Mylan Gemcitabine 200 mg Solution

What MYLAN GEMCITABINE is: MYLAN GEMCITABINE belongs to a group of medicines called "cytotoxics". These medicines kill dividing cells, including cancer cells. MYLAN GEMCITABINE may be given alone or in combination with other anti-cancer medicines, depending on the type of cancer.

What it is used for: MYLAN GEMCITABINE is used in the treatment of the following types of cancer:

• lung cancer
• pancreatic cancer
• bladder cancer
• breast cancer
• ovarian cancer

MYLAN GEMCITABINE should not be administered to you:

• if you are hypersensitive (allergic) to the active substance gemcitabine or any of the other ingredients of MYLAN GEMCITABINE (listed in section 6);
• if you are pregnant or breastfeeding (see section ‘Pregnancy and lactation’);
• if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after using gemcitabine as contained in MYLAN GEMCITABINE.

Not to be used in children.

Warnings and precautions

Tell your doctor or healthcare provider before being given the injection; MYLAN GEMCITABINE should be administered only by a doctor experienced with cancer chemotherapeutic medicines. You are allowed to be treated with MYLAN GEMCITABINE under special precautions, when your doctor is informed of the diseases you suffer from, as listed below and has agreed that you receive MYLAN GEMCITABINE:

• if you have an infection;
• if you have liver disease;
• if you have kidney disease;
• if you have asthma or other lung disease;
• if your bone marrow is depressed.

Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalised 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 (see section 4 ‘Possible side effects’).

Other precautions before or during receiving treatment with MYLAN GEMCITABINE:

• It will be necessary for your doctor to carefully monitor you, by performing regular blood tests to monitor blood counts, before or during treatment with MYLAN GEMCITABINE.
• It will also be necessary for your doctor to do regular liver and kidney function checks.
• Do not have any immunisations without your doctor's approval and avoid any contact with persons with infections, especially during periods of low blood counts.
• Before you begin using any new medicine (prescription or non-prescription) or if you develop any new medical problem while you are using this medicine, check with your doctor, nurse, or pharmacist.

Patients receiving MYLAN GEMCITABINE should be under the supervision of a doctor experienced in cancer chemotherapy. Do not share medicines prescribed for you with others. You will not be expected to give yourself MYLAN GEMCITABINE. It will be given to you by a person who is qualified to do so.

The usual dose is: FOR ADULTS ONLY:

Dosing: MYLAN GEMCITABINE will be administered only by intravenous infusion by your doctor who is experienced in cancer chemotherapy or under his supervision. It is also recommended that equipment and medicines necessary for treatment of complications be readily available. Your doctor will determine the exact dosage that you will need. The dosage may vary according to your body mass, if you are an elderly patient, or if you suffer from kidney or liver disease. The recommended dose is administered by intravenous infusion over a 30-minute period and depending on the type of cancer you have or the combination treatment that has been prescribed for you, the dosage will be repeated in weekly cycles as determined by your doctor.

Patients with kidney disease: Your dosage will need to be adjusted if you suffer from kidney disease.

Patients with liver disease: Your dosage will need to be adjusted if you have liver disease.

Elderly patients: No dosage adjustment may be necessary if you are an elderly patient.

Paediatric Use: The safety and effectiveness of MYLAN GEMCITABINE in children have not been established. Your doctor will tell you how long your treatment with MYLAN GEMCITABINE will last.

If you have the impression that the effect of MYLAN GEMCITABINE is too strong or too weak, tell your doctor or pharmacist.

If you receive more MYLAN GEMCITABINE than you should Since a healthcare professional will administer MYLAN GEMCITABINE, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget or missed a dose of MYLAN GEMCITABINE Since a healthcare provider will administer MYLAN GEMCITABINE, it is unlikely that the dose will be missed.

MYLAN GEMCITABINE can have side effects. Not all side effects reported for MYLAN GEMCITABINE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MYLAN GEMCITABINE, please consult your healthcare provider for advice.

If any of the following happens, stop receiving MYLAN GEMCITABINE and tell your doctor immediately or go to the casualty department at your nearest hospital:

• oedema: swelling of fingers, feet, or lower legs, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing,
• fainting,
• severe rash with itching, blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN)),
• 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 Generalised Exanthematous Pustulosis (AGEP)) (frequency not known).
• myocardial infarct (pain in chest, arm or back; pressure or squeezing in chest),
• thrombocytopenia (decreased blood platelets manifested by black tarry stools, blood in urine or stools, pinpoint red spots on skin, unusual bleeding from the gums, nose or mouth or any bleeding that would not stop, or bruising),
• temperature of 38 ºC 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),
• extreme tiredness and weakness, purpura or small areas of bleeding in the skin (bruises), acute renal failure (low urine output/no urine output), and signs of infection (haemolytic uraemic syndrome). It may be fatal,
• headache with changes in vision, confusion, seizures or fits (posterior reversible encephalopathy syndrome),
• generalised swelling, shortness of breath or weight gain, as you might have fluid leakage from small blood vessels into the tissues (capillary leak syndrome),
• serious damage to your liver, including liver failure and death,
• a dangerous and potentially fatal condition that happens when the blood flow to a large area of tissue is cut off (gangrene).

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to MYLAN GEMCITABINE. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• bronchospasm (shortness of breath, troubled breathing, tightness in chest, and/or wheezing),
• pulmonary oedema (coughing; noisy, rattling, or troubled breathing),
• interstitial pneumonitis (coughing; shortness of breath),
• dysrhythmia (fast or irregular heartbeat),
• anaemia (manifested by unusual tiredness or weakness),
• pain, redness, swelling, sores, ulcers, or white spots on lips and in your mouth (stomatitis),
• mild to moderate skin rash/itching, or fever (allergic reactions),
• mild proteinuria (cloudy urine) and haematuria (blood in the urine).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following: The following side effects have been reported frequently:

• nausea; vomiting; diarrhoea; constipation,
• fever, usually in conjunction with other flu-like symptoms,
• blood disorders such as leucopenia (usually without symptoms),
• somnolence (drowsiness),
• alopecia (loss of hair).

The following side effects have been reported less frequently:

• allergic/hypersensitivity reaction at injection site,
• hypotension (dizziness, fainting, light-headedness)
• kidney failure.

The following side effects have been reported but the frequency is unknown:

• inflammation in the blood vessels (peripheral vasculitis),
• blood flow to part of the large intestine is temporarily reduced (ischaemic colitis).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the “ 6.04 Adverse Drug Reactions Reporting Form ”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8

By reporting side effects, you can help provide more information on the safety of MYLAN GEMCITABINE.

• Store at or below 25 °c.
• Reconstituted solutions (vials) and infusion solutions (in sodium chloride 0,9 %) must be used immediately or within 12 hours when stored at or below 25 °C.
• Reconstituted solutions must not be refrigerated as crystallisation may occur.
• Store all medicines out of reach of children.
• Keep the container in the outer carton.
• Do not use after the expiry date stated on the label/carton/bottle.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).