Gemcitabine Sun 1000 mg powder for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Gemcitabine SUN 1000 mg powder for solution for infusion EFG

Gemcitabine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Gemcitabine SUN is and what it is used for
2. What you need to know before using Gemcitabine SUN
3. How to use Gemcitabine SUN
4. Possible side effects
5. How to store Gemcitabine SUN
6. Contents of the pack and other information

1. What Gemcitabina SUN is and what it is used for

Gemcitabina SUN is a medicine used to treat cancer and belongs to a group of medicines called "cytotoxic agents". These medicines destroy cells that are dividing, including cancer cells.

Gemcitabina SUN may be given alone or in combination with other anticancer medicines, depending on the type of cancer.

Gemcitabina SUN is used to treat the following types of cancer:

• non-small cell lung cancer (NSCLC), either alone or in combination with cisplatin.
• pancreatic cancer.
• breast cancer, in combination with paclitaxel.
• ovarian cancer, in combination with carboplatin.
• bladder cancer, in combination with cisplatin.

2. What you need to know before using Gemcitabine SUN

Do not use Gemcitabine SUN:

• if you are allergic to gemcitabine or to any of the other ingredients of this medicine (listed in section 6).
• if you are breastfeeding, you must interrupt breastfeeding during treatment with Gemcitabine SUN.

Warnings and precautions

Talk to your doctor before starting to use Gemcitabine SUN.

Before the first infusion, blood samples will be taken to assess whether your liver and kidney function are normal. Likewise, prior to each infusion, blood samples will be taken to evaluate whether you have enough red blood cells to receive Gemcitabine SUN. Your doctor may decide to adjust the dose or delay treatment depending on your general condition and whether your blood cell counts are too low. Blood samples will be taken periodically to monitor your kidney and liver function.

Inform your doctor if:

• you have or have previously had any liver, heart, blood vessel, or kidney disease, as you may not be able to receive Gemcitabine SUN.
• you have recently undergone or are scheduled to receive radiotherapy, since radiation recall reactions (early or delayed) may occur with Gemcitabine SUN.
• you have recently been vaccinated.
• you experience symptoms such as headache with confusion, seizures (epileptic fits), or changes in vision; consult your doctor immediately. This could be a very rare adverse effect affecting the nervous system called reversible posterior encephalopathy syndrome.
• you have difficulty breathing or feel very weak and look very pale, as this may be a sign of kidney failure or lung problems.
• you develop generalized swelling, shortness of breath, or weight gain, as this may indicate fluid leakage from your smallest blood vessels into your tissues.
• you have ever developed a severe skin rash, skin peeling, blisters, 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 during treatment with gemcitabine. Seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Children and adolescents

The use of this medicine is not recommended in children and adolescents under 18 years of age due to lack of safety and efficacy data in this population.

Use of Gemcitabine SUN with other medicines

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you might be pregnant, or plan to become pregnant, talk to your doctor before using this medicine. The use of Gemcitabine SUN should be avoided during pregnancy. Your doctor will discuss with you the potential risks of taking Gemcitabine SUN during pregnancy.

You must interrupt breastfeeding during treatment with Gemcitabine SUN.

Men are advised not to father a child during treatment with Gemcitabine SUN and for 6 months after treatment ends. If you wish to father a child during treatment or within 6 months after treatment ends, consult your doctor or pharmacist. You may wish to request information about sperm preservation before starting treatment.

Driving and using machines

Gemcitabine SUN may cause drowsiness, especially if you have consumed alcohol. Avoid driving or operating machinery until you are certain that treatment with Gemcitabine SUN does not make you drowsy.

Gemcitabine SUN contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; therefore, it is essentially “sodium-free”.

3. How to use Gemcitabina SUN

The recommended dose of Gemcitabina SUN is 1,000–1,250 mg per square meter of your body surface area. Your height and weight will be measured to calculate your body surface area. Your doctor will use this body surface area to calculate the correct dose for you. This dose may be adjusted or the treatment may be delayed depending on your general health and your blood cell counts.

The frequency with which you receive your Gemcitabina SUN infusion depends on the type of cancer for which you are being treated.

A hospital pharmacist or physician will have reconstituted the Gemcitabina SUN powder before administration.

You will always receive Gemcitabina SUN as an intravenous infusion into one of your veins. The infusion will last approximately 30 minutes.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Contact your doctor immediately if you notice any of the following:

Extreme tiredness and weakness, purpura or small areas of bleeding under the skin (bruising), acute kidney injury (low urine output or absence of urine), and signs of infection. These may be signs of thrombotic microangiopathy (clots forming in small blood vessels) and hemolytic uremic syndrome, which can be life-threatening.

A widespread red, scaly rash with bumps under inflamed skin (including skin folds, trunk, and upper limbs) and blisters accompanied by fever (acute generalized exanthematous pustulosis [AGEP]) (frequency not known).

You must contact your doctor immediately if you experience any of the following serious adverse effects:

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

• allergic reactions: if you develop a mild to moderate skin rash or fever
• tiredness, feeling faint, becoming easily short of breath, or looking pale (as you may have lower than normal hemoglobin levels, which is very common)
• bleeding from gums, nose or mouth, or any bleeding that does not stop, pink or reddish urine, unexpected bruising (as you may have lower than normal platelet counts, which is very common).

Common (may affect up to 1 in 10 people)

• temperature of 38°C or higher, sweating, or other signs of infection (as you may have lower than normal white blood cell count with fever, also known as febrile neutropenia)
• pain, redness, swelling, or sores in the mouth (stomatitis)
• allergic reactions: if you experience itching, difficulty breathing (it is common to have mild breathing difficulty immediately after Gemcitabine SUN infusion, which soon passes)

Uncommon (may affect up to 1 in 100 people)

• difficulty breathing (more severe lung problems)
• irregular heartbeat (arrhythmia)

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

• difficulty breathing (more severe lung problems)
• severe chest pain (myocardial infarction)

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

• severe hypersensitivity/anaphylactic allergic reaction with severe skin rash including itchy red skin, swelling of hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty swallowing or breathing), difficulty breathing, rapid heartbeat, and feeling faint (anaphylactic reaction)
• widespread swelling, shortness of breath, or weight gain, as fluid may be leaking from your small blood vessels into your tissues (capillary leak syndrome)
• headache with changes in vision, confusion, seizures or epileptic fits (reversible posterior encephalopathy syndrome)
• severe rash with itching, blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis)

Frequency not known (cannot be estimated from available data)

• widespread red, scaly rash with bumps under inflamed skin (including skin folds, trunk and upper limbs) and blisters accompanied by fever (Acute Generalized Exanthematous Pustulosis [AGEP]) (frequency not known).

Tell your doctor if you notice any of the following adverse effects:

Very common: may affect more than 1 in 10 people

• low white blood cell count in blood – difficulty breathing
• vomiting
• nausea
• hair loss
• liver problems: detected through abnormal blood test results
• blood in urine
• abnormal urine tests: protein in urine
• flu-like syndrome including fever
• swelling of ankles, fingers, feet, face (edema)

Common: may affect up to 1 in 10 people

• loss of appetite (anorexia)
• headache
• insomnia
• drowsiness
• cough
• runny nose
• constipation
• diarrhea
• itching
• sweating
• muscle pain
• back pain
• fever
• weakness
• chills
• infections

Uncommon: may affect up to 1 in 100 people

• hardening of the walls of the lung alveoli (interstitial pneumonitis)
• wheezing (spasm of the airways)
• hardening of the walls of the lungs (abnormal chest X-ray/scan)
• heart failure
• kidney failure
• severe liver damage, including liver failure
• stroke (cerebrovascular accident)

Rare: may affect up to 1 in 1,000 people

• low blood pressure
• skin peeling, ulceration or blister formation
• severe peeling and blistering of the skin
• injection site reactions
• severe lung inflammation causing respiratory failure (adult respiratory distress syndrome)
• sunburn-like skin rash that may occur in skin previously exposed to radiotherapy (late radiotherapy-associated radiodermatitis)
• fluid in the lungs
• hardening of the walls of the lung alveoli associated with radiotherapy (radiotherapy-associated toxicity)
• gangrene of fingers or toes
• inflammation of 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 intestine due to reduced blood supply (ischemic colitis)

• blood tests will detect low hemoglobin levels (anemia), low white blood cell count, and low platelet count.

• clots forming in small blood vessels (thrombotic microangiopathy).

Not known (frequency cannot be estimated from available data)

• sepsis: when bacteria and their toxins circulate in your blood and begin to damage organs

• redness of the skin with swelling (pseudocellulitis)

• a condition in which eosinophils, a type of cell normally found in the blood, accumulate in the lungs (pulmonary eosinophilia)

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines, website: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gemcitabine SUN

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

Do not use this medicine after the expiry date stated on the vial and outer packaging. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

After reconstitution:

Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage time and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 30°C.

The reconstituted solution must not be refrigerated.

Do not use this medicine if the solution appears cloudy or if an insoluble precipitate is observed.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gemcitabine SUN 1.000 mg powder for solution for infusion EFG

• The active substance is: gemcitabine (as hydrochloride)
• The other components are: mannitol, sodium acetate trihydrate, sodium hydroxide, hydrochloric acid.

One vial contains 1 g of gemcitabine (as hydrochloride).

One ml of the reconstituted solution for infusion contains 38 mg of gemcitabine (as hydrochloride).

Appearance of the product and contents of the pack

Powder for solution for infusion

White or almost white, compact lyophilized powder.

1 vial of 50 ml.

Marketing Authorization Holder and Manufacturer

SUN Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

Local Representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007-Barcelona

Spain

Tel: +34 93 342 78 90

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany: Gemcitabine SUN 1.000 mg Pulver zur Herstellung einer Infusionslösung

Spain: Gemcitabina SUN 1.000 mg polvo para solución para perfusión EFG

Italy: Gemcitabina SUN 1.000 mg polvere per soluzione per infusione

The Netherlands: Gemcitabine SUN 1.000 mg poeder voor oplossing voor infusie

Romania: Gemcitabina SUN 1.000 mg pulbere pentru solutie perfuzabila

United Kingdom (Northern Ireland): Gemcitabine 1.000 mg Powder for Solution for Infusion

Date of the most recent review of this leaflet: February 2024.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

This information is intended for healthcare professionals only:

Instructions for use, handling, and disposal

• Use aseptic techniques during reconstitution and any subsequent dilution of gemcitabine for intravenous infusion administration.
• Calculate the required dose and number of Gemcitabine SUN vials needed.
• Reconstitute each 1,000 mg vial with 25 ml of sterile 9 mg/ml (0.9 %) sodium chloride injection solution, preservative-free. Shake to dissolve. The total volume after reconstitution is 26.3 ml. The resulting concentration of gemcitabine after this dilution is 38 mg/ml, taking into account the displacement volume of the lyophilized powder. The solution may be further diluted with 9 mg/ml (0.9 %) sodium chloride injection solution, preservative-free. The reconstituted solution is a clear, colorless or pale yellow solution.
• Prior to administration, visually inspect the medicinal product for the presence of particulate matter and/or discoloration. If particles are observed, the product must not be administered.
• Reconstituted gemcitabine solutions must not be refrigerated, as crystallization may occur. Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C. From a microbiological standpoint, the product should be used immediately. If not used immediately, storage conditions and periods prior to use are the responsibility of the user and must not exceed 24 hours at temperatures below 30°C, unless reconstitution/dilution is performed under controlled and validated aseptic conditions.
• Gemcitabine solutions must be used only once. Any unused product or waste must be disposed of in accordance with local regulations.

Precautions for preparation and administration

Standard safety precautions for cytotoxic agents must be observed when preparing and disposing of the infusion solution. The solution should be handled in a safety cabinet, and protective clothing and gloves must be worn. If a safety cabinet is not available, protective masks and eye protection should be added to the protective equipment.

If the preparation comes into contact with the eyes, it may cause severe irritation. Immediately rinse the eyes thoroughly with abundant water. If irritation persists, consult a physician. If the solution is spilled onto the skin, wash thoroughly with abundant water.

Disposal

Any unused product must be disposed of in accordance with local regulations.