QUVIVIQ 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

QUVIVIQ 25 mg film-coated tablets

QUVIVIQ 50 mg film-coated tablets

daridorexant

This medicine 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. The last section of this leaflet includes 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

1. What QUVIVIQ is and what it is used for
2. What you need to know before you take QUVIVIQ
3. How to take QUVIVIQ
4. Possible side effects
5. Storage of QUVIVIQ
6. 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 called «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 helps you fall asleep faster, sleep longer, and improves your ability to function normally during the day.

2. What you need to know before you take 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 makes you suddenly fall asleep at any time.
• If you are taking medicines that may increase QUVIVIQ levels in the blood, such as:
• oral medicines for treating fungal infections, such as ketoconazole, posaconazole, voriconazole, itraconazole.
• certain medicines for treating bacterial infections, such as the antibiotics clarithromycin, josamycin, telithromycin, troleandomycin.
• certain medicines for treating HIV infection, such as ritonavir, elvitegravir, indinavir, saquinavir, telaprevir, danoprevir, lopinavir, nelfinavir, boceprevir.
• certain medicines for treating cancer, such as ceritinib, idelalisib, ribociclib, tucatinib.

Ask your doctor if the medicine you are taking prevents you from taking QUVIVIQ.

Warnings and precautions

Consult your doctor or pharmacist before starting QUVIVIQ:

• if you have depression or have 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 the severity, QUVIVIQ may not be recommended, or a lower dose may be required.
• if you have breathing difficulties (such as severe chronic obstructive pulmonary disease)
• if you have a history of falls and are over 65 years old (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 talk 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 suffer from depression and experience worsening or have thoughts of self-harm, contact your doctor immediately.

Children and adolescents

This medicine is not for children and adolescents under 18 years old because QUVIVIQ has not been tested in this age group.

Other medicines and QUVIVIQ

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, because:

• certain antibiotics (erythromycin, ciprofloxacin, clarithromycin, rifampicin), immunosuppressants (ciclosporin), antifungals (itraconazole), cancer treatments (ceritinib), or HIV treatments (ritonavir, efavirenz) may increase or decrease QUVIVIQ levels in the blood. Some of these medicines may be contraindicated with QUVIVIQ (see section “Do not take QUVIVIQ”). Your doctor will advise you.
• certain medicines that act on the brain (e.g., diazepam, alprazolam) may interact with QUVIVIQ. Your doctor will advise you.
• certain medicines for treating blood coagulation disorders, such as dabigatran, may interact with QUVIVIQ, requiring certain precautions. Your doctor will advise you.
• certain medicines for treating heart failure, such as digoxin, may interact with QUVIVIQ, requiring certain precautions. Your doctor will advise you.

Taking QUVIVIQ with food, drinks, and alcohol

Taking alcohol with QUVIVIQ may increase the risk of balance and coordination disorders.

Avoid taking grapefruit or grapefruit juice at night, as it may increase QUVIVIQ levels in the blood.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this medicine.

It is not known if QUVIVIQ can harm the fetus.

A small amount of QUVIVIQ passes into breast milk. Consult your doctor on the best way to feed your baby during treatment with QUVIVIQ.

It is not known if QUVIVIQ affects human fertility.

Driving and using machines

It is recommended that a period of approximately 9 hours elapses between taking QUVIVIQ and driving or using machines. Be careful when driving or using machines in the morning after taking QUVIVIQ. Do not engage in potentially hazardous activities if you are not sure you are fully awake, especially shortly after waking up in 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 the instructions for administration of this medicine exactly as prescribed by your doctor. If you are unsure, 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 medicines, your doctor may prescribe 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 a night, orally, 30 minutes before bedtime.
• You can take QUVIVIQ with food or without food; however, if you take it with or immediately after a heavy meal, it may take longer to work.

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, or you may feel drowsy the next morning. Do not take a double dose to make up for forgotten 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 other 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 everybody gets them. The following side effects may occur with this medicine:

Common(may affect up to 1 in 10 people):

• headache
• excessive sleepiness
• dizziness
• fatigue
• feeling sick (nausea)

Uncommon(may affect up to 1 in 100 people):

• temporary inability to move or talk (sleep paralysis) lasting several minutes when sleeping 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, tell your doctor.

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 QUVIVIQ

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 after ‘EXP’.

The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

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 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 ingredients are:

Core of the tablet: mannitol (E421), microcrystalline cellulose (E460), povidone, sodium croscarmellose (see section 2 ‘QUVIVIQ contains sodium’), silicon dioxide, magnesium stearate

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 for 50 mg tablets).

Appearance and packaging

Film-coated tablet (tablet)

QUVIVIQ 25 mg film-coated tablets

Light purple 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.

Not all pack sizes may be marketed.

Marketing authorisation holder

Idorsia Pharmaceuticals Deutschland GmbH

Marie-Curie-Strasse 8

79539 Lörrach

Germany

Manufacturer

Idorsia Pharmaceuticals Deutschland GmbH

Marie-Curie-Strasse 8

79539 Lörrach

Germany

PharmaKorell GmbH

Georges-Koehler-Str. 2

79539 Lörrach

Germany

Date of last revision of this leaflet 06/2023

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