India Product

Suredas d tablets

Suredas d tablets

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:
Pain with swelling.
Post-surgical Inflammation.
Post-surgical Oedema.
Sprain & Strain.

When you should consult your doctor?

You should consult your doctor if you experience any of the following:
Blood and lymphatic system:
Thrombocytopenia, neutropenia, leukopenia, anemia, including aplastic anemia, hemolytic anemia (especially for patients with glucose-6-phosphate dehydrogenase deficiency), sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, pain in the heart), agranulocytosis, pancytopenia.

Immune system:
hypersensitivity reactions, anaphylactic/anaphylactoid reactions, including hypotension and anaphylactic shock, angioedema (including facial edema).

Mental disorders:
Disorientation, depression, sleep disturbance, insomnia, nightmares, irritability, restlessness, apprehension, psychotic disorders, confusion, psychomotor agitation.

Nervous system:
Headache, dizziness, somnolence, paresthesia, sleep disturbance, insomnia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, dysgeusia, cerebrovascular disease.

Visual organs:
visual impairment, blurred vision, diplopia.

Organs of hearing:
Vertigo, tingling, tinnitus, dysacousia.
Cardiovascular system: palpitation, tachycardia, shortness of breath, pain in the heart, cardiac failure, myocardial infarction, arterial hypertension, vasculitis.

Respiratory system:
Bronchial asthma (including shortness of breath), bronchospasm (especially in patients sensitive to acetylsalicylic acid), pain in the chest, pneumonitis, 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.

Digestive tract:
Nausea, vomiting, diarrhea, dyspepsia, anorexia, abdominal pain, meteorism; gastritis, gastrointestinal bleeding, vomiting with blood, hemorrhagic diarrhea, melena, stomach or intestinal ulcer (with/without bleeding or perforation), colitis (including hemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis, glossitis, disorders of the esophagus, diaphragm-like intestinal strictures, pancreatitis.

Hepatobiliary system:
elevated transaminases; hepatic failure, hepatitis, hepatic necrosis, jaundice, hepatic disorders, fulminant hepatitis.

Skin and subcutaneous structures:
Itching sensation, skin rash, erythema, rash on the mucous membranes, urticaria, bullous rash, eczema, exudative erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, allergic dermatitis, hair loss, photosensitivity reaction, purpura, allergic purpura, pruritus.

Urinary system:
acute renal failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis, fluid retention.

General disorders:
Edema, asthenia, hyperhidrosis, hypoglycemia, even coma.
Diclofenac, especially in high doses (150 mg/day) and in long-term use may increase the risk of arterial thrombembolia (such as myocardial infarction or stroke).


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?

General Concomitant use with other systemic NSAIDs, such as selective COX-2 inhibitors, should be avoided due to the lack of any evidence of synergic effect and because of the possible additive adverse effects. Caution should be exercised in elderly patients. In particular, it is recommended to use the lowest effective dose in weak elderly patients with low body weight.

Bronchial asthma in anamnesis
In patients with bronchial asthma, seasonal allergic rhinitis, chronic obstructive pulmonary diseases or chronic respiratory tract infections (especially those associated with allergic symptom like rhinitis), such reactions to NSAIDs as exacerbation of asthma (so called intolerance to analgesics/analgesic asthma), Quincke's edema or urticaria occur more often. Therefore, special measures are recommended for such patients (readiness for emergency action), as well as for the patients with allergic reactions, such as rash, itching, urticaria, to other substances.

Effect on digestive tract
As well as when using other NSAIDs, including diclofenac, medical supervision and special caution are obligatory in patients with the symptoms indicating digestive tract (DT) disorders or with the history of gastric or intestinal ulcer, bleeding or perforation. Risk of bleeding in the digestive tract grows with the increasing dose in patients with the history of ulcer, especially with complications, such as bleeding or perforation, and in elderly patients. To decrease the risk of such toxic effect on digestive tract, the treatment should be started and maintained with the lowest effective doses. For such patients, as well as those requiring concomitant use of drugs containing low doses of acetylsalicylic acid (ASA) or other drugs which are supposed to increase the risk of adverse effect on DT, the use of combined therapy with protective agents (e.g. proton pump inhibitors or misoprostol) should be considered. Patients with the history of gastro-intestinal toxicity, especially elderly patients, should report any unusual abdominal symptoms (especially bleeding in the digestive tract). Caution should also be exercised in patients concomitantly receiving drugs which may increase the risk of ulcer or bleeding, such as systemic corticosteroids, anticoagulants, antithrombotic agents or selective serotonin reuptake inhibitors.

Effect on liver
Careful medical supervision is required when using diclofenac in patients with impaired liver function, as their condition may aggravate.
As well as when using other NSAIDs, including diclofenac, the level of one or several enzymes may increase. The increased enzyme levels as a rule are restored after withdrawal of the drug.
During a long-term drug therapy, regular monitoring of liver function and levels of liver enzymes is prescribed as a precaution. If liver dysfunction persists or aggravates, and clinical manifestations or symptoms may be associated with progressing liver diseases, and there are other manifestations (e.g. eosinophilia, rash) the drug should be withdrawn. The course of diseases, such as hepatitis, may take place without prodromal symptoms. Caution should be exercised in case if the drug is used in patients with hepatic porphyria, due to the likelihood of provoking an attack.

Effect on kidneys
Long-term treatment with high doses of NSAIDs, including diclofenac, often (1-10%) causes edema and arterial hypertension. Special attention should be paid to the patients with the history of impaired cardiac and renal function, arterial hypertension, elderly patients receiving concomitant treatment with diuretics, which have a significant effect on renal function, as well as to the patients with a significant decrease in extracellular fluid volume for any reason, for example, before or after major surgery. In such cases, monitoring of renal function is recommended as a caution. Discontinuation of the therapy results in a return to the condition which preceded the treatment.

Effect on hematological indices
In long-term use of this drug, like other NSAIDs, complete blood count monitoring is recommended. Like other NSAIDs, the drug may temporarily inhibit platelet aggregation. Patients with impaired hemostasis should be carefully monitored. Serratiopeptidase influence on blood coagulation so preparation should be administered with caution in patients with risk of bleeding and with disorders of blood coagulation time and in patients on anticoagulants.

Do not exceed the indicated doses.
Take into account that in patients with alcoholic non cirrhotic liver damage the risk of hepatotoxic effect of paracetamol is increased; the drug may affect the results of laboratory tests of blood glucose and uric acid levels.

Do not use the drug concomitantly with other drugs containing paracetamol of diclofenac.
The preparation should be administered with caution 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 with caution.

Drug interactions:
Diclofenac.
Lithium, digoxin.
The drug may increase plasma concentrations of lithium and digoxin. Monitoring of plasma concentrations of lithium and digoxin is recommended.

Diuretic and antihypertensive agents.When used concomitantly with diuretics of antihypertensive agents, such as beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, the drug, like other NSAIDs, may decrease their hypotensive effect. Therefore, combination of such drugs should be administered with caution, and blood pressure should be monitored in patients (especially in elderly patients). The patients should consume sufficient amount of water, and after the start and termination of concomitant treatment, renal function should be periodically monitored, in particular when using diuretics and ACE inhibitors due to the increased risk of nephrotoxicity. Concomitant use of potassium-sparing diuretics may increase serum potassium level; therefore, patients concomitantly using such drugs should control serum potassium level.

Other NSAIDs and corticosteroids.Concomitant use of the drug with other HSAIDs of corticosteroids may increase the frequency of gastrointestinal adverse effects. It is recommended to avoid concomitant use of the drug with other NSAIDs, including COX-2 selective inhibitors, due to the lack of any evidence of possible benefit from the synergistic action.
Anticoagulants and antiplatelet agents.Regular concomitant use of the drug with anticoagulants, especially with warfarin and other coumarins and antiplatelet agents, may increase the risk of bleedings. Therefore, in case of such combination of drugs, thorough and regular medical supervision is recommended.
Selective serotonin reuptake inhibitors (SSRIs).Concomitant use of NSAIDs and SSRIs may increase the risk of gastrointestinal bleeding.
Antidiabetic agents.Concomitant use of the drug and antidiabetic agents does not alter efficacy of the latter. However, there are isolated reports about hypoglycemia, as well as hyperglycemia, which necessitated dosage adjustment of hypoglycemic agents. Therefore, during Fanigan therapy blood glucose level should be monitored. Methotrexate.Caution should be exercised when using NSAIDs less than 24 hours before or after using methotrexate, as in such cases methotrexate concentration in blood, and its toxic effect may increase. Drugs stimulating the enzymes which metabolize medicinal products.The drugs stimulating the enzymes, such as rifampicin, carbamazepine, phenytoin, St. John's wort (Hypericumperforatum) etc. theoretically are able to decrease plasma concentrations of diclofenac.
Colestipol and cholestyramine. Concomitant use of Fanigan and Colestipol or cholestyramine reduces absorption of diclofenac approximately by 30% and 60%, respectively.
Cyclosporine.The effect of NSAIDs on prostaglandins synthesis in the kidneys may increase nephrotoxicity of cyclosporine; therefore, the drug dosage should be reduced when prescribing cyclosporine. Antibacterial agents - quinolone derivatives.There are isolated reports about convulsions in patients receiving concomitantly quinolone derivatives and NSAIDs.

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

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

Diclofenac:
There is no typical clinical presentation characteristic of diclofenac overdose. Overdose may cause vomiting, gastrointestinal bleeding, diarrhea, vertigo, tinnitus and convulsions. Acute renal failure and hepatic damage are possible in case of severe intoxication.

Serratiopeptidase:
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?

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 in dry, protected from sun light place at the temperature not more than 25С.
Keep it out of reach of children.

Drug Description

Active substance:
Serratiopeptidase; diclofenac sodium.
1 tablet contains serratiopeptidase 10 mg, diclofenac sodium 50 mg.

Excipients:
Maize Starch, Light Magnesium Carbonate, Lactose Monohydrate, Sodium Starch Glycolate, MCC PH 102, Cross Carmellose Sodium, PVP K-30.

Indications and dosage.

INDICATIONS:
Pain with swelling.
Post-surgical Inflammation.
Post-surgical Oedema.
Sprain & Strain.

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.

ADVERSE REACTIONS:
Blood and lymphatic system: thrombocytopenia, neutropenia, leukopenia, anemia, including aplastic anemia, hemolytic anemia (especially for patients with glucose-6-phosphate dehydrogenase deficiency), sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, pain in the heart), agranulocytosis, pancytopenia. Immune system: hypersensitivity reactions, anaphylactic/anaphylactoid reactions, including hypotension and anaphylactic shock, angioedema (including facial edema).

Mental disorders:
disorientation, depression, sleep disturbance, insomnia, nightmares, irritability, restlessness, apprehension, psychotic disorders, confusion, psychomotor agitation.

Nervous system:
Headache, dizziness, somnolence, paresthesia, sleep disturbance, insomnia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, dysgeusia, cerebrovascular disease.

Visual organs:
visual impairment, blurred vision, diplopia.

Organs of hearing:
Vertigo, tingling, tinnitus, dysacousia.
Cardiovascular system:
Palpitation, tachycardia, shortness of breath, pain in the heart, cardiac failure, myocardial infarction, arterial hypertension, vasculitis.

Respiratory system:
Bronchial asthma (including shortness of breath), bronchospasm (especially in patients sensitive to acetylsalicylic acid), pain in the chest, pneumonitis, 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.

Digestive tract:
Nausea, vomiting, diarrhea, dyspepsia, anorexia, abdominal pain, meteorism; gastritis, gastrointestinal bleeding, vomiting with blood, hemorrhagic diarrhea, melena, stomach or intestinal ulcer (with/without bleeding or perforation), colitis (including hemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis, glossitis, disorders of the esophagus, diaphragm-like intestinal strictures, pancreatitis.

Hepatobiliary system:
elevated transaminases; hepatic failure, hepatitis, hepatic necrosis, jaundice, hepatic disorders, fulminant hepatitis.

Skin and subcutaneous structures:
Itching sensation, skin rash, erythema, rash on the mucous membranes, urticaria, bullous rash, eczema, exudative erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, allergic dermatitis, hair loss, photosensitivity reaction, purpura, allergic purpura, pruritus.

Urinary system:
Acute renal failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis, fluid retention.

General disorders:
Edema, asthenia, hyperhidrosis, hypoglycemia, even coma.
Diclofenac, especially in high doses (150 mg/day) and in long-term use may increase the risk of arterial thrombembolia (such as myocardial infarction or stroke).

Drug interactions: Diclofenac.
Lithium, digoxin.The drug may increase plasma concentrations of lithium and digoxin. Monitoring of plasma concentrations of lithium and digoxin is recommended.
Diuretic and antihypertensive agents.When used concomitantly with diuretics of antihypertensive agents, such as beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, the drug, like other NSAIDs, may decrease their hypotensive effect. Therefore, combination of such drugs should be administered with caution, and blood pressure should be monitored in patients (especially in elderly patients). The patients should consume sufficient amount of water, and after the start and termination of concomitant treatment, renal function should be periodically monitored, in particular when using diuretics and ACE inhibitors due to the increased risk of nephrotoxicity. Concomitant use of potassium-sparing diuretics may increase serum potassium level; therefore, patients concomitantly using such drugs should control serum potassium level.
Other NSAIDs and corticosteroids.Concomitant use of the drug with other HSAIDs of corticosteroids may increase the frequency of gastrointestinal adverse effects. It is recommended to avoid concomitant use of the drug with other NSAIDs, including COX-2 selective inhibitors, due to the lack of any evidence of possible benefit from the synergistic action.
Anticoagulants and antiplatelet agents.Regular concomitant use of the drug with anticoagulants, especially with warfarin and other coumarins and antiplatelet agents, may increase the risk of bleedings. Therefore, in case of such combination of drugs, thorough and regular medical supervision is recommended. Selective serotonin reuptake inhibitors (SSRIs).Concomitant use of NSAIDs and SSRIs may increase the risk of gastrointestinal bleeding.
Antidiabetic agents.Concomitant use of the drug and antidiabetic agents does not alter efficacy of the latter. However, there are isolated reports about hypoglycemia, as well as hyperglycemia, which necessitated dosage adjustment of hypoglycemic agents. Therefore, during Fanigan therapy blood glucose level should be monitored. Methotrexate.Caution should be exercised when using NSAIDs less than 24 hours before or after using methotrexate, as in such cases methotrexate concentration in blood, and its toxic effect may increase. Drugs stimulating the enzymes which metabolize medicinal products.The drugs stimulating the enzymes, such as rifampicin, carbamazepine, phenytoin, St. John's wort (Hypericumperforatum) etc. theoretically are able to decrease plasma concentrations of diclofenac.
Colestipol and cholestyramine. Concomitant use of Fanigan and Colestipol or cholestyramine reduces absorption of diclofenac approximately by 30% and 60%, respectively.
Cyclosporine.The effect of NSAIDs on prostaglandins synthesis in the kidneys may increase nephrotoxicity of cyclosporine; therefore, the drug dosage should be reduced when prescribing cyclosporine. Antibacterial agents - quinolone derivatives.There are isolated reports about convulsions in patients receiving concomitantly quinolone derivatives and NSAIDs.

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

Warnings and precautions

Overdosage and Contraindications

OVERDOSAGE
Diclofenac:
There is no typical clinical presentation characteristic of diclofenac overdose. Overdose may cause vomiting, gastrointestinal bleeding, diarrhea, vertigo, tinnitus and convulsions. Acute renal failure and hepatic damage are possible in case of severe intoxication.

Serratiopeptidase:
Symptoms:
nausea, vomiting, anorexia, epigastric discomfort, in some cases – bleed streaks in sputum and bleeding.

Treatment:
The treatment is symptomatic.

CONTRAINDICATIONS:
> Hypersensitivity to diclofenac, Serratiopeptidase or to any other component of the drug.
> Acute gastric or intestinal ulcer; gastrointestinal bleeding or perforation.
> Severe hepatic failure (Child-Pugh grade C, cirrhosis or ascites).
> Severe kidney failure (creatinine clearance < 30 mL/min).
> Severe cardiac failure (СН III-IV).
> Patients who respond to diclofenac, paracetamol, aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) with bronchial asthma ("aspirin asthma"), urticaria or acute rhinitis, nasal polyps, and other allergic symptoms.
> Violation of hematopoiesis of unknown origin.
> Leukopenia.
> Moderate and severe anemia.
> Congenital hyperbilirubinemia.
> Glucose-6-phosphate dehydrogenase deficiency.
> Patients who have history of gastrointestinal bleeding or perforation, related to the use of nonsteroidal anti-inflammatory drugs.
> Inflammatory bowel disease (Crohn's disease or ulcerative colitis).
> Alcoholism.
> Treatment of postsurgical pain after coronary artery bypass surgery (or using cardiopulmonary bypass).

Clinical pharmacology.

Clinical pharmacology.
PHARMACOLOGICAL PROPERTIES:
Pharmacodynamics:
Suredase – D is a combined drug with a pronounced anti-inflammatory, analgesic and proteolytic effect.
Pharmacological activity of the drug is due to the properties of diclofenac and Serratiopeptidase, which are the components of the drug.

Diclofenac sodium has a pronounced anti-inflammatory and analgesic, and a moderate antipyretic effect. Paracetamol has a pronounced analgesic, slight antipyretic and anti-inflammatory effect. The mechanism of action is associated with inhibition of prostaglandin synthesis.
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.

Pharmacokinetics:
Diclofenac:
After the intake, the drug is rapidly and completely absorbed. Food has no effect on absorption of the drug. Plasma concentrations of active substances are linearly dependent on the dose; the maximum levels are reached in 60-90 minutes after ingestion.
Binding of diclofenac to plasma proteins (mainly albumin) reaches 99.7%. The expected volume of distribution is 0.12-0.17 L/kg. Diclofenac penetrates into synovial liquid, where its maximum concentration is reached 2-4 hours later than in blood plasma. The half-life for elimination from the synovial fluid is 3-6 hours. Diclofenac is metabolized by glucuronidation of unchanged molecule and methoxylation, which forms several phenolic metabolites, the biological activity of which is considerably inferior to the activity of the parent substance.
General plasmatic clearance of diclofenac is approximately 300 mL/min. Terminal half-life is 1-2 hours. 60% of the administered dose is excreted in the urine as glucuronic conjugates of unchanged diclofenac; the rest is excreted in the bile and feces.
Serratiopeptidase:
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:
General physic-chemical properties: White to off white, round shape, biconvex, enteric coated tablets plain on both sides.

Shelf-life:
3 years.

Storage:
Store in dry, protected from sun light place at the temperature not more than 25С.
Keep it out of reach of children.

Package:
10 tablets are in a strip, 1 strip is in a carton pack.

Conditions of supply.
By prescription.

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare Pvt Ltd

Regd. Office: D-158A, Okhla Industrial Area

Phase-1, New Delhi-110020, India

Tel: 011-41005147, 40514919

Fax: +91-11-40527575

Email: kusumhealth@kusumhealthcare.com

CIN: U65929DL1997PTC085780