Fulvestrant 250 mg/5 ml 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 Seacross is and what it is used for
2. What you need to know before you use Fulvestrant Seacross
3. How to use Fulvestrant Seacross
4. Possible side effects
5. How to store Fulvestrant Seacross
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 Seacross 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 Seacross 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 Seacross if you are pregnant. If you can become pregnant, you should use effective contraception while you are being treated with Fulvestrant Seacross and for 2 years after your last dose.

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

Fulvestrant Seacross 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 Seacross 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 pregnant or breast-feeding women and high-risk groups such as patients with liver disease, or epilepsy.

Fulvestrant Seacross contains 500 mg benzyl alcohol per injection, equivalent to 100 mg/ml.

Benzyl alcohol may cause allergic reactions. Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding or 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”).

Fulvestrant Seacross contains 750 mg benzyl benzoate per injection, equivalent to 150 mg/ml.

• 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 Seacross 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 Yellow Card Scheme website: http://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 per cent), benzyl alcohol, benzyl benzoate and castor oil refined.

Fulvestrant Seacross is a clear, colourless to yellow, viscous solution in a pre-filled syringe with ETFE coated bromobutyl rubber plunger stopper, containing 5 ml solution for injection. Two syringes must be administered to receive the 500 mg recommended monthly dose.

Fulvestrant Seacross has a pack containing 2 glass pre-filled syringes. Safety needles (Terumo SurGuard) for connection to each barrel are also provided.