100 mg tablets
What Myldamo is and what it is used for
The active substance in the tablets 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 Myldamo may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Myldamo
Do not take Myldamo if you:
- is allergic to modafinil or any of the other ingredients of this medicine (listed in section 6)
- have irregular heartbeats
- moderate to very high blood pressure ( hypertension ) that is not controlled / normalized with medication.
Warnings and cautions
Talk to your doctor or pharmacist before taking Myldamo if you:
- have heart problems or high blood pressure . Your doctor will need to check this regularly while you are taking Myldamo.
- have ever had depression , depression , anxiety , psychosis (lost perception of reality) or mania (excessive excitement or extreme happiness) or bipolar disorder because Myldamo can aggravate these conditions.
- 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 had thoughts of suicide , had aggressive thoughts or committed aggressive acts while 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.
- You may become addicted to this medicine 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.
Talk to a doctor or pharmacist:
- if you get a fever and rash together with:
- itchy skin or weakness
- myocarditis (which can be detected by test)
- hepatitis or abnormal liver function (seen on blood tests)
- increase in the number of certain types of blood cells (which can cause symptoms such as increased incidence of infection or fever such as sore throat, sore mouth or if you notice that you are more likely to get bruises or bleed for no reason).These can be signs of a hypersensitivity reaction involving several organs and can be life-threatening.
- if 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 counts (see section 4, Possible side effects ).
- if you have difficulty falling asleep and sleeping.
Children and young people
Children under 18 years of age should not take this medicine.
Other medicines and Myldamo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. My demo and some other medicines can 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 Myldamo:
- hormonal contraceptives ( birth control pills , birth control pills, IUDs and birth control patches ). You need to consider other methods of contraception while you are using Myldamo and for at least two months after stopping treatment, as Myldamo reduces the effect of the hormonal contraceptives.
- omeprazole (for acid reflux, stomach upset and stomach ulcers )
- antiviral drugs used to treat HIV infection ( 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 drugs (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 suspect you may be), planning to become pregnant, or breastfeeding, do not take Myldamo.
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 (and for two months after stopping treatment) or if you have any other questions.
You should not take this medicine if you are breastfeeding, as this medicine may pass into breast milk.
Driving and using machines
Myldamo can cause blurred vision or dizziness in up to 1 in 10 users.
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. The description 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.
Myldamo 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.
Myldamo contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to take Myldamo
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 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 recommended dose is 100 mg daily.
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 liver problems
The recommended dose is 100 mg a day.
Your doctor will regularly check your treatment to see if it is right for you.
The tablets should be swallowed whole with water.
If you take more Myldamo than you should
If you take too many tablets, you may feel sick, anxious, disoriented, confused, restless, anxious, or elated. You may also have difficulty sleeping, diarrhea, hallucinations (hearing, seeing, or experiencing things that are not real), chest pain, altered heart rate, or increased blood pressure.
If you forget to take Myldamo
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 tablet.
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.
Stop taking this medicine and contact your doctor immediately if:
- 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 your well-being. The characters can be:
- mood swings or abnormal thoughts
- aggression or hostility
- forgetfulness or confusion
- extreme feeling of happiness
- uncontrolled crying or laughing
- arousal or hyperactivity
- anxiety or nervousness
- depression, suicidal ideation or suicidal ideation
- restlessness, anxiety or psychosis (loss of contact with reality that may lead to delusions or experiencing things that are not real), emotional loneliness or blunting, personality disorder.
Other side effects include:
Very common (may affect more than 1 user in 10):
Common (may affect up to 1 in 10 people):
- drowsiness, extreme fatigue or difficulty sleeping (insomnia)
- senses the heartbeat which can be faster than normal
- chest pain
- dry mouth
- decreased appetite, nausea, stomach pain, indigestion, diarrhea or constipation
- weakness, numbness or tingling in the hands or feet (“ant crawls”)
- abnormal blood counts that show how your liver is working (elevated liver enzymes)
Uncommon (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
- 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)
- speech problems
- diabetes with high blood sugar
- elevated cholesterol
- swollen hands and feet
- disturbed sleep or abnormal dreams
- impaired 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 movements.
How to store Myldamo
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. Cans only: Discard 4 months after opening.
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 pack and other information
The active substance is modafinil.
Each tablet contains 100 mg of modafinil.
The other ingredients are lactose (see section 2 “Myldamo contains lactose”), croscarmellose sodium, povidone, and magnesium stearate.
What the medicine looks like and contents of the pack
White or off-white capsule-shaped tablets approximately 12.6 mm × 5.5 mm in size, marked with “41” on one side and “J” on the other.
The tablets are available in blister packs (made of PVC / PVdC-aluminum) with 30, 60, or 90 tablets and in plastic jars with 30 or 100 tablets. The jars contain desiccants that must not be consumed.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
104 35 Stockholm
McDermott Laboratories to Gerard Laboratories
35/36 Baldoyle Industrial Estate,
Mylan Hungary Kft.
Mylan utca 1.