SUNOSI 75 mg FILM-COATED TABLETS
How to use SUNOSI 75 mg FILM-COATED TABLETS
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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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 the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet contains information on 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
- What is Sunosi and what is it used for
- What you need to know before you take Sunosi
- How to take Sunosi
- Possible side effects
- Storage of Sunosi
- 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 very sleepy during the day, often suddenly and without warning. 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 causing collapse);
- adults with obstructive sleep apnea (OSA), a condition caused by repeated interruptions to breathing during sleep, which can make you feel very sleepy during the day. Sunosi is used in patients who are using 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 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 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 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 of the eyes called narrow-angle glaucoma.
Before starting treatment, tell your doctor or pharmacist if any of the above applies to you. 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 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 are not yet known.
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.
Talk to 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 contraceptive methods.
Sunosi should not be used during breastfeeding. You and your doctor will decide whether to stop breastfeeding or stop/reconsider Sunosi treatment, considering the benefit of breastfeeding to you and your baby and the benefit of treatment to you.
Driving and using machines
You may feel dizzy or your ability to concentrate may be affected; be especially careful when driving or using machines.
Talk to your doctor or pharmacist if you are not sure how your underlying condition or this medicine affects 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 for you. 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 (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: uncontrolled 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 bedtime. Do not take a double dose to make up for forgotten doses.
If you stop taking Sunosi
Talk to your doctor 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.
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.
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 shown.
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. These measures will help 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
Oblong tablet, yellow to yellow-brown/orange in color, 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 tablet, yellow in color, 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, unit dose, 28 and 56 film-coated tablets and in bottles of 30 and 100 film-coated tablets.
Not all 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
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 web site: http://www.ema.europa.eu.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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