Description

Dextin film-coated tablets are a pain reliever . The active ingredient is dexketoprofen, which belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs). The drug is used for the short-term treatment of mild to moderate pain of various origins, such as muscle pain or toothache.

Composition

The active substance is dexketoprofen ( Dexketoprofenum ).

1 film-coated tablet contains 36.90 mg of dexketoprofen trometamol, equivalent to 25 mg of dexketoprofen.

Excipients: corn starch, microcrystalline cellulose, sodium starch glycolate (type A), glycerol distearate, Film coating (Opadry Y-1-7000 Film coating): hypromellose, titanium dioxide (E 171), macrogol/PEG 400.

Dosage

Always use this medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you have any further questions, ask your doctor or pharmacist.

The drug is administered orally with a sufficient amount of water. Dextin is taken after a meal, which reduces the likelihood of side effects related to the stomach or intestines. In cases of acute pain, the film-coated tablets can be taken 30 minutes before a meal. The duration of use should be limited to the duration of symptoms.

Dosage for adults should be adjusted according to the intensity of pain and its duration. The usual dose is 1/2 tablet every 4–6 hours or 1 tablet every 8 hours. The maximum daily dose is 3 film-coated tablets.

Action

The drug contains dexketoprofen, a nonsteroidal anti-inflammatory drug (NSAID). Dextin has an analgesic effect.

Indications

The indication for using Dextin is the short-term treatment of mild and moderate pain of various origins, such as muscle pain, toothache, and menstrual pain.

Contraindications

Do not use Dextin if:

• allergy to dexketoprofen or any of the other ingredients of the medicine;
• hypersensitivity to acetylsalicylic acid or other NSAIDs;
• people suffering from or having previously suffered from asthma, acute allergic rhinitis, nasal polyps, urticaria, rash, angioedema, wheezing after taking acetylsalicylic acid;
• patients who have previously experienced photosensitivity, photoallergic or phototoxic reactions while taking ketoprofen or fibrates;
• people with stomach and/or duodenal ulcers or stomach or intestinal bleeding, ulceration or perforation, especially if they occurred after taking NSAIDs;
• patients with intestinal diseases associated with chronic inflammation, severe heart failure, moderate or severe renal impairment, severe liver impairment;
• patients with excessive tendency to bleeding or coagulation disorders, severely dehydrated.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (affects 1 to 10 users in 100): nausea and/or vomiting, abdominal pain, diarrhea, indigestion (dyspepsia).

Uncommon side effects (affects 1 to 10 users in 1,000): feeling of spinning, dizziness, drowsiness, sleep disturbances, nervousness, headache, palpitations, facial flushing, stomach problems, constipation, dry mouth, flatulence, rash, tiredness, pain, feeling of fever and chills, feeling unwell.

Rare side effects (affects 1 to 10 users in 10,000): stomach ulcer, bleeding or perforation of peptic ulcer, which may be seen as vomiting blood or black stools, fainting, high blood pressure, slow breathing, water retention in the limbs and peripheral swelling (e.g. 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 tests (blood tests), liver cell damage (hepatitis), acute kidney failure.

Very rare side effects (affecting less than 1 to 10 users in 10,000): anaphylactic reactions (severe hypersensitivity reactions that may lead to anaphylactic shock), ulceration of the skin, mouth, eyes and genital areas (Stevens-Johnson syndrome and Lyell's syndrome), facial swelling or swelling of the lips and throat (angioedema), shortness of breath due to narrowing of the airways (bronchospasm), shortness of breath, fast heartbeat, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), skin hypersensitivity reactions, sensitivity of the skin to light, itching, impaired kidney function, reduced white blood cell count (neutropenia), reduced platelet count (thrombocytopenia).

Warnings and precautions

Before use, consult your doctor if:

• For people with heart disease, stroke, or suspected risk factors (e.g., high blood pressure, diabetes, high cholesterol, or smoking), Dextin-type medications may slightly increase the risk of heart attack or stroke. This risk increases if the medications are used for a long time and in high doses.
• elderly patients, as they are more susceptible to side effects.
• people suffering from systemic lupus erythematosus or mixed connective tissue disease, chickenpox, with disorders of blood cell formation.

Storage:

Store below 25°C. Keep blisters in the outer carton to protect from light.
Keep the medicine out of the sight and reach of children.

Use of other medications

Please tell your doctor or pharmacist about all the medicines you are taking, have recently taken or might take, including medicines obtained without a prescription.

Dextin may interact with:

• acetylsalicylic acid, corticosteroids or other anti-inflammatory drugs,
• warfarin, heparin or other anticoagulants,
• ltem,
• methotrexate, anticancer drugs, immunosuppressive drugs,
• hydantoin and fentoin derivatives,
• sulfamethoxazole,
• ACE inhibitors, diuretics, beta-blockers, angiotensin II antagonists,
• pentoxifylline, oxypentifylline,
• zidovudine,
• aminoglycoside antibiotics,
• chlorpropamide, glicbenclamide,
• quinolone antibiotics,
• cyclosporine, tacrolimus,
• streptokinase, other thrombolytic or fibrinolytic drugs,
• probenecid,
• digoxin,
• mifepristone,
• selective serotonin reuptake inhibitors (SSRIs),
• antiplatelet drugs.

Taking the medicine with food and drink

Dextin coated tablets are recommended to be taken with food, which reduces the risk of side effects related to the stomach or intestines. If acute pain occurs, the medication can be taken on an empty stomach (at least 30 minutes before a meal), which will speed up the effect.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not use Dextin if you are pregnant or breastfeeding.

Impact on laboratory tests

The drug may interfere with fertility tests.

Impact on fertility

Dextin is not recommended for use in women planning a pregnancy or during infertility testing.

Use of the drug in children and adolescents

Dextin is intended for adults and should not be used by children and adolescents under 18 years of age.

Driving and operating machinery

Dexin may have a minor influence on your ability to drive or use machines due to possible side effects such as dizziness or drowsiness. If you experience these symptoms, do not drive or operate machinery until the symptoms subside. If you have any concerns, consult your doctor.