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Imodium 2 mg 6’s dispersing tablets




The instruction for medical use

of Imodium® medicine

the Trade name
of Imodium®

the International unlicensed

name Loperamide Dosage Form
of the Tablet, dispersed

One tablet contains
active agent in an oral cavity – loperamide a hydrochloride, 2 mg
excipients: gelatin, Mannitolum, aspartame, fragrance mint, Natrii hydrocarbonas.

The description
of White or almost white color the round lyophilized tablets.

Pharmacotherapeutic group
Antidiarrheal means. The drugs reducing a digestive tract vermicular movement. Loperamide.
The ATX A07DA03 code

the Pharmacological

Pharmacokinetics Loperamide properties is well soaked up from intestines, but owing to active metabolism of the first passing the system bioavailability is about 0.3. The tablets dispersed in a bioekvivalentna oral cavity on speed and extent of absorption to the Imodium capsules.
Linking of loperamide with proteins of blood plasma (mainly with albumine) makes 95%. Preclinical data demonstrate that loperamide is P-glycoprotein substrate.
Loperamide is mainly metabolized in a liver by formation of conjugates and emitted with bile. Oxidizing N-demethylation by means of CYP3A4 and CYP2C8 is the main way of metabolism of loperamide. As a result of this effect of the first passing plasma concentration of not changed loperamide it is insignificant are small.
At the person the elimination half-life of loperamide averages 11 hours, varying from 9 to 14 hours. Invariable loperamide and its metabolites are excreted mainly with a stake.
A pharmacodynamics
Loperamide, contacting opiate receptors in an intestines wall, suppresses release of acetylcholine and prostaglandins, reducing thereby a vermicular movement and increasing time of passing of contents on intestines. Raises a tone of an anal sphincter, reducing thereby incontinence of stool and desires by defecation.

– symptomatic therapy of acute and chronic diarrhea
– regulation of a chair at patients with ileostomy

the Route of administration and doses
Inside. The tablet is put on language, within several seconds it is dissolved then it is swallowed with saliva, without washing down with water.
Adults and children are more senior than 12 years:
Acute diarrhea: an initial dose – 2 tablets (4 mg) for adults and 1 tablet (2 mg) for children, accept further on 1 tablet (2 mg) after each act of defecation in case of a liquid chair.
Chronic diarrhea: the initial dose – 2 tablets (4 mg) a day for adults and 1 tablet (2 mg) for children, this dose further is usually individually adjusted so that the frequency of a chair was 1-2 times a day that is usually reached at a maintenance dose from 1 to 6 tablets in day.
Maximum daily dose. In acute and chronic diarrhea at adults – 8 tablets (16 mg), at children the maximum daily dose is calculated proceeding from body weight (3 tablets on 20 kg of body weight of the child – up to 8 tablets (16 mg)).
Patients of advanced age: Dose adjustment is not required.
Patients with a renal failure: Dose adjustment is not required.
Patients with a liver failure:
Special pharmacokinetic researches at patients with an abnormal liver function were not conducted. Patients with an abnormal liver function of Imodium® should use with care because of decrease in metabolism at the first passing through a liver.

As the tablets dispersed in an oral cavity are quite fragile, in order to avoid damage they should not be pressed through through a foil.
To get a tablet from the blister the following is necessary:
– take a foil by the edge and completely remove it from a cell in which there is a tablet,
– carefully press from below and take a tablet from packing.

Side effects
according to clinical trials
the Undesirable reactions observed at ≥ by 1% of the patients accepting Imodium in acute diarrhea: a headache, a constipation, the increased gas generation, nausea, vomiting.
The undesirable reactions observed at & lt, 1% of the patients accepting Imodium in acute diarrhea: dizziness, drowsiness, a headache, dryness in a mouth, an abdominal pain, a constipation, nausea, vomiting, discomfort and an abdominal distension, upper abdomens pain, rash.
The undesirable reactions observed at ≥ by 1% of the patients accepting Imodium in chronic diarrhea: dizziness, the increased gas generation, a constipation, nausea.
The undesirable reactions observed at & lt, 1% of the patients accepting Imodium in chronic diarrhea: a headache, an abdominal pain, dryness in a mouth, discomfort in a stomach, dyspepsia.
According to spontaneous messages about the undesirable phenomena
It is very rare:
– hypersensitivity reactions, anaphylactic reactions, including an acute anaphylaxis and anaphylactoid reactions.
– the lack of coordination, consciousness oppression, a hyper tone, a loss of consciousness, drowsiness, a stupor
– a miosis
– intestinal impassability, including paralytic intestinal impassability, megacolon, including option of a toxic course, a glossodynia
– a Quincke’s disease, bullous rash, including Stephens-Johnson’s syndrome, a multiformny erythema and a toxic epidermal necrolysis, rash, a small tortoiseshell
– an ischuria
– fatigue
Is in certain cases quite difficult to establish relationship of cause and effect between intake of loperamide and emergence of the listed symptoms. And also the frequency of emergence of undesirable reactions in clinical trials can not reflect emergence frequency in clinical practice.
– hypersensitivity
– acute dysentery which is characterized by a chair with impurity of blood or high temperature, and other infections of a GIT (caused including Salmonella, Shigella and Campylobacter)
– intestinal impassability (including if necessary to avoid suppression of a vermicular movement), a divertuculosis, acute ulcer colitis or a pseudomembranous coloenteritis (the diarrhea caused by reception of antibiotics)
– the first trimester of pregnancy and the period of a lactation
– children’s age up to 12 years
Imodium should not be applied to loperamide and/or other components of drug in cases when delay of a vermicular movement is undesirable because of possible risk of serious complications, such as intestinal impassability, megacolon or toxic megacolon. Imodium it is necessary to cancel immediately at appearance of a constipation, abdominal distension or intestinal impassability.
With care:
– in a liver failure

Medicinal interactions
according to preclinical trials, loperamide is substrate Rglikoproteina. At simultaneous use of loperamide (once in a dose of 16 mg) and the quinidine or a ritonavir which are P-glycoprotein inhibitors, concentration of loperamide in blood plasma increases by 2 – 3 times. The clinical value of the described pharmacokinetic interaction with P-glycoprotein inhibitors at use of loperamide in the recommended doses is unknown.
Simultaneous use of loperamide (once in a dose of 4 mg) and the itrakonazola, CYP3A4 inhibitor and a P-glycoprotein, leads to increase in plasma concentration of loperamide by 3 – 4 times. In the same research CYP2C8 inhibitor use, gemfibrozit, led to increase in concentration of loperamide in blood plasma approximately twice. The combination of an itrakonazol and a gemfibrozil by 4 times increased peak concentration of loperamide in blood plasma and by 13 times increased the general exposure in blood plasma. This increase was not associated with action on the central nervous system (CNS) which function was estimated according to psychomotor tests (i.e. to value judgment of drowsiness and the test of replacement of digital symbols).
Simultaneous use of loperamide (once in a dose of 16 mg) and a ketokonazola, CYP3A4 inhibitor and a P-glycoprotein, led to fivefold increase in concentration of loperamide in blood plasma. This increase was not connected with increase in the pharmakodinamichesky action estimated in pupil size.
At simultaneous use of desmopressin inside, concentration of desmopressin in blood plasma increased by 3 times probably because of delay of motility of digestive tract.
It is expected that drugs with similar pharmacological properties can enhance effects of loperamide, and the drugs increasing passage rate through digestive tract can reduce effects of loperamide.

Special instructions
As treatment of diarrhea loperamide has only symptomatic character, it is necessary to carry out also when it is possible, the therapy directed to elimination of the cause of diarrhea. At patients with heavy diarrhea, especially at children, loss of liquid and electrolytes can take place. In such cases it is necessary to carry out the corresponding replacement therapy (intake of liquid and electrolytes).
In the absence of clinical improvement during 48 h the reception of Imodium needs to be stopped. Patients should see a doctor.
The patients about AIDS accepting Imodium have to stop therapy at the first symptoms of an abdominal distension. The isolated messages about impassability of intestines with the increased risk of toxic megacolon at patients about AIDS and infectious colitis of a virus and bacterial etiology concerning which therapy was carried out by loperamide arrived.
Though pharmacokinetic data at patients with a liver failure are absent, at such patients of Imodium it is necessary to apply with care because of reduced metabolism at the first passing through a liver. Patients with an abnormal liver function have to be under careful observation for the purpose of early detection of signs of toxic damage of central nervous system. At patients with heavy abnormal liver functions of Imodium® it is necessary to apply only under observation of the doctor.
If medicine became useless or the expiration date expired – do not throw out it in sewage and on the street! Place medicine in a package and put in a garbage container. These measures will help to protect the environment!
Pregnancy and the period of a lactation
are not present data that loperamide possesses teratogenic or embriotoksichesky action Now. During pregnancy of Imodium it is possible to appoint only if the expected advantage of therapy for mother exceeds potential risk for a fruit, especially in the first trimester.
Small amounts of loperamide can get into breast milk at women and therefore Imodium is not recommended to be accepted during breastfeeding.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
At treatment of diarrhea loperamide, there can be a fatigue, dizziness or drowsiness. At manifestation of these symptoms the patients should refrain from driving and work with mechanisms.

Symptoms: At overdose (including at relative overdose owing to an abnormal liver function) signs of oppression of central nervous system (stupor, lacks of coordination, drowsiness, a miosis, a hyper tone of muscles, respiratory depression), an ischuria and intestinal impassability can appear. Children can be more sensitive to effects concerning central nervous system, than adults.
Treatment: At emergence of symptoms of overdose as antidote it is possible to use Naloxonum. As duration of effect of loperamide is more, than Naloxonum (1 – 3 hour), repeated use of Naloxonum can be required. Therefore, it is necessary to watch a condition of patients carefully within not less than 48 hours in time to find signs of possible oppression of central nervous system.

The form of release and packing
On 6 or 10 tablets place in blister strip packaging from PVC / the focused polyamide/aluminium of the basis and paper / polyethyleneterephthalate/aluminium of the covering foil.
On 1 blister strip packaging together with the instruction for use in the state and Russian languages put in a cardboard pack.

To Store storage conditions in the dry place at a temperature not above 25 °C.
To store out of children’s reach.
To store in original packing.

3 years
not to apply a period of storage after expiry date.

Prescription status
Without prescription

of Katalent of YuK Swindon Zaydis Limited, Frankland Road, Blagrov, Swindon, Wiltshire, SN58RU, Great Britain

the Name and the country of the owner of the registration certificate
of LLC Johnson & Johnson,
Russia, 121614, Moscow, Krylatskaya St., 17, building 2,
ph. (495) 726-55-55

Name and country of the organization packer
S. Janssen-Silag of the item. And., Italy

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of TV-Pharma LLP, Almaty, mdt. Zhetysu 3, 1, quarter 7
Ph. / fax: (727) 376-8082

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