Malaysia Product

Serrata Tablets

Serrata Tablets

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:

Inflammation after operation and traumatic injury.

As concomitant therapy for elimination of inflammatory edema and swelling in the following diseases

Otorhinolaryngology..........................Sinusitis
Gynecology.........................................Engorgement of the breast
Urology................................................ Cystitis, epididymitis
Dentistry & Oral surgery................... Pericoronitis of the wisdom tooth, alveolar abscess

Inadequate expectoration of sputum in the following diseases.

Bronchitis, bronchial asthma, and concomitant therapy with antitubercular agents in pulmonary tuberculosis.

Inadequate expectoration of sputum after anesthesia.

When you should consult your doctor?

You should consult your doctor if you experience any of the following:
In isolated cases during the preparation administration it can be observed:
• Gastro-intestinal disorders: diarrhoea, nausea, vomiting, anorexia, and epigastric discomfort.
• Respiratory tract disorders: very rare it may be nasal bleeding and streaks of blood in sputum; in literature it was reported about the case of acute eosinophil pneumonia.
• In persons with hypersensitivity allergic reactions and skin rash are possible.

WHAT TO DO IF YOU MISS A DOSE?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Serrata.

The preparation should be carefully used in patients with risk of bleeding and with disorders of blood coagulation time and in patients used anticoagulants because of the drug influence on blood coagulation.

In case of severe liver and kidneys diseases the preparation should be used carefully.

Influence on velocity reactions while driving motor transport and operating other mechanisms:

It does not influence.

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

Symptoms: nausea, vomiting, anorexia, epigastric discomfort, in some cases – bleed streaks in sputum and bleeding.
Treatment: The treatment is symptomatic.

Is it safe in pregnancy and breast-feeding?

The preparation use during pregnancy and lactation periods is not recommended due to absence of clinical data.

Storage Conditions:

Store below 30°С.
Keep it out of reach of children.

Drug Description

Composition:
Each enteric coated tablet contains
Serratiopeptidase 10mg
(20,000 serratiopeptidase units)
Additional substances: Lactose monohydrate, Maize starch, Light magnesium carbonate, Sodium starch glycollate, magnesium stearate, Оpadry White, Оpadry Enteric White.

Pharmaceutical Form: Enteric coated tablet

Description: white, circular, biconvex enteric film coated tablets.


Indications and dosage.

Indications:

Inflammation after operation and traumatic injury.

As concomitant therapy for elimination of inflammatory edema and swelling in the following diseases

Otorhinolaryngology..........................Sinusitis
Gynecology.........................................Engorgement of the breast
Urology................................................ Cystitis, epididymitis
Dentistry & Oral surgery................... Pericoronitis of the wisdom tooth, alveolar abscess

Inadequate expectoration of sputum in the following diseases.

Bronchitis, bronchial asthma, and concomitant therapy with antitubercular agents in pulmonary tuberculosis.

Inadequate expectoration of sputum after anesthesia.

Dosage:
The preparation is administered in dose of 1 tablet 2–3 times per day after meal.
Tablets should be swallowed without chewing, following with 1 glass of water.
Maximal daily dose is 30 mg.
The duration of the treatment course depends on the character and dynamics of pathology and is determined individually.

Side effects and drug interactions.

Side effects: In isolated cases during the preparation administration it can be observed:
• Gastro-intestinal disorders: diarrhoea, nausea, vomiting, anorexia, and epigastric discomfort.
• Respiratory tract disorders: very rare it may be nasal bleeding and streaks of blood in sputum; in literature it was reported about the case of acute eosinophil pneumonia.
• In persons with hypersensitivity allergic reactions and skin rash are possible.

Drug interactions
In concurrent usage with anticoagulants the preparation intensifies their activity. Such combination should be used under careful medical supervision.

Warnings and precautions

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Serrata.

The preparation should be carefully used in patients with risk of bleeding and with disorders of blood coagulation time and in patients used anticoagulants because of the drug influence on blood coagulation.

In case of severe liver and kidneys diseases the preparation should be used carefully.


Overdosage and Contraindications

Overdosage:
Symptoms: nausea, vomiting, anorexia, epigastric discomfort, in some cases – bleed streaks in sputum and bleeding.
Treatment: The treatment is symptomatic.

 Contraindications
Hypersensitivity to Serratiopeptidase or other drugs components. Blood coagulation impairment.

Clinical pharmacology.

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for disorders of the musculo-skeletal system. Enzymes.
ATC Code: M09 AB

Pharmacodynamics: Serratiopeptidase is a proteolytic enzyme, which is extracted from nonpathogenic intestinal bacteria Serratia E15. It has a fibrinolytic, anti-inflammatory and anti-edema activity. Except decreasing of inflammatory process serratiopeptidase reduces a pain as a result of blocking of painful amine release from inflamed tissues.

Serratiopeptidase binds with blood alfa-2-macroglobulin in ratio 1:1, that masks its antigenicity, but it retains its enzyme activity. Then gradually it penetrates into exudate at the inflammation site and its level in blood is gradually decreased.
Serratiopeptidase directly reduces the capillaries dilatation and controls theirs penetrability via hydrolysis of bradykinin, histamine and serotonin. Serratiopeptidase also blocks plasmin inhibitors and therefore promotes plasmin fibrinolytic activity. Due to edema reducing and microcirculation improvement serratiopeptidase makes the expectoration easier.
Enzyme activity of the preparation is 10 times more than α-chemotrypsin. It very effectively hydrolises inflammatory mediators of polypeptide nature (bradykinin etc.), fibrin, but it does not influence on living organism proteins, such as albumin and α- and γ-globulin. The preparation does not split fibrinogen; therefore it does not have a significant influence on blood coagulation processes.

The preparation well penetrates into inflammatory sites, lyses necrotizing tissue and their disintegration product, eliminates hyperemia and enhances antibiotics penetration and activity. The preparation reduces viscosity of saliva and nasal discharge, therefore enhancing their extraction.

Pharmacokinetic properties
The preparation passes through stomach in unchanged form and is absorbed in intestine. Maximal concentration in plasma is reached in 1 hour. Serratiopeptidase is detected in urine in insignificant quantity.

Pharmaceutical characteristics:

Shelf-life:
24 months.

Dosage forms and packaging available:
Serrata tablet contains serratiopeptidase as an active ingredient & packed in alu-alu strip of 10 tablets, blister & strip of 30 tablets. 1 × 10, 3 × 10, 1 × 30 or 10 × 10 such strips are packed in carton along with pack insert.

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