100 mg tablets
modafinil
What Modafinil Orifarm is and what it is used for
The active substance in the tablet is modafinil.
Modafinil can be taken by adults suffering from narcolepsy to help them stay awake. Narcolepsy is a condition that causes pronounced drowsiness during the day and a tendency to suddenly fall asleep in inappropriate situations (sleep attacks). Modafinil may improve narcolepsy and reduce the likelihood of having a sleep attack. There may also be other ways to improve your condition, your doctor may give you advice.
Modafinil contained in Modafinil Orifarm may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you take Modafinil Orifarm
Do not take Modafinil Orifarm if you:
- is allergic to modafinil or any of the other ingredients of this medicine (listed in section 6)
- have irregular heartbeats
- have uncontrolled, moderate to very high blood pressure ( hypertension ).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Modafinil Orifarm if you:
- have heart problems or high blood pressure . Your doctor will need to check this regularly while you are taking Modafinil Orifarm
- have ever had depression, depression, anxiety, psychosis (lost sense of humor) or mania (excessive arousal or extreme happiness) or bipolar disorder as Modafinil Orifarm may make these conditions worse
- have kidney or liver problems (because you need to take a lower dose )
- have previously had alcohol or drug problems .
Other things you should tell your doctor or pharmacist
- Some people have reported that they have thoughts of suicide or aggressive thoughts and actions when taking this drug. Tell your doctor immediately if you notice that you are depressed , feel aggressive or hostile towards other people or if you have suicidal thoughts or other changes in your behavior (see section 4). You may want to ask someone in your family or close friend to help you be observant of signs of depression or other changes in your behavior.
- This drug can make you addicted to it after long-term treatment. If you need to take it for a long time, your doctor will regularly check that it is still the best medicine for you.
Children
Children under 18 years of age should not take this medicine.
Other medicines and Modafinil Orifarm
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 Orifarm and some other medicines may affect each other and your doctor may need to adjust the dose you take. This is especially important if you are taking any of the following medicines with medicines containing modafinil:
- hormonal contraceptives ( birth control pills , birth control pills, IUDs and birth control patches ). You need to consider other methods of contraception while you are taking Modafinil Orifarm and for at least two months after stopping treatment, as Modafinil Orifarm reduces the effectiveness of hormonal contraceptives.
- omeprazole (for acid reflux, stomach upset and stomach ulcers )
- antiviral drugs used to treat HIV infections ( protease inhibitors , eg indinavir or ritonavir)
- ciclosporin (for transplant rejection or for arthritis or psoriasis )
- antiepileptic medicines ( eg carbamazepine, phenobarbital or phenytoin )
- antidepressants (eg amitriptyline, citalopram or fluoxetine ) or anxiety (eg diazepam )
- blood-thinning medications (eg warfarin ). Your doctor will check the blood’s ability to clot during treatment.
- calcium channel blockers or beta- blockers for high blood pressure or heart problems (eg amlodipine, verapamil or propranolol)
- drugs that lower cholesterol so-called statins (eg atorvastatin or simvastatin ).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You should not take Modafinil Orifarm if you are pregnant.
Modafinil is suspected to cause malformations if taken during pregnancy.
Talk to your doctor about which contraceptives may be suitable for you while you are taking Modafinil Orifarm (and for two months after stopping treatment) or if you have any other questions.
Breast-feeding
You should not take Modafinil Orifarm if you are breastfeeding.
Driving and using machines
Modafinil Orifarm may cause blurred vision or dizziness in up to 1 in 10 people. Do not drive or use any tools or machines if you are affected or still feel very sleepy while using this medicine.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Modafinil Orifarm contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Modafinil Orifarm
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The tablets should be swallowed whole with water.
The recommended dose is:
Adults
The usual dose is 200 mg daily. One dose can be taken once a day (in the morning) or divided into two doses (100 mg in the morning and 100 mg in the middle of the day).
Your doctor may in some cases increase the dose to one up to 400 mg daily.
Elderly patients (over 65 years)
The usual dose is 100 mg daily. One dose can be taken once a day (in the morning) or divided into two doses (50 mg in the morning and 50 mg in the middle of the day).
Your doctor will increase the dose one (up to a maximum of 400 mg daily) provided you have no liver or kidney problems.
Adults with severe kidney or liver problems
The usual dose is 100 mg a day.
Your doctor will regularly check your treatment to see if it is right for you.
If you take more Modafinil Orifarm than you should
If you take too many tablets, you may feel sick, anxious, disoriented, confused, agitated, anxious, or elated. You may also have difficulty sleeping, diarrhea, hallucinations (experiencing things that are not real), chest pain, altered heart rate, or increased blood pressure.
If you forget to take Modafinil Orifarm
If you forget to take your medicine, take the next dose as usual. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine and contact your doctor immediately
- you suddenly have difficulty breathing or have wheezing or your face, mouth or throat begin to swell
- you get a rash or itching (especially if it affects the whole body). Severe rash can cause blistering or flaky skin, sores in the mouth, eyes, nose or genitals. You may also have a high body temperature (fever) and abnormal blood levels
- you feel any change in your mental health and well-being. The characters can be:
- mood swings or abnormal thoughtsaggression or hostilityforgetfulness or confusion
- extreme feeling of happiness
- arousal or hyperactivity
- anxiety or nervousness
- depression, suicidal ideation or suicidal ideation
- restlessness, anxiety or psychosis (loss of contact with reality that can lead to delusions or to experience things that are not real), feeling of loneliness and numbness or personality disorder
Other side effects include:
Very common side effects (may affect more than 1 user in 10):
- headache
Common side effects (may affect up to 1 in 10 people):
- dizziness
- drowsiness, extreme fatigue or difficulty sleeping (insomnia)
- senses the heartbeat which can be faster than normal
- chest pain
- hemorrhage
- dry mouth
- loss of appetite, nausea, stomach pain, indigestion, diarrhea or constipation
- weakness
- numbness or tingling in the hands or feet (“ant crawls”)
- dimsyn
- abnormal blood counts that show how your liver is working (elevated liver enzymes)
- irritability
Uncommon side effects (may affect up to 1 in 100 people):
- back pain, neck pain, muscle aches, muscle weakness, leg cramps, joint pain, twitching or shaking
- vertigo (fraud)
- difficulty moving muscles smoothly or other movement problems, muscle tension, coordination problems
- hay fever symptoms with 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 ECG , and irregular or unusually slow heartbeat
- difficulty swallowing, swollen tongue or sores in the mouth
- severe flatulence, reflux (reflux of fluid from the stomach), increased appetite, weight changes, thirst or taste changes
- nausea (vomiting)
- migraine
- speech problems
- diabetes with high blood sugar
- elevated cholesterol
- swollen hands and feet
- disturbed sleep or abnormal dreams
- loss of sexual drive
- nosebleeds, sore throat or inflamed nasal mucosa ( sinusitis )
- abnormal vision or dry eyes
- abnormal urine or more frequent urination
- abnormal mens
- abnormal blood counts showing that the number of white blood cells has changed
- restlessness with increased body movement.
How to store Modafinil Orifarm
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the outer carton after EXP. The expiration date is the last day of the specified month.
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.
Contents of the package and other information
Content declaration
- The active substance is modafinil 100 mg.
- The other ingredients are: Crospovidone (polyplasdone XL-10), pregelatinized starch ( starch 1500), microcrystalline cellulose, povidone K90, povidone K30, lactose monohydrate , anhydrous colloidal silica, talc, magnesium stearate.
What the medicine looks like and contents of the pack
White or almost white, capsule-shaped tablet with “M” debossed on one side and “100 mg” on the other side.
Pack sizes:
Blister: 20, 21, 28, 30, 49, 50, 90, 91, 98, 100 tablets
Perforated unit dose blisters: 28 × 1, 30 × 1, 90 x 1, 98 × 1, 100 × 1 tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Orifarm Generics A / S
Energizer 15
5260 Odense S
Denmark
Local representative
Orifarm Generics AB
Box 56048
102 17 Stockholm
info@orifarm.com