Gemcitabine 200 Mg Powder For Solution For Infusion
Package leaflet: Information for the user
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 using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, nurse or pharmacist.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Gemcitabine powder for solution for infusion is and what it is used for
2. What you need to know before you use Gemcitabine powder for solution for infusion
3. How to use Gemcitabine powder for solution for infusion
4. Possible side effects
5. How to store Gemcitabine powder for solution for infusion
6. Contents of the pack and other information
1. WHAT GEMCITABINE POWDER FOR SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR
Gemcitabine powder for solution for infusion 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 you have.
Gemcitabine powder for solution for infusion is used in the treatment of the following types of cancers:
• non-small cell lung cancer (NSCLC), alone or together with cisplatin
• pancreatic cancer
• breast cancer, together with paclitaxel
• ovarian cancer, together with carboplatin
• bladder cancer, together with cisplatin
2. WHAT YOU NEED TO KNOW BEFORE YOU USE GEMCITABINE POWDER FOR SOLUTION FOR INFUSION
Do not use Gemcitabine powder for solution for infusion
• if you are allergic (hypersensitive) to gemcitabine or any of the other ingredients of gemcitabine (listed in section 6).
• If you are breast-feeding.
Warnings and precautions
^ore the first infusion you will have samples of your blood taken to check if your liver and kidneys are working well enough for you to receive this medicine. Before each infusion you will have samples of your blood taken to check 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 check how well your kidneys and liver are working.
Talk to your doctor or nurse or hospital pharmacist before using Gemcitabine:
If you have, or have previously had liver disease, heart disease, vascular disease or problems with your kidneys talk to your doctor or hospital pharmacist as you may not be able to receive gemcitabine.
If you have recently had, or are going to have radiotherapy, please tell your doctor as there may be an early or late radiation reaction with gemcitabine.
If you have been vaccinated recently, please tell your doctor as this can possibly cause bad effects with gemcitabine.
If during treatment with this medicine, you get symptoms such as headache with confusion, seizures (fits) or changes in vision, call your doctor right away. This could be a very rare nervous system side effect named posterior reversible encephalopathy syndrome.
If you develop breathing difficulties or feel very weak and very pale, please tell your doctor as this may be a sign of kidney failure or problems with your lungs.
If you develop generalised swelling, shortness of breath or weight gain, please tell your doctor as this may be a sign of fluid leaking from your small blood vessels into the tissue.
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
Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including vaccinations and medicines obtained without a prescription.
Pregnancy, breast-feeding and fertility Pregnancy
If you are pregnant, or thinking about becoming pregnant, tell your doctor. The use of gemcitabine should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking gemcitabine during pregnancy.
Breast-feeding
If you are breast-feeding, tell your doctor.
You must discontinue breast-feeding during gemcitabine treatment.
Fertility
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 powder for solution for infusion contains sodium
Gemcitabine powder for solution for infusion contains 3.5 mg (< 1 mmol) of sodium in each 200 mg vial and 17.5 mg (<1mmol) sodium in each 1000 mg vial i.e. essentially sodium free.
3. HOW TO USE GEMCITABINE POWDER FOR SOLUTION FOR INFUSION
The usual dose of Gemcitabine powder for solution for infusion 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 Gemcitabine powder for solution for infusion infusion will depend on the type of cancer you are being treated for.
A hospital pharmacist or doctor will have dissolved the Gemcitabine powder for solution for infusion powder before it is given to you.
You will always receive Gemcitabine powder for solution for infusion by infusion into one of your veins. The infusion will last approximately 30 minutes.
If you have further questions on the use of this product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, gemcitabine can cause side effects, although not everybody gets
them.
You must contact your doctor immediately if you notice any of the following:
• Bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is very common).
• Tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common).
• Mild to moderate skin rash (very common) / itching (common), or fever (very common); (allergic reactions).
• Temperature of 38°C or greater, sweating or other signs of infection (since you might have less white blood cells than normal accompanied by fever also known as febrile neutropenia) (common).
• Pain, redness, swelling or sores in your mouth (stomatitis) (common).
• Irregular heart rate (arrhythmia) (uncommon).
• 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 (haemolytic uraemic syndrome). It may be fatal (uncommon).
• Difficulty breathing (it is common to have mild breathing difficulty soon after the gemcitabine infusion which soon passes, however uncommonly or rarely there can be more severe lung problems).
• Severe chest pain (myocardial infarction) (rare).
• Severe hypersensitivity/allergic reaction with severe skin rash including red itchy skin, swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), wheezing, fast beating heart and you may feel you are going to faint (anaphylactic reaction) (very rare).
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• Generalised swelling, shortness of breath or weight gain, as you might have fluid leakage from small blood vessels into the tissues (capillary leak syndrome) (very rare).
• Headache with changes in vision, confusion, seizures or fits (posterior reversible encephalopathy syndrome) (very rare).
• Severe rash with itching, blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis) (very rare).
Other Side effects with Gemcitabine powder for solution for infusion include:
Very common side effects (may affect more than 1 in 10 people)
• Low white blood cells
• Difficulty breathing
• Vomiting
• Nausea
• Hair loss
• Liver problems: found through abnormal blood test results
• Blood in urine
• Abnormal urine tests: protein in urine
• Flu like symptoms including fever
• Swelling of ankles, fingers, feet, face (oedema)
Common side effects (may affect up to 1 in 10 people)
• Poor appetite (anorexia)
• Headache
• Insomnia
• Sleepiness
• Cough
• Runny nose
• Constipation
• Diarrhoea
• Itching
• Sweating
• Muscle pain
• Back pain
• Fever
• Weakness
• Chills
Uncommon side effects (may affect up to 1 in 100 people)
• Scarring of the air sacs of the lung (interstitial pneumonitis)
• Wheeze (spasm of the airways)
• Scarring of the lungs (abnormal chest X ray/scan)
• Heart failure
• Kidney failure
• Serious liver damage, including liver failure
• Stroke
Rare side effects (may affect up to 1 in 1000 people)
• Low blood pressure
• Skin scaling, ulceration or blister formation
• Sloughing of the skin and severe skin blistering
• Injection site reactions
• Severe lung inflammation causing respiratory failure (adult respiratory distress syndrome)
• A skin rash like severe sunburn which can occur on skin that has previously been exposed to radiotherapy (radiation recall).
• Fluid in the lungs
• Scarring of the air sacs of the lung associated with radiation therapy (radiation toxicity)
• Gangrene of fingers or toes
• Inflammation of the blood vessels (peripheral vasculitis)
Very rare side effects (may affects up to 1 in 10,000 people)
• Increased platelet count
• Inflammation of the lining of the large bowel, caused by reduced blood supply (ischaemic colitis)
• Low haemoglobin level (anaemia), low white blood cells and low platelet count will be detected by a blood test.
5. HOW TO STORE GEMCITABINE POWDER FOR SOLUTION FOR INFUSION
Keep this medicine out of the sight and reach of children.
Do not use after the expiry date (EXP) which is stated on the carton and the vial. The expiry date refers to the last day of that month.
Unopened vial: 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 25°C. From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately. If not use immediately, in-use storage times and conditions are the responsibility of user.
Solutions of reconstituted gemcitabine should not be refrigerated, as crystallisation may occur.
This medicine is for single use only; any unused solution should be discarded under the local requirements.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Gemcitabine powder for solution for infusion contains
The active substance is gemcitabine. Each vial contains 200 mg or 1000 mg of gemcitabine (as hydrochloride).
The other ingredients are mannitol, sodium acetate anhydrous, hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).
What Gemcitabine powder for solution for infusion looks like and contents of the pack
Gemcitabine powder for solution for infusion is a white to off-white lyophilized powder or cake, for solution for infusion in a vial. Each vial contains 200 mg or 1000 mg of gemcitabine (as hydrochloride). Each pack of Gemcitabine powder for solution for infusion contains 1 vial.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Koanaa Healthcare Limited 4th Floor Cavendish House,
369 Burnt Oak Broadway,
Edgware, HA8 5AW Middlesex United Kingdom
Manufacturer
Wave Pharma Limited 4th Floor Cavendish House,
369 Burnt Oak Broadway,
Edgware, HA8 5AW Middlesex,
United Kingdom
This medicinal product is authorised in the Member States of the EEA under the
following names:
France GEMCITABINE KOANAA 200 mg/1000 mg, poudre pour solution
pour perfusion
Malta Gemcitabine Koanaa 200 mg/1000 mg powder for solution for
infusion.
Netherlands Gemcitabine Koanaa 200 mg/1000 mg poeder voor oplossing voor
infusie
United Kingdom Gemcitabine 200 mg/1000 mg powder for solution for infusion
This leaflet was last revised in 06/2016
You might have any of these symptoms and/or conditions. You must tell your doctor as soon as possible when you start experiencing any of these side effects.
If you are concerned about any side effects, talk to your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or, pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
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