Modafinil Aurovitas 100 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Modafinil Aurovitas 100 mg tablets EFG

Please read all of this leaflet carefully before you start taking this medicine, as 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 pass it on to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

The active substance in the tablets is modafinil.

Modafinil Aurovitas can be used by adults suffering 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 Aurovitas

Do not take Modafinil

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Modafinil Aurovitas:

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

Other points to discuss with your doctor or pharmacist

• Some people have reported suicidal thoughts or suicidal behaviour, or aggressive or hostile behaviour while taking this medicine. Inform your doctor immediately if you notice that you feel depressed, feel aggression or hostility towards others, or have suicidal thoughts or other changes in your 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 behavioural changes.
• This medicine may make you feel that you need it (dependence) after long-term use.
• If you need to take it for a long period, your doctor will periodically review whether it is still the appropriate medicine for you.

Children and adolescents

Modafinil must not be used in children under 18 years of age.

Other medicines and Modafinil Aurovitas

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 and other medicines may affect each other, and your doctor may need to adjust the doses you are taking. This is especially important if you are taking any of the following medicines together with Modafinil:

• Hormonal contraceptives (including contraceptive pills, implants, intrauterine devices (IUDs), and patches). You should consider alternative contraceptive methods while taking Modafinil and for at least two months after stopping treatment, as Modafinil 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 blood clotting time during treatment.
• Calcium channel blockers 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Discuss appropriate contraceptive methods with your doctor while being treated with Modafinil (and for two months after stopping treatment), or if you have any other questions.

Driving and using machines

Modafinil may cause blurred vision or dizziness in 1 out of every 10 people. If you experience any of these effects or still feel sleepy while taking this medicine, avoid driving vehicles or operating machinery.

Modafinil Aurovitas contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

Modafinil Aurovitas contains sodium

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

3. How to take Modafinil Aurovitas

Always follow exactly your doctor's instructions for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The tablets should be swallowed whole with some water.

Adults

The recommended dose is 200 mg per day. It may 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 liver or kidney disorders.

Adults with severe liver or kidney disorders

The recommended dose is 100 mg per day.

Your doctor will periodically review your treatment to ensure it remains appropriate 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 overexcited. You may also experience difficulty sleeping, diarrhoea, hallucinations (sensations 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.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Poison Information Service. Telephone: 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take Modafinil

If you forget to take your medicine, take the next dose at your usual time. Do not take a double dose to make up for forgotten doses.

If you have any other 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 experiences them.

Stop taking this medicine and inform your doctor immediately if:

• You experience sudden wheezing, difficulty breathing, or begin to develop swelling of the face, mouth, or throat.
• You develop a rash or itching (especially if affecting the entire 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,
  • hyperexcitability or hyperactivity,
  • anxiety or nervousness,
  • depression, suicidal thoughts or behavior,
  • agitation 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 heartbeats, which may be faster than normal
• Chest pain
• Flushing
• Dry mouth
• Loss of 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 symptoms including runny or itchy nose, watery eyes
• Increased cough, asthma or shortness of breath
• Skin rash, acne or itchy skin
• Sweating
• Changes in blood pressure (increase or decrease), changes in heart tracing (ECG), and irregular or unusually slow heartbeats
• Difficulty swallowing, tongue swelling, 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
• High blood cholesterol
• Swelling of hands and feet
• Sleep disturbance or abnormal dreams
• Loss of sexual appetite
• Nosebleeds, sore throat, or nasal passage inflammation (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 adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Modafinil

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

Use within 4 months after 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 stated on the label, carton, and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. 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 other information

Composition of Modafinil Aurovitas

• The active substance is modafinil.

Each tablet contains 100 mg of modafinil.

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

Appearance of the medicine and contents of the pack

This medicine is presented as a tablet.

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

This medicine is available in:

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

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

Only some 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

Or

Arrow Génériques

26 avenue Tony Garnier,

Lyon, 69007

France

Or

Generis Farmacêutica, S.A.

Rua João de Deus 19, Venda Nova

2700-487 Amadora

Portugal

This medicine is authorized in the European Economic Area member states 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 the most recent review of this leaflet: February 2021

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