Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - sunosi

Document Subject

Generated Narrative: MedicinalProductDefinition mp4c464411361072df4cc109cbbcdd523e

identifier: http://ema.europa.eu/identifier/EU/1/19/1408/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Sunosi 75 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-4c464411361072df4cc109cbbcdd523e

identifier: http://ema.europa.eu/identifier/EU/1/19/1408/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - sunosi

Attesters

What is in this leaflet

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

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

It is used

• in adults with narcolepsy, a condition that causes you to 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 leading to collapse).

• to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP).

Do not take Sunosi if you:

• 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. Warnings and precautions 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.

Children and adolescents 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.

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 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.

Pregnancy and breast-feeding 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.

Driving and using machines 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

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How much Sunosi to take 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 ).

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

Taking Sunosi

• 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.

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

If you take more Sunosi than you should 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 Sunosi 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.

If you stop taking Sunosi Discuss with your doctor before you stop taking Sunosi.

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

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 jittery, excessive sweating
• Fast or irregular heart beats, also called palpitations, chest discomfort
• High blood pressure
• Feeling sick, diarrhoea, stomach pain, constipation, vomiting
• Cough, clenching or grinding your teeth, dry mouth
• Loss of appetite

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

• Feeling agitated, restlessness, inability to concentrate, shaking (tremors)
• Increase in heart rate much higher than normal
• Shortness of breath
• Chest pain
• Thirst
• Weight loss

Skin rash, hives and itching have also been reported.

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.

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 the bottle / blister after EXP . The expiry date refers to the last day of that month.

Blisters: This medicine does not require any special storage conditions.

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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 cores: Hydroxypropyl cellulose, magnesium stearate

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

What Sunosi looks like and contents of the pack 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.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Atnahs Pharma Netherlands B. V. Copenhagen Towers restads Boulevard 108, 5.tv DK-2300 K benhavn S Denmark

Manufacturer Cilatus Manufacturing Services Limited
Pembroke House 28-32 Pembroke Street Upper Dublin 2 Co. Dublin D02 EKIreland

This leaflet was last revised in MM/YYYY.

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