Label: information for the patient

Sunosi 75 mg film-coated tablets

Sunosi 150 mg film-coated tablets

Solriamfetol

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this label carefully before starting to take this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Sunosi contains the active ingredient solriamfetol. Solriamfetol increases the amount of natural substances dopamine and norepinephrine (noradrenaline) in the brain. Sunosi helps you stay awake and feel less drowsy.

It is used in

• adults with narcolepsy, a condition that makes you suddenly and unexpectedly feel very sleepy at any time. Some patients with narcolepsy also have symptoms of cataplexy (when muscles become weak in response to emotions such as anger, fear, laughter, or surprise, sometimes resulting in collapse);

• adults with obstructive sleep apnea (OSA), a condition caused by repeated interruptions of breathing while sleeping, which can make you feel very sleepy during the day. Sunosi is used in patients who use or have tried using a treatment for OSA, such as continuous positive airway pressure (CPAP).

Do not take Sunosi

• if you are allergic to solriamfetol or any of the other ingredients in this medication (listed in section 6);
• if you have had a heart attack in the last year;
• if you have severe heart problems such as, for example, recent chest pain or chest pain that lasts longer or is more severe than usual, uncontrolled high blood pressure, severe irregular heartbeat, or other severe heart problems;
• if you take a type of medication called a “monoamine oxidase inhibitor” (MAOI) for depression or Parkinson's disease or have taken an MAOI in the last 14 days.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sunosi if you have or have had:

• mental health problems, including psychosis (altered sense of reality) and extreme mood changes (bipolar disorder);
• heart problems, heart attack, or stroke;
• high blood pressure;
• alcoholism or any substance abuse or dependence;
• a type of eye disease called closed-angle glaucoma.

Inform your doctor or pharmacist before starting treatment if any of the above points apply to you. This is because Sunosi may worsen some of these problems. Your doctor will want to monitor how the medication affects you.

Sunosi does not replace your primary treatment for obstructive sleep apnea (OSA) such as continuous positive airway pressure (CPAP). You must continue using this treatment in addition to Sunosi.

Children and adolescents

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

Other medications and Sunosi

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take Sunosi if:

• you take a medication called a “monoamine oxidase inhibitor” (MAOI) for depression or Parkinson's disease or have taken an MAOI in the last 14 days as taking an MAOI with Sunosi may increase blood pressure.

Consult your doctor or pharmacist if you take medications that may increase blood pressure or heart rate, or if you take dopamine agonists (e.g., pramipexol, levodopa, methylphenidate) used to treat Parkinson's disease, depression, restless legs syndrome, and attention deficit hyperactivity disorder (ADHD).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Sunosi should not be used during pregnancy or in women of childbearing age who are not using effective contraceptive methods.

Sunosi should not be used during breastfeeding. You and your doctor should decide whether to avoid breastfeeding or stop or avoid treatment with Sunosi after considering the benefits of breastfeeding for you and your baby and the benefits of treatment for you.

Driving and operating machinery

You may feel dizzy or your ability to concentrate may be impaired; be especially careful when driving or operating machinery.

Consult your doctor or pharmacist if you are unsure how your underlying condition or this medication affects your ability to perform tasks that require attention, such as driving and operating machinery:

• at the start of treatment;
• if your dose is changed.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much Sunosi to take

Your doctor will indicate the dose of Sunosi that you should take.

• For narcolepsy, treatment usually begins with a dose of 75 mg once a day, in the morning upon waking. Some patients may need an initial dose of 150 mg. Your doctor will indicate if this is your case. Your doctor may prescribe a lower dose of 37.5 mg. You can obtain this dose by taking half of a 75 mg tablet. The tablet should be split using the groove.

• For AOS, treatment usually begins with a dose of 37.5 mg once a day, in the morning upon waking. You can obtain this dose by taking half of a 75 mg tablet. The tablet should be split using the groove.

• After a minimum of 3 days of treatment, your doctor may increase your daily dose to reach the most appropriate dose.

The maximum recommended dose of Sunosi is 150 mg per day.

Older adults (over 65 years of age)

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

Patients with kidney problems

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

How to take Sunosi

• Sunosi is administered orally.
• Take Sunosi orally (by mouth) in the morning upon waking.
• You can take Sunosi with food or between meals.

For how long should you take Sunosi

You should continue taking Sunosi for the time indicated by your doctor.

If you take more Sunosi than you should

The following symptoms have been observed in patients treated with 900 mg (6 times the maximum daily dose) of Sunosi: uncontrollable movements (tardive dyskinesia) and a feeling of restlessness and inability to stay still (akathisia). These symptoms disappeared when Sunosi was stopped.

Immediately contact your doctor or the nearest emergency service for advice. Bring this leaflet and the remaining tablets with you.

If you forgot to take Sunosi

If you forgot to take the medication at the usual time, you can take it if there are more than 9 hours before bedtime. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Sunosi

Consult your doctor before stopping Sunosi.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Very common adverse effects (may affect more than 1 in 10 people)

• Headache.

Common adverse effects (may affect up to 1 in 10 people)

• Anxiety, difficulty sleeping, irritability, dizziness, feeling of restlessness, excessive sweating.
• Fast or irregular heartbeat, also known as palpitations, chest discomfort.
• Increased blood pressure.
• Nausea, diarrhea, stomach pain, constipation, vomiting.
• Cough, clenching or grinding teeth, dry mouth.
• Loss of appetite.

Rare adverse effects (may affect up to 1 in 100 people)

• Agitation, restlessness, inability to concentrate, tremor.
• Increased heart rate at a much faster speed than normal.
• Shortness of breath.
• Chest pain.
• Thirst.
• Weight loss.

Also, skin rash, urticaria, and itching have been reported.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the bottle/ blister pack after CAD. The expiration date is the last day of the month indicated.

Blisters: This medication does not require special storage conditions.

Bottles: Once opened, use within 4 months. Keep the container perfectly closed to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Sunosi

The active ingredient is solriamfetol.

Sunosi 75 mg film-coated tablets

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

Sunosi 150 mg film-coated tablets

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

The other components are:

Tablet core: hydroxypropylcellulose, magnesium stearate.

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

Appearance of the product and contents of the container

Film-coated tablet

Sunosi 75 mg film-coated tablets

Oval-shaped tablet of yellow to dark yellow/orange color with “75” engraved on one face and a notch on the other. The tablet can be divided into equal doses.

Sunosi 150 mg film-coated tablets

Oval-shaped tablet of yellow color with “150” engraved on one face.

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

Only some container sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

TMC Pharma (EU) Limited

7a Durands Court

45 Parnell Street

Waterford

Co.Waterford

X91 P381

Ireland

Telephone: 900 876 202

Email:[email protected]

Manufacturer

Cilatus Manufacturing Services Limited

Pembroke House

28-32 Pembroke Street Upper

Dublin 2

Co. Dublin

D02 EK84

Ireland

Last review date of this leaflet: MM/YYYY.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu.