Phinmo 0,5 mg Capsules

PHINMO contains the active substance fingolimod, which belongs to a group of medicines known as sphingosine - 1 - phosphate (S1 - P) receptor modulators. It is used in the treatment of relapsing (returning) multiple sclerosis (MS). PHINMO does not cure MS, but it helps to reduce the number of relapses (returns) that occur and to slow the build - up of physical problems due to MS (disability progression).

How PHINMO works

Multiple sclerosis (MS) is a long - term condition that affects the central nervous system (CNS), particularly how the brain and spinal cord work. In MS, inflammation destroys the protective sheath (called myelin) around the nerves in the CNS, and stops the nerves from working properly. PHINMO helps to fight against cells that cause inflammation from reaching the brain. This reduces nerve damage caused by MS.

Do not take PHINMO:

• if you are allergic to fingolimod or any of the other ingredients of PHINMO listed in section 6.
• if you are pregnant or breastfeeding.
• if you are a woman of childbearing potential not using effective contraception.
• if, in the last 6 months, you have had a heart attack, angina, stroke or warning of a stroke or certain types of heart failure.
• if you have certain types of irregular or abnormal heartbeat (dysrhythmia), or your electrocardiogram (ECG) shows prolonged QT interval before starting PHINMO.
• if you are taking medicines for irregular heartbeat such as quinidine, procainamide, amiodarone or sotalol.

Warnings and precautions

Take special care with PHINMO: You will be observed hourly by a health care professional for at least 6 hours after taking the first dose of PHINMO so that your heart rate and blood pressure can be checked. You will be required to have an ECG (electrocardiogram) to check the health of your heart before you start PHINMO and a second ECG at the end of the 6 - hour observation. In case of abnormal ECG recording or slow heart rate at the end of the 6 - hour observation period, you may be observed overnight by a health care professional.

Do not share medicines prescribed for you with any other person. Always take PHINMO exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Do not exceed the recommended dose.

How much PHINMO to take

The dose is one capsule per day (0,5 mg of fingolimod).

How and when to take PHINMO

Take PHINMO once a day, with half a glass of water. PHINMO can be taken with or without food. Taking PHINMO at the same time each day will help you remember when to take your medicine.

How long to take PHINMO

Do not stop taking PHINMO or change your dose without talking with your doctor. If you have questions about how long to take PHINMO, talk to your doctor or your pharmacist.

PHINMO can have side effects. Not all side effects reported for PHINMO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving PHINMO, please consult your health care provider for advice.

If any of the following happens, stop taking PHINMO and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing;
• rash or itching;
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to PHINMO. You may need urgent medical attention or hospitalisation.

Store at or below 25 ºC, protect from moisture.

PHINMO 0,5 mg capsules must always be stored in the blister to protect from moisture and only be removed immediately before use. The blisters should be kept in the carton until required for use.

Store all medicines out of reach of children.

Do not use PHINMO after the expiry date which is stated on the label and carton.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).