MODAFINIL BLUEFISH 100 mg TABLETS

Introduction

Package Leaflet: Information for the User

Modafinil Bluefish 100 mg Tablets EFG

Read all of 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 signs of illness are the same as yours.
• If you get 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 Bluefish and what is it used for
2. What you need to know before you take Modafinil Bluefish
3. How to take Modafinil Bluefish
4. Possible side effects
5. Storage of Modafinil Bluefish
6. Contents of the pack and further information

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

The active substance of the tablets is modafinil.

Modafinil 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).

Modafinil Bluefish 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 you take Modafinil Bluefish

Do nottake Modafinil Bluefish

• if you are allergicto modafinil or any of the other ingredients of this medicine (listed in section 6).
• if you have irregular heartbeats
• if you have moderate or severe high blood pressure, not controlled(hypertension).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Modafinil Bluefish if

• you have heart problemsor high blood pressure. Your doctor will perform regular checks while you are being treated with Modafinil Bluefish.
• you have ever suffered from depression, low mood, anxiety, psychosis(loss of contact with reality) or mania(overexcitement or feeling of elation) or bipolar disorder, as Modafinil Bluefish may worsen your condition.
• you have kidney or liver disease(as you may need to take a lower dose).
• you have had problems with alcoholor drugsin the past.

Other aspects to discuss with your doctor or pharmacist

• Some people have reported thoughtsor behaviors of suicideor aggressionwhile taking this medicine. Tell your doctor immediatelyif you notice that you are feeling depressed, feel aggressive or hostiletowards others or have suicidal thoughtsor other changes in your behavior (see section 4). You may ask a family member or close friend to help you monitor if you present signs of depression or other changes in your behavior.
• This medicine may make you feel like you need it (dependence) 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 Bluefish 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 Bluefish 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 Bluefish:

• Hormonal contraceptives(including birth control pill, implants, intrauterine devices (IUDs) and patches). You should consider other contraceptive methods while taking Modafinil Bluefish and for at least two months after stopping treatment, as Modafinil Bluefish 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).
• Ciclosporin(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 pressureor 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 are planning to have a baby, do not take Modafinil Bluefish.

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 Bluefish (and for two months after stopping) or if you have any other questions.

Driving and using machines

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

Modafinil Bluefish contains lactose

This medicine contains (104, 208) mg of lactose per (100, 200) mg of Modafinil Bluefish tablet. This should be taken into account in patients with diabetes mellitus. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Modafinil Bluefish contains sodium

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

3. How to take Modafinil Bluefish

Follow exactly the administration instructions of this medicine given 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.

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 the treatment to check that it is suitable for you.

If you take more Modafinil Bluefish 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, Phone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you forget to take Modafinil Bluefish

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 on 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 takingthis medicine and tell your doctor immediatelyif

• 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 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 overactivity,
• 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 commonside effects (may affect more than 1 in 10 people):

• Headache

Commonside effects (may affect up to 1 in 10 people):

• Dizziness
• Somnolence, extreme tiredness or difficulty falling asleep (insomnia)
• Feeling of heartbeat, which may be faster than normal
• Chest pain
• Flushing
• Dry mouth
• Loss of appetite, nausea, stomach pain, indigestion, diarrhea or constipation, weakness, numbness or tingling in hands or feet
• Blurred vision
• Abnormal blood test results showing liver function (increase in liver enzymes).
• Irritability

Uncommonside 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 and 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 heart tracing (ECG) and irregular or unusually slow heartbeats
• Difficulty swallowing, swollen 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 increased blood sugar
• Increased cholesterol in the blood
• Swelling of hands and feet
• Disruption of sleep 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, pharmacist or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website

https://www.notificaRAM.es

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

5. Storage of Modafinil Bluefish

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

Do not take this medicine after the expiry date which is stated on the carton 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 Bluefish

The active substance is modafinil.

Each 100 mg Modafinil Bluefish tablet contains 100 mg of modafinil.

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

Appearance of the product and pack contents

Modafinil Bluefish 100 mg: capsule-shaped tablets, white or almost white, 12.65 mm x 5.55 mm, marked with "100".

Modafinil 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.

Not all pack sizes may be marketed.

Marketing authorization holder:

Bluefish Pharmaceuticals AB

P.O Box 49013

10028 Stockholm

Sweden

Manufacturer:

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 medicine from the local representative of the marketing authorization holder:

Bluefish Pharma S.L.U.,

AP 36007, 2832094 Madrid,

Sucursal 36

Date of last revision of this leaflet:January 2022

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/