Modafinil 100mg Tablets
Package leaflet: Information for the user
Modafinil 100mg tablets
Modafinil
Read all of this leaflet carefully before you start taking this medicine because it contains important information foryou.
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pharmacist.
not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
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pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Modafinil Tablets are and what they are used for
2. What you need to know before you take Modafinil Tablets
3. Howto take Modafinil Tablets
4. Possible side effects
5. Howto store Modafinil Tablets
6. Contents of the pack and other information
1. What Modafinil Tablets are and what they are used for
The active ingredient in the tablets is modafinil.
Modafinil Tablets 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 Tablets 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. What you need to know before you take Modafinil Tablets
Do nottake Modafinil Tablets ifyou:
ingredients of this medicine (listed in section 6).
pressure (hypertension).
Warnings and precautions
Take special care with Modafinil Tablets ifyou:
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Your doctor will need to check these regularly while you are taking Modafinil Tablets.
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psychosis (loss of contact with reality) or mania (over-excitement or feeling of extreme happiness) or bipolar disorder because Modafinil Tablets may make your condition worse.
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need to take a lower dose).
Children aged less than 18 years should nottake this medicine.
Other things to talk to your doctor or pharmacist about •
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.
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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 foryou.
Other medicines and Modafinil Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without prescription. Modafinil Tablets 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 Tablets:
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pill, implants, intrauterine devices (lUDs) and patches). You will need to consider other birth control methods while taking Modafinil Tablets, and for two months after stopping treatment, because Modafinil Tablets reduces their effectiveness.
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inhibitors e.g. indinavir or ritonavir).
rejection, or for arthritis or psoriasis).
phenobarbital or phenytoin).
citalopram orfluoxetine) oranxiety (e.g. diazepam).
doctor will monitor your blood clotting times during treatment.
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blood pressure or heart problems (e.g. amlodipine, verapamil or propranolol).
atorvastatin orsimvastatin).
Pregnancy and breast-feeding
If you are pregnant or brest-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 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 Tablets (and for two months after stopping) or if you have any other concerns.
Driving and using machines
Modafinil Tablets 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.
Modafinil Tablets contain lactose
These tablets contain lactose. If your doctor has told you that you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
3. Howto take Modafinil Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist ifyou are not sure.
Modafinil 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 liveror 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 Tablets 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 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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects although not everybody gets them.
Stop taking this medicine and tell your doctor straight away if:
yourface, mouth orthroat begins to swell.
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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.
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wellbeing. The signs may include:
. mood swings or abnormal thinking,
. 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 ofcontactwith 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):
Common side effects (may affect up to 1 in 10 people):
(insomnia), than normal.
indigestion, diarrhoea or constipation, needles').
working (increased liverenzymes).
Uncommon side effects (may affect up to 1 in 100 people):
leg cramps, joint pain, twitching or tremor.
movement problems, muscle tension, coordination problems.
watery eyes.
• Skin rash, acne or itchy skin.
• Sweating.
• Changes in blood pressure (high or low), abnormal heart trace (ECG), and irregular or unusually slow heartbeat.
• 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 ordry 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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.aov.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. Howto store Modafinil Tablets
Keep this medicine out of the sight and reach of children. Store below 30oC.
Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of the month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Modafinil Tablets contain:
• 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 look 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.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer 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 last revised in 11/2015.