Navelbine 30mg soft capsule

• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any of the side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Navelbine soft capsule is and what it is used for
2. What you need to know before you take Navelbine soft capsule
3. How to take Navelbine soft capsule
4. Possible side effects
5 How to store Navelbine soft capsule
6. Contents of the pack and other information.

• If you are allergic to Vinorelbine, or to any of the related family of cancer drugs called the vinca alkaloids, or any of the other ingredients of this medicine, (listed in section 6).
• If you are breast feeding.
• If you have had an operation on your stomach or small bowel, or if you have gut disorder which affects how you absorb food. These may affect how your body absorbs Navelbine.
• If you have a low white blood cell count (neutrophils, leucocytes) or a severe infection current or recent within two weeks.
• If you have a low blood platelet cell count (thrombocytopenia).
• If you plan to have a yellow fever vaccination or have just had one.
• If you require long-term oxygen therapy.

Talk to your doctor or pharmacist before taking Navelbine soft capsule if:

• You have a history of heart attack or severe chest pain.
• Your ability to carry out activities of daily living is strongly reduced.
• You have problems with your liver, or you have received radiotherapy where the treatment field included the liver.
• You have symptoms of infection (such as fever, chills, joint pain, cough).
• You plan to have a vaccination. Many vaccines (live attenuated vaccines) are not recommended during treatment.
• You have severe liver disease unrelated to your cancer. Navelbine soft capsules are not recommended in this group of patients.
• You are pregnant.

Before and during your treatment with Navelbine blood cell counts are performed to check that it is safe for you to receive treatment. If the results of this analysis are not satisfactory, your treatment may be delayed, and further checks made until these values return to normal.

This medicine is not recommended for use by children under 18 years old.

Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

Your doctor should take special attention if you are taking the following medicines:

• medicines used to thin your blood (anticoagulants),
• an anti-epileptic medicine called phenytoin,
• anti-tuberculosis medicine called rifampicin,
• antifungal medicines such as itraconazole and ketoconazole,
• anti-cancer medicines called mitomycin C or lapatinib,
• medicines that impair your immune system such as ciclosporin and tacrolimus.

Many vaccines (live attenuated vaccines) are not recommended during treatment, especially in patients who already have weakened immune systems. Please inform your doctor if you require any vaccinations.

If you are given Navelbine as well as medicines (such as cisplatin) that affect your bone marrow, it may make some of the side effects worse.

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine because there are potential risks for the infant.

You should not breast-feed if you are taking Navelbine.

If you are a woman of child-bearing potential, you must use an effective contraception (birth control) during treatment and for 7 months after the end of treatment.

If you are a man being treated with Navelbine, you are advised not to father a child during treatment and for 4 months after the last taken capsule. You should discuss sperm banking with your doctor before starting treatment because Navelbine may alter your fertility. You must use an effective contraception during treatment and for 4 months after the end of treatment.

No studies on the effects on the ability to drive and use machines have been performed. However, as in all cases, you should not drive if you feel unwell or if your doctor has advised you not to drive.

This medicine Navelbine 20 mg contains 5.36 mg sorbitol in each capsule.

This medicine Navelbine 30 mg contains 8.11 mg sorbitol in each capsule.

This medicine Navelbine 80 mg contains 14.91 mg sorbitol in each capsule.

This medicine Navelbine 20 mg contains 5 mg of alcohol (ethanol) in each capsule.

This medicine Navelbine 30 mg contains 7.5 mg of alcohol (ethanol) in each capsule.

This medicine Navelbine 80 mg contains 20 mg of alcohol (ethanol) in each capsule.

The amount in each capsule of this medicine (Navelbine 20 mg, 30 mg, 80 mg) is equivalent to less than 1 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.

This medicine (Navelbine 20 mg, 30 mg, 80 mg) contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

Vomiting can occur with Navelbine (refer to section 4, ‘Possible side effects’). If your doctor has prescribed an anti-sickness medication, always take it exactly as the doctor has told you.

Take Navelbine during a light meal; this will help to reduce the feeling of sickness.

If you have taken more Navelbine than the prescribed dose, contact a doctor immediately. Your body may sometimes react giving severe symptoms. Some of these symptoms may develop as signs of an infection (such as fever, chills, cough, joint pain). You may also become severely constipated. You must immediately contact your doctor if any of these severe symptoms occur.

Do not take a double dose to make up a forgotten dose. Contact your doctor who will take the decision about rescheduling your dose.

Your doctor will decide when you should stop your treatment. However, if you want to stop your treatment earlier, you should discuss other options with your doctor.

• A chest pain, breathlessness and fainting, which can be a symptom of a clot in a blood vessel in the lungs (pulmonary embolism),
• Headaches, changed mental state which may lead to confusion and coma, convulsions, blurred vision and high blood pressure, which could be sign of a neurological disorder such as posterior reversible encephalopathy syndrome,
• Cough, fever and chills which may be signs of a major infection or a general infection (septicemia) that can be severe
• Severe constipation with abdominal pain when your bowels have not been open for several days
• Severe dizziness, lightheadedness when you stand up, sign of a severe reduced blood pressure
• Severe chest pain which is not normal for you, the symptoms may be due to disturbance in the heart function following insufficient blood flow, so called myocardial infarction (sometimes with fatal outcome)
• Difficulty in breathing, rash affecting your whole body, or swelling of the eyelids, face, lips or throat which may be signs of an allergic reaction.

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

• Infections at different sites
• Gastric disorders; diarrhoea; constipation, abdominal pain; nausea, vomiting
• Inflammation in the mouth
• A fall in red blood cells which can make the skin pale and cause weakness or breathlessness
• A fall in platelets which can increase the risk of bleeding or bruising
• A decrease in white blood cells which makes you more vulnerable to infection
• Loss of some reflex reactions, occasionally difference in the perception of touch
• Hair loss usually mild form
• Tiredness
• Fever
• Malaise
• Weight loss, loss of appetite.

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

• Difficulties to coordinate muscle movements
• Differences in your eyesight
• Shortness of breath, cough
• Difficulties to urinate; other genitourinary symptoms
• Difficulty in sleeping
• Headache; dizziness; a difference in your taste of flavours
• Inflammation of the gullet, difficulty when swallowing food or liquids
• Skin reactions
• Chills
• Weight gain
• Joint pain, jaw pain, muscle pain
• Pain at different sites in your body and pain where your tumour is
• High blood pressure
• Liver disorders (abnormal liver test).

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

• Heart failure which can cause shortness of breath and ankle swelling, irregular heartbeats
• Lack of muscle control may be associated with abnormal gait, speech changes and abnormalities in eyes movement (ataxia).

Not known: frequency cannot be estimated from the available data

• Blood infections (sepsis) with symptoms such as high fever and deterioration in general health
• Heart attack (myocardial infarction)
• Gastrointestinal bleeding
• Low sodium level in your blood. This low sodium level may be attributed in some cases to an overproduction of a hormone causing fluid retention resulting in weakness, muscle twitching, tiredness, confusion or unconsciousness (Syndrome of Inappropriate Antidiuretic Hormone secretion - SIADH).

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

The active substance is Vinorelbine.

1 capsule contains vinorelbine tartrate equivalent to 20 mg, 30 mg or 80 mg vinorelbine.

The other ingredients are:

• The solution contains: ethanol anhydrous; purified water; glycerol; macrogol 400.
• The capsule shell contains: gelatin; glycerol 85 %; anidrisorb 85/70 (contains sorbitol (E420), sorbitan, mannitol (E421), superior polyols); colouring agents (titanium dioxide (E171) and red and/or yellow iron oxide (E172) depending on the strength); medium chain triglycerides; PHOSAL 53 MCT (contains phosphatidylcholine, glycerides)
• The edible printing ink contains: carminic acid (E120); sodium hydroxide; aluminium chloride hexahydrate; hypromellose; propylene glycol (E1520).

Navelbine 20 mg soft capsules are light brown coloured, printed with “N20”.

Navelbine 30 mg soft capsules are pink coloured, printed with “N30”.

Navelbine 80 mg soft capsules are pale yellow coloured, printed with “N80”.

Soft capsules of 20, 30 and 80 mg are available as packs of 1 blister of 1 soft capsule.

For any information on this product contact Pierre Fabre Ltd; Phone: 0800 085 5292

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio call, free of charge: 0800 198 5000 (UK only). Be ready to give the following information:

Product Name Reference Number

Navelbine 20mg soft capsule: PL 00603/0029

Navelbine 30mg soft capsule: PL 00603/0030

Navelbine 80mg soft capsule: PL 00603/0032

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