Provigil 200 Mg Tablets
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Package leaf I et: Information for the user PROVIGIL® 100 mg Tablets PROVIGIL® 200 mg Tablets
Modafinil
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaf I et. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaf I et. See section 4.
What is in 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 PROVIGIL is and what it is used for
The active ingredient in the tablets is modafinil. ModafI nil 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).
ModafI nil 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 PROVIGIL
Do not take PROVIGIL if you:
• Are allergic to modafI nil, or any of the other ingredients of this medicine (listed in section 6 'What PROVIGIL contains’).
• Have an irregular heartbeat.
• Have uncontrolled, moderate to severe high blood pressure (hypertension).
Warnings and precautions
Talk to your doctor or pharmacist before taking PrOVIGIL if you:
• Have any heart problems or high blood pressure. Your doctor will need to check these regularly while you are taking PROVIGIL.
• 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 PROVIGIL 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.
Children and adolescents
Children aged less than 18 years should 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, including medicines obtained without prescription. PROVIGIL 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 PROVIGIL:
• Hormonal contraceptives (including the contraceptive pill, implants, intrauterine devices (IUDs) and patches). You will need to consider other birth control methods while taking PROVIGIL, and for two months after stopping treatment, because PROVIGIL 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 betablockers for high blood pressure or heart problems (e.g. amlodipine, verapamil or propranalol).
• Statin medicines for lowering 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is not known if your medicine may harm your unborn baby.
Driving and using machines
PROVIGIL can cause blurred vision or dizziness in up to 1 in 10 people.
If you are affected or you fI nd that while using this medication you still feel very sleepy, do not attempt to drive or operate machinery.
PROVIGIL contains Lactose
PROVIGIL contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take PROVIGIL
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 usual 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 usual 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 kidney and liver problems The usual dose is 100 mg a day.
Your doctor will review your treatment regularly to check that it is right for you.
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Effective Date: TBD Valid For 7 Days from 10-Aug-2016 Page 2 of 4
If you take more PROVIGIL 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 (sensing 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 leaf I et and any remaining tablets with you.
If you forget to take PROVIGIL
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 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 this medicine and tell your doctor straight away if:
• You have sudden diffI culty 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:
o mood swings or abnormal thinking, o aggression or hostility, o forgetfulness or confusion, o feeling of extreme happiness, o over-excitement or hyperactivity, o anxiety or nervousness, o depression, suicidal thoughts or behaviour,
o 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 diffI culty sleeping (insomnia).
• Awareness of your heart beat, which may be faster than normal.
• Chest pain.
• Flushing.
• Dry mouth.
• Loss 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.
• Hayfever 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.
• DiffI culty swallowing, swollen tongue or mouth ulcers.
• Excess wind, ref I ux (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.
• Loss 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 leaf I et. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov. uk/yellowcard.
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 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.
This medicinal product 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 information
What PROVIGIL contains
The active substance is modafinil.
Each PROVIGIL 100 mg tablet contains 100 mg of modafI nil. Each PROVIGIL 200 mg tablet contains 200 mg of modafinil.
The other ingredients are: lactose monohydrate, pregelatinised starch (maize), microcrystalline cellulose, croscarmellose sodium, povidone K29/32, magnesium stearate as inactive ingredients.
What PROVIGIL looks like and the contents of the pack
The tablets come in a capsule shaped, white to off-white colour, 13 x 6 mm with “100” on one side for 100 mg tablets, or 16 x 7 mm with “200” on one side for 200 mg tablets.
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 manufacturers
Marketing Authorisation Holder
Teva Pharma B.V.
Swensweg 5, 2031 GA Haarlem The Netherlands
Manufacturers
Laboratoires Macors,
Rue des Caillottes, ZI Plaine des Isles, 89000 Auxerre, France.
This leaflet was last revised in 12/2015
PROVIGIL is a registered trademark of Cephalon, Inc., or its affiliates
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Teva Pharmaceuticals Europe B.V R EG0111313 Version 2.2 Approved