DEXINAL 25mg x 10 film tabl
DEXINAL 25 MG FILM-COATED TABLETS
DEXINAL 25 MG FILM-COATED TABLETS
Active substance: 36.90 mg dexketoprofen trometamol (dexketoprofen trometamol), equivalent to 25 mg dexketoprofen (dexketoprofen)
Dexketoprofen trometamol is a tromethamine salt of S-(+)-2-(3-benzoylphenyl) propionic acid - a medicinal product with analgesic, anti-inflammatory and antipyretic properties (Non-steroidal anti-inflammatory drug, NSAID), which belongs to non-steroidal anti-inflammatory drugs (M01AE). It is the S-enantiomer of the racemic mixture ketoprofen .
The mechanism of action of nonsteroidal anti-inflammatory drugs is associated with a reduction in prostaglandin synthesis by inhibiting cyclooxygenase. In addition, inhibition of prostaglandin synthesis may also affect other mediators of inflammation, such as kinins. This is an identical effect that complements the direct action.
In animal and human studies, dexketoprofen has been shown to inhibit COX-1 and COX-2 activity.
ATC code: M01АЕ17
Therapeutic indications:
Symptomatic treatment of mild to moderate pain, e.g. in the musculoskeletal system, in dysmenorrhea and toothache.
Dosage:
Adults
Depending on the type and severity of the pain, the recommended dose is 12.5 mg every 4-6 hours or 25 mg every 8 hours. The total daily dose should not exceed 75 mg.
Adverse reactions can be minimized by using the lowest effective dose for the shortest period of time to control symptoms.
Dexinal 25 mg is not intended for long-term use and treatment should be limited to the symptomatic period.
Dexinal 25 mg should not be used in children and adolescents under 18 years of age.
Contraindications
Dexinal 25 mg should not be used in:
- patients with a history of hypersensitivity reactions (eg asthma attacks, bronchospasm, acute rhinitis, nasal polyposis, urticaria or angioedema) in response to treatment with substances with similar effects (acetylsalicylic acid or other NSAIDs);
- known photoallergic or phototoxic reactions during treatment with ketoprofen or fibrates;
- patients with a history of gastrointestinal bleeding or perforation associated with previous NSAID treatment;
- patients with active peptic ulcer/gastrointestinal bleeding or a history of gastrointestinal bleeding, ulceration or perforation;
- patients with chronic dyspepsia;
- patients with other active bleeding or bleeding disorders;
- patients with Crohn's disease or ulcerative colitis;
- patients with severe heart failure;
- patients with moderately to severely impaired renal function (creatinine clearance <59 ml/min);
- patients with severely impaired liver function (Child-Pugh score 10-15);
- patients with hemorrhagic diathesis and other coagulation disorders;
- patients with severe dehydration (as a result of vomiting, diarrhea or insufficient fluid intake);
- the last trimester of pregnancy and during breastfeeding In patients with hypersensitivity to thiocolchicoside or to any of the excipients;
- During the entire period of pregnancy;
- During lactation;
- In women of childbearing potential who do not apply contraceptive measures;
- Dexinal 25 mg should not be used in children and adolescents under 18 years of age.
Effects on the ability to drive and use machines
Dexinal 25 mg affects to a small or moderate extent the ability to drive and operate machines, as it can cause dizziness and drowsiness.
Adverse drug reactions
Frequency of adverse drug reactions according to MedDRA convention
- Very common > 1/10; - are not described in the SPC
- Common >1/100 < 1/10 - Nausea and/or vomiting, abdominal pain, diarrhoea, dyspepsia
- Uncommon >1/1000 < 1/100- Insomnia, restlessness, Headache, dizziness, drowsiness, vertigo, flushing, gastritis, constipation, dry mouth, flatulence, rash, fatigue, pain, asthenia, rigor, general weakness..
- Rare > 1/10,000 < 1/1,000 – described in the SPC
- Very rare <1/10,000 – described in the SPC
Shelf life: 24 months (2 years)
Special storage conditions
To be stored below 25°C in the original packaging.
To be stored in a place inaccessible to children.
To be stored in the original packaging.
Type and contents of packaging
White, biconvex, round, film-coated 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 packed in a blister containing 10 film-coated tablets.
20 film-coated tablets packed in blisters containing 10 film-coated tablets each.
