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1. What Dexinal 25 mg is and what it is used for
Dexinal 25 mg is an analgesic drug from the group of non-steroidal anti-inflammatory drugs (NSAIDs).
Dexinal 25 mg is used to treat mild to moderate pain, such as muscle pain, painful menstruation (dysmenorrhoea) and toothache.
If after 3-4 days you do not feel better or your condition worsens, you should seek medical help.
2. What you need to know before you use Dexinal 25 mg
Do not take Dexinal 25 mg:
if you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6);
if you are allergic to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs;
if you have asthma or have ever had asthma attacks, acute allergic rhinitis (short-term inflammation of the nose), nasal polyps (growths in the nose due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips or tongue or shortness of breath), wheezing after taking aspirin or other NSAIDs;
if you have suffered from photoallergic or phototoxic reactions (a particular form of skin reddening and/or blistering when exposed to sunlight) when taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood lipid levels) ;
if you have a peptic ulcer (stomach or duodenal ulcer), stomach or intestinal bleeding, or have previously had stomach or intestinal bleeding, an ulcer or perforation;
if you have chronic digestive disorders (eg indigestion, heartburn);
if you have had stomach or intestinal bleeding or perforation as a result of previous use of non-steroidal anti-inflammatory drugs (NSAIDs) for pain;
if you have a bowel disease with chronic inflammation (Crohn's disease or ulcerative colitis);
if you suffer from serious heart failure, moderate to severe kidney problems or serious liver problems;
if you have bleeding or clotting disorders;
if you are severely dehydrated (loss of body fluids) due to vomiting, diarrhea or insufficient fluid intake;
if you are pregnant in the third trimester (last three months) of pregnancy or breast-feeding.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Dexinal 25 mg tablets:
if you have an allergy or have had allergic reactions in the past;
if you have or have had liver, kidney or heart disorders (hypertension and/or heart failure) as well as fluid retention;
if you are taking diuretics or are dehydrated and have reduced blood volume due to excessive fluid loss (eg frequent urination, diarrhea or vomiting);
if you have heart problems, have had a stroke or think you may be at risk of developing these conditions (for example, if you have high blood pressure, diabetes, high cholesterol or are a smoker), you should discuss treatment with your doctor or pharmacist;
if you are elderly, as you may be prone to side effects (see section 4). If any adverse reaction occurs, consult your doctor immediately;
if you are a woman who has a problem conceiving;
if you have a disorder in blood formation or the formation of blood cells;
if you suffer from systemic lupus erythematosus or mixed connective tissue disease (immune system disorders that affect connective tissue);
if you have had chronic intestinal inflammation (ulcerative colitis or Crohn's disease) in the past;
if you have or have suffered in the past from other stomach or intestinal disorders;
if you have chicken pox, as NSAIDs can exceptionally make the infection worse;
if you are taking other medicines that increase the risk of ulceration or bleeding, for example corticosteroids used to treat inflammatory diseases, antidepressants (selective serotonin reuptake inhibitors), anticoagulant medicines, for example aspirin or anticoagulants (medicines used to prevent blood clots , eg warfarin);
if you suffer from asthma combined with chronic rhinitis, chronic sinusitis and/or nasal polyposis, as you have an increased risk of allergy to acetylsalicylic acid and/or NSAIDs compared to the rest of the population. Taking this medicinal product may cause asthma attacks or bronchospasm.
Children and adolescents
Dexinal 25 mg has not been studied in children and adolescents. Therefore, safety and efficacy have not been established and it should not be used in children and adolescents.
Dexinal should not be administered to persons under 18 years of age.
Other medicines and Dexinal 25 mg
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Combinations not recommended:
acetylsalicylic acid (aspirin), corticosteroids or with other NSAIDs;
Dexinal 25 mg with food, drink and alcohol
Take the tablets with water.
Take the tablets with food, as this may reduce the risk of side effects of stomach or intestinal origin.
Pregnancy, lactation and fertility
Do not take Dexinal 25 mg during the third trimester of pregnancy or during breastfeeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
The use of Dexinal 25 mg is not recommended while trying to conceive or during infertility studies.
Driving and using machines
Dexinal 25 mg may slightly affect your ability to drive or operate machinery, as it is likely to cause dizziness or drowsiness. In these cases, do not drive or use machines until symptoms subside. Consult your doctor.
3. How to take Dexinal 25 mg
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is usually 1 (one) tablet (25 mg) every 8 hours, but not more than 3 tablets daily (75 mg).
If after 3-4 days you do not feel better or your condition worsens, consult your doctor. He will tell you how many tablets a day you should take and for how long.
The dose of Dexinal 25 mg depends on the type, strength and duration of the pain.
If you are elderly or if you suffer from impaired kidney or liver function, you should start treatment with a total daily dose of no more than 2 tablets (50 mg).
If Dexinal 25 mg is well tolerated, in elderly patients the initial dose can be increased to the total recommended daily dose (75 mg).
If the pain is severe and you need quick relief, take the tablets on an empty stomach (at least 30 minutes before meals).
If you have taken more than the required dose of Dexinal 25 mg
If you have taken more than the required dose of Dexinal 25 mg, you should contact a doctor or go to the nearest hospital. Take the packaging and leaflet with you.
If you forget to take Dexinal 25 mg
If you forget to take Dexinal 25 mg, take your dose when you remember, unless it is very close to your next dose.
Do not take a double dose to make up for a missed dose.
If you have any further questions related to the use of this medicinal product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people):
Nausea and/or vomiting, stomach pain, diarrhoea, digestive problems (dyspepsia).
Uncommon side effects (may affect up to 1 in 100 people):
Dizziness (vertigo), dizziness, drowsiness, sleep disturbances, nervousness, headache, palpitations, flushing, stomach problems, constipation, dry mouth, flatulence, skin rash, fatigue, pain, chills and chills, general weakness (fatigue) .
Rare side effects (may affect up to 1 in 1,000 people):
Peptic ulcer, perforation or bleeding of a peptic ulcer, which may present as vomiting blood and black stools, feeling sick, high blood pressure, slow breathing, fluid retention and peripheral edema (eg swollen ankles), swelling of the larynx, loss of appetite (anorexia), unusual feeling, itchy rash, acne, increased sweating, back pain, frequent urination, menstrual disorders, prostate problems, abnormal liver function tests (blood tests), damage to liver cells (hepatitis) , acute renal failure.
Very rare side effects:
Anaphylactic reaction (a hypersensitivity reaction that can also lead to loss of consciousness), open sores on the skin, mouth, eyes and genital area (Steven Johnson syndrome), swelling of the face or lips and throat (angioedema), difficulty breathing due to narrowing of the airways (bronchospasm), shallow breathing, rapid heartbeat, low blood pressure, inflammation of the pancreas, blurred vision, ringing in the ears (tinnitus), sensitive skin, sensitivity to light, itching, kidney disorders. Decreased number of white blood cells (neutropenia), decreased number of platelets in the blood (thrombocytopenia).
Tell your doctor immediately if you experience any stomach/intestinal side effects at the start of treatment (e.g. stomach pain, heartburn or bleeding), if you have previously suffered from any of the side effects due to long-term use of anti-inflammatory drugs, and especially if you in old age.
Stop using Dexinal 25 mg as soon as possible after you notice the appearance of a skin rash, lesions on the mucous membrane of the mouth or genitals, or any sign of allergy.
5. How to store Dexinal 25 mg
Keep out of the reach of children.
To be stored in the original packaging.
To be stored below 25 °C.
Do not use this medicine after the expiry date which is stated on the carton after "EXP". This corresponds to the last day of the month indicated.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What Dexinal 25 mg contains
The active substance is:
dexketoprofen. Each tablet contains 25 mg of dexketoprofen (as dexketoprofen trometamol).
The other ingredients are:
microcrystalline cellulose pH 101, microcrystalline cellulose pH 102, corn starch, sodium starch glycolate (Type A), glycerol dibehenate, Opadray KB white 310A180023 containing: macrogol-poly(vinyl alcohol) grafted polymer, kaolin, copovidone, sodium lauryl sulfate, titanium dioxide ( E171).
What Dexinal 25 mg film-coated tablets looks like and contents of the pack
White, biconvex, round tablets scored on both sides. The tablet can be divided into two equal doses.
Dexinal 25 mg film-coated tablets are packed in blisters of white opaque PVC/PE/PVDC - Aluminum foil.
Types of packaging:
10 film-coated tablets / 1 blister.
20 film-coated tablets / 2 blisters.
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