Fulvestrant Sandoz

Package leaflet: Information for the user

Fulvestrant Sandoz 250 mg solution for injection in pre-filled syringe

Generic medicine
Please read all of this leaflet carefully before you start using 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Fulvestrant Sandoz and what is it used for

Fulvestrant Sandoz 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 Sandoz is used either:
alone, for the treatment of postmenopausal women with a type of breast cancer called estrogen receptor-positive locally advanced or metastatic breast cancer, or
in combination with palbociclib for the treatment of women with a type of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, which is locally advanced or metastatic. Women who have not yet reached menopause will be treated with a medicine called a luteinising hormone-releasing hormone (LHRH) agonist.
When Fulvestrant Sandoz is administered in combination with palbociclib, it is important to also read the palbociclib package leaflet. If you have any doubts about the use of palbociclib, please ask your doctor.

2. What you need to know before using Fulvestrant Sandoz

Do not use Fulvestrant Sandoz

• 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 breastfeeding.
• if you have severe liver disease.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Fulvestrant Sandoz.
If any of the following conditions apply to you:

• kidney or liver problems
• low platelet count (which helps blood to clot) or bleeding disorders
• history of blood clots
• osteoporosis (loss of bone density)
• alcoholism

Children and adolescents
Fulvestrant Sandoz is not indicated for use in children and adolescents under 18 years of age.
Other medicines and Fulvestrant Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, you must inform your doctor if you are using anticoagulants (medicines that prevent blood clots).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
You must not use Fulvestrant Sandoz if you are pregnant. If there is any possibility you could become pregnant, you must use an effective contraceptive method during treatment with Fulvestrant Sandoz.
You must not breastfeed during treatment with Fulvestrant Sandoz.
Driving and using machines
Fulvestrant Sandoz is not expected to affect your ability to drive or operate machinery. However, if you feel tired after treatment, do not drive or operate machinery.
Fulvestrant Sandoz contains ethanol
This medicine contains 12% ethanol (alcohol), i.e. up to 1000 mg per dose, equivalent to 20 ml of beer or 8 ml of wine per dose.
Harmful for people suffering from alcoholism.
This should be taken into account in pregnant or breastfeeding women, children, and high-risk groups such as patients with hepatic impairment or epilepsy.
Fulvestrant Sandoz contains benzyl alcohol
This medicine contains 100 mg of benzyl alcohol in each ml.
Benzyl alcohol may cause allergic reactions.
Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems (gasping syndrome), in young children.
Do not administer to neonates (up to 4 weeks of age) unless otherwise recommended by a doctor.
Do not use for more than one week in young children (under 3 years of age) unless otherwise recommended by a doctor or pharmacist.
Ask your doctor or pharmacist for advice if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).
Ask your doctor or pharmacist for advice if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).
Fulvestrant Sandoz contains benzyl benzoate
This medicine contains 150 mg of benzyl benzoate per ml.
Benzyl benzoate may increase jaundice (yellowing of the skin and eyes) in neonates (up to 4 weeks of age).

3. How to use Fulvestrant Sandoz

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 500 mg of fulvestrant (two 250 mg injections) administered once a
month, with an additional 500 mg dose given 2 weeks after the initial dose.
Your doctor or nurse will administer Fulvestrant Sandoz by slow intramuscular injection,
one injection into each buttock.
If you have any questions about how to use this medicine, speak to your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediate medical attention may be required if any of the following side effects occur:

• Allergic reactions (hypersensitivity), including swelling of the face, lips, tongue and/or throat, which may be signs of anaphylactic reactions
• Thromboembolism (increased risk of blood clots)*
• Inflammation of the liver (hepatitis)
• Liver failure

If you experience any of the following side effects, inform your doctor, pharmacist, or nurse:
Very common side effects (may affect more than 1 in 10 people)

• Reactions at the injection site, such as pain and/or inflammation
• Abnormal levels of liver enzymes (in blood tests)*
• Nausea (feeling unwell)
• Weakness, fatigue*
• Musculoskeletal and joint pain
• Hot flushes
• Rash
• Allergic reactions (hypersensitivity), 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*
• Increased levels of bilirubin (a bile pigment produced by the liver)
• Thromboembolism (increased risk of blood clots)*
• Reduced platelet levels (thrombocytopenia)
• Vaginal bleeding
• Lower back pain radiating to one leg (sciatica)
• Sudden weakness, numbness, tingling, or loss of movement in the leg, particularly on one side of the body, sudden problems with walking or balance (peripheral neuropathy)

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

• Vaginal thickening, white discharge, and candidiasis (infection)
• Bruising and bleeding at the injection site
• Increased levels of gamma-GT, a liver enzyme detected by blood tests
• Inflammation of the liver (hepatitis)
• Liver failure
• Numbness, tingling, and pain
• Anaphylactic reactions

*Includes adverse drug reactions for which the exact contribution of Fulvestrant Sandoz cannot be assessed due to the underlying disease.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fulvestrant Sandoz

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2 °C – 8 °C).
Keep the pre-filled syringe in the original packaging to protect the medicine from light.
Healthcare professionals will be responsible for the correct storage, use, and disposal of
Fulvestrant Sandoz.
Do not use this medicine after the expiry date stated on the carton or on the label of the
syringe after Exp. The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the device or its contents are damaged in any
way, such as damage to the syringe, cloudiness, particles in suspension, or change in colour of the
solution.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Fulvestrant Sandoz contains

• The active substance is fulvestrant. Each pre-filled syringe contains 250 mg of fulvestrant in 5 ml of solution (50 mg/ml).
• The other ingredients are ethanol (96 percent), benzyl alcohol, benzyl benzoate and castor oil.

Description of the appearance of Fulvestrant Sandoz and contents of the pack
Fulvestrant Sandoz is a clear, colourless to yellowish, viscous injectable solution in a pre-filled syringe.
Fulvestrant Sandoz is available in packs containing one or two disposable pre-filled syringes. A sterile needle is also supplied.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA)
Italy

Manufacturers
Lek Pharmaceuticals d.d.
Verovskova ulica 57, 1526 Ljubljana, Slovenia
Ebewe Pharma Ges.m.b.H. Nfg.KG
Mondseestrasse 11, 4866 Unterach am Attersee, Austria

This medicinal product is authorized in the European Economic Area countries under the following names:
Portugal Fulvestrant Sandoz
Austria Fulvestrant Sandoz 50mg/ml -– Injektionslösung in einer Fertigspritze
Belgium Fulvestrant Sandoz 250 mg oplossing voor injectie, voorgevulde spuit
Bulgaria Fulvestrant Sandoz 250 mg/5 ml Solution for injection in pre-filled syringe
Czech Republic Fulvestrant Sandoz 250 mg
Germany Fulvestrant - 1 A Pharma
Denmark Fulvestrant Sandoz
Estonia Fulvestrant Sandoz
Spain Afultrant 250 mg soluciön inyectable en jeringa precargada EFG
Finland Fulvestrant Sandoz 250 mg injektioneste, liuos esitäytetyssä ruiskussa
France FULVESTRANT SANDOZ 250 mg, solution injectable en seringue préremplie
Croatia Fulvestrant Sandoz 250 mg otopina za injekciju u napunjenoj štrcaljki
Hungary Fulvestrant Sandoz 250 mg oldatos injekció előretöltött fecskendőben
Ireland Fulvestrant Rowex 250 mg/5 ml solution for injection in pre-filled syringe
Iceland Fulvestrant Sandoz 250 mg stungulyf, lausn í áfylltri sprautu
Italy Fulvestrant Sandoz
Lithuania Fulvestrant Sandoz 50 mg/ml injekcinis tirpalas užpildytame švirkšte
Luxembourg Fulvestrant Sandoz 250 mg solution injectable, seringue préremplie
Netherlands Fulvestrant Sandoz 50 mg/ml, oplossing voor injectie in voorgevulde injectiespuit
Norway Fulvestrant Sandoz 250 mg injeksjonsvæske, oppløsning
Poland Fulvestrant Sandoz
Romania Fulvestrant Sandoz 250 mg soluţie injectabilă in seringa preumpluta
Sweden Fulvestrant Sandoz 250 mg injektionsvätska, lösning i förfylld spruta
Slovenia Fulvestrant Lek 250 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
Slovakia Fulvestrant Sandoz 250 mg
United Kingdom Fulvestrant 250 mg, Solution for Injection in pre-filled syringe

The following information is intended exclusively for healthcare professionals:

Fulvestrant Sandoz 500 mg (2x250 mg/5 ml injectable solution) must be administered
using two pre-filled syringes; see section 3.
Handling instructions:
Warnings – Do not autoclave the safety needle before use. Hands must remain
behind the needle at all times during use and disposal.
The syringes are supplied with a BD SafetyGlide® or Terumo SurGuard® safety needle.

Instructions for use of the BD SafetyGlide® safety needle
For each of the two syringes:

• Carefully remove the needle and syringe from the packaging.
• Remove the protective cap from the tip of the syringe.
• Remove the safety needle (BD SafetyGlide) from its outer packaging. Attach the safety needle to the Luer-Lock.
• Rotate to secure the needle to the Luer connector. Rotate until firmly fixed.
• Remove the needle protector.

quickly to avoid damage to the needle tip.

• Remove the protective needle sheath.
• Holding the syringe with the needle pointing upwards, gently push the plunger until the medication reaches the tip of the syringe. There must be no air inside the barrel.

Administer slowly (1 or 2 minutes/injection) by intramuscular injection into the gluteal muscle. For user convenience, the "blunt" tip of the needle is aligned with the lever arm.

• After injection, apply immediately the force of a single finger to the lever arm with assisted activation to engage the safety mechanism.

NOTE: Activate away from yourself and others. Listen for the click and visually confirm that the needle tip is completely covered.

Instructions for the Terumo SurGuard® safety needle
For each of the two syringes:

• Carefully remove the needle and syringe from the packaging.
• Remove the protective cap from the tip of the syringe.

Attach the syringe to the needle using aseptic technique. Hold the base of the needle, not the sheath, and rotate the syringe clockwise.

• Move the safety shield

away from the needle and toward the syringe barrel at the angle shown in the figure. Then remove the needle cap.

• Holding the syringe with the needle pointing upwards, gently push the plunger until the medication reaches the tip of the syringe. There must be no air inside the barrel.
• Administer slowly (1 or 2 minutes/injection) by intramuscular injection into the gluteal muscle.
• At the end of the injection, withdraw the needle from the skin and use a one-handed technique to activate the safety mechanism using one of the three methods:

o Finger activation

o Thumb activation
o Activation against a surface

Activation is indicated by an audible and/or tactile "click", and can be visually confirmed.
If in doubt whether the safety mechanism has been properly activated, repeat this step.

Disposal
The pre-filled syringes are for single use only.
Any unused medicinal product and waste materials derived from this medicinal product must be disposed of in accordance with local regulations.