Domilo 0,5 mg Capsules

Domilo contains the active substance fingolimod. Fingolimod is a selective immunosuppressant and is used in adults to treat relapsing multiple sclerosis (MS) characterised by repeated attacks (relapses) of nervous system symptoms that reflect inflammation within the central nervous system.

Domilo does not cure MS, but it helps to reduce the number of relapses and to slow down the progression of physical disabilities due to MS.

Do not take Domilo:

• if you are hypersensitive (allergic) to fingolimod or any of the other ingredients of Domilo (listed in section 6).
• if you are taking or have recently taken medicine for irregular heartbeat such as quinidine, disopyramide, amiodarone or sotalol.
• if you are pregnant or breastfeeding your baby.
• if you have a lowered immune response (due to an immunodeficiency syndrome, a disease or due to medicines that suppress the immune system).
• if you have a severe active infection or active chronic infection such as hepatitis or tuberculosis.
• if you have an active cancer.
• if, in the last 6 months, you have had heart attack, angina, stroke or warning of a stroke or certain types of heart failure.

Warnings and precautions

Take special care with Domilo: Tell your doctor before you start taking Domilo:

• if you have been told you have an abnormal electrocardiogram.
• if you suffer from symptoms of slow heart rate (e.g. dizziness, nausea, or palpitations).
• if you have a history of sudden loss of consciousness or fainting (syncope).
• if you have severe breathing problems during sleep (severe sleep apnoea).
• if you are taking or have recently taken medicines that slow your heart rate (such as beta blockers, verapamil, diltiazem or ivabradine, digoxin, anticholinesteratic medicines or pilocarpine).
• if you plan to get vaccinated.
• if you have never had chickenpox.
• 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 (a condition known as macular oedema, see below), inflammation or infection of the eye (uveitis), or if you have diabetes (which can cause eye problems).
• if you have liver problems.
• if you have high blood pressure that cannot be controlled by medicines.
• if you have severe lung problems.

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

The usual dose of Domilo is: one 0,5 mg capsule once a day by mouth. Do not exceed the recommended dose. Take Domilo once a day with a glass of water. Domilo capsules should always be swallowed intact, without opening them. Domilo can be taken with or without food.

Taking Domilo at the same time each day will help you remember when to take your medicine. Your doctor will tell you how long your treatment with Domilo will last. If you have the impression that the effect of Domilo is too strong or too weak, tell your doctor or pharmacist.

If you take more Domilo than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take Domilo Do not take a double dose to make up for forgotten individual doses.

If you stop taking Domilo Do not stop taking Domilo or change your dose without talking to your doctor first. Domilo will stay in your body for up to 2 months after you stop taking it. Your white blood cell count (lymphocyte count) may also remain low during this time and the side effects described in this leaflet may still occur. After stopping Domilo you may have to wait for 6-8 weeks before starting a new MS treatment. If you have to restart Domilo more than 2 weeks after you stop taking it, the effect on heart rate normally seen when treatment is first started may re-occur and you will need to be monitored at the doctor’s surgery or clinic for re-initiation of treatment. Do not restart Domilo after stopping it for more than two weeks without seeking advice from your doctor.

Your doctor will decide whether and how you need to be monitored after stopping Domilo. Tell your doctor straight away if you think your MS is getting worse after you have stopped treatment with Domilo. This could be serious.

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

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

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

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

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Herpes virus infection (shingles or herpes zoster) with symptoms such as blisters, burning, itching or pain of the skin, typically on the upper body or the face. Other symptoms may be fever and weakness in the early stages of infection, followed by numbness, itching or red patches with severe pain
• a type of skin cancer called basal cell carcinoma (BCC) which often appears as a pearly nodule, although it can also take other forms
• depression and anxiety are known to occur with increased frequency in the MS population and have also been reported in paediatric patients treated with Domilo
• slow heartbeat (bradycardia), irregular heart rhythm

Less frequent

• pneumonia with symptoms such as fever, cough, difficulty breathing
• malignant melanoma (a type of skin cancer which usually develops from an unusual mole). Possible signs of melanoma include moles which may change size, shape, elevation or colour over time, or new moles. The moles may itch, bleed or ulcerate
• lymphoma (a type of cancer that affects the lymph system)
• squamous cell carcinoma: a type of skin cancer which may present as a firm red nodule, a sore with crust, or a new sore on an existing scar
• tumour related to infection with human herpes virus (Kaposi’s sarcoma)
• reduction in blood platelets which increases risk of bleeding or bruising
• convulsion, fits (more frequent in children and adolescents than in adults)
• a condition called posterior reversible encephalopathy syndrome (PRES). Symptoms may include sudden onset of severe headache, confusion, seizures and/or vision disturbances
• macular oedema (swelling in the central vision area of the retina at the back of the eye) with symptoms such as shadows or blind spot in the centre of the vision, blurred vision, problems seeing colours or details
• electrocardiogram anomaly (T-wave inversion)

Unknown frequency

• risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). The symptoms of PML may be similar to an MS relapse. Symptoms might also arise that you might not become aware of by yourself, such as changes in mood or behaviour, memory lapses, speech and communication difficulties, which your doctor may need to investigate further to rule out PML. Therefore, if you believe your MS is getting worse or if you or those close to you notice any new or unusual symptoms, it is very important that you speak to your doctor as soon as possible
• cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache accompanied by stiff neck, sensitivity to light, nausea, and/or confusion
• merkel cell carcinoma (a type of skin cancer). Possible signs of Merkel cell carcinoma include flesh-coloured or bluish-red, painless nodule, often on the face, head or neck. Merkel cell carcinoma can also present as a firm painless nodule or mass. Long-term exposure to the sun and a weak immune system can affect the risk of developing Merkel cell carcinoma

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent infection from flu virus with symptoms such as tiredness, chills, sore throat, aching in the joints or muscles, fever
• feeling of pressure or pain in the cheeks and forehead (sinusitis)
• ringworm, a fungal infection of the skin (tinea versicolor)
• low level of white blood cells (lymphocytes, leucocytes)
• headache, migraine
• blurred vision
• high blood pressure
• cough, breathlessness
• diarrhoea
• itchy, red, burning rash (eczema)
• hair loss
• back pain
• muscle pain
• joint pain
• weakness
• increased blood fat (triglycerides) level
• increased liver enzymes showing in blood tests
• weight loss

Less frequent

• depressed mood
• nausea
• low level of certain white blood cells (neutrophils)

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of Domilo.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

Store at or below 25 °C. Keep the capsule in the blister in the outer carton until required for use. Do not use after the expiry date stated on the label / carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).