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Document: leaflet MAH GENERIC_PL 11587-0087 change

• leaflet MAH GENERIC_PL 11587-0087
• leaflet MAH GENERIC_PL 18727-0038

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Gemcitabin 38 mg/ml • 90730-VBGB • AA • 02.16 • Pharma-Code: 276 (Dummy)

Format: 592 x132 mm • HKS 44 - Corrective action: KV01_jem_28.01.16/KV02Jem_28.01.16/KV03_jte_03.02.16/KV04_jem_03.02.16

Package leaflet: Information for the user

Gemcitabine 38 mg/ml

concentrate for solution for infusion gemcitabine

Read all of this leaflet carefully before you start receiving 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, 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.

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. No sufficient data are available about the safety and efficacy of Gemcitabine in children.

Therapeutic indications

Gemcitabine is used in the treatment of the following types of cancer:

•    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 are given Gemcitabine

Gemcitabine may only be administered if strictly indicated, and by doctors experienced in this type of therapy.

You should not be given Gemcitabine:

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

•    if you are breast-feeding.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given Gemcitabine.

Please tell your doctor if:

•    you have, or have previously had liver disease, heart disease, renal disease or vascular disease.

•    you have recently had, or are going to have radiotherapy.

•    you have been vaccinated recently.

•    you develop breathing difficulties or feel very weak and are very pale (may be a sign of kidney failure).

•    during treatment with this medicine, you get symptoms such as headache with confusion, seizures (fits) or changes in vision. This could be a very rare nervous system side effect named posterior reversible encephalopathy syndrome.

•    you develop generalised swelling, shortness of breath or weight gain, as this may be a sign of fluid leaking from your small blood vessels into the tissue.

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.

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 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 you are given this medicine.

Pregnancy

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 being treated with Gemcitabine are advised not to father a child during and up to 6 months after treatment and to seek further advice regarding cryoconservation of sperm prior to treatment because of the possibility of infertility due to therapy with gemcitabine.

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

Each 200 mg vial gemcitabine contains 460 mg (20 mmol) sodium.

Each 1,000 mg vial gemcitabine contains 2,300 mg (100 mmol) sodium.

Each 2,000 mg vial gemcitabine contains 4,600 mg (200 mmol) sodium.

To be taken into consideration by patients on a controlled sodium diet.

3. How Gemcitabine is given

The recommended dose of Gemcitabine is 1,000 - 1,250 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.

You will always receive Gemcitabine by infusion into one of your veins. The infusion will last approximately 30 minutes.

If you have 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.

Tell your doctor immediately if you notice any of the

following:

•    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).

•    Irregular heart rate (arrhythmia) (uncommon).

•    Pain, redness, swelling or sores in your mouth (stomatitis) (common).

•    Mild to moderate skin rash (very common) / itching (common), or fever (very common) (allergic reactions).

•    Tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common).

•    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 blood platelets than normal which is very common).

•    Difficulty breathing (it is very 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).

•    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).

•    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).

Side effects with Gemcitabine may include:

Very common side effects

(may affect more than 1 in 10 people):

•    Low haemoglobin level (anaemia)

•    Low white blood cells

•    Low blood platelet count

•    Difficulty breathing

•    Vomiting

•    Nausea

•    Skin rash - allergic skin rash, frequently itchy

•    Hair loss

•    Liver problems: found through abnormal blood test results

•    Blood in urine

•    Abnormal urine tests: protein in urine

•    Flu like symptoms including fever

•    Oedema (swelling of ankles, fingers, feet, face)

•    Sweating

•    Sleeping difficulties

Common side effects

(may affect up to 1 in 10 people):

•    Fever accompanied by low white blood cell count (febrile neutropenia)

•    Anorexia (poor appetite)

•    Headache

•    Insomnia

•    Sleepiness

•    Cough

•    Runny nose

•    Constipation

•    Diarrhoea

•    Pain, redness, swelling or sores in the mouth

•    Itching

•    Muscle pain

•    Back pain

•    Fever

•    Weakness

•    Chills

Uncommon side effects

(may affect up to 1 in 100 people):

•    Interstitial pneumonitis (scarring of the air sacs of the lung)

•    Spasm of the airways (wheeze)

•    Abnormal chest X-ray / scan (scarring of the lungs)

•    Irregular heart beat (arrhythmia)

•    Heart failure

•    Stroke

•    Serious liver damage, including liver failure

•    Kidney failure

•    Haemolytic uraemic syndrome (low red blood cell count with renal insufficiency)

Rare side effects

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

•    Heart attack (myocardial infarction)

•    Low blood pressure

•    Skin scaling, ulceration or blister formation

•    Injection site reactions

•    Gangrene of fingers or toes

•    Fluid in the lungs

•    Adult Respiratory Distress Syndrome (severe lung inflammation causing respiratory failure)

•    Radiation recall (a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy.

•    Radiation toxicity - scarring of the air sacs of the lung associated with radiation therapy

Very rare side effects

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

•    Increased blood platelet count

•    Anaphylactic reaction (severe hypersensitivity / allergic reaction)

•    Sloughing of skin and severe skin blistering (Stevens-Johnson syndrome, toxic epidermal necrolysis)

•    Ischaemic colitis (inflammation of the lining of the large bowel, caused by reduced blood supply)

•    Generalised swelling, shortness of breath or weight gain (capillary leak syndrome)

•    Headache with confusion, seizures (fits) or changes in vision (posterior reversible encephalopathy syndrome)

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, 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. 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 carton after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

After dilution:

When diluted with glucose 50 mg/ml (5 %) solution the chemical and physical in-use stability has been demonstrated for 15 days at 20 °C ± 5 °C protected from light.

When diluted with sodium chloride 9 mg/ml (0.9 %) solution the chemical and physical in-use stability has been demonstrated for 98 days at 20 °C ± 5 °C protected from light.

Dilutions with 9 mg/ml (0.9 %) sodium chloride solution and 50 mg/ml (5 %) glucose solution, respectively, were tested for two concentrations,

10.0 mg/ml and 1.0 mg/ml gemcitabine.

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 2 - 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.

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 contains

•    The active substance is gemcitabine (as hydrochloride). Each vial contains 200,1,000 or 2,000 mg of gemcitabine.

•    The other ingredients are disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium hydroxide (for pH-adjustment), hydrochloric acid (for pH-adjustment), polyethylene glycol 400, water for injections.

What Gemcitabine looks like and contents of the pack

Gemcitabine is a clear, colourless to light yellow

concentrate for solution for infusion in a vial.

Each vial contains 200, 1000 or 2,000 mg of gemcitabine.

Each carton of Gemcitabine contains 1 vial.

Marketing Authorisation Holder and Manufacturer

medac

Gesellschaft fur klinische Spezialpraparate mbH Theaterstr. 6 22880 Wedel Germany

Tel.: +49 4103 8006-0 Fax: +49 4103 8006-100

This medicinal product is authorised in the Member States of the EEA under the following names:

Czech Republic Gemcitabine medac 38 mg/ml koncentrat pro infuznf roztok Gemcitabin medac Gemcitabine medac Gemcitabine medac 38 mg/ml infuusiokonsentraatti, liuosta varten Gemcitabine medac 38 mg/mL solution a diluer pour perfusion Gemedac 38 mg/ml Konzentrat zur Herstellung einer Infusionslosung Gemcitabina medac Gemcitabine medac 38 mg/ml koncentrats infuziju sklduma pagatavosanai

Gemcitabine medac 38 mg/ml koncentratas infuziniam tirpalui Gemcitabine medac 38 mg/ml konsentrat til infusjonsvaeske, opplosning Gemcitabine medac Gemcitabina medac Gemcitabine medac 38 mg/ml infuzny koncentrat

Gemcitabine medac 38 mg/ml koncentrat till infusionsvatska, losning United Kingdom Gemcitabine 38 mg/ml concentrate for solution for infusion

This leaflet was last revised in February 2016.

90730-VBGB