Cyclosporine Ophthalmic drops, emulsion

What is this medicine?

CYCLOSPORINE (SYE kloe spor een) eye drops are used to increase tear production in patients who have dry eyes due to eye inflammation.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• an active eye infection

• a history of herpes keratitis

• using punctal plugs

• wear contact lenses

• an unusual or allergic reaction to cyclosporine, medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is only for use in the eye. Do not take by mouth. Follow the directions on the prescription label. Turn the vial upside down once or twice to shake the contents before use. Wash hands before and after use. Use the product immediately after opening the vial and throw the vial away right after use. Tilt your head back slightly and pull your lower eyelid down with your index finger to form a pouch. Try not to touch the tip of the dropper to your eye, fingertips, or any other surface. Squeeze the prescribed number of drops into the pouch. Close the eye for a few moments to spread the drops and apply gentle finger pressure to the inner corner of the eye for 1 to 2 minutes. Use your doses at regular intervals. Do not use your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

• other eye products, especially those that contain antiinflammatory agents

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular eye exams. Ask your doctor or health care professional if you should continue to use this medicine if you injure your eyes or need eye surgery. If you develop an eye infection, contact your doctor or health care professional immediately.

If you wear contact lenses, you should not put this medicine in your eyes while wearing the lenses. After using the eye drops, wait about 15 minutes before putting lenses in your eyes.

You can use artificial tear products while using this medicine; however you should wait at least 15 minutes before using the this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• eye discharge

• swelling around the eye

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• blurred vision

• excessive tearing

• eye burning or stinging

• eye itching

• feeling as if something is in your eye

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 25 degrees C (59 and 77 degrees F). Once a vial is open, use it right away and throw away any remaining medicine in the vial. Throw away any unused vials after the expiration date.

Cyclosporine Oral capsule

What is this medicine?

CYCLOSPORINE (SYE kloe spor een) is used to decrease the immune system's response to a transplanted organ.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• cancer

• high blood pressure

• immune system problems

• infection

• kidney disease

• liver disease

• previous coal tar, PUVA, ultraviolet, or radiation therapy

• an unusual or allergic reaction to cyclosporine, alcohol, corn oil, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast feeding

How should I use this medicine?

Take this medicine by mouth with a full glass of water. Do not take with grapefruit juice. Swallow the capsules whole. Do not chew or break the capsule. Follow the directions on the prescription label. Take your medicine at regular intervals. Take the capsules at the same time each day and at the same time in relation to meals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 6 months for selected conditions, precautions do apply.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. Call your doctor or health care professional if you miss more than one dose or if you miss doses on a regular basis.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• bosentan

• cidofovir

• cisapride

• mibefradil

• ranolazine

• red yeast rice, monascus purpureus

• St. John's wort

• tacrolimus

This medicine may also interact with the following medications:

• acyclovir

• allopurinol

• amiloride

• amiodarone

• bromocriptine

• carbamazepine

• certain antibiotics

• cimetidine

• colchicine

• danazol

• digoxin

• female hormones, including contraceptive or birth control pills

• imatinib

• medicines for fungal infections like amphotericin B, fluconazole, itraconazole, terbinafine, and ketoconazole

• medicines for blood pressure like diltiazem, nicardipine, verapamil, enalapril, ramipril, and losartan

• medicines for cholesterol like lovastatin, simvastatin, atorvastatin, and fenofibrate

• medicines for HIV infection like indinavir, nelfinavir, ritonavir, and saquinavir

• medicines that suppress the immune system

• melphalan

• methotrexate

• metoclopramide

• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen

• octreotide

• orlistat

• oxcarbazepine

• phenobarbital

• phenytoin

• ranitidine

• sirolimus

• spironolactone

• steroid medicines like prednisone or cortisone

• sulfinpyrazone

• ticlopidine

• triamterene

• vaccines

• voriconazole

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. You will have regular blood checks. Do not change the brand of medicine unless directed by your doctor or health care professional.

If you get a cold or other infection while receiving this medicine, call your doctor or health care professional. Do not treat yourself. The medicine may decrease your body's ability to fight infections.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

The medicine can cause unusual growth of gum tissue and can make your gums bleed. Practice good oral hygiene, and be careful when brushing and flossing your teeth. See your dentist regularly.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• changes in vision

• high blood pressure

• increased urge to urinate or frequent urination

• numbness or tingling in the hands and feet

• seizures

• severe stomach pain

• vomiting

• yellowing of the skin or the whites of the eyes

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• bleeding or tender gums, overgrowth of gum tissue

• diarrhea

• excessive hair growth on the face or body

• nausea

• tremors

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store this medicine between 15 and 30 degrees C (59 and 86 degrees F). Keep the medicine in the original packaging. Throw away any unused medicine after the expiration date.

Cyclosporine, Modified Oral capsule

What is this medicine?

CYCLOSPORINE (SYE kloe spor een) is used to decrease the immune system's response to a transplanted organ. The medicine is also used for rheumatoid arthritis and psoriasis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• cancer

• high blood pressure

• immune system problems

• infection

• kidney disease

• liver disease

• previous coal tar, PUVA, ultraviolet, or radiation therapy

• an unusual or allergic reaction to cyclosporine, alcohol, corn oil (Neoral only), castor oil, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast feeding

How should I use this medicine?

Take this medicine by mouth with a full glass of water. Do not take with grapefruit juice. Swallow the capsules whole. Do not chew or break the capsule. Follow the directions on the prescription label. Take your medicine at regular intervals. Take the capsules at the same time each day and at the same time in relation to meals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 1 year for selected conditions, precautions do apply.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. Call your doctor or health care professional if you miss more than one dose or if you miss doses on a regular basis.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• bosentan

• cidofovir

• cisapride

• mibefradil

• ranolazine

• red yeast rice, monascus purpureus

• St. John's wort

• tacrolimus

This medicine may also interact with the following medications:

• acyclovir

• allopurinol

• amiloride

• amiodarone

• bromocriptine

• carbamazepine

• certain antibiotics

• cimetidine

• colchicine

• danazol

• digoxin

• female hormones, including contraceptive or birth control pills

• imatinib

• medicines for fungal infections like amphotericin B, fluconazole, itraconazole, terbinafine, and ketoconazole

• medicines for blood pressure like diltiazem, nicardipine, verapamil, enalapril, ramipril, and losartan

• medicines for cholesterol like lovastatin, simvastatin, atorvastatin, and fenofibrate

• medicines for HIV infection like indinavir, nelfinavir, ritonavir, and saquinavir

• medicines that suppress the immune system

• melphalan

• methotrexate

• metoclopramide

• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen

• octreotide

• orlistat

• oxcarbazepine

• phenobarbital

• phenytoin

• ranitidine

• sirolimus

• spironolactone

• steroid medicines like prednisone or cortisone

• sulfinpyrazone

• ticlopidine

• triamterene

• vaccines

• voriconazole

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. You will have regular blood checks. Do not change the brand of medicine unless directed by your doctor or health care professional.

If you get a cold or other infection while receiving this medicine, call your doctor or health care professional. Do not treat yourself. The medicine may decrease your body's ability to fight infections.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

The medicine can cause unusual growth of gum tissue and can make your gums bleed. Practice good oral hygiene, and be careful when brushing and flossing your teeth. See your dentist regularly.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• changes in vision

• high blood pressure

• increased urge to urinate or frequent urination

• numbness or tingling in the hands and feet

• seizures

• severe stomach pain

• vomiting

• yellowing of the skin or the whites of the eyes

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• bleeding or tender gums, overgrowth of gum tissue

• diarrhea

• excessive hair growth on the face or body

• nausea

• tremors

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store Neoral between 20 and 25 degrees C (68 and 77 degrees F).

Store Gengraf between 15 and 30 degrees C (59 and 86 degrees F).

Keep the medicine in the original packaging. Throw away any unused medicine after the expiration date.

Cyclosporine, Modified Oral solution

What is this medicine?

CYCLOSPORINE (SYE kloe spor een) is used to decrease the immune system's response to a transplanted organ. The medicine is also used for rheumatoid arthritis and psoriasis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• cancer

• high blood pressure

• immune system problems

• infection

• kidney disease

• liver disease

• previous coal tar, PUVA, ultraviolet, or radiation therapy

• an unusual or allergic reaction to cyclosporine, alcohol, corn oil (Neoral only), castor oil, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Use a specially marked spoon or container to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Before taking this medicine dilute your dose with orange or apple juice that is at room temperature. Do not dilute with grapefruit juice or any other liquid. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 1 year of age for selected conditions, precautions do apply.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. Call your doctor or health care professional if you miss more than one dose or if you miss doses on a regular basis.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• bosentan

• cidofovir

• cisapride

• grapefruit juice

• mibefradil

• ranolazine

• red yeast rice, monascus purpureus

• St. John's wort

• tacrolimus

This medicine may also interact with the following medications:

• acyclovir

• allopurinol

• amiloride

• amiodarone

• bromocriptine

• carbamazepine

• certain antibiotics

• cimetidine

• colchicine

• danazol

• digoxin

• female hormones, including contraceptive or birth control pills

• imatinib

• medicines for fungal infections like amphotericin B, fluconazole, itraconazole, terbinafine, and ketoconazole

• medicines for blood pressure like diltiazem, nicardipine, verapamil, enalapril, ramipril, and losartan

• medicines for cholesterol like lovastatin, simvastatin, atorvastatin, and fenofibrate

• medicines for HIV infection like indinavir, nelfinavir, ritonavir, and saquinavir

• medicines that suppress the immune system

• melphalan

• methotrexate

• metoclopramide

• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen

• octreotide

• orlistat

• oxcarbazepine

• phenobarbital

• phenytoin

• ranitidine

• sirolimus

• spironolactone

• steroid medicines like prednisone or cortisone

• sulfinpyrazone

• ticlopidine

• triamterene

• vaccines

• voriconazole

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. You will have regular blood checks. Do not change the brand of medicine unless directed by your doctor or health care professional.

If you get a cold or other infection while receiving this medicine, call your doctor or health care professional. Do not treat yourself. The medicine may decrease your body's ability to fight infections.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

The medicine can cause unusual growth of gum tissue and can make your gums bleed. Practice good oral hygiene, and be careful when brushing and flossing your teeth. See your dentist regularly.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• changes in vision

• high blood pressure

• increased urge to urinate or frequent urination

• numbness or tingling in the hands and feet

• seizures

• severe stomach pain

• vomiting

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• bleeding or tender gums, overgrowth of gum tissue

• diarrhea

• excessive hair growth on the face or body

• nausea

• tremors

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep the medicine in the original packaging. Do not refrigerate. Throw away any unused medicine after the expiration date.