MODAFINIL TARBIS 100 mg TABLETS

Introduction

Package Leaflet: Information for the User

Modafinil Tarbis 100mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

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

Do not take Modafinil Tarbis

• if you are allergicto modafinil or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from irregular heart rhythm
• if you have moderate or severe uncontrolled high blood pressure(hypertension).

Warnings and precautions

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

• if you have heart problems or high blood pressure. Your doctor will perform regular checks while you are being treated with medicines containing modafinil.
• if you have ever suffered from depression, low mood, anxiety, psychosis (loss of contact with reality) or mania (overexcitement or elevated mood) or bipolar disorder, as medicines containing modafinil may worsen your condition.
• if you have kidney or liver disease (as you may need to take a lower dose).
• if you have had problems with alcohol or drugs in the past.

Children and adolescents

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

Other aspects to discuss with your doctor or pharmacist

Some people have reported thoughtsor behaviorsof suicideor aggressionwhile taking this medicine. Tell your doctor immediatelyif you notice that you are depressed, feel aggressive or hostiletowards others or have suicidal 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 your 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.

Using Modafinil Tarbis with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Medicines containing modafinil 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 medicines containing modafinil

• Hormonal contraceptives(including birth control pill, implants, intrauterine devices (IUDs) and patches). You should consider other contraceptive methods while taking medicines containing modafinil and for at least two months after stopping treatment, as medicines containing modafinil reduce their effectiveness.
• Omeprazole(for acid reflux, indigestion or ulcers).
• Antiviral medicines for the treatment of HIV infection (protease inhibitors, e.g. indinavir or ritonavir).
• Ciclosporin(used to prevent organ rejection after transplantation 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 check your blood clotting time during treatment.
• Calcium channel blockers or beta-blockers for high blood pressureor heart problems (e.g. amlodipine, verapamil or propranolol).
• Statins, medicines to lower cholesterol(e.g. atorvastatin or simvastatin).

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, do not take modafinil.

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

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

Driving and using machines

Medicines containing modafinil 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.

Important information about some of the ingredients of Modafinil Tarbis

Use in athletes: this medicine contains modafinil, which may produce a positive result in doping tests.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Modafinil Tarbis

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask 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.

Elderly patients (over 65 years of age)

The usual 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 liver or kidney disorders.

Adults with severe liver or kidney disorders

The usual dose is 100 mg per day.

Your doctor will periodically review the treatment to check that it is suitable for you.

If you take more Modafinil Tarbis than you should

If you have taken too many tablets, you may feel unwell, restless, disoriented, confused or excited. You may also experience difficulty sleeping, diarrhea, hallucinations (sensations that are not real), chest pain, a change in heart rate or an increase in blood pressure.

Contact the emergency department of the nearest hospital or consult your doctor or pharmacist immediately. Bring this leaflet and the remaining tablets with you. You can also call the Toxicology Information Service, phone 915620420, indicating the medicine and the amount taken.

If you forget to take Modafinil Tarbis

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 stop taking Modafinil Tarbis

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop takingthis medicine and tell your doctor immediatelyif:

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

• You experience a rash or itching (especially if it affects the whole body). Severe skin rashes can cause blisters or peeling of the skin, ulcers in the mouth, eyes, nose or genitals. You may also experience a rise in body temperature (fever) and abnormal blood test results.

• You notice any change in your mental health and well-being. These signs may include:

or mood changes or abnormal thoughts,

or aggression or hostility,

or forgetfulness or confusion,

or feeling extremely happy,

or overexcitement or hyperactivity,

or anxiety or nervousness,

or depression, suicidal thoughts or behavior,

or 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

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

- Feeling of heartbeat, which may be faster than normal

- Chest pain

- Flushing

- Dry mouth

- Loss of 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 (increase in 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 that 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 cough, asthma or shortness of breath
• Skin rash, acne or itchy skin
• Sweating
• Changes in blood pressure (increase or decrease), alteration of the heart record (ECG) and irregular or unusually slow heartbeats
• Difficulty swallowing, swollen tongue or ulcers in the mouth
• Excess gas, reflux (regurgitation of stomach liquid), increased appetite, weight changes, thirst or alteration of 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
• Loss of sexual desire
• 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 movements

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system included in Annex V* By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Modafinil Tarbis

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer packaging and blister after “EXP”. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Modafinil Tarbis 100 mg

Each tablet contains 100 mg of modafinil as the active substance. The other ingredients are lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium croscarmellose, povidone K 29/32, talc and magnesium stearate.

Appearance of the product and pack contents

White, circular, biconvex tablet.

The tablets are available in blister packs containing 20, 30, 50, 60, 90 or 100 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer

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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/