SUNOSI 150 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Sunosi 75 mg film-coated tablets

Sunosi 150 mg film-coated tablets

Solriamfetol

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• 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.

Contents of the pack

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

1. What is Sunosi and what is it used for

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

It is used in

• adults with narcolepsy, a condition that makes you feel extremely sleepy during the day, sometimes with cataplexy (when your muscles become weak in response to emotions like anger, fear, laughter or surprise, sometimes causing you to collapse);

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

2. What you need to know before you take Sunosi

Do not take Sunosi

• if you are allergic to solriamfetol or any of the other ingredients of this medicine (listed in section 6);
• if you have had a heart attack in the last year;
• if you have severe heart problems, such as recent or worsening chest pain, uncontrolled high blood pressure, severe irregular heartbeat or other severe heart problems;
• if you 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.

Warnings and precautions

Tell your doctor or pharmacist before you start taking 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;
• alcohol or substance abuse or dependence;
• a condition called glaucoma (increased pressure in the eye).

Before starting treatment, tell your doctor or pharmacist if any of the above applies to you. This is because Sunosi may worsen some of these problems. Your doctor will want to monitor how the medicine affects you.

Sunosi does not replace your main treatment for OSA, such as CPAP. You should continue to use this treatment in addition to Sunosi.

Children and adolescents

Sunosi should not be used in children or adolescents under 18 years of age. The safety and efficacy in this age group have not yet been established.

Other medicines and Sunosi

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, as taking an MAOI with Sunosi may increase blood pressure.

Tell your doctor or pharmacist if you are taking medicines that may increase blood pressure or heart rate, or if you are taking dopamine agonists (e.g. pramipexole, levodopa, methylphenidate) used to treat Parkinson's disease, depression, restless legs syndrome and ADHD.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 who are not using effective contraception.

Sunosi should not be used during breastfeeding. You and your doctor will decide whether to stop breastfeeding or stop/reduce treatment with Sunosi, taking into account the benefit of breastfeeding for you and your baby and the benefit of treatment for you.

Driving and using machines

You may feel dizzy or your ability to concentrate may be affected; be careful when driving or using machines.

Ask your doctor or pharmacist for advice if you are not sure how your underlying condition or this medicine will affect your ability to perform activities that require attention, such as driving and using machines:

• when starting treatment;
• if your dose is changed.

3. How to take Sunosi

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

How much Sunosi to take

Your doctor will tell you how much Sunosi to take.

• For narcolepsy, treatment usually starts with a dose of 75 mg once a day, in the morning when you wake up. Some patients may need a starting dose of 150 mg. Your doctor will tell you if this is the case. Your doctor may prescribe a lower dose of 37.5 mg. You can get this dose by taking half of a 75 mg tablet. The tablet should be broken using the score line.

• For OSA, treatment usually starts with a dose of 37.5 mg once a day, in the morning when you wake up. You can get this dose by taking half of a 75 mg tablet. The tablet should be broken using the score line.

• After at least 3 days of treatment, your doctor may increase your daily dose to the most suitable dose.

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

Elderly patients (over 65 years of age)

Take your 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 taken by mouth.
• Take Sunosi by mouth (orally) in the morning when you wake up.
• You can take Sunosi with or without food.

How long to take Sunosi

You should continue to take Sunosi for as long as your doctor tells you.

If you take more Sunosi than you should

The following symptoms have been seen in patients treated with 900 mg (6 times the maximum daily dose) of Sunosi: uncontrollable movements (tardive dyskinesia) and feeling restless and unable to stay still (akathisia). These symptoms went away when Sunosi was stopped.

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

If you forget to take Sunosi

If you forget to take your medicine at the usual time, you can take it if there are more than 9 hours before you go to bed. Do not take a double dose to make up for forgotten doses.

If you stop taking Sunosi

Ask your doctor for advice before you stop taking Sunosi.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Headache.

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

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

Uncommon side effects (may affect up to 1 in 100 people)

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

There have also been reports of skin rash, hives and itching.

Reporting of side effects

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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sunosi

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

Do not use this medicine after the expiry date which is stated on the carton and blister/bottle after EXP. The expiry date is the last day of the month stated.

Blister packs: This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Contents of the pack and other information

What Sunosi contains

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 core: hydroxypropylcellulose, magnesium stearate.

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

Appearance and packaging

Film-coated tablet

Sunosi 75 mg film-coated tablets

Yellow to dark yellow/orange, oblong tablet with "75" engraved on one side and a score line on the other. The tablet can be divided into equal doses.

Sunosi 150 mg film-coated tablets

Yellow, oblong tablet with "150" engraved on one side.

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

TMC Pharma (EU) Limited

7a Durands Court

45 Parnell Street

Waterford

Co.Waterford

X91 P381

Ireland

Phone: 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

Date of last revision 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.