Sunosi 150 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: 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 allow quicker identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.
Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
- If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Sunosi is and what it is used for
- What you need to know before taking Sunosi
- How to take Sunosi
- Possible side effects
- How to store Sunosi
- Contents of the pack and other information
1. What Sunosi is and what it is used for
Sunosi contains the active substance solriamfetol. Solriamfetol increases the levels of the natural substances dopamine and norepinephrine (noradrenaline) in the brain. Sunosi helps you stay awake and feel less sleepy.
It is used in
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adults with narcolepsy, a condition that causes sudden and unexpected episodes of excessive sleepiness at any time. Some patients with narcolepsy also have cataplexy symptoms (when muscles become weak in response to emotions such as anger, fear, laughter, or surprise, sometimes leading to collapse);
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adults with obstructive sleep apnoea (OSA), a condition caused by repeated interruptions in breathing during sleep, which can lead to excessive daytime sleepiness. Sunosi is used in patients who are using or have tried treatment for OSA, such as continuous positive airway pressure (CPAP).
2. What you need to know before starting Sunosi
Do not take Sunosi
- if you are allergic to solriamfetol or to any of the other ingredients of this medicine (listed in section 6);
- if you have had a heart attack within the last year;
- if you have severe heart problems, such as recently developed chest pain or chest pain that lasts longer or is more severe than usual, uncontrolled high blood pressure despite medication, serious irregular heartbeat, or other serious 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 within the last 14 days.
Warnings and precautions
Talk to your doctor or pharmacist before starting Sunosi if you have or have had:
- mental health problems, including psychosis (altered sense of reality) and extreme mood swings (bipolar disorder);
- heart problems, heart attack, or stroke;
- high blood pressure;
- alcoholism or any substance abuse or dependence;
- an eye condition called closed-angle glaucoma.
Before starting treatment, inform your doctor or pharmacist if any of the above apply to you. This is because Sunosi may worsen some of these conditions. Your doctor will want to monitor how the medicine affects you.
Sunosi does not replace your main treatment for obstructive sleep apnea (OSA), such as CPAP. You must continue using your primary treatment in addition to Sunosi.
Children and adolescents
Sunosi is not recommended for use in children or adolescents under 18 years of age. 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 need to 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 within the last 14 days, as taking an MAOI together with Sunosi may increase blood pressure.
Talk to your doctor or pharmacist if you are taking medicines that may increase blood pressure or heart rate, or if you are taking dopaminergic agonists (e.g., pramipexole, levodopa, methylphenidate) used to treat Parkinson’s disease, depression, restless legs syndrome, or ADHD.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Sunosi should not be used during pregnancy or in women of childbearing potential who are not using effective contraception.
Do not use Sunosi while breastfeeding. You and your doctor should decide whether to discontinue breastfeeding or to stop or avoid treatment with Sunosi, taking into account the benefits of breastfeeding for you and your child, and the benefit of treatment for you.
Driving and using machines
You may feel dizzy or your ability to concentrate may be affected; exercise particular caution when driving or operating machinery.
Consult your doctor or pharmacist if you are unsure how your underlying condition or this medicine affects your ability to perform activities requiring attention, such as driving and using machines:
- at the beginning of treatment;
- if your dose is changed.
3. How to take Sunosi
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
How much Sunosi should you take?
Your doctor will tell you the dose of Sunosi you should take.
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For narcolepsy, treatment usually starts with a dose of 75 mg once daily, in the morning upon waking. Some patients may require an initial dose of 150 mg. Your doctor will inform you if this applies to you. Your doctor may prescribe a lower dose of 37.5 mg. This dose can be achieved by taking half a 75 mg tablet. The tablet should be split using the score line.
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For OSA, treatment usually starts with a dose of 37.5 mg once daily, in the morning upon waking. This dose can be achieved by taking half a 75 mg tablet. The tablet should be split using the score line.
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After at least 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.
Elderly patients (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 may take Sunosi with food or between meals.
How long should you take Sunosi?
You should continue taking Sunosi for the duration 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 remain still (akathisia). These symptoms disappeared after stopping Sunosi.
Contact your doctor or the nearest emergency services immediately for advice. Bring this leaflet and any remaining tablets with you.
If you forget to take Sunosi
If you forget to take your dose at the usual time, you may take it if there are more than 9 hours remaining before going to bed. Do not take a double dose to make up for forgotten doses.
If you stop taking Sunosi
Consult your doctor before stopping treatment with Sunosi.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everybody gets 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 restless, excessive sweating.
- Fast or irregular heartbeat, also called palpitations, chest discomfort.
- Increase in blood pressure.
- Nausea, diarrhoea, stomach pain, constipation, vomiting.
- Cough, teeth grinding, dry mouth.
- Loss of appetite.
Uncommon adverse effects (may affect up to 1 in 100 people)
- Agitation, restlessness, inability to concentrate, tremor.
- Increase in heart rate to a much faster than normal rate.
- Shortness of breath.
- Chest pain.
- Thirst.
- Weight loss.
Skin rash, urticaria, and itching have also been reported.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the carton and the bottle/blister after EXP. The expiry date is the last day of the month indicated.
Blister packs: This medicine requires no special storage conditions.
Bottles: After first opening, use within 4 months. Keep the container tightly closed to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the container and other information
Composition of Sunosi
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 components are:
Tablet core: hydroxypropyl cellulose, magnesium stearate.
Film coating: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), iron oxide yellow (E172).
Appearance of the product and contents of the pack
Film-coated tablet
Sunosi 75 mg film-coated tablets
Oblong yellow to dark yellow/orange 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
Oblong yellow 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 with unit dose, 28 and 56 film-coated tablets, and in bottles containing 30 and 100 film-coated tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
TMC Pharma (EU) Limited
7a Durands Court
45 Parnell Street
Waterford
Co. Waterford
X91 P381
Ireland
Telephone: 900 876 202
E-Mail: [email protected]
Manufacturer
Cilatus Manufacturing Services Limited
Pembroke House
28-32 Pembroke Street Upper
Dublin 2
Co. Dublin
D02 EK84
Ireland
Date of the most recent 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.