Zurzuvae: detailed information

Package leaflet: Information for the patient

Zurzuvae 20 mg hard capsules, 25 mg hard capsules, 30 mg hard capsules

zuranolone
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Zurzuvae is and what it is used for
What you need to know before taking Zurzuvae
How to take Zurzuvae
Possible side effects
How to store Zurzuvae
Contents of the pack and other information

1. What Zurzuvae is and what it is used for

What Zurzuvae is
Zurzuvae is an antidepressant medicine used for the treatment of postpartum depression (PPD).
It should be taken after childbirth by adult women aged 18 years and older.

What Zurzuvae is used for
Postpartum depression is a type of depression that begins during pregnancy or shortly after childbirth.
Symptoms may include depressed mood or sadness, sleep disturbances, weight changes,
difficulty concentrating, feelings of worthlessness, loss of interest in usual activities, and
feelings of being slowed down or of anxiety.

How Zurzuvae works
Zurzuvae increases the activity of GABA (gamma-aminobutyric acid) at receptors in the brain.
GABA is involved in mood regulation. By increasing GABA activity, Zurzuvae may be effective on brain areas involved in depression. In general, symptoms begin to improve within the first three days of the 14-day treatment course with Zurzuvae.

2. What you should know before taking Zurzuvae

Do not take Zurzuvae

if you are allergic to zuranolone or to any of the other ingredients of this medicine (listed in section 6)
if you are pregnant.

Warnings and precautions
Zurzuvae can reduce alertness and awareness. It is important to discuss these possible effects with your doctor or pharmacist before taking Zurzuvae.

Do not drive vehicles for at least 12 hours after taking each dose of Zurzuvae. You may not be able to judge on your own how strongly Zurzuvae affects you and whether it is safe for you to drive.
Zurzuvae may also cause daytime drowsiness, slowed thinking, memory difficulties, confusion, and dizziness. These effects may interfere with your daily activities, including caring for your child. Do not perform potentially dangerous activities if you experience any of these effects. Inform your doctor if you notice any of these symptoms.

Talk to your doctor before taking Zurzuvae if you think you fall into any of the following categories:

if you have abused or have been dependent on alcohol, illegal substances, or prescription medicines
if you have had depression, mood problems, or suicidal thoughts or behaviors.

Ask your doctor whether any other medicines you are taking may prevent you from taking Zurzuvae.
Children and adolescents
This medicine is not intended for children and adolescents under 18 years of age. Zurzuvae has not been evaluated in this age group.
Other medicines and Zurzuvae
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Zurzuvae can affect how some medicines work, and some medicines can affect Zurzuvae. Take other medicines during treatment with Zurzuvae only if instructed by your doctor.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines, as it may be necessary to adjust the dose of Zurzuvae. See section 3, How to take Zurzuvae:

medicines that can increase the level of Zurzuvae in the blood. These include medicines used to treat:
- fungal infections, for example, ketoconazole, posaconazole, voriconazole, itraconazole
- bacterial infections, for example, the antibiotics clarithromycin, josamycin, telithromycin, troleandomycin
- HIV infection, for example, ritonavir, elvitegravir, indinavir, saquinavir, telaprevir, danoprevir, lopinavir, nelfinavir, boceprevir
- tumors, for example, ceritinib, idelalisib, ribociclib, tucatinib
medicines that can affect the nervous system, for example:
- painkillers such as opioids (e.g., methadone, tramadol, morphine, oxycodone, codeine)
- medicines that help you sleep, such as benzodiazepines (e.g., diazepam, lorazepam) and non-benzodiazepine hypnotics (e.g., zolpidem, zopiclone)
- antidepressants that cause drowsiness (e.g., amitriptyline, clomipramine, dosulepin, doxepin, mianserin, mirtazapine, trazodone, trimipramine)
- medicines used to treat seizures, nerve pain, or anxiety (e.g., gabapentin and pregabalin)
medicines that can reduce the effectiveness of Zurzuvae, for example:
- rifampicin (an antibiotic)
- St. John’s wort (a herbal remedy taken for depression)
- phenobarbital (also known as barbiturates, used for epilepsy or sleep problems)
- efavirenz (used for HIV infection)
- carbamazepine, phenytoin, and primidone (used to treat seizures).

Consult your doctor or pharmacist before taking Zurzuvae if you fall into any of the above categories (or if you have any doubts).
Zurzuvae and alcohol
Do not drink alcohol and do not take products containing alcohol during treatment with Zurzuvae without consulting your doctor. Consuming alcohol during treatment with this medicine may worsen certain side effects, such as drowsiness and fatigue.
Zurzuvae with food and drinks
Avoid grapefruit or grapefruit juice during treatment with Zurzuvae.
Pregnancy
Zurzuvae may harm the unborn child. Do not take Zurzuvae if you are pregnant.
Use reliable contraception during treatment and for 7 days after. Talk to your nurse or doctor about contraceptive methods suitable for you.
Inform your doctor immediately if you become pregnant or think you may be pregnant during treatment with Zurzuvae.
Breast-feeding
Zurzuvae passes into breast milk. You must not breast-feed unless instructed by your doctor.
Inform your doctor immediately if you are breast-feeding or plan to breast-feed.
Driving and using machines
Do not drive and do not perform potentially dangerous activities, such as operating machinery, for at least 12 hours after taking Zurzuvae (see the previous section Warnings and precautions).
Zurzuvae contains a negligible amount of sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.

3. How to take Zurzuvae

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Recommended dose
The recommended dose is 50 mg (two 25 mg capsules) taken once daily in the evening. Take it every day for 14 days. Zurzuvae is prescribed only for a single 14-day treatment course.
Do not stop taking Zurzuvae before completing the full 14-day treatment course, even if you feel better. Symptoms usually begin to improve within three days of starting treatment with Zurzuvae.
Your doctor may reduce your dose to 40 mg (two 20 mg capsules) once daily in the evening if you experience problems with side effects.
Some medicines may cause side effects when taken together with Zurzuvae. If your doctor prescribes one of these medicines during your treatment with Zurzuvae, your doctor may reduce the dose of Zurzuvae to prevent side effects when both medicines are taken together.
If you have moderate or severe kidney problems or severe liver problems, your doctor will prescribe a dose of 30 mg (one capsule) to be taken once daily in the evening.

How to take Zurzuvae capsules

Swallow the Zurzuvae capsules whole. Do not chew or open them.
Take Zurzuvae with a fatty meal or snack. This helps increase the absorption of Zurzuvae into your body so that it can be effective in treating PPD. Typical fatty foods include:
cheese, whole milk, and whole milk-based products and yogurts
meat, fatty fish
avocado, hummus, soy-based products (tofu)
nuts, peanut butter, chocolate, or nutritional bars or drinks containing fats. These can be consumed as a meal or a snack.

If you take more Zurzuvae than you should
If you take more Zurzuvae than prescribed, seek immediate medical help by contacting your doctor or going to the nearest hospital emergency department. Do not drive yourself, as you may begin to feel drowsy. Always take the medicine container with its label to show to the doctor, even if no capsules remain inside.

If you forget to take Zurzuvae
If you forget to take a dose of Zurzuvae, skip the missed dose and take the next dose at the usual time the following evening. Do not take a double dose to make up for the missed dose. Continue taking Zurzuvae once daily until you have completed the prescribed course.

If you stop taking Zurzuvae
Treatment with Zurzuvae can be stopped without the need to gradually reduce the dose.
If you have any questions about how to use 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.
Very common (may affect more than 1 in 10 people)

Drowsiness or tiredness
dizziness.

Common (may affect up to 1 in 10 people)

Diarrhoea
lack of energy
difficulty remembering information
tremor or shaking
feeling confused.

Tell your doctor or pharmacist if you notice any of the side effects listed above.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zurzuvae

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial or blister after Exp.
The expiry date refers to the last day of that month.
Store below 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zurzuvae contains
The active substance is zuranolone.
Each Zurzuvae 20 mg hard capsule contains 20 mg of zuranolone.
Each Zurzuvae 25 mg hard capsule contains 25 mg of zuranolone.
Each Zurzuvae 30 mg hard capsule contains 30 mg of zuranolone.

The other components are:
Capsule contents: croscarmellose sodium (E468), mannitol (E421), microcrystalline cellulose (E460), anhydrous colloidal silica (E551), sodium stearyl fumarate.
Capsule shell: gelatin (E441), red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172).
Capsule printing (black ink): ammonium hydroxide (E527), black iron oxide (E172), propylene glycol (E1520), shellac (E904).

Description of the appearance of Zurzuvae and package contents
Zurzuvae 20 mg hard capsules are hard capsules with a light orange cap and an ivory to light yellow body, printed with "S-217 20mg" in black ink.
Zurzuvae 25 mg hard capsules are hard capsules with a light orange cap and a light orange body, printed with "S-217 25mg" in black ink.
Zurzuvae 30 mg hard capsules are hard capsules with an orange cap and a light orange body, printed with "S-217 30mg" in black ink.

The capsules are supplied in bottles containing:

14 or 28 Zurzuvae 20 mg hard capsules, or
14 or 28 Zurzuvae 25 mg hard capsules, or
14 Zurzuvae 30 mg hard capsules.

The capsules are also supplied in blister packs containing:

28 Zurzuvae 20 mg hard capsules, or
28 Zurzuvae 25 mg hard capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder in your country:

België/Belgique/Belgien
Biogen Belgium N.V./S.A.
Tél/Tel: +32 2 219 12 18

Lietuva
Biogen Lithuania UAB
Tel: +370 5 259 6176

България
ТП БЪЛГАРИЯ
Teл.: +359 2 962 12 00

Luxembourg/Luxemburg
Biogen Belgium N.V./S.A.
Tél/Tel: +32 2 219 12 18

Česká republika
Biogen (Czech Republic) s.r.o.
Tel: +420 255 706 200

Magyarország
Biogen Hungary Kft.
Tel.: +36 (1) 899 9880

Danmark
Biogen (Denmark) A/S
Tlf.: +45 77 41 57 57

Malta
Pharma MT limited
Tel: +356 213 37008/9

Deutschland
Biogen GmbH
Tel: +49 (0) 89 99 6170

Nederland
Biogen Netherlands B.V.
Tel: +31 20 542 2000

Eesti
Biogen Estonia OÜ
Tel: +372 618 9551

Norge
Biogen Norway AS
Tlf: +47 23 40 01 00

Ελλάδα
Genesis Pharma SA
Τηλ: +30 210 8771500

Österreich
Biogen Austria GmbH
Tel: +43 1 484 46 13

España
Biogen Spain SL
Tel: +34 91 310 7110

Polska
Biogen Poland Sp. z o.o.
Tel.: +48 22 351 51 00

France
Biogen France SAS
Tél: +33 (0)1 41 37 95 95

Portugal
Biogen Portugal
Tel.: +351 21 318 8450

Hrvatska
Biogen Pharma d.o.o.
Tel: +385 (0) 1 775 73 22

România
Ewopharma România SRL
Tel: +40 21 260 13 44

Ireland
Biogen Idec (Ireland) Ltd.
Tel: +353 (0)1 463 7799

Slovenija
Biogen Pharma d.o.o.
Tel.: +386 1 511 02 90

Ísland
Icepharma hf
Sími: +354 540 8000

Slovenská republika
Biogen Slovakia s.r.o.
Tel.: +421 2 323 340 08

Italia
Biogen Italia s.r.l.
Tel: +39 02 584 9901

Suomi/Finland
Biogen Finland Oy
Puh/Tel: +358 207 401 200

Κύπρος
Genesis Pharma Cyprus Ltd
Τηλ: +357 22765715

Sverige
Biogen Sweden AB
Tel: +46 8 594 113 60

Latvija
Biogen Latvia SIA
Tel: +371 68 688 158

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/