DICLO-DENK 100 RETARD Tablet

គុណភាពព្យាបាល
ឱសថនេះមានមុខងារបំបាត់ការឈឺចាប់ ប្រឆាំងការរលាក ស្ថិតក្នុងក្រុម Anti inflammatoire non steroidien ប្រើសម្រាប់ព្យាបាលរោគសញ្ញា:
- ឈឺសន្លាក់ឆ្អឹងដែលមានសភាពស្រួចស្រាវ ឬរ៉ាំរ៉ៃរួមទាំងប្រគ្រីវ (Goutte)
- ការឈឺសន្លាក់ឆ្អឹងដែលកើតមានច្រើនកន្លែង។
- ឈឺឆ្អឹងខ្នង និងរលាកសរសៃឆ្អឹងបណ្ដាលមកពីវះកាត់ឆ្អឹងឬពុកឆ្អឹង ឬការសឹកសន្លាក់ឆ្អឹង ឬវិបត្តិខួរឆ្អឹង (Spinal disorder)
- ឈឺសរសៃជាលិកាទន់ (សើម)
- ឈឺហើមដោយរបួស ឬប៉ះទង្គិច
ដោយឱសថនេះបញ្ចេញជាតិសកម្មយឺត (Liberation retardee) ហេតុនេះ មិនគួរប្រើឱសថនេះ ចំពោះជំងឺដែលទាមទារប្រសិទ្ធភាពបន្ទាន់ទេ។
កម្រិត និងរបៀបប្រើ:  (ត្រូវអនុវត្តតាមវេជ្ជបញ្ជា)
- ត្រូវលេបឱសថនេះទាំងមូលជាមួយទឹក1កែង (គ្រប់គ្រាន់) នៅពេលបាយ ប្រសិនបើអ្នកមានវិបត្តិក្រពះ-ពោះវៀន។
- រយៈពេលព្យាបាលត្រូវកំណត់ដោយគ្រូពេទ្យ (ចំពោះអ្នកឈឺសរសៃសន្លាក់ត្រូវប្រើរយៈពេលយូរ)។
- កម្រិតប្រើជាទូទៅគឺ 1គ្រាប់ក្នុង1ថ្ងៃ កម្រិតនេះអាចប្រែប្រួលពី 50mg-150mg យោងតាមប្រភេទជំងឺ។

This is a pain-relieving and anti-inflammatory drug and belongs to the class of non-steroidal antiphlogistic/antirheumatic agents (NSAIDs).

Therapeutic indications

Symptomatic treatment of pain and inflammation in case of:

- acute joint inflammation (acute arthritides) including gout attack,

- chronic joint inflammation (chronic arthritides), especially in case of rheumatoid arthritis (chronic polyarthritis),

- Bechterew’s disease (ankylosing spondylitis) and other inflammatory rheumatoid disorders of the spine,

- acute inflammatory condition of degenerative joint or spinal disorders (arthroses and spondylarthroses),

- inflammatory soft tissue rheumatisms,

- painful swelling or inflammation after injuries,

Due to the delayed release of the active ingredient Diclofenac, Diclo-Denk 100 Retard is not suitable for initiating therapy in patients where a rapid onset of effect is required.

Dosage

The recommended dose is:

For treatment of rheumatic diseases:

The dose of diclofenac depends on the severity of the illness. The recommended daily dose for adults is between 50 and 150mg of diclofenac sodium.

Adults are given 1 tablet daily.

Type and duration of application

Swallow this tablet whole with plenty of fluids. If you have a sensitive stomach it is advisable to take this tablet with your meals.

The attending doctor will decide how long the treatment should take.

Long-term treatment with this tablet may be required for patients with rheumatic disease.

Please talk to your doctor if you have the impression that the effect of this tablet is too strong or too weak.

ហាមប្រើ: ចំពោះ
- អ្នកធ្លាប់មានប្រតិកម្មជាមួយសារធាតុផ្សំណាមួយនៃឱសថនេះ។
- អ្នកមានវិបត្តិក្នុងការផលិតគ្រាប់ឈាមក្រហម និងអ្នកមានវិបត្តិឈាមកក
- អ្នកមានជំងឺដំបៅក្រពះ-ពោះវៀន
- អ្នកហូរឈាមក្នុងក្រពះ-ពោះវៀន ខួរក្បាលនិងកន្លែងផ្សេងៗ
- កុមារអាយុក្រោម15ឆ្នាំ។

- if you are allergic to diclofenac or any of the other ingredients of this medicine.

- if you have a history of asthma attacks, swelling of the nasal mucous membranes or skin reactions associated with the use acetylsalicylic acid or other NSAIDs.

- in case of unclarified impairment of blood cell formation.

- in case of active of history of recurrent gastric or duodenal ulcers (peptic ulcers) or haemorrhage (2 or more distinct episodes of proven ulceration of bleeding).

- in case of history of gastrointestinal bleeding or perforation, related to previous NSAID therapy.

- in case of brain haemorrhage (cerebrovascular bleeding) or other active haemorrhaging.

- in case of severe liver or renal impairment.

- in case of severe heart failure (cardiac insufficiency).

- if you have established heart disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages.

- if you have or have had problems with your blood circulation (peripheral arterial disease).

- in the last three months of pregnancy.

Diclo-Denk 100 Retard is not suitable for children or adolescents under 18 years of age, as the active ingredient content is too high.

ផលរំខាន
វិបត្តិក្រពះ-ពោះវៀន (ចង្អោរ ក្អួត រាក ហើមពោះ ចុកពោះ បាត់ចំណង់អាហារ) រលាកភ្នាសពោះវៀន ដំបៅក្រពះពោះវៀន ហូរឈាមតិចៗតាមក្រពះ-ពោះវៀន បង្កអោយមានខ្វះឈាមក្រហម ឈឺក្បាល អស់កម្លាំង ហ៊ឹងត្រចៀក ស្ដាប់មិនលឺ រមាស់ស្បែក ខ្សោយតម្រងនោម នោមតិច ហើមខ្លួនឬដៃជើង រលាកថ្លើម រលាកលំពែង ខ្សោយបេះដូង ។ល។
 

Side effects

The most common adverse drug reactions affect the digestive tract. Gastric/duodenal ulcers (peptic ulcers), perforation or bleeding, sometimes fatal, may occur, particularly in elderly patients. Nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, melaena, vomiting of blood, ulcerative inflammation of the oral mucous membranes (ulcerative stomatitis), exacerbation of colitis and Crohn’s disease have been reported after use. Gastritis is less common.

Fluid retention (oedema), high blood pressure and heart attacks (“myocardial infarction”) or strokes.

Cardiac disorders

Very rare: Pounding heart (palpitations), fluid retention (oedema), cardiac insufficiency, cardiac insufficiency, cardiac infarction.

Blood and lymphatic system disorders

Very rare: Impaired haemopoiesis (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms may be: fever, sore throat, superficial lesions in the mouth, influenza-like complaints, severe lassitude, nose bleeding and dermatorrhagia. In such cases this medication is to be discontinued immediately and a doctor has to be consulted.

Patients should not self-medicate with analgesics or antipyretics. The blood count should be monitored regularly during long-term therapy.

Very rare: Haemolytic anaemia (anaemia resulting from accelerated degradation of red blood cells).

Nervous system disorders

Common: Central nervous symptoms such as headache, vertigo, light-headedness, state of excitement, irritability or fatigue.

Very rare: Sensory disturbances, distortion of taste, impaired memory, disorientation, seizures, tremor.

Eye disorders

Very rare: Impaired vision (blurred and double vision).

Disorders of the ear and labyrinth

Very rare: Ringing in the ears (tinnitus), transitory impaired hearing.

Gastrointestinal disorders

Very common: Gastrointestinal complaints, such as nausea, vomiting and diarrhoea and minor gastrointestinal bleeding, which in individual cases may cause anaemia.

Common: Indigestion (dyspepsia), flatulence, abdominal cramps, loss of appetite as well as gastric or intestinal ulcers (sometimes with bleeding and perforation).

Uncommon: Vomiting of blood (hematemesis), bloody stool or bloody diarrhoea. In cases of severe colouration of the stool or blood in stool, you must stop taking this tablet and inform your doctor immediately.

Very rare: inflammation of the oral mucosa, glossitis, oesophagus lesions, constipation as well as lower abdominal complaints such as haemorrhaging inflammation of the colon, exacerbation of Crohn’s disease or ulcerative colitis (specific inflammation of the colon associated with ulcers), inflammation of the pancreas (pancreatitis).

In very rare cases there were reports of enterostenosis.

Renal and urinary disorders

Uncommon: Development of oedema (fluid retention in the body) especially in patients with high blood pressure or impaired kidney function.

Very rare: Renal tissue damage (interstitial nephritis, papillary necrosis) that may be associated with acute renal dysfunction (renal insufficiency), protein in urine (proteinuria) and/or blood in urine (haematuria); nephrotic syndrome (fluid retention in the body [oedema] and excretion of large amounts of protein in urine). Reduced urinary output, accumulation of water in the body (oedema) as well as general malaise may be symptoms of kidney disease ranging to kidney failure. If the mentioned symptoms occur or worsen, you must stop taking Diclo-Denk 100 Retard and consult your doctor immediately.

Skin and subcutaneous tissue disorders

Uncommon: Alopecia.

Very rare: Skin rashes associated with reddening (eczema, erythema, exanthema), hypersensitivity to light, purpura, severe skin reactions such as rash with blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell syndrome).

Infections and parasitic diseases

In very rare cases associated with the use of special anti-inflammatory drugs (NSAIDs to which Diclo-Denk 100 Retard also belongs) an exacerbation of infective inflammations (e.g. development of necrotic fasciitis) has been reported. If signs of an infection (e.g. reddening, swelling, hyperthermia, pan, fever) occur or worsen during treatment with Diclo-Denk 100 Retard, a doctor should be consulted immediately.

In very rare cases, the use of diclofenac has been associated with the symptoms of non-infectious inflammation of the meninges (aseptic meningitis) such as severe headache, nausea, vomiting, fever, stiff neck or clouding of consciousness. Patients already suffering from certain autoimmune diseases, such as systemic lupus erythematosus or mixed connective tissue disorder, appear to be at increased risk.

Vascular disorders

Very rare: High blood pressure (hypertension).

Immune system disorders

Common: Hypersensitivity reactions such as skin rash and itching.

Uncommon: Hives (urticaria).

Very rare: Severe general hypersensitivity reactions that may be manifested by: facial oedema, swelling of the tongue, internal swelling of the larynx with constriction of the respiratory tract, labored breathing, palpitations, drop in blood pressure and eventually life-threatening shock. If any of these symptoms occur, and this is possible following the first application, immediate medical attention is required. In such cases, the medicine is to be discontinued immediately and a doctor has to be consulted.

In very rare cases, allergic inflammation of the blood vessels (vasculitis) and lungs (pneumonitis) was observed.

Hepatobiliary disorders

Common: An increase in blood liver enzymes.

Uncommon: Liver damage, especially during long-term therapy, acute hepatitis with or without icterus (in individual cases very severe [fulminant] course, sometimes without prodromal symptoms. Regular monitoring of liver parameters is therefore necessary during long-term therapy.

Psychiatric disorders:

Very rare: Psychotic reactions, depression, feeling of anxiety, nightmares.

អន្តរកម្មឱសថ
ឱសថនេះអាចមានអន្តរកម្មជាមួយឱសថ Digoxine, Phenytoine, Lithium, Antihypertonique, Diuretique, Methothrexate, Probenecide, Sulfinpyrazone, AINS, Antidiabetique, Prostaglandine។

(see the package insert about the details.)

Digoxin, phenytoin, lithium

Diuretics and blood pressure reducing agents (anti-hypertensives)

ACE inhibitors, angiotensin-Ⅱantagonists

Potassium-sparing diuretics

Other NSAIDs, glucocorticoids

Antiplatelet agents (e.g. acetylsalicylic acid), antidepressants (SSRI)

Methotrexate

Ciclosporin

Probenecid, sulfinpyrazone

Anticoagulants (e.g. warfarin)

Alcohol should be avoided if possible during treatment with Diclo-Denk 100 Retard.

ស្ត្រីមានផ្ទៃពោះនិងស្ត្រីបំបៅកូន
- ចំពោះស្ត្រីមានផ្ទៃពោះ ត្រូវជៀសវាងប្រើក្នុងត្រីមាសទី1 និង ទី2 លើកលែងតែមានការយល់ព្រមពីគ្រូពេទ្យ។ តែត្រូវហាមប្រើដាច់ខាតក្នុងត្រីមាសទី3 ព្រោះអាចមានហានិភ័យខ្ពស់ចំពោះម្ដាយ និងទារក។
- ចំពោះស្ត្រីបំបៅកូន អាចប្រើឱសថនេះបានសម្រាប់រយៈពេលខ្លី។ តែត្រូវផ្អាកការបំបៅកូនសិន បើប្រើរយៈពេលវែង។

Pregnancy

If a patient becomes pregnant during treatment with Diclo-Denk 100 Retard a doctor should be consulted. You may only use this tablet during the first 6 months of pregnancy after consulting your doctor. Diclo-Denk 100 Retard is contraindicated during the last 3 months of pregnancy because there is an increased risk of complications for the mother and child.

Breast-feeding

The active ingredient diclofenac and its metabolites pass in small quantities into breast milk. Since no adverse effects in infants have been made known to date, short-term use of the medicinal product should in general not require discontinuation of breast feeding. However, if high doses are prescribed or if the medicine is to be taken over a prolonged period of time, early weaning should be considered.

ការប្រុងប្រយ័ត្ន
- ត្រូវប្រុងប្រយ័ត្នប្រើឱសថនេះចំពោះ
+ អ្នកមានវិបត្តិឈាម វិបត្តិក្រពះ-ពោះវៀន (ដំបៅក្រពះ-ពោះវៀន រលាកពោះវៀនតូច ធំ)
+ អ្នកមានសម្ពាធឈាមឡើងខ្លាំង ឬខ្សោយបេះដូង ឬជំងឺតម្រងនោម ឬថ្លើម
+ អ្នកទើបតែទទួលការវះកាត់ធំ
+ អ្នកមានជំងឺ Auto-immune (Lupus, Erythemateux systemique...)
+ អ្នកមានជំងឺផ្ដាសាយ ឬរលាកច្រមុះរ៉ាំរ៉ៃ ឬជំងឺស្ទះផ្លូវដង្ហើម ឬជំងឺផ្លូវដង្ហើមរ៉ាំរ៉ៃ
+ អ្នកមានប្រតិកម្មជាមួយឱសថបំបាត់ការឈឺចាប់ផ្សេងៗ (Antalgique និង Anti inflammatoire non steroidiens)
+ អ្នកមានជំងឺហឺត អ្នកមានវិបត្តិឈាមកក និងអ្នកមានជំងឺទឹកនោមផ្អែម។
- ចំពោះអ្នកប្រើរយៈពេលយូរ ត្រូវធ្វើការវិភាគមុខងារថ្លើម មុខងារតម្រងនោម និងរូបមន្តឈាម ពិសេសមនុស្សចាស់។
- ចំពោះស្ត្រីមានផ្ទៃពោះ ត្រូវជៀសវាងប្រើក្នុងត្រីមាសទី1 និង ទី2 លើកលែងតែមានការយល់ព្រមពីគ្រូពេទ្យ។ តែត្រូវហាមប្រើដាច់ខាតក្នុងត្រីមាសទី3 ព្រោះអាចមានហានិភ័យខ្ពស់ចំពោះម្ដាយ និងទារក។
- ចំពោះស្ត្រីបំបៅកូន អាចប្រើឱសថនេះបានសម្រាប់រយៈពេលខ្លី។ តែត្រូវផ្អាកការបំបៅកូនសិន បើប្រើរយៈពេលវែង។
- ការប្រើឱសថនេះក្នុងកម្រិតខ្ពស់ និងរយៈពេលយូរ អាចមានអាការៈឈឺក្បាល តែមិនត្រូវបង្កើនកម្រិតប្រើទៀតទេ និងអាចប៉ះពាល់ដល់តម្រងនោម។
- ហាមពិសាស្រានៅពេលព្យាបាលដោយឱសថនេះ។
- អាចប៉ះពាល់ដល់សមត្ថភាពបើកបរ និងបញ្ជាម៉ាស៊ីន ខ្លះៗ ពិសេសនៅពេលពិសាសុរា។

Precautions

Gastrointestinal safety

Concurrent treatment with Diclo-Denk 100 Retard and other NSAIDs, including so-called COX-2 inhibitors, should be avoided. Adverse drug reactions may be reduced by using the lowest effective dose for the shortest duration necessary to improve symptoms.

Elderly patients

The elderly are at increased risk of adverse drug reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal. Close medical surveillance is therefore necessary n elderly patients.

Gastrointestinal bleeding, ulceration and perforation

Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported with all NSAIDs. They occurred at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.

The risk of gastrointestinal 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 agents that protect the stomach lining (e.g. misoprostol or proton pump inhibitors) should be considered for these patients as well as for patients requiring concomitant low dose aspirin of other drugs likely to increase the risk of gastrointestinal disturbances.

If you have a history of gastrointestinal adverse reactions, particularly if you are elderly, you should report any unusual abdominal symptoms (especially gastrointestinal bleeding) notably in the initial stages of treatment.

Caution is advised if you are receiving concomitant treatment with medications which could increase the risk of ulceration or bleeding, such as oral cortico-steroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors that are used in the treatment of depression or antiplatelet agents such as aspirin.

If you suffer from gastrointestinal bleeding or ulceration, treatment with Diclo-Denk 100 Retard should be discontinued.

NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as these conditions may be exacerbated.

Cardiovascular effects

Medicines such as Diclo-Denk 100 Retard may be associated with a slightly increased risk of heart attacks (“myocardial infarction”) or strokes. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

Skin reactions

Severe skin reactions with reddening and blistering, some of them fatal, are very rare in association with the use of NSAIDs (exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis/Lyell syndrome). Patients appear to be a highest risk for these reactions early in the course of therapy, as the reactions occurred during the first month of treatment in the majority of cases. Diclo-Denk 100 Retard should be withdrawn at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity, and a doctor should be consulted immediately.

Hepatic effects

Caution (discussion with the doctor or pharmacist) is advised prior to treating patients with impaired liver function, since treatment with diclofenac may exacerbate their condition. If Diclo-Denk 100 Retard is taken over a prolonged period of time or taken repeatedly, liver function should be monitored as a precautionary measure. If clinical symptoms of liver disease are detected, Diclo-Denk 100 Retard should be discontinued immediately.

Other information

Make sure your doctor knows, before you are given diclofenac

- if you smoke

- if you have diabetes

- if you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides.

Diclo-Denk 100 Retard should only be used after careful consideration of the potential benefits and risks in case of

- certain congenital impairment of blood cell formation (e.g. acute intermittent porphyria),

- certain autoimmune diseases (systemic lupus erythematosus and mixed connective tissue disease).

Close medical surveillance is required in the following cases:

- immediately after major surgery,

- in case of allergies (e.g. skin reactions in response to other medicines, asthma, hay fever), chronic swelling of the nasal mucous membranes or chronic respiratory disease with airway obstruction,

- in case of impaired renal or liver function.

Severe acute hypersensitivity reactions (anaphylactic shock for example) have been observed in very rare cases. At the first signs of a hypersensitivity reaction after intake, treatment with Diclo-Denk 100 Retard must be discontinued. The required symptomatic medical treatment must be carried out by a health care professional.

Diclofenac may temporarily inhibit platelet aggregation. Patients with blood clotting disorders should therefore be monitored carefully.

Side effects may be minimized by using the lowest effective dose for the shortest duration necessary.

As with other NSAIDs, diclofenac may mask the signs and symptoms of an infection. If signs of an infection (e.g. reddening, swelling, hyperthermia, pain, fever) occur or worsen during treatment with Diclo-Denk 100 Retard, a doctor should be consulted immediately.

If you are simultaneously taking medicine with inhibits blood clotting or which reduces blood sugar, the clotting status and/or blood sugar level should be monitored as a precaution.

Regular monitoring of renal function and blood count is required during long-term treatment with Diclo-Denk 100 Retard.

If taking Diclo-Denk 100 Retard prior to surgery, the doctor or dentist should be consulted or informed.

Prolonged use of painkillers may cause headaches with must not be treated with higher doses of the medicinal product. Consult your doctor for advice if you suffer from frequent headaches despite taking Diclo-Denk 100 Retard!

In general, habitual intake of painkillers, especially when several types of painkillers are combined, can result in permanent kidney damage with the risk of renal failure (analgesic nephropathy).

As with other drugs that inhibit prostaglandin synthesis, Diclo-Denk 100 Retard may make it more difficult for you to become pregnant.

Diclofenac is a non-steroidal antiphlogistic/anti-rheumatic agent which proved to be effective in standard animal experiments on inflammation by inhibiting prostaglandin synthesis. In humans diclofenac reduces inflammatory pain, swelling and fever. Diclofenac also inhibits ADP and collagen-induced platelet aggregation.