Pharmorubicin Rapid Dissolution
Pharmorubicin Rapid Dissolution 10 mg, 20 mg, 50 mg and 150 mg Powder for Solution for Injection for Infusion
1. What Pharmorubicin is and what it is used for
- Pharmorubicin is an injection that contains epirubicin hydrochloride. It belongs to a group of medicines called cytotoxics used for chemotherapy. Pharmorubicin causes cells that are actively growing, such as cancer cells to slow or stop their growth and increases the likelihood that they die. This medicine helps to selectively kill the cancer tissue rather than normal, healthy tissue.
- Pharmorubicin is used to treat a variety of cancers, either alone or in combination with other drugs. The way in which it is used depends upon the type of cancer that is being treated.
- It has been found to be particularly useful in the treatment of cancers of the breast, ovaries,
stomach, bowel and lung. In addition, this medicine can be given to treat cancers of the blood forming tissues such as malignant lymphomas, leukaemias and multiple myeloma.
- Pharmorubicin can also be put directly into the bladder through a tube. This is sometimes used to treat abnormal cells or cancers of the bladder wall. It can be used after other treatments to try and prevent such cells from growing again.
2. Before you are given Pharmorubicin
Do not use Pharmorubicin if you have:
- an allergy (hypersensitivity) to epirubicin or any of the other ingredients of Pharmorubicin blood cell counts, as it can lower them further.
- previously been treated with Pharmorubicin or similar chemotherapy drugs like doxorubicin or daunorubicin, as previous treatment with these similar medicines can increase the risk of side effects with this medicine.
- suffered from severe heart trouble in the past, or are presently receiving treatment for this.
Take special care with Pharmorubicin:
Tell your doctor if:
- your liver or kidneys are not working properly.
This will help your doctor decide if this medicine is suitable for you
Taking other medicines:
Please tell your doctor or pharmacist if you have recently taken any other medicines, even those not prescribed, particularly the following:
Cimetidine (a drug usually used to treat stomach ulcers and heartburn). Cimetidine can make the effects of Pharmorubicin stronger.
Pregnancy
Avoid becoming pregnant while you or your partner is being treated with this medicine. If you are sexually active, you are advised to use effective birth control to prevent pregnancy during treatment, whether you are male or female. Pharmorubicin may cause birth defects, so it is important to tell your doctor if you think you are pregnant.
Breast feeding
You should stop breast feeding before starting treatment with this medicine as some of the drug may get into your milk and possibly harm your child.
Ask your doctor or pharmacist for advice before taking any medicine whilst breast feeding.
Driving and using machinery
There are no special precautions, and you can drive or operate machinery as long as you feel fully recovered following your hospital treatment.
Important information about some of the ingredients of Pharmorubicin
This medicine contains methyl hydroxybenzoate. This may cause allergic reactions (possibly delayed) and exceptionally, bronchospasm.
3. How Pharmorubicin is given to you
If you are prescribed Pharmorubicin it will only be given to you by doctors or nurses experienced in giving chemotherapy.
This medicine will normally be given to you by a doctor or nurse through a drip (infusion) into a vein. Your doctor will decide what dose to give and the number of days treatment you will receive depending on your condition.
The dose is decided by taking into account the condition you have, your height and weight. From your height and weight the doctor will work out your body surface area; and it is this that your dose is calculated from.
Pharmorubicin made into a solution can also be put directly into the bladder to treat bladder cancer, or to help prevent it returning. The dose depends on the type of bladder cancer you have. When this medicine is injected directly into the bladder, you will be instructed not to drink any fluid for 12 hours before treatment to avoid dilution of the medicine with urine in your bladder.
While one course of treatment may sometimes be enough, more often your doctor will advise further courses in three or four weeks time. It may take several courses before your illness is under control and you feel better.
Regular checks by your doctor during Pharmorubicin treatment
During treatment your doctor will be making regular checks of your:
• Blood, to check for low blood cell counts that may need treatment.
• Heart function, Heart damage can occur when high doses of Pharmorubicin are given. This may not be detected for several weeks, so regular tests may be required during this period.
• Liver – using blood tests to check that this medicine is not affecting the way it functions in a harmful way.
• Blood uric acid levels – Pharmorubicin may increase uric acid levels in the blood which might cause gout. Another medicine may be given if your uric acid levels are too high.
If you receive high doses of Pharmorubicin:
High doses can worsen side effects like sores in the mouth or may decrease the number of white blood cells (which fight infection) and platelets (these help the blood to clot) in the blood. Should this happen, you may need antibiotics or blood transfusions. Mouth ulcers can be treated to make them less uncomfortable as they heal.
4. Possible side effects
Like all medicines Pharmorubicin can have side effects.
Please contact your doctor or nurse immediately if you notice any of the following side effects:
• Feeling dizzy, feverish, short of breath with a tight chest or throat or have an itchy rash,. This type of allergic reaction can be very serious.
• When given in combination with other anti-cancer drugs, some patients have developed a rare leukaemia (cancer of white blood cells) after completing treatment.
• White blood cell counts (which fight infection) can also drop which increases the chance of infections and fever .
• A low red blood cell count (anaemia) that can leave you feeling tired and lethargic.
• Platelets (cells that help the blood to clot) can be affected which could make you bruise or bleed more easily. It is important to seek medical advice if this happens.
Other side effects may include:
• Hair loss is common and may be quite severe. Beard growth may stop in men. Hair normally re-grows when your treatment course ends.
• Pain, burning or stinging sensation at the site where the medicine goes into your vein.
• Reddening of urine, (which is normal and related to the colour of the medicine). You should inform your doctor if it does not stop in a few days or you think there is blood in your urine.
• Irritation of the bladder or damage to the bladder wall (called necrosis).
• Soreness or ulcers in the mouth, which may not appear until 3-10 days after treatment.
• Heartburn, nausea (feeling sick), vomiting (being sick) or diarrhoea. If vomiting is very bad, other medicines called anti-emetics can be given to help you.
If you get any of the above side effects, or notice any other unusual side effects not listed in this leaflet, tell your doctor at once.
5. How to store Pharmorubicin
• The unopened vials should be stored in the original container until ready for use.
• Keep out of the reach and sight of children.
• This medicine should not be used after the expiry date printed on the box and on the vial. The pharmacist will check this when your medicine is prepared for you. If the solution is cloudy after preparation, the pharmacist will dispose of it safely.
6. Further Information
- What Pharmorubicin contains
The active substance is epirubicin hydrochloride. The other ingredients are lactose monohydrate and methyl hydroxybenzoate.
- What Pharmorubicin looks like and contents of the pack
Pharmorubicin is a freeze-dried powder in single glass vials containing 10mg, 20mg 50mg or 150mg of the active ingredient, epirubicin hydrochloride.
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