Gemcitabine Jazeera belongs to a group of medicines called “cytotoxics”. These medicines kill dividing cells, including cancer cells.
Gemcitabine Jazeera may be given alone or in combination with other anti-cancer medicines, depending on the type of cancer you have.
Gemcitabine Jazeera is used in the treatment of a number of types of cancer including:

• 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

You should not be given Gemcitabine Jazeera

• If you are allergic to gemcitabine or any of the other ingredients of this medicine (listed in section 6).
• If you are breast-feeding.

Tell the doctor if you think any of the above applies to you.

Warnings and precautions
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 also have samples of your blood taken to check if you have enough blood cells to receive Gemcitabine Jazeera. Your doctor may decide to change your 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 your kidney and liver function.

Talk to your doctor, pharmacist or nurse before using Gemcitabine Jazeera:

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 Jazeera.

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 Jazeera.

If you have been vaccinated recently, please tell your doctor as this can possibly cause bad effects with Gemcitabine Jazeera.

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 are 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 Jazeera
Please tell your doctor if you are taking, have recently taken or might take 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 Jazeera should be avoided if pregnant. Your doctor will discuss with you the potential risk of taking Gemcitabine Jazeera during pregnancy.

Breast-feeding
If you are breast-feeding, tell your doctor. You must discontinue breast-feeding during treatment with Gemcitabine Jazeera. 

Fertility
Men are advised not to father a child during, and up to 6 months after treatment with gemcitabine. If you would like to father a child during the treatment or in the 6 months following treatment, please 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 treatment can make you feel drowsy. Alcohol can make this worse. Do not drive or operate machinery until you are sure that gemcitabine has not made you feel sleepy.

Gemcitabine Jazeera contains sodium
Gemcitabine Jazeera contains sodium. Each vial of Gemcitabine Jazeera 200 mg and 1000 mg Powder for Solution for Infusion contains 0.152 mmol (3.5 mg) or 0.762 mmol (17.53 mg) sodium; respectively. This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.

The usual dose of Gemcitabine Jazeera 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 infusion will depend on the type of cancer you are being treated for.

A hospital pharmacist or doctor will have dissolved the Gemcitabine Jazeera powder before it is given to you.

You will always receive Gemcitabine Jazeera 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.

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:

• 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 38ᵒC 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. These may be features of thrombotic microangiopathy (clots forming in small blood vessels) (very rare) and haemolytic uraemic syndrome (uncommon), which may be fatal
• 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)
• Sudden weakness or numbness of your face, arms or legs, especially on one side, or slurred speech, even for a short period of time. These may be signs of a stroke (uncommon)
• 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)
• 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 may include:
Very common side effects (may affect more than 1 in 10 people)

• Low white blood cells
• Difficulty breathing
• Vomiting
• Feeling sick (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
• Difficulty sleeping (insomnia)
• Sleepiness
• Cough
• Runny nose
• Constipation
• Diarrhoea
• Itching
• Sweating
• Muscle pain
• Back pain
• Fever
• Weakness
• Chills
• Infections  

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

Rare side effects (may affect up to 1 in 1,000 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 affect 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
• Clots forming in small blood vessels (thrombotic microangiopathy)

Not known (frequency cannot be estimated from the available data)

• Skin redness with swelling (Pseudocellulitis)
• When bacteria and their toxins circulate in the blood and starts to damage the organs (sepsis)

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.

Keep this medicine out of the sight and reach of children.

Store below 30°C.

Store in the original package.

After reconstitution and dilution:

Gemcitabine Jazeera solutions are stable for 24 hours at controlled room temperature (20 to 25°C).

From a microbiological point of view, it is advised that the product is used immediately.

Discard unused portion.

Solutions of reconstituted Gemcitabine Jazeera should not be refrigerated, as crystallization may occur.

Do not use this medicine after the expiry date which is stated on the package after “EXP”. The expiry date refers to the last day of that month.

Do not use this medicine if it contains particles or if it is strongly coloured.

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.