, 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 have moderate or severe renal problems or severe hepatic 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

Take the tablets with an adequate amount of water.

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 on an empty stomach (at least 30 minutes before any meal or ingestion of food) because it will be absorbed more easily (see section 2 "Dexketoprofen MABO-FARMA 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 Dexketoprofen MABO-FARMA 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 leaflet of the medication to the healthcare professional.

If you forgot to take Dexketoprofen MABO-FARMA:

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 Dexketoprofen MABO-FARMA”).

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.

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 airway constriction (bronchospasm), lack of air, 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, or bleeding), if you have previously experienced any of these side effects due to prolonged treatment with anti-inflammatory drugs, and especially if you are elderly.

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 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 Dexketoprofeno MABO-FARMA may be associated with a small increased risk of suffering a heart attack (“myocardial infarction”) or a 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, 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, 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 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 blister pack 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.

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 of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Dexketoprofeno MABO-FARMA

The active ingredient is dexketoprofen (as dexketoprofen trometamol). Each tablet contains 25 mg of dexketoprofen.

The other components are:

Tablet core:cornstarch, microcrystalline cellulose, carboxymethyl starch sodium (Type A), glyceryl distearate.

Tablet coating:hypromellose, titanium dioxide (E-171) and macrogol.

Appearance of Dexketoprofeno MABO-FARMA and content of the container:

Scored, white, round tablets, marked with “DT2” on one side.

The approximate dimensions of the coated tablets are 9.3 ±0.5 mm x 3.9 ±0.5 mm.

Available in containers containing 10 coated tablets.

The tablets are presented in blisters (PVC/PVDC-aluminium).

Marketing authorization holder:

MABO-FARMA, S.A.

Calle Rejas 2, 1st floor

28821 Coslada

Madrid. Spain

Responsible for manufacture:

SAG MANUFACTURING S.L.U.

Crta. N-I, Km 36, San Agustín de Guadalix

28750 Madrid

Spain

GALENICUM HEALTH S.L.

Sant Gabriel, 50

08950- Esplugues De Llobregat (Barcelona) - Spain

Last review date of this leaflet: March 2024

Other sources of information

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