Medicinal Products

TIAPROFENIC ACID EG 100 mg

Generic drug from Surgam
Therapeutic class: Anti-inflammatories
Active ingredients: Tiaprofenic acid
laboratory: EG Labo

Tablet breackable
Box of 30
All forms

Indication

They arise from the anti-inflammatory activity of tiaprofenic acid, the importance of the manifestations of intolerance to which the drug results and its place in the range of anti-inflammatory products currently available.
They are limited, in adults and children from 15 kg (about 4 years old), to:
- long-term symptomatic treatment:
. chronic inflammatory rheumatism, including rheumatoid arthritis,
. some painful and disabling arthroses;
- symptomatic treatment of short duration:
. acute attacks of osteoarthritis, low back pain,
. acute post-traumatic benign conditions of the musculoskeletal system;
- dysmenorrhea after etiological research;
- symptomatic treatment of pain during inflammatory manifestations in ENT and stomatological fields. In this indication, the risks involved, in particular the extension of a concomitant septic process, are those of NSAIDs. They must be evaluated in relation to the expected analgesic benefit.

Posology TIAPROFENIC ACID 100 mg Tablet scored 30

Administration mode

Oral way.

The tablets are swallowed as is with a large glass of water or dissolved in a large glass of water.

Dosage

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

Adult :

· Attack treatment: 2 tablets at 100 mg, 3 times a day, 600 mg maximum per day.

· Maintenance treatment: from the 4th day, it is possible to reduce the dosage to 3 or 4 tablets to 100 mg, either 300 mg or 400 mg per day.

Children from 15 kg : the dosage is 10 mg / kg per day.

For information:

· 15 to 20 kg (approximately 4 to 6 years): 1/2 100 mg tablet, 3 times daily at 1 100 mg tablet, 2 times daily, or 150 mg to 200 mg daily;

· From 20 kg to 30 kg (approximately 6 to 10 years): 1 tablet to 100 mg, 2 to 3 times a day, or 200 to 300 mg per day;

· From 30 kg (around 10 years old): 1 tablet at 100 mg, 3 times a day, or 300 mg per day.

Approximate ages by weight are indicative.

Frequency of administration

The tablets should be taken preferably during meals.

The dosage is to be divided into 2 to 3 doses per day.

Against indications

This medicine is contraindicated in the following situations:

· After 24 weeks of amenorrhea (5 months pregnant) (see section on Pregnancy and breastfeeding ),

· A history of allergy or asthma triggered by taking tiaprofenic acid or substances of similar activity such as other NSAIDs, acetylsalicylic acid,

· A history of allergy to other components of the tablet,

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

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

· Severe hepatocellular insufficiency,

· Severe renal insufficiency,

· Severe heart failure,

· Child under 15 kg, ie, less than 4 years old (due to inappropriate unit dosage).

Adverse effects Tiaprofenic acid EG

Clinical studies and epidemiological data suggest that the use of certain NSAIDs (especially when used 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, infarction myocardial or cerebrovascular accident) (see Warnings and Precautions for Use section ).

Gastrointestinal effects

The most commonly observed 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, melena, hematemesis, exacerbation of rectocolitis or Crohn's disease (see Warnings and Precautions for Use section ) reported following the administration of NSAIDs. Less frequently, gastritis has been observed.

Cardiovascular effects

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

Rarely have been reported: elevation of blood pressure, tachycardia, chest pain, arrhythmia, palpitations, hypotension, congestive heart failure.

Hypersensitivity reactions

· Respiratory: the onset of asthma attack may be related in some subjects to an allergy to aspirin or NSAID (see section 4.3 ).

· General: general malaise with hypotension, angioedema, anaphylactic shock.

Skin reactions

Very rarely bullous reactions (including Stevens-Johnson syndrome and Lyell's syndrome) have been observed.

Have also been reported: rash, urticaria and worsening of chronic urticaria, pruritus, purpura.

Cases of photosensitization have been exceptionally reported.

Effects on the central nervous system

Dizziness, rare.

Renal effects

· Water-soluble retention, hyperkalemia (see Warnings and precautions for use and section Interactions with other medicinal products and other forms of interaction ).

· Functional acute renal failure (ARF) in patients with risk factors (see Warnings and Precautions section ).

· Organic kidney damage that can result in ARI: isolated cases of interstitial nephritis, acute tubular necrosis, nephrotic syndrome, papillary necrosis have been reported.

· Urinary: urinary disorders (cystalgia, dysuria and pollakiuria), hematuria or cystitis may occur. Serious cases were exceptionally reported when treatment was continued. These disorders are reversible when the treatment is stopped.

Other

Exceptionally, severe infectious skin and soft tissue complications occur during chickenpox (see Warnings and Precautions for Use section ).

Biological modifications:

· Exceptionally abnormal liver tests,

· Thrombocytopenia.

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