Medicinal Products

DICLOFENAC MYLAN 50 mg

Generic drug from Voltarene
Therapeutic class: Anti-inflammatories
Active ingredients: Diclofenac
laboratory: Mylan

Gastroresistant tablet
Bottle of 30
All forms

Indication

They come from the anti-inflammatory activity of diclofenac, 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 years old, to:

· Long-term symptomatic treatment:

o chronic inflammatory rheumatism, including rheumatoid arthritis, ankylosing spondylitis (or related syndromes, such as Fiessinger-Leroy-Reiter syndrome and psoriatic arthritis);

o some painful and disabling arthrosis.

· Short-term symptomatic treatment of acute attacks of:

o Abarticular rheumatism such as scapulohumeral periarthritis, tendonitis, bursitis,

o microcrystalline arthritis,

o arthrosis,

o back pain,

o radiculalgia.

· Essential dysmenorrhoea.

They are limited, in children from 35 kg (ie around 12 years), to inflammatory rheumatism infantile.

Dosage DICLOFENAC MYLAN 50 mg Gastroresistant tablet Bottle of 30

Administration mode

Oral way.

The tablets are swallowed as is, with 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 ).

· Adults:

o In acute treatment, in acute cases or when an intense effect is sought: 1 tablet 50 mg 3 times a day, or 150 mg per day.

o In maintenance treatment (or from the outset in some patients): 1 50 mg tablet combined with 25 mg diclofenac 1 tablet 50 mg twice daily, or 75 to 100 mg per day.
Diclofenac exists as other dosages that may be more suitable.

o Dysmenorrhoea: 1 50 mg tablet twice daily, or 100 mg daily.

· Children over 35 kg: 2 to 3 mg / kg daily divided into 2 or 3 doses.

As an indication: 1 tablet 50 mg 2 to 3 times a day, or 100 to 150 mg per day.

The maximum daily dose of 150 mg should not be exceeded.

Frequency of administration

In case of acute attack, it is advisable to take the tablets before meals.

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

Against indications

This medicine is contraindicated:

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

· History of allergy or asthma triggered by diclofenac or other substances of similar activity such as other NSAIDs, acetylsalicylic acid,

Hypersensitivity to the active substance or to any of the excipients,

· 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 35 kg (due to inappropriate dosage of this medication).

ANSM alert of 21/08/2013:

Although the benefits of diclofenac are greater than the risks, currently available data indicate an increased risk of arterial thrombotic events associated with treatment with diclofenac, comparable to that observed during treatment with the so-called selective anti-inflammatory drugs. COX-2 (coxibs).

• Diclofenac is now contraindicated in patients with known congestive heart failure (NYHA Class II-IV), ischemic heart disease, peripheral arterial disease, and / or cerebrovascular disease. Treatment of patients with these contraindications should be reassessed.

Diclofenac Mylan side effects

Clinical studies and epidemiological data suggest that the use of diclofenac, especially when used at high doses (150 mg per day) over a long duration of treatment, may be associated with a slight increase in the risk of an event. arterial thrombotic (eg, myocardial infarction or stroke) (see Warnings and Precautions ) section.

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.

Gastrointestinal effects

· Uncommon: at the start of treatment, nausea, vomiting, diarrhea, abdominal cramps, epigastric pain, dyspepsia, anorexia, belching.

· Rare: peptic ulcer, perforation or gastrointestinal bleeding. These are all the more frequent as the dosage used is high.

· Isolated cases: lower abdominal conditions such as nonspecific haemorrhagic colitis, exacerbation of ulcerative colitis. Pancreatitis has been reported, cases of constipation.

Skin effects

· Isolated cases: hair loss, photosensitization reactions.

· Very rarely bullous reactions (Stevens-Johnson, Lyell syndrome) have been observed.

Hypersensitivity reactions

· Dermatological: rash, hives, eczema.

· Respiratory: bronchospasm, hypersensitivity pneumonitis.

· Other: isolated cases of vasculitis including allergic purpura, hypotension.

· General: very rare anaphylactic / anaphylactoid reactions especially in subjects with allergy to acetylsalicylic acid.

Effects on the central nervous system

· Uncommon: headache, dizziness or lightheadedness

· Rarely: drowsiness.

· Isolated cases: convulsions, aseptic meningitis. Insomnia, irritability, asthenia, tremors have been reported.

· Isolated cases of sensory disturbances: paresthesia, visual disturbances (visual blur, diplopia), tinnitus.

Effects on the kidney

· Water-soluble retention with possible edema, hyperkalemia (see sections Warnings and precautions for use and 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.

Effects on the liver

· Uncommon: increased serum transaminases.

· Rare hepatitis with or without jaundice.

· Isolated cases: fulminant hepatitis.

Effects on the blood

· Very rarely: leukopenia, agranulocytosis, thrombocytopenia with or without purpura, bone marrow suppression, haemolytic anemia.

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