Quviviq 25 mg film-coated tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
QUVIVIQ 25 mg film-coated tablets
QUVIVIQ 50 mg film-coated tablets
daridorexant
This medicinal product is subject to additional monitoring, which will allow for rapid detection of new safety information. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions 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 you should not give it to others, even if they have the same symptoms as you, since it may harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet Contents
- What QUVIVIQ is and what it is used for
- What you need to know before taking QUVIVIQ
- How to take QUVIVIQ
- Possible adverse reactions
- How to store QUVIVIQ
- Contents of the pack and other information
1. What QUVIVIQ is and what it is used for
QUVIVIQ contains the active substance called daridorexant, which belongs to a class of medicines known as "orexin receptor antagonists".
QUVIVIQ is used to treat insomnia in adults.
How QUVIVIQ works
Orexin is a substance produced by the brain that helps keep you awake. By blocking the action of orexin, QUVIVIQ allows you to fall asleep faster, stay asleep longer, and improves your ability to function normally during the day.
2. What you need to know before taking QUVIVIQ
Do not take QUVIVIQ
- If you are allergic to daridorexant or any of the other ingredients of this medicine (listed in section 6).
- If you have narcolepsy, a condition that causes you to fall asleep suddenly and unexpectedly at any time.
- If you are taking medicines that may increase QUVIVIQ levels in the blood, such as:
- oral medicines for fungal infections, such as ketoconazole, posaconazole, voriconazole, itraconazole.
- certain medicines for bacterial infections, such as the antibiotics clarithromycin, josamycin, telithromycin, troleandomycin.
- certain medicines for HIV infection, such as ritonavir, elvitegravir, indinavir, saquinavir, telaprevir, danoprevir, lopinavir, nelfinavir, boceprevir.
- certain medicines for cancer, such as ceritinib, idelalisib, ribociclib, tucatinib.
Consult your doctor if the medicine you are taking prevents you from taking QUVIVIQ.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take QUVIVIQ:
- if you have depression or have had or have ever had suicidal thoughts
- if you have a psychiatric disorder
- if you are taking medicines that affect the brain, such as treatments for anxiety or depression
- if you have regularly used drugs (except as medicines) or have been addicted to drugs or alcohol
- if you have liver problems: depending on their severity, QUVIVIQ may not be recommended, or a lower dose may be needed.
- if you have breathing difficulties (such as severe chronic obstructive pulmonary disease)
- if you have a history of falls and are over 65 years of age (because the risk of falling is generally higher in patients >65 years).
Your doctor may want to monitor how the medicine affects you.
Talk to your doctor if you experience any of the following side effects while taking QUVIVIQ:
- sleep paralysis: temporary inability to move or speak for several minutes when waking up or falling asleep
- hallucinations: seeing or hearing vivid or disturbing things that are not real when waking up or falling asleep
If you have depression and experience worsening symptoms or have thoughts about harming yourself, contact your doctor immediately.
Children and adolescents
This medicine is not intended for children and adolescents under 18 years of age, as QUVIVIQ has not been studied in this age group.
Other medicines and QUVIVIQ
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines because:
- some antibiotics (erythromycin, ciprofloxacin, clarithromycin, rifampicin), immunosuppressants (cyclosporine), antifungals (itraconazole), cancer treatments (ceritinib), or HIV treatments (ritonavir, efavirenz) may increase or decrease the amount of QUVIVIQ in the blood. Some of these medicines may be contraindicated with QUVIVIQ (see section "Do not take QUVIVIQ"). Your doctor will advise you.
- some medicines that act on the brain (e.g., diazepam, alprazolam) could interact with QUVIVIQ. Your doctor will advise you.
- certain medicines used to treat blood clotting disorders, such as dabigatran, could interact with QUVIVIQ, which would require certain precautions. Your doctor will advise you.
- certain medicines used to treat heart failure, such as digoxin, could interact with QUVIVIQ, which would require certain precautions. Your doctor will advise you.
Taking QUVIVIQ with food, drinks and alcohol
Drinking alcohol with QUVIVIQ may increase the risk of impaired balance and coordination.
Avoid consuming grapefruit or grapefruit juice at night, as it may increase the amount of QUVIVIQ in the blood.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
It is unknown whether QUVIVIQ may be harmful to the unborn baby.
A small amount of QUVIVIQ passes into breast milk. Consult your doctor about the best way to feed your baby during treatment with QUVIVIQ.
It is unknown whether QUVIVIQ affects human fertility.
Driving and using machines
It is recommended that approximately 9 hours pass between taking QUVIVIQ and driving or operating machinery. Be cautious when driving or using machinery in the morning after taking QUVIVIQ. Do not perform potentially dangerous activities if you are not sure you are fully awake, especially shortly after waking up during the first days of treatment.
QUVIVIQ contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.
3. How to take QUVIVIQ
Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
How much QUVIVIQ to take
Your doctor will inform you of the dose of QUVIVIQ you should take.
The recommended dose is one 50 mg QUVIVIQ tablet per night.
If you have liver problems or are taking certain medications, your doctor may prescribe you a lower dose, one 25 mg QUVIVIQ tablet per night.
The duration of treatment should be as short as possible. After 3 months, your doctor will periodically reassess the need to continue treatment.
- Take QUVIVIQ once per night, orally, half an hour before going to bed at night.
- You may take QUVIVIQ with or without food; however, if taken with or right after a heavy meal, it may take longer to take effect.
If you take more QUVIVIQ than you should
If you have taken too much QUVIVIQ, you may experience excessive sleepiness and muscle weakness. Contact your doctor immediately.
If you forget to take QUVIVIQ
If you forget to take QUVIVIQ at bedtime, do not take it later during the night, otherwise you may feel sleepy the next morning. Do not take a double dose to make up for missed tablets.
If you stop taking QUVIVIQ
Treatment with QUVIVIQ can be stopped without the need to gradually reduce the dose, and without harmful effects.
If you have any further questions about 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 everyone gets them. The following side effects may occur with this medicine:
Frequent (may affect up to 1 in 10 people):
- headache
- excessive sleepiness
- dizziness
- fatigue
- feeling unwell (nausea)
Uncommon (may affect up to 1 in 100 people):
- temporary inability to move or speak (sleep paralysis) lasting several minutes when falling asleep or waking up (see section 2).
- seeing or hearing vivid or disturbing things that are not real (hallucinations; see section 2).
- allergic reactions (including skin rash, hives)
- abnormal dreams, nightmares
- sleepwalking
If you experience any of these side effects, inform your doctor.
Reporting of side effects
If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of QUVIVIQ
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after "EXP".
The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of QUVIVIQ
The active substance is daridorexant.
QUVIVIQ 25 mg film-coated tablets
Each tablet contains daridorexant hydrochloride, equivalent to 25 mg of daridorexant.
QUVIVIQ 50 mg film-coated tablets
Each tablet contains daridorexant hydrochloride, equivalent to 50 mg of daridorexant.
The other components are:
Tablet core: mannitol (E421), microcrystalline cellulose (E460), povidone, sodium croscarmellose (see section 2 "QUVIVIQ contains sodium"), silicon dioxide, magnesium stearate
Film coating: hypromellose (E464), microcrystalline cellulose (E460), glycerol, talc (E553), titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172), yellow iron oxide (E172; only in the 50 mg tablets).
Appearance of the product and contents of the pack
Film-coated tablet (tablet)
QUVIVIQ 25 mg film-coated tablets
Light violet triangular tablet, with "25" engraved on one side and "i" (Idorsia logo) on the other.
QUVIVIQ 50 mg film-coated tablets
Light orange triangular tablet, with "50" engraved on one side and "i" (Idorsia logo) on the other.
QUVIVIQ is available in blister packs containing 10, 20 or 30 film-coated tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
Idorsia Pharmaceuticals Deutschland GmbH
Marie-Curie-Strasse 8
79539 Lörrach
Germany
Manufacturer
Idorsia Pharmaceuticals Deutschland GmbH
Marie-Curie-Strasse 8
79539 Lörrach
Germany
Date of the most recent revision of this leaflet
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.