MODAFINIL 200 MG TABLETS

Active substance: MODAFINIL

View full screen / Print PDF » Download PDF ⇩

Transcript
158 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

MODAFINIL 200 mg
TABLETS
(modafinil)

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, ask your
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, talk to 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.

2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE MODAFINIL TABLETS
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 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.

Pregnancy and breast-feeding
If you are pregnant (or think that you 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.
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 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 MODAFINIL TABLETS
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 that you 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 for you.
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, 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 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. Ask your 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
10004793

350 mm

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.

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 that you 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).

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)