Modafinil 200 Mg Tablets
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Read all of this leaflet carefully before you start taking this medicine because it contains important information for you:
• Keep this leaflet. You may need to read it again.
• If you have any further questions, askyour doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talkto your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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. How to take Modafinil Tablets.
4. Possible side effects.
5. How to 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 thatyou can improve your condition and your doctor will advise you.
2. WHAT YOU NEEDTO KNOW BEFOREYOU TAKE MODAFINILTABLETS
Do not take Modafinil Tablets if you:
• are allergic (hypersensitive) to modafinil or to any of the other ingredients of this medicine (listed in section 6)
• have an irregular heartbeat
• have uncontrolled, moderate to severe high blood pressure (hypertension).
Warnings and precautions
Talk to your doctor or pharmacist before taking Modafinil Tablets, if you:
• have any heart problems or high blood pressure. Your doctor will need to check these regularly while you are taking Modafinil Tablets
• 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 Modafinil Tablets 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 and adolescents
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 thatyou 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 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 a prescription. Modafinil Tablets and certain other medicines can affect each other and your doctor may need to adjust the doses thatyou are taking. It is especially important if you are taking any of the following medicines as well as Modafinil Tablets:
• hormonal contraceptives (including the contraceptive pills, implants, intrauterine devices (IUDs) 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.
• 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)
• medicines for 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 (orthinkthatyou may be), are planning to become pregnant, or are breastfeeding, you should not take Modafinil Tablets.
It is not known if your medicine may harm your unborn baby.
Talkto your doctor about the birth control methods that will be right foryou 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 monohydrate.
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE MODAFINILTABLETS
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Adults
The recommended 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 recommended dose is 100 mg a day.
Your doctor will only increase your dose (up to the maximum 400 mg a day) provided thatyou do not have any liver or kidney problems.
Adults with severe kidney and liver problems
The recommended dose is 100 mg a day.
Your doctor will review your treatment regularly to check that it is right foryou.
Method of administration:
• Tablets should be swallowed with water.
• The tablet can be divided into equal doses.
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 medicine,askyour 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 you have any of the following side effects:
• 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:
* 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 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: may affect more than 1 in 10 people:
• headache.
Common: 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).
Uncommon: 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, extra 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 you get any of these side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.
5. HOW TO STORE MODAFINIL TABLETS
Keep out of sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the foil 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.
Do not throw away any medicines via wastewater or household waste. Askyour pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Modafinil Tablets contain:
The active substance is modafinil. Each tablet contains 200 mg modafinil.
The other ingredients are: crospovidone (Type A); crospovidone (Type B); maize starch, pregelatinised; cellulose, microcrystalline; povidone K-90; povidone K-30; lactose monohydrate; silica, colloidal anhydrous; talc; magnesium stearate.
What Modafinil Tablets look like and contents of the pack
Modafinil Tablets are 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.
Modafinil 200 mg Tablets are available in blister packs of 10 and 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, U.K.
Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
This leaflet was last revised in March 2013
M.L. No.TN00002222
948026275
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