Do not use Narimed
- if you are allergic (hypersensitive) to irinotecan hydrochloride trihydrate or any of the other ingredients of Narimed Solutioin;
- if you have any other bowel disease or a history of bowel obstruction;
- if you are breast-feeding (see “Pregnancy and breast-feeding”);
- if you have high levels of bilirubin (a waste blood product) in the blood (more than 3 times the upper limit of normal);
- if you have an imbalance of your blood cells (severe bone marrow failure);
- if you are in a poor general health (evaluated by an international standard);
- if you are using the natural remedy St John´s wort (Hypericum perforatum).
If you receive Narimed in combination with cetuximab or bevacizumab or capecitabine, please make sure that you also read the package leaflet for these medicines. The combination could lead to additional contraindications.
Take special care with Narimed
This medicine is intended for adults only. Check with your doctor if this medicine has been prescribed for use in a child.
Elderly patients require more intense surveillance during treatment.
As Narimed is an anti-cancer medicine it will be administered to you in a special unit and under supervision of a doctor qualified in the use of anti-cancer medicines. The units’ personnel will explain to you what you need to take special care of during and after the treatment. This leaflet may help you to remember that.
If you receive Narimed in combination with cetuximab or bevacizumab or capecitabine, please make sure that you also read the package leaflet for these medicinal products.
In the first 24 hours after administration of Narimed
During administration of Narimed Solution (30 – 90 minutes) and within 24 hours after administration you may experience some of the following symptoms:
- diarrhoea
- sweating
- abdominal pain
- watering eyes
- visual disturbance
- excessive mouth watering
The medical term for these symptoms is “acute cholinergic syndrome”. If you have any of these symptoms, immediately tell your doctor who will give you any treatment necessary.
From the day after treatment with Narimed until next treatment
During this period you may experience various symptoms, which may be serious and require immediate treatment and close supervision.
Diarrhoea
If your diarrhoea starts more than 24 hours after administration of Narimed (“delayed diarrhoea”) it may be serious. It is often seen about 5 days after administration. The diarrhoea should be treated immediately and kept under close supervision. Immediately after the first liquid stools do the following:
- Take any antidiarrhoeal treatment that the doctor has given you, exactly as he/she has told you. The treatment must not be changed without consulting the doctor.
- Drink large amounts of water and rehydration fluids, immediately (i.e. water, soda water, fizzy drinks, soup or oral rehydration therapy).
- Immediately inform your doctor who is supervising the treatment, and tell him/her about the diarrhoea. If you are not able to reach the doctor, contact the hospital unit supervising the Narimed treatment. It is very important that they are aware of the diarrhoea.
You must immediately tell the doctor, or the unit supervising the treatment, if
- you have diarrhoea as well as fever (over 38 °C)
- you have severe diarrhoea (and vomiting ) with excessive loss of water requiring intravenous hydration
- you still have diarrhoea 48 hours after starting the diarrhoea treatment
Note! Do not take any treatment for diarrhoea other than that given to you by your doctor and the fluids described above. Follow the doctor’s instructions. The antidiarrhoeal treatment should not be used preventive, even though you have experienced delayed diarrhoea at previous cycles.
Nausea and vomiting
If you have nausea and/or vomiting contact your doctor or the hospital unit immediately.
Neutropenia
Narimed 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. Neutropenia is often seen during treatment with Narimed and is reversible. Your doctor should arrange for you to have regular blood tests to monitor these white blood cells. If you have any fever (over 38°C) this may be an indication of infection associated with this neutropenia and requires immediate treatment. Therefore, if you have any fever, and particularly if you also have diarrhoea, contact your doctor or nurse immediately, that they can give you the necessary treatment.
Breathing difficulties
If you have any breathing difficulties contact your doctor immediately.
Impaired liver function
Before treatment with Narimed is started and before every following treatment cycle your doctor will monitor your liver function (by blood tests).
Impaired kidney function
As this medicine has not been tested in patients with kidney problems, please check with your doctor if you have any kidney problems.
Heart problems
If you are at risk of having a heart attack your doctor should monitor you very carefully while you are given Narimed and action should be taken to minimize the risk factors (e.g. smoking, high blood pressure, high levels of blood lipids).
Lowered resistance to Infections
Vaccination with a live or life-attenuated vaccine is not recommended in patients receiving Narimed, because this might result in serious or fatal infections. Killed or inactivated vaccines may be administered; however, the response to such vaccines may be diminished.
If you have one or more of the symptoms mentioned above, after you have returned home from the hospital, you should immediately contact the doctor or the hospital unit supervising your Narimed treatment.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. This is also valid for herbal medicines, strong vitamins and minerals.
The following medications can alter the effects of Narimed:
- carbamazepine, phenobarbital or phenytoin (medicines for the treatment of epilepsy)
- ketoconazole (used to treat fungal infections)
- rifampicin (used for the treatment of tuberculosis)
- atazanavir sulphate (used to treat HIV infection)
- the herbal medicine St John’s Wort (Hypericum perforatum, a treatment for depression. This must not be used during and between treatments with Narimed, as it may decrease the effect of Narimed.
- Oral anticoagulants (used to reduce blood clotting)
- Yellow fever vaccine (must not be used while you are treated with Narimed)
- Other live attenuated vaccines are also not recommended (see section “Take special care with Narimed”, chapter “Lowered resistance to Infections”).
- Ciclosporine and Tacrolimus (both used to reduce the activity of the immune system, e.g. after organ transplant)
If you require an operation, please tell your doctor or anaesthetist that you are using this medicine, as it may alter the effect of some medicines used during surgery.
Pregnancy and breast-feeding
You should not be given Narimed if you are pregnant unless clearly indicated by your doctor.
Women of child-bearing age should avoid becoming pregnant.
Contraceptive measures must be taken by both male and female patients of reproductive age during and for at least three months after cessation of therapy.
Still, if you become pregnant during this period you must immediately inform your doctor.
It is not known whether Narimed is excreted in human milk.
Consequently you must not breast-feed while you are treated with Narimed.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
During the first 24 hours after administration of Narimed you may feel dizzy or have visual disturbances. If this happens to you do not drive or use any tools or machines.
This medicine may also cause other side effects which affect your ability to drive and use tools and machines. Contact your doctor or pharmacist if you are unsure.
Important information about some of the ingredients of Narimed Solution
Narimed Solution contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free’.