What is Modafinil and what it is used for

The active substance in Modafinil is modafinil.

Modafinil can be taken by adults who suffer from narcolepsy to help them stay awake. Narcolepsy is a condition that causes excessive daytime sleepiness, with the risk of sudden fall asleep in inappropriate situations (sleep attacks). Modafinil may improve your condition and reduce your ability to get sleep attacks, 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 Modafinil

Do not take Modafinil

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 disturbances

if you suffer from uncontrolled moderate to severe high blood pressure (hypertension).

Warnings and precautions

Talk to your doctor before taking Aspendos if:

You suffer from heart problems or high blood pressure. Your doctor will need to periodically monitor your condition while taking Aspendos.

You have ever 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 ASPENDOSE may worsen 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 the age of 18 years.

Talk to your doctor or pharmacist:

There have been reports of use of modafinil in which suicidal (suicidal) and aggressive thoughts and behaviors have been reported. Tell your doctor immediately if you notice that you are depressed, aggressive or hostile to other people, or have suicidal thoughts or behavioral changes (see Section 4). You may ask a family member or friend to see if you have signs of depression or behavioral changes.

This drug has the potential for addiction (addiction) in long-term use. If you need to take this medicine for a long time, your doctor will regularly check if this is the best medicine for you.

Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines. Some medicines may interact with Aspendos 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 while taking Modafinil :

Hormonal contraceptives (including contraceptive pills,

implants, intrauterine devices and patches). Since modafinil may reduce their effectiveness, discuss with your doctor other appropriate protective equipment while using modafinil and for two months after discontinuation of treatment.

Omeprazole (a medicine for acid reflux, indigestion or ulcers).

Antiviral medicines for the treatment of HIV (protease inhibitors such as indinavir and ritonavir).

Ciclosporin (used to prevent organ rejection in transplants or arthritis and psoriasis).

Depression medications (such as amitriptyline, 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).

Stanizers 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 taking this medicine. It is not known if Modafinil can harm your child.

Discuss with your doctor the appropriate methods for preventing pregnancy while taking Modafinil (and for the first two months after stopping treatment) or if you have any further questions.

Driving and using machines

Modafinil may cause blurred vision or dizziness in 1 out of 10 people. If you experience these symptoms or if you continue to feel drowsy when taking this medicine, do not drive or operate machinery.

Important information about some of the ingredients of Modafinil

This medicinal product contains lactose as an excipient. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this product.

How to take Modafinil

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 with water.

Adults:

The usual dose is 200 mg daily. It can be taken once (morning) or divided into two doses a day (100 mg in the morning and 100 mg in the morning).

In some cases, your doctor may increase your dose to 400 mg daily.

Elderly (over 65 years):

The usual dose is 100 mg daily. It may be taken once (morning) or divided into two doses per day (50 mg in the morning and 50 mg in the morning).

Your doctor will increase your dose (up to a maximum of 400 mg) only if you have no 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 check if the dose you are taking is most appropriate for you.

If you take more Modafinil than you should

If you accidentally take too many tablets, you may feel nausea, restlessness, disorientation or anxiety. In addition, you may find it difficult to fall asleep, get diarrhea, hallucinations (seeing and hearing things that do not exist), chest pain, heart rhythm changes, or high blood pressure.

Contact your doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Always carry the medicine pack with you.

If you forget to take Modafinil

Do not take a double dose to make up for the missed 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 everyone gets them.

Stop taking this medicine and tell your doctor immediately if you get any of the following symptoms:

Difficulty in breathing or swelling of the face, mouth or throat.

Rash or itching (especially if it affects the whole body). Serious rashes can cause blistering or licking of the skin, ulcers in the mouth, eyes, nose, or genitals. You may also have fever (fever) and fake blood test results.

Change your mental state. Symptoms may include:

Change in mood or thinking

Aggressiveness or hostility

Dizziness or confusion

Feeling of Excessive Happiness

Over-agitation or hyperactivity

Anxiety or nervousness

Depression, suicidal (suicidal) thoughts or behavior

Excitement or psychosis (loss of connection with reality, which may include seeing and hearing things that do not exist), a feeling 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):

Headache

Common side effects (may affect up to 1 in 10 people):

Dizziness

Drowsiness, excessive fatigue or sleeping problems (insomnia)

Irregular or accelerated heart rhythm

Chest pain

Flushing the face

Dry mouth

Loss of appetite, nausea, stomach pain, digestive problems, diarrhea or constipation

Weakness

Stiffness or numbness of the arms or legs (tingling of the hands)

limbs)

Blurred vision

Abnormal results of liver blood tests (elevated

liver enzymes)

Uncommon side effects (may affect up to 1 in 100 people):

Back pain, neck pain, muscle pain, muscle weakness, leg cramps, general feeling of pain, trembling or tremor.

Vertigo (vertigo).

Difficulty in movement of muscles or other movement problems,

muscle tension, coordination problems.

Symptoms of hay fever that include an itchy / leaking nose or watery look

Increased cough, asthma or shortness of breath.

Skin rash, acne or itchy skin.

Sweating.

Changes in blood pressure (increase or decrease), abnormal cardiac output (ECG), irregular or abnormally slow heartbeat.

Swallowing difficulties, swollen tongue or mouth ulcers.

Increased excretion of gas, reflux (gastric fluid return), increased appetite, weight change, thirst or taste changes.

Vomiting.

Migraine.

Disturbances in speech.

Diabetes with high blood sugar.

Increased blood cholesterol.

Edema of the legs and arms.

Restless sleep or unusual dreams.

Loss of sexual desire.

Bleeding from the nose, dry throat or inflammation of the nasal passages (sinuses).

Impaired vision or dry eyes.

Impaired urination or more frequent urination than usual.

Menstrual cycle disorders.

Degraded blood test results showing that there is a change in the number of white blood cells.

Restlessness with increased body movements.

How to store Modafinil

Keep out of the reach and sight of children.

Store below 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 the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the package and additional information

What Modafinil contains

The active substance is modafinil. Each tablet contains 100 mg modafinil.

The other ingredients are: lactose monohydrate, corn starch, croscarmellose sodium (E 468), aluminum magnesium silicate, povidone K 90 (E 1201), talc (E 553b), magnesium stearate (E 527).

What Modafinil looks like and contents of the pack

Modafinil are white, round, biconvex tablets.

Modafinil is supplied in PVC / AL blisters in cartons of 20, 30, 60, 90 tablets.