Information leaflet, read carefully
Phlogenzymâ
enteric coated tablets resistant to gastric juices
Manufacturer:
MUCOS Pharma GmbH & Co., Geretsried, Germany
Composition: bromelain 90 mg, trypsin 48 mg, rutosid trihydrate 100 mg.
Inactive ingredients: lactose, magnesium stearate, stearic acid, talcum, triethylcitrate, methacrylic acid copolymer type L, macrogol 6000, vanillin, purified water, maize starch, highly dispersed silica.
Indication group: varium, enzyme preparation
Characteristics:
Phlogenzymâ contains a combination of two proteolytic enzymes (substances which cleave proteins) of plant and animal origin completed with plant flavonoid rutosid that are able to influence efficiently various phases of inflammatory and immune processes. Components of Phlogenzymâ remove harmful metabolic products at the site of inflammation and speed up absorption of edemas, bruises, and hematomas. They normalize vessel wall permeability, thus reducing edema formation. Phlogenzymâ decreases blood viscosity and improves some properties of platelets and erythrocytes participating in thrombi formation. Therefore, Phlogenzymâ improves blood circulation in tiny vessels and repairs capillary return of tissue and its nutrient and oxygen supply. Healing processes and tissue regeneration are thus supported and accelerated and pain associated with inflammation is reduced.
Indications:
The preparation may be used by adults and children older than 6 years.
Phlogenzymâ may be administered to children only
when consulted with a pediatrician who also determines the dosage.
Contraindications:
Phlogenzymâ must not be used in case of known hypersensitivity to its active or inactive ingredients. The preparation must not be used by patients with severe inborn or gained coagulation disorders (e.g. hemophilia, severe liver damage, dialyzed patients). Administration of Phlogenzym® during pregnancy and breastfeeding should be consulted with a physician. This applies also when getting pregnant during the treatment.
Adverse effects:
Phlogenzym® is usually well tolerated, there were no observed adverse effects during long-term high-dosage administration. Harmless alteration in the consistency, color and odor of stool may occur. A sensation of fullness, flatulence, and occasional episodes of nausea are possible during high-dosage administration. They can be avoided by administration of the enzyme preparation in divided doses during a day. If these symptoms persist consult your physician. Allergic reactions (skin rash) occur rarely and disappear after discontinuation of the drug. In case of their occurrence discontinue using Phlogenzymâ and consult your physician.
Interactions:
There is no evidence of incompatibility of Phlogenzym® with other simultaneously administered drugs. Nevertheless, in case of taking other prescription medicines or OTC drugs consult Phlogenzym® administration with your physician and do not take it without his recommendation. If your physician prescribes you another medicine, inform him that you use Phlogenzym®.
Dosage:
Adults are recommended to use 6 tablets daily (2 tablets 3x daily or 3 tablets 2x daily). In special cases (severe course of the disease, beginning of acute inflammation, posttraumatic and postoperative conditions when a rapid absorption of edema, bruises, and hematomas is necessary) it is possible to use 12 tablets daily (4 tablets 3x daily or 3 tablets 4x daily) after consulting it with a physician. Children are recommended to use 1 tablet per 10 kg of body weight per day. This dosage is to be divided into 2 – 4 partial doses.
Mode of administration:
Tablets should be swallowed on an empty stomach (at least 30 min. before or 2 hours after meals) without chewing and rinsed down with plenty of liquid (at least 1/4 liter).
Special precaution:
This medication does not replace antibiotic treatment of infectious
inflammation but it does increase its efficacy. The symptoms of chronic illness
may occasionally increase in severity at the beginning of therapy. Based on
current experience this means in most cases a positive reaction of the organism
on Phlogenzymâ treatment. In this case the
medication should not be discontinued, although a temporary reduction in dose
might be advisable. Under these circumstances it is necessary to consult a
physician as in case of adverse events occurrence or other unusual reactions.
Before using Phlogenzymâ in chronic illness and when
using it more than 2 months it is necessary to consult a physician. If you are
to undergo a surgery inform your physician that you are using Phlogenzymâ
.
The carbohydrate content of 1 tablet is equivalent to 4.65 kcal = 19.5 kJ.
Storage: Store at dry place at room temperature.
Warning:
KEEP THE MEDICINE OUT OF THE REACH OF CHILDREN !
The medication must not be administered after expiration date.
Packaging:
40 tablets
100 tablets
200 tablets
800 tablets
Date of the last revision: March 31, 2000
MUCOS Pharma CZ s.r.o., Uhøínìveská 448, 252 43 Prùhonice, Czech Republic