2. what you need to know before you take modafinil if you are allergic to modafinil, or to any of the other ingredients of this medicine (listed in section 6).

If you have an irregular heartbeat.

If you have uncontrolled, moderate to severe high blood pressure (hypertension).

Warnings and precautions

Talk to your doctor or pharmacist before taking Modafinil if you

Have any heart problems or high blood pressure. Your doctor will need to check these regularly while you are taking Modafinil.

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 Modafinil 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 ). 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 longterm 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 Modafinil

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without prescription.

Modafinil 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 Modafinil:

Hormonal contraceptives (including the contraceptive pill, implants, intrauterine devices (IUDs) and patches). You will need to consider other birth control methods while taking Modafinil, and for two months after stopping treatment, because Modafinil 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 beta-blockers 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, you should not take Modafinil.

Modafinil is suspected to cause birth defects if taken during pregnancy.

Talk to your doctor about the birth control methods that will be right for you while you are taking Modafinil (and for two months after stopping) or if you have any other concerns.

Driving and using machines

Modafinil can cause blurred vision or dizziness in up to 1 in 10 people. If you are affected or you find that while using this medication you still feel very sleepy, do not attempt to drive or operate machinery.

Modafinil contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.