Hycamtin 0.25 mg Hy cam tin 1 mg hard capsules Topotecan
Hycamtin 0.25 mg Hycamtin 1 mg hard capsules
Topotecan
1. What Hycamtin is and what it is used for
Hycamtin helps to destroy tumours.
Hycamtin is used to treat:
• small cell lung cancer that has come back after chemotherapy.
Your doctor will decide with you whether Hycamtin therapy is better than further treatment with your initial chemotherapy.
2. Before you take Hycamtin
Do not take Hycamtin:
• if you are allergic {hypersensitive) to topotecan or any of the other ingredients of Hycamtin.
• if you are breast feeding.
• 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.
• if you are pregnant or plan to become pregnant
• if you plan to father a child
Hycamtin may harm a baby conceived before, during or soon after treatment. You should use an effective method of contraception. Ask your doctor for advice.
Tell your doctor if any of these applies to you.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including any herbal products or medicines obtained without a prescription.
There may be a higher than usual chance of you getting side effects if you are also being treated with cyclosporin A. You will be monitored closely while you are taking these two medicines.
Remember to tell your doctor if you start to take any other medicines while you’re on Hycamtin.
Taking 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.
Hycamtin capsules may be taken with or without food.
The capsule(s) must be swallowed whole, and must not be chewed, crushed or divided.
Pregnancy and breast-feeding
Hycamtin is not recommended for pregnant women. It may harm the baby if conceived before, during or soon after treatment. You should use an effective method of contraception. Ask your doctor for advice. Do not try and become pregnant/father a child until a doctor advises you it is safe to do so.
Male patients who may wish to father a child, should ask their doctor for family planning advice or treatment. If pregnancy occurs during treatment, 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.
Important information about some of the ingredients of Hycamtin
This medicinal product contains a trace amount of ethanol (alcohol).
3. How to take Hycamtin
Always take Hycamtin exactly as your doctor has told you. You should always check with your doctor or pharmacist if you are not sure.
The dose (and number of capsules) of Hycamtin you are given will be worked out by your doctor, based on:
• your body size (surface area measured in square metres)
• the results of blood tests carried out before treatment
• the disease being treated.
The prescribed number of capsules should be swallowed whole, once a day for 5 days. Hycamtin capsules must not be opened or crushed. If the capsules are punctured or leaking, you should immediately wash your hands thoroughly with soap and water. If you get it in your eyes, wash them immediately with gently flowing water for at least 15 minutes. Consult your doctor/healthcare provider after eye contact or if you experience a skin reaction.
- Taking out a capsule
These capsules come in special packaging to prevent children removing them
1. Separate one capsule: tear along the cutting lines to separate one “pocket” from the strip.
2. Peel back the outer layer: starting at the coloured corner, lift and peel over the pocket.
3. Push out the capsule: gently push one end of the capsule through the foil layer
If you take more Hycamtin than you should
Contact a doctor or pharmacist immediately for advice 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. Just take the next dose at the scheduled time.
4.Possible side effects
Like all medicines, Hycamtin can cause side effects, although not everybody gets them.
Serious side effects: tell your doctor
These very common side effects 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).
• Diarrhoea. This can be serious. If you have more than 3 episodes of diarrhoea per day you should contact your doctor immediately.
Occasionally severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation {colitis)
This rare side effect may affect up to 1 in 1000 people treated with Hycamtin).
• Lung inflammation (interstitial lung disease): You are most at risk if you have existing lung
disease, had radiation treatment to your lungs, or have previously taken medicines that caused lung damage. Signs include:
difficulty in breathing
cough
fever
Tell your doctor immediately if you get any symptoms of these conditions, as hospitalisation may be necessary.
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); stomach pain; constipation.
• High body temperature (fever).
• Hair loss.
Common side effects
These may affect up to 1 in 10 people treated with Hycamtin:
• Allergic or hypersensitivity reactions (including rash)
• Inflammation and ulcers of the mouth, tongue or gums
• Itching sensation
• Muscle pain.
Uncommon side effects
These may affect up to 1 in 100 people treated with Hycamtin:
• Yellow skin
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)
• Itchy rash (or hives).
If you get side effects
Tell your doctor or pharmacist if any of the side effects become severe or troublesome, or if you notice any side effects not listed in this post.
5. How to store Hycamtin
Keep out of the reach and sight of children.
Do not use Hycamtin after the expiry date which is stated on the carton.
Store in a refrigerator (2°C – 8°C).
Keep the blister card in the outer carton in order to protect from light.
Do not freeze.
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. Further information
What Hycamtin contains
• The active substance is topotecan. Each capsule contains topotecan hydrochloride equivalent to 0.25 mg or 1 mg of topotecan.
• The other ingredients are: hydrogenated vegetable oil, glyceryl monostearate, gelatin, titanium dioxide (E171), and for 1 mg capsules only, red iron oxide (E172). Capsules are printed with black ink that contains black iron oxide (El72), shellac, anhydrous ethanol, propylene glycol, isopropyl alcohol, butanol, concentrated ammonia solution and potassium hydroxide.
What Hycamtin looks like and contents of the pack
Hycamtin 0.25 mg capsules are white to yellowish white and imprinted with ‘Hycamtin’ and ’0.25 mg’.
Hycamtin 1 mg capsules are pink and imprinted with ‘Hycamtin’ and ’1 mg’.
Hycamtin is available in packs containing 10 capsules of 0.25 mg or 1 mg topotecan.
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