Colocam Solution

COLOCAM belongs to a group of medicines called cytostatics (anti-cancer medicines). COLOCAM may be used alone or in combination with a number of other medicines used to treat cancer. These combinations may be used to treat cancers of the colon and rectum.

You should not be administered COLOCAM:

• If you are hypersensitive (allergic) to irinotecan hydrochloride trihydrate (the active ingredient) or any of the other ingredients of COLOCAM.
• If you have any other bowel disease or a history of bowel obstruction.
• If you are pregnant or breast feeding or if you think you might be pregnant.
• If your bilirubin upper limit count is high, tell your doctor.
• If you suffer from severe bone marrow failure.
• If you are in a poor general health.
• If you are taking the natural remedy St. John’s Wort.

Special care should be taken with COLOCAM

You will be treated by a specialist team experienced in using these kinds of treatments and managing their side effects, which are usually temporary. However, it is essential that you read the section “Possible side effects” and follow the instructions carefully if you get any of the symptoms described.

As with all anti-cancer medicines the use of COLOCAM is associated with a number of side effects which may be serious. These side effects require special management to minimise the risk of complications.

If you suffer from an inherited condition called fructose intolerance, tell your doctor or hospital pharmacist before you are given COLOCAM. COLOCAM contains sorbitol, which is unsuitable for people who cannot tolerate fructose.

COLOCAM may cause you to have diarrhoea. There are two types of diarrhoea, which can be distinguished by when they start. “Early onset” diarrhoea starts less than 24 hours after the infusion and “delayed” diarrhoea starts more than 24 hours after the infusion. If you have ANY DIARRHOEA it is IMPORTANT that you follow these instructions carefully.

If your diarrhoea starts less than 24 hours after the infusion (“early diarrhoea”) you should contact your doctor or nurse immediately and they will give you a suitable treatment.

Do not share medicines prescribed for you with any other person. COLOCAM will be given as an infusion into your veins over a period of 30 to 90 minutes.

You will not be expected to give yourself COLOCAM. It will be given to you by a person who is qualified to do so. The amount of COLOCAM you are given will depend on your age, size and general medical condition. It will also depend on any other treatment you may have received for your cancer. Your doctor will calculate your body surface area in square meters (m2).

Your doctor will tell you how long your treatment with COLOCAM will last.

If you have the impression that COLOCAM is too strong or too weak, tell your doctor or pharmacist.

If you receive more COLOCAM than you should:

Since a healthcare professional will administer COLOCAM, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

COLOCAM can have side effects. Not all side effects reported for COLOCAM are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving COLOCAM, please consult your doctor, pharmacist or other health care professional for advice.

If any of the following happens, stop treatment with COLOCAM and tell your doctor immediately or go to the casualty department at your nearest hospital:

• allergic skin reactions
• inflammation at the injection site
• inflammation of the lining of the mouth
• swelling of feet and hands, headache, increased sweating, flushing

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to COLOCAM. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• upper respiratory tract infection, running nose
• if you have high blood pressure
• if you have or might have interstitial pneumonia (a dry cough, shortness of breath, which may occur after effort or become worse over time, difficult or laboured breathing, fatigue, clubbing, or enlargement of the fingertips at the base of the nails. Clubbing may be present due to a lack of oxygen in the blood.)

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• decrease or loss in appetite, weight loss
• hair loss
• anorexia, abdominal enlargement, bloated feeling or gas, indigestion
• muscular contraction or cramps

COLOCAM may cause a decrease in the number of some of your white blood cells, which play an important role in fighting infections. This is called neutropenia. Your doctor will probably arrange for you to have regular blood tests to monitor these white blood cells. If you have any fever this may be an indication of infection associated with this neutropenia and requires immediate treatment. If you have any fever, and particularly if you also have diarrhoea, contact your doctor or nurse IMMEDIATELY so that they can give you any treatment necessary. If you have breathing difficulties, nausea and/or vomiting contact your doctor or nurse IMMEDIATELY. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store at or below 25 °C and protect from light.

Store the vials in the original cartons until required for use.

After dilution with either 0,9 % sodium chloride or 5 % dextrose solution, the diluted solution is stable for 24 hours under refrigeration (2 - 8 °C) and for 6 hours when stored at room temperature (25 °C).

Solution should be inspected visually for particulate matter and discoloration prior to administration.

Procedures for proper handling and disposal of anti-cancer medicines should always be considered.

Discard any unused portion thereafter.

Do not freeze as crystallisation may occur.

KEEP ALL MEDICINES OUT OF REACH OF AND SIGHT OF CHILDREN.

Do not use this medicine after the expiry date printed on the carton.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).