Myogit® 50
enteric-coated tablets
![MyogitRR 50](javascript:obrazek_big("http://promedcs.cz//en/../img/baleni/600_myogit50(1).jpg", "en"); "MyogitRR 50")
- Manufacturer:
- Dr. R. Pfleger Chemische Fabrik GmbH, 960 45 Bamberg, Germany.
- Sole distributor for the Czech Republic:
- PRO.MED.CS Praha a.s.
- Marketing authorisation holder:
- Dr. R. Pfleger Chemische Fabrik GmbH, 960 45 Bamberg, Germany.
- Composition:
- Diclofenacum natricum 50 mg in 1 enteric-coated tablet.
- Indication group:
- non-steroidal antiphlogistic and analgesic agent
The following information is for health professionals only.
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Characteristics:
By inhibiting cyclooxygenase, diclofenac suppresses the synthesis of prostaglandins and other agents contributing to the origin and development of the symptoms of inflammation. Its effects are antiphlogistic, analgesic, and antipyretic. After oral administration, Diclofenac is nearly completely absorbed, it is strongly bound to plasma proteins, and it well penetrates the synovial membrane changed by inflammation.
Indications:
Acute and chronic inflammatory and degenerative diseases of the locomotor system. Post-traumatic and postoperational edemas and inflammations, adjuvant treatment of painful and inflammatory affections in gynaecology (primary dysmenorrhea and adnexitis) and in otorhinolaryngology. The preparation Myogit® 50 is intended for adults and young persons over 15 years of age.
Contraindications:
Hypersensitivity to diclofenac or other nonsteroidal antiphlogistics and to other components of the preparation, active peptic ulcer, inflammatory intestinal diseases (Crohn’s disease, ulcerous colitis), disorders in hematopoiesis of unclear etiology, liver porphyry (danger of producing acute attacks of disease), the last trimester of pregnancy (danger of increased bleeding and suppression of uterine contractions) and lactation period. Women in the first six months of pregnancy can take Myogit® 50 only when it is essentially necessary. The preparation is not intended for children of body weight smaller than 20 kg.
Undesirable effects:
They occur particularly at the beginning of treatment. They include gastrointestinal disorders (pains in the epigastrium, nausea, meteorism, very rarely bleeding in the gastrointestinal tract), CNS disorders (transient headaches, light vertigoes, drowsiness), reactions from hypersensitivity (skin exanthemata, urticaria), rarely disorders of liver functions, retention of salts and fluids with edemas, disorders of hematopoiesis.
Interactions:
Concomitant administration with acetylsalicylic acid results in a decrease in plasma levels of diclofenac. Diclofenac increases the plasma levels of cyclosporin, lithium, digoxin, and methotrexate. It intensifies the effect of oral antidiabetics and oral anticoagulant agents. In patients receiving concomitantly potassium-sparing diuretics, it increases retention of potassium, decreasing the efficacy of other diuretics. Combined use of diclofenac with glucocorticoids and other nonsteroidal antiphflogistics may increase the risk of undesirable effects (bleeding into the stomach and intestines).
Caution:
Diclofenac may, particularly at the beginning of treatment, produce vertigoes, drowsiness or vision disorders and this influence the activities connected with increased attention. Caution is necessary when administering diclofenac to patients with bronchial asthma, nasal polyps, serious liver or renal disorders, and in patients with collagenosis (increased risk of aseptic meningitis). It is not advisable to drink alcohol during treatment.
Dosage:
Adults are usually administered 50 mg to 150 mg of diclofenac daily, divided into 2 to 3 single doses. Children over 6 years receive usually 2 mg per 1 kg of body weight daily, divided into 2 to 3 single doses. Young persons over 15 years of age can also take Myogit® 50. In the case of juvenile chronic arthritis, children over 20 kg are administered 1 to 3 mg/kg of body weight daily in 2 to 3 partial doses. Tablets are swallowed unchewed (before or during meals) and are sufficiently washed down.
Package:
20 enteric-coated tablets.
Complete information about the preparation is included in the drug information sheet.
Date of the latest revision of the text: March 9, 2005.
The preparation is available on medical prescription only.