Sandimmun Neoral 100 mg
Sandimmun Neoral 100 mg
Sandimmun Neoral 100 mg

Sandimmun Neoral 100 mg

Product No.:
653825.8
2 Weeks 2 Weeks (abroad may vary)
161,90 EUR

incl. 21% tax excl. Shipping costs

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Description

Sandimmun Neoral 100 mg

Neoral 100 mg

30 softgels
Active ingredient: ciclosporin

Applications of SANDIMMUN

• This medicinal product contains the active substance cyclosporin. This belongs to a group of medicines called immunosuppressants. These drugs are used to reduce the immune reaction of the body.
• What it is used and how does it work?
o If you have received an organ transplant, a bone marrow or stem cell transplantation, then to be controlled with this medicine your immune system. It prevents rejection of transplanted organs by blocking the development of certain cells that would normally attack the transplanted tissue.
o If you have an autoimmune disease in which the cells are attacked in your body by the immune reactions in your body, the drug blocked such an immune response. Such autoimmune diseases include eye problems that can damage your sight (endogenous uveitis, including Behçet's uveitis), severe cases of certain skin diseases (atopic dermatitis or atopic eczema and psoriasis), severe rheumatoid arthritis and kidney disease called nephrotic syndrome.


Absolute contraindications of SANDIMMUN

• Medicines should not be taken,
o if you are allergic to cyclosporine or any of the other ingredients of this medicine.
o with products that Hypericum perforatum (St. John's wort) included.
o with products containing dabigatran etexilate (prevents blood clots after surgery), bosentan or aliskiren (lowers high blood pressure).
• Take the medicine is not one and talk to your doctor if any of the above points apply to you. If you are not sure, talk to your doctor before taking the drug.

patients notice

• Warnings and Precautions
o If you are taking the drug after a transplant, it will only be prescribed by a doctor who has relevant experience with transplants and / or autoimmune diseases has.
o The indications may be different, depending on whether you take the medicine after a transplant or to treat an autoimmune disease.
o Pay. attention to the instructions of your doctor These could differ from the general information.
o Before and during treatment, you must contact your doctor immediately:
 if you notice signs of infection, such as fever or sore throat, with him. The drug suppresses the immune system and can also be your body's ability in the defense against infections affect.
 if you have liver problems.
 if you have kidney problems. Your doctor will perform regular blood counts with you and could change your dose if needed.
 if you develop high blood pressure. Your doctor will check your blood pressure regularly and may prescribe a drug to lower blood pressure when needed.
 if you have low magnesium levels in your body. Your doctor may prescribe medicines to supplement magnesium, especially immediately after your surgery, if you have a transplant.
 if you have high blood levels of potassium.
 if you suffer from gout.
 if you need a vaccination.
o If any of the above signs apply before or during treatment, you must immediately contact your doctor.
o Sunlight and Sun Protection
 The preparation suppresses your immune system. This increases your risk of developing cancers, especially skin cancer or cancers of the lymphatic system. You should limit your exposure to direct sunlight and UV rays, by:
 wear appropriate protective clothing.
 often apply a sunscreen with a high protection factor.
o Talk to your doctor before using this medicine:
 if you have alcohol-related problems or ever had.
 if you have epilepsy.
 if you have liver problems of any kind.
 if you are currently pregnant.
 if you are breast-feeding.
 if this drug is prescribed for a child.
 If any of the above apply to you (or if you are not sure), talk to your doctor before taking the drug because of this medicinal product contains alcohol
o Monitoring during your treatment
 Your doctor will monitor the following and verify:
 the concentrations of ciclosporin in your blood, especially if you have received a transplant,
 your blood pressure before you start your treatment and at regular intervals during treatment,
 how well your liver and kidneys are functioning,
 your blood lipids (blood fats).
 If you have any questions about how the drug works and why this medicine has been prescribed, contact your doctor.
o In addition, when you apply the preparation for another disorder than for transplantation (intermediate uveitis or posterior uveitis and Behçet, atopic dermatitis, severe rheumatoid arthritis or nephrotic syndrome), do not take the drug:
 if you have (aside from nephrotic syndrome) kidney problems.
 if you have an infection that is not adequately treated with medication.
 if you have a cancer.
 if you have high blood pressure (hypertension), which is not adequately treated with medication. If you develop high blood pressure during treatment and this can not be treated in accordance with, the treatment of your doctor should be discontinued.
 If any of the above apply to you, do not take the drug. If you are not sure, talk to your doctor or pharmacist before using this medicine.
o If you are being treated for Behcet's uveitis, your doctor will monitor you more closely if you have neurological symptoms (eg, increased forgetfulness, established during the course of time, personality changes, psychiatric disorders or mood disorders, burning sensation in the limbs, increased numbness in the limbs, tingling in the limbs, weakness in the limbs, difficulties in walking, headaches with or without nausea and vomiting, visual disturbances including impaired mobility of the eyeball).
o Your doctor will watch out if you are elderly and are being treated for psoriasis or atopic dermatitis. If you, the preparation has been prescribed to treat your psoriasis or atopic dermatitis, you must be careful to avoid any UVB irradiation or phototherapy during treatment.
o Children and adolescents
 The preparation must not be used to treat other non-transplant-related illness in children, except for the treatment of nephrotic syndrome.
o Older people (65 years and older)
 There is only limited experience with this preparation in the elderly. Your doctor will monitor how well your kidneys work.
If you are older than 65 years and have psoriasis or atopic dermatitis, you should only be treated with this preparation, if your disease is particularly difficult.
 
• Driving and using machines
o The product contains alcohol. This could affect the ability to drive and the ability to operate machinery.

pregnancy Note

• pregnancy
o Ask your doctor or pharmacist for advice before taking this medicine. Your doctor will discuss with you the potential risks of use during pregnancy.
o Tell your doctor if you are pregnant or planning to become pregnant. The experience with this preparation during pregnancy is limited. In general, the preparation during pregnancy should not be used. However, if it is necessary for you to use this medicine, your doctor will discuss the benefits and potential risk of taking during pregnancy with you.
• Lactation
o Tell your doctor if you are breastfeeding. Breastfeeding is not recommended during treatment because the drug Cyclosporin passes into breast milk and this could affect your baby.

Dosage of SANDIMMUN

• Take this medicine exactly as your doctor has told. Check with your doctor if you are unsure. Do not take more than the recommended dose.
• The dose of this medicine is adjusted by your doctor exactly to your individual needs. Too high a dose of this medicine may affect your kidneys. In particular, after a transplant regular checks of your blood counts and hospitalization will be needed. To also have the opportunity to talk to your doctor about your treatment and about any problems you may have.
• How much the drug is to be taken?
o Your doctor will determine the correct dose for you. This will depend on your body weight and also on what illness you take the medicine for the treatment. Your doctor will also tell you how often you need to take the medicine.
o In adults:
 organ, bone marrow or stem cell transplantation
 The total dose per day is usually between 2 mg per kg body weight and 15 mg per kg body weight. This daily dose is divided into two separate doses.
 Usually higher doses are applied before and immediately after your transplant. Lower doses are used once your transplanted organ or bone marrow has stabilized.
 Your doctor will adjust your dose to the optimal dose for you level. To do this, your doctor will need to do some blood tests may.
 Endogenous Uveitis
 The total dose per day is usually between 5 mg per kg body weight and 7 mg per kg of body weight. This daily dose is divided into two separate doses.
 Nephrotic Syndrome
 The total dose per day is usually in adults 5 mg per kg body weight. This daily dose is divided into two separate doses. In patients with kidney problems, the starting daily dose should not exceed 2.5 mg per kg body weight.
 Severe Rheumatoid Arthritis
 The total dose per day is usually between 3 mg per kg body weight and 5 mg per kg body weight. This daily dose is divided into two separate doses.
 psoriasis and atopic dermatitis
 The total dose per day is usually between 2.5 mg per kg body weight and 5 mg per kg body weight. This daily dose is divided into two separate doses.
o In children:
 Nephrotic Syndrome
 The total daily dose is usually in children 6 mg per kg of body weight. This daily dose is divided into two separate doses. In patients with kidney problems, the starting daily dose should not exceed 2.5 mg per kg body weight.
o Please follow even if you already feel the doctor's instructions carefully and change Never dose yourself, great.
• If your doctor surrounded by an oral cyclosporine dosage form to another
o After switching from a formulation of cyclosporine oral to another:
 Your doctor will monitor more accurately for a short time.
 You may have some side effects. If this is the case, talk to your doctor or pharmacist. Possibly your dose needs to be changed. Change your dose in any case independently, unless your doctor has expressly ordered.
• When the preparation is to take?
o Take the medicine at about the same Tageszeitein. This is especially important if you have had a transplant.
 
• How long the drug is to be taken?
o Your doctor will tell you how long you need to use it. That depends on whether you apply it after a transplant or to treat serious skin disorders, rheumatoid arthritis, uveitis or nephrotic syndrome. For severe rashes treatment usually lasts for 8 weeks.
o Take this drug as long as your doctor instructs him.
o If you have questions about how long it is taking, consult your doctor or pharmacist.
 
• If you take more than you should
o If you accidentally take too much of your medicine, contact your doctor immediately or contact the casualty department of your nearest hospital. It could be that you need a medical treatment.
 
• If you forget to take
o If you forgot to take a dose once, take it as soon as you remember. However, when it is already almost time for your next dose, skip the missed dose and go go back to your normal rate continues.
o Do not take a double dose if you have forgotten dose.
 
• If you stop taking
o Break. taking not from, unless your doctor tells you that
o Take the medicine even then, if you already feel better. Discontinuation of treatment may increase the risk of rejection of your transplant.
 
• If you have further questions about taking this medicine, contact your doctor or pharmacist.

side effects

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• Some side effects could be serious
• Tell them immediately if you notice your doctor any of the following serious side effects:
o Like all medicines that affect the immune system, ciclosporin may your body's ability to fight off infection compromise, and can also cause cancer and other cancers, especially those of the skin. Signs of infection may be fever or sore throat.
o changes in vision, loss of coordination, clumsiness, memory loss, trouble speaking or understanding what others say, and muscle weakness. These could be signs of infection in the brain, which is called progressive multifocal leukoencephalopathy.
o problems with the brain with characters such as seizures, confusion, feeling of disorientation, decreased responsiveness, personality changes, irritability, insomnia, changes in vision, blindness, coma, paralysis of body parts or the whole body, neck stiffness, loss of co-ordination with or without abnormal speech or eye movements.
o swelling in the back of the eye. This may be associated with blurred vision. It can also affect vision due to increased pressure in the head (benign intracranial hypertension).
o liver problems and liver damage with or without yellowing of the skin and eyes, nausea, loss of appetite and darkening of the urine.
o kidney problems, which can reduce the amount of urine produced strong.
o reduction of the number of red blood cells and platelets. The signs include pale skin, tiredness, breathlessness, dark-colored urine (which is a sign of the degradation of red blood cells), bruising or bleeding for no apparent reason, confusion, disorientation, decreased alertness and kidney problems.
• Other side effects include:
o Very common side effects: These side effects may affect more than 1 in 10 people.
 kidney problems
 Hypertension
 headache
 Non controllable jitter
 Excessive hair growth on the face and body
 High blood fat levels.
 If you are serious of these side effects, talk to your doctor.
o Common side effects: These side effects may 1 to 10 of 100 patients treated.
 Seizures
 liver problems
 High blood sugar levels
 fatigue
 loss of appetite
 nausea (feeling sick), vomiting, abdominal pain, constipation, diarrhea
 Excessive hair growth
 acne, hot flashes
 fever
 reduction in the number of white blood cells
 numbness or tingling
 muscle pain, muscle cramps
 gastric ulcer
 Excessive growth of the gums, which covers the teeth
 High levels of uric acid or potassium in the blood, decreased magnesium levels imBlut.
 If you are greatly impressed-adversely any of these side effects, talk to your doctor.
o Uncommon side effects: These side effects can 1 to 10 of 1,000 patients treated.
 symptoms of brain disorders, including sudden seizures, mental confusion, insomnia, disorientation, blurred vision, fainting, feeling of weakness in the limbs, impaired movements.
 rash
 General swelling
 weight gain
 Decreased number of red blood cells, decreased number of blood platelets, which may increase the risk of bleeding.
 If you are serious of these side effects, talk to your doctor.
o Rare side effects: These side effects can 1 to 10 in 10,000 patients treated.
 nervous problems with numbness or tingling in fingers and toes
 inflammation of the pancreas with strong upper abdominal pain
 muscle weakness, loss of muscle strength, pain in the muscles of the legs or hands, or anywhere in the body
 destruction of red blood cells, with the consequence of kidney problems with symptoms such as swelling of the face, stomach, hands and / or feet, decreased urination, difficulty breathing, chest pain, seizures, loss of consciousness
 menstrual disorders, breast enlargement in men.
 If you are greatly impressed-adversely any of these side effects, talk to your doctor.
o Very rare side effects: These side effects may affect less than 1 in 10,000.
 swelling at the back of the eye, which may be associated with an increase in pressure in the head, and visual disturbances.
 If you are serious of these side effects, talk to your doctor.
o Other side effects with unknown frequency: frequency can not be estimated from the available data.
 Severe liver problems with or without yellowing of the skin or eyes, nausea (feeling sick), loss of appetite, dark urine, swelling of the face, feet, hands and / or the entire body.
 bleeding under the skin or purple skin patches, sudden bleeding with no apparent cause.
 migraine or severe headache often with nausea and vomiting and sensitivity to light.
 pain in legs and feet.
 If you are serious of these side effects, talk to your doctor.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects that are not specified here.
• Additional side effects in children and adolescents
o In children and adolescents are compared to adults to expect no additional side effects.

interactions

When multiple drugs are used concomitantly, there may be interactions. Effects and side effects of drugs may be altered. Whether an interaction occurs, depends on various factors.
therefore Always speak with your doctor or pharmacist to determine whether an interaction you actually plays a role. Doctor or pharmacist Only assess your individual risk factors for interaction. If necessary to devise appropriate measures doctor or pharmacist. Put the doctor prescribed medicines without talking with your doctor or pharmacist from.
SANDIMMUN must not be administered concomitantly with medicines containing the following active ingredients:
• aliskiren
• bosentan
• dabigatran
• Dabigatran etexilate
• hypericin
• St. John's Wort
• St. John's wort extract
• St. John's wort dry extract (3.5-6: 1), extracting agent: Ethanol 60% (V / V)
• St. John's wort dry extract (3.5-6: 1), extraction means: ethanol 60% (m / m)
• St. John's wort dry extract (3-6: 1), extracting agent: Ethanol 80% (V / V)
• St. John's wort dry extract (3-6: 1), extracting agent: Methanol 80% (V / V)
• St. John's wort dry extract (3-7: 1), extracting agent: Methanol 80% (V / V)
• St. John's wort dry extract, (4.6 to 6.5: 1), extraction means: ethanol 38% (m / m)
• St. John's wort dry extract (5-7: 1), extraction means: ethanol 60% (m / m)
• St. John's wort dry extract (5-8: 1), extracting agent: Ethanol 50% (V / V)
• St. John's wort dry extract, extract agent: Ethanol 57.9% (V / V)
• lercanidipine
• rosuvastatin
• simvastatin
There is a great risk of severe, possibly even life-threatening interaction.
Please speak to your doctor immediately.
In addition, further interaction between "SANDIMMUN" and other medicinal products are known. If you still are taking other medicines, ask your pharmacist to clarify whether it can possibly be interactions with "SANDIMMUN".

Storing

Store. Medicines out of reach of children

Disposal

For the disposal of drugs, there are regional differences in recommendations. Ask. In the pharmacy according to current regulations in your region
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