PROVIGIL Tablets 100 mg/200 mg
(Modafinil)
Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What PROVIGIL is and what it is used for.
- 2. Before you take PROVIGIL.
- 3. How to take PROVIGIL.
- 4. Possible side effects.
- 5. How to store PROVIGIL.
- 6. Further information.
What Provigil Is And What It Is Used For
The name of your medicine is PROVIGIL 100 mg or 200 mg tablets. The active ingredient in them is modafinil.
PROVIGIL is a medicine that helps people with sleep problems stay awake, including the following medical conditions; narcolepsy, obstructive sleep apnoea or a moderate to severe sleep disorder (i.e. due to shift work patterns).
Before You Take Provigil
Do not take PROVIGIL if you:
- Are allergic (hypersensitive) to modafinil, or any of the other ingredients of PROVIGIL.
- Are pregnant, planning to become pregnant or breast-feeding.
- Have an irregular heartbeat.
- Have uncontrolled, moderate/severe high blood pressure (hypertension).
PROVIGIL is not recommended for children.
Take Special Care with PROVIGIL if you:
- Have any heart problems.
- Have an abnormal heart beat.
- Have problems with excessive anxiety.
- Have high blood pressure (hypertension).
- Have kidney disease.
- Have liver disease.
- Are over 65 years of age.
- Have ever had depression, low mood, psychosis (loss of contact with reality) or mania (over excitation).
If any of the above apply to you, you should speak to your doctor before taking this medicine.
Some people have reported suicidal or aggressive thoughts or behaviour while taking PROVIGIL. Be sure to tell your doctor if you notice that you are becoming depressed or have suicidal thoughts or changes in your behaviour. You may want to consider asking a family member or close friend to help you stay alert to signs of depression or changes in your behaviour.
Although this medicine has a low potential for dependence, the chance of this happening with long-term use cannot be completely ruled out.
Taking with other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription. It is especially important if you are taking:
- Hormonal contraceptives (including the contraceptive pill, implants, intrauterine devices (IUDs) and patches). Talk to your doctor about birth control methods that are right for you while using PROVIGIL, and for two months after stopping PROVIGIL.
- Medicines for acid reflux (eg omeprazole).
- Antiviral medicines (protease inhibitors).
- Ciclosporin (eg used in organ transplants, arthritis and psoriasis).
- Medicines for epilepsy (eg phenytoin).
- Medicines for depression or anxiety.
- Medicines for thinning the blood (eg warfarin).
- Medicines for high blood pressure or heart problems (eg calcium channel blockers).
- Medicines for lowering cholesterol (statins).
- Betablockers (eg propanalol).
Pregnancy and breast-feeding
If you are pregnant, think you might be or are breast-feeding you should not take PROVIGIL. It is not known if PROVIGIL may harm your unborn baby.
Driving and operating machinery
PROVIGIL can sometimes cause blurred vision or dizziness in some people. If you are affected or you find that using this medication makes you feel excessively sleepy, do not attempt to drive or operate machinery.
Important information about one of the ingredients of PROVIGIL
These tablets contain lactose. If your doctor has told you that you have an intolerance to some sugars, you should contact them before taking this medicine.
How To Take Provigil
Always take PROVIGIL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Narcolepsy and sleep apnoea
The usual dose is 200 to 400 mg a day. This can be taken once daily (in the morning) or twice daily (in the morning and at midday).
Moderate to severe chronic shift work sleep disorder
The recommended dose is 200 mg, once a day (approximately 1 hour before the start of a night shift).
Your doctor may sometimes prescribe a lower dose than this, depending on your individual circumstances.
Tablets should be swallowed whole with water.
If you take more PROVIGIL than you should
If you take too much PROVIGIL 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 PROVIGIL
If you forget to take PROVIGIL take the next dose at the usual time, do not take a double dose to make up for the forgotten one.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Provigil Side Effects
Like all medicines, PROVIGIL can cause side effects, although not everybody gets them.
Stop taking this medicine and tell your doctor immediately if you have difficulty breathing or your mouth or throat begins to swell or if you start suffering from a severe rash, itching or other skin reactions, as these may be signs of an allergic reaction.
Other side effects include the following:
Very common side effects (affecting more than 1 in 10 people):
- Headache.
Common side effects (affecting between 1 in 10 and 1 in 100 people):
- An irregular or fast heartbeat.
- Chest pain, stomach pain, indigestion.
- Weakness, flushing, feeling sick, dizziness, dry mouth.
- Diarrhoea, constipation, loss of appetite.
- Nervousness, anxiety, depression, abnormal thinking, confusion.
- Difficulty sleeping (insomnia), sleepiness, excessive tiredness.
- Pins and needles, blurred vision, abnormal liver function tests.
Uncommon side effects (affecting between 1 in 100 and 1 in 1,000 people):
- Back pain, neck pain, muscle soreness, muscle weakness, leg cramps, joint pain, twitching.
- Difficulty moving muscles smoothly, muscle tension, coordination problems, movement disorder.
- Minor allergic reactions (such as hayfever), shortness of breath, itchy/runny nose, increased cough, asthma, sore throat.
- Skin rash, acne, itchy skin, excessive sweating.
- Increased blood pressure, abnormal heart tests, irregular or unusually slow heart beat, high/low blood pressure.
- Excess wind, reflux (bringing back fluid from the stomach), increased appetite, thirst, taste alteration.
- Being sick, migraine, speech disorder.
- Difficulty swallowing, sore tongue, mouth ulcers.
- Diabetes, blood disorders, increased blood cholesterol or blood sugar.
- Swelling of hands and feet, weight changes.
- Over-activity, agitation, tremor, vertigo, hostile behaviour, feeling detached, numbness, personality disorder.
- Sleep disturbance, abnormal dreams, mood swings, aggression, forgetfulness, loss of sex drive.
- Nose bleeds, inflamed nasal passages (sinuses).
- Abnormal vision, dry eyes, abnormal urine, more frequent urination, abnormal periods.
In addition, if you experience any of the following you should tell your doctor immediately:
- Psychological effects e.g. mood elation and over excitation, suicidal behaviour, agitation, and/or psychosis (a loss of contact with reality which may include delusions or hearing sounds that are not there).
- Severe rash that may cause peeling of the skin.
- Sudden wheeziness, difficulty breathing, swelling, rash or itching, especially if it affects your whole body.
If any of these side effects become serious or you experience any side effects not listed, please tell your doctor or pharmacist.
How To Store Provigil
Keep out of the reach and sight of children.
Do not take this medicine after the expiry date shown on the pack.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
What PROVIGIL contains
Each tablet contains modafinil (either 100 mg or 200 mg) as the active ingredient. In addition the tablets also contain lactose monohydrate, pregelatinised starch, microcrystalline cellulose, croscarmellose sodium, povidone and 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.
They are supplied in packs of blister strips and each box contains 30 tablets.
Marketing Authorisation Holder
Manufacturers
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This leaflet was last approved in September 2009
For more information please call free on 0800 783 4869 or e-mail: UKMedlnfo@cephalon.com
Additional information is available from various sources including the British Snoring & Sleep Apnoea Association (www.britishsnoring.co.uk, tel. 01737 245638).
08612-1596/1
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