Medicinal Products

ARTOTEC 75 mg / 0.2 mg

Generic drug of the therapeutic class: Anti-inflammatories
active ingredients: Diclofenac, Misoprostol
laboratory: Pfizer Holding France

Gastroresistant tablet
Box of 20
All forms

Indication

Symptomatic treatment of acute attacks of rheumatic diseases in patients at risk (including age> 65 years, history of peptic ulcer disease or intolerance to NSAIDs), for which anti-inflammatory treatment is essential.

Dosage ARTOTEC 75 mg / 0.2 mg gastroresistant tablet Box of 20

Administration mode

Reserved for adults (over 15 years).

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 ).

1 tablet, 2 to 3 times a day.

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

Frequency of administration:

The dosage is to be divided into 2 doses per day, during meals.

The duration of treatment should not exceed 10 days.

Against indications

· Hypersensitivity to any of the active substances or to any of the excipients of the product.

Contraindications related to misoprostol:

· Hypersensitivity to prostaglandins,

· Pregnancy. This drug has a potent activity on uterine contractility, it can cause a termination of pregnancy (see section Pregnancy and breastfeeding ).

· Female during periods of genital activity in the absence of effective contraception (see section Pregnancy and breastfeeding ).

Contraindications related to diclofenac:

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

· 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.

Contraindications related to castor oil:

· Bowel obstruction.

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.

Artotec side effects

Related to diclofenac:

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

· Rare: 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 rare: leukopenia, agranulocytosis, thrombocytopenia with or without purpura, bone marrow aplasia, hemolytic anemia.

Linked to misoprostol:

Gastrointestinal effects:

· Moderate diarrhea, nausea (transient and moderate), abdominal discomfort.

Effects on the central nervous system:

· Headache, dizziness.

Effects on the reproductive system:

· More rarely: menstrual disorders, uterine spasm, postmenopausal vaginal bleeding.

Related to castor oil:

Gastrointestinal effects:

· Nausea, vomiting, abdominal pain.

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