COMPOSITION:
Each film coated tablet contains:
Loperamide USP ……………………….. 2 mg
Simethicone USP …………………….125 mg
DESCRIPTION:
Yellow coloured capsule shaped film coated tablet with break line on one side.

INDICATIONS:
Acute and chronic noninfectional diarrhea (allergic, psycho emotional, induced by usage of medicine, X-ray radiation, changes of dietary habits); diarrhea of travelers; syndrome of irritation bowels; normalization of stool in patients with ileostoma.
DOSAGE AND ADMINISTRATION :
Initial dose for adults and children above 12 years is 2 tablets momentary. Then it is used 1 tablet after each act of defecation, but not more than 4 tablets per day. Duration of usage is not more than 2 days.

UNDESIRABLE EFFECTS:
Dry mouth, constipation, abdominal distension, abdominal pain, nausea, vomiting, sleepiness or sleeplessness, headache and vertigo might be appeared. It is possible appearance of paralytic bowel obstruction in case of long usage in big dosage. There are possible allergic reactions:
skin rash, urticaria, in rarely cases- anaphylactic shock, toxic epidermal necrolysis (in patients with hypersensibility).

INTERACTIONS WITH OTHER MEDICAMENTS:
There is no information about existence of drug interaction of Loperamide or Simethicone with other medicines.

WARNINGS AND PRECAUTIONS:
It should be carried out the etiotropic and rehydration therapy at the same time, because of treatment by Loflatil has a symptomatic character.
In patients with disorder of liver function it is necessary to control the presents of symptoms of toxic affection of CNS. It is necessary to cancel the drug if the constipation or abdominal distension is appeared in case of treatment by Loflatil. It should exact the diagnosis and exclude the possibility of infection genesis of diarrhea when the effect is absent during 2 days.
Influence on ability to drive car and operate any other machines
It is necessary to abstain from driving and working with dangerous machines during treatment by this medicine.

OVERDOSE AND TREATMENT:
It is possible the depressing of CNS (depressing of breath, stupor, disorder of moving coordination, sleepiness, increasing of muscles tonus, miosis), paralytic bowel obstruction.
Treatment:
It is necessary twenty-four-hour monitoring of breath function. Naloxone is antidote. It could be necessary additional introduction of Naloxone, because of half-life period of Loperamide is more, than one of Naloxone
CONTRAINDICATIONS:
Higher individual hypersensibility to components of medicine, constipation, bowel obstruction, acute ulcer colitis, pseudomembranous colitis, I trimester of pregnancy, period of lactation, children under 12 years. Loflatil is not used in acute infections intestinal disease without of medical observation.

PHARMACODYNAMIC PROPERTIES:
The medicine is used for symptomatic treatment of diarrhea, meteorism, spastic pain and discomfort in abdomen. Loperamide is communicate with opioid receptors of bowels, inhibit the liberation of Acetylcholine and Prostaglandin E2α, therefore the peristaltic is decreased, the movements of the intestine contents is delayed, the absorption of water and electrolytes is increased, so the manifestations of the diarrhea are decreased.
At the same time Loperamide increases the tonus of anal sphincter. It prevents incontinence of stool and decreases the number of urges to defecate.
Simethicone is the inert surface-active substance, which decreases the surface tension of the gas bubbles in bowels in meteorism and eliminates there. It has not the central action.
PHARMACOKINETIC PROPERTIES:
After the internal usage about 40% of Loperamide is absorbed in digestive tract. The maximal concentration in plasma is attained in 4.5 hours, duration of action is about 24 hours. About 93% of Loperamide is connected with proteins of plasma. It is metabolized in liver. Half-life time 10 hours, about 5% of Loperamide is eliminated with urine in the form of metabolites, 25% – with stool in unchanged form.
Simethicone is not absorbed in digestive tract, is eliminated by transit.
STORAGE CONDITION:
Store below 30°C.
SHELF LIFE:
24 months
DOSAGE FORM AND PACKAGING AVAILABLE:
Alu-Alu strip of 10 tablets, 10 strips are packed in a carton.
NAME AND ADDRESS OF MANUFACTURER:
Kusum Healthcare Pvt. Ltd.
SP 289(A), RIICO Indl. Area,
Chopanki, Bhiwadi (Rajasthan), India
DATE OF REVISION PACK INSERT:Not Applicable

MM Reg. No.: 1709AA 4710