100 mg tablets
modafinil
What Modafinil Sandoz is and what it is used for
The active substance in the tablet is modafinil.
Modafinil Sandoz can be taken by adults suffering from narcolepsy to help 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 Sandoz can 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 Sandoz 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 Sandoz
Do not take Modafinil Sandoz
- 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 Sandoz if you
- have heart problems or high blood pressure . Your doctor will need to check this regularly while you are taking Modafinil Sandoz.
- have ever had depression, depression, anxiety, psychosis (lost perception of reality) or mania (excessive arousal or extreme happiness) or bipolar disorder because Modafinil Sandoz may aggravate these conditions
- have kidney or liver problems (because you need to take a lower one 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 medicine may 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 and young people
Children under 18 years of age should not take this medicine.
Other medicines and Modafinil Sandoz
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 Sandoz and some other medicines can affect each other and your doctor may need to adjust the dose you take. It is especially important if you are taking any of the following medicines with Modafinil Sandoz:
- 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 Sandoz and for at least two months after stopping treatment, as Modafinil Sandoz reduces the effectiveness of hormonal contraceptives.
- omeprazole (for acid reflux, stomach upset and stomach ulcers )
- antiviral drugs for the treatment of HIV infections ( protease inhibitors , eg indinavir or ritonavir)
- cyclosporine (against rejection of transplanted organs or against arthritis (joint inflammation) 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, do not take Modafinil Sandoz.
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 Sandoz (and for two months after stopping treatment) or if you have any other questions.
Driving and using machines
Modafinil Sandoz can 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 Sandoz 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.
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie it is essentially ‘sodium-free’.
How to take Modafinil Sandoz
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.
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).
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 kidney or 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.
If you take more Modafinil Sandoz than you should
If you take too many tablets, you may feel nauseous, restless, disoriented, confused, anxious, 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 Sandoz
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.
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 thoughts
- aggression or hostility
- forgetfulness 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.)
- Feels the heartbeat that can be faster than normal
- Chest pain
- Hemorrhoids
- 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 (scam)
- 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 mouth sores
- Severe flatulence, reflux (reflux of fluid from the stomach), increased appetite, weight changes, thirst or taste changes
- Nausea (vomiting)
- Migraine
- Speech problem
- Diabetes with high blood sugar
- Elevated cholesterol
- Swollen hands and feet
- Disturbed sleep or abnormal dreams
- Loss of sexual drive
- Nasal blood, sore throat or inflamed nasal mucosa ( sinusitis )
- Abnormal vision or dry eyes
- Abnormal urine or more frequent urination
- Abnormal man
- Abnormal blood levels showing that the number of white blood cells has changed.
- Restlessness with increased body movement
How to store Modafinil Sandoz
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 carton 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
What Modafinil Sandoz contains
The active substance is modafinil.
Each tablet contains 100 mg of modafinil.
The other ingredients (excipients) are lactose monohydrate, crospovidone (E1202), anhydrous lactose, povidone K30 (E1201), anhydrous colloidal silicon (E551), sodium stearyl fumarate, and talc (E553b).
What Modafinil Sandoz looks like and contents of the pack
White to off-white, 12.65 mm x 5.55 mm capsule-shaped tablet debossed with “100”.
Modafinil Sandoz is available in off-white PVC / PVDC / aluminum or off-white PVC / PE / PCTFE / aluminum blisters with 20, 30, 50, 60, 90 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Holder of approval
Sandoz A / S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark
Manufacturer
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark.
Chanelle Medical, Loughrea, Co. Galway, Ireland.
Glenmark Arzneimittel GmbH, Industriestr. 31, Gröebenzell, Bavaria, 82194, Germany