20 mg, 30 mg and 80 mg soft
vinorelbine capsules
Navelbine contains the active substance vinorelbine. It belongs to a group of medicines called vinca alkaloids and is used to treat cancer. Navelbine is used to treat certain types of lung cancer and certain types of breast cancer.
Vinorelbine contained in Navlebine may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
- if you are allergic to vinorelbine, to any other medicine in the vinca alkaloid group or to any of the other ingredients of this medicine (listed in section 6)
- if you are breast-feeding
- if you have a disease that greatly affects the absorption one from the gastrointestinal tract
- if you have previously had surgery to remove part of your stomach or small intestine
- if you have low white blood cell and / or platelet counts ( thrombocytes ), or have recently had a severe infection (last two weeks)
- if you are planning to be vaccinated or have recently been vaccinated against yellow fever
- if you are being treated with oxygen for a long time.
Warnings and cautions
Talk to your doctor or pharmacist before taking Navelbine:
- if you have previously had severe chest pain, signs of disturbance in heart function due to insufficient blood flow, so-called ischemic heart disease, such as angina and heart attack.
- if your ability to cope with everyday activities is severely impaired.
- if you have undergone radiation therapy with a radiation area that included the liver.
- if you have symptoms of infection (such as fever, chills, cough).
- if you are to be vaccinated.
- if your liver function is impaired.
Before and during treatment with Navelbine, your blood will be tested to make sure it is safe for you to receive treatment. If the results of these tests are not satisfactory, the treatment will be postponed and further tests will be performed until the values return to normal.
Children and young people
The drug is not recommended for children under 18 years of age.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is especially important if you are taking any of the following medicines:
- blood-thinning drugs, so-called anticoagulants .
- medicines for the treatment of HIV infection are so – called protease inhibitors .
- drugs for the treatment of epilepsy , such as phenytoin , carbamazepine, phenobarbital.
- drugs for the treatment of fungal infections, such as itraconazole, voriconazole, ketoconazole , posaconazole.
- anticancer drugs, such as mitomycin C or lapatinib.
- drugs for the treatment of infections , such as clarithromycin, telithromycin or rifampicin.
- herbal medicines containing St. John ‘s wort (hypericum perforatum) used to treat mild to moderate depression.
- ciclosporin and tacrolimus, which are medicines that suppress the immune system.
A combination of Navelbine and other medicines that may affect the bone marrow (white and red blood cells and platelets ) may aggravate certain side effects.
Before vaccination, you must consult a doctor as some vaccines should not be used during treatment with Navelbine
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine, as there may be risks for your baby.
Navelbine should not be used during pregnancy.
Do not take Navlebine if you are breastfeeding. Breast-feeding must be stopped if Navelbine treatment is necessary.
Fertility
Women of childbearing potential must use effective contraception during treatment and up to 3 months after stopping treatment.
Men treated with Navelbine are advised not to have children during treatment and for up to 3 months after stopping treatment. There is a risk that treatment with vinorelbine will lead to male infertility. You should therefore consider seeking advice on freezing semen before starting treatment.
Driving and using machines
No studies have been performed on the effects on the ability to drive and use machines. However, you should not drive if you feel sick or if your doctor advises you not to drive.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
This medicine contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Before and during treatment with Navelbine, your doctor will check your blood. The doctor will tell you how many capsules and what strength to take, how often to take the capsules, and for how long. This depends on your body surface area, your blood tests, and your general condition.
Navelbine is usually given once a week. A total dose of 160 mg per week should not be exceeded.
How to handle the capsules
Before opening the Navelbine blister, check that the capsule is intact. The liquid content of the capsules is harmful in contact with skin, mucous membranes, or eyes. If contact with the contents nevertheless occurs, the area should be rinsed immediately with physiological saline or water. Contact a doctor immediately if symptoms persist.
Do not swallow a damaged capsule. Return it to a doctor, hospital, or pharmacy.
Opening instructions for the blister card
1. Cut the blister card in half along the black dotted line.
2. Peel off the soft plastic wrap.
3. Push the capsule out through the aluminum foil.
Ingestion of the capsules
- The capsules should be swallowed whole with water without being chewed or sucked on. It is recommended that the capsules be taken with a meal to reduce the risk of nausea.
- If you accidentally chew or suck on the capsule, then rinse your mouth thoroughly and contact a doctor immediately.
- If you vomit a few hours after taking a Navelbine capsule, do not take a new dose .
If you are taking medicines for nausea
Vomiting may occur with Navelbine (see section 4 “Possible side effects”). If your doctor has prescribed an anti-nausea medication, always take it according to your doctor’s instructions.
If you have taken too much Navelbine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital immediately for risk assessment and advice. Serious symptoms related to your blood levels may occur and you may develop signs of infection (such as fever, chills, and cough). You can also become severely constipated.
Do not take a double dose to make up for a forgotten dose. Contact your doctor who will decide if you should take a dose at another time.
Your doctor will decide when to stop treatment. If you want to end treatment earlier, discuss this with your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately if you get any of the following symptoms while using Navelbine:
- signs of a serious infection such as malaise with symptoms such as cough, fever and chills (side effect is common and may affect up to 1 in 10 people).
- severe constipation with abdominal pain when you have not had a bowel movement for several days, it may be a bowel obstruction (side effect is less common and may occur in up to 1 in 100 users).
- severe dizziness and fainting when you get up, which is a sign of a sharp drop in blood pressure (side effect is rare and can occur in up to 1 in 1,000 users).
- severe chest pain that you have not felt before. The symptoms may be due to disturbances in the function of the heart due to insufficient blood flow, so-called heart attack, sometimes with a fatal outcome (side effect has been reported and occurs in an unknown number of users).
- difficulty breathing, dizziness, drop in blood pressure, rash and itching all over the body, or swelling of the eyelids, face, lips and / or throat, as this may be a sign of an allergic reaction (side effect has been reported and occurs in an unknown number of users).
Other side effects – if you experience any of the following side effects, tell your doctor as soon as possible
Very common (may affect more than 1 user in 10):
- Infection is in different places in the body.
- Stomach upset, diarrhea, constipation, abdominal pain, nausea, vomiting.
- Inflammation of the mouth.
- Decreased white blood cell count (which may increase the risk of infection).
- Decreased number of red blood cells ( anemia ) that can make your skin pale and cause weakness or shortness of breath.
- Reduced platelet count, which may increase the risk of bleeding or bruising.
- Loss of certain reflexes, sometimes with altered sense of touch.
- Hair loss, usually in mild form.
- Fatigue.
- Fever.
- Feeling sick.
- Weight loss, loss of appetite.
Common (may affect up to 1 in 10 people):
- Difficulty coordinating movements.
- Vision changes.
- Shortness of breath, cough.
- Difficulty urinating, other urogenital symptoms.
- Difficulty sleeping.
- Headache, dizziness, altered taste experience.
- Inflammation of the esophagus, difficulty swallowing fluid and food.
- Skin reactions.
- Freezing breaks.
Weight gain. - Joint pain ( arthralgia ), pain in the jaw, muscle pain ( myalgia )
- Pain in various places in the body and at the tumor site.
- High blood pressure .
- Liver effects (abnormal liver values).
Uncommon (may affect up to 1 in 100 people) :
- Heart failure which can cause shortness of breath and ankle swelling, heart rhythm disturbances.
- Lack of muscle control that can be associated with abnormal gait, speech changes and abnormal eye movements ( ataxia ).
Has been reported (occurs in the unknown number of users):
- Severe infection (blood poisoning) with symptoms such as high fever and a deterioration in general health.
- Myocardial infarction.
- Bleeding in the gastrointestinal tract.
- Low sodium levels in your blood resulting in weakness, muscle twitching, fatigue, confusion or unconsciousness. This low sodium level can in some cases be due to an overproduction of a hormone that causes fluid retention (Syndrome of Inappropriate Antidiuretic Hormone secretion, SIADH).
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
Store in the original package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is vinorelbine. 1 capsule contains vinorelbine tartrate equivalent to 20 mg, 30 mg or 80 mg vinorelbine.
- The other ingredients are
- Solution in the capsule: anhydrous ethanol , purified water, glycerol , macrogol.
- Gelatin capsule: gelatin, glycerol 85%, sorbitol, sorbitan, mannitol, medium triglycerides , phosphatidylcholine, glycerides, ethanol , oleic acid, ascorbyl palmitate, hydrogenated, partially hydrolysed starch , dyes (titanium dioxide (E171) and red (30 mg) (20 mg) mg, 80 mg), iron oxide (E172)).
- Ink: carmine (E120), hypromellose, propylene glycol, aluminum chloride hexahydrate, sodium hydroxide.
What the medicine looks like and contents of the pack
20 mg soft capsules: light brown with pressure N20
30 mg soft capsules: pink with pressure N30
80 mg soft capsules: light yellow with pressure N80
Pack size: blister pack with 1 soft capsule.
Marketing Authorization Holder and Manufacturer
Manufacturer :
Pierre Fabre Medicine Production
Avenue du Béarn
F-64320 Idron
France