FULVESTRANT DR. REDDY'S

Package leaflet: Information for the user

Fulvestrant Dr. Reddy’s 250 mg solution for injection in pre-filled syringe

Generic medicinal product
Please read all of this leaflet carefully before you start using this medicine as 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 others, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Fulvestrant Dr. Reddy’s is and what it is used for

Fulvestrant Dr. Reddy’s 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 is used for the treatment of advanced or metastatic breast cancer in postmenopausal women.

2. What you need to know before taking Fulvestrant Dr. Reddy’s

Do not take Fulvestrant Dr. Reddy’s:

• 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 Dr. Reddy’s if you are in any of the following conditions:

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

Children and adolescents
Fulvestrant is not indicated in children and adolescents under 18 years of age.
Other medicines and Fulvestrant Dr. Reddy’s
Tell 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 taking anticoagulants (medicines that prevent blood clots).
Pregnancy and breastfeeding
You must not use fulvestrant if you are pregnant. If there is any possibility that you could become pregnant, you must use an effective method of contraception during treatment with fulvestrant.
You must not breastfeed during treatment with fulvestrant.
Driving and using machines
Fulvestrant is not expected to affect your ability to drive or use machines. However, if you feel tired after treatment, do not drive or operate machinery.
Fulvestrant Dr. Reddy’s contains 10% w/v 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 high-risk groups such as patients with liver disease or epilepsy.
This medicine contains benzyl alcohol, which must not be administered to premature infants or neonates. It may cause toxic and allergic reactions in neonates and children up to 3 years of age.
This medicine contains castor oil, which may cause severe allergic reactions.

3. How to take Fulvestrant Dr. Reddy’s

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 injections of 250 mg/5 ml) administered once
a month, with an additional 500 mg dose given 2 weeks after the initial dose.
Your doctor or nurse will administer fulvestrant by slow intramuscular injection, one in 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 any of the following side effects occur, tell 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*

All other side effects:
Common side effects (may affect up to 1 in 10 people)
 Headache

• Hot flushes
• Vomiting, diarrhoea or loss of appetite*
• Rash
• Urinary tract infections
• Back pain*
• Increased levels of bilirubin (a bile pigment produced by the liver)
• Thromboembolism (increased risk of blood clots)*
• Allergic reactions (hypersensitivity), including swelling of the face, lips, tongue and/or throat

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

• Reduced platelet levels (thrombocytopenia)
• Thick, white vaginal 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)
• Lower back pain radiating to one leg (sciatica)
• Liver failure
• Numbness, tingling and pain
• 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)
• Anaphylactic reactions.

*Includes adverse drug reactions for which the exact contribution of fulvestrant cannot be assessed due to the underlying disease.
Reporting of side effects
If you experience any side effects, 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
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 Dr. Reddy’s

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or on the label of the syringe after the abbreviation "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 the range of 2°C - 8°C must be minimized. This includes avoiding storage at temperatures above 30°C, and not exceeding a period of 28 days at an average storage temperature below 25°C (but above 2 - 8°C).
After temperature excursions, the product must be returned immediately to the recommended storage conditions (store and transport in refrigerator at 2°C - 8°C). Temperature excursions have a cumulative effect on product quality, and the 28-day period must not be exceeded cumulatively during the 2-year shelf life of fulvestrant. Exposure to temperatures below 2°C does not damage the product provided it is not stored at temperatures below -20°C.
Keep the pre-filled syringe in the original packaging to protect from light.
Healthcare professionals are responsible for the correct storage, use, and disposal of fulvestrant.
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 Dr. Reddy’s contains

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

Description of the appearance of Fulvestrant Dr. Reddy’s and contents of the pack
Fulvestrant Dr. Reddy’s is a clear, colourless to yellow viscous solution in a pre-filled syringe
assembled with a child-resistant closure, containing 5 ml of solution for injection. To receive the recommended monthly dose of 500 mg, two syringes must be administered.
Fulvestrant Dr. Reddy’s is available in 2 pack sizes: either a pack containing 1 pre-filled glass syringe or a pack containing 2 pre-filled glass syringes. Safety needles (Terumo SurGuard) with a connection device for each syringe barrel are also supplied.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
DR. REDDY’S S.r.l.
Piazza S. Maria Beltrade, 1, 20123 Milano
Manufacturer
Dr. Reddy´s Laboratories (UK) Ltd.
6, Riverview Road, HU17 0LD
United Kingdom
betapharm Arzneimittel GmbH
Kobelweg 95, 86156
Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following names:

The following information is intended exclusively for healthcare professionals:

Fulvestrant 500 mg (two 250 mg injections) must be administered using two pre-filled syringes; see section 3.
Instructions for administration
Warnings – Do not autoclave the needle (Terumo SurGuard 3) before use. Hands must remain behind the needle during use and disposal.
For each of the two syringes:

• Remove the glass syringe barrel from the tray (Figure 1)

and check that it is not damaged.

• Break the seal of the white plastic cap on the Luer-Lok connector of the Luer syringe to remove the cap together with the attached rubber stopper (see Figure 1).
• Remove the safety needle from its outer packaging (Figure 2) (Terumo SurGuard). Attach the safety needle to the Luer-Lok connector (see Figure 2).

• Rotate until firmly in place.
• Rotate to lock the needle onto the Luer connector.
• Transport the filled syringe to the administration site.
• Remove the safety sheath of the needle (Figure 3)

and position it around the syringe barrel at the angle shown, before removing the needle cap.

• Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration.
• Expel excess air from the syringe.
• Administer slowly (1 to 2 minutes per injection) by intramuscular injection into the gluteal region (gluteal area). For user convenience, the “blunt” tip of the needle is aligned with the lever arm (see Figure 3).
• If necessary, use the finger grip.
• After injection, use one-handed technique (Figure 4)

to activate the safety mechanism using one of the three methods illustrated above (activation is confirmed by an audible and/or tactile “click” and can be visually confirmed) (see Figure 4).
NOTE: Activate away from yourself and others.
Hear the click and visually confirm that the needle tip is completely covered.
Disposal
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.