Sandimmun Neoral 50 mg soft capsules: detailed information

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Sandimmun Neoral 50 mg Soft Capsules

ciclosporin

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you personally; do not give it to others, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet Contents:

What Sandimmun Neoral is and what it is used for
What you need to know before taking Sandimmun Neoral
How to take Sandimmun Neoral
Possible side effects
How to store Sandimmun Neoral
Contents of the pack and other information

1. What Sandimmun Neoral is and what it is used for

What Sandimmun Neoral is

The name of your medicine is Sandimmun Neoral. It contains the active substance ciclosporin. It belongs to a group of medicines known as immunosuppressants. These medicines are used to reduce the body's immune responses.

What Sandimmun Neoral is used for and how it works

If you have undergone an organ, bone marrow or stem cell transplant, the function of Sandimmun Neoral is to control your body's immune system. Sandimmun Neoral prevents rejection of transplanted organs by suppressing the development of certain cells that would normally attack the transplanted tissue.
If you have an autoimmune disease, in which your body's immune response attacks its own cells, Sandimmun Neoral suppresses this immune reaction. These diseases include eye disorders that may affect your vision (endogenous uveitis, including Behçet's uveitis), severe cases of certain skin diseases (atopic dermatitis, or eczema, and psoriasis), severe rheumatoid arthritis, and a kidney disease called nephrotic syndrome.

2. What you need to know before taking Sandimmun Neoral

If you are taking Sandimmun Neoral after a transplant, it must have been prescribed only by a physician experienced in transplantation and/or autoimmune diseases.

The recommendations in this leaflet may vary depending on whether you are taking the medicine for a transplant or for an autoimmune disease.

Follow your doctor's instructions carefully. They may differ from the general information provided in this leaflet.

Do not take Sandimmun Neoral:

if you are allergic to ciclosporin or to any of the other components of this medicine (listed in section 6).
with medicines containing Hypericum perforatum (St. John's wort).
with medicines containing dabigatran etexilate (used to prevent blood clots after surgery), bosentan, or aliskiren (used to lower high blood pressure).

If any of these apply to you, do not take Sandimmun Neoral and inform your doctor. If you are unsure, consult your doctor before taking Sandimmun Neoral.

Warnings and precautions

Before and during treatment with Sandimmun Neoral, inform your doctor immediately:

if you have any signs of infection, such as fever or sore throat. Sandimmun Neoral suppresses the immune system and may also affect your body's ability to fight infections.
if you have liver problems.
if you have kidney problems. Your doctor will perform regular blood tests and may adjust your dose if necessary.
if you have high blood pressure. Your doctor will monitor your blood pressure regularly and may prescribe medication to lower it if needed.
if you have low magnesium levels in your body. Your doctor may prescribe magnesium supplements, especially shortly after surgery if you have undergone a transplant.
if you have high potassium levels in your blood.
if you suffer from gout.
if you need to receive a vaccine.

If you experience any of the above conditions before or during treatment with Sandimmun Neoral, inform your doctor immediately.

Sun protection and sunlight exposure

Sandimmun Neoral suppresses your immune system. This may increase the risk of developing cancer, particularly of the skin and lymphatic system. Therefore, you should limit your exposure to sunlight and UV rays by:

wearing appropriate protective clothing,
frequently applying a high-protection sunscreen.

Consult your doctor before taking Sandimmun Neoral:

if you have or have had alcohol-related problems.
if you suffer from epilepsy.
if you have any liver problems.
if you are pregnant.
if you are breastfeeding.
if this medicine is prescribed for a child.

If any of these situations apply to you (or you are unsure), inform your doctor before taking Sandimmun Neoral. This is because this medicine contains alcohol (see section “Sandimmun Neoral contains ethanol” below).

Monitoring during your treatment with Sandimmun Neoral

Your doctor will monitor:

blood levels of ciclosporin, especially if you have undergone a transplant,
your blood pressure before starting treatment and regularly during treatment,
the function of your liver and kidneys,
your blood lipid levels (fats).

If you have any questions about how Sandimmun Neoral works or why it has been prescribed for you, consult your doctor.

Additionally, if you are taking Sandimmun Neoral for a condition other than transplantation (intermediate or posterior uveitis and Behçet's uveitis, atopic dermatitis, severe rheumatoid arthritis, or nephrotic syndrome), do not take Sandimmun Neoral:

if you have kidney problems (except for nephrotic syndrome).
if you have an infection that is not controlled with medication.
if you have any type of cancer.
if you have uncontrolled high blood pressure (hypertension) with medication. If you develop high blood pressure during treatment that cannot be controlled, your doctor should discontinue treatment with Sandimmun Neoral.

If any of these situations apply to you, do not take Sandimmun Neoral. If you are unsure, consult your doctor or pharmacist before taking Sandimmun Neoral.

If you are being treated for Behçet's uveitis, your doctor will monitor you closely, especially if you experience neurological symptoms (e.g.: frequent forgetfulness, personality changes over time, psychiatric or mood disorders, burning sensation in the limbs, reduced sensitivity in the limbs, tingling in the limbs, limb weakness, motor disturbances, headache with or without nausea and vomiting, visual disturbances including limited eye movement).

Your doctor will monitor you closely if you are elderly and being treated for psoriasis or atopic dermatitis. If Sandimmun Neoral has been prescribed for your psoriasis or atopic dermatitis, you must not be exposed to UVB radiation or photochemotherapy during treatment.

Children and adolescents

Sandimmun Neoral must not be administered to children for indications other than transplantation, except for the treatment of nephrotic syndrome.

Elderly population (65 years of age and older)

Experience with Sandimmun Neoral in elderly patients is limited. Your doctor must monitor your kidney function. If you are over 65 years old and suffer from psoriasis or atopic dermatitis, Sandimmun Neoral should only be used if your condition is particularly severe.

Other medicines and Sandimmun Neoral

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines before or during treatment with Sandimmun Neoral:

Medicines that may affect your potassium levels. These include medicines containing potassium, potassium supplements, potassium-sparing diuretics, and certain medicines that lower your blood pressure.
Methotrexate. Used to treat tumours, severe psoriasis, and severe rheumatoid arthritis.
Medicines that may increase or decrease ciclosporin levels (the active substance in Sandimmun Neoral) in your blood. Your doctor may check your ciclosporin blood levels when starting or stopping other medicines.
Medicines that may increase ciclosporin levels in your blood include: antibiotics (such as erythromycin or azithromycin), antifungals (voriconazole, itraconazole), medicines used for heart disorders or high blood pressure (diltiazem, nicardipine, verapamil, amiodarone), metoclopramide (used to stop vomiting), oral contraceptives, danazol (used to treat menstrual disorders), medicines used to treat gout (allopurinol), cholic acid and derivatives (used to treat gallstones), protease inhibitors used to treat HIV, imatinib (used to treat leukaemia or tumours), colchicine, telaprevir (used to treat hepatitis C), cannabidiol (used, among other things, to treat epileptic seizures).
Medicines that may decrease ciclosporin levels in your blood include: barbiturates (used to help you sleep), certain anticonvulsants (such as carbamazepine or phenytoin), octreotide (used to treat acromegaly or neuroendocrine tumours in the intestine), antibacterial medicines used to treat tuberculosis, orlistat (used to help lose weight), herbal medicines containing St. John's wort, ticlopidine (used after stroke), certain medicines that lower blood pressure (bosentan), and terbinafine (an antifungal medicine used to treat foot and nail infections).
Medicines that may affect your kidneys. These include: antibacterial medicines (gentamicin, tobramycin, ciprofloxacin), antifungal medicines containing amphotericin B, medicines used for urinary tract infections containing trimethoprim, anticancer medicines containing melphalan, medicines used to reduce stomach acid (acid secretion inhibitors such as H2-receptor antagonists), tacrolimus, analgesics (non-steroidal anti-inflammatory drugs such as diclofenac), fibric acid medicines (used to reduce blood fat levels).
Nifedipine. Used to treat high blood pressure and chest pain. You may develop swollen gums that could grow over your teeth if you are taking nifedipine during ciclosporin treatment.
Digoxin (used to treat heart disorders), cholesterol-lowering medicines (HMG-CoA reductase inhibitors also known as statins), prednisolone, etoposide (used to treat cancer), repaglinide (an oral antidiabetic medicine), immunosuppressants (everolimus, sirolimus), ambrisentan, and specific anticancer medicines called anthracyclines (such as doxorubicin).
Sodium mycophenolate or mycophenolate mofetil (an immunosuppressant) and eltrombopag (used to treat bleeding disorders).

If any of these situations apply to you (or you are unsure), inform your doctor or pharmacist before taking Sandimmun Neoral.

Taking Sandimmun Neoral with food and drinks

Do not take Sandimmun Neoral with grapefruit or grapefruit juice. This is because it may affect how Sandimmun Neoral works.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking this medicine.

Inform your doctor if you are pregnant or planning to become pregnant. Experience with Sandimmun Neoral in pregnant women is limited. In general, Sandimmun Neoral should not be administered during pregnancy. If it is necessary for you to take this medicine, your doctor will discuss the potential benefits and risks of taking it during pregnancy.
Inform your doctor if you are breastfeeding. Breastfeeding is not recommended during treatment with Sandimmun Neoral. This is because ciclosporin, the active ingredient, passes into breast milk and could affect your baby.

Hepatitis C

Inform your doctor if you have hepatitis C. Your liver function may change with hepatitis C treatment, which may affect ciclosporin blood levels. Your doctor may need to closely monitor ciclosporin blood levels and adjust the dose after starting hepatitis C treatment.

Driving and using machines

You may feel drowsy, disoriented, or experience blurred vision after taking Sandimmun Neoral. Be cautious when driving or operating machinery while taking Sandimmun Neoral until you know how it affects you.

Sandimmun Neoral contains ethanol

Sandimmun Neoral contains 50 mg of alcohol (ethanol) per 50 mg capsule of Sandimmun Neoral capsules, corresponding to 11.8% v/v. A 500 mg dose of Sandimmun Neoral contains 500 mg of ethanol, equivalent to approximately 13 ml of beer or 5 ml of wine. The small amount of alcohol in this medicine will have no noticeable effect.

Sandimmun Neoral contains castor oil

Sandimmun Neoral may cause stomach discomfort and diarrhoea because it contains castor oil.

Sandimmun Neoral contains propylene glycol

This medicine contains 90.36 mg of propylene glycol in each 50 mg capsule.

If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medicines containing propylene glycol or alcohol.

Sandimmun Neoral contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per 25 mg capsule; thus, it is essentially “sodium-free”.

3. How to take Sandimmun Neoral

Follow exactly the instructions for taking this medicine as given by your doctor. If in doubt, consult your doctor again.

Do not take more than the recommended dose.

Your doctor will carefully adjust the dose of this medicine to meet your individual needs. Taking too much of this medicine may affect your kidneys. You will have regular blood tests and hospital visits, especially after transplantation. This will allow you to discuss your treatment and any problems you may have with your doctor.

How much Sandimmun Neoral should you take?

Your doctor will tell you the correct dose of Sandimmun Neoral for you. This depends on your body weight and the reason why you are taking this medicine. Your doctor will also inform you how often you should take your medicine.

In adults:

Organ, bone marrow, and stem cell transplantation

The total daily dose is usually between 2 mg and 15 mg per kilogram of body weight. This is divided into two doses.
Higher doses are usually used before and immediately after your transplant. Lower doses are used once your transplanted organ or bone marrow has stabilized.
Your doctor will adjust the dose to one that is ideal for you. To do this, your doctor may need to perform some blood tests.

Endogenous uveitis

The total daily dose is usually between 5 mg and 7 mg per kilogram of body weight. This is divided into two doses.

Nephrotic syndrome

The total daily dose for adults is usually 5 mg per kilogram of body weight. This is divided into two doses. In patients with renal impairment, the initial daily dose should not exceed 2.5 mg per kilogram of body weight.

Severe rheumatoid arthritis

The total daily dose is usually between 3 mg and 5 mg per kilogram of body weight. This is divided into two doses.

Psoriasis and atopic dermatitis

The total daily dose is usually between 2.5 mg and 5 mg per kilogram of body weight. This is divided into two doses.
In children:

Nephrotic syndrome

The total daily dose for children is usually 6 mg per kilogram of body weight. This is divided into two doses. In patients with renal impairment, the initial daily dose should not exceed 2.5 mg per kilogram of body weight.

Follow your doctor's instructions exactly and never change the dose yourself, even if you feel well.

Switching from Sandimmun to Sandimmun Neoral

You may have previously been taking another medicine called Sandimmun soft gelatin capsules or Sandimmun oral solution. Your doctor may decide to switch you to Sandimmun Neoral oral solution.

All these medicines contain ciclosporin as the active substance.
Sandimmun Neoral is a different and improved formulation of ciclosporin compared to Sandimmun. Ciclosporin is better absorbed into the blood with Sandimmun Neoral and is less likely to be affected by food intake. This means that ciclosporin blood levels remain more consistent with Sandimmun Neoral than with Sandimmun.

If your doctor switches you from Sandimmun to Sandimmun Neoral:

Do not take Sandimmun again unless your doctor tells you to.
After switching from Sandimmun to Sandimmun Neoral, your doctor will monitor you more closely for a short period of time. This is due to the change in how ciclosporin is absorbed into the blood. Your doctor will ensure you are taking the correct dose according to your individual needs.
You may experience some adverse effects. If this happens, inform your doctor or pharmacist. It may be necessary to reduce your dose. Never reduce your dose yourself unless instructed by a doctor.

If your doctor switches you from one oral ciclosporin formulation to another

After switching from one oral ciclosporin formulation to another:

Your doctor will monitor you more closely for a short period of time.
You may experience some adverse effects. If this happens, inform your doctor or pharmacist. It may be necessary to adjust your dose. Never adjust your dose yourself unless instructed by a doctor.

When to take Sandimmun Neoral

Take Sandimmun Neoral at the same time each day. This is very important if you have had a transplant.

How to take Sandimmun Neoral

Your daily dose should always be administered as two doses.

Remove the capsules from the blister. Swallow the capsules whole with a glass of water.

How long to take Sandimmun Neoral

Your doctor will tell you how long you need to take Sandimmun Neoral. This depends on whether you are taking it after a transplant or for the treatment of serious skin diseases, rheumatoid arthritis, uveitis, or nephrotic syndrome. In the case of severe skin rash, treatment usually lasts 8 weeks.

Continue taking Sandimmun Neoral for as long as your doctor tells you to.

If you have any doubts about how long you should take Sandimmun Neoral, consult your doctor or pharmacist.

If you take more Sandimmun Neoral than you should

If you accidentally take an excessive dose of the medicine, inform your doctor immediately or go to the nearest hospital emergency department. You may require medical attention.

You can also call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Sandimmun Neoral

If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose. Then continue as before.
Do not take a double dose to make up for missed doses.

If you stop taking Sandimmun Neoral

Do not stop taking Sandimmun Neoral unless your doctor tells you to.

Continue taking Sandimmun Neoral even if you feel well. Stopping treatment with Sandimmun Neoral may increase the risk of rejection of your transplanted organ.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Some adverse effects may be serious

Contact your doctor immediately if you notice any of the following serious adverse effects:

Like other medicines that act on the immune system, cyclosporine may affect your body's ability to fight certain infections and may cause tumors or other malignant diseases, especially of the skin. Signs of infection may include fever or sore throat.
Vision disturbances, lack of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and muscle weakness. These could be signs of a brain infection called progressive multifocal leukoencephalopathy.
Brain problems with symptoms such as seizures, confusion, disorientation, reduced sensation, personality changes, agitation, insomnia, vision disturbances, blindness, coma, paralysis of part or all of the body, torticollis, lack of coordination with or without abnormal speech or eye movements.
Inflammation at the back of the eye that may be associated with blurred vision. It may also affect your vision due to increased pressure inside the head (benign intracranial hypertension).
Liver injury and abnormalities, with or without yellowing of the eyes or skin, nausea, vision loss, and dark urine.
Kidney problems, which may greatly reduce the amount of urine you produce.
Decreased number of red blood cells or platelets. These signs include pale skin, fatigue, shortness of breath, dark urine (a sign of red blood cell breakdown), unexplained bleeding or bruising, confusion, disorientation, lack of attention, and kidney problems.

Other adverse effects include:

Very common: may affect more than 1 in 10 people

Kidney problems.
High blood pressure.
Headache.
Uncontrollable body agitation.
Excessive growth of facial and body hair.
Increased blood lipids.