Package Insert: Information for the User

Modafinilo Bluefish 100 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they 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 Bluefish 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 Bluefish 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 Bluefish

• if you areallergicto modafinilo or to any of the other components of this medication (listed in section 6).
• if you haveirregular heartbeats
• if you havehigh blood pressure, moderate or severe, that is not controlled(hypertension).

Warnings and precautions

Consult your doctor or pharmacist before starting to takeModafinilo Bluefish if

• you haveheart problemsorhigh blood pressure. Your doctor will perform regular checks while you are being treated withModafinilo Bluefish.
• you have ever haddepression,low mood,anxiety,psychosis(loss of contact with reality) ormania(excessive excitement or elevated mood) orbipolar disorder,sinceModafinilo Bluefishmay worsen your condition.
• you have akidney diseaseorliver disease(since you will need to take a lower dose).
• you have had problems withalcoholordrugsin the past.

Other aspects to discuss with your doctor or pharmacist

• Somepeople have reportedsuicidal thoughtsoraggressive behaviorwhile taking this medication.Inform your doctor immediatelyif you notice that you aredepressed,feel aggressive or hostiletowards others or havesuicidal 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 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.

Taking Modafinilo Bluefish 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.

ModafiniloBluefishand 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 withModafiniloBluefish:

• Contraceptiveshormones(including birth control pills, implants, intrauterine devices (IUDs) and patches). You should consider other birth control methods while takingModafiniloBluefish and for at least two months after stopping treatment, sinceModafiniloBluefish 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 transplant rejection or for arthritis or psoriasis).
• Medications forepilepsy(e.g. carbamazepine, phenobarbital or phenytoin).
• Medications fordepression(e.g. amitriptyline, citalopram or fluoxetine) oranxiety(e.g. diazepam).
• Medications to thin the blood (e.g.warfarina). Your doctor will monitor your coagulation time during treatment.
• Calcium channel blockers or beta-blockers forhigh blood pressureor heart problems (e.g. amlodipine, verapamil or propranolol).
• Statins, medications to reducecholesterol(e.g. atorvastatin or simvastatin).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, do not take Modafinilo Bluefish.

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

Consult your doctor about suitable birth control methods for you while you are being treated with Modafinilo Bluefish (and for two months after stopping treatment) or if you have any otherdoubts.

Driving and operating machinery

ModafiniloBluefishmay 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.

Modafinilo Bluefish contains lactose

This medication contains (104, 208) mg of lactose per (100, 200) mg Modafinilo tablet. This should be taken into account in patients with diabetes mellitus. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Modafinilo Bluefish contains sodium

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

Follow exactly the administration instructions for this medication as indicated 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.

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 Bluefish than you should

If you have taken too many tablets, you may feel discomfort, restlessness, disorientation, confusion, agitation, anxiety, or excitement. 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 forgot to take Modafinilo Bluefish

If you forget to take your medication, take the next dose at the usual time. Do not take a double dose to make up 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 may cause side effects, although not everyone will experience them.

Stop takingthis medicine andinform your doctor immediatelyif

• Changes in mood or abnormal thoughts,
• Aggression or hostility,
• Forgetfulness or confusion,
• Extreme feelings of happiness,
• Hypervigilance or hyperactivity,
• Anxiety or nervousness,
• Depression, suicidal thoughts or behavior,
• Restlessness 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:

Side effectsvery common(may affect more than 1 in 10 patients):

• Headache

Side effectscommon(may affect up to 1 in 10 patients):

• 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 blood test results showing liver function (elevated liver enzymes).
• Irritability

Side effectsuncommon(may affect up to 1 in 100 patients):

• Back pain, neck pain, muscle pain, muscle weakness, leg cramps, joint pain, spasms, or tremors
• Dizziness (feeling like your head is 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 (increased or decreased), altered ECG, and irregular or abnormally slow heartbeats
• Difficulty swallowing, tongue swelling, or mouth sores
• Gas, reflux (regurgitation of stomach contents), increased appetite, weight changes, thirst, or altered taste
• Feeling like vomiting
• 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 blood test results showing changes in white blood cells.
• Restlessness with increased body movements

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 the 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 take this medication after the expiration date that appears on the box and the blister 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.Deposit the packaging and medications that you no longer need at the SIGRE collection pointat the pharmacy. In case of 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 Bluefish

The active principle is modafinilo.

Each 100 mg Modafinilo Bluefish tablet contains 100 mg of modafinilo.

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

Appearance of the product and content of the container

Modafinilo Bluefish 100 mg:capsule-shaped tablets, white or off-white, 12.65 mm x 5.55 mm, marked with “100”.

Modafinilo Bluefish 100 mg is presented in opaque, white, PVC/PVDC/aluminum or opaque, white, PVC/PE/PCTFE/aluminum blisters, with 20, 30, 50, 60, 90, or 100 tablets.

Only some container sizes may be commercially marketed.

Marketing Authorization Holder:

Bluefish Pharmaceuticals AB

P.O Box 49013

10028 Stockholm

Sweden

Responsible for Manufacturing:

Chanelle Medical Unlimited Company

Loughrea

Co. Galway

Ireland

Or

Sandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Or

Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany

Or

Novartis Farmacéutica S.A., Gran Vía de les Corts Catalanes 764, 08013 Barcelona, Spain

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

Bluefish Pharma S.L.U.,

AP 36007, 2832094 Madrid,

Sucursal 36

Last review date of this leaflet:January 2022

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/