Moldova Product

Polymic Tablets

Polymic Tablets

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:
Treatment of mixed infections caused by pathogens (microorganisms and protozoa) sensitive to the preparation components:
- urogenital system diseases: acute and chronic pyelonephritis; prostatitis; cystitis; epididymitis; complicated or recurrent urinary tracts infections;
- sexually transmitted diseases.

When you should consult your doctor?

You should consult your doctor if you experience any of the following:

Gastrointestinal tract:
nausea; vomiting, abdominal pain, metal taste, diarrhea (sometimes it may be a symptom of enterocolitis and in some cases it can be hemorrhagic one), appetite loss, dry mouth, anorexia, hypoglycemia in diabetes patients, who use hypoglycemic agents.

Central nervous system:
agitation; dizziness; headache; sleep disorders (insomnia or somnolence), anxiety, inquietude, mental confusion, tremor, convulsions, rigidity, temporal loss of consciousness, peripheral sensitivity disorders (paresthesia, incoordination, taste disorders, olfaction, visual impairment); hearing impairment (tinnitus or loss of hearing), photophobia, extrapiramidal disorders, intracranial pressure increase; in patients with decreased myoclonic threshold convulsive attacks are possible; nightmare, hallucinations, unsteady gait and tremor (caused by muscle disbalance), neuropathy; in isolated cases – psychotic reactions and depression, which are dangerous, especially suicidal idea or actions; it may be exacerbation of myasthenia gravis and dysphasia.

Haemopoiesis:
anaemia; hemolytic anemia, leukopenia, eosinophilia, thrombocytopenia, pancytopenia, agranulocytosis, granulocytopenia, depression of bone marrow formation, in isolated cases hemolytic anemia development is possible.

Kidney:
kidney dysfunction; in isolated cases – acute interstitial nephritis or increase of creatinine level in serum that can lead to severe kidney insufficiency, anuria, polyuria, kidney concrements, hematuria.

Liver:
increase of liver enzymes (ASAT, ALAT, LDG, GTH, alkaline phosphatase and gamma-glutamyl transferase) and bilirubin activity, cholestatic jaundice, in isolated cases – hepatitits, even of high degree one.
Specific form of enterocolitis that can be observed in antibiotics usage – pseudomembranous colitis (in most cases it is caused by Clostridiu difficile). In case of suspicion of Clostridiu difficile the preparation treatment should be immediately stopped and an adequate treatment should be carried out. Medicines, which depress peristalsis, should not be used in such cases.

Cardio-vascular system:
arterial hypotension, tachycardia; rarely – collapse (caused by arterial pressure decreasing), cerebral thrombosis, lungs edema, torsades de pointes.

Muscular-skeletal system:
tendinitis (especially in elderly patients), arthralgia, myalgia, tendon and muscle pain (in isolated cases it may be as symptoms of rabdomyolysis).

Skin:
skin rash, itch, photosensitization, edema, Quincke's edema, edema of tongue and/or larunx with possible asphyxia, rash after influence of long-term intensive solar radiation, multiform erythema, Stevens-Jonson syndrome, Lyell's syndrome and vasculitis (in isolated cases vasculitis can lead to skin lesions that is accompanied with necrolysis, and viscera may be included).

Allergic reactions:
anaphylaxis, for example, tachycardia, fever, short breath, shock, angioneurotic edema, vascular reactions, eosinophilia. In such cases it is necessary to withdraw the treatment immediately and to carry out a replacement therapy if there is a need. In isolated cases pneumonitis may occur. Reproductive system: vaginal candidiasis.

Respiratory system:
short breath, bronchospasm, allergic pneumonitis, stridor.

Others:
asthenia, fever, vaginitis, level increase of triglyceride, cholesterol, lethargy, excessive increase or decrease of sugar level in blood, tendon discomfort, including tendon inflammation and tear (for example, Achilles tendon), especially in patients, which are concurrently treated by corticosteroids. In presence of signs of tendon inflammation the preparation therapy should be immediately discontinued and appropriate treatment for affected tendon should be administered.
It is not excluded a possibility of that Polymic® can cause porphyria attack in inclined patients.
In addition, in isolated cases (for example, impairment of taste, hearing and olfaction) side effects disappeared after Polymic® therapy withdrawal.
It is also possible a hiccup, tunica mucosa of mouth painfulness, heartburn, increase of triglyceride, cholesterol and calcium levels in serum, petechia, ecchymosis/fruise, prothrombin time lengthening, thrombotic and thrombocytopenic purpura.

Когда Вы должны проконсультироваться с вашим врачем ?

Если приближается время для принятия следующей дозы , проигнорируйте пропущенную дозу и примите следующую дозу как вам назначено.
В противном случае , примите дозу сразу , как только Вы вспомнили о ней и далее принимайте как обычно.

Things you MUST NOT DO while on this medicine?

The preparation should be used not earlier than 4 hours after use of medicines, which contain magnesium, aluminum, iron, zinc and sucralfate.
In concurrent use of the preparation with probenecid, cimetidine, furosemide and methotrexate the excretion of Polymic® with urine is slowed, and a half life period and a risk of its toxic action are increased.
NSAIDs can intensify the preparation stimulating effect on central nervous system.
It intensifies coumarin anticoagulants action and prolonges myorelaxation, caused by vecuronium bromide.
In concurrent use of warfarin it is necessary to control coagulation parameters.
In concurrent use of peroral antidiabetic drugs glycemia parameters should be checked.
Concomitant administration of phenobarbital and other enzyme inductors decreases a period of ornidazol circulation in serum, while enzyme inductors (for example, cimetidine) increase it.
Theophylline concentration in blood and its half-life period can be increased in concurrent use of Polymic®.

What to do if you accidentally take too much (overdose) of the medicine?

Symptoms:
dizziness; mental confusion; somnolence, lethargy, disorientation; convulsions; gastro-intestinal tract reactions – nausea and vomiting, erosive lesions of stomach mucosa.

Treatment:
gastric lavage; enterosorbates, magnesium sulfate, antacids are used for protection of mucous coat of stomach. In case of convulsions it is recommended an intravenous introduction of diazepam.
Hemodialysis and peritoneal dialysis accelerate the preparation excretion. The treatment is symptomatic. There is no special antidote.

Is it safe in pregnancy and breast-feeding?

Tell your doctor immediately if you become pregnant while taking this medication.
For safety of any drug during pregnancy or breastfeeding – please consult your doctor.

Storage Conditions:

Store below 25oC in dry place. Protect from direct sunlight.
Keep out of reach of children.

Drug Description

COMPOSITION:

1 tablet contains Ofloxacin 200 mg and Ornidazole 500 mg.

Excipients:
microcrystalline cellulose, sodium starchglycolate (type A), povidon (К-30), magnesium stearate, Opadry 03B53217 Orange dye.

Indications and dosage.

INDICATIONS:
Treatment of mixed infections caused by pathogens (microorganisms and protozoa) sensitive to the preparation components:

- urogenital system diseases:
acute and chronic pyelonephritis; prostatitis; cystitis; epididymitis; complicated or recurrent urinary tracts infections;

- sexually transmitted diseases.

DOSAGE:

Polymic® should be used orally without chewing and with water following. It is allowed to use the preparation before and after meal.
Polymic® dosage and duration of the treatment are depended on microorganism sensitivity, severity and type of infectious process. The dose for adults is 1 tablet two times per day during 5 days, then the treatment is prolonged for 2 – 5 days using ofloxacin tablets. The treatment should be prolonged not less then 3 days after disappearing of clinical symptoms.

Side effects and drug interactions.

ADVERSE REACTIONS:

Gastrointestinal tract:
nausea; vomiting, abdominal pain, metal taste, diarrhea (sometimes it may be a symptom of enterocolitis and in some cases it can be hemorrhagic one), appetite loss, dry mouth, anorexia, hypoglycemia in diabetes patients, who use hypoglycemic agents.

Central nervous system:
agitation; dizziness; headache; sleep disorders (insomnia or somnolence), anxiety, inquietude, mental confusion, tremor, convulsions, rigidity, temporal loss of consciousness, peripheral sensitivity disorders (paresthesia, incoordination, taste disorders, olfaction, visual impairment); hearing impairment (tinnitus or loss of hearing), photophobia, extrapiramidal disorders, intracranial pressure increase; in patients with decreased myoclonic threshold convulsive attacks are possible; nightmare, hallucinations, unsteady gait and tremor (caused by muscle disbalance), neuropathy; in isolated cases – psychotic reactions and depression, which are dangerous, especially suicidal idea or actions; it may be exacerbation of myasthenia gravis and dysphasia. Haemopoiesis: anaemia; hemolytic anemia, leukopenia, eosinophilia, thrombocytopenia, pancytopenia, agranulocytosis, granulocytopenia, depression of bone marrow formation, in isolated cases hemolytic anemia development is possible.

Kidney:
kidney dysfunction; in isolated cases – acute interstitial nephritis or increase of creatinine level in serum that can lead to severe kidney insufficiency, anuria, polyuria, kidney concrements, hematuria.

Liver:
increase of liver enzymes (ASAT, ALAT, LDG, GTH, alkaline phosphatase and gamma-glutamyl transferase) and bilirubin activity, cholestatic jaundice, in isolated cases – hepatitits, even of high degree one.
Specific form of enterocolitis that can be observed in antibiotics usage – pseudomembranous colitis (in most cases it is caused by Clostridiu difficile). In case of suspicion of Clostridiu difficile the preparation treatment should be immediately stopped and an adequate treatment should be carried out. Medicines, which depress peristalsis, should not be used in such cases.

Cardio-vascular system:
arterial hypotension, tachycardia; rarely – collapse (caused by arterial pressure decreasing), cerebral thrombosis, lungs edema, torsades de pointes. Muscular-skeletal system: tendinitis (especially in elderly patients), arthralgia, myalgia, tendon and muscle pain (in isolated cases it may be as symptoms of rabdomyolysis). Skin: skin rash, itch, photosensitization, edema, Quincke's edema, edema of tongue and/or larunx with possible asphyxia, rash after influence of long-term intensive solar radiation, multiform erythema, Stevens-Jonson syndrome, Lyell's syndrome and vasculitis (in isolated cases vasculitis can lead to skin lesions that is accompanied with necrolysis, and viscera may be included).

Allergic reactions:
anaphylaxis, for example, tachycardia, fever, short breath, shock, angioneurotic edema, vascular reactions, eosinophilia. In such cases it is necessary to withdraw the treatment immediately and to carry out a replacement therapy if there is a need. In isolated cases pneumonitis may occur. Reproductive system: vaginal candidiasis.
Respiratory system: short breath, bronchospasm, allergic pneumonitis, stridor.

Others:
asthenia, fever, vaginitis, level increase of triglyceride, cholesterol, lethargy, excessive increase or decrease of sugar level in blood, tendon discomfort, including tendon inflammation and tear (for example, Achilles tendon), especially in patients, which are concurrently treated by corticosteroids. In presence of signs of tendon inflammation the preparation therapy should be immediately discontinued and appropriate treatment for affected tendon should be administered.
It is not excluded a possibility of that Polymic® can cause porphyria attack in inclined patients. In addition, in isolated cases (for example, impairment of taste, hearing and olfaction) side effects disappeared after Polymic® therapy withdrawal.
It is also possible a hiccup, tunica mucosa of mouth painfulness, heartburn, increase of triglyceride, cholesterol and calcium levels in serum, petechia, ecchymosis/fruise, prothrombin time lengthening, thrombotic and thrombocytopenic purpura.


Drug interactions:
The preparation should be used not earlier than 4 hours after use of medicines, which contain magnesium, aluminum, iron, zinc and sucralfate.
In concurrent use of the preparation with probenecid, cimetidine, furosemide and methotrexate the excretion of Polymic® with urine is slowed, and a half life period and a risk of its toxic action are increased.
NSAIDs can intensify the preparation stimulating effect on central nervous system.
It intensifies coumarin anticoagulants action and prolonges myorelaxation, caused by vecuronium bromide.
In concurrent use of warfarin it is necessary to control coagulation parameters.
In concurrent use of peroral antidiabetic drugs glycemia parameters should be checked.
Concomitant administration of phenobarbital and other enzyme inductors decreases a period of ornidazol circulation in serum, while enzyme inductors (for example, cimetidine) increase it.
Theophylline concentration in blood and its half-life period can be increased in concurrent use of Polymic®.

Warnings and precautions

Administration during pregnancy and lactation:
It is not administered.
Children:
It is not administered.

Overdosage and Contraindications

Symptoms:
dizziness; mental confusion; somnolence, lethargy, disorientation; convulsions; gastro-intestinal tract reactions – nausea and vomiting, erosive lesions of stomach mucosa.

Treatment:
gastric lavage; enterosorbates, magnesium sulfate, antacids are used for protection of mucous coat of stomach. In case of convulsions it is recommended an intravenous introduction of diazepam.
Hemodialysis and peritoneal dialysis accelerate the preparation excretion. The treatment is symptomatic. There is no special antidote.

CONTRAINDICATIONS:
- hypersensitivity to the preparation components;
- hypersensitivity to fluoroquinolones derivatives;
- epilepsy; disseminated sclerosis;
- central nervous system lesions with decreased myoclonic threshold (after craniocerebral trauma, insult, inflammation process in cerebrum and meninx),
- patients with tendon tear after usage of fluoroquinolones in anamnesis;
- children age under 18 years old;
- pregnancy;
- lactation.

Clinical pharmacology.

PHARMACOLOGICAL PROPERTIES:

Pharmacodynamics:
In most of mixed infections, when it is present more than one kind of causative agent, it is necessary to carry out a combined therapy for full-fledged treatment. Combination of ofloxacin and ornidazole is the most effective in these cases.
Ofloxacin belongs to fluoroquinolones group. It has a wide spectrum of action. Bactericidal action of ofloxacin, as of other fluoroquinolones, is caused by its possibility to block bacterial DNA-hydrase enzyme.
Ofloxacin has a wide antibiotic spectrum against microorganisms resistant to penicillins, aminoglycosides, cephalosporins and bacteria with multiresistance.

Spectrum of action of Ofloxacin includes such kinds of microorganisms:

• aerobic gramnegative bacteria:
E. coli, Klebsiella spp., Salmonella spp., Proteus spp., Shigella spp., Yersinia spp., Enterobacter spp., Morganella morganii, Providencia spp., Vibrio spp., Citrobacter spp., Campylobacter spp., Ps. cepacia, Neisseria gonorrhoeae, N. meningitides, Haemophilus influenzae, Acinetobacter spp., Moraxella catarrhalis;

• aerobic grampositive bacteria:
staphylococcus, including strains producing and non-producing penicillinase, Streptococcus spp. (especially beta-haemolytic ones);

• Enterococcus faecalis
Streptococcus pneumoniae, Pseudomonas spp., Legionella spp., Serratia spp., Bacteriodes spp., Fusobacterium spp., Gardnerella vaqinalis, Ureaplasma urealiticum, Bruccella spp., M. tuberculosis, which are moderately sensitive to ofloxacin;
Anaerobic bacteria (except В.urealiticus), Тrероnеmа раllidum, viruses, fungi and protozoa are non-sensitive to ofloxacin.
Оrnidazole is an antiprotozoal and antibacterial agent, it is a derivative of 5-nitroimidazole. It is active against Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia (Giardia intestinalis) and against some anaerobic bacteria such as Bacteroides and Clostridium spp., and anaerobic coccus. By mechanism of action ornidazole is a DNA-tropic preparation with selective action against microorganisms, which have enzyme systems able to renew nitro group and to catalyze an interaction of proteins of ferredoxin group and nitro compounds. After preparation penetration into microbial cell it mechanism of action is caused by renewal of nitro group by influence of microorganism nitroreductase and by activity of having renewed nitroimidazole. Products of renewal form complexes with DNA, causing its degradation, and disturb processes of replication and transcription of DNA. In addition, products of metabolism of the preparation have cytotoxic properties and disturb process of cell respiration.

Pharmacokinetics:
It was not studied.
PHARMACEUTICAL CHARACTERISTICS:

General physical-chemical properties:
Capsule shaped, film coated, orange tablets with a break-line on one side.
Shelf-life:
3 years.
Storage conditions:
Store below 25° C. in dry place. Protect from direct sunlight.
Keep out of reach of children.

Package:
There are 10 tablets in a blister; 1 blister is in a carton box.
Conditions of supply:
By prescription.

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare
D-158A, OKHLA,INDUSTRIAL AREA,
PHASE-I, NEW DELHI,
Pin 110020
INDIA
Tel: 011-41005147, 011-40514919
Fax: +91-11-40527575