Medicinal Products

ACECLOFENAC EG 100 mg

Generic drug from Cartrex
Therapeutic class: Anti-inflammatories
active ingredients: Aceclofenac
laboratory: EG Labo

Coated tablet
Box of 30
All forms

Indication

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

Dosage ACECLOFENAC EG 100 mg Film-coated tablet Box of 30

Oral way. The ACECLOFENAC EG tablet should be swallowed with at least half a glass of water or other liquid.
ACECLOFENAC EG can be taken during meals. - Adults:
The maximum recommended dose is 200 mg daily, divided into two doses of 100 mg, one tablet in the morning and one tablet in the evening.
- Elderly people:
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 adverse effects may be minimized by using the lowest possible dose for the shortest duration of treatment necessary to relieve symptoms (see section on warnings and precautions for use).

Against indications

Aceclofenac is contraindicated in the following situations:

· Patients with a history of bleeding or gastrointestinal perforation, associated with previous NSAID therapy,

· Patients with active peptic ulcer, history of peptic ulcer or recurrent haemorrhage (2 or more distinct episodes of haemorrhage or ulceration),

· Patients with active hemorrhages or haemorrhagic disorders,

· Patients with severe impairment of hepatic or renal function,

· Patients with severe heart failure,

· Pregnancy, especially during the third trimester of pregnancy (see section on Pregnancy and lactation ),

· Patients with prior susceptibility to aceclofenac, to any of the excipients or in whom the administration of acetylsalicylic acid or NSAID precipitates the onset of asthma, acute rhinitis or urticaria, or patients hypersensitive to these drugs,

· Patients with a history of kidney transplantation,

· Patient with nephrotic syndrome.

Adverse effects Aceclofenac EG

Gastrointestinal

The most commonly reported side effects are gastrointestinal.

Peptic ulcer, perforation or gastrointestinal hemorrhage sometimes fatal, especially in the elderly may appear during treatment with NSAIDs (see section Warnings and precautions for use ). NSAIDs have also been reported to cause nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, stomach ulcer, exacerbation of colic and Crohn's disease (see section 5.2). caution and precautions for use ). Gastritis was observed less frequently.

Exceptionally, the occurrence of severe infectious complications in the skin and soft tissues has been reported during chickenpox in combination with NSAID therapy.

Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially when using high doses and long-term treatment) may be associated with a slightly increased risk of arterial thrombotic events (eg, infarction myocardial or cerebrovascular accident) (see Warnings and Precautions for Use section ).

The following table lists adverse reactions reported in clinical trials and after the marketing authorization of aceclofenac. These adverse effects are grouped by organ system class and estimated frequency. Very common (≥ 1/10) frequent (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10 000, <1/1000); very rare (<1 / 10, 000).

MedDRa classification

Frequency ≥ 1/100, ≥ 1/10

Rare

≥ 1/1000, <1/100

Rare

> 1/10 000, <1/1 000

Very rare / isolated cases

<1/10 000

Blood and lymphatic system

Anemia

Myelosuppression, granulocytopenia, thrombocytopenia, neutropenia, haemolytic anemia

Immune system

Anaphylactic reactions (including anaphylactic shock), hypersensitivity

Metabolism and nutrition

hyperkalemia

Psychiatric system

Depression, abnormal dreams, insomnia

The nervous system

Dizziness

Paresthesia, drowsiness, headache, dysgeusia (taste alteration)

Eye system

Visual disorders

Auditory and labyrinthine system

Dizziness, tinnitus

Heart system

Heart failure

palpitations

Vascular system

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, haemorrhagic diarrhea gastrointestinal haemorrhage Gastrointestinal ulcer

Stomatitis Intestinal perforation Exacerbation of Crohn's disease and ulcerative colitis Pancreatitis Hematemesis

Skin, subcutaneous tissue

Pruritus, rash, dermatitis, urticaria

Angioedema

Purpura, eczema, severe mucocutaneous reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis)

Renal and urinary system

Increased blood urea levels Increased blood creatinine levels

Nephrotic syndrome, renal failure

Hepatobiliary disorders

Increased levels of liver enzymes

Hepatic impairment (including hepatitis) Increased blood levels of alkaline phosphatase

General system

Edema, fatigue, cramps in the legs

Biological examinations

Weight gain

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

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

See Warnings and Precautions and Interactions with Other Drugs and Other Interactions for Warnings, Precautions and Interactions.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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