Seractil

Dexibuprofenum
Coated tablets
200 mg

Composition

One coated tablet contains:

• active ingredient: dexibuprofen 200 mg

• excipients: microcrystalline cellulose, calcium salt of carboxymethylcellulose, talc, hydroxypropylmethylcellulose, titanium dioxide, glycerol triacetate and polyethylene glycol.

Mode of action

The active ingredient of the Seractil preparation is dexibuprofen [ S(+)-ibuprofen], an analgesic, anti-inflammatory and antifebrile agent.
Dexibuprofen is one of the two enantiomers of racemic ibuprofen, consisting in 50% of S(+)-ibuprofen and in 50% of R(-)-ibuprofen. Pharmacologically active is only S(+)-ibuprofen, therefore the Seractil preparation, that contains only the active form of the drug allows to dose reduction with respect to the racemic ibuprofen.
Dexibuprofen is well absorbed from the gastrointestinal tract. Beginning of the action is observed after about 10 minutes since administration of the drug. Maximal effect is observed after 1 - 2 hours. Duration of the effect is ca. 4 hours.

Indication to use

1. Symptomatic treatment of headache, toothache, menstrual pains, pains related to injuries; post-operative pains.

As a supporting agent, the drug is used in influenzal infections and common cold accompanied by a headache.

2. Pains in rheumatoidal disorders, including:

• osseous rheumatism,

• ankylosing spondylitis,

• juvenile arthritis,

• muscular rheumatism,

• degenerative joint disease,

Counter-indications

Hypersensitivity to dexibuprofen and ibuprofen or to other constituents of the drug, as well as to other non-steroidal anti-inflammatory drugs, active gastric or duodenum ulcer and haemorrhagic diathesis. Do not give to children under 7 years of age.

Special warnings and recommended precautions

Seractil should be used with particular caution in patients with bronchial asthma or other chronic diseases of the pulmonary tract as well as in persons prone to allergy. The drug should be used with caution by patients with severe hepatic, renal or cardiac insufficiency and with hypertension not responding to any treatment.
Consultation with a doctor is recommended for patients with systemic lupus or with other autoimmunological diseases before beginning the therapy using the drug.
Laboratory tests, recommended by the doctor should be performed during a long-term therapy with the Seractil preparation. The drug can affect results of some of the tests.
In case of development of sudden, intensive disorders of the gastrointestinal tract, headache, dizziness, blurred vision or hearing disorders, swelling, the therapy with the preparation should be discontinued and the patient should consult his doctor.

Usage of the drug during pregnancy and lactation

The drug may be used in pregnancy only in absolute necessity. Unless it is recommended by the doctor, do not use during the last 3 months of pregnancy, because the drug can cause malformation of foetus and complications at childbirth. The drug should not be used during breast-feeding, because dexibuprofen is excreted with mother?s milk, although in a limited degree.

Influence of the drug on ability to drive mechanical vehicles

Seractil does not affect ability to drive mechanical vehicles. However, in persons suffering adverse reactions such as dizziness or fatigue there is a risk of limited ability to react quickly and thus a decreased ability to drive mechanical vehicles or operate machines.

Interactions with other drugs

Without consulting their doctor, patients should not use other drugs while using the Seractil preparation. Dexibuprofen enhances activity of antithrombotic drugs (mostly from the group of coumarine and heparin derivatives and some other platelet aggregation inhibitors). It increases activity, also the undesired ones of other antirheumatic agents. Dexibuprofen enhances activity of oral antidiabetics (mostly sulfonylurea derivatives), as well as phenytoin, dioxin, lithium salts and other potassium-saving diuretics. It increases toxicity of metothrexate. Simultaneous use of glycocorticosteroids enhances risk of gastrorrhagia and enterostaxis and recurrence of ulcer disease.
Dexibuprofen reduces activity of spironolactone, furosemide and the drugs used in arterial hypertension. Probenecid and sulfinpyrazone slow down elimination of dexibuprofen and extend its activity. Alcohol increases activity of dexibuprofen while simultaneously reducing gastric tolerance to this drug. Salicylic acid and its derivatives reduce the anti-inflammatory effect of the drug; the preparations should not be used simultaneously.

Dosage and mode of administration

Seractil tablets should be swallowed without crushing it in teeth, most advantageously at meals, with some liquid. Dosage of Seractil preparation should depend on the patient?s response to the drug and the smallest effective dose should be administered.

• Adults: Usually it is recommended to take the drug 3 times per day, 1-2 tablets
  200 mg (or less tablets of a higher content of the active ingredient, accordingly). The maximal daily dose of the drug is 1200 mg and it should be taken in 3 - 4 divided doses. The drug should be administered with caution to the patients 65 years of age and older.
  

• Children and youth 8 ? 16 years of age: the drug should be administered three times per day, 1/2 of a tablet each time (100 mg of dexibuprofen) but not more than three times daily 1 tablet containing 200 mg of dexibuprofen. The maximal daily dose for children and youth is 600 mg.

Overdosage

In case of overdosage or poisoning, the drug should be removed from the gastrointestinal tract, preventing its further absorption. Several doses of medicinal charcoal could be administered to achieve this and next, appropriate symptomatic treatment should be applied, depending on condition of the patient.

Adverse reactions

In general, Seractil is well tolerated. Adverse reactions are sporadic and subside rapidly after withdrawal of the drug. They may manifest themselves by nausea, vomiting, abdominal pains, diarrhoea, constipation, bleeding from the gastrointestinal tract, headache and dizziness, irritation, ear buzzing, itching and reddening of skin, oedema of limbs.

A long-time therapy with large doses can sometimes cause strong abdominal pains, recurrence of the ulcer disease of stomach or duodenum and bleeding from the gastrointestinal tract. Insomnia, depression, disorientation, sluggishness, transient disorders of vision and hearing, disorders of production of the blood cells, fever, shortness of breath associated with hypotension, liver functions disorders, renal impairment. In case of any adverse reactions associated with taking Seractil one should immediately obtain medical advice.

Available packaging

Tablets 200 mg in cardboard unit boxes containing 6, 10, 20, 30 and 60 tablets.