Neoral (cyclosporine) is used in dermatology for atopic eczema, psoriasis, and chronic urticaria, among other conditions. It is also used for many other skin conditions.PACKAGE LEAFLET: INFORMATION FOR USERS OF NEORAL (CICLOSPORINE)Neoral 25 mg capsules
Neoral 100 mg capsules
Neoral 100 mg/ml capsules, oral solution
Read all of this leaflet carefully before you start taking this medicine
. - Keep this leaflet. You may need to use it again.
- If you have any further questions, ask your doctor or pharmacist.
- Do not pass this medicine on to others. It has been prescribed for you only. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects listed in section 4 get serious, or if you notice any side effects not listed in this leaflet, talk to your doctor or pharmacist.
What is in this leaflet
? 1. What is this medicine used for?
2. When should you not use this medicine or be extra careful with it?
3. How to use this medicine?
4. Possible side effects
5. How to store this medicine
6. Further information
1. WHAT IS THIS MEDICINE USED FOR? Neoral belongs to a group of medicines called immunosuppressants. Immunosuppressants reduce your body’s response to anything it considers “foreign”, including transplanted organs and bone marrow. They can also help in diseases in which the body’s natural defences turn against your own body.
Neoral is used to prevent your body from rejecting the transplanted organ or bone marrow. Neoral is also used to treat:
- very severe psoriasis (a skin disease),
- severe atopic dermatitis (a skin disease) that cannot be treated with any other method,
- nephrotic syndrome (a kidney disease) in adults and children,
- severe rheumatoid arthritis (rheumatism) in adults.
The immune system also plays a role in these diseases.
2. WHEN SHOULD YOU NOT USE THIS MEDICINE OR SHOULD YOU TAKE EXTRA CAUTION? When should you not use this medicine?
- If you are allergic to any of the ingredients of this medicine. These can be found under section 6.
- If you are taking medicines containing lercanidipine (a medicine used to treat high blood pressure). Neoral and lercanidipine should not be used together.
- If you are taking medicines containing St. John's wort. Herbal medicines containing St. John's wort (Hypericum perforatum) should not be used at the same time as Neoral. These medicines can lower the amount of ciclosporin in the blood, thus reducing the effectiveness of Neoral. St. John's wort is used to treat depression.
- If you are being treated for psoriasis, atopic dermatitis, or rheumatoid arthritis, you should not use Neoral if your kidneys are not functioning properly or if you have high blood pressure, an infection, or certain types of cancer.
When should you be especially careful with this medicine?
- If you are going to take Neoral or have been taking it for a long time. Neoral can impair kidney and liver function. Therefore, kidney and liver function should be monitored regularly before, during, and after treatment. It is very important that you do not miss any check-ups requested by your doctor (including liver and kidney function tests and blood tests).
- Neoral reduces your body's immune system and therefore increases the risk of cancer, particularly of the skin. Therefore, you should limit your exposure to sunlight and UV light by wearing suitable protective clothing and regularly applying a sunscreen with a high protection factor.
- If you develop symptoms of infection (e.g., fever, sore throat, cold, flu, boils), inform your doctor immediately.
- If you often eat foods high in potassium (e.g., tomatoes, meat, potatoes). There is a risk of high potassium levels in the blood, which can sometimes manifest as muscle cramps, diarrhea, nausea, dizziness, and headaches (hyperkalemia).
- If you need to be vaccinated, consult your doctor beforehand.
- Neoral may increase the risk of benign increased pressure within the skull (benign increased intracranial pressure). This condition manifests as headache, nausea, vomiting, and sometimes double vision, but most importantly, blurred vision. If this condition occurs, Neoral should be stopped due to a possible risk of permanent vision loss.
- If you experience swelling of your gums as a result of using Neoral. Because this can make your gums more susceptible to inflammation, you should brush your teeth extra thoroughly. If your gums still become inflamed despite thorough brushing, ask your dentist to contact your treating physician.
- If you are using Neoral to treat psoriasis or atopic dermatitis. Skin lesions that are not typical of psoriasis or atopic dermatitis, but are suspected of being malignant, must be examined before starting treatment with Neoral. Especially if you have previously been treated with PUVA or UVB light, you should have your skin checked regularly. You should not be treated with Neoral and PUVA or UVB light simultaneously. After stopping treatment with Neoral, wait 2 to 3 days before starting any treatment with PUVA or UVB light. Due to the severity of the possible side effects, your doctor will usually not prescribe Neoral for continuous use in psoriasis. If you are using Neoral to treat atopic dermatitis. Before starting treatment with Neoral, an active cold sore (herpes simplex) must be cured.
Regular blood pressure monitoring is essential; if high blood pressure (hypertension) develops, it must be treated appropriately.
Special caution is required in patients with elevated blood uric acid levels (hyperuricemia); hyperuricemia can lead to gout.
Contact your doctor if any of the above applies to you, or has applied to you in the past.
Taking other medicines?
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Contact your doctor or pharmacist if you are taking or have recently taken any of the following medicines:
The following medicines increase the amount of ciclosporin (Neoral) in the blood:
- ketoconazole, metronidazole, fluconazole, itraconazole and voriconazole (medicines used to treat fungal infections)
- certain types of antibiotics such as erythromycin, azithromycin, clarithromycin and josamycin (medicines used to prevent/fight infections)
- hormonal contraceptives (medicines used to prevent pregnancy)
- diltiazem, nicardipine and verapamil (so-called calcium channel blockers, medicines used to treat high blood pressure or certain heart conditions)
- metoclopramide (medicine used to treat nausea)
- danazol (anti-hormone)
- methylprednisolone (hormone) in large amounts
- allopurinol (medicine used to prevent a gout attack)
- amiodarone (medicine used to treat palpitations)
- cholic acid and derivatives (drugs for lipid metabolism)
- protease inhibitors (drugs against viral infections)
- imatinib (drug used to treat, among other things, chronic myeloid leukaemia (CML) (cancer of the white blood cells))
- carvedilol (drug used to treat high blood pressure and to improve heart muscle function)
- colchicine (drug used to treat gout)
- nefazodone (drug used to treat depression).
The following medicines reduce the amount of ciclosporin (Neoral) in the blood:
- barbiturates (in some painkillers and sedatives)
- phenytoin (used for epilepsy and heart conditions, among others)
- rifampicin and nafcillin (anti-infectious agents)
- carbamazepine and oxcarbazepine (used for epilepsy, among others)
- sulfadimidine injected into a vein (an anti-infective agent)
- octreotide (used for certain tumours and during pancreatic surgery, among others)
- probucol (used in the treatment of cholesterol deposits in the skin)
- orlistat (used in the treatment of obesity)
- ticlopidine (used to prevent thrombosis)
- terbinafine (used in the treatment of skin, foot and nail fungal infections)
- herbal remedies containing St. John's wort (Hypericum perforatum) (used for depression). These medications should not be used simultaneously with Neoral. The effect of ciclosporin may be reduced for at least two weeks after taking St. John's wort. If you are already taking St. John's wort, you should stop taking it and monitor your blood ciclosporin levels. Your ciclosporin dosage may need to be adjusted. Therefore, tell your doctor if you are taking St. John's wort.
- herbal preparations
- sulfinpyrazone (used for gout)
- bosentan (a medication used to treat high blood pressure in the pulmonary blood vessels, among other things).
Both an increase and a decrease in the blood ciclosporin levels can be unfavorable.
Taking the following medications with Neoral can negatively impact kidney function:
- certain types of antibiotics such as gentamicin, tobramycin, ciprofloxacin, vancomycin, and trimethoprim (and sulfamethoxazole) (antibiotics used to prevent/fight infections)
- amphotericin B (antifungal)
- melphalan (a drug used to treat cancer)
- a certain group of painkillers which also have an anti-inflammatory and antipyretic effect such as diclofenac, naproxen and sulindac (NSAIDs)
- certain drugs that reduce the production of stomach acid such as cimetidine and ranitidine
- methotrexate (used to treat rheumatoid arthritis)
- tacrolimus, everolimus and sirolimus (drugs that suppress the immune system)
- fibrates (such as fenofibrate and bezafibrate, used to treat high blood fat levels).
Also ask your doctor for advice when taking Neoral in combination with the following medicines:
- lercanidipine (a medicine used to treat high blood pressure)
- aliskiren (a medicine used to treat high blood pressure)
- nifedipine (a medicine used to treat high blood pressure or certain heart conditions)
- digoxin (a medicine used to strengthen the heart)
- colchicine (a medicine used to treat gout)
- statins such as lovastatin, pravastatin, simvastatin, atorvastatin and fluvastatin (medicines used to treat high cholesterol)
- ATG-F (anti-thymocyte globulin F, a medicine used to prevent rejection after kidney transplants)
- mycophenolate mofetil (a medicine used to suppress the immune system)
- etoposide (a medicine used to treat cancer)
- potassium-sparing or potassium-containing medicines
- repaglinide (a medicine used to lower blood glucose).
Your doctor may check the amount of ciclosporin in your blood when you start or stop treatment with other medicines.
Neoral with food and drink
Neoral should not be taken with grapefruit juice, as the concentration of Neoral in the blood increases when taken at the same time, increasing the risk of side effects.
Because Neoral oral solution and capsules contain alcohol, you should exercise caution when consuming alcohol. For more information, see the section "Ingredients in this medicine that you need to be aware of."
Pregnancy and breastfeeding
If you are pregnant, planning to become pregnant, or breastfeeding, talk to your doctor or pharmacist before taking any medication.
Pregnancy
Experience with ciclosporin in pregnant women is limited. Neoral should not be used during pregnancy unless strictly necessary. Your doctor will then discuss the benefits and risks of use during pregnancy with you. Caution is also advised, as Neoral capsules and Neoral oral solution contain alcohol.
Breastfeeding:
Because ciclosporin passes into breast milk, you should not breastfeed while taking Neoral.
Caution is also advised, as Neoral capsules and Neoral oral solution contain alcohol.
Driving and using machines:
No studies have been conducted on the effects on the ability to drive or use machines.
Important information about the ingredients of this medicine:
Neoral capsules and Neoral oral solution contain 11.9 vol% ethanol (alcohol). This means a maximum of 100 mg per Neoral 100 mg capsule and per ml of Neoral oral solution, equivalent to 3 ml of beer or 1 ml of wine per Neoral 100 mg capsule and per ml of Neoral oral solution. Alcohol can be harmful to those who drink alcohol. Caution is advised in pregnant or breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy.
Neoral capsules and Neoral oral solution contain propylene glycol. Propylene glycol can cause similar symptoms to alcohol. Neoral capsules and Neoral oral solution contain macrogolglycerol hydroxystearate. Macrogolglycerol hydroxystearate can cause stomach upset and diarrhea.
3. HOW TO USE THIS MEDICINE: Always use this medicine exactly as your doctor or pharmacist has told you. If you are unsure about the correct use, contact your doctor or pharmacist.
Usual dosage:
Your doctor has prescribed how much Neoral to take. This amount is stated on the pharmacy label. It is important that you follow your doctor's instructions exactly, as the success of the treatment depends on them. Always take your daily dose of Neoral in two divided doses.
The correct amount of Neoral is determined for each patient; variations may occur. Your doctor must be able to ensure that you actually take the prescribed amount. Blood tests (so-called blood level determinations) help determine the correct dosage. On the day of such a blood test, Neoral should only be taken after the test.
Use in children:
Neoral can be used by children with nephrotic syndrome (a kidney disease). Little is known yet about its use in young children for other conditions.
Use in the elderly:
Experience with the use of Neoral in the elderly is also limited, but no specific problems have been reported to date when used at the recommended dosage. If you use Neoral to treat severe rheumatoid arthritis (rheumatoid arthritis), you are more likely to have high blood pressure (hypertension) and reduced kidney function.
If you notice that the effect of Neoral is too strong or too weak, contact your doctor or pharmacist.
Method of use
: Capsules:
The capsules should be swallowed whole. Neoral capsules can be taken with a glass of water; other drinks are also permitted, except grapefruit juice.
Leave the capsules in the blister packs until ready to take. The capsules have a characteristic odor.
Drink:
First use:
1. Break open the plastic cap and bend it backward.
2. Pull the cap with the locking ring completely off the bottle.
3. Remove the black stopper and throw it away.
4. Firmly press the thin tube with the white stopper (= dosing device) into the neck of the bottle.
5. Connect the syringe to the white stopper.
6. Draw the prescribed volume of oral solution into the syringe.
7. Remove any large air bubbles by moving the plunger up and down several times before removing the syringe with the prescribed dose from the bottle. The presence of a few small air bubbles is not significant and will not affect the measured dose.
8. Squeeze the medication from the syringe into a small glass half-filled with, preferably, orange or apple juice; other drinks are also permitted, except grapefruit juice.
Use a proper glass; never use a plastic cup, as Neoral will stick to it. Ensure the syringe does not touch the solution in the glass. Stir well and drink the mixture immediately afterward. Do not let it sit. Check that no Neoral remains in the glass. It is best to rinse the glass with the same liquid and drink this residue as well.
9. After use, wipe the syringe only on the outside with a dry tissue and place it back in its holder. Leave the white stopper with the thin tube (=dosing aid) in the bottle and close it with the enclosed screw cap.
For subsequent use, begin with step 5.
Duration of treatment
Treatment with Neoral usually lasts for several months or years. Treatment with Neoral for psoriasis should be stopped if insufficient results are achieved after 6 weeks. Treatment with Neoral for nephrotic syndrome and rheumatoid arthritis should be stopped if insufficient results are achieved after 3 months.
Have you taken more of this medicine than you should?
If you have taken more Neoral than you should, contact your doctor or pharmacist immediately. Try to find out how many capsules or oral solution you took and what strength. Follow your doctor's instructions carefully. The following side effects have been reported after overdoses: kidney failure and increased blood pressure (hypertension). It may be important to induce vomiting during the first few hours after taking the medicine.
Have you forgotten to take this medicine?
If you accidentally miss a dose of Neoral (capsule/oral solution), take it as soon as possible. Take your next dose at the same time as you normally would. However, if it is almost time for your next dose of Neoral, do not take the missed capsule/oral solution. You will then take your next dose of Neoral at the usual time.
Do not take a double dose to make up for a forgotten dose. If you have any questions about this, ask your doctor.
If you stop taking this medicine
Stopping your treatment with Neoral may increase the risk of rejection of your transplanted organ. Do not stop taking this medicine unless your doctor tells you to. If
you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS Like all medicines, Neoral can cause side effects, although not everybody gets them.
Side effects may:
- occur very common (affecting more than 1 in 10 patients);
- occur common (affecting less than 1 in 10 patients);
- occur uncommonly (affecting less than 1 in 100 patients);
- occur rarely (affecting less than 1 in 1,000 patients);
- occur very rarely (affecting less than 1 in 10,000 patients).
- not known (cannot be determined from the available data).
Blood and lymphatic system disorders
Uncommon: Anemia, low platelet count (thrombocytopenia).
Rare: Condition characterised by breakdown of blood combined with abnormalities of the small blood vessels in the kidneys and other organs (microangiopathic haemolytic anaemia), a syndrome with symptoms including breakdown of blood, increased tendency to bleeding, and renal impairment that occurs mainly in children aged 6 to 24 months (haemolytic uremic syndrome).
Nervous system disorders
Very common: Tremor and headache including migraine.
Common: Unexplained sensations of pins and needles, itching or tingling (paresthesia).
Uncommon: Symptoms of encephalopathy (brain disorder) such as convulsions, confusion, disorientation, decreased level of consciousness, agitation, insomnia, visual disturbances, blindness as a result of a stroke (cortical blindness), coma, reduced muscle movements (paresis), coordination problems (cerebellar ataxia), deafness due to reduced function of the inner ear (sensorineural deafness).
Rare: Nerve disorder that often starts with numbness, tingling or burning sensation in the feet and/or hands. The pain may become more severe over time and radiate upwards (motor polyneuropathy).
Very rare: Fluid accumulation at the point where the optic nerve leaves the eye (optic disc edema), including fluid accumulation in the blind spot of the eye (papilloedema) with a possible risk of permanent vision loss due to benign increased pressure within the skull (benign increased intracranial pressure), see also the section "When you need to take special care with this medicine" for a description of the symptoms of the latter condition.
Respiratory disorders
Rare: Syndrome with symptoms such as severe shortness of breath and blue discoloration of the skin, shortness of breath and difficulty breathing with wheezing (shock lung).
Gastrointestinal disorders
Common: Nausea, vomiting, abdominal pain, diarrhoea, swelling of the gums (gingival hyperplasia).
Rare: Inflammation of the pancreas accompanied by severe pain in the upper abdomen radiating to the back, and nausea and vomiting (pancreatitis).
Bladder, urinary tract and kidney disorders
Very common: Decreased kidney function.
Skin disorders
Common: Increased body hair (hypertrichosis).
Uncommon: Allergic skin rash.
Muscle and connective tissue disorders
Common: Muscle cramps, muscle pain (myalgia), bone pain.
Rare: Muscle weakness, muscle disease (myopathy).
Metabolism and nutrition disorders
Very common: High cholesterol and/or triglyceride levels in the blood (hyperlipidemia).
Common: Loss of appetite (occurs in anorexia), high uric acid levels in the blood (hyperuricemia), high potassium levels in the blood which sometimes manifest as muscle cramps, diarrhea, nausea, dizziness, headache (hyperkalemia), low magnesium levels in the blood (hypomagnesaemia).
Rare: High sugar levels in the blood (hyperglycemia).
Vascular disorders
Very common: Increased blood pressure (hypertension).
General disorders and administration site conditions
Common: Fatigue.
Uncommon: Fluid retention (oedema), weight gain.
Hepatobiliary disorders
Common: Liver disorders.
Not known: Liver damage with or without yellow eyes or skin.
Reproductive system and breast disorders
Rare: Menstrual disorders (such as painful or absent periods), breast swelling in men (gynaecomastia).
If any side effects bother you severely? Or if you notice a side effect not listed in this leaflet, please contact your doctor or pharmacist.
5. HOW TO STORE THIS MEDICINE? Keep out of the reach and sight of children.
Store the capsules below 25°C. The capsules should only be removed from the strip immediately before use.
Store the oral solution below 30°C. This applies to both the unopened bottle and after opening the bottle. After opening the bottle, the contents must be used within 2 months.
Store in the original package.
At temperatures below 20°C, the oral solution may take on a slightly jelly-like appearance. This will disappear when you carefully warm the solution back up to 30°C. The solution may also become slightly cloudy or have a small sediment, which may persist despite warming. You can continue using the oral solution as usual, as the effectiveness and safety of Neoral remain unchanged. There is also no risk of measuring too much or too little with the syringe.
Do not use this medication after the expiry date, which is stated on the label or outer packaging after "EXP." The expiry date refers to the month and year. The last day of that month is the expiry date.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These
measures will help to protect the environment. 6. FURTHER INFORMATIONWhat this medicine contains?
The active substance is ciclosporin.
The other ingredients are:
- 25 mg and 100 mg capsules: Capsule content: RRR-alpha-tocopherol (E307), ethanol, propylene glycol (E1520), corn oil mono-di-triglycerides, macrogolglycerol hydroxystearate. Capsule shell: black iron oxide (E172), titanium dioxide (E171), glycerol (E422), propylene glycol (E1520), gelatin, red ink consisting of aluminium chloride, sodium hydroxide (E524), hypromellose (E464) and carmine (E120).
- Oral solution: RRR-alpha-tocopherol (E307), ethanol, propylene glycol (E1520), corn oil mono-di-triglycerides, macrogolglycerol hydroxystearate.
What does Neoral look like and contents of the pack?
Neoral is available as 25 mg and 100 mg capsules and as an oral solution.
Each capsule contains 25 mg and 100 mg of ciclosporin respectively.
The 25 mg capsules are blue-gray, oval, soft capsules with the red imprint NVR 25 mg. The 100 mg capsules are blue-gray, oval, soft capsules with the red imprint "NVR 100 mg."
Neoral 25 mg and 100 mg capsules are sold in blister packs of 30.
The oral solution contains 100 mg of ciclosporin per ml.
The oral solution is a clear, yellow to brownish-yellow, oily liquid in a brown glass bottle. Each pack contains a 50 ml bottle, a dosing device, a 1 ml dosing syringe, and a 4 ml dosing syringe.
Marketing Authorisation Holder and Manufacturer
Novartis Pharma BV
Raapopseweg 1
6824 DP Arnhem
Telephone: 026 - 37 82 111
E-mail: mid.phnlar@novartis.com
Registered in the Register of Medicines under:
Neoral 25 mg, capsules RVG 17495
Neoral 100 mg, capsules RVG 17496
Neoral 100 mg/ml, oral solution RVG 17497
This leaflet was approved in 10/2011. |
