Malasiya Product

Loflatil Tablets

Loflatil Tablets

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:

When you should consult your doctor?

You should consult your doctor if you experience any of the following:
Usually the preparation is well tolerated. During a long-term usage of high doses there can be possible follow side effects:

GIT:
nausea, vomiting, heartburn, diarrhea.

CNS:
hyperexcitability of CNS, headache.

Urinary system:
formation of urinary, cystine and oxalate concernments.
Skin and subcutaneous tissue: allergic reactions.

Blood system:
It can cause erythrocyte hemolysis in patients with insufficiency of glucose-6-phosphatdehydrogenase of hematocytes.

What to do if you miss a dose?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

Ascozin® increases salicylates (increases a risk of crystalluria), ethynilestradiol, benzylpenicillin and tetracyclines concentrations in blood, and decreases per oral contraceptives concentration in blood. It reduces anticoagulation effect of coumarin derivatives. It improves iron drugs absorption in intestine. It increases general clearance of ethyl alcohol. Quinolone drugs, calcium chloride, salicylate, corticosteroid decrease vitamin C reserve when used for a long term. Corticosteroids (cortisone and prednisolone), which are administered in concrete diseases (arthritis, bronchial astma etc), also reduce vitamin C and zinc levels.
Concurrent usage of ascorbic acid and deferoxamine enhances tissue toxicity of iron, especially in cardiac muscle that can cause decompensation of blood circulatory system. It can be used only in 2 hours after deferoxamine injection. A long-term administration of high doses in patients, who are treated by disulfiram, inhibits disulfamide-alcohol reaction.
High doses of the preparation decrease efficacy of tricyclic depressants.

What to do if you accidentally take too much (overdose) of the medicine?

Symptoms:
nausea, vomiting, intestine spasm, diarrhea; it is possible allergic reaction, kidney dysfunction, blood pressure increase, hyperexcitability of CNS, sleep disturbance.

Treatment:
It is symptomatic.

Is it safe in pregnancy and breast-feeding?

Tell your doctor immediately if you become pregnant while taking this medication. For safety of any drug during pregnancy or breastfeeding – please consult your doctor.

Storage Conditions:

Store in a dry, protected from light place at a temperature not more than 25° C.
Keep it out of reach of children.

Drug Description

COMPOSITION:
Each film coated tablet contains: Loperamide USP ……….................... 2 mg Simethicone USP ………................125 mg

Indications and dosage.

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:
Adults:
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.

Side effects and drug interactions.

ADVERSE REACTIONS:


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).

Drug interactions:
There is no information about existence of drug interaction of Loperamide or Simethicone with other medicines..
Clinical significance of such pharmacokinetic interaction during administration of Loperamide at recommended doses (2 mg to 8 mg of maximum daily dose) is unknown.

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.

Overdosage and Contraindications

Overdose:
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.

Clinical pharmacology.

PHARMACOLOGICAL PROPERTIES:

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.

Shelf-life:
24 months.


Storage:
Store in a dry, protected from light place at the temperature not more 25° C.
Keep it out of reach of children Package:
There are 10 tablets in a strip or blister, each strip or blister is in a carton pack, and there are 10 packs in a carton box.

Conditions of supply:
Without prescription:
There are 10 tablets in a blister, each blister is in a carton pack.
There are 10 tablets in a strip, each strip is in a carton pack.

With prescription:
There are 10 tablets in a blister, each blister is in a carton pack, and there are 10 packs in a carton box.
There are 10 tablets in a strip, each strip is in a carton pack, and there are 10 packs in a carton box.

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare
D-158A, OKHLA,INDUSTRIAL AREA,
PHASE-I, NEW DELHI,
Pin 110020
INDIA
Tel: 011-41005147, 011-40514919
Fax: +91-11-40527575