How does it work?

This medicine contains the active ingredient modafinil, which is a type of medicine known as a CNS stimulant. It works by stimulating activity within the central nervous system, ie brain and spinal cord. Modafinil increases wakefulness and daytime alertness in people who experience excessive sleepiness during the day, either due to narcolepsy, or due to a syndrome called obstructive sleep apnoea. The way in which modafinil improves wakefulness is not yet fully understood, but it is believed to have an effect on specific parts of the brain responsible for keeping us awake. Modafinil's mode of action appears to be different to other CNS stimulants, such as the amphetamine group of medicines that are also sometimes used to promote wakefulness. This difference is believed to reduce modafinil's potential for abuse and dependence, though there may still be a risk of this if the medicine is used long-term.

What is it used for?

Excessive daytime sleepiness due to obstructive sleep apnoea/hypopnoea syndrome

Excessive daytime sleepiness due to the sleep disorder narcolepsy

Warning!

Dependence on this medicine may occur if it used for long-term periods of time.

This medicine may cause dizziness and blurred vision. If affected, caution is required when driving or operating machinery.

Use with caution in

Elderly people

Heart disease

High blood pressure (hypertension). The blood pressure and heart rate should be monitored.

Kidney failure

Liver failure

Severe anxiety

Women of child-bearing potential, unless effective contraception is used to prevent pregnancy

Not to be used in

Breastfeeding

Children

History of enlargement of a chamber of the heart (left ventricular hypertrophy or cor pulmonale)

Irregular heart beats (arrhythmias)

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

Uncontrolled moderate to severe high blood pressure

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.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

The safety of this medicine in pregnancy has not been established. It should not be taken by women who are pregnant, and women of child-bearing age who take this medicine should use effective contraception. Seek medical advice from your doctor.

There is no information available about the safety of this medicine during breastfeeding. For this reason, the manufacturer states that it should not be used during breastfeeding. Seek medical advice from your doctor.

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. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Headache

Blurred vision

Dry mouth

Difficulty in sleeping (insomnia)

Depression

Confusion

Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain

Alteration in results of liver function tests

Awareness of your heartbeat (palpitations)

Dizziness

Loss of appetite

Unstable moods (emotional lability)

Weakness or loss of strength (asthenia)

Nervousness

High blood pressure (hypertension)

Decreased sex drive

Chest pain

Anxiety and agitation

Increased heart rate (tachycardia)

Rash or itching

The side effects listed above may not include all of the side effects reported by the drug'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.

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