MODAFINIL AUROVITAS 100 mg TABLETS

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

Do not take Modafinil

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

Warnings and precautions

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

• if you have heart problemsor high blood pressure. Your doctor will perform regular checks while you are being treated with 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 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 alcoholor drugsin the past.

Other aspects to discuss with your doctor or pharmacist

• Some people have reported thoughtsor behaviors of 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 can 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.

Children and adolescents

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

Other medicines and Modafinil Aurovitas

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Modafinil and other medicines can 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 Modafinil:

• Hormonal contraceptives(including birth control pills, implants, intrauterine devices (IUDs), and patches). You should consider other contraceptive methods while taking Modafinil and for at least two months after stopping treatment, as Modafinil reduces 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 and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

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

Driving and using machines

Modafinil may cause blurred vision or dizziness in 1 in 10 people. If you notice any of these effects or notice that you still feel sleepy while taking this medicine, avoid driving vehicles or using machines.

Modafinil Aurovitas contains lactose

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

Modafinil Aurovitas contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per tablet; this is essentially “sodium-free”.

3. How to take Modafinil Aurovitas

Follow exactly the administration instructions of this medicine given 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.

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 liver or kidney disorders.

Adults with severe liver or kidney disorders

The recommended 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 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 (sensations 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. Bring this leaflet and the remaining tablets with you.

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

If you forget to take Modafinil

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 side effects

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

Stop taking this 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 skin 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:
• • mood changes or abnormal thoughts,
  • aggression or hostility,
  • forgetfulness or confusion,
  • feeling extremely happy,
  • overexcitement or overactivity,
  • 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:

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)
• Feeling of heartbeats, 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 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 tracing (ECG), and irregular or unusually slow heartbeats
• Difficulty swallowing, swollen tongue, or mouth ulcers
• Excess gas, reflux (regurgitation of stomach liquid), increased appetite, weight changes, thirst, or alteration of taste
• Feeling sick
• Migraine
• Speech disorders
• Diabetes with high blood sugar
• High blood cholesterol
• Swelling of hands and feet
• Sleep disturbances or abnormal dreams
• Loss of sexual appetite
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Modafinil

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

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the label, carton, and blister after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to a pharmacy for disposal. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Modafinil Aurovitas

• The active substance is modafinil.

Each tablet contains 100 mg of modafinil.

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

Appearance and packaging

This medicine is presented in tablet form.

White to off-white, capsule-shaped, uncoated tablets marked with “41” on one face and “J” on the other face.

This medicine is available in:

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

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Arrow Génériques

26 avenue Tony Garnier,

Lyon, 69007

France

O

Generis Farmacêutica, S.A.

Rua João de Deus 19, Venda Nova

2700-487 Amadora

Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

France: MODAFINIL ARROW 100 mg, comprimé

Germany: Modafinil Aurobindo 100 mg Tabletten

Netherlands: Modafinil Aurobindo 100 mg, tabletten

Spain: Modafinilo Aurovitas 100 mg comprimidos EFG

Date of last revision of this leaflet: February 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es