Modafinil Aristo 100 mg tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Modafinil Aristo 100 mg Tablets EFG

Read the entire 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.

Leaflet Contents:

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

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

The active substance in the tablets is modafinil.

Modafinilo Aristo 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).

Modafinilo Aristo 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 Aristo

Do not take Modafinil Aristo

• if you are allergic to modafinil or to any of the other ingredients of this medicine (listed in section 6).
• if you have 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 check-ups while you are on treatment with Modafinil Aristo.
• you have ever had depression, low mood, anxiety, psychosis (loss of contact with reality), 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 a lower dose).
• you have previously had problems with alcohol or drugs.

Other points to discuss with your doctor or pharmacist

• Some people have reported suicidal or aggressive thoughts or behaviors while taking this medicine. Inform your doctor immediately if you notice that you feel depressed, feel aggressive or hostile towards others, or have suicidal thoughts or other changes in behavior (see section 4). You may ask a family member or close friend to help monitor you for signs of depression or other changes in behavior.
• This medicine may cause you to feel that you need it (dependence) after long-term use. If you need to take it for a prolonged period, your doctor will periodically review whether it remains appropriate for you.

Children and adolescents

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

Taking Modafinil Aristo with other medicines

Inform 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 Aristo 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 Aristo:

• Hormonal contraceptives (including contraceptive pills, implants, intrauterine devices (IUDs), and patches). You should consider alternative contraceptive methods while taking Modafinil Aristo and for at least two additional months after stopping treatment, as Modafinil Aristo reduces their effectiveness.
• Omeprazole (for reflux acid, indigestion, or ulcers).
• Antiviral medicines for HIV infection (protease inhibitors, e.g. indinavir or ritonavir).
• Cyclosporine (used to prevent organ transplant rejection or for arthritis or psoriasis).
• Medicines for epilepsy (e.g. carbamazepine, phenobarbital, or phenytoin).
• Medicines for depression (e.g. amitriptiline, citalopram, or fluoxetine) or anxiety (e.g. diazepam).
• Medicines to thin the blood (e.g. warfarin). Your doctor will monitor your clotting time during treatment.
• Calcium channel antagonists or beta-blockers for high blood pressure or heart problems (e.g. amlodipine, verapamil, or propranolol).
• Statins, medicines to reduce cholesterol (e.g. atorvastatin or simvastatin).

Pregnancy and breastfeeding

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

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

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

Driving and using machines

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

Use in athletes

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

Modafinil Aristo contains lactose and sodium

If your doctor has diagnosed you with an intolerance to certain sugars, consult him 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 exactly the instructions for use of this medicine as given by your doctor. If in 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. This 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 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 Aristo than you should

If you have taken too many tablets, you may experience discomfort, restlessness, disorientation, confusion, agitation, anxiety, or excitement. 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.

In case of overdose or accidental ingestion, you may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount taken. It is recommended to bring the medicine pack and the package leaflet 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 further 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 will experience them.

Stop taking this medicine and inform your doctor immediately if you

• Experience sudden wheezing, difficulty breathing, or develop swelling of the face, mouth, or throat.

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

• 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 behaviour,

• agitation and/or psychosis (loss of contact with reality, which may include delusions or sensations that are not real), feeling isolated, or personality disorders.

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 heartbeat, 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 or watery eyes
• Increased cough, asthma, or shortness of breath
• Skin rash, acne, or itchy skin
• Sweating
• Changes in blood pressure (increase or decrease), abnormal heart tracing (ECG), irregular or unusually slow heartbeats
• Difficulty swallowing, swelling of the tongue, 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
• Increased blood cholesterol
• Swelling of hands and feet
• Sleep disturbances or abnormal dreams
• Loss of sexual appetite
• Nosebleeds, sore throat, or inflammation of 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 adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Aristo

Keep this medicine out of 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 refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point located in your pharmacy. If in doubt, ask your pharmacist how to properly discard unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Modfinilo Aristo

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

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

Appearance of the product and contents of the pack

Capsule-shaped, white or almost white tablets, 13 mm x 6 mm, marked with "100" on one side.

Modafinilo Aristo is available in white opaque blisters made of PVC/PVDC/aluminum or white opaque blisters made of PVC/PE/PCTFE/aluminum.

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

Only certain 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

Further information about this medicinal product is available from the local representative of the Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.
C/ Solana, 26
28850 Torrejón de Ardoz
Madrid, Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Austria: Modafinil Aristo 100 mg Tabletten
Germany: Modafinil Aristo 100 mg Tabletten
Spain: Modafinilo Aristo 100 mg comprimidos EFG

Date of most recent review of this summary: June 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/