Prospect: information for the user

Gemcitabine Aurovitas Spain 2.000 mg concentrate for solution for infusion

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor, pharmacist or nurse.

-If you experience adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospect. See section 4.

1.What is Gemcitabine Aurovitas Spain and what it is used for

2.What you need to know before starting to use Gemcitabine Aurovitas Spain

3.How to use Gemcitabine Aurovitas Spain

4.Possible adverse effects

5.Storage of Gemcitabine Aurovitas Spain

6.Contents of the package and additional information

Gemcitabina Aurovitas Spain belongs to the group of medicines known as “cytotoxics”. These medicines destroy cells that are dividing, including cancerous cells.

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

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

-Non-small cell lung cancer (NSCLC), 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.

No useGemcitabina Aurovitas Spain

-si is allergic to gemcitabina or to any of the other components ofthis medication (listed in section 6).

-if breastfeeding.

Warnings and precautions

Before the first infusion, blood samples will be taken to check if your liver and kidneys are functioning well enough to receive this medication. Similarly, before each infusion, blood samples will be taken to check if you have enough red blood cells to receive gemcitabina. Your doctor may decide to change the dose or delay treatment depending on your overall condition and if your blood cell counts are too low. Periodically, blood samples will be taken to check how your kidneys and liver are functioning.

Consult your doctor, nurse, or hospital pharmacist before starting to use this medication.

If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after using gemcitabina.

Ifyou have or have had a liver, heart, blood vessel, or kidney disease, consult your doctor or hospital pharmacist, as it may be possible that you cannot receive gemcitabina.

Inform your doctor if you have recently received or are about to receive radiation therapy, as gemcitabina may cause an early or late radiation reaction.

Inform your doctor if you have recently been vaccinated, as this may generate negative effects with gemcitabina.

If during treatment with this medication you experience symptoms such as headache with confusion, convulsions, or changes in vision, consult your doctor immediately. This could be a very rare adverse effect of the nervous system called reversible posterior encephalopathy syndrome.

Inform your doctor if you experience difficulty breathing or feel very weak and pale, as this may be a sign of kidney failure or lung problems.

Inform your doctor if you experience generalized swelling, shortness of breath, or weight gain, as these may be signs of fluid leakage from your smallest blood vessels into your tissues.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized pustular psoriasis (PEGA), have been reported in association with gemcitabina treatment. Seek medical attention immediately if you observe any of the symptoms related to these severe skin reactions described in section 4.

Children and adolescents

This medication is not recommended for use in children under 18 years due to the lack of efficacy and safety data.

Other medications and Gemcitabina Aurovitas Spain

Inform your doctor or hospital pharmacist if you are taking, have recently taken, or may need to take any other medication, including vaccines and over-the-counter medications, or if you have received or are about to receive radiation therapy.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication. Gemcitabina use during pregnancy should be avoided. Your doctor will discuss the potential risk of using gemcitabina during pregnancy with you. Women of childbearing age should use an effective contraceptive method during gemcitabina treatment and for 6 months after the last administration.

Breastfeeding

Inform your doctor if you are breastfeeding.

You should stop breastfeeding during gemcitabina treatment.

Fertility

Men are advised not to father a child during gemcitabina treatment and for 3 months after treatment. If you wish to father a child during treatment and for 3 months after treatment, consult your doctor or pharmacist. You may request information on sperm conservation before starting your treatment.

Driving and operating machinery

Gemcitabina may cause drowsiness.

Do not drive or operate machinery until you are sure that gemcitabina treatment does not cause drowsiness.

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

The frequency at which you receive your gemcitabina infusion depends on the type of cancer you are being treated for.

A hospital pharmacist or doctor will have diluted the Gemcitabina Aurovitas Spain concentrate before it is administered to you.

You will always receive this medication through an infusion in one of your veins. The infusion will last approximately 30 minutes.

This medication is not recommended for use in children under 18 years old.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

You should contact your doctor immediately if you observe any of the following side effects:

-Bleeding gums, nose, or mouth, or any bleeding that does not stop, pink or red urine, unexpected bruises (since you may have fewer platelets than normal, which is very common).

-Fatigue, feeling of dizziness, easily getting winded, or if you are pale (since you may have fewer hemoglobin levels than normal, which is very common).

-Allergic reactions: mild or moderate skin rash (very common), itching (frequent), or fever (very common).

-Temperature of 38°C or higher, sweating, or other signs of infection (since you may have fewer white blood cells than normal accompanied by fever, also known as febrile neutropenia) (frequent).

-Pain, redness, swelling, or sores in the mouth (stomatitis) (frequent).

-Irregular heart rate (arrhythmia) (rare).

-Extreme weakness and fatigue, purple spots or small areas of bleeding on the skin (hematomas), acute kidney failure (low urine production or absence of urine production) and signs of infection (hemolytic uremic syndrome). It can be fatal (rare).

-Difficulty breathing (it is common to have a mild difficulty breathing immediately after the infusion of gemcitabine, which passes quickly; however, with a low frequency or rarely, there may be more serious lung problems).

-Intense chest pain (myocardial infarction) (rare).

-Severe allergic reaction/hypersensitivity, with severe skin rash, including redness and itching of the skin, swelling of hands, feet, ankles, face, lips, mouth, or throat (which can cause difficulty swallowing or breathing), wheezing, rapid heart rate (tachycardia), and may feel like you are going to faint (anaphylactic reaction) (very rare).

-Generalized swelling, shortness of breath, or weight gain, since you may have a leakage of fluid from your smallest blood vessels to your tissues (capillary leak syndrome) (very rare).

-Headache with changes in vision, confusion, seizures, or convulsions (posterior reversible encephalopathy syndrome) (very rare).

-Severe rash with itching, appearance of blisters, or skin peeling, often accompanied by symptoms similar to the flu (Stevens-Johnson syndrome, toxic epidermal necrolysis) (very rare).

-Extreme fatigue and weakness, purple spots or small areas of bleeding on the skin (cardenales), acute kidney failure (low urine production or absence of urine production) and signs of infection. These may be signs of microangiopathic thrombosis (clots that form in small blood vessels) and hemolytic uremic syndrome, which can be fatal.

-Generalized red and scaly rash with inflamed skin under the skin, including skin folds, trunk, and upper limbs, and blisters accompanied by fever (Generalized Acute Pustular Exanthema [GPEA]) (frequency unknown).

Other side effects with gemcitabine may include:

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

Low white blood cell count

Difficulty breathing

Vomiting

Nausea

Hair loss

Liver problems: identified through abnormal blood test results

Blood in the urine

Abnormal urine tests: protein in the urine

Symptoms similar to the flu, including fever

Swelling of ankles, fingers, feet, face (edema)

Low hemoglobin level (anemia)

Common side effects (may affect up to 1 in 10 people)

Loss of appetite (anorexia)

Headache

Insomnia

Drowsiness

Cough

Stuffy nose

Constipation

Diarrhea

Itching

Sweating

Muscle pain

Back pain

Fever

Weakness

Chills

Infections

Rare side effects (may affect up to 1 in 100 people)

Pulmonary interstitial fibrosis (hardening of the walls of the alveoli)

Wheezing (spasm of the airways)

Pulmonary fibrosis (hardening of the walls of the lungs) (abnormal chest X-ray/scanner)

Heart failure

Kidney failure

Severe liver damage, including liver failure, which could be potentially fatal

Cerebral infarction (stroke)

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

Low blood pressure

Peeling of the skin, ulceration, or formation of blisters

Severe peeling of the skin and appearance of blisters on the skin

Reactions at the injection site

Severe lung inflammation that causes respiratory failure (adult respiratory distress syndrome)

Severe sunburn-like rash, which can occur on skin that has been previously exposed to radiation (late cutaneous toxicity)

Liquid in the lungs

Pulmonary interstitial fibrosis associated with radiation (radiation-associated toxicity)

Finger or hand gangrene

Peripheral vasculitis (inflammation of blood vessels)

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

Increased platelet count

Inflammation of the large intestine, caused by a reduced blood supply (ischemic colitis)

Through a blood test, you will detect if there are low hemoglobin levels (anemia), low white blood cell count, and low platelet count.

Microangiopathic thrombosis: clots that form in small blood vessels.

Frequency unknown (cannot be estimated from available data)

Sepsis: when a bacteria and its toxins circulate in your blood and start to damage your organs.

Pseudocellulitis: skin redness with swelling.

You may have any of these symptoms and/or conditions. You should inform your doctor as soon as possible if you start experiencing any of these side effects.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Unopened packaging

Store in refrigerator (between 2°C and 8°C).

After the first opening:

Physical and chemical stability has been demonstrated for use over 28 days at25°C.

From a microbiological standpoint, unless the opening method prevents the risk of microbiological contamination, the product should be used immediately. If not used immediately, storage times and conditions in use are the responsibility of the user.

Infusion solution:

Chemical and physical stability has been demonstrated for use over28 days at 2°C-8°C and approximately 25°Cafter dilution in a 0.9% sodium chloride solutionto a final concentration in the range of 2 to 25 mg/ml (2.0 mg/ml, 12 mg/ml, and 25 mg/ml). Diluted solutions are stable when packaged in PVC or PE infusion bags.

From a microbiological standpoint, the infusion solution should be used immediately. If not used immediately, storage times and conditions before use are the responsibility of the user and should normally not exceed 24 hours at2°C-8°C,unless dilution took place in controlled and validated aseptic conditions.

Do not usethis medicationafter the expiration date appearing on the vial and on the box after CAD. The expiration date is the last day of the month indicated.

Do not usethis medicationif you observe particles.

Composition ofGemcitabina Aurovitas Spain

-The active ingredient is gemcitabina(as gemcitabinahydrochloride). Each ml of concentrate for solution for infusion contains 40 mg of gemcitabina (as gemcitabinahydrochloride).

Cada vial of 50 ml contains 2,000 mg ofgemcitabina(as gemcitabinahydrochloride).

-The other components are hydrochloric acid (E-507) for pH adjustment and water for injection.

Aspect of the product and content of the package

Gemcitabina Aurovitas Spain concentrate for solution for infusion is atransparent, colourless or pale yellowsolution.

Gemcitabina Aurovitas Spain is presented in a type I colourless glass vial with a rubber stopper and closed with an aluminium cap with a polypropylene disc. The vial may be packaged with or without a plastic protective wrapper.

Package size

1 vial of 50 ml

Only some package sizes may be marketed.

Marketing authorisation holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19, Venda Nova

2700-487 Amadora

Portugal

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Last review date of this leaflet: December 2023

This information is intended solely for medical professionals or healthcare professionals:

Instructions for use

Gemcitabina Aurovitas Spain 2,000 mg concentrate for solution for infusion

Cytotoxic

Handling

To prepare or dispose of the infusion solution, follow the usual safety precautions for cytostatic agents.Women of the staff who are pregnant should not handle the product.The handling of the solution must be performed in a safety cabinet and protective overalls and gloves must be used. If a safety cabinet is not available, the equipment must be completed with a mask and protective glasses.

Ifthe productcomes into contact with the eyes, it may cause severe irritation. The eyes must be washed immediately with a large amount of water.Consult a doctor if the irritation persists. If the solution comes into contact with the skin, wash the affected area thoroughly with plenty of water.

Instructions for dilution

The only approved solvent for the dilution of Gemcitabina Aurovitas Spain concentrate for solution for infusion is a 0.9% sodium chloride injection solution (without preservatives).

-Use aseptic techniques during the dilution of gemcitabina for intravenous infusion administration.

-The diluted solution is a transparent, colourless or pale yellow solution.

-Parenteral medicines must be visually inspected before administration to check for particles or discoloration. If particles are observed, the solution should not be administered.

-The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Storage conditions

After the first opening:

Physical and chemical stability has been demonstrated in use for 28 days at25°C.

From a microbiological point of view, unless the opening method prevents the risk of microbiological contamination, the product should be used immediately. If not used immediately, the storage conditions in use are the responsibility of the user.

Infusion solution:

Chemical and physical stability has been demonstrated in use for28 days at 2°C-8°C and approximately 25°Cafter dilution in a 0.9% sodium chloride solution until a final concentration in the range of 2 to 25 mg/ml (2.0 mg/ml, 12 mg/ml and 25 mg/ml). The pH of the diluted solution is in the range of 2-3 and the osmolarity is approximately 285 mOsm/kg. Diluted solutions are stable when packaged in PVC or PE infusion bags.

From a microbiological point of view, the infusion solution should be used immediately. If not used immediately, the storage conditions before use are the responsibility of the user and should not normally exceed 24 hours at2°C-8°C,unless the dilution has taken place in controlled and validated aseptic conditions.