Modafinil 100mg Tablets
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PROVIGIL® 100mg TABLETS/MODAFINIL 100mg TABLETS
(Modafinil)
Patient Information Leaflet
This medicine is known as either of the above names but will be referred to as Provigil throughout this leaflet.
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 you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
In this leaflet:
1. What Provigil is and what it is used for
2. Before you take Provigil
3. How to take Provigil
4. Possible side effects
5. How to store Provigil
6. Further information
1. What Provigil 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 other ways that you can improve your condition and your doctor will advise you.
2. Before you take Provigil
Do not take Provigil if you:
• Are allergic (hypersensitive) to modafinil, or to any of the other ingredients of these tablets (see section 6 ‘What Provigil contains').
• Have an irregular heartbeat.
• Have uncontrolled, moderate to severe high blood pressure (hypertension).
Take special care with Provigil if you:
• Have any heart problems or high blood pressure. Your doctor will need to check these regularly while you are taking Provigil.
• Have ever had depression, low mood, anxiety, psychosis (loss of contact with reality) or mania (over-excitement or feeling of extreme happiness) or bipolar disorder because Provigil 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 member or close friend to help you look out for signs of depression 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 prescription. Provigil 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 Provigil:
• Hormonal contraceptives (including the contraceptive pill, implants, intrauterine devices (IUDs) and patches). You will need to consider other birth control methods while taking Provigil, and for two months after stopping treatment, because Provigil 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 betablockers 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 Provigil. 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 Provigil (and for two months after stopping) or if you have any other concerns.
Driving and using machines
Provigil 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 Provigil
Provigil contain 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 Provigil
Always take Provigil exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Tablets should be swallowed whole 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.
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 Provigil than you should
If you take too many tablets you may feel sick, restless, disorientated, confused agitated, anxious 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 Provigil
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, Provigil 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 (may affect more than 1 in 10 people):
• Headache.
Common side effects (may affect up to 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).
• Irritability.
Uncommon side effects (may affect up to 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.
• Restlessness with increased body movement.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Provigil
• There are no special storage instructions for Provigil 100mg tablets/Modafinil 100mg tablets.
• Do not use after the expiry date printed on the carton, label or blister strip after ‘EXP'. The expiry date refers to the last day of the month.
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.
• If the tablets become discoloured or show any other signs of deterioration, you should consult your doctor or pharmacist who will advise you what to do.
• 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
Your medicine is called Provigil 100mg tablets/Modafinil 100mg tablets.
It contains 100mg of the active ingredient modafinil in a white, capsule shaped tablet, marked '100' on one side and plain on the reverse.
Provigil 100mg tablets/Modafinil 100mg tablets also contain the following ingredients:
Lactose monohydrate, pregelatinised starch, microcrystalline cellulose, croscarmellose sodium, povidone and magnesium stearate.
Provigil 100mg tablets/Modafinil 100mg tablets are available as blister packs of 30, 60 and 90 tablets.
POM PL No: 6464/2412
This product is manufactured by Laboratoires Macors, Rue des Caillottes, ZI Plaines des Isles, 89000 Auxerre, France and procured from within the EU and repackaged by the Product Licence holder: Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 31.10.2013 Provigil is a registered trademark of Cephalon