Navelbine

Package leaflet: Information for the user

NAVELBINE 20 mg soft capsules, 30 mg soft capsules

Vinorelbine (as tartrate)
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What NAVELBINE soft capsules are and what they are used for
2. What you need to know before taking NAVELBINE soft capsules
3. How to take NAVELBINE soft capsules
4. Possible side effects
5. How to store NAVELBINE soft capsules
6. Contents of the pack and other information

1. What NAVELBINE soft capsules are and what they are used for

NAVELBINE soft capsules contain the active substance vinorelbine (as tartrate) and belong to a family of medicines used to treat tumors, known as vinca alkaloids.
NAVELBINE soft capsules are used to treat certain types of lung cancer and certain types of breast cancer in patients over 18 years of age.

2. What you should know before taking NAVELBINE soft capsules

Do not take NAVELBINE soft capsules:

• if you are allergic to vinorelbine (the active substance), to any other medicine belonging to the family of anticancer drugs known as vinca alkaloids, or to any of the other ingredients of this medicine (listed in section 6);
• if you are breastfeeding;
• if you have had surgery on the stomach or small intestine, or if you suffer from intestinal disorders;
• if you have a low neutrophil count (less than 1,500/mm³) and/or a low platelet count (less than 100,000/mm³), or if you currently have or have recently had (within the last 2 weeks) a severe infection;
• if you are planning to receive a yellow fever vaccination or have recently received one;
• if you require long-term oxygen therapy;
• if you suffer from diseases that significantly affect absorption.

Warnings and precautions
Talk to your doctor or pharmacist before taking NAVELBINE soft capsules:

• if you have a history of heart attack or severe chest pain;
• if your ability to perform daily activities is severely reduced;
• if you have received radiotherapy where the treatment field included the liver;
• if you have signs or symptoms of infection (such as fever, chills, cough);
• if you need to receive a vaccination. Live attenuated vaccines (e.g. measles vaccine, mumps vaccine, rubella vaccine, etc.) are not recommended with NAVELBINE, as they may increase the risk of life-threatening vaccine-related diseases; the use of NAVELBINE soft capsules is specifically contraindicated when receiving the yellow fever vaccine;
• if you have severe liver disease unrelated to cancer;
• if you are pregnant. Before and during treatment with NAVELBINE soft capsules, your blood cell counts will be monitored to determine whether you can receive treatment. If the results of these tests are unsatisfactory, treatment may be delayed and further monitoring performed until values return to normal.

Children and adolescents
Use is not recommended in children under 18 years of age.
Other medicines and NAVELBINE soft capsules
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor must pay special attention if you are taking the following medicines:

• medicines used to thin the blood (anticoagulants);
• antiepileptic drugs (e.g. phenytoin);
• antifungal drugs (e.g. itraconazole, ketoconazole);
• anticancer drugs such as mitomycin C, cisplatin, lapatinib;
• medicines that impair the immune system, such as cyclosporine and tacrolimus;
• P-glycoprotein activity modulating drugs;
• bactericidal antibiotics and CYP3A4 isoenzyme inducers (e.g. rifampicin).

The combination of NAVELBINE soft capsules with other medicines known to have bone marrow toxicity (affecting white and red blood cells and platelets) may also worsen certain adverse effects.
NAVELBINE soft capsules with food and drinks
NAVELBINE soft capsules should be swallowed whole with water, without chewing or sucking the capsule. It is preferable to take NAVELBINE soft capsules with a light meal. NAVELBINE soft capsules must not be taken with a hot drink, as it may dissolve the capsule too quickly.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before using this medicine, as there are potential risks to the unborn child. You must not breastfeed while taking NAVELBINE soft capsules.
Women of childbearing potential must use an effective method of contraception (birth control) during treatment and for at least three months after treatment ends.
Men treated with NAVELBINE soft capsules are advised not to father a child during and for at least three months after taking the last capsule, and should seek advice about sperm preservation before starting treatment, as NAVELBINE soft capsules may cause irreversible damage to male fertility.
Driving and using machines
No studies on the ability to drive or use machines have been conducted. However, as in all cases, you should not drive if you do not feel well or if your doctor has advised you not to drive.
NAVELBINE soft capsules contains 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 in each capsule of this medicine (Navelbine 20 mg and 30 mg) is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.
This medicine (Navelbine 20 mg and 30 mg) contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially “sodium-free”.

3. How to take NAVELBINE soft capsules

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Before and during treatment with NAVELBINE soft capsules, your doctor will perform blood cell counts. Your doctor will tell you how many capsules and which dose to take, how often to take them, and for how long treatment should continue, based on your body surface area, blood test results, and your general condition.
The total dose must never exceed 160 mg per week.
Never take NAVELBINE soft capsules more than once a week.
Before opening the blister containing NAVELBINE soft capsules, make sure there are no damaged capsules, as the liquid inside is an irritant and may be harmful if it comes into contact with the skin, eyes, or mucous membranes. If this occurs, immediately and thoroughly wash the affected area.
Do not swallow damaged capsules, but return them to your doctor or pharmacist.
To open the package:

1. Cut the blister along the dotted black line using scissors.
2. Remove the thin plastic sheet.
3. Push the capsule through the aluminum foil.

Administration of NAVELBINE soft capsules:

• Take NAVELBINE with a glass of water, preferably with a light meal. Do not take it with a hot drink, as this would dissolve the capsule too quickly.
• Do not chew or suck the capsules.
• If you accidentally chew or suck the capsule, rinse your mouth carefully with water and inform your doctor immediately.
• If you vomit within a few hours after taking NAVELBINE soft capsules, contact your doctor immediately. Do not repeat the dose.

If you are taking an anti-nausea medicine
Vomiting may occur with NAVELBINE soft capsules (see section “4. Possible side effects”). If your doctor has prescribed an anti-nausea medicine, take it exactly as directed.
Take NAVELBINE soft capsules with a light meal; this will help reduce nausea.
If you take more NAVELBINE soft capsules than you should
If you have taken more NAVELBINE soft capsules than prescribed, contact your doctor immediately.
Severe symptoms related to blood components may occur, and signs of infection (such as fever, chills, cough) may appear. You may also develop severe constipation.
If you forget to take NAVELBINE soft capsules
Do not take a double dose to make up for the missed dose. Contact your doctor, who will decide on rescheduling the dose.
If you stop treatment with NAVELBINE soft capsules
Your doctor will decide when you should stop treatment. However, if you wish to stop treatment earlier, discuss possible alternatives with your doctor.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor immediately if, while taking NAVELBINE soft capsules, you develop
any of the following symptoms:

• chest pain, shortness of breath, and fainting, which may be symptoms of a blood clot in a lung vessel (pulmonary embolism);
• headache, altered mental state that may cause confusion and coma, seizures, blurred vision, and high blood pressure, which may indicate a neurological disorder such as reversible posterior encephalopathy syndrome;
• signs of a serious infection such as cough, fever, and chills;
• severe constipation with abdominal pain when your bowel has not moved for several days;
• severe dizziness, feeling of emptiness in the head when standing up, signs of a severe drop in blood pressure;
• severe chest pain that is unusual for you; symptoms could be due to impaired heart function caused by inadequate blood flow, known as myocardial infarction (sometimes fatal);
• difficulty breathing, dizziness, low blood pressure, skin rash over the entire body, or swelling of the eyelids, lips, or throat, which may be signs of an allergic reaction;
• signs of allergy such as itching, shortness of breath.

Very common side effects (may occur in more than 1 in 10 patients):

• Infections in various sites;
• Gastrointestinal disturbances; diarrhea; constipation; abdominal pain; nausea; vomiting;
• Inflammation of the mouth;
• Reduction in red blood cells, which may cause paleness, weakness, or breathlessness;
• Reduction in platelets, which may increase the risk of bleeding or bruising;
• Reduction in white blood cells, making you more vulnerable to infections;
• Loss of certain reflexes, occasionally altered sensation to touch;
• Hair loss, usually mild;
• Fatigue;
• Fever;
• Malaise;
• Weight loss, loss of appetite.

Common side effects (may occur in up to 1 in 10 patients):

• Difficulty coordinating muscle movements;
• Visual disturbances;
• Shortness of breath, cough;
• Difficulty urinating, other genitourinary symptoms;
• Difficulty sleeping;
• Headache; dizziness; altered taste or flavour perception;
• Sore throat, 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 at the tumour site;
• High blood pressure;
• Liver disorders (abnormalities in liver function tests).

Uncommon side effects (may occur in up to 1 in 100 patients):

• Heart failure, which may cause shortness of breath or swelling of the ankles;
• Irregular heartbeat;
• Loss of muscle control, which may be associated with abnormal walking, changes in speech, and eye movement abnormalities (ataxia).

Side effects with unknown frequency (cannot be estimated from available data):

• Blood infection (sepsis) with symptoms such as high fever and general deterioration in health;
• Heart attack (myocardial infarction);
• Gastrointestinal bleeding;
• Low sodium levels in the blood causing weakness, muscle cramps, fatigue, confusion, or loss of consciousness. This decrease may in some cases be attributed to excessive production of a hormone causing fluid retention (syndrome of inappropriate antidiuretic hormone secretion, SIADH).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store NAVELBINE soft capsules

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the blister and carton (Exp.).
The expiry date refers to the last day of that month.
Store in the refrigerator (+2°C - +8°C). Keep in the original packaging.
Do not dispose of any medicine via wastewater or household waste. For safety reasons, unused capsules must be returned to the doctor or pharmacist for destruction. This will help protect the environment.

6. Package contents and other information

What NAVELBINE soft capsules contain

• The active substance is: Vinorelbine (as tartrate) 20 or 30 mg.
• The other components are: The solution contains: anhydrous ethanol, purified water, glycerol, macrogol 400. The capsule shell contains: gelatin; glycerol 85%; anidrisorb 85/70 (containing sorbitol (E420), sorbitan, mannitol (E421), higher polyols); colouring agents (E171 - titanium dioxide and E172 iron oxide red and/or yellow depending on the dosage); medium-chain triglycerides, PHOSAL 53 MCT (containing phosphatidylcholine, glycerides, alcohol). The edible printing ink contains: carminic acid (E120), sodium hydroxide, aluminium chloride hexahydrate, hypromellose, propylene glycol (E1520).

Description of the appearance of NAVELBINE Soft Capsules and package contents
NAVELBINE 20 mg soft capsules: light brown soft capsules for oral use, marked N20.
NAVELBINE 30 mg soft capsules: pink soft capsules for oral use, marked N30.
The 20 mg and 30 mg soft capsules are available in cartons containing 1 blister with 1 soft capsule.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pierre Fabre Pharma S.r.l.
Via G. Washington, 70
20146 Milano - ITALY

Manufacturer
FAREVA PAU
FAREVA PAU 1
Avenue du Béarn,
Idron, 64320,
France