Gemcitabine 10 mg/ml, solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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.

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

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

Before the first infusion you will have samples of your blood taken to check if you have sufficient kidney and liver function. 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 your kidney and liver function.

Talk to your doctor before you are given Gemcitabine if:

• you have, or have previously had liver disease, heart disease, vascular disease or problems with your kidneys as you may not be able to receive Gemcitabine
• you have recently had, or are going to have radiotherapy, as there may be an early or late radiation reaction
• you have been vaccinated recently
• you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after using gemcitabine.
  Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis (AGEP) have been reported in association with gemcitabine treatment. Seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section.

This medicine is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before this medicine is given to you. The use of Gemcitabine should be avoided during pregnancy. Your doctor will discuss with you the potential risk of treatment with Gemcitabine during pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding. 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. You may want to seek counselling on sperm storage before starting your therapy.

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.

One ml of the solution for infusion contains 4.575 mg sodium.

This medicine contains 549.00 mg (23.88 mmol) of sodium (main component of cooking/table salt) in each 120 ml infusion bag. This is equivalent to 27.5% of the recommended maximum daily dietary intake of sodium for an adult.

This medicine contains 594.65 mg (25.87 mmol) of sodium (main component of cooking/table salt) in each 130 ml infusion bag. This is equivalent to 29.7% of the recommended maximum daily dietary intake of sodium for an adult.

This medicine contains 640.50 mg (27.86 mmol) of sodium (main component of cooking/table salt) in each 140 ml infusion bag. This is equivalent to 32% of the recommended maximum daily dietary intake of sodium for an adult.

This medicine contains 686.25 mg (29.85 mmol) of sodium (main component of cooking/table salt) in each 150 ml infusion bag. This is equivalent to 34.3% of the recommended maximum daily dietary intake of sodium for an adult.

This medicine contains 732.00 mg (31.84 mmol) of sodium (main component of cooking/table salt) in each 160 ml infusion bag. This is equivalent to 36.6% of the recommended maximum daily dietary intake of sodium for an adult.

This medicine contains 777.75 mg (33.83 mmol) of sodium (main component of cooking/table salt) in each 170 ml infusion bag. This is equivalent to 38.8% of the recommended maximum daily dietary intake of sodium for an adult.

This medicine contains 823.50 mg (35.82 mmol) of sodium (main component of cooking/table salt) in each 180 ml infusion bag. This is equivalent to 41.2% of the recommended maximum daily dietary intake of sodium for an adult.

This medicine contains 915.00 mg (39.80 mmol) of sodium (main component of cooking/table salt) in each 200 ml infusion bag. This is equivalent to 45.8% of the recommended maximum daily dietary intake of sodium for an adult.

This medicine contains 1006.50 mg (43.78 mmol) of sodium (main component of cooking/table salt) in each 220 ml infusion bag. This is equivalent to 50.3% of the recommended maximum daily dietary intake of sodium for an adult.

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.

A red, scaly widespread rash with bumps under the swollen skin (including your skin folds, trunk, and upper extremities) and blisters accompanied by fever (Acute Generalized Exanthematous Pustulosis (AGEP)) (frequency not known).

You must tell your doctor immediately about any of the following serious side effects:

Very common (may affect more than 1 in 10 people)

• allergic reactions: if you develop mild to moderate skin rash or fever
• tiredness, feeling faint, becoming easily breathless or if you look pale (you might have less haemoglobin than normal)
• bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (you might have less platelets than normal).

Common (may affect up to 1 in 10 people)

• temperature of 38°C or greater, sweating or other signs of infection (you might have less white blood cells than normal accompanied by fever also known as febrile neutropenia)
• pain, redness, swelling or sores in your mouth (stomatitis)
• allergic reactions: if you develop itching
• mild breathing difficulty (it is common to have mild breathing difficulty soon after the Gemcitabine infusion which soon passes).

Uncommon (may affect up to 1 in 100 people)

• difficulty breathing due to more severe lung problems (interstitial pneumonitis, bronchospasm)
• irregular heart rate (arrhythmia).

Rare (may affect up to 1 in 1,000 people)

• difficulty breathing due to more severe lung problems (pulmonary oedema, adult respiratory distress syndrome)
• severe chest pain (myocardial infarction).

Very rare (may affect up to 1 in 10,000 people)

• 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)
• generalised swelling, shortness of breath or weight gain, as you might have fluid leakage from small blood vessels into the tissues (capillary leak syndrome)
• headache with changes in vision, confusion, seizures or fits (posterior reversible encephalopathy syndrome)
• severe rash with itching, blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Tell your doctor as soon as possible about any of the following side effects:

Very common (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 (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
• infections.

Uncommon (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 (may affect up to 1 in 1,000 people)

• low blood pressure
• skin scaling, ulceration or blister formation
• sloughing of skin and severe skin blistering
• injection site reactions
• 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 (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)
• clots forming in small blood vessels (thrombotic microangiopathy).

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

• sepsis: when bacteria and their toxins circulate in the blood and starts to damage the organs
• a condition where eosinophils, a type of cell ordinarily found in the blood, accumulate in the lungs (pulmonary eosinophilia)
• skin redness with swelling (pseudocellulitis).

Low haemoglobin level (anaemia), low white blood cells and low platelet count will be detected by a blood test.

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.

• The active substance is: gemcitabine (as hydrochloride)
• The other ingredients are: sodium chloride, water for injection, sodium hydroxide and/or hydrochloric acid (for pH adjustment).

One 120 ml infusion bag contains 1200 mg gemcitabine (as hydrochloride).

One 130 ml infusion bag contains 1300 mg gemcitabine (as hydrochloride).

One 140 ml infusion bag contains 1400 mg gemcitabine (as hydrochloride).

One 150 ml infusion bag contains 1500 mg gemcitabine (as hydrochloride).

One 160 ml infusion bag contains 1600 mg gemcitabine (as hydrochloride).

One 170 ml infusion bag contains 1700 mg gemcitabine (as hydrochloride).

One 180 ml infusion bag contains 1800 mg gemcitabine (as hydrochloride).

One 200 ml infusion bag contains 2000 mg gemcitabine (as hydrochloride).

One 220 ml infusion bag contains 2200 mg gemcitabine (as hydrochloride).

One ml of the solution for infusion contains 10 mg gemcitabine.

One ml of the solution for infusion contains 4.575 mg sodium.

Gemcitabine solution for infusion is a clear, colourless, sterile solution free from visible particulate matter.

Gemcitabine solution for infusion is supplied in carton boxes each containing 1, 5 or 10 single-dose infusion bags of 120 ml, 130 ml, 140 ml, 150 ml, 160 ml, 170 ml, 180 ml, 200 ml or 220 ml.

Not all pack sizes may be marketed.