国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ciclosporin
Waymade Healthcare Plc
L04AD01
Ciclosporin
25mg
Oral capsule
Oral
No Controlled Drug Status
Caution - AMP level prescribing advised
BNF: 08020200
UNCOMMON SIDE EFFECTS: _These side effects may affect between 1 _ _and 10 in every 1,000 people._ Symptoms of brain disorders including sudden fits, mental confusion, sleeplessness, disorientation, disturbance of vision, unconsciousness, sense of weakness in the limbs, impaired movements. Rash. General swelling. Weight gain. Low level of red blood cells, low level of platelets in your blood which could increase the risk of bleeding. If any of these affects you severely, TELL YOUR DOCTOR. RARE SIDE EFFECTS: _These side effects may affect between 1 and 10 _ _in every 10,000 people._ Nerve problems with numbness or tingling in fingers and toes. Inflammation of the pancreas with severe upper stomach pain. Muscle weakness, loss of muscle strength, pain in muscles of the legs or hands or anywhere in the body. Destruction of red blood cells, involving kidney problems with symptoms such as swelling of the face, stomach, hands and/or feet, decreased urination, breathing difficulty, chest pain, fits, unconsciousness. Changes in menstrual cycle, breast enlargement in men. If any of these affects you severely, TELL YOUR DOCTOR. VERY RARE SIDE EFFECTS: _These side effects may affect between 1 _ _and 10 in every 100,000 people._ Swelling at the back of the eye which may be associated with an increase in pressure inside the head and eyesight disturbances. If this affects you severely, TELL YOUR DOCTOR. OTHER SIDE EFFECTS WITH FREQUENCY NOT KNOWN: Frequency cannot be estimated from the available data. Serious liver problems both with and without yellowing of the eyes or skin, nausea (feeling sick), loss of appetite, dark coloured urine, swelling of the face, feet, hands and/or the whole body. Bleeding underneath the skin or purple skin patched, sudden bleeding with no apparent cause. Migraine or severe headache often with feeling and being sick (nausea, vomiting) and being sensitive to light. Pain in legs and feet If any of these affects you severely, TELL YOUR DOCTOR. 完全なドキュメントを読む
1 NAME OF THE MEDICINAL PRODUCT NEORAL Soft Gelatin Capsules 25mg Neciclopin 25 mg Soft Gelatin Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 25 mg ciclosporin. Excipients with known effect: Ethanol: NEORAL Soft Gelatin Capsules 25mg contain 11.8% v/v ethanol (9.4% m/v). Propylene glycol: 25 mg/capsule. Macrogolglycerol hydroxystearate/Polyoxyl 40 hydrogenated castor oil: 101.25 mg/capsule. For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Capsule, soft Blue-grey, oval soft gelatin capsules, imprinted with “NVR 25mg” in red. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Transplantation indications _Solid organ transplantation _ Prevention of graft rejection following solid organ transplantation. Treatment of transplant cellular rejection in patients previously receiving other immunosuppressive agents. _Bone marrow transplantation _ Prevention of graft rejection following allogeneic bone marrow and stem cell transplantation. Prevention or treatment of graft-versus-host disease (GVHD). Non-transplantation indications _Endogenous uveitis _ Treatment of sight-threatening intermediate or posterior uveitis of non-infectious aetiology in patients in whom conventional therapy has failed or caused unacceptable side effects. Treatment of Behçet uveitis with repeated inflammatory attacks involving the retina in patients without neurological manifestations. _Nephrotic syndrome _ Steroid-dependent and steroid-resistant nephrotic syndrome, due to primary glomerular diseases such as minimal change nephropathy, focal and segmental glomerulosclerosis, or membranous glomerulonephritis. Neoral can be used to induce and maintain remissions. It can also be used to maintain steroid-induced remission, allowing withdrawal of steroids. _Rheumatoid arthritis _ Treatment of severe, active rheumatoid arthritis. _Psoriasis _ Treatment of severe psoriasis in patients in whom conventional therapy is inappropriate or ineffective. _Atopic dermatitis _ Neoral is indicated in patients with 完全なドキュメントを読む