DEXTIN 25mg 30 film-coated tablets

DEXTIN 30 film-coated tablets

Dexketoprofenum 25 mg

Medicinal product without prescription - OTC drug

DEXTIN is an analgesic from the group of non-steroidal anti-inflammatory drugs (NSAIDs). DEXTIN is used for the short-term treatment of mild to moderate pain, such as muscle pain, painful menstruation, toothache.

DEXTINcomposition

The active substance is decsketoprofen. 1 film-coated tablet contains 36.90 mg of decsketoprofen with tromethamol, equivalent to 25 mg of decsketoprofen. Other ingredients are: corn starch, microcrystalline cellulose, sodium carboxymethyl starch (type A), glycerol distearate, Envelope (Opadry Y-1-7000): hypromellose, titanium dioxide (E 171), macrogol/PEG 400.

Dosage and administration ofDEXTIN

This drug should always be taken exactly as described in the patient leaflet or as prescribed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist. DEXTIN drug is intended for short-term use only, and treatment should be limited to the duration of symptoms. Adults The required dose of DEXTIN depends on the type, severity and duration of pain, and is half a tablet (12.5 mg) every 4 - 6 hours or 1 tablet (25 mg) every 8 hours. However, no more than 3 tablets per day (75 mg). In elderly patients or those with kidney or liver disease, it is recommended to start treatment with a lower total daily dose equivalent to no more than 2 tablets (50 mg). If well tolerated in the elderly, this starting dose can then be increased to the dose recommended for the general population (75 mg). For acute pain, when faster action is needed, it is recommended to take the drug on an empty stomach (at least 30 minutes before a meal), which will result in faster absorption of the drug (see section 2: "DEXTIN with food and drink)." Use in children and ad olescents This drug should not be used in children and adolescents (under 18 years of age). Use of a larger-than-recommended dose of DEXTIN If you suspect an overdose of the drug, notify your doctor or pharmacist immediately or go to the nearest hospital emergency department. Be sure to take the package of this medication or the patient leaflet with you. Omission of DEXTIN Do not use a double dose to make up for a missed dose. The next dose should be given according to the dosing schedule (see section 3: "How to use DEXTIN"). If you have any further questions about the use of this medication, ask your doctor or pharmacist.

DEXTIN - Contraindications

If the patient is allergic to decsketoprofen or any of the other ingredients of this drug (listed in section 6); If the patient is allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs); If the patient has asthma or a history of asthma attacks, acute allergic rhinitis (a brief period of inflammation of the nasal mucosa), nasal polyps (nodules inside the nose caused by allergy), urticaria (rash), angioedema (swelling of the face, eyes, lips, tongue or respiratory distress syndrome) or wheezing after taking acetylsalicylic acid or another NSAID drug; If the patient has a history of hypersensitivity reactions to light: Photoallergic reactions or phototoxic reactions (especially in the form of redness and/or blistering after exposure to sunlight) while taking ketoprofen (a nonsteroidal anti-inflammatory drug) or fibrates (drugs used to lower blood fats); If you have gastrointestinal and/or duodenal ulcers or bleeding, or if you have a history of gastrointestinal bleeding, ulceration or perforation; If you have chronic digestive disorders (e.g. indigestion, heartburn); If the patient has a history of gastrointestinal bleeding or perforation due to previous use of NSAIDs for the treatment of pain; If the patient has chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis); If the patient has severe heart failure, moderate or severe renal impairment, or severe hepatic impairment; If the patient has an excessive bleeding tendency or coagulation disorder; If the patient is severely dehydrated (excessive fluid loss from the body) due to vomiting, diarrhea, or insufficient fluid intake; If the patient is in the third trimester of pregnancy or breastfeeding.

Warnings and precautions: Discuss with your doctor or pharmacist before taking DEXTIN. If you have an allergy, or if you have a history of allergy problems; If you have kidney, liver or heart disorders (hypertension and/or heart failure), as well as fluid retention, or if you have a history of any of the above problems; In patients receiving diuretics, or in patients who have decreased hydration and reduced blood volume due to excessive fluid loss (e.g. excessive urination, diarrhea or vomiting); If the patient has heart disease, a history of stroke or is suspected to be in a risk group (e.g., if there is elevated blood pressure, diabetes, elevated cholesterol or smoking). In such cases, consult your doctor or pharmacist before taking DEXTIN. Taking medications such as DEXTIN may be associated with a slight increase in the risk of heart attack ("myocardial infarction") or stroke. This risk is increased by taking large doses of the drug for long periods of time. Do not use higher doses and longer duration of treatment than recommended; If the patient is elderly: there is an increased risk of side effects (see section 4). If side effects occur, contact your doctor immediately; If you have problems getting pregnant or are being tested for infertility (DEXTIN may interfere with female fertility and should not be used in women planning pregnancy or being treated for infertility); If you have blood or blood cell formation disorders; If you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue); If the patient has a history of chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease); If the patient has or has had other diseases of the stomach or intestines; If the patient has chickenpox, as in rare cases the use of nonsteroidal anti-inflammatory drugs can exacerbate the course of the infection; If the patient is taking other drugs that increase the risk of gastric and/or duodenal ulcers or bleeding, such as. oral steroid drugs, certain antidepressants (SSRIs, such as serotonin reuptake inhibitors), anti-clotting drugs such as acetylsalicylic acid, or anticoagulants such as warfarin. In such cases, consult your doctor before taking the drug, who may decide to administer an additional gastroprotective drug (such as misoprostol or drugs that inhibit the production of hydrochloric acid in the stomach); In patients with asthma in combination with chronic rhinitis, chronic sinusitis and/or nasal polyps, the risk of sensitization to acetylsalicylic acid and/or NSAIDs is higher than in the rest of the population. Administration of this drug may cause asthma attacks or bronchospasm, especially in patients who are allergic to acetylsalicylic acid and/or NSAIDs.

DEXTIN - Side effects

Like any drug, this medication may cause side effects, although not everyone will experience them. Possible side effects are listed below and ranked according to how likely they are to occur. Common side effects (may affect up to 1 in 10 people): Nausea and/or vomiting, abdominal pain, diarrhea, indigestion (dyspepsia). Uncommon side effects (may affect up to 1 in 100 people): Sensation of spinning, dizziness, drowsiness, sleep disturbance, nervousness, headache, palpitations, facial flushing, stomach disorder, constipation, dry mouth, bloating with gas, rash, fatigue, pain, feeling fever and chills, malaise. Rare adverse reactions (may affect up to 1 in 1,000 people): Peptic ulcer disease, bleeding or perforation of peptic ulcer, which may manifest as bloody vomit or black stools, fainting, high blood pressure, slowed respiratory rate, water accumulation in the extremities and peripheral edema (eg. swollen ankles), swelling of the larynx, loss of appetite (anorexia), abnormal sensation, itchy rash, acne, increased sweating, back pain, increased urination, menstrual disorders, prostate disorders, abnormal liver function indicators (blood tests), liver cell damage (hepatitis), acute renal failure.

Permit No. 25221 issued by the Office for Registration of Medicinal Products (URPL).

Entity responsible: Solinea Sp. z o.o. Sp. K., Elizówka, 65 Hall I, 21-003 Ciecierzyn, Poland.

Before use, read the leaflet, which contains indications, contraindications, data on adverse reactions and dosage, and information on the use of the medicinal product, or consult your doctor or pharmacist, as any drug inappropriately used threatens your life or health.