Provigil ( Modafinil )

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What is Provigil / Modafinil and when is it used?

Modafinil, which contains the active ingredient modafinil, is used by prescription for the treatment of excessive daytime sleepiness related to irresistible sleep attacks (narcolepsy) during the day (with or without sudden muscle relaxation, cataplexy).

Modafinil treatment should only be started after a thorough diagnosis has been established by a doctor who specializes in neurology (nerve disease) and / or sleep medicine.

What must also be taken into account during treatment?

You absolutely cannot use Modafinil for other types of disease or resume its use without consulting your doctor again.

When can Provigil / Modafinil not be taken?

• in case of hypersensitivity to the active ingredient modafinil or to another constituent of the medicinal product
• during pregnancy and breastfeeding
• in case of severe hypertension or hypertension of medium severity that cannot be controlled
• if you are taking an antihypertensive with the active substance prazosin
• in the presence of heart disease or heart rhythm disturbances
• if you are addicted to alcohol, medications or drugs.

When is caution required in the administration of Provigil / Modafinil?

Cases of severe rash have been reported after taking Modafinil, requiring hospitalization and cessation of therapy. The rash occurred 1 to 5 weeks after initiation of therapy (single cases have been reported after longer use (eg 3 months)). At the first signs of a rash, Modafinil should be discontinued and therapy should not be restarted. Tell your doctor if you develop symptoms of a rash.

Psychiatric side effects, including thoughts of suicide, have been reported in patients treated with Modafinil. In these cases the use of Modafinil must be stopped and not restarted. Contact your doctor immediately if you notice any onset of aggression or symptoms of psychosis or mania (excessively euphoric mood with increased dynamism), or if you notice that you feel depressed or have thoughts of suicide.

Modafinil can only be used with particular caution in case of severe anxiety (excluding treatment in specialized facilities), psychosis, depression or mania in the history, as it is possible that psychiatric symptoms may arise or worsen due to the treatment.

In the presence of severe liver or kidney disease Modafinil can only be used with particular caution.

Modafinil can increase the risk of cardiovascular events. Spontaneous notifications after approval reported heart rhythm changes, high blood pressure, and other side effects on the cardiovascular system.

In the presence of hypertension, it is essential to monitor blood pressure and heart rate. In patients with cardiovascular disease, ECG examinations should be performed regularly.

To prevent pregnancy during treatment with Modafinil, use a hormonal contraceptive 'pill' and an additional contraceptive or use an alternative form of contraception, as Modafinil may reduce the effectiveness of hormonal contraceptives. This precaution also applies for at least two months after you stop taking Modafinil.

Provigil / Modafinil tablets contain lactose. Patients with rare congenital metabolic diseases such as galactose intolerance, Lapp's lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

Modafinil can have interactions with other drugs. Therefore consult your doctor or pharmacist if you want/need to take another medicine at the same time. This should be done especially if you are taking the following medicines: contraceptives ("pill"), drugs for the treatment of depressions (tricyclic antidepressants such as clomipramine or desipramine, selective serotonin reuptake inhibitors such as citalopram and fluoxetine), drugs for the treatment of seizure diseases (such as phenytoin), cyclosporine, theophylline, medicines to thin the blood, sleeping pills and tranquilizers, omeprazole, antiviral medicines to treat HIV, or medicines to treat hypertension or heart problems (eg amlodipine, verapamil, propranolol or prazosin).

There is only very limited experience with respect to its use in children and adolescents under the age of 18 and therefore the preparation should not be used in this age group.

Since the elimination of Modafinil may be delayed in older people, the starting dose should be lower (100 mg) for patients over 65 years of age.

As with all psychoactive substances, a psychic addictive effect cannot be completely excluded for modafinil.

Modafinil can reduce the ability to react, the ability to drive a vehicle, and the ability to use tools or machines. If you suffer from narcolepsy, even while taking Modafinil you should not drive or operate machines.

Warning for those who play competitive sports: the active ingredient of this drug gives a positive result in doping tests.

Tell your doctor or pharmacist if you suffer from other illnesses, suffer from allergies or take or apply other medicines externally (even bought on your own)!

Can Provigil / Modafinil be given during pregnancy or breastfeeding?

If you are pregnant, think you may be pregnant or are planning to become pregnant, you should not take Modafinil. Modafinil is believed to cause birth defects when used in pregnancy.

For women of reproductive age, adequate contraception measures should be taken before starting treatment and for at least two months after stopping Modafinil. Your doctor will advise you about this.

During breastfeeding, Modafinil cannot be used, because Modafinil passes into breast milk.

How to use Provigil / Modafinil?

For adults, the following indications apply unless otherwise prescribed by the doctor. Follow the instructions for use, otherwise, Modafinil cannot work in the right way.

The daily dose is 2 tablets (200 mg). Depending on your individual response your doctor may increase the dose up to 4 tablets (400 mg) per day.

The daily dose can be divided into two doses (in the morning and at noon) or taken all at once (single dose) in the morning.

Take the tablets without chewing them, with some liquid. Modafinil can be taken before, during or after a meal.

In case of severely impaired liver or kidney function your doctor will adjust the dose: usually, it will be 1-2 tablets (100-200 mg) per day.

If you have taken too little Modafinil or have forgotten to take it, continue taking Modafinil at the prescribed dose. Under no circumstances should you take double the amount of tablets or make up for the forgotten dose in the afternoon or evening as this could cause you agitation, excitement and sleeplessness.

You cannot stop taking Modafinil without your doctor's consent, otherwise irresistible sleep fits may occur again or to a greater extent.

It is up to your doctor to decide how long you take Modafinil.

Do not change the prescribed dosage on your own initiative. If you think that the action of the medicine is too weak or too strong, talk to your doctor or pharmacist.

What side effects can Provigil / Modafinil have?

The following side effects may occur with the intake of Modafinil:

Nervousness, headache.

Abnormal liver function tests, increase in single dose-related enzymes (alkaline phosphatase, gamma glutamyl transferase), insomnia, anxiety, depression, altered thinking, confusion; lightheadedness, sleepiness, abnormal sensations (paraesthesia), increased muscle tension, blurred vision; tachycardia, palpitations, dilation of blood vessels, nausea, dry mouth, unpleasant taste, abdominal pain, diarrhea, loss of appetite, digestive disorders, constipation, weakness, chest pains.

Changes in the blood picture (increase/decrease in white blood cells), edema, changes in body weight, increased blood glucose values, increased blood cholesterol values, diabetes, thirst, sleep disturbances, emotional lability, decreased sexual desire, attitudes hostility, nervous irritability, disturbances in perception and perception of the self, personality disorders, change in dreams, excitement, aggressive behavior. Movement sequence disturbances, memory gaps, headache, increased motor activity, tremor, dizziness, speech disturbances, numbness, motor disturbances, visual disturbances, conjunctivitis, dry eye, increased blood pressure, changes in ECG, cardiac arrhythmias, extra heartbeats (extrasystoles), drop in blood pressure, drop in heart rate, inflammation of the pharyngeal mucosa, pain when swallowing, breathing problems, increased urge to cough, nasal discharge, sinusitis, asthma, nosebleeds, mild allergic reactions (symptoms such as hay fever), flatulence, acid belching, vomiting, inflammation of the tongue, increased appetite, swallowing disorders, mouth ulcers, sweating, rashes, itching, acne. Muscle weakness, muscle aches, muscle twitches, back pain, joint pain, leg cramps, neck pain, changes in urine, changes in urination frequency, menstrual disturbances. increased urge to cough, nasal discharge, sinusitis, asthma, epistaxis, mild allergic reactions (symptoms such as hay fever), flatulence, acid belching, vomiting, inflammation of the tongue, increased appetite, swallowing disorders, mouth ulcers, sweating, skin rashes, itching, acne. Muscle weakness, muscle aches, muscle twitches, back pain, joint pain, leg cramps, neck pain, changes in urine, changes in urination frequency, menstrual disorders. increased urge to cough, nasal discharge, sinusitis, asthma, epistaxis, mild allergic reactions (symptoms such as hay fever), flatulence, acid belching, vomiting, inflammation of the tongue, increased appetite, swallowing disorders, mouth ulcers, sweating, skin rashes, itching, acne. Muscle weakness, muscle aches, muscle twitches, back pain, joint pain, leg cramps, neck pain, changes in urine, changes in the frequency of urination, menstrual disturbances. acne. Muscle weakness, muscle aches, muscle twitches, back pain, joint pain, leg cramps, neck pain, changes in urine, changes in urination frequency, menstrual disturbances. acne. Muscle weakness, muscle aches, muscle twitches, back pain, joint pain, leg cramps, neck pain, changes in urine, changes in urination frequency, menstrual disorders.

Psychosis (with symptoms such as hallucinations, delusional ideas, altered thinking), manias, an excessive impulse to motor manifestations in case of psychic agitation and the appearance of suicidal thoughts have also been noted. Contact your doctor immediately if you notice aggression or symptoms of psychosis or delusions, or if you notice that you are feeling downcast, that your perception of the world changes or thoughts of suicide arise.

Urticaria, swelling of the skin and mucous membranes (angioedema), hypersensitivity reactions (characterized by symptoms such as rash, fever, swollen lymph nodes up to the involvement of internal organs) as well as anaphylaxis (allergic reaction, often accompanied by decreased blood pressure, dizziness, nausea and possibly difficulty in breathing). Severe skin reactions have also occurred, including cases of erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity syndrome (DRESS). In case of mucosal swelling, hypersensitivity reactions and skin reactions, please inform your doctor immediately.

Like all medicines, Modafinil must be kept out of the reach of children.

Store the medicine in a dry place at room temperature (15-25 ° C), in the original packaging. The medicinal product should not be used beyond the date indicated with "EXP" on the container.

Your doctor or pharmacist, who have detailed professional information, can give you further information.

What does Provigil / Modafinil contain?

1 tablet of Provigil / Modafinil contains 100 mg of modafinil as an active ingredient, lactose and other auxiliary substances.

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