Package Leaflet: Information for the User

Modafinilo Tarbis 100mg 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, pharmacist or nurse even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Modafinilo Tarbis

4. Possible side effects

5. Storage of Modafinilo Tarbis

6. Contents of the pack and additional information

The active ingredient in the tablets is modafinilo.

Modafinilo can be used by adults who suffer from narcolepsia to help them stay awake.

Narcolepsia is a condition that causes excessive daytime sleepiness and a tendency to fall asleep suddenly in inappropriate situations (sleep attacks). Modafinilo may improve narcolepsia and reduce the likelihood of experiencing sleep attacks, although there may be other ways to improve your condition and your doctor will inform you of them.

Do not take Modafinilo Tarbis

• if you areallergicto modafinilo or to any of the other components of this medication (listed in section 6).
• if you haveirregular heartbeats
• if you havehigh blood pressure, moderate or severe, that is not controlled(hypertension).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Modafinilo Tarbis.

-if you have heart problemsorhigh blood pressure. Your doctor will perform regular checks while you are on treatment with medications containing modafinilo.

- if you have ever haddepression,low mood,anxiety,psychosis(loss of contact with reality) ormania(excessive excitement or feeling of elation) orbipolar disorder,since medications containing modafinilo may worsen your condition.

- if you have akidney diseaseorliver disease(since you will need to take a lower dose).

- if you have had problems withalcoholordrugsin the past.

Children and adolescents

Children under 18 years old should not take this medication.

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 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 monitor regularly if it is still the appropriate medication for you.

Use of Modafinilo Tarbis with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Medications containing 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 medications containing modafinilo

• Contraceptiveshormones (including birth control pills, implants, intrauterine devices (IUDs), and patches). You should consider other birth control methods while taking medications containing modafinilo and for at least two months after stopping treatment, since medications containing modafinilo reduce 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 coagulation 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, lactation, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, do not take modafinilo.

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 medications containing modafinilo (and for two months after stopping) or if you have any other questions.

Driving and operating machines

Medications containing modafinilo may cause blurred vision or dizziness in 1 in 10 patients. If you notice any of these effects or still feel drowsy while taking this medication, avoid driving vehicles or operating machines.

Important information about some of the components of Modafinilo Tarbis

Use in athletes: This medication contains modafinilo, which may produce a positive result in doping control tests.

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

Always follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults

The usual 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 patients (age 65 years or older)

The usual 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 usual dose is 100 mg per day.

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

If you take more Modafinilo Tarbis than you should

If you have taken too many tablets, you may feel discomfort, restlessness, disorientation, confusion, 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 your doctor or pharmacist immediately. Bring this leaflet and the remaining tablets with you. You can also call the Toxicological Information Service, phone 915620420, indicating the medication and the amount ingested.

If you forget to take Modafinilo Tarbis

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 interrupt treatment with Modafinilo Tarbis

If you have any other questions about the use of this product, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop takingthis medicine andinform your doctor immediatelyif:

• Experience sudden shortness of breath, difficulty breathing, or start to experience swelling of the face, mouth, or throat.

• Experience 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:

orchanges in mood or abnormal thoughts,

oraggression or hostility,

orforgetfulness or confusion,

orextreme happiness,

orhyperexcitement or hyperactivity,

oranxiety or nervousness,

ordepression, suicidal thoughts or behavior,

oragitation 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:

Side effectsvery common(may affect more than 1 in 10 patients):

• Headache

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

-Dizziness

-Somnolence, extreme fatigue or difficulty falling asleep (insomnia)

-Sensation of rapid heartbeats, 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 patients):

-Back pain, neck pain, muscle pain, muscle weakness, leg cramps, joint pain, spasms or tremors

-Vertigo (sensation of spinning)

-Difficulty moving 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, acne or itchy skin

-Sweating

-Changes in blood pressure (increase or decrease), alteration of heart rhythm (ECG) and irregular or abnormally slow heartbeats

-Difficulty swallowing, tongue swelling or mouth sores

-Excess gas, reflux (regurgitation of stomach contents), 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 interruption or abnormal dreams

-Loss of sexual appetite

-Nasal bleeding, sore throat or inflammation of nasal passages (sinusitis)

-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 movements

Reporting side effects:

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in Annex V*. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the outer packaging and the blister 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 packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Modafinilo Tarbis 100 mg

Each tablet contains 100 mg of active ingredient modafinilo. The other components are Lactose monohydrate, Cornstarch pregelatinized, Microcrystalline cellulose, Sodium croscarmellose, Povidone K 29/32, Talc, and Magnesium stearate.

Appearance of the product and contents of the packaging

White, circular, biconvex tablet.

The tablets are presented in blisters containing 20, 30, 50, 60, 90, or 100 tablets.Only some sizes of packaging may be commercially available.

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Responsible for Manufacturing

Lacer, S.A.

c/Boters, 5

08290 Cerdanyola del vallès, Barcelona

Spain

This leaflet was approved in: July 2019

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