Fulvestrant Dr. Reddy's 250 mg Solution For Injection in Pre-Filled Syringe

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• 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.

Talk to your doctor or pharmacist or nurse before using Fulvestrant 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.

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

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).

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

You must not breast-feed while on treatment with fulvestrant.

Fulvestrant 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.

Ethanol

This medicine contains 500 mg alcohol (ethanol) in 5 ml solution. The amount in one dose (two 5 ml syringe) of this medicine is equivalent to less than 25 ml beer or 10 ml wine. The amount of alcohol in this medicine is not likely to have an effect in adults and adolescents. The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines. If you are addicted to alcohol, talk to your doctor or pharmacist before taking this medicine.

Benzyl alcohol

This medicine contains 500 mg benzyl alcohol in each5 ml vial. Benzyl alcohol may cause allergic reactions.

Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).

Benzyl benzoate

This medicine contains 750 mg benzyl benzoate in each 5 ml vial.

Castor oil

May cause severe allergic reactions.

• 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

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

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 cannot be assessed due to the underlying disease.

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 Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

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

Fulvestrant is a clear, colourless to yellow, viscous solution free from visible particles 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.

Fulvestrant has 4 pack presentations: a pack containing 1 glass pre-filled syringe, a pack containing 2 glass pre-filled syringes, a pack containing 4 glass pre-filled syringes, and a pack containing 6 prefilled syringes. Safety needles for connection to each barrel and a finger grip on each pre-filled syringe are also provided.

Not all pack sizes may be marketed.