PACKAGE LEAFLET: INFORMATION FOR THE USER Modvigil 200 mg tablets Modafinil

Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. 2. 3. 4. 5.

What Modvigil is and what it is used for Before you take Modvigil How to take Modvigil Possible side effects How to store Modvigil

1. WHAT Modvigil IS AND WHAT IT IS USED FOR

Therapeutic class: centrally acting sympathomimetic (psychostimulant). Modvigil is used in the treatment of narcolepsy (sudden and irresistible desire to sleep), with or without cataplexy (sudden loss of muscle tone).

2. BEFORE YOU TAKE Modvigil

Do not take Modvigil: if you are allergic (hypersensitive) to modafinil or any of the other ingredients of Modvigil (see Section 6), in cases of high blood pressure, in cases of cardiovascular disease, in cases of severe liver disease, in cases of severe kidney disease, when there is severe anxiety (except in the case of treatment in specialised facilities), in patients with a history of psychoses. Take special care with Modvigil The following describes when you may take Modvigil only with particular caution. Please ask your doctor about this. This also applies if these descriptions applied to you in the past. Initial prescription of this medicine is reserved to specialists in neurology or pulmonology and/or specialized neurology or pulmonology units and doctors practicing in sleep centres. It is necessary to detect and treat any anxiety that you may have before starting treatment. Your doctor will prescribe you a cardiovascular examination involving an electrocardiogram (ECG) in order to detect high blood pressure or other heart disorder (rhythm disorder, heart failure, coronary failure) that should be treated before considering treatment with modafinil. Regular cardiovascular monitoring should be performed during treatment.

Contraceptive minipills and micropills should not be used during treatment with this medicine, only normal-dose oral contraceptives (contraceptive pills) or other methods of contraception should be used. This also applies during at least one monthly cycle following the withdrawal of

Modvigil. Note for athletes Please be aware that this medicine contains modafinil, which is on the list of doping substances. Taking or using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken treatment with ciclosporin, mini/micro oral contraceptive (the pill), tricyclic antidepressants, medicines to the treatment of states of anxiety (diazepam), anticonvulsants (phenobarbital), alpha-adrenergic blockers (prazosin), beta blockers (propranolol) and calcium channel blockers, medicines for lowering cholesterol (statins), medicine to stop blood from clotting (warfarin). Please tell your doctor or pharmacist if you are taking or have recently taken any ot her medicines, including medicines obtained without a prescription. Taking Modvigil with food and drink You may take Modvigil with food and drink. Pregnancy and breast-feeding Pregnancy Since no adequate experience concerning the use of Modvigil in pregnancy is available, Modvigil should not be taken during pregnancy. Breast-feeding Modvigil should not be used during lactation. Ask the advice of your doctor or pharmacist before taking any medicine. Driving and using machines Modafinil can cause blurred vision or dizziness, that could affect the ability to drive and use machines (see section 4. Possible side effects). Important information about some of the ingredients of Modvigil: This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE Modvigil

Always take Modvigil exactly as your doctor has told you. Adults Posology The usual dose is 1 to 2 tablets (200-400 mg) per day. Method of administration Oral use. Tablets should be swallowed whole, with fluid, with or without food. Frequency of administration Take the tablets preferably only once in the morning or in two doses, one in the morning and one at noon. Duration of treatment Your doctor must always decide on the duration of the treatment based on the relevant course of illness. In general, Modvigil is intended for long-term treatment. The necessity of a continuation of treatment should be reviewed by your doctor. Reduced kidney and liver function

In patients with severely impaired liver or kidney function, the daily dose should be halved (100 mg 200 mg daily). Elderly In elderly patients, the elimination of Modvigil may be decreased. A reduction in the daily dose may thus be required. Children and adolescents Modvigil is not recommended for children and adolescents. If you take more Modvigil than you should: Contact your doctor. If you forget to take Modvigil Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, modvigill can cause side effects, although not everybody gets them. Very common: affects more than 1 user in 10: Headaches Common: affects 1 to 10 users in 100: Nervousness, depression, thought disorders, confusion, anxiety Sleep disturbances, sleepiness Blurred vision, dizziness Itching, rashes Dry mouth, weakness Stomachaches, indigestions / heartburn, nausea, diarrhoea, blockage Reduced appetite, loss of appetite Pains in the chest, fast heart frequency, palpitations Abnormal liver function values Uncommon: affects 1 to 10 users in 1,000: Light allergic reactions (e.g., symptoms of hay fever), running and itching nose Nosebleeds, sinusitis Perspiration, eruption, acne, itching Pharyngitis, ulcers in the mouth, inflammations of the tongue(sole), changes of the t aste Difficulty in swallowing in connection with earaches and swollen glands Migraine, eye defects, dry eyes Shortness of breath, reinforced cough, asthma Raised blood pressure, ECG modifications, irregularities in the rhythm and slow heartbeat, reduction in blood pressure Bleeder with fever and shivering. Reflux (liquid from the stomach penetrates into the gullet), vomiting High cholesterol levels, high blood sugar levels, diabetes Increased appetite, raised thirst Weight changes, swellings of the extremities Back pains, neck pains, muscle pains, muscle weakness with fast tiredness of the musculature, abnormal muscle movements, convulsions, joint pains, cramps in the legs Instinctive body movements, coordination disturbances Trembling, deafness, dizziness Reduced sensitivity of the body on stimulation by e.g. light, touch or pain Speech disorders Loss of memory, hyperactivity Excitement, mood fluctuations, hostile behavior, aggressive reactions, a feeling of unreality, personality disturbances Sleep disturbances, nightmares Reduced sexual interest, menstruation disturbances Urine changes, modifications in the frequency of urination Very rare: affects less than 1 user in 10,000:

Instinctive movements of the mouth or face musculature Some skin reactions have also been reported, including itching as well as rare cases of urticaria with possibility of angioedema (sudden swelling of the face and neck due to allergic reaction). If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE Modvigil

Keep out of the reach and sight of children. Do not use Modvigil after the expiry date which is stated on the carton and on the blister. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.