Package Leaflet: Information for the User

Modafinilo Aurovitas 100 mg Tablets EFG

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Modafinilo Aurovitas and what it is used for

2.What you need to know before you start taking Modafinilo Aurovitas

3.How to take Modafinilo Aurovitas

4.Possible side effects

5Storage of Modafinilo Aurovitas

6.Contents of the pack and additional information

The active ingredient in the tablets is modafinil.

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

Do not take Modafinilo

• if you areallergicto modafinilo or to any of the components of this medication (listed in section 6).
• if you haveirregular heartbeat
• if you haveuncontrolled high, moderate, or severe blood pressure (hypertension).

Warnings and precautions

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

• if you haveheart problemsorhigh blood pressure. Your doctor will perform regular checks while you are on treatment with Modafinilo.
• if you have ever haddepression, low mood, anxiety, psychosis(loss of contact with reality) ormania(hyperexcitement or feeling of elation) orbipolar disorder, as Modafinilo may worsen your condition.
• if you have a kidney or liver disease(as you may need 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 of time, 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 Modafinilo Aurovitas

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

Modafinilo 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:

• Contraceptives(including the pill, implants, intrauterine devices (IUDs), and patches). You should consider other contraceptive methods while taking Modafinilo and for at least two months after stopping treatment, as Modafinilo reduces their 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. amitriptyline, citalopram, or fluoxetine) oranxiety(e.g. diazepam).
• Medications to thin the blood (e.g.warfarina). Your doctor will monitor your blood clotting time during treatment.
• Calcium channel blockers or beta-blockers forhigh blood pressureor heart problems (e.g. amlodipine, verapamil, or propranolol).
• Statins, medications to reducecholesterol(e.g. atorvastatin or simvastatin).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

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

Driving and operating machinery

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

Modafinilo Aurovitas contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Modafinilo Aurovitas contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it 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.

Senior citizens (age 65 years or 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 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 Modafinilo 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 nearest hospital emergency department or consult immediately with your doctor or pharmacist. Bring this leaflet and the remaining tablets with you.

In case of overdose or accidental ingestion, consult immediately with your doctor or pharmacist or call the Toxicological Information Service. Phone: 91 562 04 20 indicating the medication and the amount ingested.

If you forget to takeModafinilo

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 medications,this medicationcan cause side effects, although not everyone will experience them.

Stop taking this medication andimmediately inform your doctorif:

• 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 your entire body). Severe skin rashes can cause blisters or skin peeling, mouth sores, eye, nose, or genital sores. You may also experience a 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 happiness,
  • Hypervigilance or hyperactivity,
  • Anxiety or nervousness,
  • Depression, suicidal thoughts or behavior,
  • Agitation 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 people):

• Headache

Side effectscommon(may affect up to 1 in 10 people):

• 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 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 difficulties
• Hay fever symptoms including runny nose and itchy eyes
• Increased coughing, asthma or shortness of breath
• Skin rash, acne or itchy skin
• Sweating
• Changes in blood pressure (elevated or decreased), altered ECG, 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 elevated blood sugar
• High cholesterol in the blood
• Swelling of hands and feet
• Interrupted sleep or abnormal dreams
• Loss of sexual appetite
• 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
• Lack of rest with increased body movements

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, 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 the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

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

Use within 4 months after the first opening of the high-density polyethylene (HDPE) bottle.

This medication does not require special storage conditions.

Do not use this medication after the expiration date appearing on the label, box, and blister pack after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medicines. By doing so, you will help protect the environment.

Composition of Modafinilo Aurovitas

• The active ingredient is modafinilo.

Each tablet contains 100 mg of modafinilo.

• The other components are lactose monohydrate, sodium croscarmellose, povidone (K-30), magnesium stearate.

Appearance of the product and contents of the package

This medication is presented in the form of a tablet.

Uncoated tablets of white to off-white color, in the shape of a capsule, marked with “41” on one face and “J” on the other face.

This medication is available in:

PVC/PVdC blister with aluminum foil: packaging of 1, 10, 20, 30, 50, 60, 90, 100, 120, or 500 tablets.

High-density polyethylene (PEAD) bottles with a polypropylene closure containing silica gel desiccant: packaging of 30 and 100 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Arrow Génériques

26avenue Tony Garnier,

Lyon, 69007

France

Or

Generis Farmacêutica, S.A.

Rua João de Deus 19,Venda Nova

2700-487 Amadora

Portugal

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

France:MODAFINIL ARROW 100 mg, tablet

Germany:Modafinil Aurobindo 100 mg Tabletten

Netherlands:Modafinil Aurobindo 100 mg, tabletten

Spain:Modafinilo Aurovitas 100 mg comprimidos EFG

Last review date of this leaflet: February 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es