Active ingredient
- gemcitabine hydrochloride
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: PL 31750/0039.
Gemcitabine 200 mg or 1 g powder for solution for infusion
Package Leaflet: Information for the patient
Gemcitabine 200 mg, powder for solution for infusion
Gemcitabine 1000 mg, powder for solution for infusion
gemcitabine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What Gemcitabine is and what it is used for
2. What you need to know before you are given Gemcitabine
3. How Gemcitabine is given
4. Possible side effects
5. How to store Gemcitabine
6. Contents of the pack and other information
1. What Gemcitabine is and what it is used for
Gemcitabine belongs to a group of medicines called "cytotoxics". These medicines kill dividing cells, including cancer cells.
Gemcitabine may be given alone or in combination with other anti-cancer medicines, depending on the type of cancer.
Gemcitabine is used in the treatment of the following types of cancer:
2. What you need to know before you are given Gemcitabine
You should not be given Gemcitabine:
Warnings and precautions
Talk to your doctor before you are given Gemcitabine.
Before the first infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function. Before each infusion you will have samples of your blood taken to evaluate if you have enough blood cells to receive Gemcitabine. Your doctor may decide to change the dose or delay treating you depending on your general condition and if your blood cell counts are too low. Periodically you will have samples of your blood taken to evaluate your kidney and liver function.
Please tell your doctor if:
Children and adolescents
This medicine is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy.
Other medicines and Gemcitabine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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. The use of Gemcitabine should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking Gemcitabine during pregnancy.
You must discontinue breast-feeding during Gemcitabine treatment.
Men are advised not to father a child during and up to 6 months following treatment with Gemcitabine. If you would like to father a child during the treatment or in the 6 months following treatment, seek advice from your doctor or pharmacist. You may want to seek counselling on sperm storage before starting your therapy.
Driving and using machines
Gemcitabine may make you feel sleepy, particularly if you have consumed any alcohol. Do not drive a car or use machinery until you are sure that Gemcitabine treatment has not made you feel sleepy.
Gemcitabine contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.
3. How Gemcitabine is given
The recommended dose of Gemcitabine is 1000-1250 mg for every square metre of your body's surface area. Your height and weight are measured to work out the surface area of your body. Your doctor will use this body surface area to work out the right dose for you. This dosage may be adjusted, or treatment may be delayed depending on your blood cell counts and on your general condition.
How frequently you receive your Gemcitabine infusion depends on the type of cancer that you are being treated for.
A hospital pharmacist or doctor will have dissolved the Gemcitabine powder before it is given to you.
You will always receive Gemcitabine by infusion into one of your veins. The infusion will last approximately 30 minutes.
If you have any further questions on the use of this medicine ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must contact your doctor immediately if you notice any of the following:
Extreme tiredness and weakness, purpura or small areas of bleeding in the skin (bruises), acute renal failure (low urine output or no urine output), and signs of infection. These may be features of thrombotic microangiopathy (clots forming in small blood vessels) and haemolytic uraemic syndrome, which may be fatal.
Tell your doctor about any of the following serious side-effects straight away
Very common: may affect more than 1 in 10 users
Common: may affect up to 1 in 10 users
Uncommon: may affect up to 1 in 100 users
Rare: may affect up to 1 in 1,000 users
Very rare: may affect up to 1 in 10,000 users
Tell your doctor about any of the following side effects as soon as possible
Very common: may affect more than 1 in 10 users
Common: may affect up to 1 in 10 users
Uncommon: may affect up to 1 in 100 users
Rare: may affect up to 1 in 1,000 users
Very rare: may affect up to 1 in 10,000 users
Not known (cannot be estimated from 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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Gemcitabine
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 vial and carton. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
After reconstitution:
Chemical and physical in-use stability has been demonstrated for 24 hours at 15-30°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 30°C.
The reconstituted solution should not be refrigerated.
Do not use this medicine 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 use. These measures will help protect the environment.
6. Contents of the pack and other information
What Gemcitabine 200 mg / Gemcitabine 1000 mg Powder for Solution for Infusion contains
[For 200 mg strength]
One vial contains 200 mg gemcitabine (as hydrochloride).
[For 1000 mg strength]
One vial contains 1 g gemcitabine (as hydrochloride).
One ml of the reconstituted solution for infusion contains 38 mg gemcitabine (as hydrochloride).
What Gemcitabine 200 mg /Gemcitabine 1000 mg Powder for Solution for Infusion looks like and contents of the pack
Powder for solution for infusion
White to off-white lyophilized cake.
For 200 mg strength
1 vial of 10 ml.
For 1 g strength
1 vial of 50 ml.
Marketing Authorisation Holder and Manufacturer
This leaflet was last revised in: December 2018
V026
5th Floor, Hyde Park, Hayes, 3, 11 Millington Road, Hayes, UB3 4AZ, UK
+44 (0) 208 848 8688
+44 (0) 208 848 5052