GILENYA. 0.5 mg. 28 capsules

GILENYA. 0.5 mg. 28 capsules
€ 2299.00
Add to Cart
Gilenya is used in adults for the treatment of relapsing-remitting multiple sclerosis (MS), in particular:
patients who have not responded in spite of prior interferon beta (another drug for treatment of MS).
or
patients with rapidly evolving severe MS.
Gilenya does not cure MS, but it helps reduce the number of relapses and slowing the progression of physical disability due to MS.

GILENYA. 0.5 mg. 28 capsules

 
 
What Gilenya and what it is used
What Gilenya
The active substance of Gilenya fingolimod is .

For what use Gilenya
Gilenya is used in adults for the treatment of relapsing- remitting multiple sclerosis (MS) , in particular :
patients who have not responded in spite of prior interferon beta ( another drug for treatment of MS ) .
or
patients with rapidly evolving severe MS.

Gilenya does not cure MS, but it helps reduce the number of relapses and slowing the progression of physical disability due to MS.

What is Multiple Sclerosis
MS is a chronic condition that affects the central nervous system (CNS ) , consisting of the brain and spinal cord . In MS inflammation destroys the protective sheath of neurons in the CNS ( called myelin ) and violates their proper functioning. The process is called demyelination.
Relapsing - remitting MS is characterized by recurrent seizures ( relapse ) of the nervous system caused by inflammation in the CNS. Symptoms vary from patient to patient , but generally include difficulty walking, numbness, visual disturbances or impaired coordination. Symptoms of attack may disappear completely after controlling seizures , but some violations might remain .

How does Gilenya
Gilenya helps protect the central nervous system attacks the immune system by reducing the ability of certain white cells ( lymphocytes) to move throughout the body and prevent their reaching the brain and spinal cord . This limits the damage to neurons caused by MS .

2 . What you should know before taking Gilenya
Do not take Gilenya:
if you have a weakened immune system (due to immunodeficiency syndrome , a disease or medications that suppress the immune system) ;
if you have severe active infection or active chronic infection such as hepatitis or tuberculosis ;
if you have active cancer ( unless it is a type of skin cancer called basal cell carcinoma ) ;
if you have severe liver problems ;
if you are allergic to fingolimod or any of the other ingredients of this medicine (listed in Section 6) .
If any of these apply to you, tell your doctor without taking Gilenya.

Warnings and Precautions
Talk to your doctor before taking Gilenya:
if you have irregular , abnormal heart rhythm ;
if you experience slow heartbeat ( eg, dizziness , nausea, or palpitations ) ;
if you have any heart problems , clogged blood vessels of the heart, if you have a heart attack if you have had heart failure in the past or have angina ;
if you have had a stroke ;
if you have heart failure;
if you have severe breathing problems during sleep (severe sleep apnea ) ;
if you have been told you have impaired electrocardiogram ;
if you are taking or have recently taken any medications for irregular heartbeat such as quinidine , disopyramide , amiodarone or sotalol ;
if you are taking or have recently taken any medications that slow heart rate (such as beta blockers, verapamil , diltiazem or ivabradine , digoxin, anticholinesterase agents or pilocarpine ) ;
if you have or have had a sudden loss of consciousness or fainting ( syncope) in the past;
If you plan to be vaccinated ;
if you have not had chickenpox ;
if you have or have had visual disturbances or other symptoms such as swelling of the central visual field ( the macula ) at the back of the eye ( a condition known as macular edema , see below ), inflammation or infection of the eye ( uveitis ) , or if you have diabetes ( which can lead to problems with the eyes) ;
if you have liver problems ;
if you have high blood pressure that can not be controlled with medication ;
if you have severe lung problems or " smoking history of cough ."
If any of the above applies to you , tell your doctor before taking Gilenya.

Slow heart rate (bradycardia ) and irregular heart rhythm : In
initiation of treatment Gilenya can cause a slow heart rate . As a result, it is possible to feel dizzy or tired, to feel your pulse or blood pressure to plummet . If any of these effects occur , tell your doctor because it may need immediate treatment . Gilenya can also cause irregular heartbeat , especially after the first dose . Recovery of irregular heart rhythm to normal usually within less than one day. Slow heart rate returns to normal values usually within one month.
Your doctor will ask you to stay in the office or clinic for at least 6 hours after the first dose of Gilenya and measured each hour heart rate and blood pressure can be taken appropriate measures for adverse effects that may occur when starting treatment. Before the first dose of Gilenya after 6 -hour follow-up period should you do an electrocardiogram . During this time your doctor can constantly monitor your cardiogram . If after 6 -hour follow-up period have very slow or decreasing heart rate, electrocardiogram , or if you are abnormal , you may need to be monitored for a longer period (at least 2 more hours and possibly overnight ) until they disappear . The same can be true for rechallenge with Gilenya, after a break , depending on how long the suspension is and how long you have been taking Gilenya before the interruption.
If you have or are at risk of developing an irregular heartbeat , electrocardiogram if you are abnormal , if you have heart disease or heart failure , treatment with Gilenya may not be suitable for you.
If you have had a sudden loss of consciousness or a decrease in heart rate in the past , treatment with Gilenya may not be suitable for you. Will be examined by a cardiologist ( heart specialist ) , who will advise you how to start treatment with Gilenya, including you during the night .
If you are taking medications that can lead to a lowering of the heart rate , treatment with Gilenya may not be suitable for you. Will be examined by a cardiologist who will decide whether it is possible to switch to alternative medicines that lower heart rate in order to start treatment with Gilenya. If such a change is impossible , the cardiologist will advise you how to start treatment with Gilenya, including you during the night .

If you've never had the measles : If you've never had the measles , your doctor may want to check your immunity against the virus that caused it ( varicella-zoster virus) . If you do not have protection against this virus , you need to put your vaccine before starting treatment with Gilenya. In this case, your doctor will postpone treatment with Gilenya by one month.

Infections : Gilenya decreased number of white blood cells (in particular the number of the lymphocytes ) . White blood cells fight infection . While taking Gilenya ( and for 2 months after stopping treatment ) may be ill more frequently than infections. Infections from already sick may worsen . Infections can be serious and life threatening. If you think you have an infection , fever or feel like you have the flu , call your doctor immediately.

Macular edema: If you have or have had visual disturbances or other signs of swelling of the central visual field ( the macula ) at the back of the eye , inflammation or infection of the eye ( uveitis ) or diabetes your doctor may ask you to make eye examination before starting treatment with Gilenya.
Your doctor may want to eye examinations for 3 to 4 months after starting treatment with Gilenya.
The macula is a small area of the retina at the back of the eye that allows you to distinguish between shapes, colors and individual details clearly and distinctly . Gilenya may cause edema , a condition known as macular edema . The edema usually develops within the first 4 months after starting treatment with Gilenya.
The chance to develop macular edema is higher if you have diabetes or if you have an eye infection called uveitis. In both cases , your doctor will insist that regularly pass an eye examination to allow time to catch the development of macular edema.
In case of development of macular edema , consult your physician before continuing treatment with Gilenya.
Macular edema can cause some visual symptoms as in MS relapse ( optic neuritis ) . In the early stages , patients may be asymptomatic . Tell your doctor about any changes in your vision .
Your doctor may want to send you an eye examination, particularly if:
Your central vision is blurred or has shadows ;
have blind spots in central vision ;
you hard to distinguish colors or fine detail .
Liver function tests : If you have severe liver problems should not take Gilenya. Gilenya can cause abnormal liver function tests. You may not have any symptoms , but if you notice yellowing of the skin or whites of the eyes , unusually colored urine or unexplained nausea and vomiting, tell your doctor immediately.

If any of these symptoms after starting treatment with Gilenya, tell your doctor immediately.

In the first year of treatment, your doctor will ask you to have blood tests to monitor the condition of your liver function . If the test results show the presence of liver problems may require discontinuation of treatment with Gilenya.

Hypertension
Since Gilenya resulted in a slight increase in blood pressure , your doctor may want to monitor the values of your blood pressure.

lung problems
Gilenya has minor lung function. Patients with severe lung disease or those with " smoking history of cough" have a greater chance of developing side effects .

blood count
The desired effect of treatment with Gilenya is to reduce the number of white blood cells. The effect is reversible within 2 months after stopping treatment. If required you to have any blood tests , tell the doctor that you are taking Gilenya. Otherwise it might misinterpret the results of the tests and some blood tests it is necessary to take a large amount of blood than usual.
Before starting treatment with Gilenya Your doctor will check if you have enough white blood cells in the blood, then it is possible to request regular repetition of the study. If you do not have enough white blood cells may be necessary to discontinue Gilenya.

Elderly
Experience with Gilenya in the elderly (over 65 years) is limited. Consult your doctor if you have any concerns .

Children and adolescents
Gilenya is not indicated for use in children and adolescents under the age of 18 years , as has not been studied in MS patients under 18 years.

Other medicines and Gilenya
Tell your doctor or pharmacist if you are taking , have recently taken or might take other medicines.
Tell your doctor if you are taking any of these medicines:
Drugs that suppress or modulate the immune system, including other medicines for the treatment of MS , such as interferon beta , glatiramer acetate, natalizumab or mitoxantrone . You should not take Gilenya with such medicines as they may exacerbate the effects on the immune system (see also " Do not take Gilenya");
Vaccines. During treatment and for 2 months after stopping treatment with Gilenya should not you apply certain types of vaccines (live attenuated vaccines ) because they can cause infection, from which should be protected . Other vaccines may not work as well as usual , if applied during this period ;
Medicines that slow the heart rate (eg, beta blockers such as atenolol ) . The use of Gilenya with such drugs may increase the effects on heart rate during the first days after initiation of treatment ;
Medicines for irregular heartbeat such as quinidine, disopyramide , amiodarone or sotalol . Your doctor may decide not to prescribe Gilenya, if you are taking such medications as it can enhance the effects in terms of irregular heartbeat ;
Other drugs : protease inhibitors , anti-infective agents such as ketoconazole , antifungal azoles , clarithromycin or telithromycin.
Pregnancy and lactation
Before starting treatment with Gilenya Your doctor will ask you to take a pregnancy test to make sure you are not pregnant . You should avoid becoming pregnant while taking Gilenya and for two months after discontinuation , as there is risk of harm to the baby. Consult with your doctor about appropriate methods of contraception that you should use during treatment and for 2 months after stopping treatment.
If you become pregnant while taking Gilenya, stop taking the medicine and tell your doctor immediately. Your doctor will decide what is best for you and your baby.
You should not breastfeed while taking Gilenya. Gilenya can pass into breast milk and risk of serious side effects for the baby.
Ask your doctor or pharmacist before taking any medicine .

Driving and using machines
Your doctor will tell you whether your illness allows you to safely drive or operate machinery. Gilenya is not expected to affect the ability to drive and use machines.
However, at the start of treatment will have to remain under observation at the doctor's office or in the hospital for 6 hours after the first dose of Gilenya. Your ability to drive and use machines may be impaired during this period and possibly beyond.

3 . How to take Gilenya
Treatment with Gilenya will be monitored by a physician experienced in the treatment of multiple sclerosis.
Always take this medicine exactly as your doctor tells you . If you are not sure, ask your doctor.
The dose is one capsule daily . Gilenya Take once daily with a glass of water . Gilenya can be taken with or without food.
Take Gilenya at the same time each day will help you remember to take your medicine .
Do not exceed the recommended dose.
Your doctor may decide to go directly to treatment with interferon beta to treatment with Gilenya, if there are no signs of any caused by previous treatment deviations. You may need to make your blood tests to rule out the presence of such abnormalities. It is possible after discontinuation of treatment with natalizumab have to wait 2-3 months before you start treatment with Gilenya.
If you have questions about how long it will take Gilenya, consult your doctor or pharmacist.

If you take more than the amount of Gilenya
If you take more dose Gilenya, call your doctor immediately.

If you forget to take Gilenya
If you have taken Gilenya less than 1 month and you forget to take one dose for one day , talk to your doctor before taking the next dose . He may decide to leave you under surveillance while taking the next dose.
If you are taking Gilenya for at least 1 month and you forget to take your medicine more than 2 weeks , consult your doctor before taking the next dose . He may decide to leave you under surveillance while taking the next dose. However, if you forget to take their medication less than two weeks , you can take the next dose as it was prescribed.
Never take a double dose to make up for a missed dose.

If you stop taking Gilenya
Do not stop taking Gilenya or change your dose without first consulting your doctor.
Gilenya will remain in your body for 2 months after stopping taking her number of white blood cell ( lymphocyte count ) may also remain low during this period , and those listed in this leaflet may still be available. After discontinuation of treatment with Gilenya may have to wait 6-8 weeks before you start a new treatment for MS .
If you need to restart treatment with Gilenya, after a break of more than two weeks , the effect on heart rate observed at the start of treatment to reappear and have to be seen in a doctor's office or clinic restart treatment. Do not start treatment with Gilenya after stopping for more than two weeks without checking with your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4 . Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them .

Some of the side effects may be or become serious .
Common ( may affect up to 1 in 10 people):
Cough with phlegm , discomfort in the chest , fever (signs of lung disorders) ;
Malaise with nausea , vomiting, diarrhea (signs of intestinal problems);
Herpes viral infections ( shingles ) with symptoms such as blistering , burning , itching, or pain in the mouth or genitals. Other symptoms may include fever, and weakness in the early stages of infection , followed by a tingling , itching and formation of blisters or red patches on the face or body ;
Slow heart rate (bradycardia ) , irregular heart rhythm.
Uncommon ( may affect up to 1 in 100 people):
Pneumonia, with symptoms such as fever , cough , shortness of breath ;
Macular edema (swelling of the central visual field of the retina at the back of the eye ) with symptoms such as shadows or blind spots in central vision , blurred vision , difficulty in distinguishing colors or details .
Rare (may affect up to 1 in 1000 people):
Condition called syndrome of reversible posterior encephalopathy ( Soze ) . Symptoms may include headache , confusion , seizures, and / or visual disturbances .
If you have any of the above symptoms , call your doctor immediately .

Other side effects
Very common ( may affect more than 1 in 10 people):
Influenza virus infection with symptoms such as fatigue , fever, sore throat , pain in joints and muscles , fever ;
headache ;
diarrhea ;
Back pain ;
cough;
Elevation of liver enzymes ( ALT) .
Common ( may affect up to 1 in 10 people):
Sensation of heaviness or pain in the cheeks and forehead ( sinusitis ) ;
Fungal infections of the skin, hair or nails ( ringworm ) ;
dizziness ;
Tingling or numbness ;
Severe headache , often accompanied by nausea , vomiting, and sensitivity to light (signs of migraine ) ;
Low numbers of white blood cells (lymphocytes , leukocytes) ;
weakness ;
Itchy , red , burning rash (signs of eczema) ;
hair loss ;
itching;
Weight loss;
shortness of breath ;
depression ;
Eye pain ;
Blurred vision (see also paragraph on macular edema by " Some side effects may be or could become serious " ) ;
Hypertension (Gilenya can cause a slight increase in blood pressure) ;
Elevation of liver enzymes ;
Increases in the levels of certain lipids ( triglycerides) .
Uncommon ( may affect up to 1 in 100 people):
Decreased number of certain types of white blood cells (neutrophils ) ;
Depressed mood .
Rare (may affect up to 1 in 1000 people):
Disorders of the blood vessels ;
Nervous system;
Cancer of the lymphatic system ( lymphomas ) .
If any of these affects you in more severe , inform your doctor.
If you get any side effects, tell your doctor or pharmacist. This includes all listed in this leaflet .

5 . How to store Gilenya
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after " EXP EXP :/ " . The expiry date refers to the last day of that month.
Do not store above 25 ° C.
Store in the original package to protect from moisture. Do not use packaging that is damaged or shows signs of tampering.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.

6 . Package Contents and more information
Contents of Gilenya
The active substance is fingolimod . Each capsule contains 0,5 mg fingolimod (as hydrochloride ) .

Other ingredients are:
Capsule content : magnesium stearate , mannitol ;
Capsule shell : iron oxide yellow ( E172 ), titanium dioxide (E171) , gelatin ;
Caption : shellac ( E904 ), anhydrous alcohol , isopropyl alcohol, butyl alcohol, propylene glycol , purified water, strong ammonia solution , potassium hydroxide , black iron oxide ( E172 ), yellow iron oxide ( E172 ), titanium dioxide ( E171), dimethicone
Gilenya looks like and contents of the pack
Gilenya 0,5 mg hard capsules have a white opaque body and bright yellow opaque cap . On the cap with black ink printed "FTY 0.5mg", and on the body with yellow ink printed two bands.
Gilenya is available in packs containing 7 or 28 capsules or in multi-packs containing 84 capsules (3 packs of 28 capsules) .
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder:
Novartis Europharm Limited, United Kingdom.
 
 
€ 2299.00
Add to Cart
Close