Macular oedema: Before you start Gilenya, if you have or have had visual disturbances or other signs of swelling in the central vision area (macula) at the back of the eye, inflammation or infection of the eye (uveitis) or diabetes, your doctor may want you to undergo an eye examination.

Your doctor may want you to undergo an eye examination 3 to 4 months after starting Gilenya treatment.

The macula is a small area of the retina at the back of the eye which enables you to see shapes, colours, and details clearly and sharply. Gilenya may cause swelling in the macula, a condition that is known as macular oedema. The swelling usually happens in the first 4 months of Gilenya treatment.

Your chance of developing macular oedema is higher if you have diabetes or have had an inflammation of the eye called uveitis. In these cases your doctor will want you to undergo regular eye examinations in order to detect macular oedema.

If you have had macular oedema, talk to your doctor before you resume treatment with Gilenya.

Macular oedema can cause some of the same vision symptoms as an MS attack (optic neuritis). Early on, there may not be any symptoms. Be sure to tell your doctor about any changes in your vision. Your doctor may want you to undergo an eye examination, especially if:

Liver function tests: If you have severe liver problems, you should not take Gilenya.Gilenya may cause abnormal results of liver function tests. You will probably not notice any symptoms but if you notice yellowing of your skin or the whites of your eyes, abnormal darkening of the urine or unexplained nausea and vomiting, tell your doctor straight away.

If you get any of these symptoms after starting Gilenya, tell your doctor straight away.

During the first six months of treatment your doctor will request blood tests to monitor your liver function. If your test results indicate a problem with your liver you may have to interrupt treatment with Gilenya.

High blood pressure
As Gilenya causes a slight elevation of blood pressure, your doctor may want to check your blood pressure regularly.

Lung problems
Gilenya has a slight effect on the lung function. Patients with severe lung problems or with smoker-s cough may have a higher chance of developing side effects.

Blood count
The desired effect of Gilenya treatment is to reduce the amount of white blood cells in your blood. This will usually go back to normal within 2 months of stopping treatment. If you need to have any blood tests, tell the doctor that you are taking Gilenya. Otherwise, it may not be possible for the doctor to understand the results of the test, and for certain types of blood test your doctor may need to take more blood than usual.

Before you start Gilenya, your doctor will confirm whether you have enough white blood cells in your blood and may want to repeat a check regularly. In case you do not have enough white blood cells, you may have to interrupt treatment with Gilenya.

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

Use in children
Gilenya is not intended to be used in children and adolescents below 18 years old as it has not been studied in MS patients below 18 years old.

Taking other medicines
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