MODAFINIL 100 MG TABLETS - patient leaflet, side effects, dosage

Patient leaflet - MODAFINIL 100 MG TABLETS

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. This includes any possible side

effects not listed in this leaflet.See section 4.

What is in this leaflet

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

1. what modafinil is and what it is used for

The active ingredient in the tablets is modafinil. Modafinil can be taken by adults who suffer from narcolepsy to help them to stay awake.Narcolepsy is a condition that causes excessive daytime sleepiness and a tendency to fall asleep suddenly in inappropriate situations (sleep attacks).

Modafinil may improve your narcolepsy and reduce the likelihood that you will have sleep attacks but there may still be other ways that you can improve your condition and your doctor will advise you.

2. what you need to know before you take modafinil- are allergic to modafinil or any of the other ingredients of this medicine (listed in section 6).

– have an irregular heartbeat.
– have uncontrolled,moderate to severe high blood pressure (hypertension).

Warnings and precautions

Talk to your doctor, or pharmacist before taking Modafinil if you:

have any heart problems or high blood pressure. Your doctor will need to check these regularly while you are taking Modafinil
have ever had depression, low mood, anxiety, psychosis (loss of contact with reality) or mania (over-excitement or feeling of extreme happiness) or bipolar disorder because Modafinil may make your condition worse.
have kidney or liver problems (because you will need to take a lower dose).
have had alcohol or drug problems in the past.

Other things to talk to your doctor or pharmacist about

Some people have reported having suicidal or aggressive thoughts or behaviour while taking this medicine. Tell your doctor straight away if you notice that you are becoming depressed, feel aggressive or hostile towards other people or have suicidal thoughts or other changes in your behaviour (see section 4). You may want to consider asking a family member or close friend to help you look out for signs of depression or other changes in your behaviour.
This medicine has the potential for you to become reliant (dependent) on it after long-term use. If you need to take it for a long time your doctor will check regularly that it is still the best medicine for you.

During treatment

Talk to your doctor or pharmacist:

If you notice fever and rash associated with:
– itchy skin or lack of energy,
– test results indicating inflammation of the lining of the heart,
– inflammation of the liver or test results showing an abnormal functioning of the liver,
– increase in certain type of blood cells (which may cause symptoms such as an increase in infections or fever e.g. sore throat, mouth ulcers that you get or if you notice that you bruise or bleed more easily without explanation).

These may be signs of multi-organ hypersensitivity which may be life threatening.

If you notice a skin rash or itching (especially if it affects the whole body). Severe rashes may cause blistering or peeling of the skin, ulcers in your mouth, eyes, nose or genitals. You may also have high temperature (fever) and abnormal blood test results (see section 4, Possible side effects).
If you have difficulty staying and falling asleep.

Children and adolescents

Children aged less than 18 years should not take this medicine.

Other medicines and Modafinil

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without prescription. Modafinil and certain other medicines can affect each other and your doctor may need to adjust the doses that you are taking.

It is especially important if you are taking any of the following medicines as well as Modafinil:

Hormonal contraceptives (including the contraceptive pill, implants, intrauterine devices (IUDs) and patches).You will need to consider other birth control methods while taking Modafinil, and for two months after stopping treatment, because Modafinil reduces their effectiveness.
Omeprazole (for acid reflux, indigestion or ulcers).
Antiviral medicines to treat 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. amitriptyline, citalopram or fluoxetine) or anxiety (e.g.

diazepam).

Medicines for thinning the blood (e.g. warfarin). Your doctor will monitor your blood clotting times during treatment.
Calcium channel blockers or beta-blockers for high blood pressure or heart problems (e.g. amlodipine, verapamil or propranolol
Statin medicines for lowering cholesterol (e.g. atorvastatin or simvastatin).

Pregnancy and breast-feeding

If you are pregnant (or think that you may be), are planning to become pregnant, or are breast feeding, you should not take modafinil

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

Talk to your doctor about birth control methods that might be right for you while you are taking modafinil (and for two months after stopping) or if you have any other concerns.

You should not take this medicine if you are breast-feeding as it may pass into your breast milk.

Driving and using machines

Modafinil can cause blurred vision or dizziness in up to 1 in 10 people.

If you are affected or you find that while using this medication you still feel very sleepy, do not attempt to drive or operate machinery.

Modafinil contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Modafinil contains sodium.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. how to take modafinil

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Tablets should be swallowed whole with water.

Adults

The recommended dose is 200 mg a day. This can be taken once daily (in the morning) or divided into two doses a day (100 mg in the morning and 100 mg at midday). Your doctor in some cases may decide to increase your daily dose up to 400 mg.

Elderly patients (over 65 years of age)

The recommended dose is 100 mg a day.

Your doctor will only increase your dose (up to the maximum 400 mg a day) provided that you do not have any liver or kidney problems.

Adults with severe liver problems

The recommended dose is 100 mg a day.

Your doctor will review your treatment regularly to check that it is right for you.

Tablets should be swallowed whole with water.

If you take more Modafinil than you should

If you take too many tablets you may feel sick, restless, disorientated, confused, agitated, anxious or excited. You may also have difficulty sleeping, diarrhoea, hallucinations (hearing, seeing or feeling things that are not real), chest pain, a change in the speed of your heart beat or an increase in blood pressure. Contact your nearest hospital casualty department or tell your doctor or pharmacist immediately.

Take this leaflet and any remaining tablets with you

If you forget to take Modafinil

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 a forgotten tablet.

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 taking this medicine and tell your doctor straight away if:

You have sudden difficulty breathing or wheeziness or your face, mouth or throat begins to swell.
You notice a skin rash or itching (especially if it affects your whole body) Severe rashes may cause blistering or peeling of the skin, ulcers in your mouth, eyes, nose or genitals You may also have a high temperature (fever) and abnormal blood test results
You feel any change in your mental health and wellbeing. The signs may include:
mood swings or abnormal thinking,
aggression or hostility,
forgetfulness or confusion,
feeling of extreme happiness,
uncontrolled crying or laughing
over-excitement or hyperactivity,
anxiety or nervousness,
depression, suicidal thoughts or behaviour,
agitation or psychosis (a loss of contact with reality which may include delusions or sensing things that are not real), feeling detached or numb, 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
Sleepiness, extreme tiredness or difficulty sleeping (insomnia).
Awareness of your heart beat, which may be faster than normal.
Chest pain
Flushing
Dry mouth.
Decrease of appetite, feeling sick, stomach pain, indigestion, diarrhoea or constipation
Weakness. Numbness or tingling of the hands or feet (‚pins and needles‘)
Blurred vision
Abnormal blood test results showing how your liver is working (increased 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, twitching or tremor
Vertigo (spinning sensation)
Difficulty moving muscles smoothly or other movement problems, muscle tension, coordination problems
Hay fever symptoms including itchy/runny nose or watery eyes
Increased cough, asthma or shortness of breath
Skin rash, acne or itchy skin
Sweating
Changes in blood pressure (high or low), abnormal heart trace (ECG), and irregular or unusually slow heart beat
Difficulty swallowing, swollen tongue or mouth ulcers
Excess wind, reflux (bringing back fluid from the stomach), increased appetite, weight changes, thirst or taste alteration.
Being sick (vomiting).
Migraine
Speech problems
Diabetes with increased blood sugar
High blood cholesterol
Swollen hands and feet
Disrupted sleep or abnormal dreams.
Decrease of sex drive
Nose bleed, sore throat or inflamed nasal passages (sinusitis)
Abnormal vision or dry eyes
Abnormal urine or more frequent urination
Abnormal periods
Abnormal blood test results showing that the numbers of your white blood cells have changed
Restlessness with increased body movement

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly Yellow Card Scheme Website:or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine

5. how to store modafinil

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 blister strip and the outer pack after EXP. The expiry date refers to the last day of the month. Bottles only: discard 4 months after first opening.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment

6. contents of the pack and other informationthe active substance is modafinil.

Each Modafinil 100 mg tablet contains 100 mg of modafinil

Each Modafinil 200 mg tablet contains 200 mg modafinil

The other ingredients are: lactose (see section 2 “Modafinil contains lactose”), croscarmellose sodium, povidone and magnesium stearate.

What Modafinil looks like and the contents of the pack

Modafinil 100 mg Tablets

White to off-white capsule shaped tablets with a size of approximately 12.6 mm x 5.5 mm and marked with ‘41’ on one side and ‘J’ on the other side. Available in PVC/PVdC aluminum blister packs of 30, 60 or 90 tablets and plastic bottles of 30 and 100 tablets. The bottles contain a desiccant, do not eat the desiccant.

Modafinil 200 mg Tablets

White to off-white capsule shaped tablets with a size of approximately 16.0 mm x 7.0 mm and marked with ‘4’ score-line ‘2’on one side and ‘J’ on the other side. Available in PVC/PVdC aluminium blister packs of 30 tablets or plastic bottles of 30 or 100 tablets. The bottles contain a desiccant, do not eat the desiccant.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Mylan

Potters Bar

Hertfordshire

EN6 1TL

United Kingdom

Manufacturer

McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin

Unit 35/36 Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

This medicinal product is authorized in the Member states of the EEA under the following names:

United kingdom	Modafinil 100 mg and 200 mg Tablets
Spain	Modafinilo Pharmaceuticals 100 mg comprimidos EFG
France	Modafinil Mylan Pharma 100 mg, comprime
Sweden	Myldamo
Denmark	Myldamo
Iceland	Myldamo

This leaflet was revised in 07/2020

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