LACTULOSA BIOMEDICA por. sir.
Digestive (intestinal tranquilizer), laxative.
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SÚKL code
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Medicinal product name
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Addendum
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Registration number
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0017190
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Lactulosa BIOMEDICA
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por.sir.
1x250 ml 50% |
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49/246/73-C
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Manufacturer
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Manufacturer country
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Marketing authorisation
holder |
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Holder
country |
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Biomedica,
spol. s r.o. |
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Czech Republic
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Biomedica,
spol. s r.o. |
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Czech
Republic |
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Active
substance |
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Indication
group |
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ATC group
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Legal status
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Lactulosi solutio 50%
(Lactulosum)
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49 Digestives, adsorbents
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A06AD11
Lactulose |
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OTC
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SÚKL code
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Medicinal product name
|
|
Addendum
|
|
Registration number
|
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0017191
|
|
Lactulosa BIOMEDICA
|
|
por.sir.
1x500 ml 50% |
|
49/246/73-C
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Manufacturer
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Manufacturer country
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Marketing authorisation
holder |
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Holder
country |
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Biomedica,
spol. s r.o. |
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Czech
Republic |
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Biomedica,
spol. s r.o. |
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Czech
Republic |
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Active
substance |
|
Indication
group |
|
ATC group
|
|
Legal status
|
|
Lactulosi solutio 50%
|
|
49 Digestives, adsorbents
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|
A06AD11
Lactulose |
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OTC
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(Lactulosum)
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Syrup for internal use.
For buying of this preparation for treatment of constipation is not needed a prescription by physician. For the others indications such prescription is necessary, but it is reimbursed by public medical insurance.
Composition
Lactulosum 66.7 g in 100 ml of syrup
Indications group
Digestive (intestinal tranquilizer), laxative
Characteristics
This preparation is very effective non-absorbent laxative acting directly in colon. It increases acidity in intestinal, reduces ammonium and nitrates formation, and causes stools softening. It doesn’t impair intestinal physiological function.
The preparation is suitable for adults as well as for children. To children it should be administered base on physician recommendation only.
The preparation should be use during pregnancy and lactation.
Indications
The preparation is mainly used for treatment of chronic constipation resulting from breaching of intestinal movement reflex due wrong dietary customs. Based on physician recommendation the preparation can be used with portosystemic encephalopathy (CNS disorder accompanying liver defects); also it is used to speed up intestinal passage during RTG and to shorten time for removal of typhus and/or paratyphus and others salmonellas bacteria and for treatment of salmonellas carrier.
Contraindications
The preparation shall not be use by patients with ileus and hypersensitivity to lactose. As the preparation contains small amount of lactose and galactose, it shall not be administered to patients with hypersensitivity to lactose and with galactosaemia (a rare and serious genetic condition in which the body is unable to use a sugar called galactose).
Adverse effects
In beginning of therapy this preparation can cause abdomen convulsion and flatulence, which rapidly vanish in later phases of therapy. High doses can cause diarrhoea that is easy to correct by adjusting of dosing.
Dosing and Administration
Constipation
Adults
Dosing is adjusted individually for each patient, starting from higher dose, that is reduced after three days. Starting with 15-45 ml (1-3 of table-spoon) daily, long term 10-25 ml (2-5 tea-spoons) daily.
Children
7to 15 years, starting from 15 ml (1of table-spoon) daily, later 5-10 ml (1-2 tea-spoons) daily,
from 1 to 6 years, 5-10 ml (1-2 tea-spoons) daily,
bellow 1 year, 2.5-5 ml (1/2-1 tea-spoon) daily.
In case of insufficient effects these doses can be set higher. When a therapeutic effect is reached, continue with adequately reduced holding dose.
Usually, the daily dose is consumed at once in the morning after breakfast. It is administered with water, tea or fruit juice. Overdosing results to diarrhoea and consequently dehydration and loss of electrolytes. These difficulties can be removed by adjusting of dosing or interruption of treatment.
Portosystemic encephalopathy, salmonellas, RTG intestinal examination - base on prescription of physician (see SPC – Summary of preparation data).
Warning!
Sufficient intake of fluids is required!
Patient with diabetes should use the preparation with care, because it contains small amount of free galactose and lactose.
Effects of Lactulosa BIOMEDICA syrup should interfere with other medications. Your physician should be informed about all others medications you use simultaneously, whether prescribed or not.
Don’t use the preparation without consultation with your physician longer then 2 weeks (constipation can be symptom of more serious illness).
In case that these adverse or unusual effects occur seek advice from your physician.