Prospect: information for the user

MODIODAL 100 mg tablets

modafinil

Read this prospect carefully before starting to take this medicine,because

it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribedonlyto you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this prospect. See section 4.

1. What is Modiodal and for what it is used

2. What you need to knowbefore starting totake Modiodal

3. How to take Modiodal

4. Possible adverse effects

5. Storage of Modiodal

6. Contents of the package andadditional information

The active ingredient in the tablets is modafinil.

Modafinil can be used by adults who suffer from narcolepsy to help them stay awake.

Narcolepsy is a condition that causes excessive daytime sleepiness and a tendency to fall asleep suddenly in inappropriate situations (sleep attacks). Modafinil may improve narcolepsy and reduce the likelihood of experiencing sleep attacks, although there may be other ways to improve your condition and your doctor will inform you of them.

Do not take Modiodal:

• if you areallergicto modafinilo or to any of the other components of this medication (listed in section 6).
• if you haveirregular heartbeats
• if you havehigh blood pressure, moderate or severe, that is not controlled(hypertension).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Modiodal:

• if you haveheart problemsorhigh blood pressure. Your doctor will perform regular checks while you are on treatment with Modiodal.
• if you have ever haddepression,melancholy,anxiety,psychosis(loss of contact with reality) ormania(hyperexcitement or feeling of exaltation of mood) orbipolar disorder,since Modiodal may worsen your condition.
• if you have akidney diseaseorliver disease(since you will need to take a lower dose).
• if you have had problems withalcoholordrugsin the past.

Other aspects to discuss with your doctor or pharmacist.

• Some people have reportedthoughtsoraggressive behaviorwhile taking this medication.Inform your doctor immediatelyif you notice that you aredepressed,feel aggressive or hostiletowards others or havesuicidal thoughtsor other changes in your behavior (see section 4). You can ask a family member or close friend to help you monitor if you show signs of depression or other changes in behavior.

• This medication may make you feel that you need it (dependence) after using it for a long time. If you need to take it for a long period, your doctor will monitor regularly if it is still the appropriate medication for you.

Children and adolescents

Children under 18 years old should not take this medication.

Other medications and Modiodal

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.

Modiodal and other medications may affect each other and your doctor may need to adjust the doses you are taking. It is especially important if you are taking any of the following medications with Modiodal:

• Contraceptiveshormones (including birth control pills, implants, intrauterine devices (IUDs) and patches). You should consider other birth control methods while taking Modiodal and for at least two months after stopping treatment, since Modiodal reduces its effectiveness.
• Omeprazol(for acid reflux, indigestion or ulcers).
• Antiviral medications for the treatment of HIV infection (protease inhibitors, e.g. indinavir or ritonavir).
• Ciclosporina(used to prevent organ rejection after transplantation or for arthritis or psoriasis).
• Medications forepilepsy(e.g. carbamazepine, phenobarbital or phenytoin).
• Medications fordepression(e.g. amitriptilina, citalopram or fluoxetina) oranxiety(e.g. diazepam).
• Medications to thin the blood (e.g.warfarina). Your doctor will monitor your coagulation time during treatment.
• Calcium channel blockers or beta-blockers forhigh blood pressureor heart problems (e.g. amlodipino, verapamilo or propranolol).
• Statins, medications to reducecholesterol(e.g. atorvastatina or simvastatina).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, do not take Modiodal.

Modafinilo is suspected to cause birth defects if taken during pregnancy.

Consult your doctor about suitable birth control methods for you while you are on treatment with Modiodal (and for two months after stopping it) or if you have any other questions.

Driving and operating machinery

Modiodal may cause blurred vision or dizziness in 1 in 10 patients. If you notice any of these effects or still feel drowsy while taking this medication, avoid driving vehicles or operating machinery.

Important information about some of the components of Modiodal

Use in athletes: this medication contains modafinilo, which may produce a positive result in doping control tests.

Modiodal contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The tablets should be swallowed whole with a little water.

Adults

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

In certain cases, your doctor may decide to increase your daily dose up to 400 mg.

Senior patients (over 65 years old)

The recommended dose is 100 mg per day.

Your doctor will only increase your daily dose (up to a maximum of 400 mg per day) if you do not have liver or kidney disorders.

Adults with severe liver or kidney disorders

The recommended dose is 100 mg per day.

Your doctor will regularly review the treatment to check that it is suitable for you.

If you take more Modiodal than you should

If you have taken too many tablets, you may feel discomfort, restlessness, disorientation, confusion, agitation, anxiety, or excitement. You may also experience difficulty sleeping, diarrhea, hallucinations (sensations that are not real), chest pain, a change in the speed of your heartbeats, or an increase in your blood pressure.

Contact the emergency department of the nearest hospital or consult your doctor or pharmacist immediately. Bring this leaflet and the rest of the tablets with you. You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Modiodal

If you forget to take your medication, take the next dose at the usual time.

Do not take a double dose to make up for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop takingthis medicine andinform your doctor immediatelyif you

• Experience sudden shortness of breath, difficulty breathing, or start to experience swelling of the face, mouth, or throat.
• Experience skin rash or itching (especially if it affects the entire body). Severe skin rashes can cause blisters or skin peeling, mouth sores, eye, nose, or genital sores. You may also experience an increase in body temperature (fever) and abnormal results in blood tests.
• Notice any change in your mental health and well-being. These signs may include:

• Changes in mood or abnormal thoughts,
• Aggression or hostility,
• Forgetfulness or confusion,
• Extreme feelings of happiness,
• Hypervigilance or hyperactivity,
• Anxiety or nervousness,
• Depression, suicidal thoughts or behavior,
• Restlessness and/or psychosis (loss of contact with reality that may include delusional ideas or sensations that are not real), feeling of isolation or personality disorder.

Other side effects include the following

Side effectsvery common(may affect more than 1 in 10 patients)

• Headache

Side effectscommon(may affect up to 1 in 10 patients)

• Dizziness
• Somnolence, extreme fatigue or difficulty falling asleep (insomnia)
• Palpitations, which may be faster than normal
• Chest pain
• Flushing
• Dry mouth
• Loss of appetite, discomfort, stomach pain, indigestion, diarrhea, or constipation
• Weakness.
• Numbness or tingling in hands or feet
• Blurred vision
• Abnormal results in blood tests showing liver function (elevated liver enzymes).
• Irritability

Side effectsuncommon(may affect up to 1 in 100 patients)

• Back pain, neck pain, muscle pain, muscle weakness, leg cramps, joint pain, spasms, or tremors
• Dizziness (sensation of spinning)
• Difficulty moving muscles smoothly or other movement difficulties, muscle tension, coordination difficulties
• Hay fever symptoms including runny nose and itchy eyes
• Increased cough, asthma, or shortness of breath
• Skin rash, acne, or itchy skin
• Sweating
• Changes in blood pressure (increase or decrease), alteration of heart rhythm (ECG) and irregular or abnormally slow heartbeats
• Difficulty swallowing, tongue swelling, or mouth sores
• Excess gas, reflux (regurgitation of stomach liquid), increased appetite, weight changes, thirst, or altered taste
• Desire to vomit
• Migraine
• Speech disorders
• Diabetes with increased blood sugar
• Increased cholesterol in the blood
• Swelling of hands and feet
• Interrupted sleep or abnormal dreams
• Loss of sexual appetite
• Nasal bleeding, throat pain, or inflammation of the nasal passages (sinusitis)
• Abnormal vision or dry eyes
• Abnormal urine or increased frequency of urination
• Menstrual disorders
• Abnormal results in blood tests showing changes in white blood cells.
• Restlessness with increased body movements

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.

You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not take this medication after the expiration date that appears on the blister pack and on the packaging after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Modiodal 100 mg tablets

• The active ingredient is modafinil. Each Modiodal 100 mg tablet contains 100 mg of modafinil.
• The other components are: lactose monohydrate (see section 2), maize pregelatinized starch, microcrystalline cellulose, sodium croscarmellose, povidone K29/32, and magnesium stearate.

Appearance of the product and contents of the packaging

Modiodal 100 mg is presented in tablets with a capsule shape of 13 x 6 mm, white to almost white, marked with “100” on one side.

Modiodal is available in blister packs of 10, 20, 30, 50, 60, 90, 100, or 120 tablets.

Only some sizes of packaging may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Teva Pharma, B.V.
Swensweg, 5
2031 GA- Haarlem
Netherlands

Responsible manufacturer:

Teva Operations Poland Sp. z.o.o.

ul Mogilska 80

31-546 Kraków

Poland

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Austria: MODASOMIL

Czech Republic, Germany: VIGIL

Cyprus, Denmark, France, Greece, Iceland, Netherlands, Norway, Portugal, Spain: MODIODAL

Belgium, Ireland, Italy, Luxembourg, United Kingdom (Northern Ireland): PROVIGIL

The 100 mg dose is authorized in all countries listed above. The 200 mg dose is only authorized in Germany and Ireland.

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

Anabel Segura, 11

Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid)

This leaflet was approved in April 2021.

Detailed and updated information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/