PROVIGIL 100 mg Coated Tablet

Зміст інструкції

1. Provigil 100 mg tablets
   1. What is Provigil and what is it used for
   2. What you need to know before you take Provigil
   3. How to take Provigil
   4. Possible side effects
   5. How to store Provigil
   6. Contents of the pack and other information

Provigil 100 mg tablets

modafinil

Read this leaflet carefully before you start to take 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 others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Provigil and what is it used for

The active substance contained in the tablets is modafinil.
Modafinil can be taken by adults who suffer from narcolepsy, to help them stay awake. Narcolepsy is a condition of excessive daytime sleepiness and a tendency to fall asleep
suddenly in inappropriate situations (sleep attacks). Modafinil can improve your
narcolepsy and decrease the likelihood of having sleep attacks, but 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 you take Provigil

Do not take Provigil

• if you are allergicto modafinil or 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 taking Provigil if

• you have heart problemsor high blood pressure. Your doctor will need to check it regularly while you are taking Provigil;
• you have suffered from depression, low mood, anxiety, psychosis(loss of contact with reality), mania(overexcitement or feeling of extreme happiness) or bipolar disorder, because Provigil may worsen your condition;
• you have kidney problemsor liver problems(because you may need to take a lower dose);
• you have had past alcoholor drugproblems.

Other things to discuss with your doctor or pharmacist

• Some people have reported having thoughtsor suicidalor aggressive behaviorswhile taking this medicine. Tell your doctor immediatelyif you have noticed that you are becoming depressed, aggressive or hostiletowards other people, or if you have thoughts of suicideor other changes in your behavior (see section 4). You may consider

asking a family member or friend to help you try to identify signs of
depression or other changes in your behavior;

• this medicine has the potential to make you dependent on it after prolonged use. If you need to take it for a long period, your doctor will regularly check that modafinil is still the best medicine for you.

Children and adolescents
Individuals under the age of 18 must not take this medicine.

Other medicines and Provigil
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Provigil and certain other medicines can influence each other and your doctor may need to adjust the doses
you are taking. This is particularly important if you are taking any of the following
medicines together with Provigil:

• Hormonal contraceptives(including birth control pills, implants, intrauterine devices (IUDs) and patches). Provigil may reduce their effectiveness, so you will need to use alternative or additional contraceptive methods while taking Provigil and for up to 2 months after stopping treatment.
• Omeprazole(for acid reflux, indigestion or ulcers).
• Antiviral medicines to treat HIV infection (protease inhibitors, e.g. indinavir or ritonavir).
• Cyclosporine(used to prevent organ transplant rejection, for arthritis or for psoriasis).
• Medicines for epilepsy(e.g. carbamazepine, phenobarbital or phenytoin).
• Medicines for depression(e.g. amitriptyline, citalopram or fluoxetine) or for anxiety(e.g. diazepam).
• Medicines to thin the blood (e.g. warfarin). During treatment, your doctor will check your blood clotting times.
• Calcium channel blockers or beta-blockers for high blood pressureor heart problems (e.g. amlodipine, verapamil or propranolol).
• Statins to lower cholesterol(e.g. atorvastatin or simvastatin).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, you must not take Provigil.
Modafinil is suspected to cause birth defects if taken during pregnancy. Modafinil taken
during pregnancy may increase the risk of miscarriage.
Ask your doctor which method of contraception is suitable for you while taking Provigil. You
will need to continue using the contraceptive method for 2 months after stopping
treatment with Provigil.
Provigil should not be used during breastfeeding.

Driving and using machines
Provigil can cause blurred vision or dizziness, which can affect up to 1 in 10 people. If
you are affected or, while taking this medicine, experience excessive drowsiness, you should not drive
vehicles or use machines.

Provigil contains lactoseand sodium
If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this
medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
“sodium-free”.
For athletes: the use of the drug without therapeutic necessity constitutes dopingand may
still result in positive anti-doping tests.

3. How to take Provigil

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
The tablets should be swallowed whole with water.
Adults
The recommended dose is 200 mg per day. This can be taken once a day (in the
morning) or in two doses (100 mg in the morning and 100 mg at noon).
In some cases, your doctor may decide to increase the daily dosage up to 400 mg.
Elderly patients (over 65 years)
The recommended dose is 100 mg per day.
The doctor may increase this dose (up to a maximum of 400 mg per day), provided that you
do not have liver or kidney problems.
Adults with severe liver and kidney problems
The recommended dose is 100 mg per day.
The doctor will regularly review your treatment to check that it is suitable for you.

If you take more Provigil than you should
If you take too many tablets, you may feel unwell, sleepless, disoriented, confused, agitated, anxious or
excited. You may also have difficulty falling asleep and experience diarrhea, hallucinations (hearing or seeing
things that are not real), chest pain, changes in heart rate or increased
blood pressure.
Contact the emergency room of the nearest hospital or inform your doctor or pharmacist immediately.
Bring this leaflet and any remaining tablets with you.

If you forget to take Provigil
If you forget to take the medicine, take the next dose at the usual time. Do not take a double
dose to make up for the missed dose.
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 the medicine and tell your doctor immediately if

• You experience sudden difficulty breathing or wheezing, or if your face, mouth or throat begin to swell;
• You notice a skin rash or experience itching (especially if it affects the whole body). Severe rashes can cause blisters, skin loss, sores in the mouth, eyes, nose or genitals. You may also have a fever and abnormal blood tests.
• You feel any changes in your mental health and wellbeing. Signs may include: o mood swings or abnormal thoughts; o aggression or hostility; o memory loss or confusion; o feeling extremely happy;

or overexcited or hyperactive;
or anxious or nervous;
or depressed, with thoughts or suicidal behavior;
or agitated or psychotic (a loss of contact with reality can include delusions or hearing or
seeing things that are not real), feeling indifferent or stunned, or personality disorder.

Other side effects include the following
Side effects very common(may affect more than 1 in 10 people)

• Headache.

Side effects common(may affect up to 1 in 10 people)

• Dizziness;
• Drowsiness, extreme tiredness or difficulty falling asleep (insomnia);
• Awareness of your heartbeat, which may be faster than normal;
• Chest pain;
• Hot flushes;
• Dry mouth;
• Loss of appetite, nausea, stomach pain, indigestion, diarrhea or constipation;
• Weakness;
• Numbness or tingling in the hands or feet (“pins and needles”);
• Blurred vision;
• Abnormal blood test results showing how well your liver is working (increased liver enzymes);
• Irritability.

Side effects uncommon(may affect up to 1 in 100 people)

• Back pain, neck pain, muscle pain, muscle weakness, leg cramps, joint pain, spasms or tremors;
• Vertigo (a sensation of spinning);
• 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 itching;
• Sweating;
• Changes in blood pressure (high or low), electrocardiogram abnormalities and slow or irregular heartbeat;
• Difficulty swallowing, swollen tongue or mouth ulcers;
• Excessive flatulence, reflux (stomach acid coming back up), increased appetite, changes in body weight, thirst or altered taste;
• Vomiting;
• Migraine;
• Speech problems;
• Diabetes with increased blood sugar;
• High cholesterol;
• Swelling of hands and feet;
• Disturbed sleep or abnormal dreams;
• Loss of sexual drive;
• Nosebleeds, sore throat or inflammation of the nasal passages (sinusitis);
• Abnormal vision or dry eyes;
• Abnormal urine or more frequent urination;
• Abnormal menstrual cycles;
• Abnormal blood test results showing changes in white blood cells;
• Restlessness with increased body movements.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the
national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Provigil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the packaging after
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Provigil contains

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

Description of the appearance of Provigil and contents of the pack
The tablets are capsule-shaped, from white to off-white in color, 13 x 6 mm in size, with “100”
on one side.
Provigil is available in blister packs of 10, 20, 30, 50, 60, 90, 100 or 120 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milan
Manufacturer:
Teva Operations Poland Sp. z.o.o.
ul. Mogilska
80 31-546 Krakow, Poland

This medicinal product is authorised in the Member States of the European Union with 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
Germany: VIGIL
Ireland: PROVIGIL