HYCAMTIN 1 mg HARD CAPSULES

2. What you need to know before you take Hycamtin

Do not take Hycamtin

• if you are allergic to topotecan or any of the other ingredients of this medicine (listed in section 6).
• if you are breast-feeding.
• if your blood cell count is very low.Your doctor will tell you if this is the case, based on your latest blood test results.

Tell your doctorif you are in any of these situations.

Warnings and precautions

Before starting treatment with this medicine, your doctor needs to know:

• if you have liver or kidney problems. It may be necessary to adjust your dose of Hycamtin.
• if you are pregnant or think you may be pregnant. See the section “Pregnancy and breast-feeding” below.
• if you are planning to become a father. See the section “Pregnancy and breast-feeding” below.

Tell your doctorif you are in any of these situations.

Other medicines and Hycamtin

Tell your doctor if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription or any herbal medicines.

There may be a greater chance that you will suffer side effects if you are also being treated with ciclosporin A. You will be monitored while taking these two medicines.

Remember to tell your doctor if you start taking any medicine while being treated with Hycamtin.

Pregnancy and breast-feeding

Hycamtin should not be used in pregnant women. It may harm the fetus, before, during or shortly after treatment. You must use an effective method of contraception. Do not try to become pregnant or father a child until your doctor tells you it is safe to do so.

Men who wish to become fathers should ask their doctor for advice on family planning. If your partner becomes pregnant during your treatment, tell your doctor immediately.

Avoid breast-feeding while being treated with Hycamtin. Do not restart breast-feeding until your doctor tells you it is safe to do so.

Driving and using machines

Hycamtin may cause fatigue. If you feel tired or weak, do not drive or use machines.

Important information about some of the ingredients of Hycamtin

This medicine contains small amounts of ethanol (alcohol).

3. How to take Hycamtin

Follow exactly the instructions of your doctor for taking this medicine. If you are in doubt, consult your doctor or pharmacist again.

The capsule(s) should be taken whole, and should not be chewed, crushed or divided.

The dose (and the number of capsules) of Hycamtin you receive will be calculated by your doctor based on:

• your body size (body surface area measured in square meters)
• the results of your blood tests before treatment

The prescribed number of capsules should be swallowed whole, once a day for five days.

The Hycamtin capsules should not be opened or crushed.If the capsules are pierced or leaking, you should wash your hands immediately with soap and water. If the capsule contents come into contact with your eyes, rinse them immediately with plenty of water for at least 15 minutes. Consult your doctor after eye contact or if you experience a skin reaction.Removing a capsule

These capsules come in a special container to prevent children from removing them.

1. Separate a capsule: tear along the perforated lines to separate a blister from the strip.

1. Remove the outer foil: lift and remove the foil that covers the blister, starting from the colored corner.

1. Remove the capsule: carefully push one end of the capsule along the aluminum foil.

If you take more Hycamtin than you should

If you have taken too many capsules or if a child has taken the medicine by accident, consult your doctor or pharmacist immediately.

If you forget to take Hycamtin

Do not take a double dose to make up for forgotten doses. Take the next dose at the scheduled time.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects: tell your doctor

These very commonside effects may affect more than 1 in 10peopletreated with Hycamtin:

• Signs of infection:Hycamtin may reduce the number of white blood cells and decrease your resistance to infections. This can be life-threatening. Some signs of infection are:

• fever
• severe deterioration of your general condition
• local symptoms such as sore throat or urinary problems (e.g. burning sensation when urinating, which may be due to a urinary tract infection).

• Diarrhea.It can be severe. Contact your doctor immediately if you have more than 3 episodes of diarrhea per day.
• Occasionally, the presence of severe stomach pain, fever, and possible diarrhea (rarely with blood) can be signs of intestinal inflammation (colitis)

This rareside effect may affect up to 1 in 1,000peopletreated with Hycamtin.

• Lung inflammation(interstitial lung disease): you are at greater risk if you already have a lung disease, have received radiation treatment to your lungs, or have taken medicines that have caused lung damage. The signs include:
• • difficulty breathing
  • cough
  • fever.

Tell your doctor immediatelyif you notice any of these symptoms, as you may need to be hospitalized.

Very common side effects

May affect more than 1 in 10peopletreated with Hycamtin:

• Feeling of general weakness and tiredness (anemia). In some cases, you may need to have a blood transfusion.
• Bruising or unexplained bleeding, caused by a decrease in the number of cells that help the blood to clot. This can lead to severe bleeding from relatively small wounds, such as small cuts. Rarely, this can lead to more severe bleeding (hemorrhage). Talk to your doctor for advice on how to minimize the risk of bleeding.
• Weight loss and loss of appetite (anorexia); tiredness; weakness.
• Nausea, vomiting.
• Hair loss.

Common side effects

May affect up to 1 in 10peopletreated with Hycamtin:

• Allergic reactions or hypersensitivity reactions (including skin rash).
• Inflammation and ulcers in the mouth, tongue, and gums.
• Fever.
• Stomach pain, constipation, indigestion.
• Malaise.
• Feeling of itching.

Uncommon side effects

May affect up to 1 in 100peopletreated with Hycamtin:

• Yellowing of the skin.

Rare side effects

May affect up to 1 in 1,000peopletreated with Hycamtin:

• Severe allergic reactions or anaphylacticreactions.
• Swelling caused by fluid retention (angioedema).
• Itchy skin rash (or hives).

Side effects with unknown frequency

The frequency of some side effects cannot be estimated from the available data (effects from spontaneous reports and the frequency cannot be estimated from the available data):

• Severe stomach pain, nausea, vomiting with blood, black or bloody stools (possible symptoms of gastrointestinal perforation).
• Sores in the mouth, difficulty swallowing, abdominal pain, nausea, vomiting, diarrhea, bloody stools (possible signs and symptoms of inflammation of the lining of the mouth, stomach and/or intestines [mucosal inflammation]).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Hycamtin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton.

Store in a refrigerator (between 2°C and 8°C).

Do not freeze.

Keep the blister in the outer packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Hycamtin contains

• The active substance istopotecan. Each capsule contains 0.25 mg or 1 mg of topotecan (as hydrochloride).
• The other ingredients are: hydrogenated vegetable oil, glycerol monostearate, gelatin, titanium dioxide (E171) and only for the 1 mg capsules, red iron oxide (E172). The capsules are printed with black ink containing black iron oxide (E172), shellac, anhydrous ethanol, propylene glycol, isopropyl alcohol, butanol, concentrated ammonia solution and potassium hydroxide.

Appearance and packaging

The 0.25 mg Hycamtin capsules are white to off-white and are printed with “Hycamtin” and “0.25 mg”.

The 1 mg Hycamtin capsules are pink and are printed with “Hycamtin” and “1 mg”.

The 0.25 mg and 1 mg Hycamtin capsules are available in packs containing 10 capsules.

Marketing authorisation holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley, Surrey GU16 7SR

United Kingdom

GlaxoSmithKline Manufacturing S.p.A.

Strada Provinciale Asolana 90

43056 San Polo di Torrile

Parma

Italy

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.