Read all of this leaflet carefully before you start using this medicine.

Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In this leaflet:

• 1 What Hycamtin is and what it is used for
• 2 Before you are given Hycamtin
• 3 How to use Hycamtin
• 4 Possible side effects
• 5 How to store Hycamtin
• 6 Further information

Hycamtin is used to treat:

• ovarian cancer or small cell lung cancer that has come back after chemotherapy
• advanced cervical cancer if surgery or radiotherapy treatment is not possible. When treating cervical cancer, Hycamtin is combined with another drug called cisplatin.

Your doctor will decide with you whether Hycamtin therapy is better than further treatment with your initial chemotherapy.

You should not receive Hycamtin:

• if you are allergic (hypersensitive) to topotecan or any of the other ingredients of Hycamtin.
• if you are pregnant or breast feeding, or think you may be pregnant
• if your blood cell counts are too low. Your doctor will tell you, based on the results of your last blood test.

• Tell your doctor if any of these applies to you.

Take special care with Hycamtin

Your doctor needs to know before you are given this medicine:

• if you have any kidney or liver problems. Your dose of Hycamtin may need to be adjusted.

• Tell your doctor if either of these applies to you.

Using other medicines

Tell your doctor if you are taking any other medicines or have recently taken any. This includes any herbal products or medicines you have bought without a prescription.

Remember to tell your doctor if you start to take any other medicines while you’re on Hycamtin.

Using Hycamtin with food and drink

There is no known interaction between Hycamtin and alcohol. However, you should check with your doctor whether drinking alcohol is advisable for you.

Pregnancy and breast feeding

Hycamtin is not to be given to pregnant women. Use contraception to avoid becoming pregnant while you’re being treated. If you do get pregnant, tell your doctor immediately.

Do not breast-feed if you are being treated with Hycamtin. Do not restart breast-feeding until the doctor tells you it is safe to do so.

Driving and using machines

Hycamtin can make people feel tired.

If you feel tired or weak, do not drive and do not use machines.

The usual dose

• For ovarian and small cell lung cancer: 1.5 mg per squaremetres of body surface area per day.
• For cervical cancer: 0.75 mg per squaremetres of body surface area per day.

When treating cervical cancer, Hycamtin is combined with another medicine, called cisplatin. Your doctor will advise you about the correct dose of cisplatin.

How Hycamtin is given

A doctor or nurse will give you a suitable dose of Hycamtin as an infusion (a drip). It is usually dripped into your arm over about 30 minutes.

• For ovarian and small cell lung cancer, you will have treatment once a day for 5 days.
• For cervical cancer, you will have treatment once a day for 3 days.

This pattern of treatments will normally be repeated every three weeks, for all cancers.

The treatment may vary, depending on the results of your regular blood tests.

Stopping treatment

Your doctor will decide when to stop the treatment.

Serious effects: tell your doctor

These may affect more than 1 in 10 people treated with Hycamtin.

• Signs of infections. Hycamtin may reduce the number of white blood cells and lower your resistance to infection. This can even be life threatening. Signs include:
  • fever
  • serious deterioration of your general condition
  • local symptoms such as sore throat or urinary problems (for example, a burning sensation when urinating, which may be a urinary infection)

• Tell your doctor immediately if you get any of these. A blood test will be taken to check possible reduction of white blood cells.

Very common side effects

These may affect more than 1 in 10 people treated with Hycamtin

• Feeling generally weak and tired (temporary anaemia). In some cases you may need a blood transfusion.
• Unusual bruising or bleeding, caused by a decrease in the number of clotting cells in the blood. This can lead to severe bleeding from relatively small injuries such as a small cut. Rarely, it can lead to more severe bleeding (haemorrhage). Talk to your doctor for advice on how to minimize the risk of bleeding.
• Weight loss and loss of appetite (anorexia); tiredness; weakness; feeling unwell.
• Feeling sick (nausea), being sick (vomiting); diarrhoea; stomach pain; constipation
• Inflammation and ulcers of the mouth, tongue or gums
• High body temperature (fever)
• Hair loss.

• Tell a doctor if any of these becomes troublesome.

Common side effects

These may affect up to 1 in 10 people treated with Hycamtin

• Allergic or hypersensitivity reactions (including rash)
• Yellow skin
• Itching sensation
• Muscle pain

• Tell a doctor if any of these becomes troublesome.

Rare side effects

These may affect up to 1 in 1000 people treated with Hycamtin.

• Severe allergic or anaphylactic reactions
• Swelling caused by fluid build up (angioedema)
• Mild pain and inflammation at the site of injection
• Itchy rash (or hives).

• Tell a doctor if any of these becomes troublesome.

What Hycamtin contains

The active substance is topotecan hydrochloride. Each vial contains 1 mg or 4 mg topotecan.

The other ingredients are: tartaric acid (E334), mannitol (E421), hydrochloric acid (E507) and sodium hydroxide.

What Hycamtin looks like and contents of the pack

Hycamtin comes as a powder for concentrate for solution for intravenous infusion.

It is available in packs containing either 1 or 5 vials

Each vial contains 1 mg or 4 mg of topotecan.

The powder needs to be reconstituted and diluted before infusion.

The powder in the vial provides 1 mg per ml of active substance when reconstituted as recommended.