Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
TACROLIMUS MONOHYDRATE
Accord Healthcare Limited
TACROLIMUS MONOHYDRATE
5 Milligram
Capsules Hard
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
Artwork No. Customer Description Market Language Size Min. Font Size Version No. Date - Accord Tacrolimus 0,5 / 1 / 5 mg IE-MT English 170 x 550 mm (PIL) 9 7 (Page 1 of 2) ( IB/06/G) 23.11.12 (Tacrolimus (ACC-IE-MT)NEW-PIL) Colours Used Pantone Black • difficulty in sleeping • trembling • Headache • increased blood pressure • diarrhoea • Nausea • kidney problems COMMON • reduction in blood cell counts (platelets, red or white blood cells), increase in white blood cell counts, changes in red blood cell counts • reduced magnesium, phosphate, potassium, calcium or sodium in the blood, fluid overload, increased uric acid or lipids in the blood, decreased appetite, increased acidity of the blood, other changes in the blood salts • anxiety symptoms, confusion and disorientation, depression, mood changes, nightmare, hallucinations, mental disorders • fits, disturbances in consciousness, tingling and numbness (sometimes painful) in the hands and feet, dizziness, impaired writing ability, nervous system disorders • blurred vision, increased sensitivity to light, eye disorders • ringing sound in your ears • reduced blood flow in the heart vessels, faster heartbeat • bleeding, partial or complete blocking of blood vessels, reduced blood pressure • shortness in breath, changes in the lung tissue, collection of liquid around the lung, inflammation of the pharynx, cough, flu-like symptoms • inflammations or ulcers causing abdominal pain or diarrhoea, bleedings in the stomach, inflammations or ulcers in the mouth, collection of fluid in the belly, vomiting, abdominal pains, indigestion, constipation, flatulence, bloating, loose stools, stomach problems • changes in liver enzymes and function, yellowing of the skin due to liver problems, liver tissue damage and inflammation of the liver • itching, rash, hair loss, acne, increased sweating • pain in joints, limbs or back, muscle cramp Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tacrolimus 5mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 5 mg of tacrolimus(as tacrolimus monohydrate) Excipients: 98.86 mg of lactose monohydrate For the full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Capsule hard Pink/pink hard gelatin capsules, approximately 14.30mm, size "4" imprinted with “TCR” on cap & “5” on body containing white to off white granular powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of transplant rejection in liver, kidney or heart allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Tacrolimus therapy requires careful monitoring by adequately qualified and equipped personnel. This medicinal product should only be prescribed and changes in immunosuppressive therapy, initiated by physicians experienced in immunosuppressive therapy and the management of transplanted patients. Inadvertent, unintentional or unsupervised switching of immediate- or prolonged-release formulations of tacrolimus is unsafe. This can lead to graft rejection or increased incidence of side effects, including under- or over immunosuppression, due to clinically relevant differences in systemic exposure to tacrolimus. Patients should be maintained on a single formulation of tacrolimus with the corresponding daily dosing regimen; alterations in formulation or regimen should only take place under the close supervision of a transplant specialist (see sections 4.4 and 4.8). Following conversion to any alternative formulation, therapeutic drug monitoring must be performed and dose adjustments made to ensure that systemic exposure to tacrolimus is mai Preberite celoten dokument