100 mg, 200 mg tablets
Modafinil
What Modafinil Orion is and what it is used for
Modafinil Orion tablets contain the active substance modafinil.
This medicine is intended for adults suffering from narcolepsy to help them stay awake.
Narcolepsy is a condition that affects your sleep. It causes pronounced drowsiness during the day and sleeps attacks, where you can suddenly fall asleep without warning. This medicine can reduce your sleepiness during the day and the likelihood of having a sleep attack.
Modafinil contained in Modafinil Orion may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Modafinil Orion
Do not use Modafinil Orion
Do not take Modafinil Orion :
- if you are allergic to modafinil or any of the other ingredients of this medicine (listed in section 6).
- if you have irregular heartbeat.
- if you have uncontrolled, moderate to very high blood pressure ( hypertension ).
Warnings and cautions
Talk to your doctor or pharmacist before taking Modafinil Orion, if you have or have had:
- heart problems or high blood pressure . Your doctor will need to check this regularly while you are taking this medicine.
- depression, depression, anxiety, psychosis , mania or bipolar disorder . This medicine may make these conditions worse.
- kidney or liver problems. You may need to take a lower dose .
- alcohol or drug problem.
Other things you should tell your doctor or pharmacist
- Some people have reported having suicidal or aggressive thoughts and actions when taking this medicine. Tell your doctor immediately if you notice that you are depressed, feel aggressive towards other people, if you have suicidal thoughts or notice any other changes in your behavior. You may want to ask someone in your family or close friend to help you be observant of signs of depression, anxiety, or other changes in your behavior.
- Some people may become addicted to this drug during long-term treatment. If you need to take this medicine for a long time, your doctor will regularly check that it is still the best medicine for you.
Modafinil Orion 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.
Children and young people
This medicine should not be taken by children or adolescents under 18 years of age as it may not be safe.
Other medicines and Modafinil Orion
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This medicine may affect the way some other medicines work and your doctor may want to adjust your dose.
Talk to your doctor or pharmacist if you are taking or using any of the following:
- hormonal contraceptives including birth control pills , birth control pills, IUDs and birth control patches . This medicine may reduce the effectiveness of these contraceptives. You will need to use other methods of contraception while taking this medicine and for at least two months after stopping treatment.
- omeprazole (for acid reflux, stomach upset and stomach ulcers ).
- antiviral drugs used to treat HIV infection ( protease inhibitors , such as indinavir or ritonavir).
- cyclosporine (a medicine for the rejection of transplanted organs or for arthritis or psoriasis ).
- epilepsy drugs (such as carbamazepine, phenobarbital or phenytoin ).
- medicines for depression or anxiety (such as amitriptyline, citalopram , fluoxetine , diazepam or buspirone).
- medicines for high blood pressure or heart problems (such as amlodipine, verapamil or propranolol).
- cholesterol-lowering drugs (such as atorvastatin or simvastatin ).
- insomnia drugs (triazolam or midazolam).
- warfarin (blood thinner). Your doctor will check the blood’s ability to clot during treatment.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, do not take this medicine. Modafinil is suspected to cause malformations when used during pregnancy.
Talk to your doctor about the appropriate method of contraception while you are using this medicine and for two months after stopping treatment.
Driving and using machines
This medicine may cause blurred vision or dizziness. 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.
How to take Modafinil Orion
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Adults
The recommended 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.
In some cases, your doctor may increase your daily dose up to 400 mg.
Elderly (over 65 years)
The recommended dose is 100 mg daily.
Your doctor may increase the dose one, up to a maximum of 400 mg daily, if you have no liver or kidney problems.
Adults with severe kidney or liver problems
The recommended dose is 100 mg daily.
Your doctor will regularly check your dosage to see if it is right for you.
The 200 mg tablet can be divided into two equal doses.
If you take more Modafinil Orion than you should
If you take too many tablets, you may feel nauseous, restless, disoriented, confused, or agitated. You may also have difficulty sleeping, diarrhea, hallucinations, chest pain, altered heart rate, or increased blood pressure.
If you forget to take Modafinil Orion
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 or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Stop taking this medicine and contact your doctor or emergency department IMMEDIATELY if you have any of the following symptoms:
- Difficulty breathing or wheezing, swelling of your face, mouth or throat, you get a fever or rash. This may be a sign of a severe allergic reaction .
- Flaking skin and blistering of the skin, mouth, eyes or genitals and blisters filled with fever. This may be a sign of a serious skin reaction.
- Chest pain, palpitations or increased heart rate .
- Exacerbation of depression, anxiety or psychosis , mood swings, confusion, suicidal thoughts or suicide attempts, extreme happiness or crying, feelings of loneliness and numbness, aggression or hostility.
Other side effects are
The following side effects may also occur:
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
- difficulty sleeping
- hemorrhage
- dry mouth
- magont
- loss of appetite
- nausea
- indigestion
- constipation
- diarrhea
- weakness
- numbness or tingling in the hands or feet (“ant crawls”)
- dimsyn
- nervousness, irritability
- abnormal blood counts showing elevated liver enzymes
Uncommon side effects (may affect up to 1 in 100 people):
- back, neck, muscle or joint pain, muscle weakness, leg cramps
- restlessness, involuntary muscle movements, twitching or shaking
- difficulty moving muscles smoothly or other movement or coordination problems
- vertigo (fraud)
- decreased sensation
- hay fever symptoms with runny or itchy nose or eyes
- increased cough, asthma or shortness of breath
- nosebleeds or a runny or stuffy nose
- inflamed throat or sinuses
- skin rash, acne or itchy skin
- sweating
- increased or decreased blood pressure
- abnormal ECG , irregular or slow heartbeat
- difficulty swallowing, swollen or sore tongue
- cold sores
- heavy gas formation
- nausea or vomiting (reflux of fluid from the stomach)
- increased appetite or thirst
- weight gain or weight loss
- taste changes
- migraine
- forgetfulness and memory loss
- speech problems
- diabetes or high blood sugar
- elevated cholesterol
- swollen hands and feet
- disturbed sleep or abnormal dreams
- impaired sexual drive
- vision changes or dry eyes
- abnormal urine or more frequent urination
- abnormal mens
- abnormal blood counts showing that the number of white blood cells has changed
Has been reported (occurs in an unknown number of users):
- swelling under the skin that can be hot or painful
- red, raised itchy rash
How to store Modafinil Orion
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 label, carton, and blister after EXP. The expiration date is the last day of the specified month. No special storage instructions.
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
Content declaration
- The active substance is modafinil. Each tablet contains 100 mg or 200 mg of modafinil.
- The other ingredients are lactose monohydrate , croscarmellose sodium, povidone (k-30), magnesium stearate.
What the medicine looks like and contents of the pack
Modafinil 100 mg tablets are: white to off-white, capsule-shaped, uncoated tablets, debossed with “41” on one side and “J” on the other side.
Modafinil 200 mg tablets are: white to off-white, capsule-shaped, uncoated tablets, debossed with “4” & “2” on each side of the trench on one side and “J” on the other side. The tablet can be divided into two equal doses.
The 100 mg and 200 mg tablets are available in PVC / PVdC – Aluminum foil blister packs of 30, 90, and 100 tablets. Not all pack sizes may be marketed
Marketing Authorization Holder and Manufacturer
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:
Orion Pharma AB
medinfo@orionpharma.com