Modafinil Viatris 100 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Modafinil Viatris 100 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Modafinil Viatris is and what it is used for
2. What you need to know before taking Modafinil Viatris
3. How to take Modafinil Viatris
4. Possible side effects
5. How to store Modafinil Viatris
6. Contents of the pack and other information

1. What Modafinil Viatris is and what it is used for

The active substance 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 can improve narcolepsy and reduce the likelihood of experiencing sleep attacks, although there may also be other ways to improve your condition, and your doctor will inform you about them.

2. What you need to know before taking Modafinil Viatris

Do not take Modafinil Viatris:

• If you are allergic to modafinil or to any of the other ingredients of this medicine (listed in section 6).
• If you have irregular heartbeats.
• If you have moderate or severe uncontrolled high blood pressure (hypertension).

Warnings and precautions

Talk to your doctor or pharmacist before starting Modafinil Viatris:

• If you have heart problems or high blood pressure. Your doctor will carry out regular checks while you are being treated with Modafinil Viatris.
• If you have ever had depression, low mood, anxiety, psychosis (loss of contact with reality), mania (hyperexcitability or elevated mood), or bipolar disorder, as Modafinil Viatris may worsen your condition.
• If you have kidney or liver disease (as you may need to take a lower dose).
• If you have previously had problems with alcohol or drugs.

Other issues to discuss with your doctor or pharmacist

• Some people have reported suicidal thoughts or aggressive behaviour while taking this medicine. Inform your doctor immediately if you notice that you feel depressed, feel aggressive or hostile towards others, or have suicidal thoughts or other changes in behaviour (see section 4). You may wish to ask a family member or close friend to help monitor you for signs of depression or other changes in behaviour.
• This medicine may make you feel that you need it (dependence) after long-term use. If you need to take it for a prolonged period, your doctor will periodically review whether it remains appropriate for you.

During treatment

Talk to 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,

• liver inflammation or test results showing abnormal liver function,

• increase in a certain type of blood cell (which may cause symptoms such as increased infections or fever; for example, if you have a sore throat, mouth ulcers, or notice you are bruising or bleeding more easily and without apparent reason).

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

• If you develop a skin rash or itching (especially if it affects the whole body). Serious skin rashes may 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 falling asleep or staying asleep.

Children and adolescents

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

Other medicines and Modafinil Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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 of the medicines you are taking.

It is especially important if you are taking any of the following medicines together with Modafinil Viatris:

• Hormonal contraceptives (including contraceptive pills, implants, intrauterine devices (IUDs), and patches). You should consider alternative contraceptive methods while taking Modafinil Viatris and for at least two months after stopping treatment, as Modafinil Viatris reduces their effectiveness.
• Omeprazole (for reflux acid, indigestion, or ulcers).
• Antiviral medicines for the treatment of HIV infection (protease inhibitors, e.g. indinavir or ritonavir).
• Cyclosporine (used to prevent rejection of transplanted organs 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 monitor your clotting time during treatment.
• Calcium channel antagonists or beta-blockers for high blood pressure or 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 become pregnant, you must not take this medicine.

Modafinil is suspected of causing congenital malformations if taken during pregnancy.

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

You must 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 out of every 10 patients.

If you experience any of these effects or still feel sleepy while taking this medicine, avoid driving or operating machinery.

Modafinil Viatris contains lactose.

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Modafinil Viatris contains sodium.

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

3. How to take Modafinil Viatris

Follow exactly the instructions given by your doctor for taking this medicine. 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 daily (in the morning) or divided into two daily doses (100 mg in the morning and 100 mg at midday). 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 severe hepatic or renal disorders.

Adults with severe hepatic impairment

The recommended dose is 100 mg per day.

Your doctor will review your treatment periodically to ensure it remains appropriate 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, restless, disoriented, confused, agitated, anxious, or overexcited. You may also experience difficulty sleeping, diarrhoea, 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 nearest hospital emergency department or consult your doctor or pharmacist immediately.

Take 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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop taking this medicine and inform your doctor immediately if:

• You experience sudden wheezing, difficulty breathing, or begin to have swelling of the face, mouth, or throat.
• You develop a skin rash or itching (especially if it affects the whole body). Serious skin rashes may cause blisters or peeling of the skin, sores in the mouth, eyes, nose, or genitals. You may also develop an increase in body temperature (fever) and have abnormal results in blood tests.
• You notice any changes 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,
  • uncontrollable laughing or crying,
  • hyperexcitability or hyperactivity,
  • anxiety or nervousness,
  • depression, suicidal thoughts or behaviour,
  • agitation and/or psychosis (loss of contact with reality which may include delusional ideas or sensations that are not real), feeling of isolation or personality disorder.

Other adverse effects include the following:

Very common adverse effects (may affect more than 1 in 10 people):

• Headache.

Common adverse effects (may affect up to 1 in 10 people):

• Dizziness
• Drowsiness, extreme tiredness, or difficulty falling asleep (insomnia).
• Awareness of heartbeat, which may be faster than normal.
• Chest pain
• Flushing
• Dry mouth
• Increased appetite, discomfort, stomach pain, indigestion, diarrhoea, 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 adverse 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)
• Difficulty moving muscles smoothly or other movement difficulties, muscle tension, coordination problems
• Hay fever-like symptoms, including runny or itchy nose, or watery eyes
• Increased cough, asthma, or shortness of breath
• Skin rash, acne, or itchy skin
• Sweating
• Changes in blood pressure (increase or decrease), abnormal heart tracing (ECG), and irregular or unusually slow heartbeats
• Difficulty swallowing, swollen tongue, or mouth sores
• Excess gas, reflux (regurgitation of stomach fluid), increased appetite, weight changes, thirst, or altered taste
• Nausea
• Migraine
• Speech disorders
• Diabetes with increased blood sugar
• Increased blood cholesterol
• Swelling of hands and feet
• Sleep disturbance or abnormal dreams
• Decreased libido
• Nosebleeds, sore throat, or inflammation of 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 adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report adverse effects directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 use this medicine after the expiry date stated on the outer packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. 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 components are: lactose (see section 2 "Modafinil Viatris contains lactose"), croscarmellose sodium, povidone, and magnesium stearate.

Appearance of Modafinil Viatris and contents of the pack

Modafinil Viatris 100 mg tablets

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

Only certain 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

For more information about this medicine, contact 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:

Date of revision of this leaflet: September 2020

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