Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - faslodex

Document Subject

Generated Narrative: MedicinalProductDefinition mp1f037c7eeed99a83d34b7e97df29f3bf

identifier: http://ema.europa.eu/identifier/EU/1/03/269/001 1 Syringe

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Faslodex 250 mg solution for injection.

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-1f037c7eeed99a83d34b7e97df29f3bf

identifier: http://ema.europa.eu/identifier/EU/1/03/269/001 1 Syringe

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - faslodex

Attesters

What is in this leaflet

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

Faslodex 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. Faslodex 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 Faslodex 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 Faslodex:

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 Faslodex 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 Faslodex is not indicated in children and adolescents under 18 years. Other medicines and Faslodex 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 Faslodex if you are pregnant. If you can become pregnant, you should use effective contraception while you are being treated with Faslodex and for 2 years after your last dose. You must not breast-feed while on treatment with Faslodex. Driving and using machines Faslodex 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. Faslodex contains 10% w/v ethanol (alcohol), i.e. up to 500 mg per injection, equivalent to 10 ml beer or 4 ml wine. Harmful for those suffering from alcoholism. To be taken into account in high-risk groups such as patients with liver disease, or epilepsy. Faslodex contains 500 mg benzyl alcohol per injection, equivalent to 100 mg/ml. Benzyl alcohol may cause allergic reactions. Faslodex contains 750 mg benzyl benzoate per injection, equivalent to 150 mg/ml.

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 Faslodex 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 Faslodex 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 in a refrigerator (2 C - 8 C). Temperature excursions outside 2 C - 8 C should be limited. This includes avoiding storage at temperatures exceeding 30 C, 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 4-year shelf life of Faslodex. 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 Faslodex. 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 Faslodex contains

The active substance is fulvestrant. Each pre-filled syringe (5 ml) contains 250 mg fulvestrant.

The other ingredients (excipients) are ethanol (96 per cent), benzyl alcohol, benzyl benzoate and castor oil refined. What Faslodex looks like and contents of the pack Faslodex 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. Two syringes must be administered to receive the 500 mg recommended monthly dose. Faslodex has 2 pack presentations, either a pack containing 1 glass pre-filled syringe or a pack containing 2 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 AstraZeneca AB SE-151 85 S dert lje Sweden Manufacturer AstraZeneca AB Global External Sourcing (GES) Astraall n G rtunaporten SE-151 85 S dert lje Sweden AstraZeneca UK Limited Silk Road Business Park Macclesfield Cheshire SK10 2NA United Kingdom For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660

.: +359 24455Luxembourg/Luxemburg AstraZeneca S.A./N.V. T l/Tel: +32 2 370 48 esk republika AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 Magyarorsz g AstraZeneca Kft Tel: +36 1 883 6Danmark AstraZeneca A/S Tlf: +45 43 66 64 Malta Associated Drug Co. Ltd Tel: +356 2277 8Deutschland AstraZeneca GmbH Tel: +49 40 809034Nederland AstraZeneca BV Tel: +31 79 363 2Eesti AstraZeneca Tel: +372 6549 Norge AstraZeneca AS Tlf: +47 21 00 64
AstraZeneca A.E. : + 30 210 6871 sterreich AstraZeneca sterreich GmbH Tel: +43 1 711 31 0 Espa a AstraZeneca Farmac utica Spain, S.A. Tel: +34 91 301 91 Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 France AstraZeneca T l: +33 1 41 29 40 Portugal AstraZeneca Produtos Farmac uticos, Lda. Tel: +351 21 434 61 Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 Rom nia AstraZeneca Pharma SRL Tel: +40 21 317 60 Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 sland Slovensk republika Vistor hf. S mi: +354 535 7AstraZeneca AB, o.z. Tel: +421 2 5737 7Italia AstraZeneca S.p.A. Tel: +39 02 00704Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23

: +357 22490Sverige AstraZeneca AB Tel: +46 8 553 26 Latvija SIA AstraZeneca Latvija Tel: +371 67377United Kingdom (Northern Ireland) AstraZeneca UK Ltd Tel: +44 1582 836 This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: