Package Insert: Information for the Patient

Modafinilo Aristo 100 mg Tablets EFG

Read this entire package insert carefully before taking this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist or nurse, even if they are not listed in this package insert. See section 4.

The active ingredient in the tablets is modafinilo.

Modafinilo 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).

Modafinilo Aristo may improve narcolepsy and reduce the likelihood of sleep attacks, although there may be other ways to improve your condition, and your doctor will inform you of them.

Do not take Modafinilo Aristo

• if you are allergic to modafinilo or any of the other components of this medication (listed in section 6).
• if you have irregular heartbeats.
• if you have moderate to severe, uncontrolled high blood pressure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Modafinilo Aristo if:

• you have heart problems or high blood pressure. Your doctor will perform regular checks while you are on treatment with Modafinilo Aristo.
• you have ever had depression, low mood, anxiety, psychosis (loss of contact with reality) or mania (hyperexcitement or feeling of elation) or bipolar disorder, as Modafinilo Aristo may worsen your condition.
• you have kidney or liver disease (as you will need 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 medication. Inform your doctor immediately if you notice that you are depressed, feel 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 behavior.
• This medication may make you feel that you need it (dependence) after using it for a long time. If you need to take it for a long period, your doctor will check periodically if it is still the appropriate medication for you.

Children and adolescents

Children under 18 years old should not take this medication.

Modafinilo Aristo with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Modafinilo Aristo and other medications 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 medications with Modafinilo Aristo:

• hormonal contraceptives (including the pill, implants, intrauterine devices (IUDs) and patches). You should consider other contraceptive methods while taking Modafinilo Aristo and for at least two months after stopping treatment, as Modafinilo Aristo reduces its effectiveness.
• Omeprazol (for acid reflux, indigestion, or ulcers).
• Antiviral medications for the treatment of HIV infection (protease inhibitors, e.g. indinavir or ritonavir).
• Ciclosporina (used to prevent organ rejection after transplantation or for arthritis or psoriasis).
• Medications for epilepsy (e.g. carbamazepine, phenobarbital, or phenytoin).
• Medications for depression (e.g. amitriptyline, citalopram, or fluoxetine) or anxiety (e.g. diazepam).
• Medications to thin the blood (e.g. warfarin). Your doctor will monitor your coagulation time during treatment.
• Calcium channel blockers or beta-blockers for high blood pressure or heart problems (e.g. amlodipine, verapamil, or propranolol).
• Statins, medications to reduce cholesterol (e.g. atorvastatin or simvastatin).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Modafinilo is suspected to cause congenital defects if taken during pregnancy.

Consult with your doctor about suitable contraceptive methods for you while on treatment with Modafinilo Aristo (and for two months after stopping it) or if you have any other questions.

Driving and operating machinery

Modafinilo Aristo may cause blurred vision or dizziness in 1 in 10 patients. If you notice any of these effects or still feel drowsy while taking this medication, avoid driving vehicles or operating machinery.

Use in athletes

This medication contains modafinilo, which may produce a positive result in doping control tests.

Modafinilo 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 medication.

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

Follow exactly the administration instructions for this medication as indicated 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. 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.

Older adults (age 65 years or older)

The recommended dose is 100 mg per day.

Your doctor will only increase your 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 regularly review your treatment to ensure it is suitable for you.

If you take more Modafinilo 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 heartbeats, or an increase in your blood pressure.

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

If you forget to take Modafinilo Aristo

If you forget to take your medication, take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking this medicine and immediately inform your doctor if

• 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 entire body). Severe skin rashes can cause blisters or skin peeling, mouth sores, eye, nose, or genital sores. You may also experience an increase in body temperature (fever) and abnormal results in blood tests.

• Notice any changes in your mental health and well-being. These signs may include:

• Changes in mood or abnormal thoughts,
• Aggression or hostility,
• Forgetfulness or confusion,
• Extreme feelings of happiness,
• Hyperexcitement 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), feelings of isolation or personality disorder.

Other side effects include the following:

Frequent 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)
• Palpitations, which may be faster than normal
• Chest pain
• Flushing
• Dry mouth
• Loss of appetite, discomfort, stomach pain, indigestion, diarrhea or constipation, weakness, numbness or tingling in hands or feet
• Blurred vision
• Abnormal results in blood tests showing liver function (elevated liver enzymes).
• Irritability

Less common 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 (sensation of spinning)
• Difficulty moving muscles smoothly or other movement difficulties, muscle tension, coordination difficulties
• Hay fever symptoms including runny nose and itchy eyes
• Increased coughing, asthma or shortness of breath
• Skin rash, acne or itchy skin
• Sweating
• Changes in blood pressure (increase or decrease), altered heart rhythm (ECG) and irregular or abnormally slow heartbeats
• Difficulty swallowing, tongue swelling or mouth sores
• Excess gas, reflux (regurgitation of stomach contents), increased appetite, weight changes, thirst or altered taste
• Desire to vomit
• Migraine
• Speech difficulties
• Diabetes with increased blood sugar
• Increased cholesterol in the blood
• Swelling of hands and feet
• Interrupted sleep or abnormal dreams
• Loss of sexual appetite
• Nasal bleeding, sore throat or sinusitis (inflammation of the nasal passages)
• Abnormal vision or dry eyes
• Abnormal urine or increased frequency of urination
• Menstrual disorders
• Abnormal results in blood tests showing changes in white blood cells.
• Agitation with increased body movements

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use https://www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the outer packaging and the blister pack after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications that you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Modafinilo Aristo

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

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

and talc (E553b).

Appearance of the product and content of the container

Tablets in capsule shape, white or off-white, 13 mm x 6 mm, marked with “100” on one side.

Modafinilo Aristo is presented in opaque, white, PVC/PVDC/aluminum blister or opaque, white, PVC/PE/PCTFE/aluminum blister.

Packaging of 20, 30, 50, 60, 90 or 100 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Responsible for manufacturing

Chanelle MedicalUnlimited Company

Dublin Road, Loughrea, Co. Galway,

H62 FH90, Ireland

Or

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435Berlin, Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

This medication is authorized in the member states of the European Economic Area with the following names:

AustriaModafinil Aristo 100 mg Tabletten

GermanyModafinil Aristo 100 mg Tabletten

SpainModafinilo Aristo 100 mg comprimidos EFG

Date of the last review of this prospectus:June 2019

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/