Opiflamless

Composition ;

Each Enteric Coated Tablet contains:

Active ingredients: Diclofenac sodium 25 mg

Inactive ingredients: Maize Starch,Lactose Monohydrate,Crosscarmellose sodium,Magnesium Stearate,Opadry OY- 8719 Orange,Cellulose acetate phthalate,Diethyl phthalate,Castor oil

Dosage form : Enteric Coated Tablet

CLINICAL PARTICULARS

1-Therapeutic indications

Adults and Elderly:

Relief of all grades of pain and inflammation in a wide range of conditions, including:

  • arthritic conditions: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout,

(ii) acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder), tendinitis, tenosynovitis, bursitis,

(iii) other painful conditions resulting from trauma, including fracture, low back pain, sprains, strains, dislocations, orthopaedic, dental and other minor surgery.

Children (aged 1-12 years): Juvenile chronic arthritis (25mg tablet only).

Category:
Contraindications
Interaction with other medicinal products and other forms of interaction
Pregnancy and lactation
PHARMACOLOGICAL PROPERTIES
STORAGE INSTRUCTIONS:
PACKAGE:

Contraindications

Hypersensitivity to the active substance or any of the excipients.
  • Active, gastric or intestinal ulcer, bleeding or perforation.
  • History of gastrointestinal bleeding or perforation, relating to previous NSAID therapy
  • Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
  • Last trimester of pregnancy (see Pregnancy and lactation).
  • Severe hepatic, renal or cardiac failure (see Special warnings and precautions for use).
• Like other non-steroidal anti-inflammatory drugs (NSAIDs), Diclofenac is also contraindicated in patients in whom attacks of asthma, angioedema, urticaria or acute rhinitis are precipitated by ibuprofen, acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.

Interaction with other medicinal products and other forms of interaction

The following interactions include those observed with Diclofenac gastro-resistant tablets and/or other pharmaceutical forms of Diclofenac. Lithium Digoxin Diuretics and antihypertensive agents Anticoagulants and anti-platelet agents Antidiabetics Methotrexate Ciclosporin Quinolone antibacterials Phenytoin Colestipol and cholestyramine. Cardiac glycosides. Potent CYP2C9 inhibitors

Pregnancy and lactation

Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and or cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1% up to approximately 1.5%. The risk in believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has shown to result in increased pre-and post-implantation loss and embryo-foetal lethality. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to: cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension) - renal dysfunction, which may progress to renal failure with oligo-hydroamniosis The mother and the neonate, at the end of the pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses - inhibition of uterine contractions resulting in delayed or prolonged labour Consequently, Opiflamless is contraindicated during the third trimester of pregnancy. Lactation Like other NSAIDs, Opiflamless passes into breast milk in small amounts. Therefore Opiflamless should not be administered during breastfeeding in order to avoid undesirable effects in the infant. Female fertility: As with other NSAIDs, the use of Opiflamless may impair female fertility and is not recommended in women attempting to conceive. In women who may have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Opiflamless should be considered. See Special warnings and precautions for use, regarding female fertility.

PHARMACOLOGICAL PROPERTIES

1- Pharmacodynamic properties Pharmacotherapeutic group Nonsteroidal anti-inflammatory drugs (NSAIDs). Mechanism of action Diclofenac is a nonsteroidal agent with marked analgesic/anti- inflammatory properties. It is an inhibitor of prostaglandin synthetase, (cyclo-oxygenase). Diclofenc sodium in vitro does not suppress proteoglycan biosynthesis in cartilage at concentrations equivalent to the concentrations reached in human beings. Applicable to 25mg Tablets only 2-Pharmacokinetic properties Absorption Absorption is complete but onset is delayed until passage through the stomach, which may be affected by food which delays stomach emptying. The mean peak plasma Diclofenac concentration reached at about 2 hours (50mg dose produces1.48 ± 0.65µg/ml (1.5µg/ml 5µmol/l)). 3- Preclinical safety data None stated.  4-Special precautions for storage Protect from moisture. Store below 30°C. Medicines should be kept out of the reach of children.

STORAGE INSTRUCTIONS:

Storage at a temp. not exceeding 30 ºC in dry place.

PACKAGE:

Carton box contain 1,2 or 3 (Al / PVC) blisters, each of 10 enteric coated tablets with inner leaflet

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