Sandimmun Neoral 25 mg, 50 mg and 100 mg capsules and 100 mg/mL oral solution – ciclosporin after transplantation and in autoimmune diseases

Sandimmun Neoral contains ciclosporin – an immunosuppressant, a medicine that reduces the body's immune response. It is used after transplantation of organs, bone marrow or stem cells to prevent rejection of the transplanted tissue, and in some severe autoimmune diseases: endogenous uveitis, nephrotic syndrome, severe rheumatoid arthritis, severe psoriasis and severe atopic dermatitis.

The medicine is authorised as soft capsules of 25 mg, 50 mg and 100 mg (50 capsules each) and as an oral solution 100 mg/mL (50 mL bottle with dosing syringes). Sandimmun Neoral is an improved ciclosporin formulation that is absorbed more consistently than the older Sandimmun. The dose is always set individually according to body weight, the disease and the level of the medicine in the blood.

What is Sandimmun Neoral used for and how is it taken correctly?

Key information about the medicine

What is Sandimmun Neoral used for?

According to the summary of product characteristics:

• Solid organ transplantation: prevention of graft rejection and treatment of cellular rejection in patients previously given other immunosuppressants.
• Bone marrow and stem cell transplantation: prevention of rejection after allogeneic transplantation and prevention or treatment of graft-versus-host disease (GVHD).
• Endogenous uveitis: sight-threatening non-infectious intermediate or posterior uveitis when conventional treatment has failed; Behçet's uveitis with repeated inflammatory attacks involving the retina, without neurological manifestations.
• Nephrotic syndrome, steroid-dependent or steroid-resistant, due to primary glomerular disease – to induce and maintain remission.
• Severe active rheumatoid arthritis.
• Severe psoriasis when conventional therapy is inappropriate or ineffective, and severe atopic dermatitis when systemic therapy is required.

How is Sandimmun Neoral used and dosed?

Your doctor sets the dose according to body weight, the disease and blood test results. The total daily dose is always divided into two separate doses, taken at the same times every day and consistently in relation to meals. Typical daily doses according to the package leaflet:

• Capsules: take the capsule out of the blister only when you are going to take it and swallow it whole with water. A characteristic smell when opening the blister is normal.
• Oral solution: measure the required amount with the supplied syringe (up to 1 mL – 1 mL syringe; more than 1 mL – 4 mL syringe), empty it into a small glass of drink, preferably orange or apple juice, stir and drink it at once. The syringe must not touch the liquid; after use wipe only the outside with a dry tissue.
• Switching from another ciclosporin product (e.g. from Sandimmun or another oral formulation) is done only under medical supervision, with blood level monitoring.
• Never change the dose yourself, even if you feel well.

Special patient groups

• Children: for conditions not related to transplantation the medicine is not given to children, except for nephrotic syndrome. After transplantation children often need higher doses per kilogram.
• Elderly (65+): experience is limited; the doctor starts with lower doses and pays special attention to kidney function. In psoriasis and atopic dermatitis older patients are treated only if the condition is particularly severe.
• Kidney impairment: kidney function is monitored closely; for non-transplant indications (except nephrotic syndrome) the medicine is not used in impaired kidney function.
• Liver impairment: exposure may be 2–3 times higher; in severe impairment a dose reduction with blood level monitoring may be needed.

Contraindications – when the medicine must not be used

• allergy (hypersensitivity) to ciclosporin or any of the excipients;
• concomitant use of products containing St John's wort (Hypericum perforatum);
• concomitant use of dabigatran etexilate, bosentan or aliskiren.

For non-transplant indications, according to the leaflet, the medicine is also not taken if you have kidney problems (except nephrotic syndrome), an uncontrolled infection, any type of cancer or uncontrolled high blood pressure.

Precautions and warnings

Before and during treatment tell your doctor immediately:

• if you have signs of infection (fever, sore throat);
• if you have liver or kidney problems, high blood pressure, low blood magnesium or high potassium, or gout;
• if you need a vaccination – vaccines may be less effective and live attenuated vaccines should be avoided;
• if you have hepatitis C or epilepsy, or have had problems with alcohol.

During treatment your doctor will monitor ciclosporin blood levels (especially after transplantation), blood pressure, liver and kidney function and blood lipids. Because of the increased risk of skin cancer, wear protective clothing and apply a high-protection sunscreen often; in psoriasis and atopic dermatitis you must not receive UVB radiation or phototherapy. The medicine contains ethanol (capsules 11.8% v/v; oral solution 12% v/v – up to 500 mg per dose in transplant patients), castor oil (may cause stomach upset and diarrhoea) and propylene glycol.

Interactions with other medicines, food and drink

Tell your doctor or pharmacist about all medicines you take. Your doctor may check ciclosporin levels when other medicines are started or stopped. It is particularly important to mention:

• medicines that increase ciclosporin levels: erythromycin, azithromycin, voriconazole, itraconazole, diltiazem, nicardipine, verapamil, amiodarone, metoclopramide, oral contraceptives, danazol, allopurinol, cholic acid, HIV protease inhibitors, imatinib, colchicine, telaprevir, cannabidiol;
• medicines that decrease ciclosporin levels: barbiturates, carbamazepine, phenytoin, octreotide, tuberculosis medicines, orlistat, St John's wort, ticlopidine, bosentan, terbinafine;
• medicines that affect the kidneys: gentamicin, tobramycin, ciprofloxacin, amphotericin B, trimethoprim, melphalan, H2 blockers, tacrolimus, non-steroidal anti-inflammatory drugs (e.g. diclofenac), fibrates;
• potassium-containing medicines and products, potassium supplements, potassium-sparing diuretics and some blood pressure medicines;
• methotrexate, nifedipine (gum swelling), digoxin, statins, prednisolone, etoposide, repaglinide, everolimus, sirolimus, ambrisentan and anthracyclines.

Food and drink: do not take the medicine with grapefruit or grapefruit juice.

Pregnancy and breast-feeding

Experience in pregnancy is limited; in general the medicine should not be taken during pregnancy, and if it is necessary your doctor will explain the benefits and risks. Breast-feeding is not recommended because ciclosporin passes into breast milk. Tell your doctor if you are pregnant, planning a pregnancy or breast-feeding.

Driving and using machines

There are no data on the effect of the medicine on the ability to drive or use machines. Possible side effects such as visual disturbances, confusion or seizures mean you should not drive and should contact your doctor straight away.

Possible side effects

• Very common (more than 1 in 10): kidney problems, high blood pressure, headache, uncontrollable trembling, excessive growth of body and facial hair, raised blood lipids.
• Common (up to 1 in 10): seizures, liver problems, high blood sugar, tiredness, loss of appetite, nausea, vomiting, stomach pain, diarrhoea, acne, hot flushes, fever, low white blood cell count, numbness or tingling, muscle pain and cramps, stomach ulcer, overgrowth of the gums over the teeth, high uric acid or potassium and low magnesium in the blood.
• Uncommon (up to 1 in 100): symptoms of brain disorders (sudden seizures, confusion, sleeplessness, disorientation, visual disturbance, coma, limb weakness), rash, general swelling, weight gain, low red blood cell or platelet count.
• Rare (up to 1 in 1,000): nerve damage with numbness of fingers and toes, inflammation of the pancreas, muscle weakness and pain, destruction of red blood cells with kidney problems, menstrual changes, breast enlargement in men.
• Very rare (up to 1 in 10,000): swelling at the back of the eye with raised pressure in the head and visual disturbances.
• Frequency not known: serious liver problems, bleeding under the skin, migraine or severe headache, pain in the legs and feet.

Overdose, missed dose and stopping treatment

• Overdose: if you have accidentally taken too much, contact your doctor or the nearest emergency department immediately.
• Missed dose: take it as soon as you remember, unless it is almost time for the next dose – then skip the missed one. Do not take a double dose.
• Stopping treatment: do not stop the medicine without talking to your doctor, even if you feel well – stopping may increase the risk of transplant rejection.

Related information

During immunosuppressive treatment, regular check-ups with the treating doctor, blood pressure monitoring, careful hand and oral hygiene, avoiding contact with people who have infectious diseases and consistent sun protection of the skin are important.

Composition, pack and manufacturer

• Active substance: ciclosporin – 25 mg, 50 mg or 100 mg per soft capsule; 100 mg per 1 mL of oral solution.
• Excipients (capsules): alpha-tocopherol; ethanol, anhydrous; propylene glycol; corn oil mono-, di- and triglycerides; macrogolglycerol hydroxystearate (polyoxyl 40 hydrogenated castor oil); shell: black iron oxide (E172), titanium dioxide (E171), glycerol 85%, propylene glycol, gelatin; printing ink: carminic acid and other ingredients.
• Excipients (oral solution): DL-alpha-tocopherol; ethanol, anhydrous; propylene glycol; corn oil mono-, di- and triglycerides; macrogolglycerol hydroxystearate.
• Appearance: 25 mg capsules – oval, blue-grey, imprinted "NVR 25 mg"; 50 mg – oblong, yellow-white, "NVR 50 mg"; 100 mg – oblong, blue-grey, "NVR 100 mg". Oral solution – clear, oily, light yellow to light brownish-yellow.
• Marketing authorisation holder: Novartis Pharma Services Inc. Representative Office Belgrade (Novi Beograd), Omladinskih brigada 90A, Belgrade.
• Authorisation numbers: 25 mg – 515-01-04935-21-001; 50 mg – 515-01-04936-21-001; 100 mg – 515-01-04937-21-001 (all dated 28 October 2022); oral solution – 515-01-04938-21-001 dated 9 December 2022.

Storage

• Capsules: store below 25 °C in the original package to protect from moisture; keep the capsules in the blister until use. Shelf life: 2 years.
• Oral solution: store below 25 °C and, for longer periods, not below 20 °C. Shelf life 3 years; 2 months after first opening. Below 20 °C jelly-like formations or slight sediment may appear, which disappear at room temperature and do not affect the medicine.
• Keep out of the sight and reach of children. Return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

May I drink grapefruit juice while taking Sandimmun Neoral?

No. According to the leaflet, grapefruit and grapefruit juice affect how the medicine works (they increase its blood level). The oral solution is mixed with orange or apple juice instead.

Can I take St John's wort or other herbal products?

St John's wort is contraindicated – it lowers ciclosporin levels and may jeopardise treatment. Before any herbal product or supplement, especially one containing potassium, ask your doctor or pharmacist.

What should I do if I forget a dose?

Take it as soon as you remember, unless it is almost time for the next dose – then skip the missed dose and carry on as usual. Never take a double dose.

Why does my doctor keep checking my blood and blood pressure?

The ciclosporin dose is adjusted according to its blood level, and the medicine may raise blood pressure and affect the kidneys, liver, blood lipids, potassium and magnesium. Regular checks make treatment safe.

Sources

• ALIMS – Package leaflet, Sandimmun Neoral 25 mg, 50 mg and 100 mg soft capsules (PIL, Serbian)
• ALIMS – Summary of Product Characteristics, Sandimmun Neoral capsules (SmPC, Serbian)
• ALIMS – Package leaflet, Sandimmun Neoral 100 mg/mL oral solution (PIL, Serbian)
• ALIMS – Summary of Product Characteristics, Sandimmun Neoral oral solution (SmPC, Serbian)

Sources checked on: 25 October 2026.