Modafinil Bluefish 100 mg tablets EFG

Package leaflet: Information for the user

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

The active substance in the tablets is modafinil.

Modafinilo Bluefish 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 Bluefish 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 Bluefish

Do not take Modafinil Bluefish

• 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 Bluefish if

• you have heart problems or high blood pressure. Your doctor will carry out regular checks while you are being treated with Modafinil Bluefish.
• you have ever had depression, low mood, anxiety, psychosis (loss of contact with reality), mania (hyperexcitability or elevated mood), or bipolar disorder, as Modafinil Bluefish may worsen your condition.
• you have kidney or liver disease (since you may need to take a lower dose).
• you have previously had problems with alcohol or drugs.

Other issues to discuss with your doctor or pharmacist

• Some people have reported suicidal thoughts or behaviour, aggression, or hostility while taking this medicine. Contact your doctor immediately if you notice that you feel depressed, feel aggressive or hostile towards others, or have suicidal thoughts or other changes in behaviour (see section 4). You may wish to ask a family member or close friend to help monitor you for signs of depression or other behavioural changes.
• This medicine may make you 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 the appropriate medicine for you.

Children and adolescents

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

Taking Modafinil Bluefish with other medicines

Tell 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 Bluefish and other medicines can affect each other, and your doctor may need to adjust the doses of your medicines. This is especially important if you are taking any of the following medicines together with Modafinil Bluefish:

• Hormonal contraceptives (including contraceptive pills, implants, intrauterine devices (IUDs), and patches). You should consider alternative contraceptive methods while taking Modafinil Bluefish and for at least two months after stopping treatment, as Modafinil Bluefish reduces their effectiveness.
• Omeprazole (for reflux acid, indigestion, or ulcers).
• Antiviral medicines for the treatment of HIV infection (protease inhibitors, e.g. indinavir or ritonavir).
• Ciclosporin (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 blockers 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 breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, you must not take Modafinil Bluefish.

Modafinil is suspected of causing birth defects if taken during pregnancy.

Talk to your doctor about suitable contraceptive methods while you are being treated with Modafinil Bluefish (and for two months after stopping treatment), or if you have any other questions.

Driving and using machines

Modafinil Bluefish 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.

Modafinil Bluefish contains lactose

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

Modafinil Bluefish contains sodium

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

3. How to take Modafinil Bluefish

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The tablets should be swallowed whole with some water.

Adults

The recommended dose is 200 mg per day. It can 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 severe 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 appropriate 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 overexcited. 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, Tel. 91 562 04 20, stating the name of the medicine and the amount taken. It is recommended to take the medicine container and package leaflet to the healthcare professional.

If you forget to take Modafinil Bluefish

If you forget to take your medicine, take the next dose at your 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 experiences them.

Stop taking this medicine and contact your doctor immediately if

• You experience sudden wheezing, difficulty breathing, or begin to develop swelling of the face, mouth, or throat.

• You 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 develop an increase in body temperature (fever) and have abnormal results in blood tests.

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

• mood or thought changes,

• 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 delusional ideas or unreal sensations), feeling of isolation or personality disorder.

Other side effects include the following:

Very common adverse effects (may affect more than 1 in 10 patients):

• Headache

Common adverse effects (may affect up to 1 in 10 patients):

• Dizziness
• Drowsiness, extreme tiredness, or difficulty falling asleep (insomnia)
• Awareness of heartbeats, 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 patients):

• 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, watery eyes
• Increased cough, asthma, or shortness of breath
• Skin rash, acne, or itchy skin
• Sweating
• Changes in blood pressure (increase or decrease), changes in heart tracing (ECG), and 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 desire
• Nosebleeds, sore throat, or nasal passage inflammation (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, pharmacist, or nurse, 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 Bluefish

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

Do not use this medicine after the expiry date stated on the carton 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. Empty containers and unused medicines should be taken to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Modafinil Bluefish

The active substance is modafinil.

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

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

Appearance of the product and contents of the pack

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

Modafinil Bluefish 100 mg is available in white opaque blisters made of PVC/PVDC/aluminum or white opaque blisters made of PVC/PE/PCTFE/aluminum, containing 20, 30, 50, 60, 90 or 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder:

Bluefish Pharmaceuticals AB
P.O Box 49013
10028 Stockholm
Sweden

Manufacturer responsible:

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

For further information about this medicinal product, contact the local representative of the Marketing Authorization Holder:

Bluefish Pharma S.L.U.,
P.O. Box 36007, 2832094 Madrid,
Branch 36

Date of the most recent review of this leaflet: January 2022

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