DICLOFENAC EURO
(DICLOFENAC EURO)
Composition:
active ingredient: diclofenac sodium;
1 tablet contains diclofenac sodium 50 mg;
Excipients: lactose monohydrate, corn starch, talc, magnesium stearate, colloidal anhydrous silica, croscarmellose sodium, methacrylate copolymer dispersion, sodium hydroxide, diethyl phthalate, polysorbate 80 (Tween 80), titanium dioxide (E 171), Sunset Yellow FCF dye (E 110).
Dosage form.
Pharmacotherapeutic group.
Pharmacological properties.
Pharmacodynamics.
Diclofenac sodium - the active substance of the drug, is a non-steroidal compound with pronounced antipyretic, analgesic and anti-inflammatory properties. Diclofenac sodium as a non-selective inhibitor of COX-1 and COX-2 disrupts the metabolism of arachidonic acid and inhibits the biosynthesis of prostaglandins by inhibiting the activity of the prostaglandin synthetase enzyme and thus significantly reduces the manifestation of symptoms of inflammation and increased sensitivity of nerve endings to mechanical irritation and the action of biologically active substances formed at the site of inflammation.
In rheumatic diseases, the anti-inflammatory and analgesic effect of Diclofenac Euro reduces the severity of pain (both at rest and during movement), morning stiffness, and joint swelling, thereby improving the patient's functional status.
In injuries and in the post-traumatic period, diclofenac reduces pain and inflammatory swelling.
In vitro, diclofenac sodium at concentrations equivalent to those achieved in the treatment of patients does not inhibit the biosynthesis of cartilage proteoglycans.
Clinical characteristics.
Indication.
Contraindication.
Use during pregnancy or breastfeeding.
Pregnancy. Diclofenac Euro should not be used during the first and second trimesters of pregnancy unless the potential benefit to the mother outweighs the potential risk to the fetus. For a woman attempting to conceive, or during the first or second trimester of pregnancy, the dose of the drug should be kept as low and the duration of treatment as short as possible. Like other NSAIDs, the drug is contraindicated in the third trimester of pregnancy (possible inhibition of uterine contractility and premature closure of the ductus arteriosus in the fetus).
Inhibition of prostaglandin synthesis may adversely affect the course of pregnancy and/or embryo/foetal development. Epidemiological data suggest an increased risk of miscarriage and/or cardiac malformations and gastroschisis following exposure to a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular malformations has been increased from less than 1% to approximately 1.5%.
It is possible that the risk increases with increasing dose and duration of treatment. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo/fetal lethality.
In addition, an increased incidence of various malformations, including those of the cardiovascular system, was recorded in animals treated with a prostaglandin synthesis inhibitor during organogenesis.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may affect the fetus in the following ways:
- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
- impaired renal function, which may progress to renal failure with oligohydramnios.
Effects of prostaglandin synthesis inhibitors on the mother and newborn, as well as at the end of pregnancy:
- possible prolongation of bleeding time, antiplatelet effect, which can be observed even at very low doses;
- inhibition of uterine contractions, which leads to delayed or prolonged labor.
Therefore, Diclofenac Euro is contraindicated during the third trimester of pregnancy.
Breastfeeding. Like other NSAIDs, diclofenac passes into breast milk in small amounts. Therefore, diclofenac should not be used by women during breastfeeding to avoid undesirable effects on the infant.
If treatment is necessary, breastfeeding should be discontinued.
Female fertility. Like other NSAIDs, Diclofenac may impair female fertility and is therefore not recommended for use in women attempting to conceive. In women who have difficulty conceiving or are undergoing investigation of infertility, discontinuation of Diclofenac should be considered.
Based on animal studies, impaired male reproductive function cannot be excluded. The relevance of these data to humans has not been established.
The ability to influence the reaction speed when driving vehicles or other mechanisms.
Usually, when taking the drug in recommended doses and with a short course of treatment, there is no effect on the reaction speed. However, patients who experience visual disturbances, dizziness, vertigo, drowsiness or other central nervous system disorders, lethargy or fatigue when using the drug Diclofenac Euro should not drive or operate other mechanisms.
Method of administration and doses.
Children.
The drug in this dosage is not used in children due to the high content of the active substance.
Adverse reactions.
Storage conditions.
Packaging.
10 tablets in a blister, 1 or 2, or 10 blisters in a cardboard box.
Release category: By prescription.
Producer.
Unique Pharmaceutical Laboratories (a division of J.B. Chemicals and Pharmaceuticals Ltd.).
Location of the manufacturer and its business address.
Plot No. 215-219, G. I. D. C. Industrial Area, Panoli - 394 116, Bharuch District, India.
