Cyclosporine .100 mg. 50 capsules
Cyclosporine is an immunosuppressant. It suppresses the immune system and reduces inflammation.
Cyclosporine is prescribed to prevent rejection of the new organ transplant or bone marrow. Cyclosporine is also used to treat severe psoriasis, kidney problems (nephrotic syndrome), severe arthritis and severe eczema (atopic dermatitis).
2. BEFORE YOU TAKE cyclosporine alkaloids
Do not take Cyclosporine Alkaloid:
If you are allergic (hypersensitive) to cyclosporine or to any of the ingredients;
If you are taking this medicine to treat psoriasis and other serious skin conditions or rheumatoid arthritis and you have kidney problems If you are taking this medicine for the treatment of nephrotic syndrome, continue treatment under very close supervision of your doctor
- If you have other kidney diseases other than nephrotic syndrome
- If you have psoriasis and treated with PUVA (psoralen and UV-A, UVB (UV-B), tar, radiotherapy or other immunosuppressants;
- If you have uncontrolled high blood pressure;
- If you suffer from uncontrolled infections;
- If you know that you have some kind of tumor;
- If you are taking medicines / herbal products containing Hypericum perforatum (St. John's wort);
- If you have rheumatoid arthritis and you are under 18 years of age; If you are taking tacrolimus.
Take special care with Cyclosporine Alkaloid:
Tell your doctor if any of these apply to you: If you are treated with other immunosuppressants (eg. Methotrexate); If your diet includes large amounts of potassium, or if you are taking medicines that contain potassium (ask your doctor); If you suffer from low blood magnesium levels; If you have a high content of uric acid in the blood (eg. If you have kidney disease or certain type of arthritis); If you suffer from an increased amount of lipids in the blood; If you have impaired kidney and / or liver function; If you have high blood pressure or if you are treated for high blood pressure (with potassium-sparing diuretics, ACE inhibitors, angiotensin receptor II).
Cyclosporine Alkaloid only be prescribed by a doctor, a specialist in organ transplantation, dermatology (skin diseases), nephrology (kidney disease) or rheumatology.
Patients treated with cyclosporine should avoid excessive, unprotected sun exposure.
Patients treated with cyclosporine should regularly monitor the blood pressure and renal function. By regularly taking blood concentration of cyclosporine control and blood lipids and liver function.
The concentration of cyclosporine in the blood is monitored and when taking certain other medicines, or when treatment with other drug is discontinued. Tell your doctor if you suffer from acute untreated infection with drugs.
Recommended regular dental checkups.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The following medicines may decrease the effect of cyclosporine:
Barbiturates, carbamazepine, phenytoin, phenobarbital; primidone (for the treatment of
epilepsy), nafcillin, rifampicin, griseofulvin, sulfadiazine, trimethoprim and sulfadimidine intravenous (antibiotic); octreotide (a drug which inhibits the release of certain hormones); probucol (to treat high cholesterol); orlistat (for the treatment of obesity); troglitazone (for the treatment of diabetes mellitus type II); ticlopidine (to prevent blood clotting), metamizol (analgesic), Hypericum perforatum (St. John's wort).
These drugs increase the effect of cyclosporine, macrolide antibiotics such as erythromycin, doxycycline, dzhosamitsin, roxithromycin, pristinamycin and clarithromycin (antibiotics); ketoconazole, itraconazole (antifungal agents); diltiazem, nicardipine, verapamil (used to treat high blood pressure and heart disease); metoclopramide (antiemetic); oral contraceptives; danazol (a condition associated with pain); bromocriptine (for treating infertility, and Parkinson's disease); methylprednisolone at high doses (anti); allopurinol (for treating arthritis); amiodarone, propafenone (for the treatment of cardiac arrhythmia); cimetidine, ranitidine (lowering the acidity in the stomach); Chloroquine (malaria); protease inhibitors (for the treatment of HIV-infection).
Cyclosporine may enhance the effect of the following drugs:
Diclofenac (for rheumatic pain); digoxin (for the treatment of cardiac arrhythmia); colchicines (for treating arthritis); lovastatin, pravastatin, simvastatin, atorvastatin (used to treat high cholesterol); prednisolone; nifedipine (for high blood pressure and heart disease).
Other drugs that may interact with cyclosporine, aminoglycosides (such as gentamicin and tobramycin), ciprofloxacin, vancomycin (antibiotic); amphotericin B (antifungal agent); sulfamethoxazole (for urinary infections); NSAIDs (for rheumatic pain); melphalan (chemotherapy); tacrolimus and sirolimus (immunosuppressants).
Vaccines may be less efficient during the treatment with cyclosporin.
Taking Cyclosporine Alkaloid with food and drink
- Cyclosporine can be taken regardless of meals.
- Grapefruit juice should be avoided because it may enhance the effect of cyclosporine.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
If you are pregnant, planning to become pregnant or if you become pregnant during treatment with cyclosporine, tell your doctor immediately. Cyclosporine should not be taken during pregnancy unless your doctor discussed before.
Cyclosporine should not be taken during breastfeeding.
Driving and using machines
Cyclosporine did not affect the ability to drive and use machines.
Cyclosporine contains ethanol and if it has an effect when you should not drive or operate machinery.
Important information about some of the ingredients of Cyclosporine Alkaloid
This drug contains macrogolglycerol hydroxystearate, which may cause stomach upset and diarrhea.
This medicine contains small amounts of ethanol (up to 525 mg of ethanol per dose (maximum dose), ie 5 soft capsules Cyclosporin Alkaloid 100 or 11 mg soft capsules Cyclosporin Alkaloid 50 or 21 mg soft capsules 25 mg Cyclosporine Alkaloid be approximately 13 ml beer or approximately 6 ml of wine. This quantity is harmful for those suffering from alcoholism. This amount should be given to pregnant women and nursing mothers, children and high-risk groups such as patients with liver disease or epilepsy.
3. HOW TO TAKE cyclosporine alkaloids
Always take Cyclosporine Alkaloid exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
The daily dose of cyclosporine should always be divided into two doses in the morning and evening respectively.
The capsules should be swallowed whole.
The dosage is individual. It is very careful to follow the doctor's prescription.
Bone marrow transplantation:
The dosage is individual. It is very careful to follow the doctor's prescription.
Nephrotic syndrome (kidney disease):
The recommended initial dose for adults is 5 mg / kg weight daily in two divided doses, and 6 mg / kg weight for children. Should regularly monitor the concentration of cyclosporine. In patients with impaired renal function the initial dose should not exceed 2.5 mg / kg body weight per day.
The recommended initial dose is 2.5-5 mg / kg body weight per day in two divided doses. To achieve full therapeutic effect, treatment with cyclosporine may last up to 12 weeks.
The recommended oral starting dose 2.5 mg / kg body weight per day
in two divided doses. After one month, the daily dose can be gradually increased to a maximum of 5 mg / kg body weight. For maintenance treatment, are individually adjusted to achieve the lowest clinically effective dose.
Treatment of this condition is determined individually, as the severity of the disease varies greatly. The recommended dose is 2.5-5 mg / kg body weight per day in two divided doses orally.
No special dose adjustment. Check with your doctor.
Experience in children is limited. However, cyclosporine is appointed for children over 1 year. At the recommended dose without being noticed particular problems.
If you take more than the amount of Cyclosporine Alkaloid
Contact your doctor or emergency room.
If you forget to take Cyclosporine Alkaloid
Take the missed dose as soon as you remember unless it is almost time for your next dose. In this case proceed as prescribed by skip the missed dose.
Do not take a double dose to make up for a missed dose.
If you have any questions about using this medicine, consult your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Alkaloid Cyclosporine can cause side effects, although not everybody gets them.
Very common (affecting more than 1 in 10 people)
Elevated blood lipids (e.g., cholesterol), tremor, headache, hypertension, renal problems.
Common (affect between 1 in 100 ul of 10 people) Increased uric acid in the blood, high blood potassium, low magnesium in the blood, numbness, tingling, abnormal skin sensation (paresthesia), loss of appetite, nausea, vomiting, stomach pain , diarrhea, swelling of the gums, kidney problems, increased hair growth, muscle pain or cramps, fatigue.
Uncommon (affecting between 1 in 1,000 and 1 in 100 people)
Anemia, low platelet count, signs of neurological disorder (eg. Seizures, confusion, a sense of disorientation, reduced reactivity, anxiety, insomnia, blurred vision, blindness, partial muscle paralysis, impaired muscular coordination, coma), rash, fluid retention, weight gain and development of malignant tumors.
Rare (affecting between 1 in 10.000 ul per 1000 people)
Anemia in small blood vessels, haemolytic uraemic syndrome (acute renal failure and anemia), menstrual disorders, breast enlargement in men, increased blood glucose, progressive muscle weakness, pancreatitis, muscle weakness or stiffness and spasms.
Very rare (affecting less than 1 in 10,000 people)
Swelling of the optic nerve with possible visual impairment in cases of benign intracranial pressure increased (increased pressure in the brain).
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please inform your doctor or pharmacist.
5 HOW TO STORE cyclosporine alkaloids
Keep out of reach of children.
No special temperature requirements for storage of this product.
Store in the original package to protect from moisture and light.
Cyclosporine Alkaloid not use after the expiry date stated on the label. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Cyclosporine Alkaloid?
The active substance is cyclosporin 25 mg, 50 mg and 100 mg. The other ingredients are anhydrous ethanol, tokoferilatsetat, diethylene glycol monoethyl ether, oleoyl macrogolglycerides, macrogolglycerol hydroxystearate, gelatin, glycerol, propylene glycol, titanium dioxide (E171), black iron oxide (E172) (25 mg and 100 mg), purified water.