MODAFINILO 100 mg Tablets

2. What you need to know before you take Modafinil Viatris

Do not take Modafinil Viatris:

• If you are allergic to modafinil or any of the other ingredients of this medicine (listed in section 6).
• If you have an irregular heartbeat.
• If you have moderate to severe high blood pressure that is not controlled (hypertension).

Warnings and precautions

Consult your doctor or pharmacist before starting Modafinil Viatris:

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

Other aspects to discuss with your doctor or pharmacist

• Some people have reported thoughtsor behaviors of suicideor aggressionwhile taking this medicine. Inform your doctor immediately if you notice that you feel depressed, feel aggressiveor hostiletowards others, or have suicidal thoughtsor other changes in behavior (see section 4). You may ask a family member or close friend to help you monitor if you show signs of depression or other changes in 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 periodically check if it is still the right medicine for you.

During treatment

Consult your doctor or pharmacist:

• If you experience fever or skin rash associated with:

• itching of the skin or lack of energy,
• blood test results indicating inflammation of the heart membrane,
• inflammation of the liver or abnormal blood test results showing liver dysfunction,
• increase in a certain type of blood cell (which can cause symptoms such as increased infections or fever; for example, if you suffer from sore throat, experience mouth ulcers, or notice that you develop bruises or bleed more easily and without apparent reason).

These may be symptoms of a potentially life-threatening multi-organ hypersensitivity reaction.

• If you develop a 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 have a high temperature (fever) and abnormal blood test results (see section 4, Possible side effects).
• If you have difficulty sleeping or staying asleep.

Children and adolescents

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

Other medicines and Modafinil Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. Modafinil Viatris 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 Modafinil Viatris:

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

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or breastfeeding.

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

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

Do not take this medicine if you are breastfeeding, as it may pass into breast milk.

Driving and using machines

Modafinil Viatris may cause blurred vision or dizziness in 1 in 10 patients.

If you notice any of these effects or notice that you still feel sleepy while taking this medicine, avoid driving vehicles or using machines.

Modafinil Viatris contains lactose.

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

Modafinil Viatris contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Modafinil Viatris

Take this medicine exactly as your doctor has told you. If you are not sure, ask 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 some 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 your daily dose (up to a maximum of 400 mg per day) if you do not have liver or kidney problems.

Adults with severe liver problems

The recommended dose is 100 mg per day.

Your doctor will periodically review your treatment to ensure it is suitable for you.

The tablets should be swallowed whole with a little water.

If you take more Modafinil Viatris than you should

If you have taken too many tablets, you may feel unwell, anxious, disoriented, confused, agitated, anxious, or excited. You may also experience difficulty sleeping, diarrhea, hallucinations (hearing, seeing, or feeling things that are not real), chest pain, a change in your heart rate, or an increase in your blood pressure. Contact the emergency department of your nearest hospital or consult your doctor or pharmacist immediately.

Bring this leaflet and any remaining tablets with you

If you forget to take Modafinil Viatris

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 on 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 taking this medicine and inform your doctor immediately if:

• You experience sudden shortness of breath, difficulty breathing, or start to experience swelling of the face, mouth, or throat.
• You develop a 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 have a high 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,
• uncontrolled laughter or crying,
• 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
• Somnolence, extreme tiredness, or difficulty sleeping (insomnia).
• Feeling of palpitations, which may be faster than normal.
• Chest pain
• Flushing
• Dry mouth.
• Increased 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 (increased 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 like 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 coughing, asthma, or shortness of breath
• Skin rash, acne, or itchy skin
• Sweating
• Changes in blood pressure (increase or decrease), alteration of the heart tracing (ECG), and irregular or unusually slow heartbeats
• Difficulty swallowing, swollen tongue, or mouth sores
• Excess gas, reflux (regurgitation of stomach liquid), increased appetite, weight changes, thirst, or altered 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
• Decreased libido
• 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 movement

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Modafinil Viatris

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 outer packaging and blister after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Modafinil Viatris

The active substance is modafinil.

Each Modafinil Viatris 100 mg tablet contains 100 mg of modafinil

The other ingredients are: lactose (see section 2 "Modafinil Viatris contains lactose"), sodium croscarmellose, povidone, and magnesium stearate.

Appearance of Modafinil Viatris and pack contents

Modafinil Viatris 100 mg tablets

White or almost white, capsule-shaped tablets, approximately 12.6 mm x 5.5 mm, and marked with a "41" on one side and a "J" on the other. Available in packs of aluminum/PVC-PVdC blister packs of 30, 60, or 90 tablets and plastic bottles of 30 and 100 tablets. The bottles contain a desiccant; do not ingest the desiccant.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin

Unit 35/36 Baldoyle Industrial Estate,

Grange Road, Dublin 13

Ireland

or

Mylan Hungary Kft.

Mylan utca 1.

Komárom, H-2900

Hungary

You can request more information about this medicine from the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Revision date of this leaflet:September 2020

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/