Download Opefera 28 Capsules

SPECIALIST INFORMATION LEAFLET
OPEFERA
TRADE NAME
Opefera
INTERNATIONAL NONPROPRIETARY NAME
PHARMACEUTICAL FORM
Capsules.
Description: Hard gelatin capsules, white, size №00, containing grey-yellow powder with brown speckles.
COMPOSITION
1 capsule contains
Active substances:
Lyophilized bacteria
Lactobacillus rhamnosus
Lactobacillus plantarum
Streptococcus thermophilus
Lactobacillus acidophilus
Bifidobacterium spp.
Saccharomyces boulardii
Matricaria chamomilla dry extract
Inulin
1.94×109 CFU:
0.5×109 CFU
0.2×109 CFU
0.5×109 CFU
0.5×109 CFU
0.24×109 CFU
65 mg
50 mg
200 mg
Excipient: magnesium stearate.
Capsule shell composition: titanium dioxide, gelatin.
АТС CODE
A07FA01
PHARMACOTHERAPEUTIC GROUP
Antidiarrheal preparations of biological origin that regulate intestinal microflora. Preparations containing
microorganisms that produce lactic acid.
PHARMACOLOGICAL PROPERTIES
Opefera is a unique combined probiotic that optimizes body functions, regulates the balance and normalizes
the composition of the intestinal microflora.
Lactobacteria contained in Opefera decompose carbohydrates with lactic acid production. The acidic
medium created by these bacteria promotes development of bifidobacteria that make up to 85-95% of the
intestinal microflora of a human body. Combination of Lactobacillus plantarum culture and bifidobacteria
improves barrier functions of intestinal epithelium and decrease its permeability, modifies allergens by way
of fermentation, thus forming local immune response and reduces the incidence of food allergy.
Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus plantarum and Streptococcus
thermophilus exercise strong direct antimicrobial and antitoxic activity. Streptococcus thermophilus possess
maximum lactase activity and synthetizes polysaccharides that are growth medium for lactobacteria, due to
which these species of bacteria display symbiosis, compensate for metabolism of each other and stimulate
mutual growth.
Saccharomyces boulardii exercise direct antagonistic activity against numerous species of pathogenic and
opportunistic microorganisms, produce antitoxic effect (especially against bacterial cyto- and enterotoxins).
Saccharomyces boulardii improve enzymatic function of the intestine and possess natural resistance to
antibiotics.
Matricaria chamomilla extract produces an antiinflammatory and gastroprotective effect, improves tissue
regeneration processes, and eliminates symptoms of flatulence.
Inulin is a vegetable polysaccharide, a polymer of D-fructose; it increases absorption of calcium and
magnesium, favours lipid and carbohydrate metabolism, and decreases blood cholesterol and glucose
concentrations. Inulin produces a favourable effect on intestinal microflora and stimulates growth of
bifidobacteria.
Bifidobacteria and lactobacteria possess high antagonistic activity against a broad range of pathogenic and
opportunistic microorganisms, inhibit life activity of Staphylococcus aureus, Shigellae, rotaviruses,
Proteuses, entropathogenic Escherichia coli, and of some yeast-like fungi, and prevent adhesion of these to
the intestinal membrane. Lacto- and bifidobacteria create favourable conditions for development of
beneficial intestinal microflora, promote and regulate physiological balance of intestinal microflora, and
normalize microbiocenosis of the GIT. Lacto- and bifidobacteria increase non-specific body resistance and
exercise immune modulating effect.
Bacteria of normal microflora, contained in Opefera, activate parietal digestion, participate in enzymatic
decomposition of proteins, lipids and carbohydrates, in bile acids and cholesterol metabolism processes
(exercise hypocholesterinemic activity). Lacto- and bifidobacteria synthetize amino acids, pantothenic acid,
vitamin К and group В vitamins, and improve absorption of iron, calcium and vitamin D.
INDICATIONS
- recovery and normalization of intestinal microflora, improvement of digestion;
- treatment of gastroenteritis, dyspepsia;
- prophylaxis and treatment of diarrhea associated with antibiotics, hospital diarrhea;
- treatment of transient intestinal dysfunction (both diarrhea and constipation), associated with diet changes,
trips and other reasons;
- treatment of lactase deficiency;
- prophylaxis of atopic diseases (allergic rhinitis, asthma or eczema) and treatment of these as part of
complex therapy;
- improvement of immunity and of overall body resistance against diseases.
DOSAGE AND ADMINISTRATION
Opefera is administered orally after meals, followed with some water.
For children under 3 years old and patients who are unable to swallow a whole capsule, open a capsule and
empty its content into a spoon and mix with a small amount of water.
Children aged 1 to 3 years: 1 capsule 2 times daily;
Children aged 3 to 12 years: 1 capsule 3 times daily.
Adults and adolescents over 12 years: 1-2 capsules 3 times daily.
Duration of treatment depends on the reason of dysbacteriosis and individual peculiarities of the body.
CONTRAINDICATIONS
Known hypersensitivity to any of the components.
SIDE EFFECTS
Allergic reaction to any of the components can occur because of the hypersensitivity (very rarely).
SPECIAL INDICATIONS
Probiotic therapy in the following patient groups should be carried out under the care of a physician:
- patients with disturbed or suppressed immune system, especially patients with advanced aids or patients
with allotransplants and patients receiving chemotherapy;
- patients with endocarditis or myocarditis, patients after an operation on the large intestine or the oral cavity
and a tooth operation;
- patients with acute dyspancreatism, including those with insulin-dependent diabetes. Probiotics can
improve sugar uptake and thereby cause insulin shock in patients. During administration of probiotics blood
glucose level should be measured constantly and insulin dose should be decreased respectively.
- children with short intestine syndrome, suffering from D-lactic acidosis. It is necessary to take preventive
measures to avoid production of D-lactate by the bacterial strains.
- patients with bloody diarrhea.
In all the above listed cases beneficial action of probiotics exceeds possible risk.
INFLUENCE ON ABILITY TO DRIVE AND OPERATE OTHER MECHANISMS
Opefera does not influence on ability to drive and operate other mechanisms.
PREGNANCY AND LACTATION
Administration of the drug in pregnant and breast-feeding women is possible after a consultation with the
physician in charge.
PEDIATRIC USE
Administration of probiotics in children under 1 year old is possible only under doctor`s prescription in order
to develop their own intestinal microflora.
DRUG INTERACTIONS
There are no data about side effects and undesirable reactions in case of drug interactions.
OVERDOSE
No cases of Opefera overdose have been reported to date.
PACKAGING
28 capsules in a bottle.
1 bottle together with an enclosed leaflet in a carton box.
STORAGE CONDITIONS
Store in a protected from moisture place at temperature not exceeding 18°С.
Keep out of reach of children!
Store the bottle in the refrigerator after opening and use it during one month.
SHELF LIFE
2 years from the date of manufacture.
Do not apply after the expiry date.
SALES TERMS
Sold without prescription.
MANUFACTURER
The holder of trade mark and Marketing Authorization is
“DR SERTUS İLAÇ SANAYİ VE TİCARET LİMİTED ŞİRKETİ”, TURKEY.
Manufactured by
“KENDY LTD”, 8 Gurmazovsko shose, 2227 Bozhurishte, Bulgaria.