Label: information for the user

Hycamtin 0.25mg hard capsules

Hycamtin 1mg hard capsules

topotecan

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, even if they are not listed in this label. See section4.

Hycamtin helps to eliminate tumors.

Hycamtin is used to treat small cell lung cancerthat has recurred after receiving chemotherapy.

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

Do not take Hycamtin

• if you are allergic to topotecan or any of the other ingredients in this medication (listed in section6).
• if you are breastfeeding.
• if your blood cell count is very low.Your doctor will tell you if this is the case, based on the results of your last blood test.

Inform your doctorif you are in any of these situations.

Warnings and precautions

Your doctor needs to know:

• if you have liver or kidney problems. Your dose of Hycamtin may need to be adjusted.
• if you are pregnant or think you may become pregnant. See the section “Pregnancy and breastfeeding” below.
• if you think you may become a father. See the section “Pregnancy and breastfeeding” below.

Inform your doctorif you are in any of these situations.

Other medications and Hycamtin

Inform your doctor if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription or any herbal medication.

You may be more likely to experience side effects if you are also being treated with cyclosporin A. You will be monitored while taking these two medications.

Remember to inform your doctor if you start taking any medication while you are being treated with Hycamtin.

Pregnancy and breastfeeding

Hycamtin is not recommended for use in pregnant women. It may cause harm to the fetus, before, during, or shortly after treatment. You should use an effective contraceptive method. Do not attempt to become pregnant or father a child until your doctor tells you it is safe to do so.

Men who wish to father a child should seek advice from their doctor about family planning.If your partner becomes pregnant during your treatment, inform your doctor immediately.

Avoid breastfeeding if you are being treated withHycamtin. Do not resume breastfeeding until your doctor tells you it is safe to do so.

Driving and operating machinery

Hycamtinmay cause fatigue. If you feel tired or weak, do not drive and do not operate machinery.

Important information about one of the components of Hycamtin

This medication contains small amounts of ethanol (alcohol).

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

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

• Your body size (surface area measured in square meters)
• The results of blood tests performed before treatment

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

Hycamtin capsules must not be opened or crushed.If the capsules are perforated or leaking, wash your hands immediately with soap and water thoroughly. 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 skin reaction.Removing a capsule

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

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

2. Remove the outer foil:lift and remove the foil covering the compartment, starting from the colored corner.

3. 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 medication accidentally, consult your doctor or pharmacist immediately.

If you forget to take Hycamtin

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects: report to your doctor

These side effectsvery frequentmay affectmore than 1 in 10peopletreated with Hycamtin:

• Signs of infections:Hycamtin may reduce the number of white blood cells and decrease their resistance to infections. This may pose a risk to life. Some signs of infection are:

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

• Diarrea.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) may be signs of intestinal inflammation (colitis)

This side effectraremay affectup to 1 in 1,000peopletreated with Hycamtin.

• Pulmonary inflammation(interstitial lung disease): you have a higher risk if you already have a lung disease, have received radiation treatment in your lungs, or have previously taken medications that caused lung damage. The signs include:
• • difficulty breathing
  • cough
  • fever.

Report to your doctor immediatelyif you notice any of these symptoms, as they may require hospitalization.

Very frequent side effects

May affectmore than 1 in 10peopletreated with Hycamtin:

• General feeling of weakness and fatigue (temporary anemia). In some cases, a blood transfusion may be necessary.
• Unexplained bruises or bleeding, caused by a decrease in the number of cells that participate in blood clotting. This may lead to severe bleeding from relatively small injuries such as small cuts. Rarely, this may lead to more severe bleeding (hemorrhage). Consult your doctor for advice on how to minimize the risk of bleeding.
• Weight loss and loss of appetite (anorexia); fatigue; weakness.
• Nausea, vomiting.
• Hair loss.

Frequent side effects

May affectup to 1 in 10peopletreated with Hycamtin:

• Allergies or hypersensitivity reactions (including skin rash).
• Inflammation and ulcers in the mouth, tongue, and gums.
• Fever.
• Stomach pain, constipation, indigestion.
• Discomfort.
• Itching sensation.

Rare side effects

May affectup to 1 in 100peopletreated with Hycamtin:

• Yellowing of the skin.

Rare side effects

May affectup to 1 in 1,000peopletreated with Hycamtin:

• Severe allergic reactions or anaphylactic reactions.
• Swelling caused by fluid retention (angioedema).
• Skin rash with itching (orhives).

Side effects of unknown frequency

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

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

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging.

Store in refrigerator (between2°Cand8°C).

Do not freeze.

Store the blister in theouter packagingto protect it from light.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

Composition of Hycamtin

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

Appearance of the product and contents of the pack

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

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

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

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Responsible for manufacturing

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

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of the summary of product characteristics:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu/.