Dexketoprofeno cinfa 25 mg capsulas duras efg
Introduction
Leaflet: information for the user
Dexketoprofen cinfa 25 mg hard capsules EFG
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.
5Storage of Dexketoprofen cinfa
6.Contents of the pack and additional information
1. What is Dexketoprofeno cinfa and what is it used for
Dexketoprofeno is a pain reliever belonging to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
It is used in adults for the short-term symptomatic treatment of mild to moderate acute pain, such as muscle pain or joint pain, menstrual pain and dental pain.
2. What you need to know before starting to take Dexketoprofen cinfa
Do not take Dexketoprofeno cinfa
- If you are allergic to dexketoprofen or to any of the other ingredients of this medicine (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 inflammation of the nasal mucosa), nasal polyps (fleshy formations inside the nose due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips, or tongue, or difficulty breathing) or chest wheezing after taking acetylsalicylic acid (aspirin) 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 taking of ketoprofen (a nonsteroidal anti-inflammatory drug) or fibrates (medicines used to reduce blood fat levels);
- If you have peptic ulcers, stomach or intestinal bleeding, or if you 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 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 inadequate hydration and reduced blood volume due to excessive fluid loss (e.g. excessive urination, diarrhea, or vomiting);
- If you have heart problems, have had a stroke, or think you may be at risk of these conditions (e.g. have high blood pressure, diabetes, high cholesterol, or are a smoker) consult this treatment with your doctor or pharmacist. Medicines like Dexketoprofeno cinfa may be associated with a small increased risk of having heart attacks or strokes. 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 elderly, 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 production and blood cells;
- If you have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect 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 medicines that increase the risk of peptic ulcers or bleeding, for example, oral corticosteroids, some antidepressants (SSRI type), agents that prevent blood clotting in the blood such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin. In these cases, consult your doctor before taking this medicine: your doctor may prescribe an additional medicine to protect your stomach (e.g. misoprostol or other medicines 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 medicine may cause asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.
Infections
Dexketoprofeno may mask the signs of an infection, such as fever and pain. Therefore, it is possible that this medicine 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. If you take this medicine while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.
Avoid using this medicine if you have varicella.
Children and adolescents
This medicine 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.
Other medicines and Dexketoprofeno cinfa
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, even those purchased without a prescription. 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 this medicine, you are taking any of the following medicines:
Not recommended associations:
- Acetylsalicylic acid, corticosteroids, and other anti-inflammatory drugs;
- Warfarin, heparin, and other medicines used to prevent blood clotting;
- Lithium, used to treat some mood disorders;
- Metotrexate(cancer medicineandimmunosuppressant),usedathighdosesof 15mg/week;
- Hidantoínas and phenytoin, used for epilepsy;
- Sulfamethoxazole, used for bacterial infections.
Associations requiring caution:
- ACE inhibitors, diuretics, and angiotensin II antagonists, used for high blood pressure and heart conditions;
- Pentoxifilina and oxpentifilina, 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 taken into account:
- Quinolones (e.g. ciprofloxacin, levofloxacin) used for bacterial infections;
- Ciclosporina or tacrolimus, used to treat immune system diseases and organ transplants;
- Estreptoquinasa and other thrombolytic and fibrinolytic medicines; that is, medicines used to break down blood clots;
- Probenecid, used for gout;
- Digoxina, used in the treatment of chronic heart failure;
- Mifepristone, used as an abortifacient (to interrupt pregnancy);
- Antidepressants of the SSRI type;
- Antiplatelet agents used to reduce platelet aggregation and blood clotting;
- Betabloqueantes, used for high blood pressure and heart conditions;
- Tenofovir, deferasirox, pemetrexed.
If you have any doubts about taking other medicines with dexketoprofeno, consult your doctor or pharmacist.
Taking Dexketoprofeno cinfa with food, drinks, and alcohol
Generally, it is recommended to take the medicine with meals to reduce the possibility of causing stomach problems (see also section 3, "Form of administration").
The use of NSAIDs in combination with alcohol may worsen the adverse reactions caused by the active ingredient.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine, as it may not be suitable for you.
Do not take this medicine during the last three months of pregnancy or during breastfeeding, 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 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 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 checks.
The use of this medicine may affect fertility, so it is not recommended to use this medicine while trying to conceive or while studying a fertility problem.
Driving and using machines
This medicine 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 cinfa contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule; that is, it is essentially "sodium-free".
3. How to take Dexketoprofen cinfa
Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. The necessary dose of the medication may vary, depending on the type, intensity, and duration of pain.
Your doctor will tell you how many capsules you should take per day and for how long.
The effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
Adults 18 years and older
Generally, the recommended dose is 1 capsule (25 mg of dexketoprofen) every 8 hours, without exceeding 3 capsules per day (75 mg).
Patients with advanced age or renal or hepatic insufficiency
If you are an elderly patient, or you suffer from mild renal problems or mild to moderate liver problems, it is recommended to start treatment with a maximum of 2 capsules per day (50 mg of dexketoprofen).
In elderly patients, this initial dose can be increased later according to the general recommended dose (75 mg of dexketoprofen) if the medication has been well tolerated.
You should not use dexketoprofen if you have 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 old).
Administration form
Take the capsules 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 disorders. However, if your pain is more intense and you need faster relief, take the capsule with an empty stomach (at least 15 minutes before any food or ingestion of food) because it will be absorbed more easily (see section 2 "Taking Dexketoprofen cinfa with food, drinks, and alcohol").
If you take more Dexketoprofen cinfa than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.
If you forgot to take Dexketoprofen cinfa
Do not take a double dose to compensate for the missed doses. Take the next dose when it is due (according to section 3 “How to take Dexketoprofen cinfa”).
If you have any other doubts about the use of this medication, ask your doctor or pharmacist.
4. Possible Adverse Effects
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. Since the list is based in part on the side effects observed with the use of dexketoprofeno tablets, and since dexketoprofeno in capsules is absorbed more quickly than tablets, it is possible that the actual frequency of side effects (gastrointestinal) may be higher with capsules.
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, prostatic 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, eyes, and genital areas (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), 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 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 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 Dexketoprofeno cinfa may be associated with a small increase in the 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 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.
5. Conservation of Dexketoprofen cinfa
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 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.
6. Contents of the packaging and additional information
Dexketoprofeno cinfa Composition
- The active ingredient is dexketoprofeno (as dexketoprofeno trometamol). Each capsule contains 25 mg of dexketoprofeno.
- The other components are:
Contentsofthecapsule:carboxymethylcellulose sodium type A (from potato), cornstarch, microcrystalline cellulose, diestearoylglycerol.
Composition of the capsule: gelatin, titanium dioxide (E-171), yellow iron oxide (E-172) and Brilliant Blue FCF (E-133).
Appearance of the product and contents of the packaging
Hard capsules of 21.7 ± 0.3 mm with cap and body of green color. The capsules are packaged in aluminum/aluminum unit-dose blisters.
They are presented in containers that contain 20 capsules.
Holder of the marketing authorization and responsible for manufacturing
Cinfa Laboratories, S.A
Olaz-Chipi Road, 10. Areta Industrial Estate
31620 Huarte (Navarra) – Spain
Date of the last review of this leaflet:May 2024
Detailed information about this medicine 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 about this medicine by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/89548/P_89548.html
QR code to:https://cima.aemps.es/cima/dochtml/p/89548/P_89548.html
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