Medicinal Products

ACECLOFENAC QUALIMED 100 mg

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

Coated tablet
Box of 30
All forms

Indication

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

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

Oral way.
The tablets are swallowed whole with at least half a glass of water or other liquid. Aceclofenac can be taken during meals.
- Adults: the maximum recommended dose is 200 mg daily in two doses, one tablet of 100 mg morning and evening.
- Elderly: In general, there is no need 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 impairment: In mild to moderate hepatic impairment, the dosage will be reduced. The recommended starting dose is 100 mg daily.
- Renal impairment: in patients with mild renal impairment, there is no need to decrease the dosage; however, precautions should be taken.

Against indications

CONTRAINDICATED:
- Aceclofenac is contraindicated in the following situations:
. hypersensitivity to aceclofenac or to any of the excipients or hypersensitivity to molecules of similar activity such as other NSAIDs, aspirin,
. patients who take aspirin or other NSAIDs may start asthma attacks, bronchospasm, acute rhinitis or urticaria,
. evolving gastroduodenal ulcer or history of recurrent gastroduodenal ulcer,
. digestive hemorrhage or any other nature,
. severe heart failure,
. severe hepatic and renal insufficiency,
. during the last three months of pregnancy: during the third trimester of pregnancy, administration of prostaglandin synthesis inhibitors exposes the fetus to: cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension) ; renal dysfunction may progress to renal failure with oligohydramnios. Administration of prostaglandin synthesis inhibitors at the end of pregnancy exposes the mother and the future newborn to: possible prolongation of bleeding, an antiplatelet effect may occur even at low doses; inhibition of uterine contractions resulting in delay and prolongation of labor. Therefore, NSAIDs are contraindicated during the 3rd trimester of pregnancy.
- Children: the safety and efficacy of the product have not been demonstrated in children and adolescents.
NOT RECOMMENDED :
- Breast-feeding: There are no data on the excretion of aceclofenac in breast milk. Therefore, continuation of breastfeeding or treatment with this drug should be considered taking into account the expected benefit of breastfeeding for the child and the expected benefit of the treatment for the mother.
- Associations advised against : methotrexate; lithium; oral anticoagulants.

Adverse effects Aceclofenac Qualimed

- The most frequently reported adverse reactions are gastrointestinal disorders (dyspepsia: 7.5%, abdominal pain: 6.2%, nausea: 1.5% and diarrhea: 1.5%) and occasional dizziness.
- Skin conditions such as pruritus and rash have been reported. Abnormal levels of liver enzymes and plasma creatinine have also been reported.
- The undesirable effects 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.
- Blood and lymphatic system:
. Rare> 1/10000, <1/1000 : Anemia.
. Very rare / isolated cases <1/10000 : Granulocytopenia, thrombocytopenia, neutropenia, hemolytic anemia.
- Immune system :
Rare> 1/10000, <1/1000 : Anaphylactic reactions (including anaphylactic shock), hypersensitivity.
- Metabolism and nutrition:
Very rare / isolated cases <1/10000 : Hyperkalemia.
- Psychiatric system:
Very rare / isolated cases <1/10000 : Depression, abnormal dreams, insomnia.
- The nervous system :
. Common> 1/100, <1/10 : Dizziness.
. Very rare / isolated cases <1/10000 : Paresthesia, tremor, drowsiness, headache, dysgeusia (taste alteration).
- Eye system:
Rare> 1/10000, <1/1000 : Visual disturbances.
- Auditory and labyrinthine system:
Very rare / isolated cases <1/10000 : Dizziness, tinnitus.
- Cardiac system:
. Rare> 1/10000, <1/1000 : Hypertension, worsening of hypertension, heart failure.
. Very rare / isolated cases <1/10000 : Palpitations.
- Vascular system :
Very rare / isolated cases <1/10000 : Flushing, flushing, vasculitis.
- Respiratory system, thorax and mediastinum:
. Rare> 1/10000, <1/1000 : Dyspnoea.
. Very rare / isolated cases <1/10000 : Bronchospasm.
- Gastrointestinal system:
. Frequent> 1/100, <1/10 : Dyspepsia, abdominal pain, nausea, diarrhea.
. Uncommon> 1/1000, <1/100 : Flatulence, gastritis, constipation, vomiting, oral ulceration.
. Rare> 1/10000, <1/1000 : Melena, gastrointestinal ulcerations, haemorrhagic diarrhea, gastrointestinal haemorrhage.
. Very rare / isolated cases <1/10000 : Stomatitis, hematemesis, gastric ulcer, pancreatitis.
- Hepatobiliary system:
Very rare / isolated cases <1/10000 : Hepatitis.
- Skin, subcutaneous tissues:
. Uncommon> 1/1000, <1/100 : Pruritus, rash, dermatitis, urticaria.
. Rare> 1/10000, <1/1000 : Edema of the face.
. Very rare / isolated cases <1/10000 : Purpura, eczema, severe mucocutaneous reactions.
- Renal and urinary system:
Very rare / isolated cases <1/10000 : Nephrotic syndrome, renal failure.
- General system:
Very rare / isolated cases <1/10000 : Edema, fatigue, cramps in the legs.
- Biological examinations:
. Common> 1/100, <1/10 : Elevation of liver enzymes.
. Uncommon> 1/1000, <1/100 : Elevation of uremia and serum creatinine.
. Very rare / isolated cases <1/10000 : Elevation of alkaline phosphatase, weight gain.
- Other class adverse effects reported with NSAIDs:
Very rare (<1/10000) : urinary and renal disorders, interstitial nephritis.
- See warnings and precautions for use and interactions for warnings, precautions and interactions.

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