Neoral 25mg capsules

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Ciclosporin

Saatavilla:

Dowelhurst Ltd

ATC-koodi:

L04AD01

INN (Kansainvälinen yleisnimi):

Ciclosporin

Annos:

25mg

Lääkemuoto:

Oral capsule

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Caution - AMP level prescribing advised

Tuoteyhteenveto:

BNF: 08020200

Pakkausseloste

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.

Valmisteyhteenveto

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