Introduction

Prospect: Information for the patient

Sandimmun 250mg/5 ml concentrate for infusion solution

ciclosporina

Read this prospect carefully before starting to take this medication, as it contains important information for you.

Keep this prospect, as you may need to read it again.
If you have any doubts, consult your doctor or pharmacist.
This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

1.What is Sandimmun and for what it is used

2.What you need to know before starting to use Sandimmun

3.How to use Sandimmun

4.Possible adverse effects

5.Storage of Sandimmun

6.Contents of the package and additional information

1. What is Sandimmun and what is it used for

What isSandimmun

The name of your medication is Sandimmun.It contains the active ingredientciclosporina.The concentrate is used to prepare a solution that is administered via intravenous infusion.It belongs to a group of medications known as immunosuppressants.These medications are used to decreasethe body's immune reactions.

What is Sandimmun used for and how it works

Sandimmun is used to control the body's immune systemafteran organ transplant, including bone marrow and stem cell transplants.It prevents organ transplant rejection by slowing the development of certain cells that would normally attack the transplanted tissue.

2. What you need to know before starting to use Sandimmun

Only a doctor with experience in transplantation will prescribe Sandimmun for you.

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

Do not use Sandimmun:

If you are allergic to ciclosporin or any of the other ingredients in this medicine (see section 6, as well as the section “Sandimmun contains castor oil and ethanol”).
with medicines that contain Hypericum perforatum (St. John's Wort).

-with medicines that contain dabigatrán etexilate (used to prevent blood clots after surgery)or bosentán and aliskirén(used to lower high blood pressure).

If this applies to you, do not use Sandimmun andinform your doctor. If you are unsure, consult your doctor before using Sandimmun.

Warnings and precautions

Inform your doctor immediately before and during treatment with Sandimmun:

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

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

Protection from the sun and sunlight

Sandimmun suppresses your immune system. This may increase your risk of developing cancer, particularly skin cancer and lymphoma. Therefore, you should limit your exposure to the sun and UV rays as follows:

Wearing protective clothing.
Applying sunscreen with a high protection factor frequently.

Consult your doctor before taking Sandimmun:

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

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

Monitoring during your treatment with Sandimmun

Your doctor will monitor:

the levels of ciclosporin in your blood, especially if you have undergone a transplant,
your blood pressure before starting treatment and regularly during treatment,
how well your liver and kidneys are functioning,
your levels of lipids in the blood (fats).

If you have any questions about how Sandimmun works or why you have been prescribed this medicine, consult your doctor.

Children and adolescents

There is limited experience with Sandimmun in children.

Older adults (65 years of age and older)

There is limited experience with Sandimmun in older adults. Your doctor should monitor how well your kidneys are functioning.

Other medicines and Sandimmun

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

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

Medicines that can affect your potassium levels. These include medicines that contain potassium, potassium supplements, potassium-sparing diuretics, and some medicines that lower your blood pressure.
Metotrexate.It is used to treat tumors, severe psoriasis, and severe rheumatoid arthritis.

Medicines that can increase or decrease the levels of ciclosporin (the active ingredient in Sandimmun) in your blood. Your doctor may check the level of ciclosporin in your blood when you start or stop taking other medicines.

Medicines that can increase the level of ciclosporin in your blood include: antibiotics (such as erythromycin or azithromycin), antifungals (voriconazole, itraconazole), medicines used for heart problems 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), bile acid and derivatives (used to treat gallstones), protease inhibitors used to treat HIV, imatinib (used to treat leukemia or tumors), colchicine, telaprevir (used to treat hepatitis C),cannabidiol (its use includes, among others, the treatment of epilepsy seizures).
Medicines that can decrease the level of ciclosporin in your blood include: barbiturates (used to help you sleep), certain anticonvulsant medicines (such as carbamazepine or phenytoin), octreotide (used to treat acromegaly or neuroendocrine tumors in the intestine), antibiotics used to treat tuberculosis, orlistat (used to help you lose weight), herbal medicines that contain St. John's Wort, ticlopidine (used after a stroke), certain medicines that lower blood pressure (bosentan), and terbinafine (an antifungal medicine, used to treat fungal infections of the feet and nails).

Medicines that can affect your kidneys. These include: antibiotics (gentamicin, tobramycin, ciprofloxacin), antifungal medicines that contain amphotericin B, antibiotics used to treat urinary tract infections that contain trimethoprim, cancer medicines that contain melphalan, medicines used to reduce stomach acid (H2 receptor antagonists), tacrolimus, analgesics (non-steroidal anti-inflammatory drugs, such as diclofenac), acidophilic medicines (used to reduce cholesterol in the blood).
Nifedipine.It is used to treat high blood pressure and chest pain. You may experience gum inflammation that can grow over your teeth if you take nifedipine during your treatment with ciclosporin.
Digoxin (used to treat heart problems), 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 cancer medicines called anthracyclines (such as doxorubicin).
Mycophenolate sodium 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 using Sandimmun.

Use of Sandimmun with food and drinks

Do not use Sandimmun with grapefruit or grapefruit juice. This is because it may affect the way Sandimmun works.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using this medicine.

Inform your doctor if you are pregnant or intend to become pregnant.The experience with Sandimmun in pregnant women is limited. In general, Sandimmun should not be administered during pregnancy. If you need to use this medicine, your doctor will discuss the potential benefits and risks of using it during pregnancy.
Inform your doctor if you are breastfeeding.Breastfeeding is not recommended during treatment with Sandimmun. This is because ciclosporin, the active ingredient, passes into breast milk and may 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 the levels of ciclosporin in your blood. Your doctor may need to closely monitor the levels of ciclosporin in your blood and adjust the dose after starting hepatitis C treatment.

Driving and operating machinery

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

Sandimmun contains castor oil and ethanol

This medicine may cause severe allergic reactions because it contains castor oil.

Sandimmun concentrate for solution for infusion contains 278 mg of alcohol (ethanol) per ml, which corresponds to 34.4% v/v.A dose of 100 mg ofSandimmuncontains 556 mg of ethanol, which is equivalent to approximately14 mlof beer or 6 ml of wine.The small amount of alcohol in this medicine will have no perceptible effect.

3. How to Use Sandimmun

Follow the medication administration instructions exactly as indicated by your doctor.If you are unsure, consult your doctor again.

How much Sandimmun you will receive

Your doctor will tell you the correct dose of Sandimmun for you. This depends on your body weight and the reason you are taking this medication.

The usual total daily dose is typically between 3 and 5 mg per kilogram of body weight. This is divided into two doses.
Higher doses are usually used before and just after your transplant. Lower doses are used once your transplanted organ or bone marrow is stabilized.
Your doctor will adjust the dose to what is ideal for you. Your doctor may need to do some blood tests to do this.

How Sandimmun will be used

The medication will be diluted before use between 1:20 and 1:100 with saline solution or 5% glucose, using proper aseptic technique and administered via slow infusion over 2 to 6 hours. Discard the medication dilutions after 24 hours of preparation.

How long Sandimmun will be used

You will be switched to cyclosporine in the form of capsules or oral solution (both taken by mouth) as soon as possible.

If you have received too much Sandimmun

Too much of the medication can affect your kidneys. You will have regular blood tests and hospital visits. This will give you the opportunity to discuss your treatment and any problems you may have with your doctor.

Inform your doctor immediately if you think you have received too much Sandimmun.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Some side effects can be serious

Inform your doctor immediatelyif you notice any of the following serious side effects:

Appearance of signs of anaphylactoid reactions after intravenous administration of Sandimmun. These reactions may consist of facial flushing and upper chest redness, fluid in the lungs, difficulty breathing, wheezing, changes in blood pressure (you may feel like you are going to faint) and rapid heart rate (tachycardia).
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 be fever or sore throat.
Visual disturbances, lack of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and muscle weakness. These may be signs of a brain infection called progressive multifocal leukoencephalopathy.
Brain problems with signs such as seizures, confusion, disorientation, decreased sensitivity, changes in personality, agitation, insomnia, visual disturbances, blindness, coma, paralysis of part or all of the body, torticollis, lack of coordination with or without abnormal speech or eye movement.
Inflammation in the back of the eye that may be associated with blurred vision. It may also affect your vision due to an increase in pressure within the head (benign intracranial hypertension).
Liver damage and alteration with or without yellow coloration in the eyes or skin, nausea, loss of vision, and dark urine.
Kidney problems, which may significantly reduce the amount of urine you produce.
Decrease in the number of red or white blood cells. These signs include pale skin, fatigue, shortness of breath, dark urine (sign of red blood cell rupture), unexplained bleeding or bruising, confusion, disorientation, lack of attention, and kidney problems.

Other side effects include:

Very common:may affect more than 1 in 10people

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