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Modafinil 100mg Tablets

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Adults with severe kidney and liver problems The usual dose is 100 mg a day.

Your doctor will review your treatment regularly to check that itisrightforyou.

If you take more Modafinil Tablets than you should:

If you take too many tablets you may feel sick, restless, disorientated, confused or excited. You may also have difficulty sleeping, diarrhoea, hallucinations (sensing things that are not real), chest pain, a change in the speed of your heart beat or an increase in blood pressure Contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. Take this leaflet and any remaining tablets with you.

If you forget to take Modafinil Tablets:

If you forget to take your medicine take the next dose at - the usual time, do not take a double dose to make up for [ the forgotten one.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Modafinil Tablets can cause side effects although not everybody gets them.

Stop taking this medicine and tell your doctor straight away if:

•    You have sudden difficulty breathing or wheeziness or your face, mouth or throat begins to swell.

•    You notice a skin rash or itching (especially if it affects your whole body). Severe rashes may cause blistering or peeling of the skin, ulcers in your mouth, eyes, nose or genitals. You may also have a high temperature (fever) and abnormal blood test results.

•    You feel any change in your mental health and wellbeing. The signs may include:

. moodswingsorabnormalthinking,

. aggression or hostility,

. forgetfulness or confusion,

. feeling of extreme happiness,

.    over-excitement or hyperactivity,

.    anxiety or nervousness,

. depression, suicidal thoughts or behaviour,

.    agitation or psychosis (a loss of contact with reality

which may include delusions orsensing things that are not real), feeling detached or numb, or personality disorder.

Other side effects include the following:

Very common side effects (affecting more than 1 in 10 people):

•    Headache.

Common side effects (affecting fewer than 1 in 10 people):

•    Dizziness.

•    Sleepiness, extreme tiredness or difficulty sleeping (insomnia).

•    Awareness of your heart beat, which may be faster than normal.

•    Chest pain

•    Flushing.

•    Dry mouth.

•    Loss of appetite, feeling sick, stomach pain, indigestion, diarrhoea or constipation.

•    Weakness.

•    Numbness or tingling of the hands or feet ('pins and needles').

•    Blurred vision.

•    Abnormal blood test results showing how your liver is working (increased liver enzymes).

Uncommon side effects (affecting fewer than 1 in 100 people):

•    Back pain, neck pain, muscle pain, muscle weakness, leg cramps, joint pain, twitching or tremor.

•    Vertigo (spinning sensation).

•    Difficulty moving muscles smoothly or other movement problems, muscle tension, coordination

•    problems.

•    Hayfever symptoms including itchy/runny nose or watery eyes.

•    Increased cough, asthma or shortness of breath.

•    Skin rash, acne or itchy skin.

•    Sweating.

•    Changes in blood pressure (high or low), abnormal heart trace (ECG), and irregular or unusually

•    slow heart beat.

•    Difficulty swallowing, swollen tongue or mouth ulcers.

•    Excess wind, reflux (bringing back fluid from the stomach), increased appetite, weight changes, thirst or taste alteration.

•    Being sick (vomiting)

•    Migraine.

•    Speech problems.

•    Diabetes with increased blood sugar.

•    High blood cholesterol.

•    Swollen hands and feet.

•    Disrupted sleep or abnormal dreams,

•    Loss of sex drive.

•    Nose bleed, sore throat or inflamed nasal passages (sinusitis).

•    Abnormal vision or dry eyes.

•    Abnormal urine or more frequent urination.

•    Abnormal periods.

•    Abnormal blood test results showing that the numbers of yourwhite blood cells have changed.

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 MODAFINIL TABLETS

Keep out of the reach and sight of children.

Store below 30°C

Do not use after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.

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.

6. FURTHER INFORMATION

What Modafinil Tablets contains:

• The active ingredient is modafinil. Each tablet contains modafinil 100 mg.

• The other ingredients (excipients) are: Lactose monohydrate, maize starch, croscarmellose sodium (E468), aluminium magnesium silicate, povidone K 90 (E1201), talc(E553b), magnesium stearate(E572).

What Modafinil Tablets looks like and the contents of the pack

Modafinil Tablet is a white, round, biconvex, tablet.

The tablets are packed in PVC/AL blisters; packs of 20, 30,60,90 tablets are available.

Marketing Authorisation Holder:

Morningside Healthcare Ltd 115 Narborough Road, Leicester LE30PA, U.K.

Manufacturer:

Medochemie Ltd.,

1-10 Constantinoupoleos,

3011 Limassol, Cyprus

This leaflet was approved in 02/2011

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