PRODUCT INFORMATION FOR THE USER

Gemcitabina FLYNN 200 mg powder for solution for infusion EFG

Gemcitabina

Read this leaflet carefully before you start using the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are experiencing are serious or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Gemcitabina FLYNN is a medication used to treat cancer that belongs to the group of medications called “cytotoxics.” These medications destroy cells that are dividing, including cancerous cells.

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

Gemcitabina FLYNN 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.

Do not use Gemcitabina FLYNN powder for solution for infusion

• If you are allergic (hypersensitive) to gemcitabine or to any of the other components of Gemcitabina FLYNN powder for solution for infusion.
• If you are breastfeeding, you must interrupt breastfeeding during treatment with Gemcitabine.

Special precautions for Gemcitabina FLYNN powder for solution for infusion

Before the first infusion, blood samples will be taken to evaluate if your liver and kidney function is correct. Similarly, before each infusion, blood samples will be taken to evaluate if you have enough red blood cells to receive Gemcitabine. Your doctor may decide to change the dose or delay treatment depending on your general condition and if your blood cell counts are too low. Periodically, blood samples will be taken to evaluate the function of your kidney and liver.

Inform your doctor if:

• You have or have had previously liver, heart or vascular disease.
• You have recently received or are going to receive radiation therapy.
• You have recently been vaccinated.
• You experience difficulty breathing or feel very weak and very pale (it may be a sign of kidney failure).

It is recommended that men not decide to have a child during treatment with Gemcitabine and during the 6 months following this. If you wish to be a father of a child during treatment and the 6 months following this, ask your doctor or pharmacist for advice. You can request information on sperm conservation before starting your treatment.

Use of other medications

Inform your doctor or hospital pharmacist if you are taking or have recently taken any other medication, including vaccines and over-the-counter medications.

Pregnancy and breastfeeding

If you are pregnant or think you may become pregnant, inform your doctor. Gemcitabine should be avoided during pregnancy. Your doctor will discuss the potential risk of taking Gemcitabine during pregnancy with you.

Inform your doctor if you are breastfeeding.

You must interrupt breastfeeding during treatment with Gemcitabine.

Driving and operating machinery

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

Important information about one of the components of Gemcitabina FLYNN powder for solution for infusion

Gemcitabine FLYNN powder for solution for infusion contains 3.5 mg (<1>

The usual 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 overall health 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 dissolved the Gemcitabina FLYNN powder for infusion solution before it is administered to you.

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

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

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

The frequencies of the side effects observed are defined as:

• Very common, affecting more than 1 in 10 patients treated
• Common, affecting between 1 and 10 in 100 patients treated
• Uncommon, affecting between 1 and 10 in 1,000 patients treated
• Rare, affecting between 1 and 10 in 10,000 patients treated
• Very rare, affecting less than 1 in 10,000 patients treated
• Unknown: this frequency cannot be estimated from the available data

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

side effects:

• Fever or infection (common): if you have a temperature of 38°C or higher, sweating, or other signs of infection (since you may have fewer white blood cells than normal, which is very common).
• Irregular heart rate (arrhythmia) (unknown frequency).
• Pain, redness, swelling, or sores in the mouth (common).
• Allergic reactions: if you present a skin rash (very common) / itching (common), or fever (very common).
• Fatigue, feeling of dizziness, easily getting winded, or if you are pale (since you may have fewer red blood cells than normal, which is very common).
• 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).
• Difficulty breathing (it is very common to have mild difficulty breathing immediately after Gemcitabine infusion, which passes soon, however, occasionally or rarely there may be more serious lung problems).

The side effects of Gemcitabine may include:

Very common side effects

• Low red blood cell count (anemia)
• Low white blood cell count
• Low platelet count
• Difficulty breathing
• Vomiting
• Nausea
• Skin rash - allergic skin rash, frequently with itching
• Hair loss
• Liver problems: identified through abnormal blood test results
• Blood in the urine
• Abnormal urine test results: protein in the urine
• Flu-like syndrome including fever
• Edema (swelling of ankles, fingers, feet, face)

Common side effects

• Fever accompanied by a low white blood cell count
• Loss of appetite
• Headache
• Insomnia
• Drowsiness
• Cough
• Stuffy nose
• Constipation
• Diarrhea
• Pain, redness, swelling, or sores in the mouth
• Itching
• Sweating
• Muscle pain
• Back pain
• Fever
• Weakness
• Chills

Uncommon side effects

• Interstitial pneumonitis (hardening of the walls of the lung alveoli)
• Respiratory tract spasm (sibilant breathing)
• Abnormal chest X-ray/scanner (hardening of the lung walls)

Rare side effects

• Heart attack (myocardial infarction)
• Low blood pressure
• Peeling of the skin, ulceration, or blistering
• Reactions at the injection site

Very rare side effects

• Increased platelet count
• Anaphylactic reactions (severe hypersensitivity/allergic reaction)
• Severe skin peeling and blistering

Side effects of unknown frequency

• Irregular heart rate (arrhythmia)
• Adult respiratory distress syndrome (severe lung inflammation causing respiratory failure).
• Late cutaneous toxicity associated with radiation therapy - (a severe sunburn-like rash) that may occur in skin previously exposed to radiation therapy.
• Pulmonary edema
• Radiation therapy-associated toxicity - hardening of the lung alveoli walls associated with radiation therapy.
• Ischemic colitis (inflammation of the large intestine membrane, caused by reduced blood supply).
• Heart failure
• Renal failure
• Gangrene of the toes or hands
• Severe liver damage, including liver failure
• Cerebral infarction (stroke)

You may experience any of these symptoms and/or conditions. Inform your doctor as soon as possible if you begin to experience side effects.

If you are concerned about any side effect, consult your doctor.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Gemcitabina FLYNN powder for infusion solution after the expiration date (CAD) that appears on the carton.

Sealed vial: store at a temperature below 25°C

Reconstituted solution: The product must be used immediately. When prepared according to the instructions, it has been demonstrated that the chemical and physical properties of gemcitabina reconstituted solutions are stable for 24 hours stored at 20-25°C. A subsequent dilution may be performed by a healthcare professional. Gemcitabina reconstituted solutions should not be refrigerated as it may cause crystallization.

This medication must be used only once. The disposal of unused medication and all materials that have been in contact with it, will be carried out in accordance with the hospital's standardized procedure for the disposal of cytotoxic medications

What Gemcitabina FLYNN powder for solution for infusion contains

• The active ingredient is gemcitabina. Each vial contains 200 mg of gemcitabina (as gemcitabine hydrochloride).
• The other components are mannitol (E421), sodium acetate, hydrochloric acid and sodium hydroxide.

Appearance of Gemcitabina FLYNN powder for solution for infusion and contents of the package

Gemcitabina FLYNN is a white or off-white powder or powder agglomerate for solution for infusion packaged in a vial. Each vial contains 200 mg of gemcitabina. Each package of Gemcitabina FLYNN powder for solution for infusion contains 1 vial.

Marketing Authorization Holder:

Flynn Pharma Ltd

Alton House, 4 Herbert Street, Dublin 2

Ireland

Manufacturer:

THYMOORGAN PHARMAZIE GMBH

Schiffgraben, 23 (Vienenburg)

Germany

This medicinal product is authorized in the Member States of the European Economic Area with the following names :

This leaflet was approved in April 2010

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INFORMATION FOR THE MEDICAL PROFESSIONAL

Gemcitabina FLYNN 200 mg powder for solution for infusion

The following information is directed solely to medical or healthcare professionals:

Instructions for use, handling and disposal

1. Use aseptic techniques during reconstitution and any subsequent dilution of gemcitabina for intravenous infusion.

1. Calculate the dose and number of vials of Gemcitabina required.

1. Reconstitute each vial of 200 mg with 5 ml of sterile sodium chloride injection, 9 mg/ml (0.9%) without preservatives, or each vial of 1,000 mg with 25 ml of sterile sodium chloride injection, 9 mg/ml (0.9%) without preservatives. Shake to dissolve. The total volume after reconstitution is 5.26 ml (vial of 200 mg) or 26.3 ml (vial of 1,000 mg) respectively. The resulting concentration of gemcitabina from this dilution is 38 mg/ml, including consideration of the volume displacement of the lyophilized powder. It can be further diluted with a sterile sodium chloride injection, 9 mg/ml (0.9%), without preservatives. The reconstituted solution is a clear colorless or pale yellow solution.

1. Before administration, visually inspect the medicines for possible particulate matter and/or color change. If particulate matter is observed, do not administer.

1. The gemcitabina solutions reconstituted should not be refrigerated as it may cause crystallization. Chemical and physical stability has been demonstrated in use for 24 hours at 20-25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, the storage conditions and period prior to use, shall be the responsibility of the user and shall not be longer than 24 hours at room temperature.

1. The Gemcitabina solutions must be used once. Any unused or waste product should be disposed of in accordance with local regulations.

Precautions for preparation and administration

Normal safety measures for cytostatic agents should be taken when preparing and disposing of the infusion solution. The manipulation of the solution should be carried out in a safety cabinet and protective clothing and gloves should be used. If a safety cabinet is not available, the equipment should be supplemented with masks and eye protection.

If the preparation comes into contact with the eyes, it may cause severe irritation. The eyes should be thoroughly flushed with plenty of water immediately. If the irritation persists, a doctor should be consulted. If the solution is spilled on the skin, it should be thoroughly flushed with plenty of water.

Disposal

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with the hospital's standardized procedure for the disposal of cytotoxic drugs.