Sigan of the tab. of p/o No. 4

Sigan - nonsteroid anti-inflammatory and antirheumatic medicament for symptomatic treatment of a pain syndrome and spasmodic states.

Structure

• active ingredients: 1 tablet contains: 100 mg of Nimesulide; 20 mg of a ditsikloverin of a hydrochloride;
• other components: waterless lactose, starch corn, silicon dioxide colloidal waterless, sodium krakhmalglikolit (type A), sodium of a kroskarmeloz, povidone, cellulose microcrystalline, talc, magnesium stearate;
• film cover: gipromelloza, talc, titan dioxide (E 171), macrogoal 6000, dye quinolinic yellow supr (E 104).

Contraindication

• Hypersensitivity to active ingredients or any auxiliary component of medicine.
• Giperergichesky reactions in the anamnesis (for example, a bronchospasm, rhinitis, a small tortoiseshell) in connection with use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
• Hepatotoxic reactions to Nimesulide in the anamnesis.
• Accompanying use of other substances with potential hepatotoxicity.
• Alcoholism and medicament addiction.
• Gastrointestinal bleedings or perforation in the anamnesis connected with preliminary application of NPVS.
• Round ulcer in a phase of aggravation or existence in the anamnesis of bleeding in a digestive tract, an ulcer or perforation, paralytic intestinal impassability, a stenosis of peloric department of digestive tract with obstruction, heavy ulcer colitis or toxic megacolon, refluxezof
• Cerebrovascular bleeding or other hemorrhages and also the diseases which are followed by bleeding.
• Fever and/or grippopodobny symptoms.
• Suspicion of sharp surgical pathology.
• Children's age.
• Pregnancy and period of feeding by a breast.

Side reactions

At use of medicine can arise the following side effects, mainly within the first week after an initiation of treatment.

from a cardiovascular system: tachycardia, heartbeat, consciousness, feeling of inflows.

from nervous system: dizziness, headache, paresthesias, violation of sensitivity, drowsiness, nervousness, dyskinesia, violation of stability of gait, lethargy, insomnia, general weakness, increased fatigue, syncopal conditions (loss of consciousness), numbness of the upper and lower extremities.

Mental disorders: hallucinations, confusion of consciousness and/or excitement, speech disorders, change of mood, a ring in ears, psychosis, a coma, a disorientation, short-term loss of memory, a hallucination, a dysarthtia, an ataxy, euphoria, inadequate emotional reactions are –24 hours after lowering of a dose).

Route of administration

Drug appoint the adult after careful assessment of a ratio advantage/risk.

is Applied inside after a meal, washing down with enough liquid.

For adults – on 1 tablet (100 mg of Nimesulide) 1–2 times a day – in the morning and in the evening. Daily dosage: 200 mg of Nimesulide.

Maximum duration of treatment – 5 days.

Feature of application

Use during pregnancy or feeding by a breast

Use of Nimesulide can break female fertility and is not recommended to the women who are going to become pregnant. As well as other non-steroidal anti-inflammatory medicaments suppressing synthesis of prostaglandins, Nimesulide can cause premature closing of a botalovy channel, pulmonary hypertensia, an oliguria, an oligoamnios. Risk of developing bleeding, an atony of a uterus and peripheral hypostases increases. Considering lack of data on use of medicine to pregnant women, Sigan is contraindicated during pregnancy. As it is unknown whether Nimesulide gets into breast milk, use of medicine is contraindicated during feeding by a breast.

Children

Use of medicine is contraindicated to children.

Ability to influence speed of response at control of motor transport or other mechanisms

during treatment needs to be careful at control of motor transport and other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Overdose

Symptoms of sharp overdose of NPVS are usually limited to the following: apathy, drowsiness, nausea, vomiting and pain in epigastric area. These symptoms, as a rule, are reversible at maintenance therapy. Developing of gastrointestinal bleeding is possible. Arterial hypertension, OPN, respiratory depression and a coma are seldom possible. There were messages about anaphylactoid reactions at application of therapeutic doses of NPVS which can arise at overdose. At overdose of NPVS the patients should provide the symptomatic and supporting treatment. There are no specific antidotes. There is no information on removal of Nimesulide by means of a hemodialysis, but if to consider its high extent of linking with proteins of plasma (to 97.5%), then it is improbable that dialysis will be effective at overdose.

Overdose of a ditsikloverin is characterized by two-staging: at first there is an excitement of the central nervous system which is shown concern, emergence of illusions, hallucinations, a resistant mydriasis, tachycardia, arterial hypertension. Then there is an oppression of the central nervous system up to coma.

Symptoms: a headache, nausea, vomiting and an abdominal pain, a loss of appetite, pallor of skin, increase in intraocular pressure, dizziness, misting of sight, expansion of pupils, hot and dry skin, dryness in a mouth, difficulty when swallowing, excitement of the central nervous system, tachycardia, change of respiration rate

emergence of kurarepodobny action (neuromuscular blockade, feeling of weakness in muscles and paralysis).

Treatment: symptomatic therapy. During the first hours at sharp poisoning it is necessary to wash out a stomach via the probe, to apply activated carbon and osmotic depletive. It is necessary to control functions of kidneys and a liver. Apply diazepam to removal of psychomotor excitement (0.5% solution, 2 ml).

to Store

in original packing at a temperature not over 25 ºС out of children's reach.