MODIODAL 100 mg TABLETS

2. What you need to know before you take Modiodal

Do not take Modiodal:

• if you are allergicto modafinil or any of the other ingredients of this medicine (listed in section 6).
• if you have irregular heartbeats
• if you have moderate to severe high blood pressure, not controlled(hypertension).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Modiodal:

• if you have heart problemsor high blood pressure. Your doctor will perform regular checks while you are being treated with Modiodal.
• if you have ever suffered from depression, low mood, anxiety, psychosis(loss of contact with reality) or mania(overexcitement or feeling of elation) or bipolar disorder, as Modiodal may worsen your condition.
• if you have kidney or liver disease(as you may need to take a lower dose).
• if you have had problems with alcoholor drugsin the past.

Other aspects to discuss with your doctor or pharmacist.

• Some people have reported thoughtsor behaviors of suicideor aggressionwhile taking this medicine. Tell your doctor immediatelyif you notice that you are feeling depressed, feeling aggressive or hostiletowards others or having suicidal 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 your behavior.

• This medicine may make you feel like you need it (dependence) after using it for a long time. If you need to take it for a long period, your doctor will check periodically if it is still the right medicine for you.

Children and adolescents

Children under 18 years of age should not take this medicine.

Other medicines and Modiodal

Tell your doctor or pharmacist if you are using or have recently used or may have to use any other medicines.

Modiodal and other medicines 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 medicines with Modiodal:

• Hormonal contraceptives(including birth control pill, implants, intrauterine devices (IUDs) and patches). You should consider other contraceptive methods while taking Modiodal and for at least two months after stopping treatment, as Modiodal reduces their effectiveness.
• Omeprazole(for acid reflux, indigestion or ulcers).
• Antiviral medicines for the treatment of HIV infection (protease inhibitors, e.g. indinavir or ritonavir).
• Ciclosporin(used to prevent organ rejection after transplantation or for arthritis or psoriasis).
• Medicines for epilepsy(e.g. carbamazepine, phenobarbital or phenytoin).
• Medicines for depression(e.g. amitriptyline, citalopram or fluoxetine) or anxiety(e.g. diazepam).
• Medicines to thin the blood (e.g. warfarin). Your doctor will check your blood clotting time during treatment.
• Calcium channel blockers or beta-blockers for high blood pressureor heart problems (e.g. amlodipine, verapamil or propranolol).
• Statins, medicines to lower cholesterol(e.g. atorvastatin or simvastatin).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, do not take Modiodal.

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

Consult your doctor about suitable contraceptive methods for you while being treated with Modiodal (and for two months after stopping) or if you have any other questions.

Driving and using machines

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

Important information about some of the ingredients of Modiodal

Use in athletes: this medicine contains modafinil, which may produce a positive result in doping tests.

Modiodal contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

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

3. How to take Modiodal

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

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.

Elderly patients (over 65 years of age)

The recommended dose is 100 mg per day.

Your doctor will only increase the 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 review your treatment periodically 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 unwell, restless, disoriented, confused, agitated, anxious or excited. 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 remaining tablets with you. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Modiodal

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

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

If you have any further questions about the use of 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.

Stop takingthis medicine and tell your doctor immediatelyif

• You experience sudden shortness of breath, difficulty breathing or start to experience swelling of the face, mouth or throat.
• You experience skin rash or itching (especially if it affects the whole body). Severe skin rashes can cause blisters or peeling of the skin, sores in the mouth, eyes, nose or genitals. You may also experience a rise in body temperature (fever) and abnormal blood test results.
• You notice any change in your mental health and well-being. These signs may include:

• mood changes or abnormal thoughts,
• aggression or hostility,
• forgetfulness or confusion,
• feeling extremely happy,
• overexcitement or overactivity,
• anxiety or nervousness,
• depression, suicidal thoughts or behavior,
• agitation 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

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, extreme tiredness or difficulty sleeping (insomnia)
• Feeling of heartbeat, which may be faster than normal
• Chest pain
• Flushing
• Dry mouth
• Loss of appetite, nausea, stomach pain, indigestion, diarrhea or constipation
• Weakness.
• Numbness or tingling in hands or feet
• Blurred vision
• Abnormal blood test results showing liver function (increase in liver enzymes).
• Irritability

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

• Back pain, neck pain, muscle pain, muscle weakness, leg cramps, joint pain, spasms or tremors
• Dizziness (feeling that your head is spinning)
• Difficulty moving your muscles smoothly or other movement difficulties, muscle tension, coordination difficulties
• Symptoms of hay fever including runny nose and itchy eyes
• Increased cough, asthma or shortness of breath
• Skin rash or acne or itchy skin
• Sweating
• Changes in blood pressure (increase or decrease), alteration of heart tracing (ECG) and irregular or unusually slow heartbeats
• Difficulty swallowing, swollen tongue or sores in the mouth
• Excess gas, reflux (regurgitation of stomach liquid), increased appetite, weight changes, thirst or alteration of taste
• Feeling sick
• Migraine
• Speech disorders
• Diabetes with increased blood sugar
• Increased cholesterol in the blood
• Swelling of hands and feet
• Sleep disturbance or abnormal dreams
• Loss of sexual desire
• Nosebleeds, sore throat or inflammation of the nasal passages (sinusitis)
• Abnormal vision or dry eyes
• Abnormal urine or increased frequency of urination
• Menstrual disorders
• Abnormal blood test results showing changes in white blood cells.
• Restlessness with increased body movements

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Modiodal

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

Do not take this medicine after the expiry date which is stated on the blister and on the carton after “EXP”. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Modiodal 100 mg tablets

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

Appearance and packaging

Modiodal 100 mg is presented in capsule-shaped tablets, 13 x 6 mm in size, white to almost white, marked with “100” on one face.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí - Barcelona

Spain

Manufacturer:

Teva Operations Poland Sp. z.o.o.

ul Mogilska 80

31-546 Kraków

Poland

This medicine is authorized in the Member States of the European Economic Area under 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 the countries mentioned above. The 200 mg dose is only authorized in Germany and Ireland.

For further information about this medicine, please contact the local representative of the marketing authorization holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona 69

08970 Sant Joan Despí - Barcelona

Spain

This leaflet was approved in April 2021.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/