Special Warning : אזהרת שימוש

4.4      Special warnings and precautions for use

-      The medicated patch should be applied only to intact, non-diseased skin, and not to skin wounds or open injuries, and should not be worn when bathing or showering.
-     The medicated patch should not come into contact with or be applied to the mucosae or the eyes.
-     Not for use with occlusive dressing.
-     Discontinue the treatment immediately if a skin rash develops after applying the medicated patch.
-     Do not administer concurrently, by either the topical or the systemic route, any medicinal product containing diclofenac or other NSAIDs.
-     The possibility of systemic adverse events from application of topical diclofenac cannot be excluded if the preparation is used over a prolonged period (see the product information on systemic forms of Diclofenac). Although systemic effects should be low, the patch should be used with caution in patients with renal, cardiac or hepatic impairment, history of peptic ulceration or inflammatory bowel disease or bleeding diathesis. Non-steroidal anti-inflammatory drugs should be used with particular caution in elderly patients who are more prone to adverse events.
-     Patients should be warned against exposure to direct and solarium sunlight in order to reduce the risk of photosensitivity.
-     Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergenic disease or allergy to acetylsalicylic acid or other NSAID. The medicated patch should be used with caution in patients with or without chronic asthma in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or other non-steroidal anti- inflammatory agents (see 4.3 Contraindications). In order to minimise the occurrence of undesirable effects it is recommended to use the lowest effective dose for the shortest duration necessary to control symptoms, without exceeding the approved maximum 14 days (Please see section 4.2 and 4.8).
Fetal Toxicity

Premature Closure of Fetal Ductus Arteriosus:
-     Avoid use of NSAIDs, including lornoxicam, in pregnant women at about 30 weeks gestation and later. NSAIDs, including lornoxicam, increase the risk of premature closure of the fetal ductus arteriosus at approximately this gestational age.

Oligohydramnios/Neonatal Renal Impairment:
-     Use of NSAIDs, including lornoxicam, at about 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as       48 hours after NSAID initiation. Oligohydramnios is often, but not always, reversible with treatment discontinuation. Complications of prolonged oligohydramnios may, for example, include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
-     If NSAID treatment is necessary between about 20 weeks and 30 weeks gestation, limit lornoxicam use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if lornoxicam treatment extends beyond 48 hours.
Discontinue lornoxicam if oligohydramnios occurs and follow up according to clinical practice [see 4.6 Fertility, pregnancy and lactation].

Effects on Driving

4.7   Effects on ability to drive and use machines
Diclofenac medicated patch application has no influence on the ability to drive anduse machines.