zuranolone: package leaflet

What Zurzuvae is
Zurzuvae is an antidepressant medicine used to treat postpartum depression (PPD). It should be taken after giving birth by adults aged 18 years or older.

What Zurzuvae is used for
Postpartum depression is depression that begins during pregnancy or soon after giving birth.

Symptoms can include low mood or sadness, sleep disturbances, changes in weight, difficulty in concentrating, feelings of worthlessness, loss of interest in favourite activities, and feelings of being slowed down or anxiety.

How Zurzuvae works
Zurzuvae increases the activity of GABA (gamma-aminobutyric acid) on receptors in the brain.
GABA is involved in the regulation of mood. By increasing the activity of GABA, Zurzuvae may help the parts of the brain affected by depression. Typically, symptoms start to improve by the third day of the 14 day Zurzuvae treatment course.

Do not take Zurzuvae
- if you are allergic to zuranolone or any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant.

Warnings and precautions

Zurzuvae can reduce awareness and alertness. It is important to discuss these possible effects with your doctor or pharmacist before taking Zurzuvae.
- Do not drive for at least 12 hours after taking each Zurzuvae dose. You may not be able to tell on your own how much Zurzuvae is affecting you and whether you are safe to drive.
- Zurzuvae may also cause sleepiness, slow thinking, trouble remembering, confusion, and dizziness during the day. These effects may interfere with your daily activities, including taking care of your child. Do not perform potentially dangerous activities if you feel any of these effects.
Tell your doctor if you notice any of these signs.

Talk to your doctor before taking Zurzuvae if you think any of these apply:
- if you have abused or been addicted to alcohol, illegal drugs or prescribed medicines
- if you have had depression, mood problems or suicidal thoughts or behaviour.

Ask your doctor if other medicines you are taking prevent you from taking Zurzuvae.

Children and adolescents
This medicine is not for children and adolescents under 18 years of age. Zurzuvae has not been tested in this age group.

Other medicines and Zurzuvae
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Zurzuvae can affect the way some medicines work and some medicines can have an effect on Zurzuvae. Only take other medicines while you are on Zurzuvae if your doctor tells you that you can.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines as your dose of Zurzuvae may need to be adjusted. See section 3, How to take Zurzuvae:
- medicines that may increase the level of Zurzuvae in your blood. These include those used to treat:
- fungal infections, such as ketoconazole, posaconazole, voriconazole, itraconazole
- bacterial infections, such as the antibiotics clarithromycin, josamycin, telithromycin, troleandomycin
- HIV infection, such as ritonavir, elvitegravir, indinavir, saquinavir, telaprevir, danoprevir, lopinavir, nelfinavir, boceprevir
- cancer, such as ceritinib, idelalisib, ribociclib, tucatinib.

• medicines that can affect the nervous system, such as:
• painkillers like opioids (such as methadone, tramadol, morphine, oxycodone, codeine)
• sleep aids like benzodiazepines (such as diazepam, lorazepam), and nonbenzodiazepine hypnotics (such as zolpidem, zopiclone)
• antidepressants causing drowsiness (such as amitriptyline, clomipramine, dosulepin, doxepin, mianserin, mirtazapine, trazodone, trimipramine)
• medicines used to treat seizures, nerve pain or anxiety (such as gabapentin and pregabalin).

• medicines that may reduce how well Zurzuvae works, such as:
• rifampin (antibiotic)
• St. John’s Wort (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).

Talk to your doctor or pharmacist before taking Zurzuvae, if any of the above apply to you (or you are not sure).

Zurzuvae with alcohol
Do not drink alcohol or take products containing alcohol while taking Zurzuvae without talking to your doctor. Taking alcohol while on this medicine may make side effects such as drowsiness and sleepiness worse.

Zurzuvae with food and drink
Avoid grapefruit or grapefruit juice while taking Zurzuvae.

Pregnancy
Zurzuvae may cause harm to an unborn baby. Do not take Zurzuvae if you are pregnant.

Use reliable contraception during treatment and for 7 days afterwards. Speak to your nurse or doctor about suitable methods of contraception for you.

Tell your doctor straight away if, during treatment with Zurzuvae you become pregnant or think you are pregnant.

Breast-feeding
Zurzuvae passes into breast milk. You should not breast-feed unless your doctor tells you you can.

Tell your doctor straight away if you are breast-feeding or plan to breast-feed.

Driving and using machines
Do not drive or take part in any potentially dangerous activities such as operating machinery for at least 12 hours after taking Zurzuvae (see above section warnings and precautions).

Zurzuvae contains a negligible amount of sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free’.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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 only prescribed for a single 14 day course of treatment.

Do not stop taking Zurzuvae until you finish your 14 day treatment course, even if you feel better.
Typically, symptoms start to improve by the third day of Zurzuvae treatment.

Your doctor may reduce your dose to 40 mg (two 20 mg capsules) taken once daily in the evening if you have trouble with side effects.

Some medicines may cause side effects when taken at the same time as Zurzuvae. If your doctor prescribes one of these medicines while you are taking Zurzuvae, your doctor may reduce the dose of Zurzuvae to prevent side effects when taking both medicines at the same time.

If you have any moderate or severe kidney-related problems or severe liver problems, your doctor will prescribe a dose of 30 mg (one capsule) taken once daily in the evening.

How to take Zurzuvae capsules
- Swallow Zurzuvae capsules whole without chewing or opening them.

- Take Zurzuvae with food containing fat. This will help to increase the absorption of Zurzuvae into your body so it can be effective to treat your PPD. Typical fat-containing foods include:
- Cheese, whole milk, whole milk dairy products and yoghurt
- Meats, oily fish
- Avocado, hummus, soy-based products (tofu)
- Nuts, peanut butter, chocolate, fat-containing nutritional bars or drinks.
These can be taken as either a meal or a snack.

If you take more Zurzuvae than you should
If you take more Zurzuvae than you should, seek medical help immediately, either by calling your doctor or going to the nearest hospital emergency (A&E) department. Do not drive yourself because you may start to feel sleepy. Always take the labelled medicine container with you to show the doctor, even if there are no capsules left.

If you forget to take Zurzuvae
If you forget to take Zurzuvae, skip the missed dose and take the next dose at your regular time in the evening the next day. Do not take a double dose to make up for forgetting a dose. Continue taking Zurzuvae once daily until the remainder of the prescription is completed.

If you stop taking Zurzuvae
Treatment with Zurzuvae can be stopped without needing to gradually reduce the dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.

Very common (may affect more than 1 in 10 people)
- drowsiness or sleepiness
- dizziness.

Common (may affect up to 1 in 10 people)
- loose stools (diarrhoea)
- lack of energy
- trouble remembering information
- trembling or shaking
- feeling confused.

Tell your doctor, or pharmacist if you notice any of the side effects above.

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.

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 bottle or blister after EXP.

The expiry date refers to the last day of that month.

Store below 25 ºC.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

What Zurzuvae contains

The active substance is zuranolone.

Each hard capsule of Zurzuvae 20 mg contains 20 mg of zuranolone.

Each hard capsule of Zurzuvae 25 mg contains 25 mg of zuranolone.

Each hard capsule of Zurzuvae 30 mg contains 30 mg of zuranolone.

The other ingredients are:

Capsule contents: croscarmellose sodium (E468), mannitol (E421); microcrystalline cellulose (E460);
silica, colloidal anhydrous (E551); sodium stearyl fumarate.

Capsule shell: gelatin (E441); red iron oxide (E172); titanium dioxide (E171); yellow iron oxide (E172).

Capsule print (black ink): ammonium hydroxide (E527); black iron oxide (E172); propylene glycol (E1520); shellac glaze (E904).

What Zurzuvae looks like and contents of the pack

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 provided in bottle packs containing:
- 14 or 28 hard capsules of Zurzuvae 20 mg, or
- 14 or 28 hard capsules of Zurzuvae 25 mg, or
- 14 hard capsules of Zurzuvae 30 mg

The capsules are provided in blister packs containing:
- 28 hard capsules of Zurzuvae 20 mg, or
- 28 hard capsules of Zurzuvae 25 mg.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

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 ЕВОФАРМА
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

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.