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Document: leaflet MAH GENERIC_PL 22805-0029 change

• leaflet MAH GENERIC_PL 22805-0029
• leaflet MAH GENERIC_PL 30684-0221

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Modafinil 200 mg Tablets

Modafinil

In this leaflet:

1.    What Modafinil is and what it is used for

2.    Before you take Modafinil

3.    How to take Modafinil

4.    Possible side effects

5.    How to store Modafinil

6.    Further information

1. WHAT MODAFINIL IS AND WHAT IT IS USED FOR

The active ingredient in the tablets is modafinil.

Modafinil can be taken by adults who suffer from narcolepsy to help them to stay awake. Narcolepsy is a condition that causes excessive daytime sleepiness and a tendency to fall asleep suddenly in inappropriate situations (sleep attacks). Modafinil may improve your narcolepsy and reduce the likelihood that you will have sleep attacks but there may still be otherways thatyou can improve yourcondition and your doctorwill advise you.

2. BEFORE YOU TAKE MODAFINIL

Do not take Modafinil if you

•    are allergic (hypersensitive) to modafinil or to any of the other ingredients of Modafinil (see section 6 ‘What Modafinil contains').

•    Have an irregular heartbeat.

•    Have uncontrolled, moderate to severe high blood pressure (hypertension).

Take special care with Modafinil if you

•    Have any heart problems or high blood pressure. Your doctor will need to check these regularly while you are taking Modafinil.

•    Have ever had depression, low mood, anxiety, psychosis (loss of contact with reality) or mania (overexcitement or feeling of extreme happiness) or bipolar disorder because Modafinil may make your condition worse.

•    Have kidney or liver problems (because you will need to take a lower dose).

•    Have had alcohol or drug problems in the past.

Children aged less than 18 years should not take this medicine.

Other things to talk to your doctor or pharmacist about

•    Some people have reported having suicidal or aggressive thoughts or behaviour while taking this medicine. Tell your doctor straight away if you notice that you are becoming depressed, feel aggressive or hostile towards other people or have suicidal thoughts or other changes in your behaviour (see section 4). You may want to consider asking a family memberor close friend to helpyou look outfor signs ofdepression or other changes in your behaviour.

•    This medicine has the potential for you to become reliant (dependent) on it after long-term use. If you need to take it for a long time your doctor will check regularly that it is still the best medicine for you.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Modafinil and certain other medicines can affect each other and your doctor may need to adjust the doses that you are taking. It is especially important if you are taking any of the following medicines as well as Modafinil:

•    Hormonal contraceptives (including the contraceptive pills, implants, intrauterine devices (IUDs) and patches). You will need to consider other birth control methods while taking Modafinil, and for two months after stopping treatment, because Modafinil reduces their effectiveness.

•    Omeprazole (for acid reflux, indigestion or ulcers).

•    Antiviral medicines to treat HIV infection (protease inhibitors e.g. indinavir or ritonavir).

•    Ciclosporin (used to prevent organ transplant rejection, or for arthritis or psoriasis).

•    Medicines for epilepsy (e.g. carbamazepine, phenobarbital or phenytoin).

•    Medicines for depression (e.g. amitriptyline, citalopram or fluoxetine) or anxiety (e.g. diazepam).

•    Medicines for thinning the blood (e.g. warfarin). Your doctor will monitor your blood clotting times during treatment.

•    Calcium channel blockers or beta-blockers for high blood pressure or heart problems (e.g. amlodipine, verapamil or propranalol).

•    Statin medicines for lowering cholesterol (e.g. atorvastatin or simvastatin).

Pregnancy and breast-feeding

If you are pregnant (or think that you may be), are planning to become pregnant, or are breast feeding, you should not take Modafinil. It is not known if your medicine may harm your unborn baby.

Talk to your doctor about the birth control methods that will be right for you while you are taking Modafinil (and for two months after stopping) or if you have any other concerns.

Driving and using machines

Modafinil can cause blurred vision or dizziness in up to 1 in 10 people. If you are affected or you find that while using this medication you still feel very sleepy, do not attempt to drive or operate machinery.

Important information about some of the ingredients of this product:

This medicinal product contains lactose.

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE MODAFINIL

Always take Modafinil exactly as your doctor has told you.You should check with your doctor or pharmacist if you are not sure.

Tablets should be swallowed with water.

Adults

The usual dose is 200 mg a day. This can be taken once daily (in the morning) or divided into two doses a day (100 mg in the morning and 100 mg at midday).

Your doctor in some cases may decide to increase your daily dose up to 400 mg.

Elderly patients (over 65 years of age)

The usual dose is 100 mg a day. This can be taken once daily (in the morning) or divided into two doses a day (50 mg in the morning and 50 mg at midday).

Your doctor will only increase your dose (up to the maximum 400 mg a day) provided that you do not have any liver or kidney problems.

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 it is right for you.

If you take more Modafinil 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

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 medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Modafinil 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:

o mood swings or abnormal thinking, o aggression or hostility, o forgetfulness or confusion, o feeling of extreme happiness, o over-excitement or hyperactivity, o anxiety or nervousness, o depression, suicidal thoughts or behaviour,

o agitation or psychosis (a loss of contact with reality which may include delusions or sensing 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 your white blood cells have changed

If any of these side effects become troublesome or you experience any side effects not listed, please tell your doctor, pharmacist or nurse.

5. HOW TO STORE MODAFINIL

Keep out of reach and sight of children.

Do not use Modafinil after the expiry date, which is stated on the label and the carton after EXP 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.

6. FURTHER INFORMATION

What Modafinil contains:

The active substance is Modafinil.

Each tablet contains 200 mg modafinil

The other ingredients are: Crospovidone (Type A), Crospovidone (Type B), Starch (maize) Pregelatinised, Cellulose Microcrystalline, Povidone K-90, Povidone K-30, Lactose Monohydrate, Silica colloidal anhydrous, Talc, Magnesium Stearate.

What Modafinil looks like and contents of the pack

Modafinil is white to off white coloured capsule shaped tablets debossed with “M” on one side and “200 MG” on the other side with a breakline between 200 and MG.

The tablet can be divided into equal halves.

Packed in blister pack of 10 or 30

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Orchid Europe Ltd

Building 3, Chiswick Park

566, Chiswick High Road, Chiswick,

London, W4 5YA, United Kingdom

This medicinal product is authorised in the Member States of the EEA under the following names:

Modafenil Orchid Europe Ltd 200 mg Tabletten Modafenil Orchid Europe Ltd 200 mg Comprimes Modafenil Orchid Europe Ltd 200 mg Tabletten Modafinil Orchid Europe Modafinil Orchid 200 mg Tabletti Modafinil Orchid 200 mg Tabletter Modafinil Orchid Europe Ltd 200 mg Comprimes Modafinil Orchid Europe Ltd 200 mg Tabletten Modafinil 200 mg Tablets

Modafinil Orchid Europe Ltd 200 mg Compresse Modafinil Orchid 200 mg Tabletten Modafinil Orchid Europe Ltd Modafinilo Orchid 200 mg Comprimidos Modafinil Orchid Europe Ltd 200 mg Tabletter Modafinil 200 mg Tablets

This leaflet was last approved in 07/2010.

M.L.No. TN00002222 XXXXXXXXX