Provigil

What is it used for?

• Relieving excessive daytime sleepiness due to the sleep disorder narcolepsy.
• ADHD in children-Conflicting studies for use in children-Discuss with your Doctor

Use with caution in

• Elderly people.
• Heart disease.
• High blood pressure (hypertension)
• Kidney failure.
• Liver failure.
• Severe anxiety.
• People with a history of psychosis, depression or mania.
• People with a history of drug, alcohol or substance abuse.

Not to be used in

• Irregular heart beats (arrhythmias).
• Uncontrolled moderate to severe high blood pressure (hypertension).
• History of enlargement of a chamber of the heart.
• People with a floppy heart valve (prolapsed mitral valve) who have experienced the 'mitral valve prolapse syndrome' when taking CNS stimulants (ask your doctor about this if you have heart valve problems).
• Pregnancy.
• Breastfeeding.
• Rare hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption (Provigil tablets conatin lactose).
• There is insufficient information regarding the safety and efficacy of this medicine in children. It is not recommended for children. Studies are conflicting at this stage for use in children, consult your Doctor for more information.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Very common (affect more than 1 in 10 people)

• Headache.

Common (affect between 1 in 10 and 1 in 100 people)

• Fast heart rate and awareness of your heart beat (palpitations).
• Chest pain.
• Dizziness.
• Sleepiness.
• Pins and needles sensations.
• Blurred vision.
• Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain.
• Dry mouth.
• Loss of appetite.
• Weakness or loss of strength (asthenia).
• Difficulty sleeping (insomnia).
• Nervousness, anxiety and agitation.
• Depression.
• Confusion.
• Alteration in results of liver function tests.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Unstable moods (emotional lability).
• Changes in weight.
• Dry eyes.
• Twitching or tremor.
• Movement disorder.
• Speech disorder.
• Memory loss.
• Shortness of breath.
• Nosebleeds.
• Mouth ulcers.
• Skin reactions such as rash or itching (see warning above).
• Muscle or joint pain.
• Raised blood sugar or cholesterol levels.
• Changes in your blood pressure.
• Psychiatric reactions.
• Decreased sex drive.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

This medicine may reduce the effectiveness of oral contraceptive pills and patches because it may speed up the breakdown (metabolism) of the hormones in the body. For this reason, women who are using hormonal contraceptives should use an additional method of contraception, such as condoms, to help prevent pregnancy. Alternatively, it may be more appropriate to use a different method of contraception altogether, particularly for women using this medicine long-term. Whichever method is used, effective contraception should be continued for two months after stopping treatment with modafinil. It is important for women to discuss contraception with their doctor before they start treatment with this medicine.

Antiepileptic medicines such as carbamazepine and phenobarbital may reduce the blood level of this medicine.

Modafinil may increase the blood level of the antiepileptic medicine phenytoin, and people taking both these medicines should have their phenytoin levels monitored.

Modafinil may decrease the blood level of the following medicines:

• buspirone
• calcium channel blockers
• ciclosporin
• midazolam
• protease inhibitors for HIV infection
• statins for lowering cholesterol
• triazolam.

Modafinil may increase the blood levels of antidepressant medicines in a particular group of people known as ‘poor metabolisers’. These people lack a particular enzyme (CYP2D6) that breaks down medicines in the body, and so may need a lower dose of antidepressant if also taking modafinil.

The manufacturer of this medicine recommends that people who are taking the anti-blood-clotting medicine (anticoagulant) warfarin should have their blood clotting time monitored regularly during the first two months of treatment with this medicine and after any dose changes.

If you have any more questions please ask your Pharmacist.

Remember to keep all medicines out of reach of children

Please Note: We have made every effort to ensure that the content of this information sheet is correct at time of publish, but remember that information about drugs may change. This sheet does not list all the uses and side-effects associated with this drug. For full details please see the drug information leaflet which comes with your medicine. Your doctor will assess your medical circumstances and draw your attention to any information or side-effects which may be relevant in your particular case.

References:

http://www.netdoctor.co.uk/brain-and-nervous-system/medicines/provigil.html

http://www.provigil.com

http://en.wikipedia.org/wiki/Modafinil

http://www.rxlist.com/provigil-drug.htm

http://www.drugs.com/provigil.html

http://www.medicinenet.com/modafinil/article.htm

http://www.webmd.com/drugs/drug-16964-Provigil.aspx?drugid=16964&drugname=Provigil