Modiodal 100 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

MODIODAL 100 mg tablets

modafinil

Read the entire leaflet carefully before you start taking this medicine, because

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 must not be given to other people, even if they have the same symptoms, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Modiodal is and what it is used for

The active substance in the tablets is modafinil.

Modafinil 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). Modafinil 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 Modiodal

Do not take Modiodal:

• if you are allergic to modafinil or to any of the other ingredients of this medicine (listed in section 6).
• if you have an irregular heartbeat.
• if you have moderate to severe, uncontrolled high blood pressure (hypertension).

Warnings and precautions

Talk to your doctor or pharmacist before starting Modiodal:

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

Other points to discuss with your doctor or pharmacist:

• Some people have reported suicidal thoughts or behaviors, or aggressive behavior while taking this medicine. Contact your doctor immediately if you notice that you feel depressed, feel aggressive or hostile toward others, have suicidal thoughts, or any other changes in behavior (see section 4). You may wish to ask a family member or close friend to help monitor you for signs of depression or other behavioral changes.

• 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 the appropriate medicine for you.

Children and adolescents

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

Other medicines and Modiodal

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Modiodal 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 Modiodal:

• Hormonal contraceptives (including contraceptive pills, implants, intrauterine devices (IUDs), and patches). Modiodal may reduce their effectiveness, so you will need to start using alternative or additional contraceptive methods while taking Modiodal and for at least two months after stopping treatment.
• Omeprazole (for acid reflux, indigestion, or ulcers).
• Antiviral medicines for HIV infection (protease inhibitors, e.g. indinavir or ritonavir).
• Cyclosporine (used to prevent rejection of transplanted organs 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 used 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 pressure or heart problems (e.g. amlodipine, verapamil, or propranolol).
• Statins, medicines used 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, you should not take Modiodal.

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

Taking modafinil during pregnancy could increase the risk of miscarriage.

Consult your doctor about suitable contraceptive methods while you are being treated with Modiodal.

You must continue using contraceptive methods for two months after stopping treatment with Modiodal.

You should not take modafinil while breastfeeding.

Driving and using machines

Modiodal 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.

Modiodal contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Modiodal

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. It can be taken once daily (in the morning) or divided into two doses per day (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 Modiodal 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.

Contact the nearest hospital emergency department or consult your doctor or pharmacist immediately. Bring this leaflet and any remaining tablets with you. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the medication and the amount ingested.

If you forget to take Modiodal

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 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 contact your doctor immediately if you

• Experience sudden wheezing, difficulty breathing, or begin to have swelling of the face, mouth, or throat.

• Develop a skin rash or itching (especially if it affects the whole body). Serious 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.

• 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 of extreme happiness,

• Hyperexcitability or hyperactivity,

• Anxiety or nervousness,

• Depression, suicidal thoughts or behaviour,

• Agitation and/or psychosis (loss of contact with reality that may include delusional ideas or unreal sensations), feeling of isolation or personality disorder.

Other side effects include the following

Very common side effects (may affect more than 1 in 10 people)

• Headache

Common side 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 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 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), changes in heart recording (ECG), and irregular or unusually slow heartbeats
• Difficulty swallowing, swollen 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 disturbance or abnormal dreams
• Loss of sexual appetite
• 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
• Restlessness with increased body movements

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet.

You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Modiodal

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

Do not use this medicine after the expiry date stated on the blister and outer packaging following "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. Unused medicines and their containers should be returned to a pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Modiodal 100 mg tablets

• The active substance is modafinil. Each Modiodal 100 mg tablet contains 100 mg of modafinil.
• The other components are: monohydrate lactose (see section 2), pregelatinized corn starch, microcrystalline cellulose, sodium croscarmellose, povidone K29/32 and magnesium stearate.

Appearance of the product and contents of the pack

Modiodal 100 mg is presented as capsule-shaped tablets of 13 x 6 mm, white to almost white, marked with “100” on one side.

Modiodal is available in blister packs containing 10, 20, 30, 50, 60, 90, 100 or 120 tablets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí - Barcelona

Spain

Manufacturer:

Teva Operations Poland Sp. z.o.o.

ul Mogilska 80

31-546 Kraków

Poland

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Austria: MODASOMIL

Czech Republic, Germany: VIGIL

Cyprus, Denmark, France, Greece, Iceland, Netherlands, Norway, Portugal, Spain: MODIODAL

Belgium, Ireland, Italy, Luxembourg, United Kingdom (Northern Ireland): PROVIGIL

The 100 mg dose is authorised in all the countries listed above. The 200 mg dose is only authorised in Germany and Ireland.

Further information on this medicinal product is available from the local representative of the Marketing Authorisation Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona 69

08970 Sant Joan Despí - Barcelona

Spain

This leaflet was last approved in August 2025

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