Active ingredient
- paclitaxel
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL41013/0016 .
Paclitaxel 6 mg/ml concentrate for solution for infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
Paclitaxel 6 mg/ml Concentrate for Solution for Infusion
Paclitaxel
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Paclitaxel Injection is and what it is used for
2. What you need to know before you use Paclitaxel Injection
3. How to take Paclitaxel Injection
4. Possible side effects
5. How to store Paclitaxel Injection
6. Contents of the pack and other information
1. What Paclitaxel Injection is and what it is used for
The name of your medicine is ‘Paclitaxel 6 mg/ml Concentrate for Solution for Infusion’ but in the rest of the leaflet it will be called “Paclitaxel Injection”.
Paclitaxel belongs to a group of anti-cancer medicines called taxanes. These agents inhibit the growth of cancer cells.
Paclitaxel Injection is used to treat:
Ovarian cancer:
Breast cancer:
Advanced non-small-cell lung cancer:
AIDS-related Kaposi's sarcoma:
2. What you need to know before you use Paclitaxel Injection
Do not use Paclitaxel Injection:
If any of these apply to you, talk to your doctor before starting treatment with Paclitaxel Injection.
Paclitaxel Injection is not recommended for use in children (under 18 years).
Warnings and precautions
Talk to your doctor or pharmacist or nurse before using Paclitaxel Injection. Take special care with Paclitaxel Injection
To minimize allergic reactions, you will be given other medicines before you receive Paclitaxel Injection.
Tell your doctor immediately if any of these apply to you.
Paclitaxel Injection should always be administered into veins. Administration of Paclitaxel Injection in the arteries can cause inflammation of the arteries, and you can suffer from pain, swelling, redness and heat.
Other medicines and Paclitaxel Injection
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Speak to your doctor when taking paclitaxel at the same time as any of the following:
Paclitaxel Injection with food, drink and alcohol
Paclitaxel Injection is unaffected by food and drink.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Paclitaxel concentrate for solution for infusion must not be given if you are pregnant unless clearly advised. This medicine may cause birth defects, therefore, you must not become pregnant during treatment with paclitaxel and you and/or your partner must use an effective method of contraception whilst you are receiving treatment with paclitaxel and for six months after treatment has finished. If pregnancy occurs during treatment, or within the six months after treatment has finished, inform your doctor immediately.
Male patients treated with paclitaxel are advised not to father a child during and up to six months after treatment.
If you are breast-feeding, tell your doctor. It is not known if paclitaxel passes into breast milk. Because of the possibility of harm to the infant stop breast-feeding if you are taking Paclitaxel Injection. Do not restart breast-feeding unless your doctor has allowed you to.
Fertility
Paclitaxel may have an anti-fertility effect which could be irreversible. Male patients are therefore advised to seek advice on conservation of sperm prior to treatment.
Driving and using machines
Paclitaxel Injection may cause side effects such as tiredness (very common) and dizziness (common) that may affect your ability to drive and use machinery. If you experience these symptoms, do not drive or operate machinery until they have fully resolved. If you are given other medicines as part of your treatment, you should ask your doctor for advice on driving and using machines.
This medicine contains alcohol. Therefore it may be unwise to drive immediately after a course of treatment.
Important information about some of the ingredients of Paclitaxel Injection
Paclitaxel Injection contains castor oil (about 50% polyethoxylated 35 caster oil) that may cause severe allergic reactions. If you are allergic to castor oil, talk to your doctor before you receive Paclitaxel Injection.
Paclitaxel Injection contains alcohol (49.7%v/v ethanol) – each millilitre of Paclitaxel Injection includes 0.392 g of alcohol. A Paclitaxel Injection dose of 300 mg/50 ml contains 20 g of alcohol, equivalent to 429 ml beer or 179 ml wine.
Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.
The amount of alcohol in this medicinal product may alter the effects of other medicines.
3. How to take Paclitaxel Injection
If you have any further questions on the use of this product, ask your doctor.
If you are given more Paclitaxel Injection than you should
There is no known antidote for Paclitaxel Injection overdose. You will receive treatment of your symptoms.
If a dose of Paclitaxel Injection has been missed
If you think a dose has been missed let your doctor or nurse know.
A double of the dose should not be given if a dose has been forgotten.
If you stop using Paclitaxel Injection
Your doctor will decide when to stop treatment with paclitaxel.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you notice any signs of allergic reactions. These may include one or more of the following:
These can all be signs of serious side effects.
Tell your doctor immediately:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Very rare (may affect up to 1 in 10,000 people):
Not known (the frequency cannot be determined based on the available data):
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Paclitaxel Injection
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 after EXP. The expiry date refers to the last day of that month.
Before opening
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light.
After opening before dilution
From a microbiological point of view, once opened the product may be stored for a maximum of 28 days at 25°C. Other in-use storage times and conditions are the responsibility of the user.
After dilution
From a microbiological point of view, the diluted product should be used immediately. If not used immediately, store in a refrigerator (2 to 8°C) for no more than 24 hours, unless dilution has taken place in controlled and validated aseptic conditions. For more details on the stability after dilution, see the section for health-care professionals.
Do not use if you notice a cloudy solution or an insoluble precipitate.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer used. These measures will help to protect the environment.
6. Contents of the pack and other information
What Paclitaxel Injection contains
What Paclitaxel Injection looks like and contents of the pack
Paclitaxel Injection is a clear colourless to slightly yellow viscous solution.
It is available in vials containing 5 ml, 16.7 ml and 50 ml of concentrate for solution for infusion.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Manufacturer in the UK:
Manufacturer in the Northern Ireland
This leaflet was last revised in 06/2021.
Stanmore Place, Honeypot Lane, Stanmore, London, HA7 1BT
+44 (0208 731 5273
+44 (0)208 731 5273
+44 (0)208 731 5273
+44 (0)203 727 0712
+44 (0)203 727 0712