0.25 / 1 mg Topotecan hard capsules
1. What Hycamtin is and what it is used for
Hycamtin helps to destroy your tumor.
Hycamtin is used to treat small cell lung cancer that has recurred after chemotherapy.
Your doctor will decide with you whether Hycamtin treatment is better than continuing treatment with the chemotherapy you were treated with from the beginning.
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 levels are too low. Your doctor will then inform you based on the test results of your most recent blood test.
Tell your doctor if any of these apply to you.
Warnings and cautions
Before starting treatment, your doctor must tell you:
- if you have any kidney or liver problems. Your Hycamtin dose may then need to be adjusted.
- if you are pregnant or planning to become pregnant. See section “Pregnancy and breast-feeding” below.
- if you are a man and planning to have children. See section “Pregnancy and breast-feeding” below.
Tell your doctor if any of these apply to you.
Other medicines and Hycamtin
Tell your doctor if you have recently taken, or might take any other medicines, including medicines obtained without a prescription and herbal medicines.
There may be a higher-than-normal risk of side effects if you are also treated with cyclosporine A. You will be closely monitored if you are taking these medicines at the same time.
Remember to tell your doctor if you start taking any other medicine while you are taking Hycamtin.
Pregnancy and breastfeeding
Hycamtin is not recommended for pregnant women. It can harm a fetus during or shortly after treatment. You should use an effective contraceptive. Ask your doctor for advice. Do not try to get pregnant until your doctor tells you it is safe to do so.
Male patients who wish to have a child should ask their doctor for advice on family planning or treatment. If your partner becomes pregnant during treatment, you must tell your doctor immediately.
Do not breastfeed if you are being treated with Hycamtin. Do not start breastfeeding again until your doctor tells you that it is safe to do so.
Driving and using machines
Hycamtin may make you feel tired. If you feel tired or weak, do not drive or use machines.
Hycamtin contains ethanol
This medicine contains small amounts of ethanol (alcohol).
3. How to take Hycamtin
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The capsule (s) must be swallowed whole and must not be chewed, crushed, or divided.
The Hycamtin- dose (and the number of capsules) you receive is determined by your doctor, based on:
- your body surface area (measured as square meters)
- the results of the blood samples taken before treatment.
The prescribed number of capsules should be swallowed whole once daily for 5 days.
Hycamtin capsules must not be opened or crushed. If the capsules are punctured or leaking, wash your hands immediately with soap and water. If you get the contents of the capsule in your eyes, immediately rinse your eyes with a gentle jet of water for at least 15 minutes. Contact a doctor after eye contact or if you get a skin reaction.
To take out a capsule
The capsules are provided in special packages to prevent children from taking them out.
If you take more Hycamtin than you should
Ask your doctor or pharmacist immediately if you have taken too many capsules or if a child has accidentally taken the medicine.
If you forget to take Hycamtin
Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual 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 common side effects can occur in more than 1 in 10 people treated with Hycamtin:
- Signs of infection : Hycamtin may reduce the number of white blood cells and reduce your resistance to infection . This can lead to life-threatening conditions. Symptoms include:
- fever
- severe deterioration of your general condition
- local symptoms such as sore throat or difficulty urinating (for example, a burning sensation when urinating, which may be due to a urinary tract infection).
- Diarrhea. It can be serious. If you get more than 3 episodes of diarrhea per day, contact your doctor immediately.
- Sometimes severe abdominal pain, fever and possibly diarrhea (in rare cases bloody) can be signs of inflammation in the intestines ( colitis ).
This rare side effect can occur in up to 1 in 1,000 people treated with Hycamtin:
- Pneumonia ( interstitial lung disease ): You are most at risk if you have a pre-existing lung disease, have had radiation therapy to your lungs, or if you have previously taken medication that caused lung damage. Signs of this can be:
- breathing difficulties
- cough
- fever.
Contact your doctor immediately if you get symptoms of any of these conditions as it may be necessary to be hospitalized.
Very common side effects are
These may occur in more than 1 in 10 people treated with Hycamtin:
- Feeling of general weakness and tiredness (temporary anemia ( anemia )). In some cases, you may need a blood transfusion .
- Easier to get bruises and bleeding, due to a decrease in the number of coagulating cells in the blood. This can lead to major bleeding from relatively small wounds such as small cuts. In rare cases, this can lead to severe bleeding ( hemorrhage ) . Talk to 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.
Common side effects are
These can occur in up to 1 in 10 people treated with Hycamtin:
- Allergic or hypersensitivity s (including rash).
- Inflammation and sores in the mouth, tongue or gums.
- Fever.
- Stomach ache, constipation, indigestion.
- General feeling of discomfort.
- Skin itching.
Uncommon side effects are
These can occur in up to 1 in 100 people treated with Hycamtin:
- Yellowish skin.
Rare side effects are
These can occur in up to 1 in 1,000 people treated with Hycamtin:
- Severe allergic or anaphylactic reactions.
- Swelling due to fluid retention ( angioedema ).
- Itchy rash (or hives ).
Side effects are without known frequency
The frequency of some side effects is not known (derived from spontaneous reports and the frequency can not be calculated from the available data)
- Severe abdominal pain, nausea, vomiting of blood, black or bloody stools (possible symptoms of gastrointestinal perforation [gastrointestinal perforation]).
- Sores in the mouth, difficulty swallowing, abdominal pain, nausea, vomiting, diarrhea, bloody stools (possible signs and symptoms of inflammation of the mucous membranes of the mouth, stomach and / or intestines [mucositis]).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store 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 (2ºC-8ºC).
Do not freeze.
Store the blister in the outer carton. Sensitive to 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 to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is topotecan. Each capsule contains 0.25 mg or 1 mg of topotecan (as hydrochloride).
- The other ingredients are: hydrogenated vegetable oil, glyceryl monostearate, gelatin, titanium dioxide (E171) and only for 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.
What the medicine looks like and contents of the pack
Hycamtin 0.25 mg capsules are opaque, white to off-white, and marked with “Hycamtin” and “0.25 mg”.
Hycamtin 1 mg capsules are pink and marked with “Hycamtin” and “1 mg”.
Hycamtin 0.25 mg and 1 mg are available in packs of 10 capsules.
Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
Novartis Pharmacéutica SA
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
GlaxoSmithKline Manufacturing SpA
Strada Provinciale Asolana 90
43056 San Polo di Torrile
Parma
Italy
Contact the representative of the marketing authorization holder to find out more about this medicine:
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