MODAFINIL ARISTO 100 mg TABLETS

Introduction

Patient Information Leaflet

Modafinil Aristo 100 mg tablets EFG

Read 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or 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 Aristo and what is it used for
2. What you need to know before taking Modafinil Aristo
3. How to take Modafinil Aristo
4. Possible side effects
5. Storage of Modafinil Aristo
6. Contents of the pack and further information

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

The active substance of the tablets is modafinil.

Modafinil Aristo 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 Aristo 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 taking Modafinil Aristo

Do not take Modafinil Aristo

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Modafinil Aristo if:

• you have heart problems or high blood pressure. Your doctor will perform regular checks while you are being treated with Modafinil Aristo.
• 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 Aristo may worsen your condition.
• you have kidney or liver disease (as you may need to take a lower dose).
• you have had problems with alcohol or drugs in the past.

Other aspects to discuss with your doctor or pharmacist

• Some people have reported suicidal thoughts or aggressive behavior while taking this medicine. Tell your doctor immediately if you notice that you are feeling depressed, aggressive or hostile towards others or have suicidal thoughts or 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 (dependent) 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.

Taking Modafinil Aristo with other medicines

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

Modafinil Aristo 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 Modafinil Aristo:

• Hormonal contraceptives (including birth control pills, implants, intrauterine devices (IUDs), and patches). You should consider other contraceptive methods while taking Modafinil Aristo and for at least two months after stopping treatment, as Modafinil Aristo 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).
• Cyclosporin (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 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, cholesterol-lowering medicines (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 Aristo (and for two months after stopping) or if you have any other questions.

Driving and using machines

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

Use in athletes

This medicine contains modafinil, which may produce a positive result in doping tests.

Modafinil Aristo contains lactose and sodium

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

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

3. How to take Modafinil Aristo

Follow the instructions for taking this medicine exactly as your doctor has told you. If you are unsure, 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 to 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 your treatment to ensure it is suitable for you.

If you take more Modafinil Aristo 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 heartbeat, or an increase in your blood pressure.

In case of overdose or accidental ingestion, you can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Modafinil Aristo

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 other 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 immediately if

• 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, sores 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 hyperactivity,
• anxiety or nervousness,
• depression, suicidal thoughts or behavior,
• 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 palpitations, which may be faster than normal
• Chest pain
• Flushing
• Dry mouth
• Loss of appetite, nausea, stomach discomfort, indigestion, diarrhea, or constipation, weakness, numbness, or tingling in hands or feet
• Blurred vision
• Abnormal blood test results showing liver function (elevated 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 or 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 tracing (ECG), and irregular or unusually slow heartbeat
• Difficulty swallowing, swelling of the tongue, or sores 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 elevated blood sugar
• Elevated cholesterol in the blood
• Swelling of hands and feet
• Sleep disturbances 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.
• Agitation with increased body movements

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System https://www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Modafinil Aristo

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

Do not use this medicine after the expiry date stated on the outer packaging and blister after "EXP". The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

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 further information

Composition of Modafinil Aristo

The active substance is modafinil. Each tablet contains 100 mg of modafinil.

The other ingredients are: lactose monohydrate, crospovidone type A (E1202), lactose anhydrous, povidone K30 (E1201), colloidal anhydrous silica (E551), sodium stearyl fumarate, and talc (E553b).

Appearance and packaging

Tablets with a capsule shape, white or almost white, 13 mm x 6 mm, marked with "100" on one side.

Modafinil Aristo is presented in opaque white PVC/PVDC/aluminum or PVC/PE/PCTFE/aluminum blisters.

Pack sizes of 20, 30, 50, 60, 90, or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Manufacturer

Chanelle Medical Unlimited Company

Dublin Road, Loughrea, Co. Galway,

H62 FH90, Ireland

Or

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin, Germany

You can obtain further information on this medicine from the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

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

Austria Modafinil Aristo 100 mg Tabletten

Germany Modafinil Aristo 100 mg Tabletten

Spain Modafinilo Aristo 100 mg tablets EFG

Date of last revision of this leaflet:June 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/