Philippines Product

Diclotol Tablets

Diclotol Tablets

Why you have been prescribed this medicine?

You should consult your doctor if you experience any of the following:
Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

When you should consult your doctor?

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

Gastrointestinal:
The most commonly-observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.
Hypersensitivity: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angiodema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).

Cardiovascular and cerebrovascular:
Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.
Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events.
The majority of adverse reactions reported have been reversible and of a minor nature. The most frequent are gastro-intestinal disorders, in particular dyspepsia, abdominal pain, nausea and diarrhoea, and occasional occurrence of dizziness. Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.
Investigations: Abnormal hepatic enzyme and serum creatinine levels have also been reported.

Other adverse reactions reported less commonly include:
Renal: Nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome and renal failure.

Hepatic:
Abnormal liver function, hepatitis and jaundice.
Neurological and special senses: Visual disturbances, optic neuritis, headaches, paraesthesia, reports of aseptic meningitis with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation, depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise, fatigue and drowsiness.

Haematological:
Agranulocytosis, aplastic anaemia and haemolytic anaemia.

Dermatological:
Bullous reactions including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis (very rare). Photosensitivity.
If serious adverse reactions occur, Diclotol should be withdrawn.
The following is a table of adverse reactions reported during clinical studies and after authorization, grouped by System-Organ Class and estimated frequencies.

MedDRa SOC

Common

Uncommon

Rare

Very rare/ isolated reports

 

<10%->1%

<1%->0.1%

<G.1%->0.01%

< 0.01%

 

 

 

 

 

Blood and lymphatic

 

 

Anaemia

Granulocytopenia

system disorders

 

 

 

Thrombocytopenia

 

 

 

 

Neutropenia Haemolytic

 

 

 

 

anaemia

 

 

 

 

 

Immune system

 

 

Anaphylactic reaction

 

disorders

 

 

(including shock)

 

 

 

 

Hypersensitivity

 

 

 

 

 

 

Metabolism and nutrition

 

 

 

Hyperkalemia

disorders

 

 

 

 

Psychiatric disorders

 

 

 

Depression Abnormal dreams

 

 

 

 

Insomnia

Nervous system disorders

Dizziness

 

 

Paraesthesia Tremor

 

 

 

 

Somnolence Headache

 

 

 

 

Dysgeusia (abnormal taste)

Eye disorders

 

 

Visual disturbance

 

 

 

 

 

 

Ear and labyrinth disorders

 

 

 

Vertigo

Cardiac disorders

 

 

 

Palpitations

Vascular disorders

 

 

 

Flushing Hot flush

Respiratory, thoracic

 

 

Dyspnoea

Bronchospasm Stridor

and mediastinal disorders

 

 

 

 

 

 

 

 

 

Gastrointestinal disorders

Dyspepsia Abdominal

Flatulence Gastritis

Melaena

Stomatitis

 

pain Nausea Diarrhoea

Constipation Vomiting

 

Haematemesis

 

 

Mouth ulceration

 

Gastrointestinal haemorrhage

 

 

 

 

Gastric ulcer Pancreatitis

 

 

 

 

 

Hepatobiliary disorders

 

 

 

Hepatitis Jaundice

 

 

 

 

 

Skin and subcutaneous

 

Pruritus Rash

Face oedema

Purpura Dermatitis bullous

tissue disorders

 

Dermatitis Urticaria

 

 

 

 

 

 

 

Renal and urinary

 

 

 

Renal insufficiency

disorders

 

 

 

Nephrotic syndrome

 

 

 

 

 

General disorders and

 

 

 

Oedema Fatigue

administration site conditions

 

 

 

Cramps in legs

 

 

 

 

 

Investigations

Hepatic enzyme

Blood urea increased

 

Blood alkanine

 

increased

Blood creatinine

 

phosphatase increased

 

 

increased

 

Weight increase

 

 

 

 

 

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?

Hypersensitivity to aceclofenac or to any of the excipients.
Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
NSAIDs are contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs.
Severe heart failure, hepatic failure and renal failure
History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Aceclofenac should not be prescribed during pregnancy, especially during the last trimester of pregnancy, unless there are compelling reasons for doing so. The lowest effective dosage should be used.

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

Symptoms
Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal irritation, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, hypotension, respiratory depression, fainting, occasionally convulsions. In cases of significant poisoning acute renal failure and liver damage are possible.

Therapeutic measure
Patients should be treated symptomatically as required.
Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose.
Specific therapies such as dialysis or haemoperfusion are probable of no help in eliminating NSAIDs due to their high rate of protein binding and extensive metabolism.
Good urine output should be ensured.
Renal and liver function should be closely monitored.
Patients should be observed for at least four hours after ingestion of potentially toxic amounts.
In case of frequent or prolonged convulsions, patients should be treated with intravenous diazepam.
Other measures may be indicated by the patient's clinical condition.
Management of acute poisoning with NSAIDs essentially consists of supportive and symptomatic measures.

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:

STORAGE CONDITION
Store at temperatures not exceeding 30°C.

Drug Description

FORMULATION
Each film-coated tablet contains:
Aceclofenac ………… 100 mg
DESCRIPTION
White, circular, biconvex film coated tablets.

Indications and dosage.

THERAPEUTIC INDICATIONS
Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

RECOMMENDED DOSE
Adults
The recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening.

Children
There are no clinical data on the use of Aceclofenac tablets in children and therefore it is not recommended for use in children under 18 years of age.

Elderly
If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.
The pharmacokinetics is not altered in elderly patients, therefore it is not necessary to modify the dose or dose frequency.

Renal insufficiency
There is no evidence that the dosage of Aceclofenac needs to be modified in patients with mild renal impairment, but as with other NSAIDs caution should be exercised.

Hepatic insufficiency
There is some evidence that the dose of Aceclofenac should be reduced in patients with hepatic impairment and it is suggested that an initial daily dose of 100 mg be used.

MODE OF ADMINISTRATION
Aceclofenac (Diclotol) tablets should be swallowed whole with a sufficient quantity of liquid. To be taken preferably with or after food.

Absolute contraindications:
Not to be given to those patients who have history of: - Stroke:
cerebrovascular accident CVA
- Heart attack: Myocardial Infarction, MI
- Coronary Artery bypass graft, CABG
- Congestive heart failure (CHF) NYHA II-IV

Side effects and drug interactions.

ADVERSE REACTIONS:
Gastrointestinal:
The most commonly-observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.
Hypersensitivity: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angiodema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).

Cardiovascular and cerebrovascular:
Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.
Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events.
The majority of adverse reactions reported have been reversible and of a minor nature. The most frequent are gastro-intestinal disorders, in particular dyspepsia, abdominal pain, nausea and diarrhoea, and occasional occurrence of dizziness. Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.
Investigations: Abnormal hepatic enzyme and serum creatinine levels have also been reported.

Other adverse reactions reported less commonly include:
Renal: Nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome and renal failure.

Hepatic:
Abnormal liver function, hepatitis and jaundice.
Neurological and special senses: Visual disturbances, optic neuritis, headaches, paraesthesia, reports of aseptic meningitis with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation, depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise, fatigue and drowsiness.

Haematological:
Agranulocytosis, aplastic anaemia and haemolytic anaemia.

Dermatological:
Bullous reactions including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis (very rare). Photosensitivity.
If serious adverse reactions occur, Diclotol should be withdrawn.
The following is a table of adverse reactions reported during clinical studies and after authorization, grouped by System-Organ Class and estimated frequencies.

MedDRa SOC

Common

Uncommon

Rare

Very rare/ isolated reports

 

<10%->1%

<1%->0.1%

<G.1%->0.01%

< 0.01%

 

 

 

 

 

Blood and lymphatic

 

 

Anaemia

Granulocytopenia

system disorders

 

 

 

Thrombocytopenia

 

 

 

 

Neutropenia Haemolytic

 

 

 

 

anaemia

 

 

 

 

 

Immune system

 

 

Anaphylactic reaction

 

disorders

 

 

(including shock)

 

 

 

 

Hypersensitivity

 

 

 

 

 

 

Metabolism and nutrition

 

 

 

Hyperkalemia

disorders

 

 

 

 

Psychiatric disorders

 

 

 

Depression Abnormal dreams

 

 

 

 

Insomnia

Nervous system disorders

Dizziness

 

 

Paraesthesia Tremor

 

 

 

 

Somnolence Headache

 

 

 

 

Dysgeusia (abnormal taste)

Eye disorders

 

 

Visual disturbance

 

 

 

 

 

 

Ear and labyrinth disorders

 

 

 

Vertigo

Cardiac disorders

 

 

 

Palpitations

Vascular disorders

 

 

 

Flushing Hot flush

Respiratory, thoracic

 

 

Dyspnoea

Bronchospasm Stridor

and mediastinal disorders

 

 

 

 

 

 

 

 

 

Gastrointestinal disorders

Dyspepsia Abdominal

Flatulence Gastritis

Melaena

Stomatitis

 

pain Nausea Diarrhoea

Constipation Vomiting

 

Haematemesis

 

 

Mouth ulceration

 

Gastrointestinal haemorrhage

 

 

 

 

Gastric ulcer Pancreatitis

 

 

 

 

 

Hepatobiliary disorders

 

 

 

Hepatitis Jaundice

 

 

 

 

 

Skin and subcutaneous

 

Pruritus Rash

Face oedema

Purpura Dermatitis bullous

tissue disorders

 

Dermatitis Urticaria

 

 

 

 

 

 

 

Renal and urinary

 

 

 

Renal insufficiency

disorders

 

 

 

Nephrotic syndrome

 

 

 

 

 

General disorders and

 

 

 

Oedema Fatigue

administration site conditions

 

 

 

Cramps in legs

 

 

 

 

 

Investigations

Hepatic enzyme

Blood urea increased

 

Blood alkanine

 

increased

Blood creatinine

 

phosphatase increased

 

 

increased

 

Weight increase

 

 

 

 

 


Drug Interactions
Other analgesics including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects.
Anti-hypertensives:
Reduced anti-hypertensive effect.
Diuretics: Reduced diuretic effect. Diuretics can increase the risk of nephrotoxicity of NSAIDs. Although it was not shown to affect blood pressure control when co-administered with bendrofluazide, interactions with other diuretics cannot be ruled out. When concomitant administration with potassium-sparing diuretics is employed, serum potassium should be monitored.
Cardiac glycosides:
NSAIDs may exacerbate cardiac failure, reduce GFR (glomerular filtration rate) and increase plasma glycoside levels. Lithium: Decreased elimination of lithium

Methotrexate: Decreased elimination of methotrexate. Caution should be exercised if NSAIDs and methotrexate are administered within 24 hours of each other, since NSAIDs may increase plasma levels, resulting in increased toxicity.
Ciclosporin: Increased risk of nephrotoxicity.
Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone. Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding.
Anti-coagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin. Close monitoring of patients on combined anti-coagulants and Aceclofenac (Diclotol) therapy should be undertaken.
Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs):
Increased risk of gastrointestinal bleeding.

Warnings and precautions

Pregnancy and lactation:
Pregnancy:
Congenital abnormalities have been reported in association with NSAID administration in man; however, these are low in frequency and do not appear to follow any discernible pattern. In view of the known effects of NSAIDs on the foetal cardiovascular system (risk of closure of the ductus arteriosus) and on the possible risk of persistent pulmonary hypertension of the new born, use in the last trimester of pregnancy is contraindicated. The regular use of NSAIDs during the last trimester of pregnancy may decrease uterine tone and contraction. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child. NSAIDs should not be used during the first two trimesters of pregnancy or labour unless the potential benefit to the patient outweighs the potential risk to the foetus.
Animal studies indicate that there was no evidence of teratogenesis in rats although the systemic exposure was low and in rabbits, treatment with aceclofenac (10 mg/kg/day) resulted in a series of morphological changes in some foetuses.

Lactation:
In limited studies so far available, NSAIDs can appear in breast milk in very low concentrations. NSAIDs should, if possible, be avoided when breastfeeding.

The use of Aceclofenac should therefore be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the foetus.

Effects on ability to drive and use machines
Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.

PRECAUTIONS
Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
The use of Aceclofenac (Diclotol) with concomitant NSAIDs including cyclooxygenase- 2 selective inhibitors should be avoided.

Elderly:
The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.

Respiratory disorders:
Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients.

Cardiovascular, Renal and Hepatic Impairment:
The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. Renal function should be monitored in these patients.

Renal:
The importance of prostaglandins in maintaining renal blood flow should be taken into account in patients with impaired cardiac or renal function, those being treated with diuretics or recovering from major surgery. Effects on renal function are usually reversible on withdrawal of Aceclofenac tablets.

Hepatic:
If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur, Aceclofenac (Diclotol) tablets should be discontinued. Close medical surveillance is necessary in patients suffering from mild to moderate impairment of hepatic function. Hepatitis may occur without prodromal symptoms.
Use of Aceclofenac tablets in patients with hepatic porphyria may trigger an attack.
Cardiovascular and cerebrovascular effects:
Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.
Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with aceclofenac after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).

Gastrointestinal bleeding, ulceration and perforation:
GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.
Close medical surveillance is imperative in patients with symptoms indicative of gastro-intestinal disorders, with a history suggestive of gastrointestinal ulceration, with ulcerative colitis or with Crohn's disease, bleeding diathesis or haematological abnormalities.
The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk.

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or antiplatelet agents such as aspirin.
When GI bleeding or ulceration occurs in patients receiving aceclofenac, the treatment should be withdrawn.
NSAIDs should be given with care to patients with a history of gastrointestinal disease as these conditions may be exacerbated.

SLE and mixed connective tissue disease:
In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis.

Dermatological:
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Aceclofenac should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Impaired female fertility:
The use of Aceclofenac may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Aceclofenac should be considered.

Hypersensitivity reactions:
As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur without earlier exposure to the drug.

Overdosage and Contraindications

OVERDOSES AND TREATMENT
Symptoms
Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal irritation, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, hypotension, respiratory depression, fainting, occasionally convulsions. In cases of significant poisoning acute renal failure and liver damage are possible.

Therapeutic measure
Patients should be treated symptomatically as required.
Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose.
Specific therapies such as dialysis or haemoperfusion are probable of no help in eliminating NSAIDs due to their high rate of protein binding and extensive metabolism.
Good urine output should be ensured.
Renal and liver function should be closely monitored.
Patients should be observed for at least four hours after ingestion of potentially toxic amounts.
In case of frequent or prolonged convulsions, patients should be treated with intravenous diazepam.
Other measures may be indicated by the patient's clinical condition.
Management of acute poisoning with NSAIDs essentially consists of supportive and symptomatic measures.

CONTRAINDICATIONS
Hypersensitivity to aceclofenac or to any of the excipients.
Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
NSAIDs are contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs.
Severe heart failure, hepatic failure and renal failure.
History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Aceclofenac should not be prescribed during pregnancy, especially during the last trimester of pregnancy, unless there are compelling reasons for doing so. The lowest effective dosage should be used.

Clinical pharmacology.

PHARMACOKINETICS
After oral administration, aceclofenac is rapidly and completely absorbed as unchanged drug. Peak plasma concentrations are reached approximately 1.25 to 3.00 hours following ingestion. Aceclofenac penetrates into the synovial fluid, where the concentrations reach approximately 57% of those in plasma. The volume of distribution is approximately 25 L.
The mean plasma elimination half-life is around 4 hours. Aceclofenac is highly protein bound (>99%). Aceclofenac circulates mainly as unchanged drug. 4' Hydroxyaceclofenac is the main metabolite detected in plasma. Approximately two thirds of the administered dose is excreted via the urine, mainly as hydroxymetabolites.
No changes in the pharmacokinetics of aceclofenac have been detected in the elderly.

PHARMACODYNAMICS
THERAPEUTIC INDICATIONS
Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

STORAGE CONDITION
Store at temperatures not exceeding 30°C.
DOSAGE FORMS AND PACKAGING AVAILABLE
Aceclofenac (Diclotol) 100 mg Film-Coated Tablet Alu/Alu blister Pack of 10's (Box of 50's)
CAUTION
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.
NAME AND ADDRESS OF MANUFACTURER
Kusum Healthcare Private Limited
SP-289(A) RIICO Indl. Area, Chopanki
(Bhiwadi), Distt- Alwar, Rajasthan, INDIA
IMPORTED AND DISTRIBUTED BY
S.M.H.P Marketing & Consultancy
G/F Manor Bldg. 2629 Taft Avenue,
Malate, Manila, PHILIPPINES
DATE OF REVISION OF PACKAGE INSERT
Not Applicable

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