Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - fulvestrant

Document Subject

Generated Narrative: MedicinalProductDefinition mpd843c48300874227785506f7092e03c1

identifier: http://ema.europa.eu/identifier/EU/1/17/1253/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Fulvestrant Mylan 250 mg solution for injection in prefilled syringe

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-d843c48300874227785506f7092e03c1

identifier: http://ema.europa.eu/identifier/EU/1/17/1253/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - fulvestrant

Attesters

What is in this leaflet

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

Fulvestrant Mylan contains the active substance fulvestrant, which belongs to the group of estrogen blockers. Estrogens, a type of female sex hormones, can in some cases be involved in the growth of breast cancer.

Fulvestrant Mylan is used either:

• alone, to treat postmenopausal women with a type of breast cancer called estrogen receptor positive breast cancer that is locally advanced or has spread to other parts of the body (metastatic), or
• in combination with palbociclib to treat women with a type of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer, that is locally advanced or has spread to other parts of the body (metastatic). Women who have not reached menopause will also be treated with a medicine called a luteinizing hormone releasing hormone (LHRH) agonist.

When fulvestrant is given in combination with palbociclib, it is important that you also read the package leaflet for palbociclib. If you have any questions about palbociclib, please ask your doctor.

Do not use Fulvestrant Mylan

• if you are allergic to fulvestrant or to any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant or breast-feeding
• if you have severe liver problems

Warnings and precautions
Talk to your doctor or pharmacist or nurse before using Fulvestrant Mylan if any of these apply to you:

• kidney or liver problems
• low numbers of platelets (which help blood clotting) or bleeding disorders
• previous problems with blood clots
• osteoporosis (loss of bone density)
• alcoholism

Children and adolescents Fulvestrant Mylan is not indicated in children and adolescents under 18 years.

Other medicines and Fulvestrant Mylan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, you should tell your doctor if you are using anticoagulants (medicines to prevent blood clots).

Pregnancy and breast-feeding You must not use Fulvestrant Mylan if you are pregnant. If you can become pregnant, you should use effective contraception while you are being treated with Fulvestrant Mylan and for 2 years after your last dose.

You must not breast-feed while on treatment with Fulvestrant Mylan.

Driving and using machines Fulvestrant Mylan is not expected to affect your ability to drive or use machines. However, if you feel tired after treatment do not drive or use machines.

Fulvestrant Mylan contains 10% w/v alcohol (ethanol) i.e. 500 mg in each 5 ml, equivalent to less than 25 ml beer or 10 ml wine per one treatment dose (i.e. two syringes). The small amount of alcohol in this medicine will not have any noticeable effects.

Fulvestrant Mylan contains benzyl alcohol This medicine contains 500 mg benzyl alcohol in each 5 ml which is equivalent to 100 mg/ml (10% w/v). Benzyl alcohol may cause allergic reactions.

Fulvestrant Mylan contains benzyl benzoate This medicine contains 750 mg benzyl benzoate in each 5 ml, which is equivalent to 150 mg/ml (15%w/v).

Always use 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 500 mg fulvestrant (two 250 mg/5 ml injections) given once a month, with an additional 500 mg dose given 2 weeks after the initial dose.

Your doctor or nurse will give you Fulvestrant Mylan as a slow intramuscular injection, one into each of your buttocks.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You may need immediate medical treatment if you experience any of the following side effects:

• Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat that may be signs of anaphylactic reactions

• Thromboembolism (increased risk of blood clots)*

• Inflammation of the liver (hepatitis)

• Liver failure

Tell your doctor, pharmacist, or nurse if you notice any of the following side effects:

Very common side effects (may affect more than 1 in 10 people)

• Injection site reactions, such as pain and/or inflammation
• Abnormal levels of liver enzymes (in blood tests)*
• Nausea (feeling sick)
• Weakness, tiredness*
• Joint and musculoskeletal pain
• Hot flushes
• Skin rash
• Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat

All other side effects:

Common side effects (may affect up to 1 in 10 people)

• Headache
• Vomiting, diarrhoea, or loss of appetite*
• Urinary tract infections
• Back pain*
• Increase of bilirubin (bile pigment produced by the liver)
• Thromboembolism (increased risk of blood clots)*
• Decreased levels of platelets (thrombocytopenia)
• Vaginal bleeding
• Lower back pain irradiating to leg on one side (sciatica)
• Sudden weakness, numbness, tingling, or loss of movement in your leg, especially on only one side of your body, sudden problems with walking or balance (peripheral neuropathy)

Uncommon side effects (may affect up to 1 in 100 people)

• Thick, whitish vaginal discharge and candidiasis (infection)

• Bruising and bleeding at the site of injection

• Increase of gamma-GT, a liver enzyme seen in a blood test

• Inflammation of the liver (hepatitis)

• Liver failure

• Numbness, tingling and pain

• Anaphylactic reactions

• Includes side effects for which the exact role of Fulvestrant Mylan cannot be assessed due to the underlying disease.

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. 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 or syringe labels after EXP. The expiry date refers to the last day of that month.

Store and transport refrigerated (2 C - 8 C).

Temperature excursions outside 2 C - 8 C should be limited and not exceeding a 28 day period where the average storage temperature for the product is below 25 C (but above 2 C - 8 C). After temperature excursions, the product should be returned immediately to the recommended storage conditions (store and transport in a refrigerator 2 C - 8 C). Temperature excursions have a cumulative effect on the product quality and the 28 day time period must not be exceeded over the duration of the shelf life of Fulvestrant Mylan. Exposure to temperatures below 2 C will not damage the product providing it is not stored below 20 C.

Keep the pre-filled syringe in the original package in order to protect from light.

Your healthcare professional will be responsible for the correct storage, use and disposal of Fulvestrant Mylan.

This medicine may pose a risk to the aquatic environment. 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 protect the environment.

What Fulvestrant Mylan contains

• The active substance is fulvestrant. Each pre-filled syringe (5 ml) contains 250 mg fulvestrant.
• The other ingredients (excipients) are benzyl benzoate (see section 2 Fulvestrant Mylan contains benzyl benzoate ), benzyl alcohol (see section 2 Fulvestrant Mylan contains benzyl alcohol ), ethanol anhydrous (see section 2 Fulvestrant Mylan contains 10% w/v alcohol (ethanol) ), castor oil, refined.

What Fulvestrant Mylan looks like and contents of the pack Fulvestrant Mylan is a clear, colourless to yellow, viscous solution in a pre-filled syringe fitted with a tamper-evident closure, containing 5 ml solution for injection.
Fulvestrant Mylan has 4 pack presentations, either a pack containing 1 glass pre-filled syringe or a pack containing 2 glass pre-filled syringes or a pack containing 4 glass pre-filled syringes or a pack containing 6 glass pre-filled syringes. Safety needles (BD SafetyGlide) for connection to each barrel are also provided.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
MYLAN PHARMACEUTICALS LIMITED Damastown Industrial Park Mulhuddart
Dublin DUBLIN Ireland

Manufacturer MYLAN TEORANTA Inverin Co. Galway IRELAND

MYLAN GERMANY GmbH Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1 Bad Homburg v. d. Hoehe Hessen, 61GERMANY

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

Belgi /Belgique/Belgien Mylan bvba/sprl Tel/T l: + 32 (0)2 658 61 Lietuva Mylan Healthcare UAB
Tel: +370 5 205 1

: +359 2 44 55 Luxembourg/Luxemburg Mylan bvba/sprl T l/Tel: + 32 (0)2 658 61 (Belgique/Belgien)

esk republika Viatris CZ s.r.o. Tel: +420 222 004 Magyarorsz g Mylan EPD Kft. Tel.: + 36 1 465 2Danmark Viatris ApS Tlf: +45 28 11 69 Malta V.J.Salomone Pharma Ltd Tel: + 356 21 22 01 Deutschland Viatris Healthcare GmbH
Tel: + 49 800 0700 Nederland Mylan BV Tel: +31 (0)20 426 3Eesti BGP Products Switzerland GmbH Eesti filiaal
Tel: + 372 6363 Norge Viatris AS Tlf: + 47 66 75 33
Generics Pharma Hellas
: +30 210 993 6 sterreich Arcana Arzneimittel GmbH Tel: +43 1 416 2Espa a Viatris Pharmaceuticals, S.L.U. Tel: + 34 900 102 Polska Mylan Healthcare Sp. z.o.o. Tel.: + 48 22 546 64 France Viatris Sant
T l: +33 4 37 25 75 Portugal Mylan, Lda. Tel: + 351 21 412 72 Hrvatska Mylan Hrvatska d.o.o. Tel: +385 1 23 50 Rom nia BGP Products SRL Tel: + 40 372 579 Ireland Mylan Ireland Limited Tel: +353 1 8711Slovenija Viatris d.o.o. Tel: + 386 1 23 63 sland Icepharma hf. S mi: + 354 540 8Slovensk republika Viatris Slovakia s.r.o. Tel: +421 2 32 199 Italia Mylan Italia S.r.l. Tel: + 39 02 612 46Suomi/Finland Viatris Oy Puh/Tel: + 358 20 720 9
Varnavas Hadjipanayis Ltd : + 357 2220 7Sverige Viatris AB
Tel: + 46 (0)8 630 19 Latvija Mylan Healthcare SIA
Tel: +371 676 055 United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: +353 18711This leaflet was last revised in {MM/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: