ACTIMODAN 100 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Actimodan, 100 mg, tablets
3. Actimodan, 200 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
4. What is Actimodan and what is it used for
5. Important information before taking Actimodan
   1. When not to take Actimodan:
   2. Warnings and precautions
   3. Children and adolescents
   4. Actimodan and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Actimodan contains lactose monohydrate and sodium
6. How to take Actimodan
   1. Recommended dose
   2. Method of administration
   3. Taking a higher dose of Actimodan than recommended
   4. Missing a dose of Actimodan
7. Possible side effects
   1. Other side effects:
   2. Reporting side effects
8. How to store Actimodan
9. Contents of the pack and other information
   1. What Actimodan contains
   2. What Actimodan looks like and contents of the pack
   3. Marketing authorization holder
   4. Importer/Manufacturer
   5. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Actimodan, 100 mg, tablets

Actimodan, 200 mg, tablets

Modafinil

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Actimodan and what is it used for
• 2. Important information before taking Actimodan
• 3. How to take Actimodan
• 4. Possible side effects
• 5. How to store Actimodan
• 6. Contents of the pack and other information

1. What is Actimodan and what is it used for

Actimodan contains the active substance modafinil.
Actimodan is indicated for the treatment of excessive daytime sleepiness associated with narcolepsy with or without cataplexy (loss of muscle tone).
Excessive daytime sleepiness is defined as difficulty maintaining wakefulness and increased risk of falling asleep in inappropriate situations.
Modafinil may be taken by adult patients with narcolepsy to maintain wakefulness. Narcolepsy is a disease that causes excessive daytime sleepiness and a tendency to fall asleep suddenly in inappropriate situations (sleep attacks). Taking modafinil may improve narcolepsy and reduce the likelihood of sleep attacks. Improvement may also be achieved by using other methods; information about these methods can be obtained from your doctor.

2. Important information before taking Actimodan

When not to take Actimodan:

Warnings and precautions

Before starting to take Actimodan, discuss it with your doctor or pharmacist:

Some patients taking modafinil have reported suicidal or aggressive thoughts or aggressive behavior. You should immediately inform your doctor if you experience depression, feelings of aggression or hostility towards others, suicidal thoughts, or other changes in your behavior (see section 4). You may ask a family member or close friend to pay attention to any signs of depression or other changes in your behavior.
This medicine may be addictiveduring long-term use. If it is necessary to use the medicine for a longer period, your doctor will regularly check if it is still the best medicine for you.
There have been reports of severe skin reactions such as severe rash, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) associated with modafinil.
If a rash occurs, you should stop taking Actimodan and not restart it, and immediately contact your doctor.

Children and adolescents

The medicine should not be used in children and adolescents under 18 years of age.

Actimodan and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Modafinil may interact with some other medicines.
Your doctor may need to adjust the doses of the medicines you are taking.
This is especially important if you are taking any of the following medicines with Actimodan:

• hormonal contraceptives(including tablets, implants, intrauterine devices, and contraceptive patches). You should consider using other contraceptive methods during treatment with Actimodan and for 2 months after stopping treatment, as modafinil reduces the effectiveness of these contraceptives;
• omeprazole(a medicine used to treat stomach acid reflux, indigestion, or stomach ulcers);
• antiviral medicines used to treat HIV infection(protease inhibitors, such as indinavir or ritonavir);
• cyclosporin(a medicine used to prevent organ rejection or to treat arthritis or psoriasis);
• medicines used to treat epilepsy(such as carbamazepine, phenobarbital, or phenytoin);
• medicines used to treat depression(such as amitriptyline, citalopram, or fluoxetine) or anxiety disorders (such as diazepam);
• blood thinners(such as warfarin). During treatment, your doctor will check your blood clotting time;
• calcium channel blockers or beta blockersused to treat high blood pressure or heart problems (such as amlodipine, verapamil, or propranolol);
• statinsused to lower cholesterol levels (such as atorvastatin or simvastatin);
• psychotropic medicines(such as diazepam, midazolam).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant (or think you may be pregnant), you should not take Actimodan.
It is not known whether the medicine can harm the unborn child.
If you are breastfeeding, you should not take Actimodan. It is not known whether the medicine passes into breast milk.
A woman of childbearing potential should discuss with her doctor which contraceptive methods are appropriate for her during treatment with modafinil (and for 2 months after stopping treatment) or if she has any other concerns.

Driving and using machines

The medicine may cause blurred vision or dizziness. If you experience these symptoms or if you still feel very sleepy while taking this medicine, you should not drive or operate machinery.

Actimodan contains lactose monohydrate and sodium

Lactose monohydrate
If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking the medicine.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that it is essentially "sodium-free".

3. How to take Actimodan

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dose

Adults
The usual dose of the medicine is 200 mg per day. This dose can be taken once a day (in the morning) or in two divided doses per day (100 mg in the morning and 100 mg at noon).
In some cases, your doctor may decide to increase the daily dose to 400 mg in one or two divided doses.
Elderly patients (over 65 years)
The usual dose of the medicine is 100 mg per day.
Patients with liver function disorders
The usual dose of the medicine is 100 mg per day.
Your doctor will regularly review your treatment to ensure it is suitable for you.

Method of administration

The tablets should be swallowed whole with water.

Taking a higher dose of Actimodan than recommended

If you have taken more than the recommended dose of the medicine, you should immediately contact the nearest hospital or inform your doctor.
You should take this leaflet and any remaining tablets with you.
Overdose symptoms may occur: insomnia, central nervous system symptoms such as restlessness, disorientation, confusion, mental excitement, and hallucinations; gastrointestinal symptoms such as nausea and diarrhea, and cardiovascular symptoms such as tachycardia, bradycardia, hypertension, and chest pain.

Missing a dose of Actimodan

If you miss a dose, you should take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should immediatelystop taking this medicine and contact your doctor or go to the emergency department of the nearest hospital if you experience:

• angioedema (severe allergic reaction - sudden swelling of the face, limbs, or joints without itching and pain). Swelling in the head and neck area may cause difficulty swallowing and breathing;
• mood swings or thinking disorders;
• aggression or hostility;
• forgetfulness or confusion;
• excessive excitement or euphoria - symptoms of mania;
• anxiety or nervousness;
• depression, suicidal thoughts, or behaviors;
• excitement or psychosis (loss of contact with reality, which may include delusions), hallucinations (perception of non-existent things), depersonalization (feeling of detachment or numbness, or personality disorder).

Other side effects:

Very common(occurring in more than 1 in 10 people):

• headache.

Common(occurring in less than 1 in 10 people):

• dizziness;
• sleepiness or sleep disorders (insomnia);
• palpitations, tachycardia (feeling of irregular and faster heartbeat than usual);
• chest pain;
• vasodilation (flushing);
• dry mouth;
• loss of appetite, nausea, stomach pain, indigestion, diarrhea, constipation;
• general weakness, numbness or tingling of hands or feet ("pins and needles");
• blurred vision;
• abnormal liver function test results (dose-dependent increase in liver enzyme activity);
• irritability.

Uncommon(occurring in less than 1 in 100 people):

• CNS stimulation;
• back pain, neck pain, muscle pain, muscle weakness, calf cramps, joint pain;
• vertigo (feeling of spinning);
• difficulty with muscle movement or other movement difficulties, with muscle tension, with coordination (increased muscle tone, tremors, lack of coordination, movement disorder);
• hyperkinesia, dyskinesia (uncoordinated and involuntary movements of limbs or whole body, twisting and arching, involuntary movements of lips, tongue protrusion);
• symptoms of hay fever, including nasal itching, runny nose, or tearing of the eyes;
• increased cough, asthma, shortness of breath;
• skin rash, acne, or itching of the skin;
• sweating;
• hypertension, hypotension, abnormal ECG, and irregular or very slow heartbeat;
• difficulty swallowing (dysphagia), tongue inflammation, mouth ulcers;
• bloating, reflux (stomach acid flowing back), increased appetite, weight changes, changes in thirst or taste;
• nausea (vomiting);
• migraine;
• speech disorders;
• diabetes;
• high blood sugar levels - hyperglycemia;
• high cholesterol levels - hypercholesterolemia;
• swelling of hands and feet;
• sleep disorders, unusual dreams;
• decreased libido;
• nosebleeds, sore throat, sinusitis, rhinitis;
• abnormal vision, dry eye syndrome;
• abnormal urine, frequent urination;
• menstrual disorders;
• abnormal blood test results showing changes in white blood cell count;
• psychomotor hyperactivity;
• hypoesthesia - sensory disorders.

Frequency not known(frequency cannot be estimated from the available data):

• urticaria, hypersensitivity reactions (characterized by fever, rash, lymph node enlargement, and signs of simultaneous involvement of other organs), anaphylaxis;
• delusions;
• skin reactions including polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Actimodan

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Markings on the blister: Lot - batch number, EXP - expiry date.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Actimodan contains

• The active substance of the medicine is modafinil. Each tablet contains 100 mg or 200 mg of modafinil.
• The other ingredients of the medicine are: lactose monohydrate, sodium carmellose, povidone K 30, magnesium stearate.

What Actimodan looks like and contents of the pack

Actimodan 100 mg is a white or almost white uncoated tablet with the markings "41" on one side and "J" on the other, measuring 12.6 mm × 5.5 mm.
The packaging of the medicine is blisters in a cardboard box. The packaging contains 30 or 100 tablets.
Actimodan 200 mg is a white or almost white uncoated tablet with the markings "4" and "2" separated by a dividing line on one side and "J" on the other, measuring 16.0 mm × 7.0 mm.
The tablet can be divided into equal doses.
The packaging of the medicine is blisters in a cardboard box. The packaging contains 30 or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
Partyzancka 133/151
95-200 Pabianice
Phone: +48 (42) 22-53-100

Importer/Manufacturer

APL Swift Services (Malta) Ltd,
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

Date of last revision of the leaflet:

• 23.02.2022