Medicinal Products

ACECLOFENAC INTAS PHARMACEUTIC 100 mg

Generic drug from Cartrex
Therapeutic class: Anti-inflammatories
active ingredients: Aceclofenac
laboratory: Intas Pharmaceuticals Ltd

Coated tablet
Box of 30
All forms

Indication

Symptomatic treatment of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

Dosage ACECLOFENAC INTAS PHARMACEUTIC 100 mg Film-coated tablet Box of 30

Oral way.

The tablets are swallowed whole with at least half a glass of water or another liquid. ACECLOFENAC INTAS PHARMACEUTICALS can be taken during meals.

adults

The maximum recommended dose is 200 mg daily in two doses, one 100 mg tablet in the morning and evening.

Elderly

In general, it is not necessary to reduce the dosage; however, precautions should be taken (see section Warnings and precautions for use ).

children

The safety and efficacy of the product have not been demonstrated in children and adolescents.

Hepatic insufficiency

In mild to moderate hepatic impairment, the dosage will be reduced. The recommended starting dose is 100 mg daily.

Renal insufficiency

In mild renal impairment, there is no need to decrease the dosage; however, precautions should be taken.

The occurrence of side effects may be minimized by using the lowest possible dose for the shortest course of treatment required to relieve symptoms (see Warnings and Precautions section ).

Against indications

Aceclofenac is contraindicated in the following situations:

Hypersensitivity to aceclofenac or to any of the excipients or hypersensitivity to nearby activity molecules such as other NSAIDs, aspirin,

· Patients taking aspirin or other NSAIDs may start asthma attacks, bronchospasm, acute rhinitis or urticaria,

· Progressive peptic ulcer, history of peptic ulcer or recurrent hemorrhage (2 or more distinct episodes of haemorrhage or ulceration objectivized),

· Gastrointestinal haemorrhage or any other kind,

· History of bleeding or digestive perforation during previous NSAID treatment,

· Severe heart failure,

· Severe hepatic or renal insufficiency,

· During the last three months of pregnancy (see section on Pregnancy and lactation ).

Adverse effects Aceclofenac Intas Pharmaceutic

The most commonly reported side effects are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, can occur, especially in the elderly (see section Warnings and precautions for use ). Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, ulcerative stomatitis, abdominal pain, melaena, hematemesis, exacerbation of ulcerative colitis or Crohn's disease (see Warnings and precautions for use ) have been reported following the administration of NSAIDs. Less frequently, gastritis has been observed.

Edema, hypertension, and heart failure have been reported in association with NSAID therapy.

Very rarely bullous reactions have been reported including Stevens-Johnson syndrome and Lyell syndrome.

Exceptionally, the occurrence of severe infectious skin or soft tissue complications during chickenpox has been reported in association with NSAID therapy.

Adverse reactions reported during clinical trials and / or notified during the marketing of the product are presented by organ system and in order of frequency.

MedDRa classification

Frequent

1/100, <1/10

Rare

1/1000, <1/100

Rare

1/10000, <1/1000

Very rare / isolated cases

<1/10000

Blood and lymphatic system

Anemia

Granulocytopenia, thrombocytopenia, neutropenia, hemolytic anemia

Immune system

Anaphylactic reactions (including anaphylactic shock), hypersensitivity

Metabolism and nutrition

hyperkalemia

Psychiatric system

Depression, abnormal dreams, insomnia

MedDRa classification

Frequent

1/100, <1/10

Rare

1/1000, <1/100

Rare

1/10000, <1/1000

Very rare / isolated cases

<1/10000

The nervous system

Dizziness

Paresthesia, tremor, drowsiness, headache, dysgeusia (taste alteration)

Eye system

Visual disorders

Auditory system and labyrinth

Dizziness, tinnitus

Heart system

Heart failure

palpitations

Vascular system

Hypertension, worsening of hypertension

Flushing, flushing, vasculitis

Respiratory system, thorax and mediastinum

Dyspnea

bronchospasm

Gastrointestinal system

Dyspepsia, abdominal pain, nausea, diarrhea

Flatulence, gastritis, constipation, vomiting, oral ulceration

Melena, gastrointestinal ulceration, haemorrhagic diarrhea, gastrointestinal haemorrhage

Stomatitis, hematemesis, gastric ulcer, pancreatitis

Hepatobiliary system

Hepatitis

Skin, subcutaneous tissue

Pruritus, rash, dermatitis, urticaria

Edema of the face

Purpura, eczema, severe mucocutaneous reactions

Renal and urinary system

Nephrotic syndrome, renal failure

General system

Edema, fatigue, cramps in the legs

Biological examinations

Elevation of liver enzymes

Elevation of uremia and serum creatinine

Elevation of alkaline phosphatase, weight gain

The most commonly reported adverse reactions in clinical trials are
Gastrointestinal (dyspepsia: 7.5%, abdominal pain: 6.2%, nausea: 1.5% and diarrhea: 1.5%) and occasional dizziness.

Dermatological assignments such as pruritus and rash have been reported. Abnormal levels of liver enzymes and plasma creatinine have also been reported.

Clinical studies and epidemiological data suggest that the use of certain NSAIDs (especially at high doses and over a long period of time) may be associated with a small increase in the risk of arterial thrombotic events (eg myocardial infarction or cerebrovascular accident). (see section Warnings and Precautions ).)

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