Leaflet: information for the user

dexketoprofen cinfa12.5 mg film-coated tablets

dexketoprofen trometamol

Read this leaflet carefully before you start to take 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.

Contents of the pack and additional information.

DDexketoprofen cinfa is a pain reliever belonging to the group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is used to treat mild to moderate pain, such as muscle pain or joint pain, menstrual pain (dysmenorrhea), dental pain.

Do not take dexketoprofeno cinfa:

• If you are allergic to dexketoprofeno trometamol 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 taking of ketoprofeno (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 (for example, 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 kidney failure, or severe liver failure;
• 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 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 dexketoprofeno cinfa:

• 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 insufficient hydration and reduced blood volume due to excessive fluid loss (for example, excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of strokes, or think you may be at risk of these conditions (for example, you have high blood pressure, suffer from diabetes, have high cholesterol, or are a smoker) consult this treatment with your doctor or pharmacist. Medications like dexketoprofeno cinfa may be associated with a small increase in the risk of suffering heart attacks ("myocardial infarction") or strokes ("cerebral vascular accident"). 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 (dexketoprofeno may decrease your fertility, so do not take it if you are planning to become pregnant or if you are undergoing fertility studies);
• If you have a disorder in blood production and blood cells;
• If you have systemic lupus erythematosus or mixed connective tissue disease (autoimmune diseases that affect connective tissue);
• If you have chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you have gastrointestinal or intestinal disorders;
• If you have chickenpox, as NSAIDs may exceptionally worsen the infection;
• If you are taking other medications that increase the risk of peptic ulcers or bleeding, for example, oral corticosteroids, some antidepressants (SSRI type), blood thinners like acetylsalicylic acid (aspirin) or anticoagulants like warfarin. In these cases, consult your doctor before taking dexketoprofeno: your doctor may prescribe an additional medication to protect your stomach (for example, misoprostol or other medications that block stomach acid production).
• If you have asthma, combined with 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.

Children and adolescents

Dexketoprofeno 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 dexketoprofeno cinfa 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 if taken together.

Inform your doctor, dentist, or pharmacist if, in addition to dexketoprofeno, 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, 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;
• Sulfonilureas (for example, chlorpropamide and glibenclamide), used for diabetes;
• Metotrexate, used at low doses, less than 15 mg/week;

Associations to consider:

• Quinolones (for example, 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 for chronic heart failure;
• Mifepristone, used as an abortifacient (to interrupt pregnancy);
• SSRI 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 dexketoprofeno, consult your doctor or pharmacist.

Taking dexketoprofeno cinfa 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 experiencing stomach or intestinal adverse effects. However, in the 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 more quickly.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medication, as dexketoprofeno may not be suitable for you.

Do not take dexketoprofeno during breastfeeding.

Do not take dexketoprofeno 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 bleed and delay or prolong delivery more than expected. Do not take dexketoprofeno 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, dexketoprofeno 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.

It is not recommended to use dexketoprofeno 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 machinery

Dexketoprofeno may slightly affect your ability to drive and operate machinery, as it may cause drowsiness or dizziness as adverse effects during treatment. If you notice these effects, do not use machinery or drive until these symptoms disappear. Consult your doctor.

dexketoprofeno cinfa contains sodium.

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 dose of dexketoprofen cinfa you need may vary, depending on the type, intensity, and duration of pain. Your doctor will tell you how many tablets to take per day and for how long.

Generally, the recommended dose is1 tablet (12.5 mg of dexketoprofen) every 4 - 6 hours, without exceeding 6 tablets per day (75 mg).

If you are an elderly patient or suffer from any kidney or liver disease, it is recommended to start therapy with a maximum of 4 tablets per day (50 mg).

In elderly patients, this initial dose may be increased subsequently in accordance with the general recommended dose (75 mg of dexketoprofen) if dexketoprofen cinfa 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 dexketoprofen cinfa 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 dexketoprofen cinfa 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 dexketoprofen cinfa

Do not take a double dose to make up for the missed doses. Take the next dose when due (in accordance with section 3 “How to take dexketoprofen cinfa”).

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can 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):

Dizziness (vertigo), 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 a 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 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), shortness of breath, 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, 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 dexketoprofeno cinfa 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 dexketoprofeno cinfa 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, hematological reactions (purpura, aplastic and hemolytic anemia, and more rarely agranulocytosis and medullary hypoplasia) may appear.

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 and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Store below 25°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 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.

Dexketoprofen cinfa composition

The active ingredient is dexketoprofen trometamol (18.45 mg) equivalent to 12.5 mg of dexketoprofen.

The other components are: cornstarch, microcrystalline cellulose, carboxymethyl starch sodium (type A) (from potato), glyceryl distearate and Opadry Y-1-7000 containinghypromellose (E-464), titanium dioxide (E-171), macrogol 400.

Product appearance and packaging contents

Dexketoprofen cinfa 12.5 mg are coated, non-scored, white, biconvex, and cylindrical tablets marked with DT1 on one side.

They are presented in PVC-PVDC/ALU blisters. Each package contains 20, 40, or 500 (clinical package) coated tablets with a film. Some package sizes may only be marketed.

Marketing authorization holder and responsible manufacturer

Cinfa Laboratories, S.A

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:March 2023

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

You can access detailed and updated information on this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/77840/P_77840.html

QR code link to:https://cima.aemps.es/cima/dochtml/p/77840/P_77840.html