Malasiya Product

Diclotol Tablets

Diclotol Tablets

Why you have been prescribed this medicine?

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

When you should consult your doctor?

You should consult your doctor if you experience any of the following:
Usually the preparation is well tolerated. During a long-term usage of high doses there can be possible follow side effects:

GIT:
nausea, vomiting, heartburn, diarrhea.

CNS:
hyperexcitability of CNS, headache.

Urinary system:
formation of urinary, cystine and oxalate concernments.
Skin and subcutaneous tissue: allergic reactions.

Blood system:
It can cause erythrocyte hemolysis in patients with insufficiency of glucose-6-phosphatdehydrogenase of hematocytes.

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?

Ascozin® increases salicylates (increases a risk of crystalluria), ethynilestradiol, benzylpenicillin and tetracyclines concentrations in blood, and decreases per oral contraceptives concentration in blood. It reduces anticoagulation effect of coumarin derivatives. It improves iron drugs absorption in intestine. It increases general clearance of ethyl alcohol. Quinolone drugs, calcium chloride, salicylate, corticosteroid decrease vitamin C reserve when used for a long term. Corticosteroids (cortisone and prednisolone), which are administered in concrete diseases (arthritis, bronchial astma etc), also reduce vitamin C and zinc levels.
Concurrent usage of ascorbic acid and deferoxamine enhances tissue toxicity of iron, especially in cardiac muscle that can cause decompensation of blood circulatory system. It can be used only in 2 hours after deferoxamine injection. A long-term administration of high doses in patients, who are treated by disulfiram, inhibits disulfamide-alcohol reaction.
High doses of the preparation decrease efficacy of tricyclic depressants.

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

Symptoms:
nausea, vomiting, intestine spasm, diarrhea; it is possible allergic reaction, kidney dysfunction, blood pressure increase, hyperexcitability of CNS, sleep disturbance.

Treatment:
It 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 a dry, protected from light place at a temperature not more than 25° C.
Keep it out of reach of children.

Drug Description

COMPOSITION:

Each lm-coated tablet contains: Aceclofenac EP ………… 100 mg Excipients: Microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, stearic acid, opadry white, isopropyl alcohol and dichloromethane.

Indications and dosage.

INDICATIONS:
Adults: The recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one tablet in the evening. Children: No clinical data on the use of Aceclofenac tablets in children and therefore it is not recommended for use in children. Elderly: The elderly, who are more likely to be suffering from impaired renal, cardiovascular or hepatic function and receiving concomitant medication, are at increased risk of the serious consequences of adverse reactions. 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 insufciency: There is no evidence that the dosage of Aceclofenac needs to be modied in patients with mild renal impairment, but as with other NSAIDs caution should be exercised. Hepatic insufciency: 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 Diclotol tablets should be swallowed whole with a sufcient quantity of liquid. To be taken preferably with or after food.

Side effects and drug interactions.

ADVERSE REACTIONS:

“Inform doctors about unexpected reactions after using drugs.”.

SOCMedDRa

Common
>1/100,
<1/10

Uncommon
>1/1000, <1/100

 
Rare
>1/10000, <1/1000

Very rare / occasionally <1/10000

Haemopoiesis and lymphatic system disorders

 

 

Anemia

Granulocytopenia, thrombocytopenia, neutropenia, hemolytic anemia

Immune system disorders

 

 

Anaphylactoid reactions (including shock), hypersensitivity

 

Metabolic and nutritional disorders

 

 

 

Hyperpotassemia

Psychiatric disorders

 

 

 

Depression, unusual dreams, insomnia

Central nervous system disorders

Dizziness

 

 

Paresthesia, tremor, somnolence, headache, dysgeusia (taste impairments)

Vision disorders

 

 

Vision impairments

 

Ear and labyrinth disorders

 

 

 

Vertigo, tinnitus

Heart disorders

 

 

Arterial hypertension, complicated arterial hypertension, heart failure

Palpitation

Vascular disorders

 

 

 

Hyperemia, flush, vasculitis

Respiratory system and mediastinal disorders

 

 

Wheeze

Bronchospasm, stridor

Gastrointestinal tract disorders

Dyspepsia, stomach pain, nausea, diarrhea

Flatulence, gastritis, constipation, vomiting, oral cavity ulcers

Melena (including hemorrhagic diarrhea), ulcers in part of gastrointestinal tract, gastrointestinal bleedings

 

                      
Hepatobiliary system disorders

 

 

Hepatitis

 

Skin disorders

 

Itching, exanthema, dermatitis, urticaria

Facial edema

Hemorrhagic rash, eczema, severe skin and mucous membranes reactions

Kidneys and urinary system disorders

 

 

 

Nephrotic syndrome, renal failure

General disorders and local reactions

 

 

 

Edema, increased fatigability, foot muscles convulsions

Laboratory examinations results

Liver enzymes increasing

Increase of urea and creatinine blood levels

 

Alkaline phosphatase level increase, body weight increase



Drug interactions:
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, atulence, 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) nonspeci c 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

Warnings and precautions

Pregnancy and lactation:
Pregnancy: There is no information on the use of aceclofenac during pregnancy. Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/fetal development. Data from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation or gastroschisis after use of prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5 %. The risk is believed to increase with dose and duration of therapy.loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the rst and second trimester of pregnancy, aceclofenac should not be given unless clearly necessary. If aceclofenac is used by a woman attempting to conceive, or during the rst and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction, which may progress to renal failure with oligo-hydroamniosis; the mother and the neonate, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses. - inhibition of uterine contractions resulting in delayed or prolonged labour. Consequently, aceclofenac is contraindicated during the third trimester of pregnancy. Lactation: There is no information on the secretion of aceclofenac to breast milk; there was however no notable transfer of radio labelled (14C) aceclofenac to the milk of lactating rats. The use of Preservex should therefore be avoided in pregnancy and lactation unless the potential benets to the other outweigh the possible risks to the foetus. Fertility: The use of Diclotol may impair female fertility and is not recommended in women attempting to conceive. In women who have difculties conceiving or who are undergoing investigation of infertility, withdrawal of Preservex should be considered

Overdosage and Contraindications

Overdose:
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 signicant poisoning acute renal failure and liver damage are possible.
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-inammatory 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.

PHARMACOLOGICAL PROPERTIES:

Pharmacodynamics.
Pharmacotherapeutic Group:
Non Steroidal Anti inammatory & Antirheumatic ATC CODE: M01AB16
Pharmacodynamic Properties: The mode of action of aceclofenac is largely based on the inhibition to prostaglandin synthesis. Aceclofenac is a potent inhibitor of the enzyme cyclo-oxygenase, which is involved in the production of prostaglandins.

PHARMACEUTICAL CHARACTERISTICS:
Pharmacokinetic Properties:
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 uid, 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
Shelf-life:
2 years.

Storage:
Store below 30°C.

Package:
Alu/Alu blister of 14 tablets, 2 or 10 blisters in a carton box. Alu/Alu blister of 10 tablets, 10 blisters in a carton box..
14 tablets in blister, 2 blisters in carton pack № 28 (14 × 2).

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