Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - veoza

Document Subject

Generated Narrative: MedicinalProductDefinition mp28b6beabb1138dcf80cd8cb464115640

identifier: http://ema.europa.eu/identifier/EU/1/23/1771/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Veoza 45 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-28b6beabb1138dcf80cd8cb464115640

identifier: http://ema.europa.eu/identifier/EU/1/23/1771/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - veoza

Attesters

What is in this leaflet

1. What Veoza is and what it is used for
2. What you need to know before you take Veoza
3. How to take Veoza
4. Possible side effects
5. How to store Veoza
6. Contents of the pack and other information

Veoza contains the active substance fezolinetant. Veoza is a non-hormonal medicine used in menopausal women to reduce moderate-to-severe vasomotor symptoms (VMS) associated with menopause. VMS are also known as hot flashes or night sweats.

Before menopause, there is a balance between oestrogens, a female sex hormone, and a protein made by the brain known as neurokinin B (NKB) that regulates your brain s temperature control centre. As your body goes through menopause, oestrogen levels decline and this balance is disrupted, which can lead to VMS. By blocking NKB binding in your temperature control centre, Veoza reduces the number and intensity of hot flashes and night sweats.

Do not take Veoza

• if you are allergic to fezolinetant or any of the other ingredients of this medicine (listed in section 6).
• with medicines known as moderate or strong CYP1A2 inhibitors (e.g., ethinyl oestradiol containing contraceptives, mexiletine, enoxacin, fluvoxamine). These medicines can reduce the breakdown of Veoza in the body, leading to more side effects. See Other medicines and Veoza
  below.
• if you are pregnant or think you may be pregnant. Warnings and precautions Talk to your doctor or pharmacist before taking Veoza
• your doctor may ask for your full medical history, including family history.
• if you have ongoing liver disease or liver problems. Your doctor may want to monitor your liver enzymes periodically.
• if you have kidney problems. Your doctor may not prescribe this medicine to you.
• if you currently have or previously had breast cancer or another oestrogen-related cancer. During treatment, your doctor may not prescribe this medicine to you.
• if you are taking hormone replacement therapy with oestrogens (medicines used to treat oestrogen deficiency symptoms). Your doctor may not prescribe this medicine to you.
• if you have a history of seizures. Your doctor may not prescribe this medicine to you. Children and adolescents Do not give this medicine to children and adolescents under 18 years of age, because this medicine is only for menopausal women. Other medicines and Veoza Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines without a prescription.

Certain medicines may increase the risk of side effects of Veoza by increasing the amount of Veoza in the blood. These medicines must not be taken while you are taking Veoza, and include:

• Fluvoxamine (a medicine used to treat depression and anxiety)
• Enoxacin (a medicine used to treat infections)
• Mexiletine (a medicine used to treat symptoms of muscle stiffness)
• Ethinyl oestradiol containing contraceptives (medicines used to prevent pregnancy) Pregnancy and breast-feeding Do not take this medicine if you are pregnant or breast-feeding, or if you think you might be pregnant. This medicine is for use only by menopausal women. If you become pregnant while taking this medicine, stop taking it immediately and talk to your doctor. Women of childbearing potential should use effective non-hormonal contraception. Driving and using machines Veoza has no effect on the ability to drive or use machines.

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

The recommended dose is one 45 mg tablet taken by mouth once daily. Instructions for proper use

• Take this medicine at about the same time each day.
• Swallow the tablet whole with liquids. Do not break, crush, or chew the tablet.
• Take with or without food. If you take more Veoza than you should If you have taken more tablets than you have been told to take, or if someone else accidentally takes your tablets, contact your doctor or pharmacist straight away.

Symptoms of overdose may include headache, feeling sick (nausea), or a tingling or prickling sensation (paraesthesia). If you forget to take Veoza If you forget to take your medicine, take the missed dose as soon as you remember on the same day, and at least 12 hours before the next scheduled dose. If there is less than 12 hours before the next scheduled dose, do not take the missed dose. Return to your regular schedule the following day. Do not take a double dose to make up for a forgotten individual dose.

If you miss several doses, tell your doctor and follow the advice given to you. If you stop taking Veoza Do not stop taking this medicine unless your doctor tells you to do so. If you decide to stop taking this medicine before finishing the prescribed course of treatment, you should talk to your doctor first.

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.

Common (may affect up to 1 in 10 people)

• diarrhoea
• difficulty sleeping (insomnia)
• increase in levels of certain liver enzymes (ALT or AST), as shown in blood tests
• stomach (abdominal) pain 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 carton and blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 Veoza contains

• The active substance is fezolinetant. Each film-coated tablet contains 45 mg of fezolinetant.
• The other ingredients are: Tablet core: mannitol (E421), hydroxypropyl cellulose (E463), low-substituted hydroxypropyl cellulose (E463a), microcrystalline cellulose (E460), magnesium stearate (E470b). Film-coating: hypromellose (E464), talc (E553b), macrogol (E1521), titanium dioxide (E171), iron oxide red (E172). What Veoza looks like and contents of the pack Veoza 45 mg tablets are round, light red, film-coated tablets (tablets) debossed with the company logo
  and 645 on the same side.

Veoza is available in PA/Aluminium/PVC/Aluminium unit dose blisters in cartons.

Pack sizes: 10 1, 28 1, 30 1, and 100 1 film-coated tablets.

Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Astellas Pharma Europe B.V. Sylviusweg 2333 BE Leiden The Netherlands Tel: +31 (0)71 5455For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Astellas Pharma B.V. Branch T l/Tel: +32 (0)2 5580Lietuva Astellas Pharma d.o.o. Tel.: +370 37 408

Te .: +359 2 862 53 Luxembourg/Luxemburg Astellas Pharma B.V. Branch Belgique/Belgien T l/Tel: +32 (0)2 5580 esk republika Astellas Pharma s.r.o. Tel: +420 221 401 Magyarorsz g Astellas Pharma Kft. Tel.: +36 1 577 8Danmark Astellas Pharma a/s Tlf: +45 43 430Malta Astellas Pharmaceuticals AEBE Tel: +30 210 8189Deutschland Astellas Pharma GmbH Tel.: +49 (0)89 454Nederland Astellas Pharma B.V. Tel: +31 (0)71 5455Eesti Astellas Pharma d.o.o. Tel: +372 6 056 Norge Astellas Pharma Tlf: +47 66 76 46
Astellas Pharmaceuticals AEBE : +30 210 8189 sterreich Astellas Pharma Ges.m.b.H. Tel.: +43 (0)1 8772Espa a Astellas Pharma S.A. Tel: +34 91 4952Polska Astellas Pharma Sp.z.o.o. Tel.: +48 225451 France Astellas Pharma S.A.S. T l: +33 (0)1 55917Portugal Astellas Farma, Lda. Tel: +351 21 4401Hrvatska Astellas d.o.o. Tel: +385 1670 0Rom nia S.C.Astellas Pharma SRL Tel: +40 (0)21 361 04 Ireland Astellas Pharma Co. Ltd. Tel: +353 (0)1 4671Slovenija Astellas Pharma d.o.o. Tel: +386 14011 sland Vistor hf S mi: +354 535 7Slovensk republika Astellas Pharma s.r.o. Tel: +421 2 4444 2Italia Astellas Pharma S.p.A. Tel: +39 (0)2 921Suomi/Finland Astellas Pharma Puh/Tel: +358 (0)9 85606

Astellas Pharmaceuticals AEBE : +30 210 8189Sverige Astellas Pharma AB Tel: +46 (0)40-650 15 Latvija Astellas Pharma d.o.o. Tel: +371 67 619United Kingdom (Northern Ireland) Astellas Pharma Co., Limited Free call from Northern Ireland: 0800 783 5International number: +353 (0)1 4671This leaflet was last revised in

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