Sunosi 75 mg film-coated tablets

• 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Sunosi is and what it is used for
2. What you need to know before you take Sunosi
3. How to take Sunosi
4. Possible side effects
5. How to store Sunosi
6. Contents of the pack and other information

• are allergic to solriamfetol or any of the other ingredients of this medicine (listed in section 6)
• had a heart attack in the past 1 year
• have serious heart problems, such as chest pain of recent onset, or chest pain that is lasting longer or is more severe than usual, high blood pressure not properly controlled with medicines, serious irregular heart beat or other serious heart problems
• are taking a type of medicine called a ‘monoamine oxidase inhibitor’ (MAOI) for depression or Parkinson’s disease, or have taken an MAOI in the last 14 days.

Talk to your doctor or pharmacist before taking Sunosi if you have or have had:

• mental health problems, including psychosis (altered sense of what is real) and extreme changes in mood (bipolar disorder)
• heart problems, heart attack or stroke
• high blood pressure
• alcoholism or any drug abuse or dependence
• an eye condition called angle closure glaucoma.

Tell your doctor or pharmacist if any of the above applies to you before starting treatment. This is because Sunosi may make some of these problems worse. Your doctor will want to monitor how the medicine affects you.

Sunosi does not replace your OSA primary treatment such as CPAP. You should continue to use such treatment as well as Sunosi.

Sunosi is not recommended in children or adolescents under 18 years of age. The safety and efficacy are not yet known in this age group.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take Sunosi if:

• you are taking a medicine called a ‘monoamine oxidase inhibitor’ (MAOI) for depression or Parkinson’s disease, or have taken an MAOI in the last 14 days because taking an MAOI with Sunosi may increase your blood pressure.

Check with your doctor or pharmacist if you are taking medicines that can increase your blood pressure or heart rate, or if you are taking dopaminergic agents (e.g. pramipexole, levodopa, methylphenidate) which are used to treat Parkinson’s disease, depression, restless leg syndrome and ADHD.

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.

Sunosi should not be used during pregnancy or in women of childbearing potential not using effective contraception.

You should not use Sunosi during breast-feeding. You and your doctor must decide whether to avoid breast-feeding or to stop or avoid Sunosi therapy, taking into account the benefit of breast-feeding for you and your child and the benefit of therapy for you.

Infants exposed to Sunosi should be monitored for signs of the potential side-effects as listed in Section 4.

You may feel dizzy or your ability to concentrate may be impaired; take special care when driving or using machines.

Talk to your doctor or pharmacist if you are not sure how your underlying condition or this medicine affects you with activities that require attention, such as driving and handling machinery:

• at the beginning of treatment
• if your dose is changed

Your doctor will advise you on the dose of Sunosi to take.

• For narcolepsy, treatment is normally started with a dose of 75 mg once per day, in the morning when you wake up. Some patients may need a 150-mg starting dose. Your doctor will advise you if this applies to you. Your doctor may prescribe you a lower dose of 37.5 mg. You can get this dose by taking half of one 75 mg tablet. The tablet should be broken using the score line.
• For OSA, treatment is normally started with a dose of 37.5 mg once per day, in the morning when you wake up. You can get this dose by taking half of one 75 mg tablet. The tablet should be broken using the score line.
• After at least 3 days’ treatment, your doctor may increase your daily dose to the most appropriate dose.

The recommended maximum dose of Sunosi is 150 mg daily.

Elderly (aged more than 65 years)

Take the usual daily dose unless you have kidney problems (see below “Patients with kidney problems”).

If you have kidney problems your doctor may need to adjust the dose.

Sunosi is for oral use.

Take Sunosi by mouth in the morning when you wake up.

You can take Sunosi with food or between meals.

You should continue to take Sunosi for as long as you are told to by your doctor.

The following symptoms were observed when patients received Sunosi 900mg (6 times the maximum daily dose): uncontrollable movements (tardive dyskinesia) and feeling restless and unable to keep still (akathisia). These symptoms resolved when Sunosi was stopped.

Contact your doctor or nearest emergency department immediately for advice. Take this leaflet and any remaining tablets with you.

If you forget to take your medicine at the usual time, you can still take it if it is more than 9 hours before bedtime. Do not take a double dose to make up for a forgotten dose.

Discuss with your doctor before you stop taking Sunosi.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

The active substance is solriamfetol.

Sunosi 75 mg film-coated tablets

Each tablet contains solriamfetol hydrochloride, equivalent to 75 mg of solriamfetol.

Sunosi 150 mg film-coated tablets

Each tablet contains solriamfetol hydrochloride, equivalent to 150 mg of solriamfetol.

The other ingredients are:

Tablet cores: Hydroxypropyl cellulose, magnesium stearate

Film coating: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), iron oxide yellow (E172).

Film-coated tablet

Sunosi 75 mg film-coated tablets

Yellow to dark yellow/orange oblong tablet with “75” debossed on one side and a score line on the opposite side. The tablet can be divided into equal doses.

Sunosi 150 mg film-coated tablets

Yellow oblong tablet with “150” debossed on one side.

Sunosi is available in blister packs of 7 x 1 film-coated tablets in PVC/PCTFE/Aluminium perforated unit dose blisters, 28 and 56 film-coated tablets and in bottles of 30 and 100 film-coated tablets.

Not all pack sizes may be marketed.

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