Navelbine

Package Leaflet: Information for the Patient

NAVELBINE, 20 mg, Soft Capsules

NAVELBINE, 30 mg, Soft Capsules

Vinorelbine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Navelbine and what is it used for
• 2. Important information before taking Navelbine
• 3. How to take Navelbine
• 4. Possible side effects
• 5. How to store Navelbine
• 6. Contents of the pack and other information

1. What is Navelbine and what is it used for

Navelbine contains the active substance vinorelbine (in the form of vinorelbine tartrate) and belongs to a group of medicines called Vincaalkaloids, used in the treatment of cancer.
Navelbine is used to treat certain types of lung cancer and certain types of breast cancer in patients over 18 years of age.

2. Important information before taking Navelbine

When not to take Navelbine:

• if you are allergic (hypersensitive) to the active substance (vinorelbine) or to other medicines containing Vincaalkaloids used in cancer treatment, or to any of the other ingredients of this medicine (listed in section 6); in case of breastfeeding;
• in case of previous stomach or small intestine surgery, or in case of intestinal disorders;
• if you have a low number of neutrophils and (or) platelets, or if you are undergoing or have undergone an acute infection in the last two weeks;
• if you have recently been vaccinated against yellow fever or plan to be vaccinated;
• if you require long-term oxygen therapy.

Warnings and precautions

Before starting treatment with Navelbine, talk to your doctor or pharmacist if:

• you have had a heart attack or severe chest pain in the past;
• your ability to perform daily activities has been significantly reduced;
• you have undergone radiation therapy, and the liver was in the radiation field;
• you have symptoms of infection such as fever, chills, cough;
• vaccination is planned. Live, attenuated vaccines (e.g., measles, mumps, rubella) should not be administered with Navelbine, as this may increase the risk of life-threatening disease due to vaccine-related disease;
• liver function is not normal;
• you are pregnant.

Before and during treatment with Navelbine, it is necessary to monitor blood morphology to check if the treatment is safe for the patient.
If the results of the blood morphology test are not satisfactory, the doctor may recommend a repeat test or the treatment may be postponed until the blood picture normalizes.

Children and adolescents

Navelbine is not recommended for use in children under 18 years of age.

Navelbine and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Your doctor should pay special attention if you are taking the following medicines:

• blood thinners (anticoagulants);
• antiepileptic drugs (e.g., phenytoin);
• antifungal drugs (e.g., itraconazole);
• oncology drugs such as mitomycin C or lapatinib;
• drugs that suppress the immune system, such as cyclosporine and tacrolimus.

Taking Navelbine with other medicines that damage the bone marrow (causing changes in blood morphology) may increase the severity of some side effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before taking this medicine and ask for genetic counseling, as vinorelbine may damage genetic material in cells, which is a potential risk to the child. The use of Navelbine is contraindicated during pregnancy, unless the doctor assesses that the expected individual benefits clearly outweigh the potential risk. You should not breastfeed while taking Navelbine.
Women of childbearing age must use effective methods of contraception during treatment and for 7 months after its completion.
Men taking Navelbine should not plan to conceive a child during treatment and for 4 months after its completion.
Before starting treatment, they should seek advice on sperm preservation due to possible irreversible infertility resulting from Navelbine therapy. It is essential to use effective methods of contraception during treatment and for 4 months after its completion.

Driving and using machines

No studies have been conducted on the effect of Navelbine on the ability to drive and use machines. In no case should you drive or operate machines if you feel unwell or if your doctor decides that you should not perform these activities.

Navelbine soft capsules contain sorbitol, alcohol, sodium

Navelbine 20 mg contains 5.36 mg of sorbitol in each capsule.
Navelbine 30 mg contains 8.11 mg of sorbitol in each capsule.
Navelbine 20 mg contains 5 mg of alcohol (ethanol) in each capsule.
Navelbine 30 mg contains 7.5 mg of alcohol (ethanol) in each capsule.
The amount of alcohol (ethanol) in each capsule of this medicine (Navelbine 20 mg, 30 mg) is equivalent to less than 1 ml of beer or 1 ml of wine.
A small amount of alcohol in this medicine will not cause noticeable effects.
This medicine (Navelbine 20 mg, 30 mg) contains less than 1 mmol of sodium (23 mg) per capsule, i.e., the medicine is considered "sodium-free".

3. How to take Navelbine

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
Before and during treatment, your doctor will order a blood test. The results of this test will determine the dose and start time of therapy. Your doctor will determine the strength and number of capsules, how often to take them, and the duration of treatment.
Dosage will depend on the patient's body surface area, blood test results, and overall condition.
The total weekly dose should not exceed 160 mg.
Navelbine should not be taken more often than once a week.
Before taking Navelbine, check that the capsules are not damaged.
The liquid contents of the capsule have irritating properties and can cause damage to the eyes, skin, or mucous membranes if they come into contact with them.
If contact occurs, the area should be rinsed immediately with water or physiological saline solution.
Do not swallow a damaged capsule, return it to your doctor or pharmacist.
How to open the child-resistant packaging:

• 1. Cut the blister along the line.
• 2. Tear off the soft plastic foil.
• 3. Push the capsule out of the aluminum foil.

How to take Navelbine soft capsules:

• 1. Navelbine should be swallowed with water, but it is recommended to take it with a light meal. Do not swallow capsules with hot drinks, as this accelerates their dissolution.
• 2. Do not suck or chew the capsules.
• 3. If a capsule is accidentally chewed or sucked, rinse your mouth thoroughly with water or physiological saline solution and contact your doctor immediately.
• 4. If vomiting occurs within a few hours of taking the medicine, contact your doctor immediately. Do not take a double dose to make up for it.

Use of anti-emetic medicines

During treatment with Navelbine, nausea and vomiting may occur (see section 4 "Possible side effects"). If your doctor recommends anti-emetic medicines, always take them exactly as directed.
Navelbine should be taken with a light meal to help reduce the feeling of nausea.

Taking a higher dose of Navelbine than recommended

In case of taking a higher dose of Navelbine than recommended, contact your doctor immediately. Serious changes in blood morphology may occur, which can cause symptoms of infection (such as fever, chills, cough), as well as severe constipation.

Missing a dose of Navelbine

In case of missing a dose of Navelbine, do not take a double doseto make up for it.
Contact your doctor, who will decide on changing the dosage.

Stopping treatment with Navelbine

The decision to stop treatment will be made by your doctor. If you want to stop treatment earlier, you should discuss it with your doctor.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Navelbine can cause side effects, although not everybody gets them.

Contact your doctor immediately if you experience any of the following side effects while taking Navelbine:

• Chest pain, shortness of breath, and fainting, which may be symptoms of a blood clot in a blood vessel in the lungs (pulmonary embolism);
• Headache, altered mental state, which can lead to confusion and coma, seizures, blurred vision, and high blood pressure, which may be symptoms of a neurological disorder, such as posterior reversible encephalopathy syndrome
• Symptoms of severe infections, such as cough, fever, chills;
• Severe constipation accompanied by abdominal pain caused by not having a bowel movement for several days;
• Severe dizziness, feeling of emptiness in the head when standing up, signs of significantly decreased blood pressure;
• Severe chest pain that has not occurred before, which may be a symptom of heart problems related to insufficient blood flow; this is called a heart attack (in some cases leading to death);
• Difficulty breathing, dizziness, decreased blood pressure, rash covering the entire body or swelling of the eyelids, lips, or throat, which may be symptoms of an allergic reaction.

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

• Infections in various locations;
• Gastrointestinal disorders: diarrhea, constipation, abdominal pain, nausea, vomiting;
• Inflammation of the mucous membrane of the mouth;
• Decreased number of red blood cells, which can cause paleness of the skin and weakness or shortness of breath;
• Decreased number of platelets, which can increase the risk of bleeding or bruising;
• Decreased number of white blood cells, which can cause susceptibility to infections;
• Weakening of some reflexes, sometimes disturbances of sensation;
• Hair loss, usually mild;
• Fatigue;
• Fever;
• Malaise;
• Weight loss, loss of appetite.

Common side effects(may affect less than 1 in 10 people)

• Difficulty with muscle coordination;
• Visual disturbances;
• Shallow breathing, cough;
• Difficulty urinating and other symptoms related to the genitourinary system;
• Difficulty sleeping;
• Headache, dizziness, taste disturbances;
• Inflammation of the esophagus, difficulty swallowing food or liquids;
• Skin reactions;
• Chills;
• Weight gain;
• Joint pain, jaw pain, muscle pain;
• Pain in various parts of the body and pain in the tumor area;
• High blood pressure;
• Abnormal liver function (abnormal liver function test results).

Uncommon side effects(may affect less than 1 in 100 people)

• Heart failure, which can cause shortness of breath and swelling in the ankles, irregular heartbeat;
• Loss of muscle control, which may be accompanied by disturbances of gait, speech, changes, and disturbances of eye movement (ataxia).

Rare side effects(frequency cannot be estimated from the available data)

• Blood infection (sepsis) with symptoms such as high fever and worsening of general health;
• Heart attack (myocardial infarction);
• Gastrointestinal bleeding;
• Low sodium levels in the blood, which can cause weakness, muscle tremors, fatigue, confusion, loss of consciousness, and is associated with excessive production of a hormone that causes fluid retention (Syndrome of Inappropriate Antidiuretic Hormone Secretion - SIADH).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Navelbine

Store in a refrigerator (2°C - 8°C). Store in the original package.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Navelbine contains

• The active substance of Navelbine is vinorelbine (in the form of vinorelbine tartrate) in a dose of 20 mg or 30 mg.
• The other ingredients of the medicine are: Capsule contents: anhydrous ethanol, purified water, glycerol, macrogol 400. Capsule shell for 20 mg: gelatin, glycerol 85%, ANIDRISORB 85/70 (D-sorbitol and 1,4-sorbitan solution), yellow iron oxide (E 172), titanium dioxide (E 171), medium-chain triglycerides, mixture of medium-chain triglycerides and PHOSAL 53 MCT (phosphatidylcholine, glycerides, ethanol). Capsule shell for 30 mg: gelatin, glycerol 85%, ANIDRISORB 85/70 (D-sorbitol and 1,4-sorbitan solution), red iron oxide (E 172), titanium dioxide (E 171), medium-chain triglycerides, mixture of medium-chain triglycerides and PHOSAL 53 MCT (phosphatidylcholine, glycerides, ethanol). Ink composition: carmine (E 120), sodium hydroxide, aluminum chloride hexahydrate, hypromellose, propylene glycol, isopropyl alcohol, purified water.

What Navelbine looks like and contents of the pack

Navelbine 20 mg, soft capsules: light brown capsules with the imprint N20
Navelbine 30 mg, soft capsules: pink capsules with the imprint N30
Navelbine is available in packs containing 1 blister pack of 1 soft capsule.
Not all pack sizes may be marketed.

Marketing authorization holder

Pierre Fabre Medicament
Les Cauquillous
81500 Lavaur
France

Manufacturer:

FAREVA PAU
FAREVA PAU 1,
Avenue du Bearn
64320 IDRON
France

For further information, please contact the representative of the marketing authorization holder:

Pierre Fabre Medicament Polska Sp. z o.o.
ul. Belwederska 20/22
00-762 Warsaw
Tel: 022 559 63 00
Date of last revision of the leaflet:January 2024