Prospect: information for the patient

Modafinilo Viatris 100mg tablets EFG

Read this prospect carefully before starting to take this medication, as 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 medication has been prescribed only to you and should not be given to other people, even if they have the same symptoms as you, 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 section4.

1.What is Modafinilo Viatrisand for what it is used

2.What you need to know before starting to take Modafinilo Viatris

3.How to take Modafinilo Viatris

4.Adverse effects

5.Storage of Modafinilo Viatris

6.Contents of the package and additional information

The active ingredient in the tablets is modafinilo. Modafinilo 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).

Modafinilo may improve narcolepsy and reduce the likelihood of sleep attacks, although there may be other ways to improve your condition, and your doctor will inform you of them.

Do not take Modafinilo Viatris:

• If you are allergic to modafinilo or any of the other components of this medication (listed in section6).
• If you have irregular heartbeats.
• If you have moderate to severe, uncontrolled high blood pressure (hypertension).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Modafinilo Viatris:

• If you haveheart problemsorhigh blood pressure. Your doctor will perform regular checks while you are on treatment with Modafinilo Viatris.
• If you have ever haddepression, low mood, anxiety, psychosis(loss of contact with reality),mania(excessive excitement or elevated mood) orbipolar disorder, as Modafinilo Viatris may worsen your condition.
• If you havekidney diseaseorliver disease(as you may need a lower dose).
• If you have a history ofproblems with alcoholordrugs.

Other aspects to discuss with your doctor or pharmacist

• Some people have reportedthoughtsorbehavioural changeswhile taking this medication. Inform your doctor immediately if you notice that you aredepressed,feel aggressiveorhostiletowards others or havethoughts of suicideor other changes in your behaviour (see section4). You can ask a family member or close friend to help you monitor for signs of depression or other changes in your behaviour.
• This medication may cause you to 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 check regularly to see if it is still the right medication for you.

During treatment

Consult your doctor or pharmacist:

• If you experience fever or skin rash associated with:

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

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

• If you experience a skin rash or itching (especially if it affects your entire body). Severe skin rashes may cause blisters or skin peeling, mouth sores, eye, nose, or genital sores. You may also experience high temperature (fever) and abnormal blood test results (see section4, Possible side effects).
• If you have difficulty falling asleep or staying asleep.

Children and adolescents

Children under 18 years old should not take this medication.

Other medications and Modafinilo Viatris

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication, including those purchased without a prescription. Modafinilo Viatris 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 Modafinilo Viatris:

• Birth control hormones (including the pill, implants, intrauterine devices (IUDs) and patches). You should consider alternative birth control methods while taking Modafinilo Viatris and for at least two months after stopping treatment, as Modafinilo Viatris reduces the effectiveness of birth control.
• Omeprazole (for acid reflux, indigestion or ulcers).
• Antiviral medications for HIV treatment (such as protease inhibitors, e.g. indinavir or ritonavir).
• Ciclosporin (used to prevent organ rejection after transplantation or for arthritis or psoriasis).
• Medications for epilepsy (such as carbamazepine, phenobarbital or phenytoin).
• Medications for depression (such as amitriptyline, citalopram or fluoxetine) or anxiety (such as diazepam).
• Medications to thin the blood (such as warfarin). Your doctor will monitor your coagulation time during treatment.
• Calcium channel blockers or beta-blockers for high blood pressure or heart problems (such as amlodipine, verapamil or propranolol)
• Statins, medications to reduce cholesterol (such as atorvastatin or simvastatin).

Pregnancy and breastfeeding

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

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

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

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

Driving and operating machinery

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

If you experience any of these effects or still feel drowsy while taking this medication, avoid driving vehicles or operating machinery.

Modafinilo Viatris contains lactose.

If your doctor has told you that you have a certain sugar intolerance, contact them before taking this medication.

Modafinilo Viatris contains sodium.

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of 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.

Older adults (age 65 years and older)

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 severe liver or kidney problems.

Adults with severe liver problems

The recommended dose is 100 mg per day.

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

The tablets should be swallowed whole with a little water.

If you take more Modafinilo Viatris 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 (hearing, seeing, or feeling things 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.

Carry this leaflet and the rest of the tablets with you.

If you forget to take Modafinilo Viatris

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 taking this medicine and immediately inform your doctor if:

• You experience sudden shortness of breath, difficulty breathing, or start to experience swelling of the face, mouth, or throat.
• You present a 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,
• Incontrollable laughter or crying,
• Hyperexcitement or hyperactivity,
• 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 fatigue or difficulty falling asleep (insomnia).
• Sensation of rapid heartbeats.
• Chest pain.
• Redness.
• Dry mouth.
• Increased 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.

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 (sensation of spinning head).
• 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), altered heart rhythm (ECG) and irregular or abnormally slow heartbeats.
• Difficulty swallowing, tongue swelling or mouth sores.
• Gas, reflux (regurgitation of stomach contents), increased appetite, weight changes, thirst or altered taste.
• Desire to vomit.
• Migraine.
• Speech difficulties.
• Diabetes with increased blood sugar.
• Increased cholesterol in the blood.
• Swelling of hands and feet.
• Interrupted sleep or abnormal dreams.
• Decreased libido.
• Nasal bleeding, sore throat or sinusitis (inflammation of the nasal passages).
• 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 movement.

Reporting side effects

If you experience side effects, consult your doctor or pharmacist, even if they do not appear in this leaflet. You can also report side effects directly throughthe Spanish System for Pharmacovigilance of Medicines for Human Use: https://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 outer packaging and the blister pack 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 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 Modafinilo Viatris

The active ingredient is modafinilo.

Each Modafinilo Viatris 100 mg tablet contains 100 mg of modafinilo.

The other components are: lactose (see section 2 "Modafinilo Viatris contains lactose"), croscarmelosa sódica, povidona, and estearato de magnesio.

Appearance of Modafinilo Viatris and packaging contents

Modafinilo Viatris 100 mg tablets

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

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible 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 medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Last review date of this leaflet:September 2020

More detailed and up-to-date information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/