Modiodal 100mg. 30 tablets
What Modiodal is and what it is used for
The active substance in Modiodal is modafinil.
Modafinil can be taken by adults who have narcolepsy to help them stay awake. Narcolepsy is a condition that causes excessive daytime sleepiness, with the risk of falling asleep suddenly in inappropriate situations (sleep attacks). Modafinil may improve your condition and reduce the chance of getting a sleep attack, but there may still be other ways to improve your condition that you will discuss with your doctor.
2. What you need to know before taking Modiodal
Do not take Modiodal
if you are allergic to modafinil or any of the other ingredients of this medicine (listed in section 6)
if you suffer from heart rhythm disorders
if you suffer from uncontrolled moderate to severe high blood pressure (hypertension).
Warnings and precautions
Talk to your doctor before taking Modiodal if:
You suffer from heart problems or high blood pressure. Your doctor will need to periodically monitor your condition while taking Modiodal
You have once suffered from depression, poor mood, anxiety, psychosis (loss of connection with reality) or mania (over-excitement or feeling of excessive happiness), or bipolar disorder because Modiodal can aggravate these symptoms.
You suffer from kidney or liver disease (you will need to take a lower dose).
You have had problems with alcohol or drug addiction in the past.
Children and adolescents
This medicine should not be taken by children under 18 years of age.
Talk to your doctor or pharmacist:
There have been reports of use of modafinil in which there have been suicidal (suicidal) and aggressive thoughts and behavior. Tell your doctor immediately if you notice that you are depressed, aggressive or hostile to other people, or have suicidal thoughts or behavior changes (see Section 4). You may want to ask a family member or friend to monitor for signs of depression or behavioral changes.
This medicine has the potential for long-term addiction (addiction). If you need to take this medicine for a long time, your doctor will regularly monitor if it is the right medicine for you.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines may interact with Modiodal and your doctor may need to change the dose you are taking.
It is especially important to tell your doctor if you are taking any of the following products while you are taking Modiodal
Hormonal contraceptives (including contraceptive pills,
implants, intrauterine devices and patches). Since modafinil may reduce their effectiveness, discuss with your doctor other appropriate precautions for you during the use of modafinil and for two months after discontinuation of treatment.
Omeprazole (a medicine for acid reflux, stomach upset or ulcers).
Antiviral medicines for the treatment of HIV (protease inhibitors such as indinavir and ritonavir).
Cyclosporine (used to prevent organ transplant rejection or arthritis and psoriasis).
Medicines for depression (such as amitripilin, citalopram or fluoxetine) or anxiety (such as diazepam).
Blood thinners (such as warfarin). Your doctor will monitor your blood clotting time during treatment.
Calcium channel blockers or beta blockers used to treat high blood pressure or heart problems (such as amlodipine, verapamil or propranolol).
Stations used to lower cholesterol (such as atorvastatin or simvastatin).
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine. It is not known if Modiodal can harm your child.
Discuss with your doctor the appropriate methods of pregnancy protection while you are taking Modiodal (and for the first two months after stopping treatment) or if you have any further questions.
Driving and using machines
Aspendos may cause blurred vision or lightheadedness in 1 in 10 people. If you experience these symptoms or find that you still feel drowsy when taking this medicine, do not drive or use machines.
Important information about some of the ingredients of Modiodal
This medicinal product contains lactose as an adjuvant. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.
How to take Modiodal
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The tablets should be taken whole with water.
The usual dose is 200 mg daily. It can be taken once (in the morning) or divided into two doses daily (100 mg in the morning and 100 mg in the afternoon).
In some cases, your doctor may increase the dose you take up to 400 mg daily.
Elderly patients (over 65 years):
The usual dose is 100 mg daily. It can be taken once (in the morning) or divided into two doses daily (50 mg in the morning and 50 mg in the afternoon).
Your doctor will only increase your dose (up to a maximum of 400 mg) if you are not suffering from liver or kidney problems.
Adults suffering from serious liver and kidney disease
The usual daily dose is 100 mg daily.
Your doctor will monitor your condition periodically to see if the dose you are taking is right for you.
If you take more Modiodal than you should
If you accidentally take too many pills, you may experience nausea, restlessness, disorientation or anxiety. In addition, it may be difficult for you to fall asleep, get diarrhea, hallucinations (seeing and hearing things that do not exist), chest pain, changes in heart rate, or high blood pressure.
Contact your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Always carry the medicine pack with you.
If you forget to take Modiodal
Do not take a double dose to make up for a forgotten dose and take the next dose at the usual time.
If you are not sure, 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 immediately if you experience any of the following symptoms:
Shortness of breath or swelling of the face, mouth or throat.
Rash or itching (especially if it affects the whole body). Serious rashes can cause blisters or skin peeling, mouth, eye, nose or genital ulcers. You may also experience high fever and fake blood test results.
Change in your mental state. Symptoms may include:
A change in mood or thinking
Aggressiveness or hostility
Distraction or confusion
Feeling of excessive happiness
Over-excitement or hyperactivity
Anxiety or nervousness
Depression, suicidal (suicidal) thoughts or behavior
Arousal or psychosis (loss of connection to reality, which may include seeing and hearing things that do not exist), feelings of invulnerability or stiffness, or personality disorders.
Other side effects with modafinil may be:
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Sleepiness, excessive fatigue or problems falling asleep (insomnia)
Irregular or accelerated heart rate
Flushing of the face
Loss of appetite, nausea, stomach pain, digestive problems, diarrhea or constipation
Stiffness or tingling of the hands or feet (tingling)
Abnormal results of liver blood tests (elevated
Uncommon side effects (may affect up to 1 in 100 people):
Back pain, neck pain, muscle pain, muscle weakness, leg cramps, general pain, trembling or tremor.
Difficult movement of muscles or other motor problems,
muscle tension, coordination problems.
Symptoms of hay fever that include itching / running nose or watery look
Increased cough, asthma or shortness of breath.
Skin rash, acne or itchy skin.
Changes in blood pressure (increase or decrease), abnormal cardiac examination results (ECG), irregular or abnormally slow heart rhythm.
Swallowing difficulties, swelling of the tongue or mouth ulcers.
Increased gas release, reflux (return of gastric fluid), increased appetite, change in weight, thirst or taste changes.
Disturbances in speech.
Diabetes with high blood sugar.
Elevated cholesterol in the blood.
Swelling of the legs and arms.
Restless sleep or unusual dreams.
Loss of sexual desire.
Nasal bleeding, dry throat or inflammation of the nasal passages (sinuses).
Blurred vision or dry eyes.
Disturbed urination or more frequent urination than usual.
Deteriorated blood test results that show a change in white blood cell count.
Anxiety with elevated body movements.
How to store Modiodal
Keep out of the reach and sight of children.
Do not store above 30 ° C
Do not use this medicine after the expiry date which is stated on the carton and on each blister. The expiry date refers to the last day of that month.
Do not dispose of medicines in sewage or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Container contents and additional information
What Modiodal contains
The active substance is modafinil. Each tablet contains 100 mg of modafinil.
The other ingredients (excipients) are: lactose monohydrate, corn starch, croscarmellose sodium (E 468), aluminum magnesium silicate, povidone K 90 (E 1201), talc (E 553b), magnesium stearate (E 527).