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Description
PANZINORM FORTE 20000
A trade name
of PANZINORMFORTE 20000
the International unlicensed name
Is not present
the Dosage form
of the Tablet, film coated
Structure
One tablet contains
active agent – Pancreatinum of 269.12 – 279.44 mg with enzymatic activity of a lipase of 20000 PIECES *, amylases of 12000 PIECES *, proteases of 900 PIECES *
excipients: lactoses monohydrate, cellulose microcrystalline, krospovidon, silicon dioxide colloidal anhydrous, magnesium stearate, a gipromelloza, methacrylic acid – copolymer of ethyl acrylate, titanium dioxide (E171), talc, a simetikon-emulsion, fragrance vanillin 501345C, fragrance a bergamot 501356T, a macrogoal 6000, sodium of a karmelloz, polysorbate 80.
* – PIECES are given on EF *
the Description
of the Tablet of round shape, with a biconvex surface, film coated from white till light gray color, with a fragrant smell. On cross section two layers are visible.
Pharmacotherapeutic group
Drugs, digestant, (including fermental drugs). Digestive fermental drugs. Pancreatinum.
The ATX A09AA02 code
The pharmacological
Pharmacokinetics Enzymes properties of a pancreas are the natural substances promoting digestion of nutrients.
The acid resisting cover protects active enzymes from gastric juice. Enzymes are proteins and like the enzymes produced in a human body, they mainly are deactivated and collapse in intestines processes of an autolysis and proteolysis.
A small part of the enzymes accepted inside is removed with a stake.
The Tablet PANZINORM pharmacodynamics FORTE 20000 compensate insufficiency of enzymes of a pancreas, accelerate catabolic metabolism and improve a clinical picture of the broken digestion. Active enzymes are released in a small intestine where they make the action. The high activity of a lipase has key value for treatment of the broken digestion caused by a lack of digestive enzymes of a pancreas. The lipase hydrolyzes fats in fatty acids and glitserol, thus providing their absorption and absorption of oil-soluble vitamins. Amylase hydrolyzes carbohydrates in dextrins and sugar while proteases provide destruction of proteins. PANZINORM FORTE 20000 increases absorption of all types of food and improves digestion of the patient. He prevents or reduces a steatorrhea and eliminates the symptoms arising owing to digestion disturbance.
PANZINORM FORTE 20000 can reduce pain in chronic pancreatitis. It is result of effect of the protease inhibiting secretion of enzymes of a pancreas.
Indications
– insufficiency of vneshnesekretorny function of a pancreas chronic pancreatitis, a mucoviscidosis
– chronic inflammatory and dystrophic diseases of a stomach
– the states after a stomach resection which are followed by disturbances of digestion of food, a meteorism, diarrhea (as a part of combination therapy)
– disturbance of digestion at a food error
– chronic inflammatory and dystrophic diseases of intestines, liver, gall bladder
– preparation to radiological and to ultrasound examination of abdominal organs
the Route of administration and doses
the Dosage has to be established individually.
Treatment should be begun with low doses: on 1 tablet 3 times daily, during the main meals. If symptoms of fermental insufficiency of a pancreas remain, the dosage can gradually increase. It is usually enough to take from 1 to 2 pill during the main meals (3 times daily). If it is necessary, the patient can also take 1 pill during light meal.
Doses can also be above, however, the patient should accept the lowest dose necessary for elimination of symptoms that in particular is important for patients with a mucoviscidosis.
It is not necessary to swallow the desiccant which is in a bottle!
Side effect
– allergic reactions
– diarrhea
– a hyper uricosuria, increase in level of uric acid in blood plasma
– in a mucoviscidosis in case of exceeding a necessary dose of Pancreatinum is possible development of strictures (fibrous colonopathy) in ileocecal department and in the ascending part of a colon.
Contraindications
– hypersensitivity to proteins of pork origin or to drug substances
– acute pancreatitis
– exacerbation of chronic pancreatitis
– children’s and teenage age up to 18 years
Medicinal interactions
Enzymes of a pancreas inhibit absorption of folic acid. If the drugs with similar action (hydrocarbonate and Cimetidinum) are at the same time taken, and also at long-term treatment by high doses of enzymes of a pancreas, it is recommended to carry out periodic check of serumal concentration of folate and/or administration of folic acid.
Enzymes of a pancreas can reduce iron absorption, but the clinical value of this interaction is not clear.
The acid resisting cover of the tablets PANZINORM FORTE 20000 collapses in a duodenum. If contents of a duodenum contain the increased amount of acid, enzymes are not released in time. The reduction of secretion of gastric acid reached by means of reception of H2 of the antagonist of receptors or inhibitors of the proton pump increases efficiency of the pancreas enzymes accepted inside at some patients and PANZINORM FORTE 20000 does possible reception of smaller doses.
The special
instructions Tablet Cover interferes with injury of a mucous membrane of a mouth by enzymes of a pancreas and protects enzymes from influence of gastric juice. Patients should swallow tablets entirely, without chewing them. At rare the patient with a mucoviscidosis which accepted high doses of enzymes of a pancreas (more than 10000 PIECES of EF of a lipase on 1 kg of body weight a day) the narrowing of the canal of a large intestine or an ileal and colonic part (fibrous colonopathy) of intestines developed. If there are signs of intestinal impassability at the patient accepting PANZINORM FORTE 20000 the fibrous colonopathy can be considered as the possible reason.
Use in pediatrics:
Safety of use by children was not established yet.
Pregnancy and the period of a lactation Safety of use PANZINORM FORTE 20000 at pregnancy and in the period of a lactation is not established.
Special information on some
PANZINORM ingredients FORTE 20000 contains lactose. Patients with rare hereditary problems of intolerance of a galactose, Lapp lactose deficiency or bad absorbability of glucose and a galactose should not use this drug.
The feature of influence on ability to run the vehicle or potentially dangerous mechanisms
does not influence.
The overdose
Is not present the facts confirming that the overdose can cause system intoxication.
Symptoms: nausea, vomiting, diarrhea, a hyperuricemia or an uricosuria, perianal irritation and, very often, generally at patients with a mucoviscidosis, a fibrous colonopathy.
Treatment: it is necessary to stop administration of drug, good hydration and symptomatic therapy
the Form of release and packing
of the Tablet, film coated is necessary.
On 10 tablets place in blister strip packaging from a film of OPA/Al/PVC and aluminum foil or on 10, 30 or 100 tablets together with a hydrosorbent place in the bottle of yellow glass corked by the screwing-up aluminum cover with polyethylene laying.
The free space in a bottle is filled with cotton wool.
On bottles paste labels.
On 1, 3 or 10 planimetric packs or on 1 bottle together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in the place protected from moisture at a temperature not over 25C. To store in original packing.
To store out of children’s reach!
3 years
not to apply a period of storage after the expiry date specified on packing.
Prescription status
Without prescription
the Producer
of KRK, of, the place Is new, Slovenia
Shmaryeshka 6, 8501 the place, Slovenia
the Owner of the registration certificate Is new:
KRK, of, the place Is new, Slovenia
Additional information
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